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Claim Construction of Markush Groups and other Alternative Limitations  Presented by: Kevin B. Laurence  Stoel Rives LLP American Conference Institute’s  Sixth Advanced Forum on Biotech Patents San Francisco, California February 16, 2006
Disclaimer ,[object Object]
The views expressed in this presentation are solely those of the presenter and do not represent the views of Stoel Rives LLP or clients of Stoel Rives LLP.
Note that while every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.,[object Object]
When possible, it is preferable to use a generic phrase instead of alternative limitations.
However, for some technologies, alternative limitations are the only option to obtain the needed scope of protection.,[object Object]
Exemplary Alternative Limitations in Chemical Compound Claims A compound of the formula R-X; or a pharmaceutically acceptable salt thereof. with at least one entity chosen from A, B, and C greater than or equal to with the proviso that . . . when n is 1, then X is not chosen from A or B either before or after  branches may be identical or different  at least one polymer selected from A and B, wherein the ratio by weight of A and/or B to X is . . .
Conjunction, Disjunction:  What's Your Function A limitation in a claim for a chemical compound typically has a scope which is clearly inclusive or exclusive based on the context. The meaning of alternative limitations in claims directed to technology other than chemical compounds may be less clear.  Careless use of alternative claim limitations in such contexts can introduce ambiguity.
Conjunction, Disjunction:  What's Your Function Avoid expensive grammar lessons from the Federal Circuit when using "and," "or," or "and/or" in alternative limitations by giving careful consideration to the intended meaning. Is the objective a recitation which is inclusive or exclusive?  Consider a definition in the boilerplate paragraph before the claims.  For example, "[i]n the claims, the conjunction "and" is inclusive, the conjunction "or" is exclusive and the conjunction "and/or" is either inclusive or exclusive."
Elizabeth Barrett Browning'sSonnet XLIII How do I love thee?  Let me count the ways. I love thee to the depth and breadth and height My soul can reach, when feeling out of sight  For the ends of Being and ideal Grace. I love thee to the level of every day's Most quiet need, by sun and candlelight.  I love thee freely, as men strive for Right; I love thee purely, as they turn from Praise. I love thee with the passion put to use In my old griefs, and with my childhood's faith. I love thee with a love I seemed to lose With my lost saints—I love thee with the breath,  Smiles, tears, of all my life!—and, if God choose, I shall but love thee better after death.
Elizabeth Barrett Browning's Sonnet XLIII Formatted as a Patent Claim  A method for expressing the ways that I love thee, comprising: loving thee to the depth and breadth and height my soul can reach, when feeling out of sight for the ends of Being and ideal Grace; loving thee to the level of every day's most quiet need, by sun and candlelight; loving thee freely, as men strive for Right; loving thee purely, as they turn from Praise; loving thee with the passion put to use in my old griefs, and with my childhood's faith; loving thee with a love I seemed to lose with my lost saints; loving thee with the breath, smiles, tears, of all my life; AND loving thee better after death, if God so chooses.
Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001) (NEWMAN, Lourie; Mayer, dissenting)  Kustom Signals owns a patent directed to a traffic radar gun for determining the speed of a vehicle.  In the patent, the user selects whether to identify and display the speed of either the strongest target (a large truck or closest vehicle) or the fastest target vehicle. The Applied Concepts radar device operated similarly except that both a strongest and fastest analysis of the return signal are always performed.  The radar then displayed either the speed of the target producing the strongest signal, or speeds of both the fastest and strongest target signals. Applied Concepts asserted that its calculation of the speeds of both the strongest and fastest vehicles is excluded by the claims.
Fed. Cir. Says "or“ Is Exclusive in Kustom Signals Independent claims 1, 16, and 20 of U.S. Patent No. 5,528,246 recite a "method of processing Doppler return information in a traffic radar comprising the steps of . . .    Claim 1 recites "searching said components in memory for the component that meets preselected magnitude OR frequency criteria. Claim 16 recites "means for searching the components stored in said memory means to identify the component that meets preselected magnitude OR frequency criteria. Claim 20 recites "means under operator control for selecting EITHER a greatest magnitude OR highest frequency search, whereby EITHER strongest signal OR fastest signal target identification is provided.
Fed. Cir. Says "or“ Is Exclusive in Kustom Signals Patentee, Kustom Signals, argued that "OR" should not be restricted to a search of either the fastest target data (frequency) or the strongest target data (magnitude). Kustom Signals attempted to support its position by referencing a computer dictionary which distinguishes between the logical operators: "AND" which returns a "true" value if and only if both values are true, "OR" which returns a "true" value when one or both  values are true, and  "XOR" which returns a "true" value when only one value is true.
Fed. Cir. Says "or“ Is Exclusive in Kustom Signals FC rejected the plaintiff-appellant's claim construction as it was clear that "or" was used in its ordinary meaning, it clearly referenced alternatives and was not used like a technical programming operator. Reference was made to Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) which held that "a patentee may chose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history." FC affirmed the DC's grant of summary judgment of noninfringement.
Chief Judge Mayer's Dissent in Kustom Signals - "or“ Is Inclusive Chief Judge Mayer:  "[O]r should be construed inclusively to mean 'one or another or both.'  First the plain meaning of 'or' can be 'either or both.'  If a store owner says, 'If it hails or snows today, we will close the store,' then the owner will still close the store if it happens to hail and snow." His interpretation hinged on the construction of the claim elements under 35 USC §112 ¶6 which requires reference to the flowcharts in the specification.  The flowcharts support an interpretation that "or" is inclusive as the patentee urged with reference to the Boolean operators.
Brown v. 3M, 263 F.3d 1349 (Fed. Cir. 2001) (NEWMAN, Clevenger; Mayer, dissenting)  Brown owns a patent directed to method for combating the Y2K dilemma.   Claim:  An apparatus for processing year-date data in a computer systems, the apparatus comprising: . . .  [a]t least one database file stored in the memory containing records with year-date data with years being represented by at least one of two-digit, three digit, OR four-digit year-date representations ; and  a mechanism for converting the year-date data representations in the database file to a two-digit year-date data representation." DC and FC:   The apparatus was capable of converting only two-digit, only three-digit, only four-digit or any combination of two-, three-, and four-digit date-data.  There is no basis for reading "or" as "and."
Fed. Cir. Says "or“ Is Exclusive in Brown v. 3M Prior art reference teaches the handling of year dates in two-digit format.  Patentee argued that the three-digit and four-digit date conversion were not anticipated by the prior art reference . FC:  Since the conversion capability was claimed in the alternative, infringement would occur whether or not three-digit or four-digit year dates were also offset. That which infringes if later anticipates if earlier so the claim is anticipated.
Chief Judge Mayer's Dissent in Brown v. 3M - "or“ Is Inclusive Chief Judge Mayer:  "The court errs by reading the claim term 'or' exclusively, while the district court appropriately read it inclusively when construing the claim."  Again, his interpretation hinged on the construction of the claim elements under 35 USC §112 ¶6 which requires interpretation by reference to the structure or acts disclosed in the specification.  "The preferred embodiment in the specification discloses a process for converting all such possible year-date combinations to two-digit representations. . .  The presence of this disclosure mandates the construction of the 'mechanism for converting . . .' limitation as one that requires the capacity to process two-, three-, and four-digit dates, even if full capacity of the device is not always utilized."
Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304  (Fed. Cir. 2002) (DYK, Newman, Michel) Schumer owns a patent directed to "digitizers," which are computer peripherals that translate a user's hand motions or instructions into digital coordinates suitable for use by a computer system. Claim preamble:  A method  . . . which coordinate system has a point of origin and has an angle of rotation with respect to the digitizer and has a scale  Claim body:  because one of the following elements is different from the digitizer's coordinate system:  location of the point of origin, or angle of rotation, or scale . . .
Fed. Cir. Holds in Schumerthat OR = Alternatives DC:  Claim preamble requires that the device have all three of these attributes, i.e., a point of origin, angle of rotation and scale so no infringement. FC:  Claim preamble "simply describes features that necessarily exist in any coordinate system for a digitizer-a point of origin, an angle of rotation and a scale. FC:  "[L]anguage of the preamble is superfluous." FC:  "DC substituted the word 'and' from the preamble for the word 'or' used in the body of the claim."
Fed. Cir. Holds in Schumerthat OR = Alternatives FC:  DC's claim construction contradicts the plain meaning of the word "or" in the claims. . . FC:  Webster's 3rd Int'l Dictionary defines "or" as follows:  "used as a function word to indicate (1) an alternative between different or unlike things, states, or actions . . . (2) choice between alternative things, states, or courses." We have consistently interpreted the word "or" to mean that the items in the sequence are alternatives to each other.
Fed. Cir. Holds in Schumerthat OR = Alternatives "In Brown v. 3M, 265 F.3d 1349 (Fed. Cir. 2001), we upheld the DC's construction of the word "or" in the claim as meaning that the apparatus was capable of converting "'only two-digit, only three-digit, only four-digit, or any combination of two-, three-, and four-digit date-data,'" by finding that the interpretation of the word "or" involved a "plain reading of the claim text.  These are not technical terms or art, and do not require elaborate interpretation."  "In Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001), we agreed with the DC's construction of "or" as "designating alternatives."  We noted that "there is no indication that Kustom used these words in a different meaning.  Particularly, there is no basis whatsoever for believing that Kustom intended its usage of 'or' somehow to embrace 'and.'"
Patent Litigation re Generic Version of Merck's Fosamax® Product Merck & Co., Inc.v. Teva Pharmaceuticals USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003) (NEWMAN, Prost; Mayer, dissenting). Teva filed an ANDA to sell a generic version of Merck's Fosamax® product for treatment of osteoporosis Merck sued Teva in accordance with 35 USC § 271(e)(2) for infringement of U.S. Patent No. 4,407,761 The only claim of U.S. Patent No. 4,407,761  A method of treatment of urolithiasis and inhibiting bone reabsorption which consists of administering to a patient in need thereof an effective amount of 4-amino-1-hydroxybutane-1,1-biphosphonic acid.
In Merck v. Teva, Claim Drafter Left out the Salt! Teva countered that it did not infringe as the claim is directed to the acid while TEVA's ANDA was for the monosodium salt. Like food, this claim would have been more savory if the drafter had included salt! The claim should have read:  A method of treatment of urolithiasis and inhibiting bone reabsorption which consists of administering to a patient in need thereof an effective amount of 4-amino-1-hydroxybutane-1,1-biphosphonic acid OR A  PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.
In Merck v. Teva, Method Infringed Based on Specification and PHOSITA DC & FC:  Claim is infringed by administration of the salt. The patent refers to formulation of various biphosphonic acids for administration "as the sodium salt," "in the salt form," "in the form of Na salt," and as "4-amino-1-hydroxybutan-1,1-biphosphonic acid, sodium salt."  Witnesses testified that a PHOSITA would understand that the active agent is 4-amino-1-hydroxybutane-1,1-biphosphonic acid, and that the method of treatment of bone disorders includes use of the active agent in the form of the salt.
Judge Mayer's Dissent in Merck v. Teva:  Salt is not an Inherent Alternative Limitation in Claim Chief Judge Mayer's dissent:  the term "acid" does not include both acids and salts.  Majority's claim construction is contrary to plain reading. Specification:  In some instances, acid is named when referring to salt.  "But in the vast majority of instances, the specification distinguishes between the two."  Examples show the "patentee is able to distinguish between the two when he so chooses." Witnesses made it clear that the acid and its salt are distinct. The literal scope of the claim can extend only to the acid itself.
Claim for Acid Asserted Against Product with the Acid's Salt Stephens v. Tech International, 393 F.3d 1269 (Fed. Cir. 2004) (MAYER, Rader, Schall). Claim:  A method to remove detectable amounts of an unwanted substance from a human urine sample comprising:  . . . contacting the human urine sample with an amount of chromium trioxide . . ." In response to a rejection based on a prior reference which taught the use of sodium dichromate as a chemical oxidizing agent, the patentee limited its chemical oxidizing agent to chromium trioxide.  But the claim was limited only to the extent that the claimed indicia and color remain substantially unaffected. Tech's accused product used sodium dichromate.
Stephens v. Tech Int'l Becomes Just about Attorney's Fees DC entered a summary judgment of non-infringement.  A subsequent settlement was reached whereby all claims were dismissed except for a claim for attorneys fees.   DC later found that the case was exceptional, and awarded attorney fees to the defendant.  DC based its finding on decisions that (among other things): the infringement argument was in bad faith.   FC rejected each of these decisions and ruled that the case was not exceptional.
Infringement Claim in Stephens v. Tech Int'l Justified Based on Merck v. Teva FC:  Claim did not read on the defendant's product, which instead used sodium dichromate.  But sodium dichromate is the salt form of chromium trioxide, so that in solution they can be identical.  In Merck v. Teva Pharmaceuticals, it was held that a claim to treating a patient by administering an acid covered administration of the salt.  Accordingly, the patent owner had adequate grounds to believe that the defendant's salt product infringed.
Stephens v. Tech Int'l:  Not all Claims for an Acid Inherently Claim the Acid's Salt FC:  We do not announce that all claims of an acid encompass the salt; it must still be determined whether or not persons having skill in the applicable art deem the acid and salt to be interchangeable.  Because the use of chromic acid encompasses the use of sodium dichromate in the field of urinalysis, Spectrum had adequate grounds to believe that Tech directly infringed . . .
Stephens v. Tech Int'l:  In Light of Record, Claim for Acid "Inherently" Claims its Salt FC:  DC erred in finding that Spectrum had no basis for suing under the doctrine of equivalents. While Spectrum narrowed the claim in light of a reference which taught the use of sodium dichromate, it did so "only to the extent of claiming that one of Spectrum's claimed indicia and color remain substantially unaffected."  Accordingly, the prosecution history does not bar a claim of equivalence. "In light of the record as whole, Spectrum inherently claimed the use of sodium dichromate when it claimed chromium trioxide."
Don't Rely on an Inherent Alternative Limitation Note that Chief Judge Mayer appears to have changed his views in the interval between his dissent in Merck v. Tevaand authoring the opinion in Stephens v. Tech International. Would the outcome in Merck v. Tevahave been different if the claim in the patent recited a composition or a compound instead of a method of treatment?   Failure to recite a salt as an alternative to the claimed compound was not fatal in Merck v. Tevanor was it in Stephens v. Tech International.  Nevertheless it is still prudent to use alternative limitations to recite complexes, derivatives, and the like.  Alternative limitations are worth their salt!
Markush Groups Markush groups are an acceptable form of alternative expression.  In Ex parte Markush, 1925 C.D. 126, 340 O.G. 839 (Comm'r Pat. 1924), the applicant initially recited a dye with an element "diazotized solution of aniline or its homologues or halogen substitutes."   In response to an objection that the claim was alternative in form, the applicant presented a claim which recited:  "material selected from the group consisting of aniline, homologues of aniline and halogen substitutes of aniline."   The claim was ultimately accepted because there was no generic word which covered the species.
Markush Group Variants in MPEP Initially the Patent Office strictly required use of the phrase "X selected from the group consisting of." Eventually, it also became acceptable to recite the alternative form if conventional Markush language would have been acceptable. The common variants which are explicitly approved in MPEP §2173.05(h) are:   "wherein X is selected from the group consisting of A, B and C" and "wherein X is A, B or C."
Markush Group's Community of Characteristics The materials set forth in the Markush group must belong to "a recognized physical or chemical class or to an art-recognized class" OR the members of the group must be characterized in the specification as possessing "at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property."  MPEP §2173.05(h)
Markush Group's Community of Characteristics (cont'd) "Where a Markush expression is applied only to a portion of chemical compound, the propriety of the grouping is determined by a consideration of the compound as whole, and does not depend on there being a community of property in the members of the Markush expression." MPEP §2173.05(h)
Markush Group - Intermediates In re Harnisch, 631 F.2d 716 (C.C.P.A. 1980) overturned a rejection of a listed group of compounds which are not functionally equivalent and possess different chemical properties such as dyestuffs and intermediates for the production of such dyes.  The group was accepted as the compounds were considered functionally as well as structurally similar. It is acceptable to recite compounds related as sequential intermediates.  Ex parte Bella and Chiaino, 224 USPQ 293 (Pat. & Tr. Office Bd. App. 1984).
Clusters and Sub-clusters in Markush Groups If possible, present a generic claim followed by a dependent claim with a Markush group.  Especially, if some elements have a known or a superior functionality.  This approach provides a back-up validity position. It is acceptable to have Markush groups of varying scope such as A, B, C and D in one claim and A, B, and C in another claim.  MPEP §2173.05(h) and MPEP §2173.05(o)
Prosecution of Claims with Markush Groups - Proposed Rule 1.75(b)(1)  On 01/03/06 the Patent Office requested comments on how Markush claims should be counted for purposes of 37 CFR § 1.75(b)(1). "Should the Office simply count each alternative in the claim as a separate claim for purposes of 37 CFR § 1.75(b)(1)?   Should the Office count each alternative in the claim as a separate claim for purposes of 37 CFR § 1.75(b)(1) unless the applicant shows that each alternative in the claim includes a common core structure and a common core property or activity, in which the common core structure constitutes a structural distinctive portion in view of existing prior art is essential to the common property or activity (see MPEP 1850)?"
Proposed Rule 1.75(b)(1) and Compound Claims Imagine handling the prosecution for a patent application with compound claims containing multiple Markush groups in light of the proposed 37 CFR § 1.75(b)(1). For example, look at the independent claim in Pfizer's U.S. Patent No. 5,250,534 which contains the compound claims directed to sildenafil citrate, Pfizer's Viagra® product.
Pyrazolopyrimidinone Agents A compound of the formula:  wherein R1 is H, C1-C3 alkyl, C3-C5cycloakyl or C1-C3perfluroalkyl; R2is H, C1-C6 alkyl optionally substituted by OH, C1-C3alkoxy or C3-C6cycloalkyl, or C1-C3perfluoroalkyl; R3 is C1-C6 alkyl, C3-C6alkenyl, C3-C6alkynyl, C3-C7cycloalkyl, C1-C6perfluoroalkyl or (C3-C6cycloalkyl) C1-C6 alkyl; R4 taken together with the nitrogen atom to which it is attached completes a 4-N-(R6)-piperazinyl group; R5 is H, C1-C4 alkyl, C1-C3alkoxy, NR7R8, or CONR7R8; R6 is H, C1-C6 alkyl, (C1-C3alkoxy) C2-C6 alkyl hydroxy C2-C6 alkyl, (R7R8N)C2-C6 alkyl, (R7R8NCO)C1-C6 alkyl, CONR7R8, CSNR7R8 or C(NH)NR7R8; R7 and R8 are each independently H, C1-C4 alkyl, (C1-C3alkoxy)C2-C4alkyl or hydroxy C2-C4 alkyl; and pharmaceutically acceptable salts thereof.
Covers Sildenafil Citrate R1 is C1 alkyl		R4 is piperazine R2 is C3 alkyl		R5 is H R3 is C2 alkyl		R6 is C1 alkyl
Additional Proposed Rules The Patent Office did not propose a specific rule change to address the issue regarding how claims that read on multiple species using alternative language should be counted for purposes of proposed 37 CFR 1.75(b)(1). On August 10, 2007, the Patent Office requested additional comments in a document titled:  Examination of Patent Applications That Include Claims Containing Alternative Language.
Novelty and Nonobviousness of Markush Claims "The novelty and nonobviousness of a claim with a Markush group is determined much as in the case of other generic claims.  If an applicant claims an invention with an element defined as a Markush group of A, B, C, and D, and the prior art discloses the combination with element D, then the claim is invalid.  Similarly, if the prior art renders the combination with element D obvious to one with ordinary skill in the relevant art, then the claim is invalid under Section 103."  Chisum §8.06[2][f].
Novelty and Nonobviousness of Markush Claims By presenting elements A, B, C, and D in a Markush group, an applicant or patentee is representing that the elements A, B, C, and D are functional equivalents.   However, the importance of this representation depends on whether the functional equivalence was recognized in the art.  It may be prudent to avoid exclusively clustering elements which are known equivalents with those which have been newly identified by the inventor(s) as equivalents.
Novelty and Nonobviousness of Markush Claims In re Ruff, 256 F.2d 590 (C.C.P.A. 1958). "To sum it all up, actual equivalence is not enough to justify a refusal of a patent on one member of a group when another member is in the prior art.  The equivalence must be disclosed in the prior art or be obvious within the terms of Section 103." With reference to In re Ruff, it is stated at Chisum §8.06[2][f] that "the applicant's own finding of equivalency is not prior art."
Novelty and Nonobviousness of Markush Claims Applying the holding of In re Ruff means that if elements A, B, C, and D have a newly discovered equivalent functionality and one of these elements is found in the prior art then the other elements are still novel and nonobvious. However when the equivalent functionality is known in the prior art the ability to avoid a novelty or obviousness rejection by removing an element from a Markush group may depend on characterizations made in the patent application.
Novelty and Nonobviousness of Markush Claims "The general rule is that the lesser Markush subgroup is no more patentable than the original group for the reason that the nature of the genus has not been altered by canceling some of its members."  Comment, "Markush Groups," 37 J. Pat. Off. Soc'y 164, 201 (1955) (citing Ex parte Burke, 1934 C.D. 5, 441 O.G. 509 (Comm'r Pat. 1934) for the establishment of the general rule and its exception).
Novelty and Nonobviousness of Markush Claims "This general rule is controlling in most situations.  However, from the beginning of Markush practice, the rule has been subject to a recognized exception:  The applicant may validly patent a Markush subgroup of lesser scope than the the original by showing that the members of the subgroup have a common quality which is distinctive from the characteristic common to the original group as a whole, which is distinctive from the characteristic common to the original group as a whole, which is not shared by the cancelled members of the original group, and which is sufficiently unobvious and meritorious to impart patentability to the subgroup over the original group."  Comment, "Markush Groups," 37 J. Pat. Off. Soc'y 164, 201 (1955).
Ecolochem – Validity of Markush Claims Ecolochem, Inc. v. Southern California Edison Co., 863 F. Supp. 1165 (C.D. Cal. 1994), aff'd in part, rev'd in part, 91 F.3d 169 (Fed. Cir. 1996) (unpublished table decision) (MICHEL, Newman, Clevenger), aff'd in part, rev'd in part after remand, 227 F.3d 1361 (Fed. Cir. 2000) (MICHEL, Clevenger, Rader), cert. denied, 121 S. Ct. 1607 (2001). Claim:  "an ion exchange resin selected from the group consisting of mixed bed resin and cation resin." Ecolochem argued that, notwithstanding the claims' Markush language, a mixed bed and a cation resin are not always "alternatively usable for the purposes of the invention."   FC.  "This argument has no merit.  Ordinarily, parties using Markush language cannot defeat challenges to validity by focusing on the differences between the members of a Markush group."
Ecolochem – Validity of Markush Claims FC:  "By using Markush language, Ecolochem implicitly asserts that the members of the group are 'alternatively usable for the purposes of the invention, and therefore regardless of which of the alternative is [used], the compound as a whole will exhibit the disclosed utility.'" citing Application of Skoll, 523 F. 2d 1392 (C.C.P.A. 1975) inEcolochem, Inc. v. Southern California Edison Co., (Fed. Cir. 1996) (unpublished table decision).
"Consisting of A, B and C" Does Not Cover Combinations Thereof Abbott Laboratories v. Baxter Pharmaceutical Products Inc., 334 F.3d 1274 (Fed. Cir. 2003) (RADER, Gajarsa, Dyk). Claim:  An anesthetic composition comprising:  a Lewis acid inhibitor in an amount effective to prevent degradation by a Lewis acid of said quantity of sevoflurane, said Lewis acid inhibitor selected from the group consisting of water, butylatedhydroxytoluene, methylparaben, propylparaben, propofol, and thymol.  FC:  The accused composition was held not to infringe a claim reciting a group consisting of A, B and C as the accused composition included A and B not just a singe species such as A or B.  To avoid such an outcome, qualifying language is required.
Abbott v. Baxter - Markush Groups with the Transitional Phrase “Consisting of“ Are Closed "In KJC Corp., this court stated that "an indefinite article 'a' or 'an' in patent parlance carries the meaning of 'one or more' in open-ended claims containing the transitional phrase 'comprising.'" KJC Corp., 223 F.3d at 1356. However, such an indefinite article used in conjunction with a Markush grouping does not receive such latitude because a proper Markush group is limited by the closed language term "consisting of." See Mannesmann Demag Corp. v. Engineered Metal Prods. Co., 793 F.2d 1279, 1282 (Fed. Cir. 1986) (confirming that the phrase "consisting of" appearing in a clause of a claim specifically limits only the element set forth in that clause). Therefore, although "a" without more generally could mean one or more in an open-ended patent claim, "a" with "consisting of" in this case indicates only one member of a Markush group. See KJC Corp., 223 F.3d at 1356"
Abbott v. Baxter - Use of “Qualifying Language“ Is Recommended to Cover Combinations "If a patentee desires mixtures or combinations of the members of the Markush group, the patentee would need to add qualifying language while drafting the claim. See Meeting Held to Promote Uniform Practice In Chemical Divisions, 28 J. Pat. & Trademark Off. Soc'y 849 (1946) (citing examples of qualifying language such as:  "and mixtures thereof" and "at least one member of the group")." "Thus, without expressly indicating the selection of multiple members of a Markush grouping, a patentee does not claim anything other than the plain reading of the closed claim language."
Abbott v. Baxter - Qualifying Language in Markush Groups As noted, the 1946 JPTOS article cited in Abbott Labs v. Baxter Pharmaceutical provides two examples of qualifying language:"and mixtures thereof"and "at least one member of the group. . ."
Claim Construction - Modifiers in Alternative Limitations Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870 (Fed. Cir. 2004) (PROST, Mayer; Michel, concurring). Claim:  An online television program schedule system comprising:  first means for storing at least one of a desired program start time, a desired program end time, a desired program service, and a desired program type;  Claim gist:  at least one of a desired A, a desired B, ... and a desired N The question is:  what does "at least one of" modify?  Is this limitation satisfied by:  picking a single member from at least one of A, B, ... or N; OR must you pick at least one from A, and at least one from B, ... and at least one from N.
Superguide v. DirecTV - Modifiers in Alternative Limitations FC:  "At least one of" means "one or more."   The issue then becomes what does "at least one of" modify?  The criteria listed in the claim at issue consist of four categories (program start time, program end time, program service, and program type).  Each category is further comprised of many possible values.  FC agreed with DC and DirecTV that the phrase "at least one of" modifies each category in the criteria list, i.e., one or more values in each category.
Superguide v. DirecTV - Modifiers in Alternative Limitations SuperGuide contended that: Patent Office rules dictated that it use "and" instead of "or" the DC erroneously relied on a figure that does not cover the assertedclaims examples in the specification describe a user who has chosen only two desired programming criteria (e.g., start time and stop time) during prosecution the patentee repeatedly characterized the invention as requiring the presence of one or more of the four listed criteria and interchangeably used the terms "or" and "and."
Superguide v. DirecTV - Modifiers in Alternative Limitations DirecTV countered that: the DC construction is supported by the patentee's use of the constructive "and" and by the grammatical rule requiring that the phrase "at least one of" be applied to each category in the list. disputed that Patent Office rules dictated use of "and" instead of "or" every embodiment in the specification of a desired criteria list teaches a conjunctive list that is consistent with the plain meaning of the claims patentee did not refute the Examiner's characterization of the criteria list as being conjunctive accepting SuperGuide interpretation would enlarge scope beyond its ordinary meaning
Superguide v. DirecTV - Modifiers in Alternative Limitations Based on ordinary rules of grammar, FC says you must pick one from each category: The phrase "at least one of" precedes a series of categories of criteria, and the patentee used the term "and" to separate the categories of criteria, which connotes a conjunctive list.  A common treatise on grammar teaches that "an article of a preposition applying to all the members of the series must either be used only before the first term or else be repeated before each term."  William Strunk, Jr. & E. B. White, The Elements of Style 27 (4th ed. 2000).  Thus, "[i]n spring, summer, or winter" means "in spring, in summer, or in winter."  Id.  Applying this grammatical principle here, the phrase "at least one of" modifies each member of the list, i.e., each category in the list. ...
Superguide v. DirecTV - Ordinary Rules of Grammar FC says the patentee was not precluded from using the term "or."  Accordingly, the FC did not address SuperGuide's argument that it was precluded from using a "Markush" format. FC further concluded that nothing in the specification rebuts the presumption that the patentee intended the plain and ordinary meaning of this language. FC also declined "to enlarge the claim scope from its plain and ordinary meaning based on the prosecution history because the patentee did not clearly and explicitly define the term "and" in the covered criteria list as "or."
Suggested Claim Language in Light of Superguide v. DirecTV Footnote 10:  Indeed, SuperGuide does not articulate its argument that "at least one of" means "one or more of the four listed criteria" without using the term "or" to separate the four listed categories. See Brown v. 3M, 265 F.3d 1349, 1352 (Fed. Cir. 2001). (NEWMAN, Clevenger; Mayer, dissenting) (interpreting the phrase "at least one of two-digit, three-digit, or four-digit year-date representations" as "only two-digit, only three-digit, only four-digit, or any combination of two-, three-, and four-digit date-data"). Bottom line:  If a conjunctive list is desired recite:  wherein X is at least one of A, B and C.  If not, recite "wherein X is at least one of A, B or C.
You can do three but I can do more.  You have three but I have four. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005) (RADER, Michel; Archer, dissenting). Gillette sued Energizer alleging Energizer's QUATTRO®, a four-bladed wet-shave safety razor, infringed claims of its patent. The question on appeal is whether the claim is limited to a razor with exactly three blades. Claim:  "A safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades with parallel sharpened edges located between the guard and cap. . ."
Gillette v. Energizer – "Group of" = Open Claim Language FC:  both "comprising" and "group of" are open claim language.  The majority also says that this is consistent with the file history.  Also, the specification teaches principles of razor design that apply to razors with more than four blades.  But this case is an appeal from denial of a preliminary injunction, so the majority says that the construction is preliminary, and that the district court may reach a different result based on a more complete record.
Gillette v. Energizer – "Group of" = Open Claim Language For the proposition that the claim is open, the majority turns, in part, to some unusual avenues of claim construction: A negative pregnant in the MPEP.  The PTO will reject a Markush claim to "group of" without "consisting"' therefore "group of" without "consisting" is "presumptively open." A statement by the defendant in proceedings in the EPO on a counterpart patent:  "The defendant itself endorsed an open interpretation of "comprising" when it argued to the European Patent Office (EPO) that a virtually identical claim in Gillette's European counterpart ... would not exclude an arrangement with four or more blades. This blatant admission by this same defendant before the EPO clearly supports this court's holding that those skilled in the art would construe the claims of the '777 patent to encompass razors withmore than three blades."
Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . . Judge Archer dissents in unusually strong terms.  He agrees (by implication) that "group of" is generally open, but says that here "the written description makes clear that this term is not used as an open claiming term."  The specification also makes clear that three blades is the invention, not merely a preferred embodiment.
Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . . "In sum, the patent specification  Repeatedly and consistently teaches that the safety razor of the invention is one having three blades;  Teaches preferred embodiments which vary the configuration of the blades but in no way changes the number of blades of the invention; and  Discourages the use of more than two blades in a blade unit except for the three-bladed blade unit having the claimed geometry. I believe these teachings together clearly demonstrate that the inventors did not regard a blade unit with four blades arranged in the described geometry as their invention. Therefore, "comprising" and "group of" should not be construed to include a safety razor having more than three blades."
Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . .  Dissent continued: "Anyone reading the '777 patent would be left with the indelible impression that the patentee had invented a three-bladed, and only three-bladed, safety razor with blades having the described variable blade span and blade exposure. Only with a crystal ball could a competitor in the safety-razor industry have concluded that the '777 patent could cover a four-bladed razor."
Take Away Points re Markush Claims and Alternative Limitations While it is best to avoid alternative limitations in independent claims when possible, they are often vital.   How should alternative limitations be recited to gain the claim construction desired?

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Markush Groups and other Alternative Claim Limitations

  • 1. Claim Construction of Markush Groups and other Alternative Limitations Presented by: Kevin B. Laurence Stoel Rives LLP American Conference Institute’s Sixth Advanced Forum on Biotech Patents San Francisco, California February 16, 2006
  • 2.
  • 3. The views expressed in this presentation are solely those of the presenter and do not represent the views of Stoel Rives LLP or clients of Stoel Rives LLP.
  • 4.
  • 5. When possible, it is preferable to use a generic phrase instead of alternative limitations.
  • 6.
  • 7. Exemplary Alternative Limitations in Chemical Compound Claims A compound of the formula R-X; or a pharmaceutically acceptable salt thereof. with at least one entity chosen from A, B, and C greater than or equal to with the proviso that . . . when n is 1, then X is not chosen from A or B either before or after branches may be identical or different at least one polymer selected from A and B, wherein the ratio by weight of A and/or B to X is . . .
  • 8. Conjunction, Disjunction: What's Your Function A limitation in a claim for a chemical compound typically has a scope which is clearly inclusive or exclusive based on the context. The meaning of alternative limitations in claims directed to technology other than chemical compounds may be less clear. Careless use of alternative claim limitations in such contexts can introduce ambiguity.
  • 9. Conjunction, Disjunction: What's Your Function Avoid expensive grammar lessons from the Federal Circuit when using "and," "or," or "and/or" in alternative limitations by giving careful consideration to the intended meaning. Is the objective a recitation which is inclusive or exclusive? Consider a definition in the boilerplate paragraph before the claims. For example, "[i]n the claims, the conjunction "and" is inclusive, the conjunction "or" is exclusive and the conjunction "and/or" is either inclusive or exclusive."
  • 10. Elizabeth Barrett Browning'sSonnet XLIII How do I love thee? Let me count the ways. I love thee to the depth and breadth and height My soul can reach, when feeling out of sight For the ends of Being and ideal Grace. I love thee to the level of every day's Most quiet need, by sun and candlelight. I love thee freely, as men strive for Right; I love thee purely, as they turn from Praise. I love thee with the passion put to use In my old griefs, and with my childhood's faith. I love thee with a love I seemed to lose With my lost saints—I love thee with the breath, Smiles, tears, of all my life!—and, if God choose, I shall but love thee better after death.
  • 11. Elizabeth Barrett Browning's Sonnet XLIII Formatted as a Patent Claim A method for expressing the ways that I love thee, comprising: loving thee to the depth and breadth and height my soul can reach, when feeling out of sight for the ends of Being and ideal Grace; loving thee to the level of every day's most quiet need, by sun and candlelight; loving thee freely, as men strive for Right; loving thee purely, as they turn from Praise; loving thee with the passion put to use in my old griefs, and with my childhood's faith; loving thee with a love I seemed to lose with my lost saints; loving thee with the breath, smiles, tears, of all my life; AND loving thee better after death, if God so chooses.
  • 12. Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001) (NEWMAN, Lourie; Mayer, dissenting) Kustom Signals owns a patent directed to a traffic radar gun for determining the speed of a vehicle. In the patent, the user selects whether to identify and display the speed of either the strongest target (a large truck or closest vehicle) or the fastest target vehicle. The Applied Concepts radar device operated similarly except that both a strongest and fastest analysis of the return signal are always performed. The radar then displayed either the speed of the target producing the strongest signal, or speeds of both the fastest and strongest target signals. Applied Concepts asserted that its calculation of the speeds of both the strongest and fastest vehicles is excluded by the claims.
  • 13. Fed. Cir. Says "or“ Is Exclusive in Kustom Signals Independent claims 1, 16, and 20 of U.S. Patent No. 5,528,246 recite a "method of processing Doppler return information in a traffic radar comprising the steps of . . . Claim 1 recites "searching said components in memory for the component that meets preselected magnitude OR frequency criteria. Claim 16 recites "means for searching the components stored in said memory means to identify the component that meets preselected magnitude OR frequency criteria. Claim 20 recites "means under operator control for selecting EITHER a greatest magnitude OR highest frequency search, whereby EITHER strongest signal OR fastest signal target identification is provided.
  • 14. Fed. Cir. Says "or“ Is Exclusive in Kustom Signals Patentee, Kustom Signals, argued that "OR" should not be restricted to a search of either the fastest target data (frequency) or the strongest target data (magnitude). Kustom Signals attempted to support its position by referencing a computer dictionary which distinguishes between the logical operators: "AND" which returns a "true" value if and only if both values are true, "OR" which returns a "true" value when one or both values are true, and "XOR" which returns a "true" value when only one value is true.
  • 15. Fed. Cir. Says "or“ Is Exclusive in Kustom Signals FC rejected the plaintiff-appellant's claim construction as it was clear that "or" was used in its ordinary meaning, it clearly referenced alternatives and was not used like a technical programming operator. Reference was made to Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) which held that "a patentee may chose to be his own lexicographer and use terms in a manner other than their ordinary meaning, as long as the special definition of the term is clearly stated in the patent specification or file history." FC affirmed the DC's grant of summary judgment of noninfringement.
  • 16. Chief Judge Mayer's Dissent in Kustom Signals - "or“ Is Inclusive Chief Judge Mayer: "[O]r should be construed inclusively to mean 'one or another or both.' First the plain meaning of 'or' can be 'either or both.' If a store owner says, 'If it hails or snows today, we will close the store,' then the owner will still close the store if it happens to hail and snow." His interpretation hinged on the construction of the claim elements under 35 USC §112 ¶6 which requires reference to the flowcharts in the specification. The flowcharts support an interpretation that "or" is inclusive as the patentee urged with reference to the Boolean operators.
  • 17. Brown v. 3M, 263 F.3d 1349 (Fed. Cir. 2001) (NEWMAN, Clevenger; Mayer, dissenting) Brown owns a patent directed to method for combating the Y2K dilemma. Claim: An apparatus for processing year-date data in a computer systems, the apparatus comprising: . . . [a]t least one database file stored in the memory containing records with year-date data with years being represented by at least one of two-digit, three digit, OR four-digit year-date representations ; and a mechanism for converting the year-date data representations in the database file to a two-digit year-date data representation." DC and FC: The apparatus was capable of converting only two-digit, only three-digit, only four-digit or any combination of two-, three-, and four-digit date-data. There is no basis for reading "or" as "and."
  • 18. Fed. Cir. Says "or“ Is Exclusive in Brown v. 3M Prior art reference teaches the handling of year dates in two-digit format. Patentee argued that the three-digit and four-digit date conversion were not anticipated by the prior art reference . FC: Since the conversion capability was claimed in the alternative, infringement would occur whether or not three-digit or four-digit year dates were also offset. That which infringes if later anticipates if earlier so the claim is anticipated.
  • 19. Chief Judge Mayer's Dissent in Brown v. 3M - "or“ Is Inclusive Chief Judge Mayer: "The court errs by reading the claim term 'or' exclusively, while the district court appropriately read it inclusively when construing the claim." Again, his interpretation hinged on the construction of the claim elements under 35 USC §112 ¶6 which requires interpretation by reference to the structure or acts disclosed in the specification. "The preferred embodiment in the specification discloses a process for converting all such possible year-date combinations to two-digit representations. . . The presence of this disclosure mandates the construction of the 'mechanism for converting . . .' limitation as one that requires the capacity to process two-, three-, and four-digit dates, even if full capacity of the device is not always utilized."
  • 20. Schumer v. Laboratory Computer Systems, Inc., 308 F.3d 1304 (Fed. Cir. 2002) (DYK, Newman, Michel) Schumer owns a patent directed to "digitizers," which are computer peripherals that translate a user's hand motions or instructions into digital coordinates suitable for use by a computer system. Claim preamble: A method . . . which coordinate system has a point of origin and has an angle of rotation with respect to the digitizer and has a scale Claim body: because one of the following elements is different from the digitizer's coordinate system: location of the point of origin, or angle of rotation, or scale . . .
  • 21. Fed. Cir. Holds in Schumerthat OR = Alternatives DC: Claim preamble requires that the device have all three of these attributes, i.e., a point of origin, angle of rotation and scale so no infringement. FC: Claim preamble "simply describes features that necessarily exist in any coordinate system for a digitizer-a point of origin, an angle of rotation and a scale. FC: "[L]anguage of the preamble is superfluous." FC: "DC substituted the word 'and' from the preamble for the word 'or' used in the body of the claim."
  • 22. Fed. Cir. Holds in Schumerthat OR = Alternatives FC: DC's claim construction contradicts the plain meaning of the word "or" in the claims. . . FC: Webster's 3rd Int'l Dictionary defines "or" as follows: "used as a function word to indicate (1) an alternative between different or unlike things, states, or actions . . . (2) choice between alternative things, states, or courses." We have consistently interpreted the word "or" to mean that the items in the sequence are alternatives to each other.
  • 23. Fed. Cir. Holds in Schumerthat OR = Alternatives "In Brown v. 3M, 265 F.3d 1349 (Fed. Cir. 2001), we upheld the DC's construction of the word "or" in the claim as meaning that the apparatus was capable of converting "'only two-digit, only three-digit, only four-digit, or any combination of two-, three-, and four-digit date-data,'" by finding that the interpretation of the word "or" involved a "plain reading of the claim text. These are not technical terms or art, and do not require elaborate interpretation." "In Kustom Signals, Inc. v. Applied Concepts, Inc., 264 F.3d 1326 (Fed. Cir. 2001), we agreed with the DC's construction of "or" as "designating alternatives." We noted that "there is no indication that Kustom used these words in a different meaning. Particularly, there is no basis whatsoever for believing that Kustom intended its usage of 'or' somehow to embrace 'and.'"
  • 24. Patent Litigation re Generic Version of Merck's Fosamax® Product Merck & Co., Inc.v. Teva Pharmaceuticals USA, Inc., 347 F.3d 1367 (Fed. Cir. 2003) (NEWMAN, Prost; Mayer, dissenting). Teva filed an ANDA to sell a generic version of Merck's Fosamax® product for treatment of osteoporosis Merck sued Teva in accordance with 35 USC § 271(e)(2) for infringement of U.S. Patent No. 4,407,761 The only claim of U.S. Patent No. 4,407,761 A method of treatment of urolithiasis and inhibiting bone reabsorption which consists of administering to a patient in need thereof an effective amount of 4-amino-1-hydroxybutane-1,1-biphosphonic acid.
  • 25. In Merck v. Teva, Claim Drafter Left out the Salt! Teva countered that it did not infringe as the claim is directed to the acid while TEVA's ANDA was for the monosodium salt. Like food, this claim would have been more savory if the drafter had included salt! The claim should have read: A method of treatment of urolithiasis and inhibiting bone reabsorption which consists of administering to a patient in need thereof an effective amount of 4-amino-1-hydroxybutane-1,1-biphosphonic acid OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.
  • 26. In Merck v. Teva, Method Infringed Based on Specification and PHOSITA DC & FC: Claim is infringed by administration of the salt. The patent refers to formulation of various biphosphonic acids for administration "as the sodium salt," "in the salt form," "in the form of Na salt," and as "4-amino-1-hydroxybutan-1,1-biphosphonic acid, sodium salt." Witnesses testified that a PHOSITA would understand that the active agent is 4-amino-1-hydroxybutane-1,1-biphosphonic acid, and that the method of treatment of bone disorders includes use of the active agent in the form of the salt.
  • 27. Judge Mayer's Dissent in Merck v. Teva: Salt is not an Inherent Alternative Limitation in Claim Chief Judge Mayer's dissent: the term "acid" does not include both acids and salts. Majority's claim construction is contrary to plain reading. Specification: In some instances, acid is named when referring to salt. "But in the vast majority of instances, the specification distinguishes between the two." Examples show the "patentee is able to distinguish between the two when he so chooses." Witnesses made it clear that the acid and its salt are distinct. The literal scope of the claim can extend only to the acid itself.
  • 28. Claim for Acid Asserted Against Product with the Acid's Salt Stephens v. Tech International, 393 F.3d 1269 (Fed. Cir. 2004) (MAYER, Rader, Schall). Claim: A method to remove detectable amounts of an unwanted substance from a human urine sample comprising: . . . contacting the human urine sample with an amount of chromium trioxide . . ." In response to a rejection based on a prior reference which taught the use of sodium dichromate as a chemical oxidizing agent, the patentee limited its chemical oxidizing agent to chromium trioxide. But the claim was limited only to the extent that the claimed indicia and color remain substantially unaffected. Tech's accused product used sodium dichromate.
  • 29. Stephens v. Tech Int'l Becomes Just about Attorney's Fees DC entered a summary judgment of non-infringement. A subsequent settlement was reached whereby all claims were dismissed except for a claim for attorneys fees. DC later found that the case was exceptional, and awarded attorney fees to the defendant. DC based its finding on decisions that (among other things): the infringement argument was in bad faith. FC rejected each of these decisions and ruled that the case was not exceptional.
  • 30. Infringement Claim in Stephens v. Tech Int'l Justified Based on Merck v. Teva FC: Claim did not read on the defendant's product, which instead used sodium dichromate. But sodium dichromate is the salt form of chromium trioxide, so that in solution they can be identical. In Merck v. Teva Pharmaceuticals, it was held that a claim to treating a patient by administering an acid covered administration of the salt. Accordingly, the patent owner had adequate grounds to believe that the defendant's salt product infringed.
  • 31. Stephens v. Tech Int'l: Not all Claims for an Acid Inherently Claim the Acid's Salt FC: We do not announce that all claims of an acid encompass the salt; it must still be determined whether or not persons having skill in the applicable art deem the acid and salt to be interchangeable. Because the use of chromic acid encompasses the use of sodium dichromate in the field of urinalysis, Spectrum had adequate grounds to believe that Tech directly infringed . . .
  • 32. Stephens v. Tech Int'l: In Light of Record, Claim for Acid "Inherently" Claims its Salt FC: DC erred in finding that Spectrum had no basis for suing under the doctrine of equivalents. While Spectrum narrowed the claim in light of a reference which taught the use of sodium dichromate, it did so "only to the extent of claiming that one of Spectrum's claimed indicia and color remain substantially unaffected." Accordingly, the prosecution history does not bar a claim of equivalence. "In light of the record as whole, Spectrum inherently claimed the use of sodium dichromate when it claimed chromium trioxide."
  • 33. Don't Rely on an Inherent Alternative Limitation Note that Chief Judge Mayer appears to have changed his views in the interval between his dissent in Merck v. Tevaand authoring the opinion in Stephens v. Tech International. Would the outcome in Merck v. Tevahave been different if the claim in the patent recited a composition or a compound instead of a method of treatment? Failure to recite a salt as an alternative to the claimed compound was not fatal in Merck v. Tevanor was it in Stephens v. Tech International. Nevertheless it is still prudent to use alternative limitations to recite complexes, derivatives, and the like. Alternative limitations are worth their salt!
  • 34. Markush Groups Markush groups are an acceptable form of alternative expression. In Ex parte Markush, 1925 C.D. 126, 340 O.G. 839 (Comm'r Pat. 1924), the applicant initially recited a dye with an element "diazotized solution of aniline or its homologues or halogen substitutes." In response to an objection that the claim was alternative in form, the applicant presented a claim which recited: "material selected from the group consisting of aniline, homologues of aniline and halogen substitutes of aniline." The claim was ultimately accepted because there was no generic word which covered the species.
  • 35. Markush Group Variants in MPEP Initially the Patent Office strictly required use of the phrase "X selected from the group consisting of." Eventually, it also became acceptable to recite the alternative form if conventional Markush language would have been acceptable. The common variants which are explicitly approved in MPEP §2173.05(h) are: "wherein X is selected from the group consisting of A, B and C" and "wherein X is A, B or C."
  • 36. Markush Group's Community of Characteristics The materials set forth in the Markush group must belong to "a recognized physical or chemical class or to an art-recognized class" OR the members of the group must be characterized in the specification as possessing "at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property." MPEP §2173.05(h)
  • 37. Markush Group's Community of Characteristics (cont'd) "Where a Markush expression is applied only to a portion of chemical compound, the propriety of the grouping is determined by a consideration of the compound as whole, and does not depend on there being a community of property in the members of the Markush expression." MPEP §2173.05(h)
  • 38. Markush Group - Intermediates In re Harnisch, 631 F.2d 716 (C.C.P.A. 1980) overturned a rejection of a listed group of compounds which are not functionally equivalent and possess different chemical properties such as dyestuffs and intermediates for the production of such dyes. The group was accepted as the compounds were considered functionally as well as structurally similar. It is acceptable to recite compounds related as sequential intermediates. Ex parte Bella and Chiaino, 224 USPQ 293 (Pat. & Tr. Office Bd. App. 1984).
  • 39. Clusters and Sub-clusters in Markush Groups If possible, present a generic claim followed by a dependent claim with a Markush group. Especially, if some elements have a known or a superior functionality. This approach provides a back-up validity position. It is acceptable to have Markush groups of varying scope such as A, B, C and D in one claim and A, B, and C in another claim. MPEP §2173.05(h) and MPEP §2173.05(o)
  • 40. Prosecution of Claims with Markush Groups - Proposed Rule 1.75(b)(1) On 01/03/06 the Patent Office requested comments on how Markush claims should be counted for purposes of 37 CFR § 1.75(b)(1). "Should the Office simply count each alternative in the claim as a separate claim for purposes of 37 CFR § 1.75(b)(1)? Should the Office count each alternative in the claim as a separate claim for purposes of 37 CFR § 1.75(b)(1) unless the applicant shows that each alternative in the claim includes a common core structure and a common core property or activity, in which the common core structure constitutes a structural distinctive portion in view of existing prior art is essential to the common property or activity (see MPEP 1850)?"
  • 41. Proposed Rule 1.75(b)(1) and Compound Claims Imagine handling the prosecution for a patent application with compound claims containing multiple Markush groups in light of the proposed 37 CFR § 1.75(b)(1). For example, look at the independent claim in Pfizer's U.S. Patent No. 5,250,534 which contains the compound claims directed to sildenafil citrate, Pfizer's Viagra® product.
  • 42. Pyrazolopyrimidinone Agents A compound of the formula: wherein R1 is H, C1-C3 alkyl, C3-C5cycloakyl or C1-C3perfluroalkyl; R2is H, C1-C6 alkyl optionally substituted by OH, C1-C3alkoxy or C3-C6cycloalkyl, or C1-C3perfluoroalkyl; R3 is C1-C6 alkyl, C3-C6alkenyl, C3-C6alkynyl, C3-C7cycloalkyl, C1-C6perfluoroalkyl or (C3-C6cycloalkyl) C1-C6 alkyl; R4 taken together with the nitrogen atom to which it is attached completes a 4-N-(R6)-piperazinyl group; R5 is H, C1-C4 alkyl, C1-C3alkoxy, NR7R8, or CONR7R8; R6 is H, C1-C6 alkyl, (C1-C3alkoxy) C2-C6 alkyl hydroxy C2-C6 alkyl, (R7R8N)C2-C6 alkyl, (R7R8NCO)C1-C6 alkyl, CONR7R8, CSNR7R8 or C(NH)NR7R8; R7 and R8 are each independently H, C1-C4 alkyl, (C1-C3alkoxy)C2-C4alkyl or hydroxy C2-C4 alkyl; and pharmaceutically acceptable salts thereof.
  • 43. Covers Sildenafil Citrate R1 is C1 alkyl R4 is piperazine R2 is C3 alkyl R5 is H R3 is C2 alkyl R6 is C1 alkyl
  • 44. Additional Proposed Rules The Patent Office did not propose a specific rule change to address the issue regarding how claims that read on multiple species using alternative language should be counted for purposes of proposed 37 CFR 1.75(b)(1). On August 10, 2007, the Patent Office requested additional comments in a document titled: Examination of Patent Applications That Include Claims Containing Alternative Language.
  • 45. Novelty and Nonobviousness of Markush Claims "The novelty and nonobviousness of a claim with a Markush group is determined much as in the case of other generic claims. If an applicant claims an invention with an element defined as a Markush group of A, B, C, and D, and the prior art discloses the combination with element D, then the claim is invalid. Similarly, if the prior art renders the combination with element D obvious to one with ordinary skill in the relevant art, then the claim is invalid under Section 103." Chisum §8.06[2][f].
  • 46. Novelty and Nonobviousness of Markush Claims By presenting elements A, B, C, and D in a Markush group, an applicant or patentee is representing that the elements A, B, C, and D are functional equivalents. However, the importance of this representation depends on whether the functional equivalence was recognized in the art. It may be prudent to avoid exclusively clustering elements which are known equivalents with those which have been newly identified by the inventor(s) as equivalents.
  • 47. Novelty and Nonobviousness of Markush Claims In re Ruff, 256 F.2d 590 (C.C.P.A. 1958). "To sum it all up, actual equivalence is not enough to justify a refusal of a patent on one member of a group when another member is in the prior art. The equivalence must be disclosed in the prior art or be obvious within the terms of Section 103." With reference to In re Ruff, it is stated at Chisum §8.06[2][f] that "the applicant's own finding of equivalency is not prior art."
  • 48. Novelty and Nonobviousness of Markush Claims Applying the holding of In re Ruff means that if elements A, B, C, and D have a newly discovered equivalent functionality and one of these elements is found in the prior art then the other elements are still novel and nonobvious. However when the equivalent functionality is known in the prior art the ability to avoid a novelty or obviousness rejection by removing an element from a Markush group may depend on characterizations made in the patent application.
  • 49. Novelty and Nonobviousness of Markush Claims "The general rule is that the lesser Markush subgroup is no more patentable than the original group for the reason that the nature of the genus has not been altered by canceling some of its members." Comment, "Markush Groups," 37 J. Pat. Off. Soc'y 164, 201 (1955) (citing Ex parte Burke, 1934 C.D. 5, 441 O.G. 509 (Comm'r Pat. 1934) for the establishment of the general rule and its exception).
  • 50. Novelty and Nonobviousness of Markush Claims "This general rule is controlling in most situations. However, from the beginning of Markush practice, the rule has been subject to a recognized exception: The applicant may validly patent a Markush subgroup of lesser scope than the the original by showing that the members of the subgroup have a common quality which is distinctive from the characteristic common to the original group as a whole, which is distinctive from the characteristic common to the original group as a whole, which is not shared by the cancelled members of the original group, and which is sufficiently unobvious and meritorious to impart patentability to the subgroup over the original group." Comment, "Markush Groups," 37 J. Pat. Off. Soc'y 164, 201 (1955).
  • 51. Ecolochem – Validity of Markush Claims Ecolochem, Inc. v. Southern California Edison Co., 863 F. Supp. 1165 (C.D. Cal. 1994), aff'd in part, rev'd in part, 91 F.3d 169 (Fed. Cir. 1996) (unpublished table decision) (MICHEL, Newman, Clevenger), aff'd in part, rev'd in part after remand, 227 F.3d 1361 (Fed. Cir. 2000) (MICHEL, Clevenger, Rader), cert. denied, 121 S. Ct. 1607 (2001). Claim: "an ion exchange resin selected from the group consisting of mixed bed resin and cation resin." Ecolochem argued that, notwithstanding the claims' Markush language, a mixed bed and a cation resin are not always "alternatively usable for the purposes of the invention." FC. "This argument has no merit. Ordinarily, parties using Markush language cannot defeat challenges to validity by focusing on the differences between the members of a Markush group."
  • 52. Ecolochem – Validity of Markush Claims FC: "By using Markush language, Ecolochem implicitly asserts that the members of the group are 'alternatively usable for the purposes of the invention, and therefore regardless of which of the alternative is [used], the compound as a whole will exhibit the disclosed utility.'" citing Application of Skoll, 523 F. 2d 1392 (C.C.P.A. 1975) inEcolochem, Inc. v. Southern California Edison Co., (Fed. Cir. 1996) (unpublished table decision).
  • 53. "Consisting of A, B and C" Does Not Cover Combinations Thereof Abbott Laboratories v. Baxter Pharmaceutical Products Inc., 334 F.3d 1274 (Fed. Cir. 2003) (RADER, Gajarsa, Dyk). Claim: An anesthetic composition comprising: a Lewis acid inhibitor in an amount effective to prevent degradation by a Lewis acid of said quantity of sevoflurane, said Lewis acid inhibitor selected from the group consisting of water, butylatedhydroxytoluene, methylparaben, propylparaben, propofol, and thymol. FC: The accused composition was held not to infringe a claim reciting a group consisting of A, B and C as the accused composition included A and B not just a singe species such as A or B. To avoid such an outcome, qualifying language is required.
  • 54. Abbott v. Baxter - Markush Groups with the Transitional Phrase “Consisting of“ Are Closed "In KJC Corp., this court stated that "an indefinite article 'a' or 'an' in patent parlance carries the meaning of 'one or more' in open-ended claims containing the transitional phrase 'comprising.'" KJC Corp., 223 F.3d at 1356. However, such an indefinite article used in conjunction with a Markush grouping does not receive such latitude because a proper Markush group is limited by the closed language term "consisting of." See Mannesmann Demag Corp. v. Engineered Metal Prods. Co., 793 F.2d 1279, 1282 (Fed. Cir. 1986) (confirming that the phrase "consisting of" appearing in a clause of a claim specifically limits only the element set forth in that clause). Therefore, although "a" without more generally could mean one or more in an open-ended patent claim, "a" with "consisting of" in this case indicates only one member of a Markush group. See KJC Corp., 223 F.3d at 1356"
  • 55. Abbott v. Baxter - Use of “Qualifying Language“ Is Recommended to Cover Combinations "If a patentee desires mixtures or combinations of the members of the Markush group, the patentee would need to add qualifying language while drafting the claim. See Meeting Held to Promote Uniform Practice In Chemical Divisions, 28 J. Pat. & Trademark Off. Soc'y 849 (1946) (citing examples of qualifying language such as: "and mixtures thereof" and "at least one member of the group")." "Thus, without expressly indicating the selection of multiple members of a Markush grouping, a patentee does not claim anything other than the plain reading of the closed claim language."
  • 56. Abbott v. Baxter - Qualifying Language in Markush Groups As noted, the 1946 JPTOS article cited in Abbott Labs v. Baxter Pharmaceutical provides two examples of qualifying language:"and mixtures thereof"and "at least one member of the group. . ."
  • 57. Claim Construction - Modifiers in Alternative Limitations Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870 (Fed. Cir. 2004) (PROST, Mayer; Michel, concurring). Claim: An online television program schedule system comprising: first means for storing at least one of a desired program start time, a desired program end time, a desired program service, and a desired program type; Claim gist: at least one of a desired A, a desired B, ... and a desired N The question is: what does "at least one of" modify? Is this limitation satisfied by: picking a single member from at least one of A, B, ... or N; OR must you pick at least one from A, and at least one from B, ... and at least one from N.
  • 58. Superguide v. DirecTV - Modifiers in Alternative Limitations FC: "At least one of" means "one or more." The issue then becomes what does "at least one of" modify? The criteria listed in the claim at issue consist of four categories (program start time, program end time, program service, and program type). Each category is further comprised of many possible values. FC agreed with DC and DirecTV that the phrase "at least one of" modifies each category in the criteria list, i.e., one or more values in each category.
  • 59. Superguide v. DirecTV - Modifiers in Alternative Limitations SuperGuide contended that: Patent Office rules dictated that it use "and" instead of "or" the DC erroneously relied on a figure that does not cover the assertedclaims examples in the specification describe a user who has chosen only two desired programming criteria (e.g., start time and stop time) during prosecution the patentee repeatedly characterized the invention as requiring the presence of one or more of the four listed criteria and interchangeably used the terms "or" and "and."
  • 60. Superguide v. DirecTV - Modifiers in Alternative Limitations DirecTV countered that: the DC construction is supported by the patentee's use of the constructive "and" and by the grammatical rule requiring that the phrase "at least one of" be applied to each category in the list. disputed that Patent Office rules dictated use of "and" instead of "or" every embodiment in the specification of a desired criteria list teaches a conjunctive list that is consistent with the plain meaning of the claims patentee did not refute the Examiner's characterization of the criteria list as being conjunctive accepting SuperGuide interpretation would enlarge scope beyond its ordinary meaning
  • 61. Superguide v. DirecTV - Modifiers in Alternative Limitations Based on ordinary rules of grammar, FC says you must pick one from each category: The phrase "at least one of" precedes a series of categories of criteria, and the patentee used the term "and" to separate the categories of criteria, which connotes a conjunctive list. A common treatise on grammar teaches that "an article of a preposition applying to all the members of the series must either be used only before the first term or else be repeated before each term." William Strunk, Jr. & E. B. White, The Elements of Style 27 (4th ed. 2000). Thus, "[i]n spring, summer, or winter" means "in spring, in summer, or in winter." Id. Applying this grammatical principle here, the phrase "at least one of" modifies each member of the list, i.e., each category in the list. ...
  • 62. Superguide v. DirecTV - Ordinary Rules of Grammar FC says the patentee was not precluded from using the term "or." Accordingly, the FC did not address SuperGuide's argument that it was precluded from using a "Markush" format. FC further concluded that nothing in the specification rebuts the presumption that the patentee intended the plain and ordinary meaning of this language. FC also declined "to enlarge the claim scope from its plain and ordinary meaning based on the prosecution history because the patentee did not clearly and explicitly define the term "and" in the covered criteria list as "or."
  • 63. Suggested Claim Language in Light of Superguide v. DirecTV Footnote 10: Indeed, SuperGuide does not articulate its argument that "at least one of" means "one or more of the four listed criteria" without using the term "or" to separate the four listed categories. See Brown v. 3M, 265 F.3d 1349, 1352 (Fed. Cir. 2001). (NEWMAN, Clevenger; Mayer, dissenting) (interpreting the phrase "at least one of two-digit, three-digit, or four-digit year-date representations" as "only two-digit, only three-digit, only four-digit, or any combination of two-, three-, and four-digit date-data"). Bottom line: If a conjunctive list is desired recite: wherein X is at least one of A, B and C. If not, recite "wherein X is at least one of A, B or C.
  • 64. You can do three but I can do more. You have three but I have four. Gillette Co. v. Energizer Holdings, Inc., 405 F.3d 1367 (Fed. Cir. 2005) (RADER, Michel; Archer, dissenting). Gillette sued Energizer alleging Energizer's QUATTRO®, a four-bladed wet-shave safety razor, infringed claims of its patent. The question on appeal is whether the claim is limited to a razor with exactly three blades. Claim: "A safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades with parallel sharpened edges located between the guard and cap. . ."
  • 65.
  • 66. Gillette v. Energizer – "Group of" = Open Claim Language FC: both "comprising" and "group of" are open claim language. The majority also says that this is consistent with the file history. Also, the specification teaches principles of razor design that apply to razors with more than four blades. But this case is an appeal from denial of a preliminary injunction, so the majority says that the construction is preliminary, and that the district court may reach a different result based on a more complete record.
  • 67. Gillette v. Energizer – "Group of" = Open Claim Language For the proposition that the claim is open, the majority turns, in part, to some unusual avenues of claim construction: A negative pregnant in the MPEP. The PTO will reject a Markush claim to "group of" without "consisting"' therefore "group of" without "consisting" is "presumptively open." A statement by the defendant in proceedings in the EPO on a counterpart patent: "The defendant itself endorsed an open interpretation of "comprising" when it argued to the European Patent Office (EPO) that a virtually identical claim in Gillette's European counterpart ... would not exclude an arrangement with four or more blades. This blatant admission by this same defendant before the EPO clearly supports this court's holding that those skilled in the art would construe the claims of the '777 patent to encompass razors withmore than three blades."
  • 68. Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . . Judge Archer dissents in unusually strong terms. He agrees (by implication) that "group of" is generally open, but says that here "the written description makes clear that this term is not used as an open claiming term." The specification also makes clear that three blades is the invention, not merely a preferred embodiment.
  • 69. Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . . "In sum, the patent specification Repeatedly and consistently teaches that the safety razor of the invention is one having three blades; Teaches preferred embodiments which vary the configuration of the blades but in no way changes the number of blades of the invention; and Discourages the use of more than two blades in a blade unit except for the three-bladed blade unit having the claimed geometry. I believe these teachings together clearly demonstrate that the inventors did not regard a blade unit with four blades arranged in the described geometry as their invention. Therefore, "comprising" and "group of" should not be construed to include a safety razor having more than three blades."
  • 70. Judge Archer's Dissent in the Razor War – "Group of" Is Open But . . . Dissent continued: "Anyone reading the '777 patent would be left with the indelible impression that the patentee had invented a three-bladed, and only three-bladed, safety razor with blades having the described variable blade span and blade exposure. Only with a crystal ball could a competitor in the safety-razor industry have concluded that the '777 patent could cover a four-bladed razor."
  • 71. Take Away Points re Markush Claims and Alternative Limitations While it is best to avoid alternative limitations in independent claims when possible, they are often vital. How should alternative limitations be recited to gain the claim construction desired?
  • 72. Take Away Points re Markush Claims and Alternative Limitations Closed group: "A group consisting of A, B, and C" (MPEP §2173.05(h) Closed group that includes combinations: "A group consisting of A, B, C, and mixtures thereof." (Abbott v. Baxter) Includes combinations: "at least one member of the group." (Abbott v. Baxter) If a closed term is used, qualifying language such as "combinations thereof" should be added when appropriate.
  • 73. Take Away Points re Markush Claims and Alternative Limitations It is stated in MPEP§2173.05(h) that it is improper to use the term "comprising" instead of "consisting of." Ex parte Dotter, 12 USPQ 382 (Bd. App. 1931). Closed transition terms such as "consisting of" should be avoided in preference of open terms such as "is." MPEP §2173.05(h) specifies that the following format for Markush groups is acceptable: "wherein X is A, B or C." Consider the following formats for Markush groups which have open transition terms and cover combinations: Wherein X is at least one of A, B or C. With at least one X chosen from A, B or C. 505982