1. BITS Pilani
Pilani Campus
PATENT
APPLICATION
EXAMINATION

2. BITS Pilani
Pilani Campus
PreparedBy:-
Abhisheknama)
PHARMACEUTICALSCIENCE;
BITSPILANI- PILANI CAMPUS. 2

3. BITS Pilani, Pilani Campus
Overview
Examination- In INDIA
Request for examination
Examination procedure
Difference in examination procedure
between INDIA & U.S.
Usefulness of searching prior-arts.
Case-studies.
CONTENTS:-
07/08/2013 3PHA G 545

4. BITS Pilani, Pilani Campus
A patent application can be filed at any of the four patent
offices in India (Kolkata, Delhi, Mumbai or Chennai). The
patent application passes through the following stages:
A. Filing
B. Publication
C. Examination
D. Opposition
E. Grant
OVERVIEW
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5. BITS Pilani, Pilani Campus
Procedure For Obtaining APatent:-
Rejection
Within 48
months

6. BITS Pilani, Pilani Campus
Whole examination contains two parts:-
(i) REQUEST FOR EXAMINATION
(ii) EXAMINATION:-
(a) Formal Examination
(b) Patentability analysis
(c) Searching for prior-arts
 Technical Expertise
 Uniformity in line with laws and regulations, and
guidelines
 Accuracy
 Fairness
 Transparency
EXAMINATION- IN INDIA
PHA G 545

7. BITS Pilani, Pilani Campus
• Examination is the process of ensuring that an application
complies with the requirements of the relevant patent
laws.
• The Request for Examination can be made by the Applicant
or by any other party and must contain the necessary
information for the Patent Office to recognize what
application is being requested to be examined [Patent
Rules, s. 149 and 95) by filing with the Patent Office a
Request for Examination in form 18 together with the
necessary fee [Patent Act, s. 11(B) and Rules 24(B)(1)] of
INR 2500 if the applicant is a natural person and INR 10,000
is the applicant is legal entity within 48 months from the
date of priority or filing whichever is later.
REQUEST FOR EXAMINATION:-
707/08/2012 PHA G 545

8. BITS Pilani, Pilani Campus
If PCT application is filed, and applicant wants to file their
application in INDIA then in national phase, the Request for
Examination can be made by the Applicant or by any other
party by filing with the Patent Office a Request for
Examination after expiry of 31 monthes in form 18 together
with the necessary fee (under rules 20(4)(ii)) of INR 3500 if
the applicant is a natural person and INR 14,000 is the
applicant is a legal entity.

9. BITS Pilani, Pilani Campus
• However, if secrecy directions have been given for the
application, the request can be made six months after the
directions are revoked or thirty six months from the
date of priority or filing, if that date is later.
• Where a timely Request is not filed, and the application
goes abandoned [Patent Act, s. 73(1)(d) and 73(1)(e)], the
Patent Office may reinstate the application upon
Request for Reinstatement, Request for Examination
and payment of the prescribed fee of INR 2500.00 by
natural person. [Patent Act, s. 73(3)]
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10. BITS Pilani, Pilani Campus
• On receiving the request, the controller shall direct the
patent application to the Examiner for examination. To
start with, the examiner makes a formal examination by
verifying the correctness of all documents filed with
the application. Later, he verifies the patentability of the
application. The patentability analysis includes the
existence of novelity, inventive step, Industrial
application, and Enablement and Best mode.
• After confirming that the application falls within the scope
of patentable subject matter, the examiner conducts a
prior art search to check if there is prior art, which
anticipates the invention claimed.
EXAMINATION
PHA G 545

11. BITS Pilani, Pilani Campus
• Prior art search for anticipation includes search for
anticipation by publication, filing of complete
specification, etc.
• The examiner will give the examination report within 1
month from the date of reference by controller and that
term shall not exceed three months.
• If the examination report is adverse, the controller sends
a notice to the applicant and gives him an opportunity to
correct and if necessary an opportunity of hearing.
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12. BITS Pilani, Pilani Campus
• The Controller might ask the applicant to amend the
application in order to proceed further. If the applicant
does not make such changes, the application might be
rejected.
• The Controller has the power to divide the application,
post date the application, substitute applicants and reject
the application.
• An order of division will be given if the application
contains more than one invention and if it is required to
file separate applications for each invention.
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PHA G 545

13. BITS Pilani, Pilani Campus
• The application might be post dated to a period of six
months if requested by the applicant.
• Substitution of inventors is generally done if the inventor
has been wrongfully mentioned or if a joint inventor has
not been mentioned in the application.
• The controller has the power to reject the application, if
the applicant does not comply with his requirements.
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PHA G 545

14. BITS Pilani, Pilani Campus
i. Classification of patent applications according to subject
matter group at the time of receipt of application.
ii. Determination of priority date on a claim basis (rather
than entire application).
iii. Responsibilities of Examiner
iv. Responsibilities of the Controller
PROCEDURE OF PATENT
APPLICATION EXAMINATION IN INDIA
PHA G 545

15. BITS Pilani, Pilani Campus
• To conduct comprehensive investigation of an application and
prepare a report under section 12;
• Report to quote relevant pieces of prior art effecting patentability of
a claim and provide an extract thereof ;
• To conduct an inter-office search covering all four patent offices;
• To raise objections rather than comment on missing forms.
• The Examiner's report will be a permanent part of a file's note
sheet and non-editable at the Controller's end; Include a draft
summary/gist of objections-this gist editable by Controller at
end; Include any amendments to the complete specification;
• Examiner to comply with these instruction to submit the report to
the Controller.
Responsibilities of Examiner
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16. BITS Pilani, Pilani Campus
To consider the Examiner's report on a primary basis, controller can
add to the gist if in his opinion Examiner has missed a major point on
patentability;
Conduct hearings on the application: Examiner may be present and
sign the note sheet; Controller to record minutes of the what is
revealed in the meeting in the note sheet;
Responsibility of rejecting/accepting an application lies with
Controller;
In case Controller refuses an application, it will be noted in the note
sheet and a reasoned order of refusal to follow within
reasonable time;
Responsibilities of Controller
PHA G 545

17. BITS Pilani, Pilani Campus
In INDIA,
• SEARCHING THE PRIOR-ARTS
• EXAMINATION.
In U.S. , a separate search is not conducted,
but rather search and examination are combined. In such
case, a separate search report is not issued, and it is not
until the application is examined that the applicant is
informed of prior art which the patent office examiner
considers relevant.
Difference in examination
procedure in India and U.S.:-
PHA G 545

18. BITS Pilani, Pilani Campus
• The search report is useful to the applicant to determine
whether the application should be pursued or if there is prior
art which prevents the grant of a useful patent, in which case
the application may be abandoned before the applicant invest
further expense.
• The search report is also useful for the public and the
competitors, so that they may have an idea of the scope of
protection which may be granted to the pending patent
application.
Usefulness of searching prior-
arts:-
1807/08/2012 PHA G 545

19. BITS Pilani, Pilani Campus
After the application has been read and the claimed invention
understood, a prior art search for the claimed invention is made.
With the results of the prior art search, including any references
provided by the applicant, the patent application should be
reviewed and analyzed in conjunction with the state of the prior art
to determine whether the claims define a useful, novel, nonobvious,
and enabled invention that has been clearly described in the
specification. The goal of examination is to clearly articulate any
rejection early in the prosecution process so that the applicant
has the opportunity to provide evidence of patentability and
otherwise reply completely at the earliest opportunity. The
examiner then reviews all the evidence, including arguments
and evidence responsive to any rejection, before issuing the
next Office action.
Patent office action:-

20. BITS Pilani, Pilani Campus
Where the examiner determines that information
reasonably necessary for the examination should be
required from the applicant under 37 C.F.R. 1.105, such
a requirement should generally be made either prior to or
with the first Office action on the merits.
The nature of examination of patent application is follow the
37 C.F.R. 1.104 Nature of examination. In which
class c having rejection of claims.
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21. BITS Pilani, Pilani Campus
(1) Invention directed to a category of unpatentable invention.
(2) Invention clearly contrary to law of nature or not industrially
applicable.
(3) In case where the description of claims are so ambiguous that
the invention cannot be conceived.
(4) Invention, the detailed description of which is too unclear or
insufficient for a person skilled in the art to carry out the
claimed invention.
(5) If novelty and/or non-obviosness is not there, Examiner must cite
the best reference for rejecting the claim.
Grounds for rejection of patent
application

22. BITS Pilani, Pilani Campus
Association for Molecular Pathology, et
al. v. Myriad Genetics, Inc.
Prior to the case, the U.S. Patent Office accepted patents on isolated DNA
sequences as a composition of matter. It specifically challenging certain
claims in issued patents owned or controlled by Myriad Genetics that
cover isolated BRCA genes along with cDNA which are useful in methods
to diagnose propensity to cancer by looking for mutated DNA
sequences, and methods to identify drugs using isolated DNA
sequences.
Examiner reject the application :- The Patent Act defines the scope of
patentable subject-matter in 35 U.S.C. § 101; that laws of nature, abstract
ideas, and natural phenomenon cannot be patented.
The case was originally heard in Southern District Court of New York, which
ruled that all the challenged claims were not patent eligible. Myriad then
appealed to the Federal Circuit Appeals Court. The Circuit court
overturned the previous decision in part, ruling that isolated DNA which
does not exist alone in nature can be patented and that the drug
screening claims were valid, and confirmed in part, finding the
diagnostic claims unpatentable.

23. BITS Pilani, Pilani Campus
The plaintiffs appealed to the Supreme Court. On November 30, 2012,
the Supreme Court agreed to hear the plaintiffs' appeal of the
Federal Circuit's ruling. On June 13, 2013, in a unanimous decision,
the Supreme Court invalidated Myriad's claims to isolated genes.
The Court held that merely isolating genes that are found in
nature does not make them patentable.
Proponents of the validity of these patents argued that they encourage
investment in biotechnology and promote innovation in genetic
research.
Reason for rejection:- These patents stifle innovation by preventing
others from conducting cancer research, limit options for cancer
patients in seeking genetic testing, and are not valid because they
claim genetic information that is not inventive, but is rather
produced by nature.
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24. BITS Pilani, Pilani Campus
Monsanto Company’s application for a patent covering “a method of
producing a transgenic plant with increasing heat tolerance, salt
tolerance or drought tolerance.”
THE CLAIMED INVENTION. Claim 1 in the Monsanto application–the
only independent claim in the application–was directed to a method
of producing a transgenic plant comprising the following steps:
a) inserting into the genome of plant cells a recombinant DNA molecule
comprising a DNA encoding a cold shock protein, wherein said
DNA encoding said cold shock protein is operably linked to a
promoter and operably linked to a 3′ transcription termination DNA
polynucleotide;
(b) obtaining transformed plant cell containing said recombinant DNA;
(c) regenerating plants from said plant cells; and
(d) selecting a plant for increased heat tolerance, salt tolerance, or
drought tolerance.
IndianIPBoardUpholds RejectionofPlant Stress
TolerancePatent

25. BITS Pilani, Pilani Campus
THE PATENT OFFICE’S DENIAL OF THE APPLICATION. The patent office
refused Monsanto’s application on the grounds that the claimed invention
lacked an inventive step in view of several items of prior art, including an
article in the Journal of Bacteriology and two prior patent applications.
According to the patent office, the structure and function of the “cold shock
protein” was already known in cited prior art and was obvious to a person
skilled in the relevant art. The patent office further determined that the
invention claimed by Monsanto was the mere application of an already
known cold shock protein in producing cold stress tolerant plant and tolerant
to heat, salt and drought conditions.
Moreover, the office found that the claims included the “essential biological
process of regeneration and selection, which includes growing of [a] plant in
[a] specific stress condition.”
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26. BITS Pilani, Pilani Campus
NO CLAIM TO AN ESSENTIALLY BIOLOGICAL PROCESS. In its
July 5 opinion, the Appellate Board disagreed with the determination
that the application disclosed an “essentially biological process” that
was statutorily excluded from patent eligibility. The Board reasoned
that the method claimed by Monsanto–
… is a method that includes an act of human intervention on a plant cell
and producing in that plant cell some change. Therefore the
[Controller of Patents] erred in finding this method as essentially
biological process and excluded under section 3(j) [of the Patents
Act 1970]. We set aside his findings to that extent.
OBVIOUSNESS AND LACK OF NOVELTY. Monsanto’s victory on the
exclusion issue, however, was insufficient to reverse the office
action denying its application. The Board wrote that it “confirm[ed]
and concur[red] with the findings” of the patent office with regard to
the lack of novelty and obviousness of the claimed invention.
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27. BITS Pilani, Pilani Campus
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