Patent application examination by abhishek nama bits pilani

BITS PilaniPilani Campus

PATENT APPLICATION EXAMINATION

BITS PilaniPilani Campus

Prepared By:-

Abhishek nama)

PHARMACEUTICAL SCIENCE;

BITS PILANI- PILANI CAMPUS. 2

BITS Pilani, Pilani Campus

OverviewExamination- In INDIARequest for examinationExamination procedureDifference in examination procedure

between INDIA & U.S.Usefulness of searching prior-arts.Case-studies.

CONTENTS:-

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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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Procedure For Obtaining A Patent:-

Rejection

Within 48 months


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

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• 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:-

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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.


• 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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http://www.jurisdiction.com/pact.htm




• 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

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• 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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• 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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• 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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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

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• 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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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

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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.:-

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• 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:-

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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:-


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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(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


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.

http://www.law.cornell.edu/uscode/text/35/101


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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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.

Indian IP Board Upholds Rejection of Plant StressTolerance Patent


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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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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