Claim amendments during prosecution of a patent application is a common practice. Applicants make such amendments, voluntarily or in response to objections raised in the office actions, to secure grant of their patent applications. Under Indian Patent Law, said amendments are governed by Section 59(1)[1] of the Patents Act, 1970 that outlines the framework for amending application for a patent or a complete specification or any document relating thereto. Said section states that claim amendments must be restricted to the ‘purpose of incorporation of actual fact’ and that the amendments must be affected by way of ‘disclaimers, corrections, or explanations. The intent behind this provision is to maintain the integrity of the as-filed application while allowing for necessary amendments, without introduction of any new subject matter that was not originally disclosed.

Even though amendment of claims is a common practice across globe; there has been indeterminacy and confusion surrounding the scope of allowable claim amendments due to varying interpretations of the statute, leading to a myriad of opinions, leading to ambiguity in what is allowable. Since different Controllers at the IPO interpret Section 59(1) differently, there was no clarity with regards to permissible claim amendments. ‘Literal construction with faithful adherence to the plain words of the statute’[2] was considered as a golden rule of interpretation. Accordingly, Section 59(1) was construed to strictly mean that any amendment of claims, which led to the scope of amended claims not being falling wholly within the scope of originally filed claims, were forbidden. In other words, the scope of the originally filed claims and the amended claims was required to be the same. Consequently, even applications having potential inventive merit were being rendered non-patentable. Issues were faced in the matters of subject matter eligibility, wherein it may have been required to incorporate subject matter from the specification, to meet the patentability requirement.

However, over time, jurisprudence in India, regarding claim amendments, has evolved positively, with various judgements being passed that has helped in providing the much-needed clarity. In this regard, the judgements in Nippon A&L Inc. vs The Controller of Patents[3] and Allergan Inc. vs The Controller of Patents[4] have emphasized the need to construe amendments more liberally than narrowly and the importance of considering claims and specification without dichotomizing the two. After said rulings, the examiners at the IPO have become more receptive to allowing addition of subject matter from the specification, as opposed to being restricted to only the originally filed claims, while evaluating the scope of claim amendments.

The present article discusses recent judgements pertaining to Section 59(1) that provide the various benchmarks and parameters to be considered while evaluating the scope of claim amendments. While the judgements underscore the need to understand the substance of claims by the examiners; applicants are also advised to exercise caution while making amendments without expanding the scope of claims to mitigate the risk of rejection of a patent application.

Benchmarks and Parameters for Evaluation of Claim Amendments

In The Regents of The University of California vs Controller General of Patents, Design and Trademark & Anr.[5], an appeal was filed by the appellant (The Regents of The University of California) under Section 117A against an order passed by the respondent (Assistant Controller of Patents and Designs) rejecting the Patent application no. 10336/DELNP/2013. Said application was objected for lack of novelty, obviousness and subject matter eligibility under Sections 3(i) and 3(k) in the First Examination Report (FER) issued. In response to the objections raised in the FER, amendments were made to restrict the claim scope. However, the respondent was not convinced and a hearing notice was issued in the matter retaining all the objections. The amended claims filed were additionally objected under Section 59(1). In order to overcome said objections, further claim amendments were undertaken. The application was again refused under Section 59(1) alleging that the amended claim 1 was beyond the scope of the originally filed claim.

While the respondent alleged that the claim amendments were not permissible under Section 59(1), the appellant contended that the impugned order passed by the respondent was ‘whimsical’, being based on a faulty and incorrect interpretation of Section 59(1). It was submitted that the amended claims were narrower in scope and that they were already disclosed in the originally filed claims and the specification. The appellant argued that while assessing the amendments made, the respondent failed to appreciate the invention and its ‘substance’ from the perspective of a ‘person skilled in the art’ and that the ‘test for added subject matter’ was not applied. The appellant provided detailed reasoning with a comprehensive comparative chart, depicting all the claim amendments made during the entire course of prosecution, to assert that the amendments made were in accordance with Section 59(1).

After due consideration of the submissions made by both the parties, the Court delineated the six parameters, for evaluation of scope of claim amendments as envisaged under Section 59(1) of the Act. The Court stated that:

(i) Disclaimer; or

(ii) Correction; or

(iii) Explanation.

Additionally, the proposed amendments must be tested against the following parameters:

(iv) Amendment should serve the purpose of incorporation of actual facts;

(v)   Effect of the amendment should not allow matter not in substance, disclosed originally or shown in the specification;

(vi) Amended claim of the specification should fall within the scope of the original claim of the specification.”

Based on said criteria; the Court methodically evaluated the claim amendments, and noted that the amendments undertaken were in accordance with Section 59(1). The Court further opined that, “amendments serve only as an explanation to the original claims, amount to incorporation of actual facts, and do not disclose any matter which was not originally disclosed in the claims of specification filed before the amendment”. The impugned order was thus, set aside for being based on flawed interpretation of Section 59(1). The appeal was allowed and the patent application was remanded back for fresh consideration.

Understanding of Claim Substance is Crucial for Determination of Claim Scope

The importance of understanding the ‘substance’ was highlighted by the Madras High Court in Techpolymers Industria E Comercio LTDA vs. The Deputy Controller of Patents and Designs[6]. In said case, an appeal was filed by Techpolymers (appellant) against the rejection order issued by the Deputy Controller of Patents and Designs (respondent) with respect to the application number 7994/CHENP/2012 related to use of a lubricated thermoplastic polymer for the preparation of the injected-molded articles.

In response to the FER issued in the matter, amended claims were filed by the appellant along with detailed explanations with respect to the cited prior art documents (D1-D4). A hearing notice was then issued in the matter, wherein the respondent had raised an objection under Section 59(1) alleging that the amended claim goes beyond the original filed claim. Further claim amendments were undertaken, however, the application was refused by the respondent for Lack of Inventive step under Section 2(1)(ja) and Section 59(1).

During the appeal proceedings, the appellant argued that the submissions made by them, in response to FER and the hearing, were not duly considered by the respondent while arriving at the impugned order. Further, more weightage was given to the language than the ‘substance’ of the invention.

The Court observed that the ground of ‘lack of inventive step’ was unfounded as the explanations placed on record by the appellant were not considered. It was further noticed that the respondent had focused more on the ‘semantics of the language employed’ rather than ‘the substance of the invention and the specification’. A comparison of the originally filed claim and the amended claim revealed that the objection under Section 59(1) was also invalid. While the original claim recited, “the use of a lubricated polyamide for the preparation of articles by injection molding”; the amended claim read, “A method of preparing an article, the method comprising injection molding the article using a lubricated polyamide”. While this change in terminology from ‘use’ to ‘method’ was construed as broadening of the claim scope by the respondent; the Court found it otherwise. As per the Court’s understanding and analysis, “the original claim uses the word ‘use of lubricated polyamide’ whereas, the amended claim conveys the idea that it relates to the method of using the same substance”.In this context, the Court also emphasized upon the requirement to look into the ‘substance’ of the invention rather focusing merely on the use of words. The Court stated that, “Section 59 is not intended to be used for wrong understanding of the language employed by an applicant, since an applicant will also be a person of science and not of language.”

The Appeal was thus, allowed and the matter was remanded back for a de novo consideration with directions that the claims be considered by some other Controller.

The issue regarding focus on the ‘semantics of language’ rather than the ‘substance of the invention’ and rejection of patent applications based on erroneous understanding of the concept in question, was again deliberated in Toyota Jidosha Kabushiki Kaisha vs The Assistant Controller of Patents and Designs[7]. In said matter, an appeal was filed by the Toyota Jidosha Kabushiki Kaisha (appellant) to set aside a refusal order passed by The Assistant Controller of Patents and Designs (respondent) in respect of the patent application no. 6305/CHENP/2010 titled, “Gene For Increasing the Production of Plant Biomass and/ or Seeds and Methods for Use thereof". On not being satisfied with response to the FER (First Examination Report) a hearing notice was issued for the application by the respondent. In the hearing notice issued, objections with respect to non-patentable subject matter under Sections 3(j)[8] and lack of Inventive Step were retained. At the time of filing the written submissions, one word amendment was made to the independent claim by inserting the word ‘in vitro’, which according to the appellant was made in accordance with the respondent’s suggestion during the hearing. The rejection order passed in the matter cited all the Sections as referred to in the hearing notice along with Section 59.

During the proceedings, it was argued by the appellant that the invention under consideration involved two aspects namely, artificial creation of a gene sequence and insertion of said sequence into the plant genome to increase the production of biomass. The insertion of sequence is not practically feasible without human intervention. The use of the word ‘in vitro’ is thus, superfluous in the context of the invention. Accordingly, the conclusion drawn by the respondent that insertion of said term led to broadening the scope of the claim was faulty and clearly reflected the incorrect conceptual interpretation.

The Court concluded that the incorporation of the term ‘in vitro’ did not lead to expansion of the claim scope under Section 59 and underscored the importance of focusing on the scientific merit of the invention and understanding of the context rather than emphasizing on the semantics of language employed to describe the scientific concepts. The appeal was thus, allowed and the matter was remanded back to the Patent Office for re-consideration.

As evident from the judgements discussed above, it is very crucial to understand and appreciate the invention before determining the scope of amended claims. Further, based on the various judicial precedents regarding scope of claim amendments under Section 59; it is a settled position in Indian Patent Law that if proposed claim amendments lead to narrowing down of the claim scope; they ought to be allowed. However, in case, the scope of claims is expanded to include subject matter that is not originally disclosed; said amendments shall be disallowed.

Permissible Claim Amendments: Balancing the Scope

Permissibility of claim amendments is judged solely on the ascertained scope. The Courts have reiterated time and again that ‘narrowing’ of claim scope is allowable. In a recent judgement in Honeywell International Inc vs. The Controller of Patents[9], relying on various judicial precedents, the Court echoed that if the amendments carried out lead to chiselling of the original claims, without including any additional subject matter not disclosed in the original claims or the specification; they ought to be allowed. In said case, during the prosecution, the ‘composition’ claims were reworded as ‘compound’ claims deleting the composition aspect. The application was rejected on the premise that the amendments were beyond the scope of the originally filed claims. Even though the rejection order did not cite Section 59 and no reasoning was proffered, it was evident that application was refused as per said provision. The analysis of the claim amendments undertaken revealed that “the original claim of a composition comprising the compound had been simply pared down [narrowed down] to the claim in the compound itself”. No different compound had been claimed post amendment. It was held that, “the amended claim was of the compound which was a subset of the original claim, which was of composition containing the compound.” It was emphasised that the amendments must be read expansively before acceptance. Accordingly, the amendments were found to be allowable. The rejection order was thus, set aside remanding the matter back for fresh consideration.

While narrowing down the scope of claim amendments is allowed; broadening of claim scope is forbidden. Accordingly, when amending the claims during the prosecution stage, utmost caution must be exercised by the applicant to ensure that claim scope is not unnecessarily expanded leading to potential rejection of the application. In a recent judgement passed by the Delhi High Court in Ovid Therapeutics, Inc. vs Assistant Controller of Patents and Designs[10], it was held that a patent application is not liable to be granted if there is broadening of the scope of claims after amendments and if there is not enough data to demonstrate significant enhancement of therapeutic efficacy. In said case, an appeal was filed by the appellant (Ovid therapeutics, Inc.) against the refusal order issued by the Assistant Controller of Patents and Designs (respondent), with respect to the appellant’s patent application no. 201717000025. The application titled “Methods of increasing tonic inhibition and treating secondary insomnia” filed with 28 claims relating to a method of increasing tonic inhibition of neurons was objected on various grounds such as lack of novelty and inventive step, non- patentability under Sections 3 (i) and 3 (e) of the Act as well as lack of definitiveness and insufficiency of disclosure under Sections 10(4)(c) & 10(5) of the Act. In view of the objections raised, the method claims were amended to recite a composition. A hearing was appointed in the matter and the written submissions were duly filed. However, the application was refused citing various grounds including broadening of the scope of claims in violation of Section 59.

During the appeal proceedings, the appellant contended that the amended claims were clearly and succinctly based on the subject matter disclosed in the specification and thus, fell within the scope of the originally filed claims. However, the respondent argued otherwise. While deliberating upon the question of whether the amended claims were within the scope of the originally filed claims; the Court analysed the amended claims vis-à-vis the originally filed claims to ascertain the scope of amended claims. Said analysis revealed the following differences:

(a) Amended claim did not contain the limitation of the originally filed claim 1. Also reference to the specific disease for which the composition was intended was removed.

(b) While the original claim was directed to a method; the amended claim related to a composition.

(c) The amended claim specified the range of Gaboxadol that was not there in the originally field claim 1.

While the last two amendments led to narrowing of the scope; the first amendment (as referred to above) led to expansion of the claim scope due to the omission of the name of the disease. The Court observed that “the field of description clearly describes that the method and composition is to be used for the purpose of treating secondary insomnia and the fact that the medical condition is not written in the amended claims show that the same has gone beyond the specification as also the description of the invention.” Accordingly, it was concluded that the scope of the claims before the Court at the stage of appeal was broader than the originally filed claims. Therefore, the objection raised under Section 59 of the Act was found to be tenable and the Appeal was dismissed.

Said judgement underscores the potential risk of rejection of an application, if the claim scope is broadened during the prosecution stage. Therefore, the onus is also on the applicant to ensure careful evaluation of the scope of claim amendments. Striking a balance while deciding the scope of claim amendments is very critical for obtaining desired protection. While the IPO can be held accountable if paring down of claim scope is not allowed and remedial measures can be taken; expansion of claim scope can lead to potential rejection.

Issuance of Rejection Orders and Responsibilities of the Indian Patent Office (IPO)

It has been recently observed that the Courts are coming down heavily on the IPO in matters wherein it is found that unreasoned orders have been issued violating the principle of natural justice and where the applicants are either not provided a chance to present their submissions or the submissions made are not taken on record. While deciding appeals related to rejection orders issued under Section 59, said matter came to the fore yet again in two of the recent judgements: Genomatica Inc. v. The Controller of Patents and Designs[11] and Regeneron Pharmaceuticals, Inc. v.. The Assistant Controller of Patents and Designs[12].

In Genomatica Inc., it was observed that the Controller rejected the application based on an earlier set of claims, under Sections 10(4) and 19(5), that was filed since the amended claims on record were not found to allowable under Section 59. Therefore, the judgement was passed on the “given up amendments” without providing the appellant to present their submission with regards to objection under Section 59. The Court held that, “when a set of claims undergoes amendments made to the existing claims, the amended claims get superimposed on the previous set of claims, and therefore, it is not permissible for the Controller to read something which is not before him/her.” It was emphasized that the respondent ought to have heard the appellant before issuing the impugned order.

In Regeneron, the application filed by the appellant (Regeneron Pharmaceuticals, Inc.) was rejected by the respondent (The Assistant Controller of Patents and Designs) due to non-compliance of the requirement under Section 59(1), without assigning any reason. The contention of the appellant that no new features have been incorporated in the claim was not considered. The Court held that being unreasoned, the impugned order was not sustainable in the eye of law. Accordingly, the matter was remitted for fresh consideration.

Concluding Remarks

Navigating claim amendments during prosecution of a patent application is one of the most critical and trickiest part to ensure that the desired claim protection is obtained. To arrive at allowable amendments is nothing less than a challenge. Till recently, when the statute governing claim amendments was being interpreted literally by the IPO, applicants were faced with various obstacles in securing grant of a patent application, which was probably not the case in other jurisdictions. However, with ‘purposive interpretation’ becoming the norm and multiple judicial precedents laying down the determinants and parameters that ought to be taken into account while considering the scope of claim amendments, the future of Indian patent landscape indeed looks promising. The evolving jurisprudence with regards to the interpretation of Section 59(1) has provided able guidance which would go a long way in effectively manoeuvring the path to successful grant of applications.