DETAILED ACTION
Disposition of Claims
Claims 1, 10, 18, 26, and 35-41 remain pending. Claims 2-9, 11-17, 19-25, and 27-34 remain cancelled. No amendments have been presented. Claims 1, 10, 18, 26, and 35-41 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of the parent application 2020/0237913 A1, Published 07/30/2020.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Of note, there is not an attorney of record on file due to a lack of an official power of attorney of record. While a customer number has been provided on the ADS submitted 01/23/2024, this is not the equivalent of a power of attorney or an authorization to act in a representative capacity. In order to expedite prosecution in the instant application, it is suggested that a power of attorney be filed as per MPEP §402 or MPEP §1807, or an Authorization to Act in a Representative Capacity be filed as per MPEP §403 in order for the Office to freely and openly discuss the merits of the case with the applicant's representative(s). Please refer to the Application Assistance Unit (AAU) at 888-786-0101, HelpAAU@uspto.gov, or https://www.uspto.gov/learning-and-resources/support-centers/application-assistance-unit-aau if you have questions regarding the proper filing of a power of attorney.
Response to Arguments
Applicant's arguments filed 03/17/2026 regarding the previous Office action dated 12/18/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Claim Interpretation
The claim scope and interpretation has not changed and can be found in a previous Office action.
Double Patenting
The text regarding nonstatutory double patenting was presented in a previous Office action.
(Rejections maintained in part and extended – necessitated by amendment.) Claims 1, 10, 18, 26, and 35-41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9,212,217 in view of Esue (supra);
Claims 1, 10, 18, 26, and 35-41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,365,639 in view of Esue (supra);
Claims 1, 10, 18, 26, and 35-41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,155,806 in view of Esue (supra);
Claims 1, 10, 18, 26, and 35-41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,059,883 in view of Esue (supra);
Claims 1, 10, 18, 26, and 35-41 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,054,539 in view of Esue (supra).
The rationale behind these rejections over these related patents was set forth in a previous Office action, and will not be repeated herein.
(Rejection maintained in part and extended – necessitated by amendment.) Claims 1, 10, 18, 26, and 35-41 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 8-9, 11-13, and 19-30 of copending Application No. 18/752,260 in view of Esue (supra). The rationale behind this rejection was set forth in a previous Office action, and will not be repeated herein.
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the withdrawal of the prior obviousness rejections should also prompt the withdrawal of the NSDP rejections utilizing the same art, namely Robinson and Esue. The withdrawal of the prior obviousness rejection over Robinson and Esue is not determinative of whether a non-statutory double patenting rejection is appropriate. Obviousness under 35 U.S.C. §103 and non-statutory double patenting are distinct legal doctrines serving different purposes, as 35 U.S.C. §103 prevents patenting over prior art, while non-statutory double patenting (NSDP) prevents unjustified extension of patent term over claims that are not patentably distinct from claims in a commonly owned patent or a copending patent application. While Robinson and Esue were previously applied in a §103 rejection, the present NSDP rejections are not based on Robinson and Esue as prior art. Rather, the rejection is based on the claims of the reference patents and application themselves, which disclose the same antibody and the knowledge in the art (as evidenced and exemplified by Robinson and Esue) demonstrates that the instantly claimed formulation would have been an obvious modification.
The reference patents and application all claim the same antibody of instant claim 1. The instant claims are directed to a specific composition comprising said antibody at a specified concentration in a specific formulation. The difference between the claimed subject matter and the patented or copending claims is therefore limited to formulation parameters (e.g. concentration of antibody and buffer/reagent/excipient selection.) Optimization of antibody concentration and selection of pharmaceutically-acceptable carriers, buffers, excipients, and the like, is well within the routine skill in the art and the instantly claimed formulation represents conventional formulation choices, as evidenced by Robinson and Esue. As such, the claimed composition would have been an obvious variation of the antibody in the patent claims or copending claims.
Applicant’s argument appears to suggest that because the Office withdrew a prior obviousness rejection over Robinson and Esue that the Office is precluded from maintaining a NSDP rejection. This is factually incorrect. The withdrawal of the §103 may reflect, for example, limitations in the applicability of those references as prior art, but does not resolve whether the claimed invention is patentably distinct from the claims in a commonly owned patent or copending application. The purpose of a NSDP rejection, again, is to prevent an unjustified extension of exclusivity for subject matter that is not patentably distinct. Allowing a second patent on a routine formulation of the same antibody would effectively extend the patent term for the underlying invention (e.g. the antibody) without a meaningful inventive distinction.
Applicant further argues that a reference (in this instance, Robinson) cannot render itself obvious, and is understood in the limited sense that a disclosure cannot be used as prior art against its own claims. However, that principle is not applicable here. The present rejection is based on the claims of the reference patents or copending application, not on Robinson as prior art. Robinson is not relied upon as the legal basis for the rejections, but rather as evidence of the level of ordinary skill in the art at the time of filing and the routine nature of the claimed formulation. Moreover, to the extent that Applicant may challenge the availability of the teachings of Robinson, it is noted that Robinson was published prior to the effective filing date of the instant application and qualifies as prior art under 35 U.S.C. §102(a)(1). Thus, the teachings relied upon to demonstrate the routine formulation optimization were publicly available to a person of ordinary skill in the art.
The disclosure of Robinson explicitly contemplates the antibody of the instant claims and the patented and copending claims, as well as pharmaceutical compositions comprising said antibody. Robinson teaches that a skilled artisan knows such compositions and is well-aware of routinely optimizing said compositions. However, Robinson fails to teach the specific components of the formulations as instantly claimed, which is why the teachings of Esue were incorporated into this rejection to highlight what Robinson referenced, namely that the art was aware of how to optimize antibody formulations such as those instantly claimed, with the same buffers, excipients, and carriers as instantly claimed in the amounts as instantly claimed. Taken as a whole over the prior art, the instant claims are not patentably distinct from the patented or copending claims in the combined view of Robinson and Esue.
Accordingly, the rejections are maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/Primary Examiner, Art Unit 1671
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