DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 2-16, 18-28, 30, 32-33, 35-40, 42-53, 55-56, 58-71, 73-82, and 84-92 have been cancelled. Claims 93-103 have been newly added.
Applicant is advised that the 10/15/2025 claim set did not include the status of claims 73-82. Claims 73-77 were cancelled in the response filed 4/12/2024. Claims 78-82 were cancelled in the response filed 4/30/2025. Applicant must file a new claim set with their next response where the status of each claim is set forth.
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
Claim 34 is allowable in view of the claim amendments. New claims 102-103 depend upon claim 34 and are also allowable.
Claim 29 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Applicant is advised that should claim 95 be found allowable, claim 99 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17 and 93-101 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 17 has been amended into independent form and no longer depends upon claim 1. The language of “at least 90% amino acid sequence identity” to SEQ ID NOS: 18 and 22 permits mutation within the CDR regions responsible for antigen binding. The recited CDR sequences in claim 1 are no longer required to be retained in the antibodies of claim 17 because claim 17 is no longer dependent upon claim 1. The genus of antibodies claimed is not adequately described. While anti-human PD-L1 antibodies having the VH and VL CDRs of instant claim 1 are adequately described, no reasonable structure-function correlation has been established that is commensurate in scope for VH and VL having CDRs that differ from those of claim 1. Amino acid changes in the CDRs of an antibody would have been known to affect binding properties. The specification does not describe representative examples to support the full scope of the claims.
The genus of antibodies encompassed by claim 17 and dependent claims is not adequately described.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The ’280 patent has inventors Altintas, Satijn, Rademaker, Parren, Sahin, Gieseke, Muik, Grunwitz and applicants Genmab A/S and Biontech SE.
The ‘395 patent and the co-pending 17/821,837 patent application has inventors Altintas, Satijn, Rademaker, Parren, Sahin, Gieseke, Muik, Grunwitz, Van den Brink, and Verzijl and applicants Genmab A/S and Biontech SE.
The instant application has inventors Altintas, Satijn, Van den Brink, Verzijl, Rademaker, Parren, and De Goeij and applicant Genmab A/S.
That is, the inventorship and applicants are not identical.
Claims 1, 17, 31, 41, 54, 57, 83, 93, 95-99, and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,968,280.
Although the claims at issue are not identical, they are not patentably distinct from each other because the PD-L1 antibody in the issued claims having a VH of SEQ ID NO: 17 and a VL of SEQ ID NO: 21 corresponds to a PD-L1 antibody meeting the limitations of the claims. In particular, the multispecific antibodies of the issued claims meet the limitations of instant claim 31, 41, 54, 95-97, and 99. With respect to instant claims 83 and 101, it would have been obvious and conventional to add a pharmaceutically acceptable carrier to the antibodies of the issued claims. Issued SEQ ID NO: 17 (containing the CDRs of SEQ ID NOS: 18, 19, and 20) corresponds to instant SEQ ID NO: 18 (containing the CDRs of instant SEQ ID NOS: 19, 20, and 21) and issued SEQ ID NO: 21 (containing the CDRS of SEQ ID NO: 22, DDN, and SEQ ID NO: 23) corresponds to instant SEQ ID NO: 22 (containing the CDRS of instant SEQ ID NO: 23, DDN, and SEQ ID NO: 24).
The instant claims are not patentably distinct from the issued claims.
Claims 1, 17, 31, 41, 54, 57, 83, 93, 95-99, and 101 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,459,395.
Although the claims at issue are not identical, they are not patentably distinct from each other because the PD-L1 antibody in the issued claims having a VH of SEQ ID NO: 17 and a VL of SEQ ID NO: 21 corresponds to a PD-L1 antibody meeting the limitations of the instant claims. In particular, the multispecific antibodies of the issued claims meet the limitations of instant claim 31, 41, 54, 95-97, and 99. With respect to instant claims 83 and 101, it would have been obvious and conventional to add a pharmaceutically acceptable carrier to the antibodies of the issued claims. Issued SEQ ID NO: 17 (containing the CDRs of SEQ ID NOS: 18, 19, and 20) corresponds to instant SEQ ID NO: 18 (containing the CDRs of instant SEQ ID NOS: 19, 20, and 21) and issued SEQ ID NO: 21 (containing the CDRS of SEQ ID NO: 22, DDN, and SEQ ID NO: 23) corresponds to instant SEQ ID NO: 22 (containing the CDRS of instant SEQ ID NO: 23, DDN, and SEQ ID NO: 24).
The instant claims are not patentably distinct from the issued claims.
Claims 1, 17, 31, 41, 54, 57, 72, 83, 93, 95-99, and 100-101 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 89, 101, 104-105, 116-118, 123-124, and 127-128 of copending Application No. 17/821,837 (11/26/2025 claim set). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of copending application 17/821,837 are directed to multispecific antibodies that bind to human CD137 and human PD-L1. Copending claim 104 as it depends upon claim 89 requires a VH of SEQ ID NO: 17 and a VL of SEQ ID NO: 21 for binding to human PD-L1. SEQ ID NO: 17 is identical to instant SEQ ID NO: 18. SEQ ID NO: 21 is identical to instant SEQ ID NO: 22. Claim 101 as it depends upon claim 89 requires the CDRs for SEQ ID NOS: 17 and 21. Co-pending claims 118 and 123-124 disclose the limitations of instant claims 72 and 100. With respect to instant claims 83 and 101, it would have been obvious and conventional to add a pharmaceutically acceptable carrier to the antibodies of the issued claims.
The instant claims are not patentably distinct from the co-pending claims.
This application is a CON of U.S. Patent No. 11,459,395.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. The co-pending application is senior to the instant application with respect to patent term filing date.
Applicant’s arguments with respect to the double patenting rejections set forth above are not persuasive.
Ex parte Baurin is not a precedential Board decision and is therefore not binding.
Applicant argues that none of the reference patents or patent applications qualifies as an NSDP reference because each reference patent or patent applications has a later patent term filing date compared to the instant application and expires later than any patent issuing from the instant application.
Applicant relies on several Federal Circuit cases including Allergan USA, Inc. V. MSN Lab ys Priv. Ltd., 111 F.4th 1358 (Fed. Cir. 2024); In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023); Novartis AG V. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018); Novartis Pharms. Corp. V. Breckenridge Pharm. Inc., 909 F.3d 1355 (Fed. Cir. 2018); Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014); Acadia Pharms. Inc. v. Aurobindo Pharma Ltd., 706 F. Supp.3d 477 (D. Del. 2023), aff'd, 2025 WL 1618201 (Fed. Cir. June 9, 2025)).
The case law relied on has limited application in this case. Ezra Ventures addresses the interaction between patent term extension ("PTE") under 35 U.S.C. § 156 and obviousness-type double patenting. 909 F.3d at 1373-74 ("[O]bviousness- type double patenting does not invalidate a validly obtained PTE."). Cellect grapples with the issue of how patent term adjustment ("PTA") affects an obviousness-type double patenting ("ODP") analysis. 81 F.4th at 1226-29 ("ODP for a patent that has received PTA, regardless whether or not a terminal disclaimer is required or has been filed, must be based on the expiration date of the patent after PTA has been added."). In Breckenridge, the court encountered a "particular situation" involving "an earlier-filed, earlier-issued, pre-URAA patent that expires after the later-filed, later-issued, post-URAA patent due to a change in statutory patent term law." 909 F.3d at 1366. The court used the pre-URAA patent's issuance date as the reference point for its obviousness-type double patenting analysis. Id. The Gilead court answered "a narrow question: Can a patent that issues after but expires before another patent qualify as a double patenting reference for that other patent?" and "h[e]ld that an earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent under the circumstances here." 753 F.3d at 1211-12, 1217. And the Allergan court answered a different but equally narrow question: "can a first-filed, first-issued, later-expiring claim be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date?" and "h[e]ld that it cannot. "111 F.4th at 1366. Acadia "is entirely controlled by" Allergan and "appl[ied] Allergan's holding that 'a first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date. 2025 WL 1618201 at * 1 (quoting Allergan, 111 F.4th at 1369). The facts that underpinned the Federal Circuit's holdings in those cases are different from the facts in this case. A case that has a similar fact pattern to the instant case is In re Fallaux, 564 F.3d 1313, 1316 (Fed. Cir. 2009). Fallaux is a precedential decision.
In Fallaux, the examiner rejected the pending claims in the Fallaux application for obviousness-type double patenting over certain claims of two reference patents. 564 F.3d at 1314-15. The Fallaux family of applications originated in a PCT application filed in June 1995. Id. at 1315. The first U.S. application in the family was filed in March 1997. Id. The Fallaux application was the fifth continuation application, claiming priority to the 1997 application. Id. The reference patents were filed in June 1998 and July 1999, respectively, and issued in July 2002 and January 2002, respectively. Id. The Board of Patent Appeals and Interferences, affirmed the examiner's rejection. Id. at 1314-15. And the Federal Circuit affirmed the Board's decision. Id. at 1319.
Like this case, the reference patents in Fallaux have later patent term filing dates compared to the application under examination. Because they are post-URAA patents, they would expire twenty years from the patent term filing dates. See Allergan, 111 F.4th at 1367 (explaining that post-URAA, "a patent's term is now measured from its effective filing, or priority, date"). The application under examination was also filed post-URAA, and thus, any patent issued from the application would expire before the reference patents expired. Yet, the Federal Circuit upheld the Board's decision, affirming the NSDP rejection of the pending claims over the reference patents with later patent term filing dates and later expiration dates because "there is a second justification for obviousness-type double patenting - harassment by multiple assignees." Fallaux, 564 F.3d at 1318.
In Fallaux, the Federal Circuit relied on a different "justification for obviousness-type double patenting-harassment by multiple assignees" in upholding the Board's decision affirming the NSDP rejection. 564 F.3d at 1319. The court later applied the multiple-assignee-harassment rationale again. See Hubbell, 709 F.3d 1147-48 ("Because it is undisputed that an infringer of the [reference] patent would also infringe the application [under examination], the multiple assignee harassment justification adopted in Van Ornum and reaffirmed in Fallaux applies here."); see also Cellect, 81 F.4th at 1230 (concluding "the Board did not err in determining that a risk of separate ownership existed and, even in the absence of separate ownership, that a terminal disclaimer would have been required to ensure common ownership" and stating "[w]hile [the patent owner] has not engaged in actions that resulted in divided ownership in the past, and it has promised that it will not do so in the future, neither fact suffices to abrogate the potential future risk of multiple owners or assignees").
The guidance under MPEP § 804.02(VI) states that "it is appropriate for an examiner to require a terminal disclaimer that will address the risk of separate ownership even where it is possible that there would be no unjustified timewise extension of the right to exclude."
It is maintained that the double patenting rejections are proper.
Applicant is again advised that co-pending applications; 17/172, 698; 17/172,700; 17/289,602; 17/795,318; 18/038,818; 18/696,689; and 18/698,354 currently have claims directed to overlapping subject matter with the instant claims for human PD-L1 antigen-binding domains with identical sequences (although not necessarily having the same SEQ ID NOS). However, any provisional double patenting rejection would be withdrawn if it was the last remaining rejection as each of these co-pending applications is junior to the instant application with respect to patent term filing date. As such, no provisional double patenting rejections will be made at this time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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