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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/31/2026 has been entered.
Applicant’s amended claims, filed 3/31/2026, is acknowledged.
Claims 1-31, 34, and 51 are cancelled.
Claims 32, 33, 35-50, and 52 are currently pending.
Claims 40-42 and 48-50 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Claims 32, 33, 35-39, 43-47, and 52 are under examination directed to a monospecific antibody that binds to PD-1.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/31/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner in its entirety.
Claim Objections
Claim 52 currently recites “…antibody of monoclonal claim 32…” and should most likely recite “…monoclonal antibody of claim 32…” to correct a minor typographical error.
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.
Claim 52 is 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 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 52 uses open language “a heavy chain amino acid sequence comprising SEQ ID NO: 16” and “a light chain amino acid sequence comprising SEQ ID NO: 12”, the phrase results in an antibody comprising the claimed antibody or any portion of the claimed sequences. For example, the claim terminology “a heavy chain amino acid sequence comprising SEQ ID NO: 16” does not place size limits on the heavy chain sequences, but rather reads on any portion of the claimed sequence of SEQ ID NO: 16. The sequences are generic with respect to size, encompassing anything from dimers on up to the full size of the claimed SEQ ID NOs.
It is recommended to amend the claim to recite, for example, “the heavy chain amino acid sequence set forth in SEQ ID NO: 16” and “the light chain amino acid sequence set forth in SEQ ID NO: 12” to resolve this issue.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 32, 33, 35-39, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clinical Trial NTC03352531 (1/18/2018 version, in Office Action mailed 11/03/2025), as evidenced by Mislang et al. (Annals of Oncology, Volume 31, S1300 – S1301, 157P, in Office Action mailed 11/03/2025) and Köhler (Nature. 1975 Aug 7;256(5517):495-7. doi: 10.1038/256495a0).
The claims are anticipated for the same reasons set forth in the previous Office Action mailed on 11/03/2025.
Applicant’s arguments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the Office cites In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), but the facts of the instant case are different from the facts of the present case and cited prior art. Applicant argues that the cited prior art teaches the name of the antibody encompassed by the instant claims, penpulimab/AK-105/12C12H1L1(hGITM), but not the amino acid sequence of the antibody. Applicant further argues that the cited prior arts are not enabling because the amino acid sequence of penpulimab was not taught.
This has been found to be not convincing.
Regarding the prior art teaching the claimed antibody, the prior art teaches the antibody clone penpulimab. The amino acid sequence of this antibody structure are considered inherent to the penpulimab antibody. Applicant argues (remarks pg. 7): “[t]here is no evidence in the record that a skilled artisan could determine the non-disclosed sequence information based on the disclosure of the names alone”.
This has been found to be not persuasive because In re Crish, the applicant claimed an hINV promoter region based on its nucleotide sequence (i.e., recombinant/not a naturally occurring sequence). The claims at issue in re Crish “related to purified DNA molecules having promoter activity for the human involcrine gene (hINV)”. Id., 73 USPQ2d at 1365. The court held that the claimed promoter sequence designated as SEQ ID NO: 1 was obtained by sequencing the same prior art plasmid and was therefore anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. Id. At 1256 and 1259, 73 USPQ2d at 1366 and 1369. The Courts have held that there is no requirement that those of ordinary skill in the art know of the inherent property. See MPEP 2131.01(d) and MPEP 2112-2113.
Like the references in Crish, the prior art of NTC03352531 discloses a material (an antibody) containing the same sequence recited in the claims. It is undisputed that NTC03352531 discloses an antibody that contains the amino acids recited in Applicant’s claims. That disclosure is anticipatory, even if it was not until the present application that Applicants characterized penpulimab/AK-105/12C12H1L1(hGITM) by its amino acid sequences.
The disclosure of the CDRs, VH and VL of penpulimab/AK-105/12C12H1L1(hGITM) is only further characterization of otherwise old product.
Regarding the prior art as an enabling disclosure, the prior art names the specific antibody hybridoma clone that is claimed by the instant application. One with ordinary skill in the art can use this antibody clone information to produce the claimed antibody clone, for example by purchasing the hybridoma cells, culturing the cells, and then isolating the antibody from supernatant. For example, Köhler et al. teaches such methods of isolating antibodies from such hybridomas (pg. 495): “[w]e describe here the derivation of a number of tissue culture cell lines which secrete anti-sheep red blood cell (SRBC) antibodies. The cell lines are made by fusion of a mouse myeloma and mouse spleen cells from an immunized donor.”
Regarding newly added claim 52, these heavy and light chain sequences are also considered inherent to the penpulimab/AK-105/12C12H1L1(hGITM) antibody, meeting the claim limitations.
Therefore, the reference teachings anticipate the instantly claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 32, 35, 36, 38, 39, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN106977602A, on IDS submitted 9/21/2022, also provided with machine translation, in Office Action mailed 11/03/2025) in view of McCarthy et al. (US PGPub 20150337053, in Office Action mailed 11/03/2025), as evidenced by U.S. Patent No. 10,465,014 (Pat ‘014).
The claims are anticipated for the same reasons set forth in the previous Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant has amended claim 32 to recite “…wherein the heavy chain constant region of the monoclonal antibody comprises amino acid mutations consisting of only L234A, L235A, and G237A according to the EU number system.”
Applicant further argues that the Fc mutations have an unexpected effect on antibodies, and refers to Example 5 and Table 7 of the instant disclosure to demonstrate this unpredictability of these Fc mutations that have on antibodies with different VH/VL regions.
This has been found to be not convincing.
Regarding the amendments to claim 32, the claim now recites (emphasis added):
“…heavy chain constant region of the monoclonal antibody comprises amino acid mutations consisting of only L234A, L235A and G237A according to the EU numbering system, and wherein the monospecific antibody does not bind to an antigen that is not PD-1.”
Giving the broadest reasonable interpretation, the claim recites antibodies comprising the recited amino acid mutations consisting of only L234A, L235A, and G237A, which would encompass additional point mutations such as the additional mutations taught by McCarthy et al.
Regarding Applicant’s arguments of unpredictable results, the stated motivation to introduce the Fc mutations in the Office Action mailed 11/03/2025 is to reduce ADCC and CDC, which is achieved through reduced binding to Fc receptors and C1q. Table 7 of the instant specification discloses binding kinetics of different antibodies to C1q:
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Table 7 discloses that compared to its wildtype counterpart, 14C12H1L1 with the L234A, L235A, and G237A mutations have abolished binding to C1q, while 5C10H2L2 still has binding to C1q. However, a comparison of 5C10H2L2 binding to C1q with a wildtype Fc region was not measured to determine if the Fc mutations reduced C1q binding. To demonstrate that the anti-PD-LI mutant had unexpected results, it would need to be compared to its wild-type counterpart to show that the ADCC/CDC has increased over that of the wildtype after the mutations were introduced.
Applicant fails to show that the results were unexpected in the face of the teachings of McCarthy et al. that teaches the L234A/L235A/G237A Fe mutations reduce FcR and Clq binding, and therefore ADCC and CDC, when compared to the same antibody without these Fc mutations (Example 8), which is the outcome of adding these Fe mutations to the 14Cl2H1Ll anti-PD-I antibody, defeating Applicant's claim of surprising results. Rather, "expected beneficial results are evidence of obviousness of a claimed invention. Just as unexpected beneficial results are evidence of unobviousness. In re Skoner, 517 F.2d 947, 950 (CCPA 1975).
Additionally, U.S. Patent No. 10,465,014 (Pat ‘014) is provided as an evidentiary reference to demonstrate that 5C10HG2L2-IgG1mt has reduced/abolished CDC activity, as expected. Example 17 of Pat ‘014 teaches: “[t]he results demonstrate that 5Cl0H2L2-IgGlmt does not have CDC effect on HCC1954 cells.”, demonstrating that these Fc mutations reduced ADCC/CDC with this antibody as well. Therefore, the predictable result of the introduction of the L234A, L235A, and G237A mutations occurred with both the 14C12H1L1 and 5C10H2L2 antibody clones.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Gandhi et al. (N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16, in Office Action mailed 11/03/2025).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues (Remarks pg. 9): “Ghandi describes chemotherapy regimens in combination with pembrolizumab (a completely different anti-PD1 antibody that does not comprise Fc mutations) in the treatment of non-small cell lung cancer…”
This has been found to be not convincing. One with ordinary skill in the art would be motivated to combine the references for the reasons discussed in the Office Action mailed on 11/03/2025. Briefly, one with ordinary skill would be motivated to formulate the anti-PD-1 antibody of Li et al. in view of McCarthy et al. into pharmaceutical compositions to treat cancer with at least one additional therapeutic for the purposes of treating cancer such as non-small cell lung cancer, as taught by Gandhi et al.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-45 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (supra) in view of Bloom et al. (WO2009143526, in Office Action mailed on 11/03/2025).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues (Remarks pg. 9):
“As acknowledged by the Office on page 12 of the Final Office Action, Li is silent regarding Fc domain amino acid mutations. The Office cites Bloom as teaching the three claimed amino acid mutations. However, Bloom teaches these 3 amino acid mutations in the context of a monoclonal antibody targeting a completely different target - IL-21R. There is nothing in Bloom that teaches or suggests utilizing these three mutations in an antibody targeting a completely different target antigen - PD1. Bloom is, in fact, completely silent regarding alternative uses of these three amino acid mutations. As such, one of skill in the art would have no motivation to combine the teachings of Li and Bloom.”
Applicant further argues that the Fc mutations have an unexpected effect on antibodies, and refers to Example 5 and Table 7 of the instant disclosure to demonstrate this unpredictability of these Fc mutations that have on antibodies with different VH/VL regions.
This has been found to be not convincing. The L235A, L236A, and G237A Fc point mutations have an expected function of reducing ADCC and CDC levels of an antibody, as discussed supra. Bloom et al. teaches modifications to an antibody’s Fc region via point mutations that reduce ADCC and CDC. One with ordinary skill in the art would appreciate these alterations could be applied to any antibody’s Fc region regardless of the sequence of the VH and VL to achieve this function.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Keefe (WO2016164528, in Office Action mailed 11/03/2025).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the Fc region taught by Keefe was incorporated into antibodies that target FLT-1 and not PD-1, and therefore one with ordinary skill in the art would have no motivation to combine the teachings, and the Fc mutations have an unexpected effect on antibodies, and refers to Example 5 and Table 7 of the instant disclosure to demonstrate this unpredictability of these Fc mutations that have on antibodies with different VH/VL regions.
This has been found to be not convincing. The L235A, L236A, and G237A Fc point mutations have an expected function of reducing ADCC and CDC levels of an antibody, as discussed supra. Bloom et al. teaches modifications to an antibody’s Fc region via point mutations that reduce ADCC and CDC. Keefe teaches a heavy chain constant region with these mutations that ne with ordinary skill in the art would appreciate can be applied to any antibody’s Fc region regardless of the sequence of the VH and VL to make an antibody structure with the taught point mutations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 37 and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (supra) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Wong et al. (WO2016069727, in Office Action mailed 11/03/2025).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025. Newly added claim 52 is included because the combined references teach these heavy chain and light chain sequences, which are individually recited in claims 33 and 37.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Wong et al. does not teach Fc mutations (Remarks pg. 11). This has been found to be not convincing, as in the Office Action mailed on 11/03/2025 states that Wong et al. teaches an antibody light chain constant region sequence that can be used as the constant region of any light chain regardless of the variable region, and one would be motivated to do so to produce a full-length antibody with a variable region and a Fc region.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Gandhi et al. (supra).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that Gandhi et al. does not teach Fc mutations. This has been found to be not convincing, as in the Office Action mailed on 11/03/2025 states that Wong et al. teaches an antibody light chain constant region sequence that can be used as the constant region of any light chain regardless of the variable region, and one would be motivated to do so to produce a full-length antibody with a variable region and a Fc region.
This has been found to be not convincing. One with ordinary skill in the art would be motivated to combine the references for the reasons discussed in the Office Action mailed on 11/03/2025. Briefly, one with ordinary skill would be motivated to formulate the anti-PD-1 antibody of Li et al. in view of Bloom et al into pharmaceutical compositions to treat cancer with at least one additional therapeutic for the purposes of treating cancer such as non-small cell lung cancer, as taught by Gandhi et al.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 32, 33, 35-39, 43, 44, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NTC03352531 (supra) in view of Korman et al. (U.S. Patent No. 8,008,449, in Office Action mailed 11/03/2025).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the Office rejects all of the claims however only provides an articulated rationale to teach the combination of claim 47. However, as stated in the Office Action mailed on 11/03/2025, the teachings of NTC03352531 are discussed in the 35 U.S.C § 102 rejection supra and anticipate claims 32, 33, 35-39, and 52.
Applicant further argues that NTC03352531 does not teach the amino acid sequences of penpulimab/AK-105/12C12H1L1(hGITM), however this has been found to be not convincing for the reasons discussed in the 35 U.S.C § 102 rejection supra, and one with ordinary skill in the art would have motivation to combine the references for the same reasons discussed in the Office Action mailed on 11/03/2025.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 32, 33, 35-39, 45-47, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NTC03352531 (supra) in view of Gandhi et al. (supra).
The claims are rejected for the same reasons as set forth in the Office Action mailed on 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the Office rejects all of the claims however only provides an articulated rationale to teach the combination of claim 47. However, as stated in the Office Action mailed on 11/03/2025, the teachings of NTC03352531 are discussed in the 35 U.S.C § 102 rejection supra and anticipate claims 32, 33, 35-39, and 52.
Applicant further argues that NTC03352531 does not teach the amino acid sequences of penpulimab/AK-105/12C12H1L1(hGITM), however this has been found to be not convincing for the reasons discussed in the 35 U.S.C § 102 rejection supra, and one with ordinary skill in the art would have motivation to combine the references for the same reasons discussed in the Office Action mailed on 11/03/2025 to make the pharmaceutical/therapeutic compositions comprising the antibody, at least one other chemotherapeutic, and an acceptable excipient.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 32, 35, 36, 38, 39, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of McCarthy et al. (US PGPub 20150337053, in Office Action mailed 11/03/2025, supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 43 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45, and further in view of Korman et al. (U.S. Patent 8,008,449, in Office Action mailed 11/03/2025, supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Korman et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Korman et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Korman et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45, and further in view of Gandhi et al. (N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16, in Office Action mailed 11/03/2025, supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Gandhi et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of Bloom et al. (WO2009143526, in Office Action mailed on 11/03/2025, supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 and Pat ‘527, each in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45, and further in view of Keefe (WO2016164528, in Office Action mailed 11/03/2025, supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al., and further in view of Keefe, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 and Pat ‘527, each in view of Bloom et al., and further in view of Keefe, for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al., and further in view of Keefe et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-6 of U.S. Patent No. 12,076,398 (Pat '398, in Office Action mailed 11/03/2025)
claims 1-24 of U.S. Patent No. 12,195,527 (Pat '527, in Office Action mailed 11/03/2025)
each in view of Bloom et al. (supra) and Keefe (supra) as applied to claims 32, 33, 35, 36, 38, 39, and 45, and further in view of Wong et al. (WO2016069727, in Office Action mailed on 11/03/2025 supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘398 and Pat ‘527, each in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘398 and Pat ‘527, each in view of Bloom et al. and Keefe, and further in view of Wong et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-45 are on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,578,128 (Pat ‘128, in Office Action mailed 11/03/2025) in view of McCarthy et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘128 in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘128 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘128 in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,578,128 (Pat ‘128, supra) in view of McCarthy et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘128 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘128 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘128 in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,578,128 (Pat ‘128, supra) in view of Bloom et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘128 in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,578,128 (Pat ‘128, supra) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45, and further in view of Keefe (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al., and further in view of Keefe, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘128 in view of Bloom et al., and further in view of Keefe, for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al., and further in view of Keefe, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 37 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,578,128 (Pat ‘128, supra) in view of Bloom et al. (supra) and Keefe et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘128 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘128 in view of Bloom et al. and Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over each of:
claims 1-21 of co-pending U.S. Application No. 18/286,755 (App '755, in Office Action mailed 11/03/2025)
claims 1-11 of co-pending U.S. Application No. 18/291,128 (App '128, in Office Action mailed 11/03/2025)
claims 34 and 37-58 of co-pending U.S. Application No. 17/630,467 (App '467, in Office Action mailed 11/03/2025)
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by each of App ‘755, App ‘128, and App ‘467 for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that App ‘755 and App ‘128 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Applicant further argues that the instant application is patentably distinct from each of App ‘755, App ‘128, and App ‘467, for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Additionally, regarding App ‘467 only (Remarks pg. 18), Applicant argues that the application recites bispecific antibodies, while the instant application is directed to monospecific antibodies.
To using the broadest reasonable interpretation of the invention claimed by App ‘467, the application is construed in light of the specification. The specification of App ‘467 teaches (pg. 13): “…for the bispecific antibody, the first protein functional region is linked to the second protein functional region either directly or via a linker fragment…”
This demonstrated that the bispecific antibody claimed by App ‘467 is a fusion of two monospecific antibodies, and thus one with ordinary skill in the art would understand that a monospecific anti-PD-1 antibody would be an intermediate product in the creation of the claimed bispecific antibody, and therefore would be a monospecific antibody that only binds PD-1, rendering the instantly claimed invention obvious.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by each of App ‘755, App ‘128, and App ‘467, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 33, 35, 36, 38, 39, and 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-21 of co-pending U.S. Application No. 18/286,755 (App '755, in Office Action mailed 11/03/2025)
claims 1-11 of co-pending U.S. Application No. 18/291,128 (App '128, in Office Action mailed 11/03/2025)
claims 34 and 37-58 of co-pending U.S. Application No. 17/630,467 (App '467, in Office Action mailed 11/03/2025)
each in view of Keefe (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘755, App ‘128, and App ‘467, each in view of Keefe, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘755, App ‘128, and App ‘467, each in view of Keefe, for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘755 and App ‘128 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘755, App ‘128, and App ‘467, each in view of Keefe, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-21 of co-pending U.S. Application No. 18/286,755 (App '755, in Office Action mailed 11/03/2025)
claims 1-11 of co-pending U.S. Application No. 18/291,128 (App '128, in Office Action mailed 11/03/2025)
claims 34 and 37-58 of co-pending U.S. Application No. 17/630,467 (App '467, in Office Action mailed 11/03/2025)
each in view of Keefe (supra), as applied to claims 32, 33, 35, 36, 38, 39, and 43-47 above, and further in view of Wong et al. (supra)
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘755, App ‘128, and App ‘467, each in view of Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘755, App ‘128, and App ‘467, each in view of Keefe, and further in view of Wong et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘755 and App ‘128 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘755, App ‘128, and App ‘467, each in view of Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-16, 22, 26, and 29-39 of co-pending U.S. Application No. 17/996,878 (App '878, in Office Action mailed 11/03/2025)
claims 9, 15-29, and 35-46 of co-pending U.S. Application No. 18/264,138 (App '138, in Office Action mailed 11/03/2025)
each in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘878 and App ‘138, each in view of Gandhi et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘878 and App ‘138 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-16, 22, 26, and 29-39 of co-pending U.S. Application No. 17/996,878 (App '878, in Office Action mailed 11/03/2025)
claims 9, 15-29, and 35-46 of co-pending U.S. Application No. 18/264,138 (App '138, in Office Action mailed 11/03/2025)
each in view of Gandhi et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-47 above, and further in view of Keefe (supra)
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al., and further in view of Keefe, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘878 and App ‘138, each in view of Gandhi et al., and further in view of Keefe, for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘878 and App ‘138 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al., and further in view of Keefe, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 38 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-16, 22, 26, and 29-39 of co-pending U.S. Application No. 17/996,878 (App '878, in Office Action mailed 11/03/2025)
claims 9, 15-29, and 35-46 of co-pending U.S. Application No. 18/264,138 (App '138, in Office Action mailed 11/03/2025)
each in view of Gandhi et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, 39, and 43-47 above, and further in view of Wong et al. (supra)
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘878 and App ‘138, each in view of Gandhi et al. and Keefe, and further in view of Wong et al., for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘878 and App ‘138 are later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘878 and App ‘138, each in view of Gandhi et al., and further in view of Keefe, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 39, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App '010, in Office Action mailed 11/03/2025) in view of McCarthy et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 43 and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App ‘010, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 39, and 44 above, and further in view of Korman et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al., and further in view of Korman et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of McCarthy et al., and further in view of Korman et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al., and further in view of Korman et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App ‘010, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 39, and 44 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of McCarthy et al., and further in view of Gandhi et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App '010, in Office Action mailed 11/03/2025) in view of Bloom et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App ‘010, supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 44 above, and further in view of Keefe et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al., and further in view of Keefe et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of Bloom et al., and further in view of Keefe et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al., and further in view of Keefe et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/250,010 (App ‘010, supra) in view of Bloom et al. (supra) and Keefe (supra) as applied to claims 32, 33, 35, 36, 38, 39, and 44 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘010 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘010 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘010 in view of Bloom et al. and Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, 43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-41 of co-pending U.S. Application No. 18/780,086 (App ‘086, in Office Action mailed 11/03/2025) in view of McCarthy et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 44 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-41 of co-pending U.S. Application No. 18/780,086 (App ‘086, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, 43, and 45 above, and further in view of Korman (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al., and further in view of Korman, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of McCarthy et al., and further in view of Korman for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al., and further in view of Korman, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-41 of co-pending U.S. Application No. 18/780,086 (App ‘086, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, 43, and 45 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of McCarthy et al., and further in view of Gandhi et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, 43, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-41 of co-pending U.S. Application No. 18/780,086 (App ‘086, in Office Action mailed 11/03/2025) in view of Bloom et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-41 of co-pending U.S. Application No. 18/780,086 (App ‘086, supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, 43, and 45 above, and further in view of Keefe et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al., and further in view of Keefe et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of Bloom et al., and further in view of Keefe et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al., and further in view of Keefe et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending U.S. Application No. 18/780,086 (App ‘086, supra) in view of Bloom et al. (supra) and Keefe (supra) as applied to claims 32, 33, 35, 36, 38, 39, 43, and 45 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘086 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘086 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘086 in view of Bloom et al. and Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, originally U.S. Application No. 18/067,669 in Office Action mailed 11/03/2025) in view of McCarthy et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat '919 in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat '919 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat '919 in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 43 and 44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45 above, and further in view of Korman (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘919 in view of McCarthy et al., and further in view of Korman, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘919 in view of McCarthy et al., and further in view of Korman for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘919 in view of McCarthy et al., and further in view of Korman, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pat ‘919 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pat ‘919 in view of McCarthy et al., and further in view of Gandhi et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pat ‘919 in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, supra) in view of Bloom et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pap ‘919 in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that Pap ‘919 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, 39, and 45 above, and further in view of Keefe et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al., and further in view of Keefe et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pap ‘919 in view of Bloom et al., and further in view of Keefe et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that Pap ‘919 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al., and further in view of Keefe et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,479,919 (Pat '919, supra) in view of Bloom et al. (supra) and Keefe (supra) as applied to claims 32, 35, 36, 38, 39, and 45 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from Pap ‘919 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that Pap ‘919 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by Pap ‘919 in view of Bloom et al. and Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, in Office Action mailed 11/03/2025) in view of McCarthy et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of McCarthy et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al., and further in view of Korman, for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of McCarthy et al., and further in view of Korman for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al., and further in view of Korman, to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, supra) in view of McCarthy et al. (supra) as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al., and further in view of Gandhi et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of McCarthy et al., and further in view of Gandhi et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of McCarthy et al., and further in view of Gandhi et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, in Office Action mailed 11/03/2025) in view of Bloom et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of Bloom et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, supra) in view of Bloom et al. (supra) as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al., and further in view of Keefe et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of Bloom et al., and further in view of Keefe et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al., and further in view of Keefe et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-79 of co-pending U.S. Application No. 17/272,121 (App ‘121, supra) in view of Bloom et al. (supra) and Keefe (supra) as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al. and Keefe, and further in view of Wong et al., for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘121 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘121 in view of Bloom et al. and Keefe, and further in view of Wong et al., to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 33, 35, 36, 38, 39, 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending U.S. Application No. 18/264,191 (App ‘191, in Office Action mailed 11/03/2025).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘191 for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘191 for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘191 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘191 to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 33, 35, 36, 38, 39, and 43-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending U.S. Application No. 18/264,191 (App ‘191, supra) in view of Keefe (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘191 in view of Keefe for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘191 in view of Keefe for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘191 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘191 in view of Keefe to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending U.S. Application No. 18/264,191 (App ‘191, supra) in view of Keefe (supra), as applied to claims 32, 33, 35, 36, 38, 39, and 43-47 above, and further in view of Wong et al (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘191 in view of Keefe, and further in view of Wong et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘191 in view of Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘191 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘191 in view of Keefe, and further in view of Wong et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 35, 36, 38, 39, and 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, 11, 15, 16, 19, 20, 23, 26, 28-31, 33, and 36 of co-pending U.S. Application No. 18/696,546 (herein App ‘546, in Office Action mailed 11/03/2025) in view of Korman et al (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘546 in view of Korman et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘546 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, 11, 15, 16, 19, 20, 23, 26, 28-31, 33, and 36 of co-pending U.S. Application No. 18/696,546 (App ‘546, supra) in view of Korman et al. (supra) as applied to claims 32, 35, 36, 38, 39, 43-45, and 51 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al., and further in view of Gandhi et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘546 in view of Korman et al., and further in view of Gandhi et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘546 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al., and further in view of Gandhi et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, 11, 15, 16, 19, 20, 23, 26, 28-31, 33, and 36 of co-pending U.S. Application No. 18/696,546 (App ‘546, supra) in view of Korman et al. (supra), as applied to claims 32, 35, 36, 38, 39, 43-45, and 51 above, and further in view of Keefe (supra). This is a new grounds of rejection necessitated by Applicant’s amendments.
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al., and further in view of Keefe for the same reasons discussed in the Office Action mailed 11/03/2025.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘546 in view of Korman et al., and further in view of Keefe for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘546 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al., and further in view of Keefe to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claim 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 10, 11, 15, 16, 19, 20, 23, 26, 28-31, 33, and 36 of co-pending U.S. Application No. 18/696,546 (App ‘546, supra) in view of Korman et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, 39, 43-45, and 51 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims are a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al. and Keefe, and further in view of Wong et al. for the same reasons discussed in the Office Action mailed 11/03/2025.
Regarding claim 52, the combined references teach both of these heavy and light chain sequences, which are independently claimed in instant claims 33 and 37, meeting the claim limitations.
Applicants arguments and amendments, filed 3/31/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the instant application is patentably distinct from App ‘546 in view of Korman et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for the 35 U.S.C. § 103 rejection supra. However, these arguments were found to be not convincing for the reasons discussed supra.
Applicant additionally argues that App ‘546 is a later filed applications and therefore do not qualify are references for nonstatutory double patenting. However, these are provisional double patent rejections.
Therefore, the invention encompassed by the instant claims were a prima facie obvious variant of the invention claimed by App ‘546 in view of Korman et al. and Keefe, and further in view of Wong et al. to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.
Claims 32, 33, 35-39, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-42 of co-pending U.S. Application No. 18/024,471 (App ‘471, in Office Action mailed on 11/03/2025).
The claims of App ‘471 have been amended since the last Office Action, necessitating a new rejection. Applicant’s arguments have been rendered moot in light of this new rejection.
App ‘471 claims an antibody comprising a VH of SEQ ID NO: 103, which is 100% identical instant SEQ ID NO: 6, and a VL of SEQ ID NO: 104, which is 100% identical to instant SEQ ID NO: 8 (claim 32). App ‘128 additionally claims an anti-PD-1 monoclonal antibody comprising the heavy chain sequence of SEQ ID NO: 82 and a light chain sequence of SEQ ID NO: 84 (claim 38). SEQ ID NO: 82 of App ‘471 is 100% identical to instant SEQ ID NO: 16:
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SEQ ID NO: 84 of App ‘471 is 100% identical to instant SEQ ID NO: 12:
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Thus, App ‘471 claims the anti-PD-1 monoclonal antibody encompassed by instant claims 32, 33, 35-39, and 52.
It would have been obvious to one with ordinary skill in the art, before the effective filing date of the instant application, to have modified the invention claimed by App ‘471 to produce an anti-PD-1 monoclonal antibody comprising the heavy and light chain sequences of instant SEQ ID NO: 82 and 84, respectively (i.e., the limitations of instant claims 32, 33, and 35-37), as this monoclonal antibody is an intermediate product of the claimed combination therapeutic of App ‘471. One would have been motivated to make this change for the purposes of generating an anti-PD-1 monoclonal antibody for use, for example, for diagnostic purposes to identify PD-1 expressing cells in a subject.
Claims 38 and 39 are included because the functions recited in the wherein clauses flow naturally from the teachings of the prior art. (citing Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985 (“The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.”), and Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of... a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer.”)).
An obvious formulation cannot become nonobvious simply by measuring and claiming an activity of the formulation in a particular context, “because ‘[t]o hold otherwise would allow any formulation—no matter how obvious—to become patentable merely by testing and claiming an inherent property.’” Persion Pharm., slip op. at 13 (Fed. Cir. Dec. 27, 2019) (citing Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354 (Fed. Cir. 2012)); see also Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945) (“It is not invention to perceive that the product which others had discovered had qualities they failed to detect.”).
The invention of claims 32, 33, 35-39, and 52 are a prima facia obvious variant of the invention claimed by App ‘471. This is a provisional double patenting rejection.
Claims 32, 33, 35-39, 43-45, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-42 of co-pending U.S. Application No. 18/024,471 (App ‘471, supra) in view of Korman (supra).
The claims of App ‘471 have been amended since the last Office Action, necessitating a new rejection. Applicant’s arguments have been rendered moot in light of this new rejection.
The invention of claims 32, 33, 35-39, and 52 are a prima facia obvious variant of the invention claimed by App ‘471. App ‘471 does not claim conjugates comprising the antibody and a conjugate moiety (instant claim 43), kits comprising the anti-PD-1 antibody (instant claim 44), pharmaceutical compositions (instant claim 45).
Korman et al., in the same field of endeavor, teaches anti-PD-1 antibodies can be packaged into kits with a label indicating the intended use of the antibody (Column 48, lines 56-62 and Column 56, lines 49-60). Korman et al. additionally teaches anti-PD-1 antibodies can be conjugated to a toxin to potentiate the effect of the antibody (Column 61, lines 32-48), and pharmaceutical compositions comprising the antibody and an acceptable carrier (Column 7, lines 57-60).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the antibody of App ‘471 in view of Korman et al. to make compositions and/or kits comprising the antibody with a reasonable expectation of success, as Korman et al. teaches PD-1 antibodies can be packaged into kits and formulated into pharmaceutical compositions and one with ordinary skill in the art would be able to apply these to other PD-1 antibodies such as the one taught by App ‘471. One would have been motivated to make these changes for the purposes of either packaging the anti-PD-1 antibody into a kit with a label for intended use.
The invention of claims 32, 33, 35-39, 43-45, and 52 is a prima facia obvious variant of the invention claimed by App ‘471 in view of Korman et al. This is a provisional double patenting rejection.
Claims 32, 33, 35-39, 46, 47, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-42 of co-pending U.S. Application No. 18/024,471 (App ‘471, supra) in view of Gandhi et al. (supra).
The claims of App ‘471 have been amended since the last Office Action, necessitating a new rejection. Applicant’s arguments have been rendered moot in light of this new rejection.
The invention of claims 32, 33, 35-39, and 52 are a prima facia obvious variant of the invention claimed by App ‘471. App ‘471 does not claim a combination of the anti-PD-1 antibody in combination with a chemotherapeutic (instant claim 47), or a pharmaceutical composition comprising the antibody, a chemotherapeutic, and an acceptable carrier (instant claim 46).
Gandhi et al., in the same field of endeavor, teaches a combination of chemotherapy and the anti-PD-1 antibody pembrolizumab resulted in “significantly higher rates of response and longer progression-free survival that chemotherapy alone” in patients with metastatic non-small-cell lung cancer (Abstract). The chemotherapeutic was a combination of pemetrexed and a platinum based drug, which were formulated into a pharmaceutical combination with the anti-PD-1 antibody and saline as an acceptable carrier (“Trial Design and Treatment” section). Figure 1 demonstrates the higher response rates of patients administered a combination of the PD-1 antibody and chemotherapy (see the 35 U.S.C. 103 rejection supra).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have combined the anti-PD-1 antibody claimed by App ‘471 with a chemotherapy such as pemetrexed and a platinum based drug with a reasonable expectation of success, as Gandhi et al. teaches this (entire document). One would have been motivated to make this change for the purposes of creating a combination therapy to treat patients with metastatic non-small-cell lung cancer with “significantly higher rates of response and longer progression-free survival that chemotherapy alone” (Gandhi et al., Abstract).
The invention of claims 32, 33, 35-39, 46, 47, and 52 are a prima facia obvious variant of the invention claimed by App ‘471 in view of Gandhi et al. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, 39, and 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19, 21, 23, and 26-44 of co-pending U.S. Application No. 17/779,425 (App ‘425) in view of Bloom et al. (supra).
App ‘425 claims anti-PD-1 antibodies comprising the VH sequence of SEQ ID NO: 9 and the VL sequence of SEQ ID NO: 17 (claim 14).
SEQ ID NO: 9 of App ‘425 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 11 of App ‘425 is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘425 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
Bloom et al., in the same field of endeavor, teaches IgG Fc mutations including the combination of L234A, L235A, and G237A triple-mutant that does not contain the other Fc mutations such as P238S, H268A, A330S, or P331S (i.e., the limitations of instant claim 51; Bloom et al. ¶[0173]): “In another embodiment, the Fe region of the binding protein contains three constant region mutations, L234A, L235A, and G237 A (i.e., "triple-mutant" or "TM").”
Bloom et al. teaches that antibodies comprising an IgG1 constant region with these Fc mutations have reduced ADCC when compared to their wildtype counterparts (¶[0270], Example 9.12, and Figure 15; emphasis added): “Only one anti-IL-21R antibody, AbZ, which has a wild-type human IgG1 constant region, showed ADCC above the background level displayed by a control anti-IL-13 antibody that did not bind to the target cells. All antibodies with the same variable domains as AbZ, including forms with human IgG4 (Ab Y), and those with double-mutant (AbX) and triple-mutant (AbT) forms of human IgG1, showed only background levels of ADCC…”
Bloom et al. additionally teaches that this triple-mutant Fc domain has reduced C1q binding and CDC (¶[0271], Example 9.13, Figure 16; emphasis added): “Only one anti-IL-21R antibody, AbZ, which has a wild-type human IgG 1 constant region, showed Clq binding above the background level displayed by a control antibody with a triple-mutant human IgG 1 constant region that had previously been shown to lack Clq binding. All antibodies with the same variable domains as AbZ, including forms with human IgG4 (Ab Y), and those with double-mutant (AbX) and triple-mutant (AbT) forms of human IgG1, showed only background levels of Clq binding…”
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the antibody claimed by App ‘425 in view of Bloom et al. to make an anti-PD-1 antibody with a mutated IgG1 Fc region comprising the L234A, L235A, and G237A amino acid substitutions, as Bloom et al. teaches Fc mutations that one of ordinary skill could easily apply to the anti-PD-1 antibodies of App ‘425. One would have been motivated to make this change for the purposes of reducing ADCC and CDC and thus reducing toxic side effects of the administered antibody.
Claims 38 and 39 are included because while Bloom et al. does not explicitly teach these limitations such as the affinity constants recited in the claims, the functions recited in the wherein clauses are considered inherent functions to the IgG1 Fc structure with the L234A, L235A, and G237A amino acid substitutions.
Regarding instant claim 43, App ‘425 claims conjugates comprising the antibody and a conjugated moiety (claim 18), meeting the claim limitations.
Regarding instant claim 44, App ‘425 claims kits conjugates comprising the antibody (claim 19), meeting the claim limitations.
Regarding instant claim 45, App ‘425 claims pharmaceutical compositions comprising the antibody and an acceptable excipient (claim 21), meeting the claim limitations.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19, 21, 23, and 26-44 of co-pending U.S. Application No. 17/779,425 (App ‘425) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Keefe (supra).
The invention of claims 32, 35, 36, 38, 39, and 43-45 are a prima facie obvious variant of the invention claimed by App ‘425 in view of Bloom et al., as discussed supra. The combined references do not teach two heavy chain comprising instant SEQ ID NO: 16 (i.e., the limitations of instant claim 33).
Bloom et al. additionally teaches SEQ ID NO: 196, which is a IgG constant region with the L234A/L235A/G237A triple mutant, however this is not the same constant region used in instant SEQ ID NO: 16.
Keefe, in the same field of endeavor, teaches L234A/L235A/G237A triple mutant IgG1 constant regions including SEQ ID NO: 88 (¶[0194]). Keefe teaches that these mutants reduce Fc binding and effector function (¶[0191]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the combined teachings of App ‘425 and Bloom et al. further in view of Keefe to make an anti-PD-1 antibody comprising the VH of SEQ ID NO: 9 claimed by App ‘425 and the modified L234A/L235A/G237A triple mutant IgG1 constant region of SEQ ID NO: 88 of Keefe with a reasonable expectation of success, as both Bloom et al. and Keefe teach L234A/L235A/G237A triple mutant IgG constant regions that can be used with an antibody such as the once claimed by App ‘425. These two L234A/L235A/G237A triple mutant Fc regions taught by Bloom et al. and Keefe are considered art-recognized equivalents as they are both L234A/L235A/G237A triple mutant Fc regions that reduce ADCC and CDC. See Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.) One would have been motivated to make this change for the purposes of introducing the L234A/L235A/G237A Fc mutations to the anti-PD-1 antibody of App ‘425 in view of Bloom et al.
The VH claimed by SEQ ID NO: 9 of App ‘425. combined with the heavy chain IgG1 triple mutant taught by SEQ ID NO: 88 of Keefe yields a heavy chain that is 100% identical to instant SEQ ID NO: 16 (i.e., instant claim 33):
Qy 1 EVQLVESGGGLVQPGGSLRLSCAASGFAFSSYDMSWVRQAPGKGLDWVATISGGGRYTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLVESGGGLVQPGGSLRLSCAASGFAFSSYDMSWVRQAPGKGLDWVATISGGGRYTYY 60
Qy 61 PDSVKGRFTISRDNSKNNLYLQMNSLRAEDTALYYCANRYGEAWFAYWGQGTLVTVSSAS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 PDSVKGRFTISRDNSKNNLYLQMNSLRAEDTALYYCANRYGEAWFAYWGQGTLVTVSSAS 120
Qy 121 TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGL 180
Qy 181 YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEAAGAPS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 YSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEAAGAPS 240
Qy 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNST 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 VFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNST 300
Qy 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELT 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 YRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELT 360
Qy 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQ 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 KNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQ 420
Qy 421 GNVFSCSVMHEALHNHYTQKSLSLSPGK 448
||||||||||||||||||||||||||||
Db 421 GNVFSCSVMHEALHNHYTQKSLSLSPGK 448
Making a monoclonal antibody with this VH and constant region combination would generate an antibody with two of these heavy chains.
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘425 in view of Bloom et al., and further in view of Keefe. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19, 21, 23, and 26-44 of co-pending U.S. Application No. 17/779,425 (App ‘425) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, 39, and 43-45 above, and further in view of Wong et al. (supra).
The combined teachings of App ‘425, Bloom et al., and Keefe have been discussed supra. App ‘425 claims the anti-PD-1 VL sequence of SEQ ID NO: 11, and Bloom et al. teaches a different light chain constant region that the one used in instant SEQ ID NO: 12 (Bloom et al. teaches a light chain constant region of SEQ ID NO: 196, which is a lambda type). Bloom et al. additionally teaches that light chain constant regions may be either lambda or kappa type (¶[0181]). However, the combined teachings do not teach the entire light chain of instant SEQ ID NO: 12 (i.e., the limitations of instant claims 37 and 52).
Wong et al., in the same field of endeavor, teaches human Igκ light chain constant regions that can be used in antibody light chains, including SEQ ID NO: 95 (pg. 184, Table 10). Wong et al. further teaches that this can be used as the light chain constant region for a full-length antibody (¶[0135])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the combined teachings of App ‘425, Bloom et al., and Keefe further in view of Wong et al. to generate full-length anti-PD1 antibodies with the Igκ constant region taught by SEQ ID NO: 95 of Wong et al. with a reasonable expectation of success, as all the references concern antibody engineering that one with ordinary skill in the art would be able to apply to the anti-PD1 antibody of App ‘425. Additionally, the Igκ and kappa light chain constant regions taught by Wong et al. and Bloom et al. respectively are considered art-recognized equivalents as they are both constant regions that can be used in an antibody light chain. See Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980) (The mere fact that phthalocyanine and selenium function as equivalent photoconductors in the claimed environment was not sufficient to establish that one would have been obvious over the other. However, there was evidence that both phthalocyanine and selenium were known photoconductors in the art of electrophotography. "This, in our view, presents strong evidence of obviousness in substituting one for the other in an electrophotographic environment as a photoconductor." 209 USPQ at 759.) One would have been motivated to make this change for the purposes of making a full-length anti-PD1 antibody with a light chain constant region.
Adding the VL taught by SEQ ID NO: 11 of App ‘425 to the Igκ taught by SEQ ID NO: 95 of Wong et al. generates a light chain that is 100% identical to instant SEQ ID NO: 12 (i.e., the limitations of instant claim 37):
Qy 1 DIQMTQSPSSMSASVGDRVTFTCRASQDINTYLSWFQQKPGKSPKTLIYRANRLVSGVPS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 DIQMTQSPSSMSASVGDRVTFTCRASQDINTYLSWFQQKPGKSPKTLIYRANRLVSGVPS 60
Qy 61 RFSGSGSGQDYTLTISSLQPEDMATYYCLQYDEFPLTFGAGTKLELKRTVAAPSVFIFPP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 RFSGSGSGQDYTLTISSLQPEDMATYYCLQYDEFPLTFGAGTKLELKRTVAAPSVFIFPP 120
Qy 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT 180
Qy 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
||||||||||||||||||||||||||||||||||
Db 181 LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC 214
Making a monoclonal antibody with this VL and constant region combination would generate an antibody with two of these light chains (i.e., the limitations of instant claims 37 and 52).
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘425 in view of Bloom et al. and Keefe, and further in view of Wong et al. This is a provisional double patenting rejection.
Claims 46 and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-19, 21, 23, and 26-44 of co-pending U.S. Application No. 17/779,425 (App ‘425) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, 39, and 43-45 above, and further in view of Gandhi et al. (supra).
The combined teachings of App ‘425 and Bloom et al. are discussed supra. The combined reference teachings of App ‘425 and Bloom et al. do not teach a combination of the anti-PD-1 antibody in combination with a chemotherapeutic, or a pharmaceutical composition comprising the antibody, a chemotherapeutic, and an acceptable carrier (i.e., instant claims 46 and 47).
Gandhi et al., in the same field of endeavor, teaches a combination of chemotherapy and the anti-PD-1 antibody pembrolizumab resulted in “significantly higher rates of response and longer progression-free survival than chemotherapy alone” in patients with metastatic non-small-cell lung cancer (Abstract). The chemotherapeutic was a combination of pemetrexed and a platinum based drug, which were formulated into a pharmaceutical combination with the anti-PD-1 antibody, and saline as an acceptable carrier (“Trial Design and Treatment” section). Figure 1 demonstrates the higher response rates of patients administered a combination of the PD-1 antibody and chemotherapy (cropped version below):
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have combined the anti-PD-1 claimed by App ‘425 in view of Bloom et al. with a chemotherapy such as pemetrexed and a platinum based drug with a reasonable expectation of success, as Gandhi et al. teaches this combination of anti-PD-1 antibodies and chemotherapy (entire document). One would have been motivated to make this change for the purposes of creating a combination therapy to treat patients with metastatic non-small-cell lung cancer with “significantly higher rates of response and longer progression-free survival than chemotherapy alone” (Gandhi et al., Abstract).
Therefore, the invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘425 in view of Bloom et al., and further in view of Gandhi et al. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 20, 23-25, 28, and 30-37 of co-pending U.S. Application No. 18/024,478 (App ‘478) in view of Bloom et al. (supra).
App ‘478 claims antibodies comprising anti-PD-1 monospecific antibodies comprising a VH of SEQ ID NO: 9 and a VL of SEQ ID NO: 11 (claim 5).
SEQ ID NO: 9 of App ‘478 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 11 of App ‘478 is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘478 additionally claims the L234A, L235A, and G237A Fc mutations (claim 3). App ‘478 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘478 in view of Bloom et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 20, 23-25, 28, and 30-37 of co-pending U.S. Application No. 18/024,478 (App ‘478) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘478 in view of Bloom et al., and further in view of Keefe for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 20, 23-25, 28, and 30-37 of co-pending U.S. Application No. 18/024,478 (App ‘478) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘478 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 47 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 20, 23-25, 28, and 30-37 of co-pending U.S. Application No. 18/024,478 (App ‘478) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘478 in view of Bloom et al., and further in view of Gandhi et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 20, 23-25, 28, and 30-37 of co-pending U.S. Application No. 18/024,478 (App ‘478) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman et al. (supra).
The invention encompassed by claims 32, 35, 36, 38, and 39 is a prima facie obvious variant of the combined teachings of App ‘478 in view of Bloom et al. as discussed supra. The combined teachings do not teach conjugates comprising the antibody and a conjugate moiety (instant claim 43), kits comprising the anti-PD-1 antibody (instant claim 44), pharmaceutical compositions (instant claim 45).
Korman et al., in the same field of endeavor, teaches anti-PD-1 antibodies can be packaged into kits with a label indicating the intended use of the antibody (Column 48, lines 56-62 and Column 56, lines 49-60). Korman et al. additionally teaches anti-PD-1 antibodies can be conjugated to a toxin to potentiate the effect of the antibody (Column 61, lines 32-48), and pharmaceutical compositions comprising the antibody and an acceptable carrier (Column 7, lines 57-60).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the antibody of App ‘478 in view of Bloom et al. further in view of Korman et al. to make compositions and/or kits comprising the antibody with a reasonable expectation of success, as Korman et al. teaches PD-1 antibodies can be packaged into kits and formulated into pharmaceutical compositions and one with ordinary skill in the art would be able to apply these to other PD-1 antibodies such as the one taught by App ‘478 in view of Bloom et al. One would have been motivated to make these changes for the purposes of either packaging the anti-PD-1 antibody into a kit with a label for intended use.
The invention encompassed by the instant claims is a prima facia obvious variant of the invention claimed by App ‘478 in view of Bloom et al., and further in view of Korman et al. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of co-pending U.S. Application No. 18/264,242 (App ‘242) in view of Bloom et al. (supra).
App ‘242 claims antibodies comprising anti-PD-1 monospecific antibodies comprising a VH of SEQ ID NO: 37 and a VL of SEQ ID NO: 39 (claim 24).
SEQ ID NO: 37 of App ‘242 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 39 of App ‘242 comprises a sequence that is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘242 additionally claims the L234A, L235A, and G237A Fc mutations (claim 32). App ‘242 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘242 in view of Bloom et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of co-pending U.S. Application No. 18/264,242 (App ‘242) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘242 in view of Bloom et al., and further in view of Keefe for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of co-pending U.S. Application No. 18/264,242 (App ‘242) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘242 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 47 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of co-pending U.S. Application No. 18/264,242 (App ‘242) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘242 in view of Bloom et al., and further in view of Gandhi et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-34 of co-pending U.S. Application No. 18/264,242 (App ‘242) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman et al. (supra).
The invention encompassed by claims 32, 35, 36, 38, and 39 is a prima facie obvious variant of the combined teachings of App ‘242 in view of Bloom et al. as discussed supra. The combined teachings do not teach conjugates comprising the antibody and a conjugate moiety (instant claim 43), kits comprising the anti-PD-1 antibody (instant claim 44), pharmaceutical compositions (instant claim 45).
Korman et al., in the same field of endeavor, teaches anti-PD-1 antibodies can be packaged into kits with a label indicating the intended use of the antibody (Column 48, lines 56-62 and Column 56, lines 49-60). Korman et al. additionally teaches anti-PD-1 antibodies can be conjugated to a toxin to potentiate the effect of the antibody (Column 61, lines 32-48), and pharmaceutical compositions comprising the antibody and an acceptable carrier (Column 7, lines 57-60).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the antibody of App ‘242 in view of Bloom et al. further in view of Korman et al. to make compositions and/or kits comprising the antibody with a reasonable expectation of success, as Korman et al. teaches PD-1 antibodies can be packaged into kits and formulated into pharmaceutical compositions and one with ordinary skill in the art would be able to apply these to other PD-1 antibodies such as the one taught by App ‘242 in view of Bloom et al. One would have been motivated to make these changes for the purposes of either packaging the anti-PD-1 antibody into a kit with a label for intended use.
The invention encompassed by the instant claims is a prima facia obvious variant of the invention claimed by App ‘242 in view of Bloom et al., and further in view of Korman et al. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-67 of co-pending U.S. Application No. 18/955,907 (App ‘907) in view of Bloom et al. (supra).
App ‘907 claims antibodies comprising anti-PD-1 monospecific antibodies comprising a VH of SEQ ID NO: 9 and a VL of SEQ ID NO: 11 (claim 27).
SEQ ID NO: 9 of App ‘907 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 11 of App ‘907 comprises a sequence that is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘907 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘907 in view of Bloom et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-67 of co-pending U.S. Application No. 18/955,907 (App ‘907) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘907 in view of Bloom et al., and further in view of Keefe for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-67 of co-pending U.S. Application No. 18/955,907 (App ‘907) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘907 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 47 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-67 of co-pending U.S. Application No. 18/955,907 (App ‘907) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘907 in view of Bloom et al., and further in view of Gandhi et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-67 of co-pending U.S. Application No. 18/955,907 (App ‘907) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘907 in view of Bloom et al., and further in view of Korman et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of co-pending U.S. Application No. 18/840,378 (App ‘378) in view of Bloom et al. (supra).
App ‘378 claims antibodies comprising anti-PD-1 monospecific antibodies comprising a VH of SEQ ID NO: 18 and a VL of SEQ ID NO: 20 (claim 13).
SEQ ID NO: 18 of App ‘378 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 20 of App ‘378 comprises a sequence that is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘378 additionally claims the L234A, L235A, and G237A Fc mutations (claim 10). App ‘378 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘378 in view of Bloom et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of co-pending U.S. Application No. 18/840,378 (App ‘378) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘378 in view of Bloom et al., and further in view of Keefe for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of co-pending U.S. Application No. 18/840,378 (App ‘378) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘378 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 47 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of co-pending U.S. Application No. 18/840,378 (App ‘378) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘378 in view of Bloom et al., and further in view of Gandhi et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-18, 20-23, and 26 of co-pending U.S. Application No. 18/840,378 (App ‘378) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘378 in view of Bloom et al., and further in view of Korman et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 32, 35, 36, 38, and 39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of co-pending U.S. Application No. 19/176,458 (App ‘458) in view of Bloom et al. (supra).
App ‘458 claims antibodies comprising anti-PD-1 monospecific antibodies comprising a VH of SEQ ID NO: 8 and a VL of SEQ ID NO: 10 (claims 31 and 32).
SEQ ID NO: 8 of App ‘458 is 100% identical to instant SEQ ID NO: 6:
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SEQ ID NO: 10 of App ‘458 comprises a sequence that is 100% identical to instant SEQ ID NO: 8 (i.e., the anti-PD-1 antibody sequence of instant claims 32, 35, and 36):
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App ‘458 does not claim full-length IgG1 anti-PD-1 antibodies comprising the variable sequences and the L234A/L235A/G237A Fc mutations (i.e., the limitations of instant claims 32, 35, and 36).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘458 in view of Bloom et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claim 33 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of co-pending U.S. Application No. 19/176,458 (App ‘458) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Keefe (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘458 in view of Bloom et al., and further in view of Keefe for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 37 and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of co-pending U.S. Application No. 19/176,458 (App ‘458) in view of Bloom et al. (supra) and Keefe (supra), as applied to claims 32, 33, 35, 36, 38, and 39 above, and further in view of Wong et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘458 in view of Bloom et al. and Keefe, and further in view of Wong et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 47 and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of co-pending U.S. Application No. 19/176,458 (App ‘458) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Gandhi et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘458 in view of Bloom et al., and further in view of Gandhi et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Claims 43-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of co-pending U.S. Application No. 19/176,458 (App ‘458) in view of Bloom et al. (supra), as applied to claims 32, 35, 36, 38, and 39 above, and further in view of Korman et al. (supra).
The invention encompassed by the instant claims is a prima facie obvious variant of the invention claimed by App ‘458 in view of Bloom et al., and further in view of Korman et al. for the same reasons discussed for App ‘425 supra. This is a provisional double patenting rejection.
Conclusion
No claim is allowed.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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