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 .
Election/Restrictions
Applicant’s election without traverse of HER2 in the reply filed on 11 March 2026 (referred to herein as Remarks) is acknowledged.
Status of the Claims
Claims 1-116 were originally filed 10 May 2023. The preliminary amendment filed 11 January 2024 has been entered. Claims 59, 62-64, 69-73, 85-87, and 117-123 are pending. Claims 69-73 and 118-121 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 March 2026.
Claims 59, 62-64, 85-87, 117, 122, and 123 are currently under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 59, 62-64, 86, 87, 117, 122, and 123 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2020/099653 (referred to herein as Verheijden as cited on the IDS received 10/01/2025) as evidenced by Daiichi (see Daiichi. Request for extension of patent term under 35 USC § 156: Antibody drug conjugate. Received 02/13/2020).
Verheijden discloses humanized anti-SIRPα antibodies suitable for anti-cancer therapy (see Verheijden abstract). Specifically, Verheijden discloses the anti-SIRPα antibodies can be used in combination therapy with trastuzumab deruxtecan (see Verheijdenpg. 51 line 8). Trastuzumab deruxtecan is a HER2 ADC comprising the instantly claimed linker drug combination linked via a thioether and has an antibody drug conjugate of about 8.0 as evidenced by the FDA drug information (see Daiichi pg. 3, bottom and paragraph directly above structure; see also below).
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171
646
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Verheijden discloses the humanized anti-SIRPα antibodies administered in combination with additional agents can be done so in the same/different formulations, concurrent, or sequentially (see Verheijden pg. 51 lines 11-13). The cancer to be treated can be Her2 positive breast cancer, colon cancer, bladder cancer, pancreatic cancer, and the cancer is preferably treated with an additional targeted therapeutic agent (e.g., a HER2 positive breast cancer treated with a HER2 agent) (see Verheijden para spanning pgs. 6-7). This is pertinent to instant claims 59, 64, 86, 87, and 117.
Claims 62, 63, 122, and 123 are drawn to particular sequences associated with the HER2 antibody. The instantly claimed sequences are identical to those of trastuzumab deruxtecan as evidenced by Daiichi (see Daiichi pg. 2 bottom, pg. 3 top; see sequence comparison below). It is noted the instant claims are drawn to both an “antibody comprising” and a “heavy/light chain consisting of”. Thus, while the claims encompass one less residue than disclosed in Daiichi the “comprising” allows for additional elements to be present. Alternatively, Daiichi discloses the HER2 binding domain, trastuzumab, exists in two variants one of which has the terminal lysine cleaved from the heavy chain. This terminally cleaved lysine variant is identical to the instantly claimed residues 1-499 of Seq ID No: 1. This is pertinent to instant claims 62 and 63. Given Verheijden discloses a HER2 antibody with an identical heavy and light chain it naturally flows the CDRs, VH, and VL regions are also identical. This is pertinent to instant claims 122 and 123.
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.
Claim 85 is rejected under 35 U.S.C. 103 as being unpatentable over Verheijden and WO2020013170 A1 (as cited on the IDS received 05/10/2023 A12) published 16 January 2020. It is noted US Patent Publication US20210155707 (referred to herein as Matozaki) will be used as an English translation given both are part of the same patent family and therefore have the same underlying disclosure. It is noted WO2020013170 A1 qualifies as prior art under 35 USC 102(a)(1).
In addition to the teachings set forth above, Verheijden, discloses combining therapeutic antibodies with an antagonistic antibody against SIRPα or an anti-CD47 antibody can enhance the efficacy of the therapeutic antibody (see Verheijden pg. 1 last para). Specifically, preliminary work has suggested SIRPα antibodies were able to increase the neutrophil-mediated ADCC of trastuzumab opsonized SKBR3 cells (see Verheijden pg. 2 lines 10-13). The anti-SIRPα antibodies functions by blocks the inhibitory SIRPα signaling thereby increasing ADCC, ADCP, and/or ADAP activity (see Verheijden pg. 1 last para). Specifically, Verheijden discloses anti-SIRPα antibodies could nearly double the ADCC activity of trastuzumab (see Verheijden figure 4, pg. 8 lines 6-14, figure 13 pg. 79, 1st para).
Matozaki discloses preliminary combination therapies with anti-SIRPα antibodies suggest they can induce a more potent tumor immune response when used in combination with various anti-tumor agents (see Matozaki pg. 1 para [0009]). The anti-SIRPα antibodies bind specifically to human SIRPα and inhibit SIRPα/CD47 activity (see Matozaki pg. 2 para [0024]). Specifically, Matozaki discloses an anti-SIRPα antibody comprising Seq ID Nos: 41 and 37 (see Matozaki pgs. 3-4 para [0057, 0058]). The anti-SIRPα antibody is administered with an anti-HER2 antibody and can be used to treat breast cancer, colon cancer, bladder cancer, and pancreatic cancer (see Matozaki pg. 4, 2nd col. bottom, pg. 5, 1st col. 1st full para). Matozaki names trastuzumab as an example of a HER2 antibody the claimed anti-SIRPα antibodies can be used in combination therapy (see Matozaki pg. 14 para [0202]). The anti-SIRPα_H1L3 variant exhibited a binding inhibitory activity equivalent to or higher than that of the parent antibody cD13 (chimeric form) and did not exhibit ADCP activity in CD47 positive human Burkitt’s lymphoma cell line Raji or Ramos cells when used alone but did exhibit ADCP activity in combination with rituximab (see Matozaki pg. 28 para [0324, 0329], figure 15A-C, 16).
Therefore the ordinary artisan would have substituted the humanized anti-SIRPα antibodies in the combination anti-SIRPα trastuzumab deruxtecan therapy in a method of treating breast cancer as taught by Verheijden with the anti-SIRPα antibodies disclosed in Matozaki as these are art recognized equivalents for the same purpose. There is a reasonable expectation of success given both bind the same target, inhibit CD47 signaling and increase activity of additional therapeutic agents. It is also noted both references disclose using the antibodies in combination for increasing the potency of the therapeutic agent, treating the same cancer (e.g., breast cancer), and suggest the additional agent targets HER2 and specifically names trastuzumab.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 64 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The scope of the antibody drug ratio (DAR) of the HER2 ADC in claim 64 is unclear. The claim recites “the antibody-drug conjugate is in the range of from 7 to 8”. It is unclear if the DAR is “in the range of 7 to 8” (i.e., excludes 7 and 8) or alternatively is “is from 7 to 8” (i.e., includes 7 and 8).
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 59, 62-64, 85-87, 117 and 122-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 14, and 19-21 of U.S. Patent No. 12,024,566 B2 (referred to as ‘566 patent ) in view of Verheijden.
The ‘566 patent claims an anti-SIRPα antibody comprising Seq ID Nos: 41 and 37 (see ‘566 patent claims 1 and 8(1)), a pharmaceutical composition comprising the antibody and therapeutic antibody wherein the therapeutic antibody targets HER2 and is for breast cancer (see ‘566 patent claims 19-21).
The teachings of Verheijden are set forth above.
The ordinary artisan would have substituted the anti-SIRPα antibodies disclosed in Verheijden for the claimed anti-SIRPα antibodies in the ‘566 patent) in a method of treating breast cancer by administering a combination of anti-SIRPα antibodies and trastuzumab deruxtecan as taught by Verheijden.
Claims 59,62-64,85-87,117 and 122-123 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/374,973 (referred to herein as ‘973) in view of Verheijden.
The ‘973 application claims an anti-SIRPα antibody comprising Seq ID Nos: 41 and 37 (see ‘973 claims 1(1)), a pharmaceutical composition comprising the antibody and therapeutic antibody wherein the therapeutic antibody targets HER2 and is for breast cancer (see ‘973 claims 9, 12, and 14).
The teachings of Verheijden are set forth above.
The ordinary artisan would have substituted the anti-SIRPα antibodies disclosed in Verheijden for the claimed anti-SIRPα antibodies in the ‘973 application in a method of treating breast cancer by administering a combination of anti-SIRPα antibodies and trastuzumab deruxtecan as taught by Verheijden.
This is a provisional nonstatutory double patenting rejection.
Sequence Comparison
(Qy) Seq ID No: 1 compared to (Db) Daiichi Trastuzumab deruxtecan heavy chain
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837
704
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(Qy) Seq ID No: 2 compared to (Db) Daiichi Trastuzumab deruxtecan light chain
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572
730
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(Qy) Seq ID No: 13 compared to (Db) Matozaki Seq ID No: 41
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841
708
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(Qy) Seq ID No: 16 compared to (Db) Matozaki Seq ID No: 37
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465
713
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Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571)-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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