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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 24, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Status of the Claims
Claims 1-15, 22, and 24-26 are under consideration in this office action.
Withdrawn Rejections
Any objection or rejection of record pertaining to cancelled claim 23 is rendered moot by applicant’s cancellation of said claim.
Applicant’s arguments, see pg 5, filed July 24, 2026, with respect to the rejection of claims 12-13 under 35 U.S.C. 112(b) as being indefinite have been fully considered and are persuasive. The rejection under 112(b) has been withdrawn.
Applicant’s arguments, see pg 5-7, filed July 24, 2026, with respect to the rejection of claims 1-15, 22, and 24-26 under 35 U.S.C. 112(a) as failing to meet the written description requirement have been fully considered and are persuasive. The rejection under 112(a) has been withdrawn.
Claim Rejections - 35 USC § 103
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.
Claims 1-15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015151080, published October 8, 2015 (“Yongxin”; IDS from 3/14/2024).
Claim 1 is directed to a method of treating a subject with cancer comprising administering an anti-ICAM1 antibody drug conjugate. Other claims are further limited to various drugs and linkers.
Yongxin teaches antibody-drug conjugates comprised of an antibody, linkers, and cytotoxic agents [(pg 1, ln 4-9); pg 5, ln 10-20), as in the antibody-drug conjugate of instant claim 1 and the linker of instant claim 5. The antibody of Yongxin may be the anti-ICAM1 antibody Enlimomab pegol (pg 29, ln 13), as in claim 1. Enlimomab is known in the art to be R6.5, as evidenced by US Patent 5,324,510 (column 10, ln 21-26; IDS from 3/14/2024), therefore, Enlimomab teaches R6.5 of instant claims 12-13. The antibody of the antibody-drug conjugate of Yongxin may be a monoclonal antibody, Fab fragment, F(ab’)2 fragment, diabody, or single chain antibody (pg 24, ln 22-29), as in instant claim 10. The monoclonal antibody may be chimeric or humanized (pg 25, ln 23-26), as in instant claims 11 and 13.
Yongxin teaches that the antibodies are agent that are able to bind tumor cells that express ICAM1 (pg 33-34), as in the treatment of ICAM1-expressing cancer of instant claim 1. Yongxin teaches a method of treating breast cancer, the method comprising administering the antibody-drug conjugate (pg 36), as in the new breast cancer limitation of instant claim 1. Yongxin teaches that the subject is human (pg 12, ln 6-8), as in instant claim 22.
Yongxin teaches that the antibody-drug conjugate maybe comprised of the drugs DM1, DM4 (pg 82, ln 7), MMAE, and MMAF (pg 54, ln 21-3)2, as in instant claims 2-4.
The linker of the antibody-drug conjugate of Yongxin may be the cleavable linkers Val-cit, SPDB, Sulfo-SPBD, or MC (pg 17, ln 19-pg 18, ln 3; pg 91, 9-16), as in instant claims 6-7. Yongxin also teaches that the linker may be the non-cleavable linker MMC (pg 17, ln 19-23), as in instant claims 8-9.
Yongxin teaches that the drug to antibody ratio is more than 4 (pg 4, ln 27-32), which overlaps with the ratio range in instant claim 14; in a specific embodiment, the drug/antibody ratio is 4.0 (pg 75), as in claim 15.
Although Yongxin teaches all the individual limitations of the claim, this reference does not explicitly set forth a specific embodiment comprised of the claimed combination for the antibody drug conjugate in a method of treating cancer. However, it would have been obvious to the ordinary artisan prior to the effective filing date of the claimed invention to arrive at the claimed antibody drug conjugate in the treatment of cancer and have a reasonable and predictable expectation of success. One of ordinary skill in the art would have been able to generate this preferred antibody drug conjugate via routine optimization of the method of Yongxin (see MPEP § 2144.05). This is because the artisan has good reason to pursue known options within their technical grasp to obtain predictable results.
Thus, because Yongxin teaches the antibody drug conjugate and the method of treating cancer, the burden is on the applicant to demonstrate that the method of treating cancer comprised of the claimed antibody drug conjugate is directed to unexpected results. Types of unexpected results include greater than expected results, superiority of a property shared with the prior art, presence of an unexpected property, or absence of an expected property (see MPEP 716.02(a)I.
Claims 1-15, 22, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2015151080, published October 8, 2015 (“Yongxin”) as applied to claims 1-15 and 22 above, and further in view of Wang et al, published online December 10, 2018 (PTO-892 from 3/24/2026).
The teachings of Yongxin are discussed above; Yongxin does not teach a method for treating triple negative breast cancer (TNBC), as required by claims 24-26.
Wang et al teaches administration of doxorubicin (DOX) loaded cyanine 5.5 engineered mesoporous organosilica nanoparticles (PMOs) linked to an anti-ICAM1 antibody for the treatment of TNBC (Wang abstract). Wang et al also teaches that ICAM-1 is overexpressed in TNBC tissues and cell lines and its expression is closely related to the development and metastasis of TNBC (pg 631, column 1, para 2). Animals treated with DOX@PMO-CY5.5-ICAM1 had final tumor volumes of 464 mm3 compared to 1174 mm3 in untreated animals (pg 636, column 1, para 2 and Fig 5e), demonstrating that ICAM-1 targeted treatment strategies are efficacious for TNBC.
Given that Yongxin teaches a method of treating breast cancer comprised of the claimed antibody drug conjugate, and further given that Wang et al has identified the breast cancer subtype TNBC is responsive to anti-ICAM linked DOX@PMP-CY5.5, it would have been obvious to one of ordinary skill in the art to substitute the conjugate of Yongxin with the anti-ICAM loaded nanoparticle of Wang et al and have a reasonable expectation of success. This is because a known work in one field of endeavor may prompt variation of it for use in the same field (MPEP 2143.I.F). Such is the case here, where the ordinary artisan would apply the anti-ICAM1 antibody drug conjugate of Yongxin in the method of treating TNBC using anti-ICAM1 targeting taught by Wang et al. The motivation to do so comes from Wang et al, which teaches that anti-ICAM1 targeted therapy is a promising treatment strategy for TNBC (abstract). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the antibody-drug conjugate in the method of Wang et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes.
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 1-15, 22, and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9, 11, 13, 15, and 17 of copending Application No. 17/637,305 in view of Wang et al, published online December 10, 2018. Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to overlapping subject matter: a method of treating a subject with cancer comprising administering the same anti-ICAM1 drug conjugate.
Claim 1 of ‘305 is directed to a method of treating pancreatic cancer comprising administering an antibody drug conjugate comprising and anti-ICAM1 antibody conjugate to a drug, as in instant claim 1. Moreover, ‘305 teaches recite identical drugs, linkers, and antibody drug ratio (‘305 claims 2, 4-6, 9, 11, 13, 15, and 17), as in instant claims 2-15 and 22.
The ‘305 claims do not teach a method for treating breast cancer or triple negative breast cancer (TNBC), as required by the claims.
Wang et al teaches administration of doxorubicin (DOX) loaded cyanine 5.5 engineered mesoporous organosilica nanoparticles (PMOs) linked to an ICAM1 antibody in the treatment of TNBC (Wang abstract). Wang et al teaches that ICAM-1 is overexpressed in TNBC tissues and cell lines and that its expression is closely related to the development and metastasis of TNBC (pg 631, column 1, para 2). The DOX@PMO-CY5.5-ICAM1 treated animals had final tumor volumes of 464 mm3 compared to 1174 mm3 in untreated animals (pg 636, column 1, para 2 and Fig 5e), demonstrating that ICAM-1 targeted treatment strategies are efficacious for TNBC.
Given that ‘305 claims teach a method of treating cancer comprised of the claimed antibody drug conjugate, and further given that Wang et al has identified the breast cancer subtype TNBC is responsive to anti-ICAM associated DOX@PMP-CY5.5, it would have been obvious to one of ordinary skill in the art to substitute the conjugate of ‘305 with the anti-ICAM loaded nanoparticle of Wang et al and have a reasonable expectation of success. This is because a known work in one field of endeavor may prompt variation of it for use in the same field (MPEP 2143.I.F). Such is the case here, where the ordinary artisan would apply the anti-ICAM1 antibody drug conjugate of ‘305 in the method of treating TNBC using anti-ICAM1 targeting taught by Wang et al. The motivation to do so comes from Wang et al, which teaches that anti-ICAM1 targeted therapy is a promising treatment strategy for TNBC (abstract). Furthermore, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) discloses combining prior art elements according to known methods to yield predictable results; the combination is obvious unless its application is beyond that person's skill. It would have been within the technical grasp of the ordinary artisan to apply the antibody-drug conjugate in the method of Wang et al to obtain predictable results. Such amounts to combining prior art elements according to known methods to achieve predictable outcomes.
Response to Arguments
Applicant's arguments filed July 24, 2026 have been fully considered but they are not persuasive.
Applicant argues that the skilled person would have no reason to select the claimed anti-ICAM1 antibody-drug conjugate because Yongxin teaches a large number of antibodies to be conjugated to any one of a large list of drugs (remarks, pg 7). The reference discloses conjugating the improved PBD derivatives to Enlimomab. In addition, the reference discloses using the ADCs to target cancers where the target antigen is over expressed and specifically names breast cancer a type of cancer to be treated. Since Yongxin discloses the claimed antibody drug conjugate, an anticipatory rejection was considered; however, Yongxin discloses multiple embodiments for both the antibody and the drug, and an obviousness type rejection was deemed to be more appropriate. Prior art rejections need not be supported by a finding that the combination was the preferred or most desirable combination over the other alternatives. Rather, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck &Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. V. Pamlab LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 Fed. Cir. 2005). MPEP § 2123(I) states “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Regarding the rejection under 35 U.S.C. 103 and the NSDP rejection, applicant asserts that Wang does not cure the deficiencies of Yongxin (or ‘305), because Wang teaches the use of a nanoparticle as a drug carrier for the anti-ICAM-1 antibody and not an antibody-drug conjugate (remarks, pg 8). While Wang does not disclose the claimed antibody drug conjugate, it is not necessary for this secondary reference to do so, as it is used to teach the utility of anti-ICAM1 antibodies in the treatment of breast cancer. Further, it is noted that the instant rejection was not necessarily established based on Wang teaching an antibody drug conjugate as claimed, but rather, it was to establish that methods of treating breast cancer with ICAM1 antibodies were already known in the art, thereby providing motivation to use the claimed antibody in the method of treating breast cancer.
Regarding the rejections of the claims on the ground on nonstatutory double patenting as being unpatentable over copending Application No. 17/637,305, applicant argues that amended claim 1, drawn to a method of treating breast cancer, no longer overlaps in scope with ‘305, which is drawn to a method of treating pancreatic cancer. Notably, the claims of ‘305 teach a method comprising the same administration steps. When the claims are considered over ‘305 in view of Wang, which teaches a method of treating breast cancer using an anti-ICAM1 antibody, the copending claims remain patentably indistinct. The rejection is maintained.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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