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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/06/2026 has been entered.
Election/Restrictions
Newly submitted claim 27 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: new claim is directed to a method of cancer treatment by administering instantly claimed composition. Such method would belong to non-elected Group II as specified in Restriction Requirement filed on 09/11/2024.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 27 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7-8, 10-12, 18, 22-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are broadly drawn to kits-of-parts comprising polyplex comprising polyIC, polymeric conjugate, targeting moieties capable of binding to cancer antigen and antibodies targeting PD-1.
Claims encompass a wide genus of targeting moieties capable of binding to cancer antigen.
The specification does not adequately describe the structure required for the targeting moiety to be capable of binding to cancer antigen. Specification describes some targeting moieties such as EGF, HER2 and DUPA in paragraph [0134], which target specific cancer antigens such as EGFR, HER2 and PSMA (see paragraph [0076]), and teaches that such moieties can be antibodies and their fragments and aptamers (see paragraph [0182]). Further, specification describes other possible cancer antigens to target, without describing any targeting moieties to those antigens (see paragraph [0132]).
Such recited species of the specification are not representative of the entire claimed genus. Without further description of the structure required for the function, one would not be able to readily envision which targeting moieties have the structure to be capable of binding to cancer antigens.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University V. Hoffman-La Roche Inc., Nos. 07- 1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification's disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California V. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ") Regents of the University of California V. Eli Lilly & Co., 43 USPQ2d 1398.
The claims are rejected under the written description requirement for failing to disclose adequate species to represent the claimed genus, the genus being targeting moieties that are "capable of binding to a cancer antigen”.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, "Written Description" Requirement", published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species for agents within the instant genus that function as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
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.
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(s) 1, 7-8, 10-12, 18-19, 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levitzki et al (WO 2015/173824, November 2015, cited from IDS) and in further view of Nagato et al (Clin Cancer Res; 20(5), 2014, 1223-1234, cited from IDS).
Levitzki et al teach polyplexes comprising double-stranded RNA and polymeric conjugates consisting of linear polyethyleneimine (PEI) covalently linked to one or more polyethylene glycol (PEG) moieties, each PEG moiety conjugated to targeting moiety capable of binding to a cancer antigen (see Abstract). Such double-stranded RNA can be polyinosinic- polycytidylic acid double stranded RNA (polyIC), the polymeric conjugate can consist of linear PEI (LPEI) covalently linked to one PEG moiety (LPEI-PEG 1: 1) or to three PEG moieties (LPEI- PEG 1: 3), and the cancer antigen can be EGFR, HER2 or PSMA (see paragraph [0041]). Targeting moiety can be human EGF or DUPA (see paragraph [0051] parts (e) and (g)) or HER2 affibody (see paragraph [0020]) or HER2 antibody (see paragraphs [0039-0040]). Such polyplexes can be used for treatment of cancer (see paragraph [0056)).
Levitzki et al do not teach a kit-of-parts comprising polyplex as described above and at least one antibody capable of modulating PD-1 immune checkpoint protein.
Nagato et al teach effective immunotherapy for cancer treatment comprising administration of polyIC in combination with antibody targeting PD-1 (see pages 1228, 1232, Figure 4C).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to create a kit-of-parts comprising polyplexes taught by Levitzki et al and antibodies taught by Nagato et al, arriving at instant invention. Levitzki et al teach effective polyplexes for delivery of polyIC, while Nagato et al teach combination cancer therapy comprising polyIC and PD-1 targeting antibody, motivating one of the ordinary skill in the art to use polyplexes taught by Levitzki et al for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
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, 7-8, 10-12, 18-19, 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16-19, 21-22 of copending Application No. 18/247,961 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '961 recite kit-of-parts comprising polyplex identical to instantly claimed comprising targeting moiety capable of binding to PSMA and antibody targeting PD-1, anticipating instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7-8, 10-12, 18-19, 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-45 of copending Application No. 17/653,221 (reference application) in view of Nagato et al, above. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '221 recite polyplex for delivery of polyIC identical to instantly claimed (see claim 22 and 34). Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '221 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘221 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7-8, 10-12, 18-19, 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/316,828 (reference application) in view of Nagato et al, above. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from '828 recite polyplex for delivery of polyIC, identical to instantly claimed. Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '828 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘828 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7-8, 10-12, 18-19, 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,278,991 in view of Nagato et al, above. Claims from '991 recite polyplex for delivery of polyIC identical to instantly claimed, which comprises targeting moieties capable of binding to EGFR or HER2. Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '991 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘991 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
Claims 1, 7-8, 10-12, 18-19, 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 10,543,232 in view of Nagato et al, above. Claims from '232 recite polyplex for delivery of polyIC identical to instantly claimed, which comprises targeting moieties capable of binding to EGFR or HER2. Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '232 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘232 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
Claims 1, 7-8, 10-12, 18-19, 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,298,376 in view of Nagato et al, above. Claims from '376 recite methods for treating cancer by administering polyplex for delivery of polyIC identical to instantly claimed, which comprises targeting moieties capable of binding to EGFR or HER2. Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '376 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘376 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
Claims 1, 7-8, 10-12, 18-19, 22-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,679,160 in view of Nagato et al, above. Claims from '160 recite methods for treating cancer by administering polyplex for delivery of polyIC identical to instantly claimed, which comprises targeting moieties capable of binding to cancer antigen, PSMA. Teachings of Nagato et al are discussed above. It would have been obvious to combine polyplex from '160 with antibody taught by Nagato et al to create more effective treatment for cancer by using polyplexes from ‘160 for delivery of polyIC in combination with antibody targeting PD-1 as taught by Nagato et al, arriving at instant invention.
Response to Arguments
Applicant's arguments filed 03/06/2026 have been fully considered but they are not persuasive.
Concerning 103 rejection Applicant argues that claimed combination of polyplex with PD-1 antibody shows synergistic effect, therefore overcoming obviousness rejection. In response first it is noted that such effect was shown for a specific combination with EGF as targeting moiety. Scope of majority of instant claims is wider, because the targeting moiety is not defined in the claims or different targeting moiety is used. Further, there is evidence in the art that combination cancer therapies involving polyIC provide synergistic effects. For example, Fischetti et al (Cytokine, 2017, 99: 287-296) teach that polyIC in combination with cytokines provides synergistic effect on cytokine response (see Abstract). Further, Nagato et al, cited above, teach that combination cancer treatment with polyIC and PD-L1 antibody provides synergistic effect (see second column on page 1225). Thus, synergistic effect can be expected for combining polyIC and PD-1 antibody as well. Therefore, modified 103 and double patenting rejections are maintained.
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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