DETAILED ACTION
The amendment submitted on November 21, 2025 has been entered. Claims 1-25 and 27-31 are pending in the application. Claims 1-23 are withdrawn. Claims 24-25 and 27-31 are rejected for the reasons set forth below. No claim is allowed.
This communication includes at least one new ground of rejection that was neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement, so this Office action is non-final. See MPEP 706.07(a) (final rejection, when proper on second action).
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Election/Restrictions
Applicant’s election without traverse of Group V, drawn to a kit comprising a pharmaceu-tical composition comprising an IAP inhibitor, is acknowledged. Claims 1-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Withdrawn Rejections
The rejection of claims 24-25 and 27-30 under pre-AIA 35 U.S.C. 102(b) as being antici-pated by Palermo et al., WO 2005/097791 A1, is withdrawn because the limitations of claim 26, which was not rejected on this basis, have been incorporated into the independent claim.
The rejection of claims 24-25, 27-29, and 31 under pre-AIA 35 U.S.C. 102(b) as being anticipated by Charest et al., WO 2008/016893 A1, is withdrawn for the same reason.
New Grounds for Rejection Claim Rejections – 35 USC § 112
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 24-25 and 27-29 are rejected under pre-AIA 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the compound of instant claims 30-31, does not reasonably provide enablement for the full scope of all IAP inhibitors. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claimed invention is in the pharmaceutical arts. The independent claim is drawn to a kit comprising, among other things, an IAP inhibitor and an antigen. The broadest claim, i.e., claim 24, places no structural limitations whatsoever on the nature of the IAP inhibitor. The stated purpose of the kit is to provide a vaccine, including a method of using it in a method of treating cancer. See applicant’s specification at pp. 2-3. The search of the prior art reveals that the area of cancer vaccines is beset with numerous technical challenges that would burden the skilled artisan with undue experimentation when attempting to practice the invention commen-surate in scope with the claims. The following three references are cited as being representative of the state of the prior art:
Bowen et al., “Current challenges for cancer vaccine adjuvant development,” Expert Rev. Vaccines 2018;17(3):207-15.
Fan et al., “Therapeutic cancer vaccines: advancements, chal-lenges, and prospects,” Signal Transduct. Target Ther. 2023;8(1):450.
Gupta et al., “Recent Advances in Cancer Vaccines: Challenges, Achievements, and Futuristic Prospects,” Vaccines (Basel), 2022;10(12):2011.
Bowen (p. 207) discloses:
The development of cancer vaccines faces unique obstacles that generally do not impede development of conventional infectious disease vaccines. For example, our nascent understanding of the risk factors and early biomarkers of cancer development, as well as the heterogeneity in tumor types and progression, require target-ing primarily of preexisting tumors with therapeutic vaccines, rather than the generally more effective use of prophylactic vaccines. These realities present two fundamental problems; the problem of tumor immune suppression and the problem of anti-genicity.
Bowen further states that “[w]hile vaccines that target the effector arm of the immune system generate some promising antitumor responses, many of them fail to block the regulatory responses associated with the tumor” (p. 212). Bowen further cautions that “single adjuvanted vaccines,” like those of the instant claims, “are unlikely to result in clinically relevant antitumor responses due to the inability to induce potent and appropriate and/or relevant immune responses.” Fan likewise discloses that “[a]lthough an increase of anti-tumor effector cells have been detected after vaccination, only modest clinical benefits have been achieved in small-scale populations” (p. 15). Fan further cautions that it is a “great challenge to study the interactions between immune cells and tumors as well as to assess the alterations in immune cell phenotype and function after anti-tumor therapies due to the intricacies of the human immune system” (p. 15). According to Fan, wide-ranging experimentation is required for the following features in order to develop a cancer vaccine: tumor antigen selection (pp. 2-5), vaccine constituents (pp. 6-9), combination therapy with other treatments (p. 10), dosage and route of administration (pp. 10-14), among other things. Even after conducting such experiments, “only modest clinical benefits have been achieved in small-scale populations” (p. 15). Fan is therefore evidence of the low level of predictability in this technology area. Gupta similarly discloses that cancer vaccines are “extraordinarily complex” and the “development of effective cancer vaccines remains elusive and extraordinarily challenging” (p. 2). One of skill in the art would therefore understand that this technology area lacks predictability.
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predict-able factors, such as mechanical or electrical elements. On the other hand, in applications directed to inventions in arts where the results are unpredictable, such as the present applica-tion, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, including most chemical reactions and physiological activity, more may be required. This is because in art areas having a high degree of uncertainty, including the area of cancer immunology and vaccines, it is not reasonably predict-able from the disclosure of one species what other species will work. See MPEP 2164.03 (relationship of predictability of the art and the enablement requirement).
Given the numerous technical challenges known in the prior art as it relates to cancer vaccines, one of skill in the art would look to applicant’s specification for information about how the claimed invention is used in actual practice. The working examples in applicant’s specification (see, e.g., Example 11 at pp. 48-53) all relate to one particular compound, referred to as “LBW 242.” This is the compound of instant claims 30-31. As explained above, one of skill in the art would not find it credible that one species would be predictive of utility of any and all IAP inhibi-tors within the scope of the instant claims. The examiner therefore concludes that one of skill in the art would be burdened with undue experimentation when attempting to practice the claimed method commensurate with its scope.
Maintained Rejections 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 possi-ble 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 provi-sions 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 accompa-nied 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 24-25 and 27-31, as amended, remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,786,491 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘491 Patent (cited in the prior action) claims (see claim 1) immune enhancing complexes of compounds of Formula I, which are the same as the compounds of instant claim 28. It also claims (see claim 2) similar compounds of Formula II, which are the same as claim 29. It also claims compositions further comprising antigens. See claims 4-5 of the ‘491 Patent. The printed instructions for use recited in the instant claims have not been accorded patentable weight for the reasons discussed in the prior action. Applicant has not substantively responded to this rejection, so it is maintained. See applicant’s Remarks, submitted November 21, 2025, at p. 17.
Claims 24-25 and 27-31, as amended, remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,382,905 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘905 Patent (cited in the prior action) claims a vaccine comprising an immunogenic quantity of an antigen and an adjuvant comprising an IAP inhibitor. See claim 1 of the ‘905 Patent. Dependent claims 2 and 3 are drawn to IAP inhibitors that are the same as those of instant claims 28-29. This rejection is maintained for the same reasons discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
March 16, 2026