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 .
DETAILED ACTION
The Amendment filed 12/4/2025 in response to Office Action of 10/23/2025, is acknowledged and has been entered. Claims 1-8 are now pending. Claims 1-5 are amended. Claims 6-8 are new. The species of claims 4 and 5 have been rejoined.
Election/Restrictions
Claims 1-2 and 6-8 are allowable. Claim 3, previously withdrawn from consideration as a result of a restriction requirement, requires all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions groups I and II, as set forth in the Office action mailed on 7/24/2025, is hereby withdrawn and claim 3 is hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 7/24/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
The following rejections cited in office action 10/23/2025 are hereby withdrawn:
35 U.S.C. 112(a) written description and 35 U.S.C. 112(b) rejections – in view of amendments
35 U.S.C. 103 rejection – in view of Applicant arguments
Claims 1-3 and 4-8 are currently being examined.
New Rejections
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 4 and 5 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. This is a written description rejection.
Claim 4 is drawn to a method of treating melanoma in a subject, comprising administering to the subject Caerin 1.1/1.9m an anti-CD47 antibody clone MIAP301 and a therapeutic vaccine: wherein the vaccine consists of a: (1) a melanoma therapeutic vaccine, (2) MPLA, and (3) α-IL10r.
The written description is on treatment of the therapeutic vaccine as recited by the claims above. It has been interpreted that one of skill in the art cannot construct a cancer vaccine without knowing what the structure or the target of the vaccine. It is not clear how one can make and administer a cancer vaccine without knowing the structure of the vaccine. The definition of a vaccine in the online Merriam-Webster on-line dictionary is a preparation that is administered (as by injection) to stimulate the body’s immune response against a specific infectious agent or disease.
The instant specification does not disclose any specific examples of a therapeutic vaccine, just recites that a therapeutic vaccine is used. The instant specification does not provide adequate written description of the claimed genus of “vaccines.”
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. 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, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, the therapeutic vaccine targeting melanoma.
The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[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.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
In this case, the specification does not describe the genus of that are capable of functioning in a vaccine that satisfies either the Lilly or Enzo standards. The instant claims attempt to claim every type of cancer vaccine and do not limit it to the specific type of cancer vaccine that is recited in the claims. A search of the art demonstrates the complexity and challenges of utilizing cancer vaccines. Gracia-Grijo et al. (Frontiers in Immunology 2019 10 1-19) teaches the complications of cancer vaccines targeting neoantigens. Gracia-Grijo teaches although clinical trials testing vaccines targeting neoantigens have demonstrated they are safe and well tolerated, whether individualized immunotherapies targeting neoantigens can mediate effective antitumor responses in a broader patient population, remains an open question. Gracia-Grijo teaches that despite all the technological innovation and development of novel screening assays, the rapid and precise identification of the bona fide neoantigens in any given patient remains a major hurdle that will need to be overcome to translate the potential of neoantigen targeting into effective therapies for patients with cancer. [Conclusion, pg 14] Hu et al (Nature Reviews Immunology 2018 18, 168–182) teaches the complications of cancer vaccine production and use, including but not limited to, tumor heterogeneity between and within tumors is a major challenge to the development of cancer immunology. [pg 3, building cancer vaccines] Although the specification provides an example of one cancer vaccine, it does not provide enough support for the full scope of cancer vaccines as claimed. Thus, out of an unknown and likely very large number of structures and targets capable of being used in a vaccine, the specification only discloses one example of a cancer vaccine. The specification does not disclose sufficient examples of cancer vaccines that are capable of treating cancer.
Thus, the specification does not provide an adequate written description of the genus of cancer vaccines that is required to practice the claimed invention. The instant disclosure does not adequately describe the scope of the claimed genus, which encompasses a substantial variety of subgenera. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
Allowable Subject Matter
Claims 1-3 and 6-8 are allowed.
The following is an examiner’s statement of reasons for allowance: The arguments presented by the Applicant are persuasive to overcome the rejections under 35 U.S.C. 103. The combination of steps and components are nonobvious over the prior art. The Applicants argued that the claimed method produces a significant result of synergy between Caerin 1.1/1.0 and the anti-CD47 agent, MIAP301 that is not expected over the disclosure of the cited prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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/SARAH A ALSOMAIRY/Examiner, Art Unit 1646
/Zachariah Lucas/Supervisory Patent Examiner, Art Unit 1600