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 .
Claim Status
Claim listing filed on January 5, 2026 is pending. Claims 12-13 are amended. Claim 14 is canceled. Claims 15-22 are new. Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions or species. Claims 12-13 and 15-22 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claim 14 has rendered all previous rejections directed to this claim moot.
The amendments to the specification and the claims have overcome all objections of record, and the specification objections and the claim objections are withdrawn.
The rejection of Claims 12-13 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to Claim 1. Specifically, “a mammal” has proper antecedent basis.
The rejection of Claims 12-13 under 35 U.S.C. 112(a) as failing to comply with the written description requirement and enablement requirement is withdrawn in view of Applicant’s amendments to Claim 1. Specifically, amended Claim 12 is directed to a method of treating cancer by administering a composition comprising both an ASC speck and a tumor antigen.
The rejection of Claims 12-13 under 35 U.S.C. 103 as being unpatentable over Sahillioglu US 9,725,491 (of record) in view of Higgins et al. Cancer Biol Ther. 2009 (of record) is withdrawn in view of Applicant’s remarks filed January 5, 2026. It is persuasive that Sahillioglu teaches that ASC proteins participate in inflammasome signaling and promote caspase-1 activation. Based on the state of the art both before and after the effective filing date of the claimed invention, ASC specks with caspase-1 activity also activate IL-1β and promote tumorigenesis (as evidenced by Protti and Liu of record in the non-final office action filed 08/05/2025). Because the antigen-delivery ASC specks taught by Sahillioglu promote caspase-1 activation which is known to be tumorigenic in the ASC protein context, one of ordinary skill would not be able to apply the antigen-delivery platform to tumor antigens with a reasonable expectation of success in treating cancer. In other words, it is not obvious to utilize a tumorigenic ASC speck as an antigen-delivery platform in cancer immunotherapy. The teachings of Higgins do not overcome this deficit.
The rejection of Claims 12-13 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 23-24 of U.S. Patent No. 9,725,491 (of record) in view of Higgins et al. Cancer Biol Ther. 2009 (of record) is withdrawn in view of Applicant’s remarks filed January 5, 2026. It is persuasive that ASC specks are known to activate inflammasome pathways and induce strong inflammatory responses, including IL-1β release, which the literature recognizes can have tumor-promoting effects. Therefore, a person of ordinary skill could not pair the ASC speck taught by U.S. Patent No. 9,725,491 with the tumor antigen taught by Higgins with a reasonable expectation of success in treating cancer.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 15 and 19 are 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.
Claim 15 recites wherein the tumor antigen is an OVA-derived antigen. It is unclear what structural variations are encompassed by the term “derived” and no definition is provided in the specification. For example, do “OVA-derived antigens” comprise fragments of OVA, mutational variants of OVA, or both fragments and mutational variants? The structural metes and bounds of “OVA-derived antigen” are unclear, and Claim 15 is rejected for indefiniteness.
Claim 19 recites the limitation "the ASC proteins" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, Claim 19 is interpreted as “wherein the tumor antigen is carried by the ASC speck through hydrophobic interactions between the tumor antigen and the ASC speck.”
Note, the tumor antigen of Claim 21 is interpreted as a product-by-process (MPEP § 2113). Claim 21 recites wherein the tumor antigen is incorporated into the ASC speck during speck assembly. The product (the tumor antigen) is described by a process (incorporated into the ASC speck during speck assembly). The process does not add a methodological step to the method of Claim 12 and is instead used to describe the tumor antigen. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims (MPEP § 2113). Therefore, Claim 21 is interpreted as “wherein the tumor antigen is incorporated into the ASC speck.”
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating cancers expressing OVA by administering a composition comprising an ASC speck and OVA, does not reasonably provide enablement for treating any type of cancer by administering a composition comprising an ASC speck and OVA (Claim 15). 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 breadth of the claims and nature of the invention:
The nature of the invention is complex, encompassing a method of treating any type of cancer by administering a composition comprising an ASC speck and a chicken ovalbumin protein (OVA) to a mammal in need thereof (Claim 15).
When analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be "given their broadest reasonable interpretation consistent with the specification." See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The state of the prior art and level of predictability in the art:
The level of predictability in the art depends, most importantly, on whether the claimed invention can be practiced by one of ordinary skill in the art. It is well-understood in the art that tumor antigens can be therapeutically administered to induce an anti-tumor immune response wherein many cancer-specific tumor antigens have been characterized (as evidenced by
Higgins et al. Cancer Biol Ther. 2009; of record; Table 1 and page 1440 paragraph 3). It is understood that the administered tumor antigen must correlate to an antigen expressed by the tumor cell. For example, administering the tumor antigen CEA increased CEA-specific T-cell responses against tumor cells expressing CEA in colorectal cancer patients (Higgins page 1443 paragraph 1). However, OVA is an exogenous protein that serves as a well-defined, trackable antigen in experimental models where tumor cells are genetically modified to express OVA (Vitro Biotech 2025; paragraphs 3 and 19). While OVA is a useful model for studying immunotherapies (Vitro Biotech 2025; paragraph 3), there is no evidence that OVA has an anti-tumor effect in cells that do not express OVA. There is no support in the Applicant’s disclosure leading one of ordinary skill to overcome the lack of predictability in administering an ASC speck and OVA to treat any type of cancer including tumors that do not express OVA.
Level of skill in the art:
The level of skill would be high encompassing oncology, immunotherapy, genetics, etc.
Amount of direction provided by inventor and the existence of working examples:
The specification teaches administering tOVA-ASC (ASC speck comprising a truncated chicken ovalbumin protein antigen, tOVA) to treat EG7-OVA tumors (lymphoma tumor cells genetically-modified to express OVA) in mice. However, the specification provides no evidence that a composition comprising an ASC speck and OVA has anti-tumor activity in tumors that do not express OVA. A person having ordinary skill in the art would have to make a substantial inventive contribution to evaluate the anti-tumor activity of a composition comprising an ASC speck and OVA in a representative number of cancer types with and without OVA expression, since there is no guidance within the disclosure as filed pertaining to this embodiment.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
Given that the nature of the claims is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in human clinical trials or in animal models, that are predictive of treatment in a representative number of cancer types with and without OVA expression in order to demonstrate the invention could be used with a reasonable expectation of success. The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the treatment with a reasonable expectation of success.
The instant specification does not enable the invention to treat any type of cancer by administering a composition comprising an ASC speck and OVA (Claim 15).
Allowable Subject Matter
Claims 12-13, 16-18, and 20-22 allowed.
Conclusion
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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