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 .
Claims Status
Claim(s) 1-21 is/are currently pending.
Applicant’s election without traverse of (A) TLR4, (B) PGPC, (C) whole tumor cell lysate and (D) checkpoint inhibitors species in the reply filed on 05Nov2025 is acknowledged.
Claim(s) 3, 9, and 21 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05Nov2025.
Claim(s) 1-2, 4-8, and 10-20 are presented for examination on the merits.
Specification
The use of trade name(s) or mark(s) used in commerce (e.g., Enzo, Invivogen, Cayman Chemical, Gibco, Sigma Aldrich, FlowJo, Becton-Dickenson, Miltenyi Biotech, molecular probes, Graphpad Prism, ThermoFisher Scientific), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-2, 4-8, and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/067302 A2 (hereinafter “WO302”), in view of Zanoni et al. (2017, Immunity 47, 697–709; Oct 17, 2017; hereinafter “Zanoni”).
Regarding instant claim(s) 1-2, 4-8, 10-11, 16, WO302 teaches a method of inducing or enhancing an adaptive immune response to treat cancer (such as TNBC) in a subject comprising administering a tumor antigen (e.g., cancer immunogen) that is a tumor lysate [e.g., title; abstract; ¶ 0010-0011, 0089, 0095, 0126-0128, 0194], MPLA TLR4 ligand [e.g., ¶ 0039], and oxPAPC (e.g., non-canonical inflammasome activating lipid) [e.g., ¶ 012].
Regarding instant claim(s) 12-13, WO302 further teaches the hyperactivated cells are human [e.g., ¶ 0040, 0116, 0195-0196; fig. 8].
Regarding instant claim(s) 14, WO302 further teaches that the composition is made from biocompatible FDA-approved materials [e.g., ¶ 0006, 0113, 0117, 0195, 0224].
Regarding instant claim(s) 15, WO302 further teaches the composition can be used to prevent inflammatory conditions (e.g., prophylactic treatment of cancer) [e.g., ¶ 0119].
Regarding instant claim(s) 17, WO302 further teaches hyperactivated DCs induce T cell activation [e.g., ¶ 0057, 0080, 0252, 0267-0269; fig. 25, 48].
Regarding instant claim(s) 18-20, WO302 further teaches combination therapy with checkpoint inhibitors [e.g., ¶ 0269].
WO302 does not expressly teach a method of inducing or enhancing an adaptive immune repose to a cancer in a subject comprising administering (1) tumor lysate, LPS TLR4 ligand, and PGPC wherein (a) the subject is human, (b) the tumor lysate, LPS and PGPC are part of a pharmaceutical composition, (c) the immune response is prophylactic, (d) the immune response is therapeutic, (e) the immune response comprises T cell activation, (e) treatment further comprises the administration of one or more checkpoint inhibitors, or (f) the therapeutic interventions are co-administered or sequentially administered.
Zanoni teaches that PGPC and LPS together induce hyperactivation of dendritic cells (DC) and macrophages, whereas oxPAPC only induced DC hyperactivation [e.g., pgs. 703-704, “Specific oxPAPC components Hyperactivate…” ].
It would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to substitute the TLR4 ligand MPLA and the non-canonical activating lipid oxPAPC in the method of inducing or enhancing adaptive immune response to treat cancer as taught by WO302, with the LPS TLR4 ligand and the PGPC non-canonical activating lipid as taught by Zanoni, in the context of designing and developing a TLR4 directed cancer therapy. A PHOSITA would have been motivated to substitute the TLR4 ligand MPLA and the non-canonical activating lipid oxPAPC in the method of inducing or enhancing or inducing adaptive immune response to treat cancer as taught by WO302, because WO302 teaches the base therapeutic method and Zanoni teaches that the advantages of LPS and PGPC together include hyperactivation of both DCs and macrophages, whereas oxPAPC was only shown to hyperactivate DCs. Further, WO302 teaching the administration of the composition to a subject and that the composition comprises biocompatible FDA-approved materials necessarily teaches a pharmaceutical composition. Additionally, WO302’s teachings of administration to a subject as well as teaching examples in human cells necessarily teaches the subject is a human. There would have been a reasonable expectation of success for a PHOSITA to substitute the TLR4 ligand MPLA and the non-canonical activating lipid oxPAPC in the method of inducing or enhancing or inducing adaptive immune response to treat cancer as taught by WO302 because WO302 teaches the base therapeutic method and Zanoni teaches that the application of LPS and PGPC together induced hyperactivation in both DCs and macrophages. This rationale aligns with the principle of simple substitution of one known element for another to obtain predictable results, supporting a conclusion of obviousness (see MPEP § 2141).
Further, it would have been obvious to a PHOSITA to modify the modified method of inducing or enhancing adaptive immune response to treat cancer as taught by WO302 and Zanoni (see above) to include the (1) the immune response is prophylactic, (2) the immune response is therapeutic, (3) the immune response comprises T cell activation, (4) treatment further comprises the administration of one or more checkpoint inhibitors, or (5) the therapeutic interventions are co-administered or sequentially administered as taught by WO302, because WO302 and Zanoni teach the modified method, and WO302 teaches the base method as well as variations to the method. Further, WO302’s teaching of the composition for cancer therapy necessarily teaches the immune response is therapeutic, and the teachings of the administration of the composition and a checkpoint inhibitor necessarily meets the limitations “co-administered or sequentially administered” because those are the only two options that are possible (co-administered means at the same time; sequentially administered means at different times). There is an expectation of success for a PHOPSITA to substitute the modified method of inducing or enhancing adaptive immune response to treat cancer as taught by WO302 and Zanoni (see above) to include the method variants as further taught by WO302, because WO302 and Zanoni teach the modified method, and WO302 teaches the base method as well as variations to the method. This rationale aligns with the principle of simple substitution of one known element for another to obtain predictable results, supporting a conclusion of obviousness (see MPEP § 2141).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643