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
Claims 1-19 and 21 are currently pending and a preliminary amendment to the claims filed on 08/27/2025 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Claim Objections
Claims 1, 3 and 13-19 are objected to a minor informality under 37 CFR 1.75.
Each of claims 1, 3 and 13-18 reciting “STING” and abbreviated materials of claim 18 should be spelled out in the first encounter, if available.
Claim 19 recites “Niraparib, and Talazoparib (TLZ),…” which would be better recite “Niraparib, Talazoparib (TLZ) …
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitations “polysaccharide, protein, and vitamin E analogues, and the claim also recites (such as hyaluronic acid, chitosan and starch), (such as gelatin and collagen) and (alpha tocopheryl acetate, d-alpha tocopheryl succinate .), respectively which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is requested.
Claims 13-17 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Base claim 1 recites “STING agonist” or “PARP inhibitor (PARPi)” in an alternative manner. However, its dependent claim 13 recites “both the STING agonist and the PARPI”. That is, claim 1 should have stated: a depot comprising A and/or B. Therefore, it may not be said that dependent claim 13 does not further limit base claim 1 in a proper manner. The remaining claims 14-16 are also rejected due to the rejection of claim 13.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-12, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US2022/0183963A1) in view of Wang et al., “STING agonism reprograms tumor-associated macrophages and overcomes resistance to PARP inhibition in BRCA1-deficient models of breast cancer”, Nature Communications, 2022, 13: pp. 1-17.
Applicant claims the below claim 1 filed on 08/27/2025:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical cancer treatment research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from depot medicine, pharmacy, physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Kim teaches implantable depots to treat cancer wherein the depots are useful for localized, sustained, controlled release of therapeutic agents and the depot may be configured to be implanted within a patient proximate cancerous tissue (=tumor site)(title and abstract); the depot comprises a biodegradable polymer mixed with a locally-acting therapeutic agent to treat cancer (abstract) and thus the therapeutic agent is distributed in the polymer, and the therapeutic agent includes olaparib, talazoparib (TLZ) tosylate, rucaparib, veliparib, pamiparib, or fuzulo (e.g., [1672]) which reads on the claimed PARPi and (instant claims 1-2 and 19); the depot releases the therapeutic agent at the treatment site (=tumor site) for a period of time that is no less than 15 days (e.g., claim 1 of prior art) which is identical to the range of instant claim 4, and no less than 30 days (e.g., claim 3 of prior art) which overlaps the range of 15-100 days of instant claim 5. See MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”(instant claims 3-5); the depot is delivered to the tumor site using a needle ([0406], [0468], [0887]) (e.g., 18-22G including 19G ([1508], [1513] and [1748]) (instant claims 6-7); the biodegradable polymer includes at least one of polyglycolide (PGA), polycaprolactone (PCL), poly(DL-lactic acid) (PLA), poly(alpha-hydroxy acids), poly(lactide-co-glycolide) (PLGA or DLG), poly(DL-lactide-co-caprolactone) (DL-PLCL), poly(trimethylene carbonate) (PTMC), polydioxanone (PDO), poly(4-hydroxy butyrate) (PHB), polyhydroxyalkanoates (PHA), poly(phosphazene), polyphosphate ester), poly(amino acid), polydepsipeptides, poly(butylene succinate) (PBS), polyethylene oxide, polypropylene fumarate, polyiminocarbonates, poly(lactide-co-caprolactone) (PLCL), poly(glycolide-co-caprolactone) (PGCL) copolymer, poly(D,L-lactic acid), polyglycolic acid, poly(L-lactide-co-D,L-lactide), poly(L-lactide-co-glycolide), poly(D,L-lactide-co-glycolide), poly(gycolide-trimethylene carbonate), poly(ethyl glutamate-co-glutamic acid), poly(tert-butyloxy-carbonylmethyl glutamate), poly(glycerol sebacate), tyrosine-derived polycarbonate, poly 1,3-bis-(p-carboxyphenoxy) hexane-co-sebacic acid, polyphosphazene, ethyl glycinate polyphosphazene, polycaprolactone co-butylacrylate, a copolymer of polyhydroxybutyrate, a copolymer of maleic anhydride, a copolymer of poly(trimethylene carbonate), polyethylene glycol (PEG), hydroxypropylmethylcellulose and cellulose derivatives, polysaccharides (such as hyaluronic acid, chitosan and starch), proteins (such as gelatin and collagen) or PEG derivatives, polyaspirins, polyphosphagenes, collagen, starch, pre-gelatinized starch, hyaluronic acid, chitosans, gelatin, alginates, albumin, fibrin, vitamin E analogs, such as alpha tocopheryl acetate, d-alpha tocopheryl succinate, D-lactide, D,L-lactide, L-lactide, D,L-lactide-caprolactone (DL-CL), D,L-lactide-glycolide-caprolactone (DL-G-CL), dextrans, vinylpyrrolidone, polyvinyl alcohol (PVA), PVA-g-PLGA, PEGT-PBT copolymer (polyactive), methacrylates, poly(N-isopropylacrylamide), PEO-PPO-PEO (pluronics), PEO-PPO-PAA copolymers, PLGA-PEO-PLGA, PEG-PLG, PLA-PLGA, poloxamer 407, PEG-PLGA-PEG triblock copolymers, SAIB (sucrose acetate isobutyrate)hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl methylcellulose, carboxymethylcellulose or salts thereof, Carbopol®, poly(hydroxyethylmethacrylate), poly(methoxyethylmethacrylate), poly(methoxyethoxy-ethylmethacrylate), polymethylmethacrylate (PMMA), methylmethacrylate (MMA), gelatin, polyvinyl alcohols, propylene glycol, and poly(DL-lactide-co-glycolide-co-caprolactone) (e.g., [0682]) which reads on the claimed biodegradable polymer (instant claim 8) and in some embodiment, PLGA is used as a biodegradable polymer (e.g., [0008]) (instant claim 9) wherein t the PLGA comprises equal parts lactide and glycolide. In some embodiments, said PLGA comprises 75% lactide and 25% glycolide, or 85% lactide and 15% glycolide (e.g.,[0008]) in which the proportions of lactide and glycolide are identical to the instant ranges (instant claims 10-11) and the depot comprises therapeutic agent in an amount of about 1 mg to 4 mg which overlaps the instant range of 1 to 10mg. MPEP 2144.05 above (instant claim 12); and the prior art further teaches a method of treating cancer such as bladder or breast cancer via the controlled, sustained release of a therapeutic agent, the method comprising administering the said depot to the target tumor site (e.g., [0088]-[0093])(instant claim 21).
In light of the foregoing, instant claims 1-12, 19 and 21 are obvious over Kim.
Claims 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US2022/0183963A1) as applied to instant claims 1-12, 19 and 21 in view of Wang et al., “STING agonism reprograms tumor-associated macrophages and overcomes resistance to PARP inhibition in BRCA1-deficient models of breast cancer”, Nature Communications, 2022, 13: pp. 1-17.
Kim was discussed with respect to instant claims 1-12, 19 and 21 noted above.
The difference between the instant application and Kim is that Kim does not expressly teach STING agonist as claimed. This deficiency in Kim is cured by the teachings of Wang.
Wang discloses systemic administration of a STING agonist breaches multiple layers of tumor cell-mediated suppression of immune cells, and synergizes with PARPi to suppress tumor growth (e.g., abstract); the STING agonist includes DMXAA, ADU-S100 and PARPi includes Olaparib (See e.g., Fig. 5); and STING agonists improve therapeutic response of orthotopic BP tumors to Olaparib in syngeneic immunocompetent mice in vivo, and that is, STING agonists overcome immune suppression and markedly improve the response of Braca1-deficient breast tumors to Olaparib in vivo (e.g., page 9); systemic delivery of STNIG agonist potentiates the therapeutic efficacy of Olaparib independently of tumor cell-intrinsic STING, CD8+ T cell infiltration, antitumor cytokine production by CD8+ T cells, and the proportions of effector CD8+T cells were significantly increased by combined treatment with Olaparib and IP rejection of DMXAA (see e.g., Fig. 6c) and STING agonist was able to activate and mobilize host immune cells to exert antitumor immunity and host STING is essential for the therapeutic efficacy of combined Olaparib and STING agonist (e.g., page 10) (instant claims 13-16 and 18).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the teachings of Kim with combination of STING agonist and PARPi, as suggested by Wang, in order to synergistically enhance therapeutic effects of cancer treatment.
Accordingly, instant clams 13-16 and 18 are obvious over Kim in view of Wang.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
The claims examined are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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