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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 26, 2026 has been entered.
Claim Status
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-9 and 11-12 are under consideration in this office action.
Priority
Applicant’s claims for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35
U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Application claims benefit to PRO 62/870,181, filed July 3, 2019. However, applicant has not complied with one or more conditions for receiving the benefit of this earlier filing date under 35 U.S.C. 365(c): The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, PRO 62/870,181 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitation of new amended claim 1, wherein the PARP inhibitor is talazoparib, is not included in the priority document. Accordingly, claim 1 and
dependent claims 2-9 and 11-12 are not entitled to the benefit of the prior application. Claims 1-9 and 11-12 are given an earliest effective filing date of January 8, 2020, which is the filing of date of PRO 62/958,573.
Withdrawn Objections/Rejections
Any objection or rejection of record pertaining to canceled claim 10 is rendered moot by applicant’s cancellation of said claim.
The rejection of claims 1-9 and 11-12 under 35 U.S.C. 112(a) for failing to comply with the written description requirement are withdrawn in view of applicant’s amendment to indicate the claimed species of LPA, PERK, and PARP inhibitors.
The rejection of claims 1-9 and 11-12 under 35 U.S.C. 102(a)(1) and 102(a)(2) is withdrawn in view of applicant’s amendment to limit the PARP inhibitor to the species talazoparib.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-9 and 11-12 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 1 uses parentheses to enclose “DGPP 8.0”, “ammonium salt”, “NSC161613”, “chemical name (R)-1-(4′-(3-methyl-4-(((1-phenylethoxy)carbonyl)amino)isoxazol-5-yl)-[1,1′-biphenyl]-4-yl)cyclopropane-1-carboxylic acid”, “chemical name [(2R)-2-[[(Z)-Octadec-9-enoyl]amino]-3-[4-(pyridin-3-ylmethoxy)phenyl]propyl]dihydrogen phosphate”, “chemical name 2-[3-(4-nitrophenoxy)phenyl]-1,3-dioxoisoindole-5-carboxylic acid), NSC12404 (chemical name 2-[(9-Oxo-9H-fluoren-2-yl)carbamoyl]benzoic acid”, “chemical name 2-[[3-(1,3-Dioxo-1H-benz[de]isoquinolin-2(3H)-yl)propyl]thio]-benzoic acid”, “chemical name 4,5-dichloro-2-((9-oxo-9H-fluoren-2-yl)carbamoyl)-benzoic acid”, “chemical name 2-((9,10-dioxo-9,10-dihydroanthracen-2-yl)carbamoyl) benzoic acid”, “chemical name (Z,Z)-4,4′-[1,3-Phenylenebis(oxy-4,1-phenyleneimino)]bis[4-oxo-2-butenoic acid]”, “chemical name 2-({3-[(3-propoxybenzoyl)amino]-benzoyl}amino)benzoic acid”, “chemical name 14-(decanoylamino)benzyl]phosphonic acid”, and “chemical name (bis(monoacylglycerol)phosphate)”. The use of parentheses that encompass a limitation in the claim is found indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention or are just set forth as possible examples.
Claim 2-3 and 6-7, which are dependent from claim 1, recite “compared to control dendritic cells untreated by the one or more inhibitors.” Claim 1 is directed to a composition comprising at least one inhibitor of LPA or PERK and a PARP inhibitor; this composition comprises at least two inhibitors. Thus, it is unclear if “the one or more inhibitors” limitation of claims 2-3 and 6-7 is referring to only the LPA and PERK inhibitors or all three inhibitors. This rejection could be overcome, for example, by amending the claims to recite instead ”compared to control untreated dendritic cells”, as recited in instant claim 8.
Claim 9, which is dependent from claim 1, is directed to a composition comprising AMG PERK 44, GLPG 1690, talazoparib, or a combination thereof. As claim 1 is directed to a composition comprising at least one inhibitor of LPA or PERK and a PARP inhibitor, all combinations of claim 9 are not possible, and the scope of the claim is unclear. This rejection could be overcome, for example, by amending the claim to be a composition “comprising talazoparib and AMG PERK 44, GLPG1690, or both.”
Claim 11 recites the limitation "the progression of cancer”. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the survival". There is insufficient antecedent basis for this limitation in the claim.
Claims 4-5 and 8 are included in this rejection for failing to cure the indefiniteness of the base claim.
Claim Rejections - 35 USC § 103
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.
Claims 1-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Litton et al, published August 23, 2018 (instant PTO-892) and Tang et a published January 3, 2020 (instant PTO-892).
The claims are directed to compositions comprising one or more inhibitors of LPA production/function or PERK activation and the PARP inhibitor talazoparib.
Litton et al teaches that talazoparib has antitumor activity in patients with breast cancer (abstract). Patients received an oral dose of talazoparib (pg 755, column 1, para 1), as in the composition of instant claims 1 and 9.
Tang et al teach that enhanced LPA signaling is a major promoter of therapy resistance in cancer (pg 62, column 2, para 2). Tang et al teach that administration of GLPG1690, an inhibitor of LPA production, can improve the efficacy of breast cancer treatments (pg 64, column 1). GLPG was administered in a suspension of methyl cellulose (pg 64, column 2, para 4), as in the composition of instant claims 1 and 9.
More specifically, Tang et al teach that combination therapy with GLPG1690 and doxorubicin synergistically inhibits breast tumor growth (pg 68, column 2). Doxorubicin is known in the art to inhibit PARP activity, as evidenced by Zaremba et al (abstract; instant PTO-892).
Given that Litton et al teaches that talazoparib is effective in the treatment of breast cancer and further given that Tang et al teach that combination therapy with GLPG1690 and an inhibitor of PARP exhibits enhanced inhibition of breast tumor growth compared to PARP inhibitor alone (i.e. doxorubicin) , it would have been obvious to one of ordinary skill in the art to substitute the PARP inhibitor of Tang et al with the PARP inhibitor of Litton et al and have a reasonable expectation of success. This is because, as is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious.
Moreover, the ordinary artisan would be motivated to formulate a composition comprising talazoparib and GLP1690 because both agents are known in the art to be efficacious in the treatment of breast cancer. Section 2144.06 of the MPEP provides guidance as to obviousness of art recognized equivalence for the same purpose: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from they having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Therefore, a composition comprised of an LPA inhibitor and a PARP inhibitor would have been obvious and predictable given the prior art teachings of the Litton et al and Tang et al. This is because the artisan has good reason to pursue known options within their technical grasp to obtain predictable results. Such would amount to the combining of prior art elements according to known methods to achieve predictable outcomes.
Since the composition taught by Litton et al in view of Tang et al satisfies all structural limitations set forth in claim 1, it necessarily follows that the composition inherently possesses the functional properties of claims 2-8 and 11-12, absent objective evidence to the contrary. These include increasing type-I-interferon expression in dendritic cells in a mammalian subject, as in claims 1 and 7-8; reducing LPA production or signaling, as in claim 2; reducing expression of PERK, IL6, IL1B, PTGS2, Enpp2, VEGFA or a combination thereof, as in claim 3; reducing expression Atf4, Ddit3, Asns, or a combination thereof, as in claim 4; increasing expression of Ddx58, 1fit1, Ifit2, Isg15, Ciita, Oas1a, Oas1g, Oas2, or a combination thereof, as in claim 5; increasing type-I-interferons in dendritic cells, as in claim 6; reducing the progression of cancer in the mammalian subject, as in claim 11; and prolonging the survival of the mammalian subject, as in claim 12. See MPEP § 2112(I), which states: “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the composition claimed, the properties applicant discloses and/or claims are necessarily present.
Response to Arguments
Applicant’s arguments filed January 26, 2026 with respect to claims 1-9 and 11-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675