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Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Withdrawn Objections/Rejections
The rejection of claims 1-9 and 11-12 under 35 U.S.C. 112(b) for being indefinite are withdrawn in view of applicant’s amendment.
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.
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 (PTO-892 from 3/31/2026) and Tang et a published January 3, 2020 PTO-892 from 3/31/2026).
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 compositions of instant claims 1 and 9.
Given that Litton et al teaches that talazoparib is effective in the treatment of breast cancer and further given that Tang et al teach a combination therapy comprising GLPG1690, it would have been obvious to one of ordinary skill in the art to generate a formulation comprised of talazoparib and GLPG1690. The ordinary artisan would be motivated to do so because both agents are known in the art to be useful in the treatments 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). For a composition that may be applied for the treatment of cancer, the ordinary artisan would expect that the combined effect of the two agents would be at least additive, with potential for a synergistic effect, thus enhancing the therapeutic efficacy of the treatment. Accordingly, the cumulative reference teachings render obvious the claimed composition comprising two anti-cancer agents.
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 June 29, 2026 have been considered.
Regarding the rejection under 35 U.S.C. 103, the argument that doxorubin and talazoparib are not art-recognized equivalents (remarks, pg 7-8) are persuasive, and this language has been removed from the obviousness rejection above. The examiner, however, maintains their position that it would have been obvious to generate a composition comprising talazoparib and GLPG1690 based on the combined teachings of Litton and Tang because both agents are known in the art to be useful in the treatment of breast cancer.
Applicant asserts that a shared indication of breast cancer does not make the claimed combination obvious (remarks, pg 8). This argument is not persuasive (see MPEP 2144.06.I); "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 their having been individually taught in the prior art." In re Kerkhoven. One would combine the agents and do so with a reasonable expectation of success; no specific teaching suggestion is needed for the combination – the idea of combining them flows logically from they having been individually taught in the prior art as useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). For a composition that may be applied for the treatment of cancer, the ordinary artisan would expect that the combined effect of the two agents would be at least additive, with potential for a synergistic effect, thus enhancing the therapeutic efficacy of the treatment. Accordingly, the cumulative reference teachings render obvious the claimed composition product.
Applicant argues that the combined teaching of Litton and Tang would not have carried a reasonable expectation of success because Tang teaches that the autotaxin inhibitor GLPG1690 increases the efficacy of radiotherapy and doxorubicin in a mouse model of breast cancer, and one would not expect that GLPG1690 when combined with talazoparib would reproduce the synergy demonstrated by Tang (remarks, pg 9). This argument is not persuasive because the product claim uses the open language “comprising”, which allows for the addition of other therapeutic agents, including the chemotherapeutic doxorubicin, as taught by Tang. Both Tang and Litton are relevant to the claimed composition because each independently teaches the use of one of the claimed therapeutic agents. Although Tang discloses the first agent in combination with doxorubicin or radiotherapy, that disclosure does not remove the reference form consideration because the reference does not disclose the precise combination recited in the claim. The claim is drafted using open-ended “comprising”, which allows for the composition to include additional components beyond those expressly recited in the claim. The additional agent disclosed in Tang does not negate the conclusion of obviousness for the claimed composition. The rejection under 35 U.S.C. 103 is maintained.
Conclusion
No claim is allowed.
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 JENNIFER BENAVIDES whose telephone number is (571)272-0545. The examiner can normally be reached M-F 9AM-5PM (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571)272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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