DETAILED ACTION
This action is in reply to papers filed 11/21/2024. Claims 1-8 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20250082702A1, Published 3/13/2025.
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, 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al. (PgPub US20070202080A1, Published 8/30/2007, Ref. 1 in IDS filed 11/21/2024), Balar et al. (Journal of Clinical Oncology 2016 34:18_suppl, published online 6/20/2016, Ref. 15 in IDS filed 11/21/2024), Deng et al. (MAbs. 2016; 8(3):593-603, published online 2/26/2016; Ref. 16 in IDS filed 11/21/2024) and Gao et al. (Clin Cancer Res (2009) 15 (3): 971–979).
Regarding claim 1,in-part, Yun teaches administering to an individual with a bladder cancer (as in claim 7) (Pg. 6, para. 79) a pharmaceutical composition comprising a recombinant oncolytic adenovirus comprising a gene encoding Interleukin 12 (IL-12) (Pg. 3, para. 35- “…a variety of therapeutic genes useful in treating various diseases may be carried in the gene delivery system of this invention. Non-limiting examples of the therapeutic genes include …. IL-12...”); and a gene encoding relaxin (as further in claim 1) (Pg. 1, para. 1), and administering anticancer agents (Pg. 7, para. 84) to the individual, wherein in one embodiment the anticancer agent is cisplatin, and wherein said recombinant oncolytic adenovirus and said anticancer agents are administered simultaneously (as in claim 5) (Pg. 7, para. 87- “The pharmaceutical composition may be administered prior to or simultaneously with administration of certain medicament.”). Note that Examiner has construed the chemotherapeutic agent cisplatin as a ‘medicament’ as Yun at Pg. 7, para. 89 states that the term encompasses anticancer drugs. Absent evidence to the contrary, a cisplatin is an anticancer drug. Continuing, Yun teaches the pharmaceutical composition of this invention degrades extracellular matrix surrounding tissues to be targeted by medicaments to enhance tissue penetration of medicaments, increasing significantly a pharmacological efficacy of medicaments (Pg. 7, para. 87).
Regarding claim 2, Yun teaches the recombinant oncolytic adenovirus has one or more deletion regions selected from the group consisting of an E1 region and an E3 region, the gene encoding IL-12 (nucleotide of interest (Pg. 2, para. 30)) is inserted into the E1 region of the recombinant adenovirus (as in claim 3) and the gene encoding relaxin is inserted into the E1 or E3 region of the recombinant oncolytic adenovirus (as in claim 4) (Pg. 4, para. 43). With respect to claim 6, Yun (b) teaches the present inventors have made intensive researches to improve the transduction efficiency of gene delivery systems, particularly, to enhance the transduction (or spreading) efficiency of the efficiency of gene delivery systems in tissues, as a result, discovering that decorin could dramatically improve the transduction efficiency of gene delivery systems and recombinant adenoviruses expressing decorin could significantly exhibit the potential to penetrate into tumor tissues and anti-tumor effect (Pg. 1, para. 7~ enhance anti-tumor activity).
However, Yun fails to teach an immune checkpoint inhibitor such as PD-L1 immune checkpoint inhibitor (as further in claim 1).
Before the effective filing date of the claimed invention, Balar et al. taught cisplatin-based chemo is a standard 1L treatment for metastatic urothelial carcinoma (mUC), a type of bladder cancer, and the only treatment that prolongs overall survival; however, age or comorbidities render many patients ineligible, and 30-50% receive no treatment. Continuing, Balar teaches Atezo (MPDL3280A), a PD-L1 immune checkpoint inhibitor (as further in claim 1 ) (see Deng et al., Abstract and Title), is active and well tolerated in platinum-treated mUC, justifying testing atezo as 1L treatment in cisplatin-ineligible patients. Balar adds that patients were chemo naive in the metastatic setting and cisplatin ineligible. Atezo 1200 mg was given IV every 3 weeks until PD. Balar observed that Atezo had clinically meaningful activity in 1L cisplatin-ineligible mUC patients, and preliminary OS is encouraging. Balar concludes that the durable nature of response and favorable AE profile makes this an attractive alternative to chemo (see entire Abstract).
And although Balar teaches bladder cancer, Balar fails to teach said bladder cancer is a recurrent cancer (as in claim 8).
Before the effective filing date of the claimed invention, Gao et al. investigated the extent of PD-Ls expression in HCC cell lines and tumor samples from a large, random HCC cohort. Gao showed that elevated PD-L1 expression in HCC is significantly associated with tumor aggressiveness and enhanced risk for postoperative recurrence (as in claim 9). Gao teaches their results were further validated in an independent data set. As such, Gao suggests PD-L1 may represent a target for HCC immunotherapy and a potential biomarker to facilitate patient assignment to such treatment as well as aid in the determination of prognosis both before and after therapy (Pg. 978).
When taken with the teachings of Yun et al., wherein Yun teaches a method of administering to a bladder cancer patient a pharmaceutical composition comprising a recombinant oncolytic adenovirus comprising a gene encoding Interleukin 12 (IL-12) and a gene encoding relaxin simultaneously with a medicament such as cisplatin, one of ordinary skill in the art would have found it prima facie obvious to substitute the cisplatin of Yun et al. for the MPDL3280A of Balar et al. in bladder cancer patients who are older or are have comorbidities.
The skilled artisan would have found it prima facie obvious to make such a substitution because Balar notes that age and comorbidities render many patients ineligible for cisplatin treatment and, as a result, between 30-50% receive no treatment. A reasonable expectation of success is present here because Balar observed clinically meaningful activity when MPDL3280A was administered to cisplatin-ineligible mUC patients and Yun notes that the pharmaceutical composition degrades extracellular matrix surrounding tissues to be targeted by medicaments thus enhancing tissue penetration of said medicaments and thereby increasing significantly the pharmacological efficacy of such medicaments. Moreover, one of ordinary skill in the art would have a reasonable expectation of success in using Balar’s PD-L1 immune checkpoint inhibitor treatment to treat a recurrent bladder cancer because Gao suggests elevated PD-L1 expression in cancer is significantly associated with tumor aggressiveness and enhanced risk for postoperative recurrence. Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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