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
Request for Continued Examination Under 37 CFR 1.1143
A request for continued examination (RCE) 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 mailed on June 18, 2026 has been entered.
Claims 1, 5, 6, 8, 9, 13, 14, 16, 17, 21, 22, 24 and 25 are pending in the instant application.
Claims 1, 6, 8, 9, 14, 16, 17, 22, 24 and 26 have been amended.
Accordingly, claims 1, 5, 6, 8, 9, 13, 14, 16, 17, 21, 22, 24 and 25 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Arguments
Applicant's Amendment and Response filed June 18, 2026 has been considered. Communications, rejections and/or objections not reiterated from the previous Office Action mailed March 26, 2026 are hereby withdrawn. Any arguments addressing said rejections and/or objections are moot. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Claim Rejections - 35 USC § 102
In the previous Office Action mailed March 26, 2026, claims 9, 13, 14 and 16 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mishra et al. (J Surg Res. 2015 February; 193(2): 745-753). This rejection is withdrawn in view of Applicant’s Amendment to the claims filed June 18, 2026.
Claim Rejections - 35 USC § 103
In the previous Office Action mailed March 26, 2026, claims 1, 5, 6, 8, 17, 21, 22, 24 and 25 were rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Scientific Reports, Vol. 9: No. 5039, 2019 Mar 25, pages 1-14). This rejection is withdrawn in view of Applicant’s Amendment to the claims filed June 18, 2026.
Claim Rejections - Improper Markush Grouping
In the previous Office Action mailed March 26, 2026, claims 1, 5, 6, 8, 17, 21, 22, 24 and 25 were rejected on the basis that the claims contain an improper Markush grouping of alternatives. This rejection is withdrawn in view of Applicant’s Amendment to the claims filed June 18, 2026.
Applicant’s Amendment to the claims filed June 18, 2026 necessitated a new grounds of rejection as presented below:
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.
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 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 1, 5, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon Pyo Choi et al. (Biochemical and Biophysical Research Communications 427 (2012) 642-648, plus Supplementary Information).
The claims are drawn to a method of alleviating resistance to a platinum-based chemotherapeutic agent administered to a subject, comprising administering to the subject a composition, the composition comprising a therapeutic agent, the therapeutic agent comprising (i) an siRNA that inhibits integrin b4 (ITGB4) expression, or (ii) an siRNA that inhibits ITGB4 expression and an siRNA that inhibits paxillin (PXN) expression; wherein the subject has developed or is at an elevated risk of developing resistance to the platinum-based chemotherapeutic agent.
Yoon Pyo Choi et al. teach administering to a subject a composition comprising an shRNA that inhibits ITGB4 expression. For example, Yoon Pyo Choi et al. teach depletion of ITGB4 via shRNA efficiently suppresses ovarian cancer cell proliferation, migration, and invasion in a xenograft tumor formation model in vivo. See Tables 4B-b, Supplementary Table 4 and Figure S3, for example. NOTE: Yoon Pyo Choi et al. teach a shRNA that inhibits ITGB4 expression, however it is well-known that the cell's endogenous machinery processes the shRNA hairpin into a functional siRNA as evidenced by Josh Roberts (siRNA or shRNA? Picking the Right Knockdown Reagent. Biocompare. October 23, 2014). In view of the common knowledge possessed by the skilled artisan, the Examiner will interchangeably refer to the composition taught by Yoon Pyo Choi et al. as ITGB4 siRNA and/or ITGB4 shRNA.
Regarding those claims that recite that the subject has developed or is at risk of developing resistance to a platinum-based chemotherapeutic, it should be noted that given the common knowledge possessed by the skilled artisan, it is understood that any subject with a malignant cancer, such as ovarian cancer is at risk of developing resistance to a platinum-based chemotherapeutic.
While Yoon Pyo Choi et al. does not explicitly identify that administering a composition comprising an siRNA that inhibits ITGB4 expression will alleviate resistance to a platinum-based chemotherapeutic agent in the subject, Yoon Pyo Choi et al. discloses the same composition and teach the exact same method step as instantly claimed. Any underlying mechanism of action would naturally flow and be inherent to administration of the composition to the subject. See MPEP 2112 as it relates to inherency.
Furthermore, the instant specification serves as evidence of record establishing this inherency. Failure of those skilled in the art to contemporaneously recognize an inherent property (i.e. a biological mechanism of action) of a prior art reference does not preclude a finding of anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999). See also Ex parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993).
Note that the Office does not have the facilities and resources to provide the factual evidence needed in order to determine the alleviation of resistance to a platinum-based chemotherapeutic agent in a subject following administration of a composition comprising an siRNA that inhibits ITGB4 expression. In the absence of evidence to the contrary, the burden is upon the Applicant to prove that the claimed method of administering to a subject a composition comprising an siRNA that inhibits ITGB4 expression is different from the method of administering to a subject a composition comprising an siRNA that inhibits ITGB4 expression of the prior art such that the method of the prior art cannot have the intended use/functionality, thereby establishing patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ2d 1922(PTO Bd. Pat. App. & Int. 1989).
The Examiner has provided sound basis in fact and technical reasoning that reasonably supports the determination that the allegedly inherent characteristic necessarily flows from what has been specifically disclosed within the prior art and has shifted the burden to Applicant to provide evidence to the contrary.
Before the effective filing date of the claimed invention, a method of administering to a subject having ovarian cancer a composition comprising an siRNA that inhibits ITGB4 expression was taught in the prior art.
It would have been obvious and one of skill in the art would have been motivated to devise the method of Applicant's claimed invention for the purpose of the studying the biological effects of ITGB4 inhibition in ovarian cancer treatment.
A person of ordinary skill in the art would have expected reasonable success of devising the method of Applicant's claimed invention using the successful teachings and suggestions of Yoon Pyo Choi et al.
Therefore, the subject matter of claims 1, 5, 6 and 8 is obvious over Yoon Pyo Choi et al., absent some evidence to the contrary.
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Claims 17, 21, 22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon Pyo Choi et al. (Biochemical and Biophysical Research Communications 427 (2012) 642-648, plus Supplementary Information) in view of McGuire et al. (New Engl J Med. 1996 Jan 4;334(1):1-6) (submitted and made of record in the Office Action filed November 18, 2025).
The claims are drawn to a method of treating cancer in a subject, comprising administering to the subject: a platinum-based chemotherapeutic agent, and a composition comprising a therapeutic agent capable of alleviating resistance to the platinum-based chemotherapeutic agent, the therapeutic agent comprising (i) an siRNA that inhibits integrin b4 (ITGB4) expression, or (ii) an siRNA that inhibits ITGB4 expression and an siRNA that inhibits paxillin (PXN) expression; wherein the subject has developed or is at an elevated risk of developing resistance to the platinum-based chemotherapeutic agent.
Yoon Pyo Choi et al. is relied upon as discussed above.
Yoon Pyo Choi et al. do not teach a method of treating cancer in a subject, comprising administering to the subject a platinum-based chemotherapeutic agent.
McGuire et al. teach that the incorporation of the chemotherapeutic agents, cisplatin-paclitaxel into first-line therapy improves the duration of progression-free survival and of overall survival in women with advanced ovarian cancer.
Regarding those claims that recite that the subject has developed or is at risk of developing resistance to a platinum-based chemotherapeutic, it should be noted that given the common knowledge possessed by the skilled artisan, it is understood that any subject with a malignant cancer, such as ovarian cancer is at risk of developing resistance to a platinum-based chemotherapeutic.
Regarding those claims that recite wherein the chemotherapeutic agent is administered at a reduced dose compared to the dose of the chemotherapeutic agent when administered alone, Applicant is reminded that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. See In re Aller, 105 USPQ 233. Also see MPEP 2144.05. In other words, it is not inventive to discover the optimum or workable ranges by routine experimentation and optimization.
Before the effective filing date of the claimed invention, a method of treating ovarian cancer in a subject, comprising administering to the subject a chemotherapeutic agent such as cisplatin was known. See McGuire et al. Before the effective filing date of the claimed invention, a method of treating ovarian cancer in a subject, comprising administering an siRNA that inhibits ITGB4 expression was taught in the prior art of Yoon Pyo Choi et al.
It would have been obvious and one of skill in the art would have been motivated to combine the teachings of McGuire et al. with those of Yoon Pyo Choi et al. for the purpose of combination therapy and potential synergistic therapeutic effects against ovarian cancer in a subject.
A person of ordinary skill in the art would have expected reasonable success of devising the method of Applicant's claimed invention using the successful teachings and suggestions of both Yoon Pyo Choi et al. and McGuire et al.
Therefore, the subject matter of claims 17, 21, 22, 24 and 25 is obvious over Yoon Pyo Choi et al. in view of McGuire et al.
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Claims 9, 13, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon Pyo Choi et al. (Biochemical and Biophysical Research Communications 427 (2012) 642-648, plus Supplementary Information) in view of Choi et al. (Cancer Res (2014) 74 (19_Supplement): 2, Abstract) (submitted and made of record in the Office Action filed November 18, 2025).
The claims are drawn to a composition for alleviating resistance to a platinum-based chemotherapeutic agent in a subject, comprising a therapeutic agent capable of alleviating resistance to the platinum-based chemotherapeutic agent, the therapeutic agent comprising siRNA that inhibits integrin b4 (ITGB4) expression and an siRNA that inhibits paxillin (PXN) expression; wherein the subject has developed or is at an elevated risk of developing resistance to the platinum-based chemotherapeutic agent. NOTE: The language, “capable of” denotes a latent property. For the purposes of examination and prior art, the Examiner will interpret the siRNA that inhibits integrin ITGB4 expression and the siRNA that inhibits PXN expression as capable of alleviating resistance to a platinum-based chemotherapeutic agent in a subject, absent some evidence to the contrary.
Yoon Pyo Choi et al. is relied upon as discussed above. As noted, the Examiner is interpreting the ITGB4 siRNA of Yoon Pyo Choi et al. as capable of alleviating resistance to a platinum-based chemotherapeutic agent in a subject, absent evidence to the contrary.
Yoon Pyo Choi et al. do not teach an siRNA that inhibits paxillin (PXN) expression.
Choi et al. teach an siRNA that inhibits paxillin (PXN) expression. For example, Choi et al. disclose paxillin silencing using siRNA incorporated in DOPC nanoliposomes resulted in 55% reduction in tumor growth in a HeyA8 orthotopic ovarian cancer mouse model. As noted, the Examiner is interpreting the PXN siRNA of Choi et al. as capable of alleviating resistance to a platinum-based chemotherapeutic agent in a subject, absent evidence to the contrary.
Before the effective filing date of the claimed invention, a composition capable of alleviating resistance to a platinum-based chemotherapeutic agent in a subject, comprising a therapeutic agent comprising a siRNA that inhibits ITGB4 expression was known in the prior art. See Yoon Pyo Choi et al. Additionally, before the effective filing date of the claimed invention, a composition capable of alleviating resistance to a platinum-based chemotherapeutic agent in a subject, comprising a therapeutic agent comprising a siRNA that inhibits PXN expression was also known in the prior art. See Choi et al.
It would have been obvious and one of skill in the art would have been motivated to combine the teachings of Yoon Pyo Choi et al. with those of Choi et al. for the purpose of combination therapy and potential synergistic therapeutic effects against potential capabilities of alleviating resistance to a platinum-based chemotherapeutic agent in a subject. Also, it would have been obvious and one of skill in the art would have been motivated to combine the teachings of Yoon Pyo Choi et al. with those of Choi et al. for the purpose of combination therapy and potential synergistic therapeutic effects against ovarian cancer in a subject.
A person of ordinary skill in the art would have expected reasonable success of devising the composition of Applicant's claimed invention using the successful teachings and suggestions of both Yoon Pyo Choi et al. and Choi et al.
Therefore, the subject matter of claims 9, 13, 14 and 16 is obvious over Yoon Pyo Choi et al. in view of Choi et al.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/ Primary Examiner, Art Unit 1635
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