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 1-20 are pending in the instant application.
Claims 3 and 20 are withdrawn from consideration
Claims 13-18 are amended.
Claims 1-2 and 4-19 are examined herein.
Priority
The instant application is a CIP of PCT/US2021/051718, filed on 23 September 2021, and claims benefit of priority to U.S. Provisional Application No. 63082207, filed on 23 September 2020, U.S. Provisional Application No. 63165270, filed on 24 March 2021, U.S. Provisional Application No. 63178379, filed on 22 April 2021, and U.S. Provisional Application No. 63184051, filed on 04 May 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 23 September 2020.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 07 May 2024, 16 January 2025, 01 October 2025, and 17 February 2016, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 17 February 2026 has been entered.
In view of applicant amendment to claims 13-18, the 112(b) rejections of record are withdrawn.
With respect to the 103 rejection, Applicant amendment has been considered but is not found persuasive for at least the following reasons. Applicant argues the office action was deficient in establishing prong (2) and prong (3) of KSR prong (B). Regarding prong (2), Applicant argues the prior art does not disclose the function of the elected species, according to the instant invention, as Yang is directed to treating viral, bacterial, and fungal infections, not cancer. Yang discloses the elected species functions as a reverse transcriptase inhibitor (RTI), as the instant invention also discloses. While the method of using is not shared between the instant invention and Yang, their function is shared. The method of using a reverse transcriptase inhibitor for the treatment of cancer is then supported by Ting.
Regarding prong (3), Applicant argues substitution of the elected species, taught by Yang, for zalcitabine, taught by Ting, would not have been predictable. Applicant points to the instant compound 29 (elected species) and compound 31 (pictured below) which differ only in the substitution of a thymine base in compound 31 for compound 29’s cytosine. Applicant argues that compound 29 exhibits great efficacy in more cell lines than compound 31, and this shows that substitution of one RTI for another would not lead to predictable results. However, the Examiner would argue that the derivatives of zalcitabine (pictured below) do show predictable results. Compound 29 (elected species) and compound 30 (pictured below) are both zalcitabine derivatives, comprising extra substituents on the oxolane moiety, not another RTI with half the core being a different ring system as seen with compound 31. Compounds 29 and 30 are shown to exhibit similar efficacy across all tested cell lines (Table 8, page 92-96 of specification). The skilled artisan would expect similar results for derivatives or analogs of zalcitabine.
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For these reasons the 103 rejections are maintained below.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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 (i.e., changing from AIA to pre-AIA ) 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 1-2, 4-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ting et al. (WO2020142629; cited by applicant on 1449 IDS) in view of Yang et al. (US5192749A).
Regarding claims 1 and 2, Ting discloses the method of treating cancer comprising administering an effective amount of a reverse transcriptase inhibitor (RTI) (page 58, line 4-5).
Ting does not teach administering the elected specie, 4'-cyano-2'-deoxycytidine, however Ting discloses administering 2',3'-dideoxycytidine or zalcitabine (pictured below), a reverse transcriptase inhibitor and another cytidine analog.
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Yang teaches 4’-substituted nucleosides as reverse transcriptase inhibitors (column 23, line 21). Example 5, 2'-deoxy-4'-cyanocytidine (pictured below from STN search), is the elected species.
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It would be prima facie obvious to one of ordinary skill in the art to substitute one reverse transcriptase inhibitor for another and expect similar results. The expectation of success is further compounded by the structural similarities of zalcitabine and the elected specie, as both are analogs of cytidine. As Ting demonstrates application of reverse transcriptase inhibitors to the method of treating cancer, one skilled in the art would be guided to apply additional reverse transcriptase inhibitors to the method. The work of Yang offers the additional reverse transcriptase inhibitor, 2'-deoxy-4'-cyanocytidine. Thus, applying at least prong B of KSR one could substitute one inhibitor for another that are both known as reverse transcriptase inhibitors.
Regarding claim 4, Ting discloses the method of treating epithelial cancer (page 14, line 5).
Regarding claim 5, Ting discloses the method of treating breast cancer (page 14, line 7).
Regarding claim 6, Ting discloses the method of treating colon cancer (page 14, line 8).
Regarding claim 7, Ting discloses the method of treating lung cancer (page 14, line 6).
Regarding claim 8, Ting discloses the method of treating pancreatic cancer (page 14, line 6).
Regarding claim 9, Ting discloses the method of prostate breast cancer (page 14, line 7).
Regarding claim 10, Ting discloses the method of treating ovarian cancer (page 14, line 8).
Regarding claim 11, Ting discloses the method of treating heading and neck cancer (page 59, line 5).
Regarding claim 12, Ting discloses the method of administering a second therapeutic agent (page 68, line 5).
Regarding claim 13, Ting discloses the additional therapeutic agent can be tamoxifen (page 71, line 17), paclitaxel (page 70, line 4), cyclophosphamide (page 70, line 3), docetaxel (page 70, line 14),
gemcitabine (page 71, line 16), fluorouracil (page 70, line 19), bevacizumab (page 70, line 8), or atezolizumab (page 69, line 9).
Regarding claim 14, Ting discloses the additional therapeutic agent can be oxaliplatin (page 70, line 4), fluorouracil (page 70, line 19), bevacizumab (page 70, line 8), pembrolizumab (page 69, line 8), or avelumab (page 69, line 8).
Regarding claim 15, Ting discloses the additional therapeutic agent can be pembrolizumab(page 69, line 8), nivolumab (page 69, line 8), atezolizumab (page 69, line 8), cyclophosphamide (page 70, line 3), cisplatin (page 71, line 17), or gemcitabine (page 71, line 16).
Regarding claim 16, Ting discloses the additional therapeutic agent can be gemcitabine (page 71, line 16), fluorouracil (page 70, line 19), sunitinib (page 70, line 4), or paclitaxel (page 70, line 4).
Regarding claim 17, Ting discloses the additional therapeutic agent can be docetaxel (page 70, line 14) or pembrolizumab (page 69, line 8).
Regarding claim 19, Ting discloses the clinical trial NCT03144804 (page 87, line 9) as evidence of the success of RTIs on colorectal cancer. This study excluded patients on antiviral medication for HIV (page 19 of Study Protocol).
Claims 1-2, 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ting et al. (cited above) in view of Yang et al. (cited above) and in further view of Lanz et al. (Ann Transl Med. 2019;7(Suppl 8):S362).
The work of Ting and Yang are disclosed above and incorporated by reference herein.
Regarding claim 18, Ting discloses the method of treating prostate cancer and the method of an additional therapeutic agent.
Ting does not teach administering an antiandrogen with an RTI to treat prostate cancer.
Lanz teaches antiandrogens in the treatment of prostate cancer as these inhibitors can prevent nuclear translocation thereby stopping the expression of proliferation genes.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Ting teaches combiniation therapy with an RTI for the treatment of prostate cancer, however Ting does not teach an antiandrogen, such as apalutamide, as the additional therapeutic agent. Lanz teaches the importance of antiandrogens in the treatment of prostate cancer; particularly apalutamide, as it is more efficacious than its predecessors. It would be prima facie obvious to one of ordinary skill in the art to substitute the additional therapeutic agents taught by Ting for an antiandrogen based on the teaching of Lanz.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Conclusion
Claims 1-2 and 4-19 are rejected.
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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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