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 .
Priority
This Application is a 371 of PCT/CN2021/113514, filed Aug.19, 2020 and claims foreign priority to CN202010843823.6, CN202011236522.3 and CN202110431905.4, filed Aug. 20, 2020, Nov. 19, 2020 and Apr. 21, 2021, respectively, in the People’s Republic of China.
Claim Status
Claims 11-19 are pending. Claims 12-14 and 16-18 are withdrawn pursuant to the restriction requirement mailed Sept. 15, 2025. Claims 11, 15 and 19 are active and subject to examination.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claims 3, 6 and 9 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The rejection of claims 1-3, 5-11 and 15 under 35 U.S.C. 102(a)(2) as being anticipated by Su et al. (US 2022/0259201 A1) is withdrawn.
The rejection of claims 1-3, 5-11 and 15 under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (US 12,297,197 B2, filed Apr. 3, 2020) is withdrawn.
The above rejections were overcome by Applicant’s amendments to the claims.
Claim Rejections – 35 USC § 103 – New Grounds of Rejection Necessitated by Amendment
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.
Claim(s) 11, 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 12,297,197 B2, filed Apr. 3, 2020) (of record).
Claims 11 and 19 are directed towards the compound:
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.
Wang teaches the compound 87, which is almost identical to the compound 94 as in claims 11 and 19:
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Wang, Specification, col. 159-160, table 1, Ex. 18.
Wang teaches that this compound is particularly effective in inhibiting tumor growth in a mouse cancer model:
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Wang, Specification, col. 245.
While Wang does not specifically teach compound 94 which contains a deuterated methyl on the piperazine, one of ordinary skill in the art would have a reasonable expectation of success to deuterate the methyl on the piperazine of Ex. 18 of Wang because Wang specifically teaches that the compound can be deuterated to reduce toxicity and side effects, increase drug stability, enhance curative efficacy, and prolong biological half-life:
Again, for example, hydrogen can be substituted by heavy hydrogen to form a deuterated drug. The bond consisting of deuterium and carbon is firmer than the bond formed by ordinary hydrogen and carbon. Compared with an undeuterated drug, the deuterated drug has the advantages of reduced toxic and side effects, increased drug stability, enhanced curative efficacy and prolonged biological half-life. Transformations in all the isotopes of the compound of the present disclosure, whether radioactive or not, are included in the scope of the present disclosure.
Wang, Specification, col. 127, lines 34-44.
The Federal Circuit has recently ruled that such modifications are obvious because one of ordinary skill in the art would reasonably expect that deuterated compounds would exhibit altered ADME properties as compared to the parent compound. Sun Pharm. Indus., Inc. v. Incyte Corp., No. 2019-2011, Document No. 117 (Fed. Cir. August 22, 2023) (“The Board had substantial evidence to conclude that a person of ordinary skill would have had a reasonable expectation that she could succeed in modifying ruxolitinib to arrive at its tetra- and octo-deuterated analogs, which she would expect to display ‘superior ADME properties.’”(at 12)).
Therefore, claims 11 and 19 were prima facie obvious at the time of filing.
Claim 15 is directed towards a pharmaceutical composition comprising the compound of claim 11 and a pharmaceutically acceptable carrier.
One of ordinary skill in the art would have a reasonable expectation of success to formulate a pharmaceutical composition comprising the compound of claim 11 and a pharmaceutically acceptable carrier because similar pharmaceutical compositions are commonly known in the art.
For example, carrier. Wang teaches a pharmaceutical composition comprising a similar compound and a pharmaceutically acceptable carrier (solvent in the below table):
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Wang, Specification, col. 243, Table 9;
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Wang, Specification, Compound 69, col. 161, Table 1.
Wang teaches that this carrier was also used in Experimental Example 3, wherein compound 18 was administered, the results of which are shown above in Table 11:
TGI was calculated by the difference between the median tumor volume of mice in the solvent group and the median tumor volume of mice in the drug group, and expressed as the percentage of median tumor volume in the solvent control group… The 5% DMSO+10% polyoxyl 15 hydroxystearate (Solutol)+85% 120 was used as the negative control.
Wang, Specification, col. 244.
Therefore, claim 15 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Conclusion
No claim is found to be allowable.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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