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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated 06/15/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 05/04/2026 are acknowledged.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments. Please see the examiner’s response to applicants arguments below.
Response to Arguments
Applicants’ main argument is that Sakakibara does not teach or suggest the claimed methylene-substituted thiazole. Rather, Sakakibara teaches thiazole derivatives bearing carbonyl-based substituents, including a methoxycarbonyl group. The Examiner appears to treat such carbonyl substitution as sufficiently equivalent to the claimed methylene group such that it could be replaced by an aliphatic spacer allegedly taught by Makhaeva.
Claims require a methylene group in between thiazole and functional group B, wherein functional group can be any functional group. Claimed methylene group can be interpreted as a linker group, which should create space (aka flexibility) between thiazole and functional group.
Pending rejection already acknowledged that Sakakibara silent on methylene group in between thiazole and functional group B, however, cited Makhaeva teaches advantages of linker groups, such as methylene groups.
Applicants response simply states that methylene group is not equivalent to carbonyl group and cannot be exchangeable. But applicants remarks failed to explain or show any disadvantages of incorporating methylene group and its effect on the property of the compound.
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 of this title, 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 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 1-3, 5-8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sakakibara (US 6,004,934) in view of Makhaeva (Russian Chemical Bulletin Edition, Nov 2018, vol.67, No.11, 2121-2126).
For claim 1:
Sakakibara teach the dolastatin 10 [see column 2] and its corresponding derivative represented by the following formula:
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.
Above formula reads applicants claimed dolastatin 10 analog other than group A, if in the above formula, R1 and R2 are i-Pr, R3 is secondary butyl, R4 is methyl, Q is represented by, for example,
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or its corresponding ester or amide or other recited functional groups etc. [see column 6], wherein -COOH reads applicants group ‘B’.
Difference is that Sakakibara silent on applicants variable ‘A’, which is linear or branched C1-6 alkyl group, wherein C1-6 alkyl group is a methylene group (-CH2-). In other words, art is silent on a linker, viz., linear or branched C1-6 alkyl group in between heterocyclic ring and functional group, wherein C1-6 alkyl group is a methylene group (-CH2-).
However, -CH2- groups are common linkers in the organic chemistry, since these are flexible compared to other linkers. For example, Makhaeva teaches advantages of -CH2-CH2- linker compared to other linkers [see Table 1]. Therefore, one would be motivated to incorporate a flexible linker in between desired functional and the core of the compound.
For claims 2-3:
Makhaeva teaches -CH2-CH2- [see Table 1]. However, the length of the linker can be tuned since it is result effective variable and so, a skilled person in the art would determine the length of the linker through a routine experimentation and arrive at suitable linker with a reasonable expectation of success.
Alternatively, -CH2- and -CH2-CH2- are adjacent homologs, which are obvious over each other according to established case law. MPEP 2144.09 states “Compounds which are….homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by –CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA).
For claims 5-6 and 8:
Sakakibara teaches various functional groups, such as carboxyl, ester, amide etc. [see columns 6-7], and it is silent on hydroxyl functional group.
However, -OH or -CH2-OH along with other functional groups are common in the art. When these are incorporated on a chemical group, the resulted property is expected, based on charge or polarity or hydrophobicity etc. A skilled person in the art would choose suitable functional groups for their desired molecule and so, this limitation is obvious, absent evidence to the contrary.
For claim 7:
Sakakibara teaches methyl group for applicants claimed R group at the same position [see formula I].
For claim 20:
Sakakibara teaches pharmaceutical composition of their dolastatin derivative [see claim 1].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components, such as dolastatin, alkylene spacers and functional groups, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed dolastatin 10 analog with a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. 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 SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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