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 .
Applicants' arguments, filed August 11, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Comments and Notes
It appears that Applicants used double brackets to delete the chemical structures previously present in claims such as in claim 65. However, double brackets are only to be used when strike-through cannot be easily perceived and for the deletion of five or fewer character (37 CFR 1.121(c)(2)). Neither of those conditions apply to the chemical structures of the instant claims. Additionally, the positioning of the brackets could make it unclear if a blank line between the previously present structure and newly inserted structure was being deleted rather than the entirety of the structure positioned above the brackets being deleted.
In the interest of compact prosecution, a Notice of Non-Compliant Amendment has not been prepared despite the improper amendments. Failure to properly format future claim amendments may result in the mailing of a Notice of Non-Compliant Amendment.
Drawings
The drawings were received on August 11, 2025. These drawings are not accepted. While some of the issues identified in the Office Action mailed April 18, 2025 were addressed in the replacement drawings were remedied, exact molecular weights are still given for compounds with ovoid shapes in Figures 3 and 4 with no explanation as to the meaning of the ovoid shape and/or an explanation as to how such compounds can have an exact molecular weight given when the structure is not completely specified in either the drawings themselves or the accompanying arguments. The abbreviations present in figures such as figures 7 and 8 are still present and no explanation as to the abbreviations are present in either the drawings themselves or the accompanying arguments. Therefore the objection to the drawings is maintained as not all of the issues have been completely address.
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 65 and 84 – 88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The first compound of amended claim 65 is not disclosed by the disclosure as originally filed (see the circled portion on the left hand side of the molecule).
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While structures comprising this fragment are disclosed, the terminal group on the left hand side of the molecule is not disclosed by any compound.
The dependent claims fall therewith.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to page and line number wherein support may be found for this particular compound.
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 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) 65, 80 and 84 – 93 were rejected under 35 U.S.C. 103 as being unpatentable over Wester et al. (WO 2019/115547). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 18, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that Webster does not teach or suggest the R-DOTAGA isomer. The mere presence of the flat structure is not enough to render the individual isomers as there must be a clear reason or rational for a person of ordinary skill in the art to combine said elements in the claimed manner. That one of ordinary skill in the art could be motivated to try to make the R-DOTAGA isomer does not mean that they would be motivated to do try to make R-DOTAGA. Non-DOTAGA bearing carbon atoms can be modified in Webster [Note that Applicants use “Webster” to refer to the applied Wester et al. (see top of p 24 of the response filed August 11, 2025).] The Office has failed to identify why this stereocenter is so special that it would warrant special attention from one of ordinary skill in the art. Webster does not disclose a preference for the stereocenter at the carbon adjacent to the DOTAGA group and Applicants respectfully contends the Examiner has relied on improper hindsight based on the amended claims to arrive at the R-DOTAGA isomer.
These arguments are unpersuasive. The stereochemistry of certain positions was labeled in the compounds such as compound (In) at the bottom of p 52. For bonds such as the carbon atom by the DOTAGA group in question, no stereochemistry was indicated by Wester et al. which one of ordinary skill in the art would interpret as encompassing both possible stereoisomers at that atom. This contrasts within the positions within the molecule highlighted on p 25 of the Remarks that have the specified stereochemistry by Wester et al., reasonably suggesting to one of ordinary skill in the art that the spatial arrangement at those positions was more closely investigated compared to other stereocenters that were not, such as the location in question. Applicants have not provided any evidence of unexpected results arising from the claimed enantiomer at this location that would overcome the prima facie case of obviousness given the high structural similarity of the enantiomers that are presumed to have similar although not exact biological activity given the chiral nature of biological systems. Therefore one of ordinary skill in the art need not “try” to make such a compound as molecules either the R and S configuration at this stereocenter are present in the structure as disclosed, and the instantly claimed compound is not patentably distinguished over the applied prior art.
Conclusion
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618