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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 6/18/2026 wherein claims 1-6, 39, 142, and 164 were amended and claims 7-26, 28-30, 32-38, 40-62, 64-77, 79-120, 122-124, 128-131, 133-141, 143-163, and 165-179 were canceled.
Note(s): Claims 1-6, 27, 31, 39, 63, 78, 121, 125-127, 132, 142, and 164 are pending.
Priority
This application is a 371 of PCT/US21/46049 filed 8/14/2021 and PCT/US21/46049 claims benefit to PRO 63/066,001 filed 8/14/2020.
Note(s): The application is fully supported by the provisional application. Thus, the earliest effective filing date is 8/14/2020.
Applicant’s Election
Once again, Applicant's election without traverse of Group I (pending claims 1-6, 27, 31, 39, 63, 78, and 125-127) filed 12/8/2025 is acknowledged. The restriction requirement was deemed proper and made FINAL.
Applicant elected the species
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. The compound reads upon claim 1,
A1 and A2 are hydrogen; Yi, Y2, Y3, and Y4 are hydrogen; R1 and R2 are each
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; n is 3; Ra is methyl; X1 is methyl; X2 is a platinum(IV) chelating group; A3 is propyl; Ys is -NRdC(O)-; Rd is hydrogen; A4 is ethyl; Rc is
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; R6 is carboxy; L2 and L3 are C1-C18 alkyldicarboxylate; L4 and L5 are C1-C12 diaminocycloalkane; L6 is hydroxy; X3 and X4 are ethyl; X5 is 3-hydroxypropyl; X6 is methyl; and Li is nitrate. The elected species reads upon claims 1-6, 27, 31, 39, 63, and 125-127.
Initially, Applicant’s elected species was searched. However, since no prior art was found that could be used to reject the claims, the search was extended claims to the species cited in the rejection below. The search was not further extended because prior art was found which could be used to reject the claims.
Claim Interpretation
Amended independent claim 1 is directed to compounds of formula
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with the variables as defined therein.
Independent claims 142 and 164 are directed to methods of imaging and treating a subject with
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wherein the variables as defined therein.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 6/18/2026 to the rejection of claims 1-5, 27, and 127 made by the Examiner under 35 USC 103 has been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejection. Therefore, the said rejection is hereby WITHDRAWN.
NEW GROUND OF REJECTION
103 Rejection
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 1-6, 27, 31, 39, 63, and 125 are rejected under 35 U.S.C. 103 as being unpatentable over Thiabaud et al (Chemistry – A European Journal, 2014, Vol. 20, Nol. 29, pages 8942-8947) in view of Mody et al (US 2004/0171602).
Independent claim 1 is directed to compounds of formula
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with the variables as defined therein.
Claims 2-6, 27, 31, 39, 63, and 125 are variations of claim 1 wherein different variable are highlighted therein in. Please see variable definitions in the respective claim.
Thiabaud et al is directed to Pt(IV) texaphyrin conjugates wherein the metal is Gd(III) (see entire document, especially, page 8943, Scheme I , see excerpt below; page 8944, Scheme II). In the structures of Thiabaud et al disclosed in Schemes 1 and 2, the values of the variables are as follows.
Compound 4 (variables assigned based on Applicant’s Formula I): X1 = methyl; X2 =
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; Y1 = hydrogen; A1 and A2 = hydrogen; R1 and R2 =
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wherein Ra = alkyl and n = 1-8 (for claims 1-5); Ra and Ra’ = alkoxy for claim 6; Y4 = hydrogen; X6 = methyl; Y3 = hydrogen; X3 = alkyl; X4 = alkyl; X2 = platinum (IV) chelating group (-A3-Y5-A4-Rc); A3 and A4 = alkanediyl; X5 = substituted alkyl; R6 = carboxyl; L6 = hydroxide; Rc =
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; Y5 = NRdC(O); and L2-L5 = two of the variables are halides (e.g., Cl) and the other two are ammonia (NH3).
Compound 5 (variables assigned based on Applicant’s Formula I): X1 and X2 =
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; Y1 = hydrogen; A1 and A2 = hydrogen; R1 and R2 =
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wherein Ra = hydrogen and n = 1-8; Y4 = hydrogen; X6 = methyl; Y3 = hydrogen; X3 = alkyl; X4 = alkyl; X2 = platinum (IV) chelating group (-A3-Y5-A4-Rc); A3 and A4 = alkanediyl; X5 = substituted alkyl; Rc =
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; R6 = carboxyl; Y5 = NRdC(O); L6 = hydroxide; and L2-L5 = two of the variables are halides (e.g., Cl) and the other two are ammonia (NH3).
Page 8943, Scheme 1
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Thiabaud et al disclose a compound that differs from the pending invention in the metal cation conjugated thereto. Specifically, the compounds of Thiabaud et al contain a Gd(III) instead of a Mn(II).
Mody et al is directed to metallotexaphyrin compounds that are structurally similar to Applicant’s Formula I,
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(see entire document, especially, abstract; page 10, Formula IA; page 23, claims 1 and 2; and page 24, claims 11 and 21). In particular, the structures of Mody et al have the formula
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(for example, see page 23, claim 1) and disclose Mn(II) and Gd(III) not only as being equivalent metal cations, but preferred metal cations, that are conjugated at position M on their metallotexaphyrin structure (page 2, paragraph [0016]). In addition, Mody et al disclose the radiolabeling of a metallotexaphyrin structure with both gadolinium and manganese (page 18, paragraphs, [0255]-[0256]; page 24, claim 11). As a result, it would have been obvious to one of ordinary skill in the art prior to the effective date of the pending invention to replace the Gd of Thiabaud et al with Mn(II) because both Thiabaud et al and Mody et al are directed to texaphyrin compounds that may be labeled with Mn(II) and Gd(III). Hence, the replacement of one equivalent/preferred metal cation with another one disclosed by Mody et al is within the ordinary skill of a practitioner. Furthermore, since both Thiabaud et al and Mody et al are within the same field of endeavor, there reference teachings are combinable.
For the reasons set forth supra, the limitations of the cited claims are rendered obvious by the cited prior art.
Withdrawn Claim
Claims 78, 121, 126, 127, 132, 142, and 164 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-examined species/invention.
Comments/Notes
It should be noted that the full scope of elected Group I was not searched.
Conclusion
Claims 1-6, 27, 31, 39, 63, and 125 are rejected. Claims 78, 121, 126, 127, 132, 142, and 164 are withdrawn.
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.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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, Michael G. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 13, 2026
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