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 6/20/2025 wherein claims 1-6, 39, 132, 142, and 164 were amended and claims 7-26, 28, 29, 32-38, 40-62, 64-77, 79-120, 122-124, 128-131, 133-141, 143-163, and 165-179 were canceled. The amendment filed 12/8/2025 is a duplicate of the 6/20/2025 amendment.
Note(s): Claims 1-6, 27, 30, 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 parent application. Thus, the earliest effective filing date is 8/14/2020.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1-6, 27, 30, 31, 39, 63, 78, 121, and 125-127) filed 12/8/2025 is acknowledged. The restriction requirement is still deemed proper and is therefore 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, 30, 31, 39, 63, 121, 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 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
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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with the variables as defined therein.
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 1-5, 27, and 127 are rejected under 35 U.S.C. 103 as being unpatentable over Quartarolo et al (J. Chem. Theory Comput., 2007, Vol. 3, pages 860-869) in view of Sessler et al (US Patent No. 6,825,186), and in further 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.
Pending claims 2-5 and 27 (see claims) all read on independent claim 1 and identify the various variable definitions therein.
Quartarolo et al is directed photodynamic therapy photosensitizer texaphyrin complexes. The complexes contain a transition metal (Mn, Fe, Co, Ni, Cu, or Zn) (see entire document, especially, abstract). In the introduction, Quartarolo et al disclose that photodynamic therapy is a non-invasive medical technique for the treatment of different types of diseases in oncology (branch of medicine that deals with the study, treatment, diagnosis, and prevention of cancer) and ophthalmology. In addition, it is disclosed that the photosensitizer shows preferably high accumulation in cancer cells when injected into human body tissue and then irradiated by visible light (imaged) (pages 860-861, bridging paragraph).
Quartarolo et al disclose Compound 1b (page 861),
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wherein Applicant’s variables in the pending invention are defined as follows: R1 and R2 = alkoxy; A1 and A2 = hydrogen; Y1, Y2, Y3, and Y4 = hydrogen; and X1, X2, X3, X4, X5, and X6 = alkyl. Quartarolo et al disclose that M may be Mn.
Sessler et al is directed to methods and compositions of treating atheroma, tumors, and other neoplastic tissue (see entire document, especially, abstract; column 1, lines 15-17; column 12, lines 45-52; column 15, lines 51-58). The texaphyrins of Sessler et al have the structure
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. The structure in Sessler et al reads on Applicant’s invention and Quartarolo et al when Applicant’s variables in the pending invention are defined as follows: R1 and R2 = alkoxy; A1 and A2 = hydrogen; Y1, Y2, Y3, and Y4 = hydrogen; and X1, X2, X3, X4, X5, and X6 = alkyl. In Sessler et al invention M may be Mn(II) or Mn(III) (column 6, line 35 through column 7, line 8).
Also, it is noted that the structure in columns 7-8, line 15,
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. Still, Sesslers et al disclose that radiation sensitizers are compounds that preferentially localize in tumors (column 16, lines 4-12). I a method treating tumors, atheroma, and other neoplastic tissue comprising administering a texaphyrin substance to a subject, allowing a sufficient time for the substance to preferentially accumulate in the cells of tumors, atheroma, or other neoplastic tissue (columns 33-34, claim 1).
It would have been obvious to a skilled artisan that (1) the species of Quartarolo et al is useful in treating and imaging cancer as set forth in the introduction, pages 860-861, bridging paragraph) which discloses that photodynamic therapy enable one to treat different types of diseases in oncology. (2) Both Quartarolo et al and Sesslers et al reads on the same species as Quartarolo et al. (3) The species of Sesslers et al are also used for treatment of tumors/cancers. For the reasons supra, the limitations of claims 1-5 and 27 are met.
Claim 127 is directed to a pharmaceutical composition comprising a compound of independent claim 1.
Both Quartarolo et al and Sessler et al disclose the same species as stated supra. In addition, Sessler et al disclose that pharmaceutical compositions comprising the texaphyrin may be administered to a subject with various excipients/carries (column 19, lines 26-48; column 19-20, bridging paragraph). Thus, the limitation of claim 127 is met.
For the reasons set forth above, the pending invention is rendered obvious by the cited prior art. As both inventions are directed to overlapping subject matter.
Withdrawn Claim
Claims 78, 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.
Claim Objections
Claims 6, 30, 31, 39, 63, 121, 125, and 126 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Note(s): The claims are objected to only to the extent that they read on the specific elected species as set forth supra.
Comments/Notes
It should be noted that the full scope of elected Group I was not searched.
Quartarolo et al (J. Chem. Theory Comput., 2007, Vol. 3, pages 860-869) cited in the 103 rejection was mailed to Applicant with the office action dated 9/29/2025. Thus, the document is not included with this office action.
Applicant is respectfully requested to make the following changes for clarity of the claimed invention: (1) in claim 1, lines 5 and 7, before “wherein” delete the comma; (2) in claim 1, line 20, after “group”, delete “;” ; (3) in claim 2, lines 5 and 7, before “wherein” delete the comma; (4) in claim 2, line 17, deleted “;” after “group”; (5) in claim 3, lines 5 and 7, before “wherein” delete the comma; (6) in claim 3, line 15, after “group”, delete “;”; (7) in claim 4, lines 5 and 7, before “wherein” delete the comma; (8) in claim 4, line 12, after “group”, delete “;”; (9) in claim 5, lines 5 and 7, before “wherein” delete the comma; (10) in claim 5, line 14, after “group”, delete “;”; (11) in claim 6, lines 5 and 7, before “wherein” delete the comma; (12) in claim 6, line 13, after “group”, delete “;”; (13) in claim 142, lines 5 and 7, before “wherein” delete the comma; (14) in claim 142, line 21, after “group”, delete “;”; (15) in claim 164, lines 6 and 8, before “wherein” delete the comma; (16) in claim 164, line 20, after “group”, delete “;”.
Conclusion
Claims 1-5, 27, and 127 are rejected. Claims 78, 132, 142, and 164 are withdrawn. Claims 6, 30, 31, 39, 63, 121, 125, and 126 are objected.
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.
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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.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
March 13, 2026