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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/15/2026 has been entered.
Withdrawn rejections
The rejection of claim 21 under 35 U.S.C. 102(a)(1) as being unpatentable
over Stephen DiMagno, US 20180066298A1 is withdrawn over the claim cancellation.
New Grounds of Rejection due to the Applicant’s Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected 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.
Claim 3 recites “R9 is H, C1-C6 alkyl, or a protecting group.” However, substituent R9 is not included as part of Formula II, which creates ambiguity as this feature is not part to the Markush group. Appropriate correction is required.
Maintained Rejection with changes per claim Amendment and cancelation
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 (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.
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 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Berkman et al. (WO 2018098390) in view of DiMagno (US 20180066298) and Babich et al. (WO 2018187631).
Regarding claim 2-10, Berkman (page 49-50; page 8-9, [0024]- [0026]) teaches a compound of formula (Ij) that meets each and every chemical structure variable of the claimed invention; wherein each R1 to R8 are hydrogen; R is a detectable label or therapeutic drug; n is 3; m is 2; p is 1; L1 and L2 are each independently a covalent bond or a divalent linking group.
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Berkman (page 50, claim 18) teaches Z linker with an extra ethyl group and also a similar linker in compound of Formula (Ii), without the ethyl group, showing that alkyl length is a variable. Thus, a person of ordinary skill in the art (POSITA) would consider selecting different alkyl lengths as routine optimization in drug development and arrive at the claimed invention.
Berkman does not explicitly teach thioamide linkage.
DiMagno (page 8, [0070]), however, teaches various non-natural amino acids, including those containing thioamide linkages.
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DiMagno (page 6, [0047]) also teaches that thioamide linkages are more stable to in vivo hydrolysis, or are more stable to peptidase activity as compared to amide linkages Therefore, a POSITA would recognize such benefit and substitute the amide linker from Berkman’s teachings with thioamide linker from DiMagno to arrive at the claimed invention. One would have been
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motivated to do so because DiMagno teaches that thioamide linkages are more stable to in vivo hydrolysis, and are more stable to peptidase activity as compared to amide linkages as disclosed by Berkman
Regarding claim 11-12, Berkman (page 51), and as applied to claim 2-10 above, teaches a compound that meets each and every chemical structure variable of the claimed invention.
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Regarding claim 13-14, Berkman (page 50), and as applied to claim 2-10 above, teaches a compound that meets each and every chemical structure variable of the claimed invention
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Regarding claim 15, Berkman (page 51), and as applied to claim 2-10 above, teaches a compound that meets each and every chemical structure variable of the claimed invention.
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Regarding to claim 16-20, Babich (page 113, RSP077), and as applied to claim 2-10 above, teaches a compound wherein n= 3, m and p = 1; all of the Rs are hydrogen, L1 linker attaches to a chelating agent, and L2 linker. Although, the chelating agent taught by
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Babich contains four acetic acids residues instead of three, nonetheless, despite of that, it would still be obvious that a POSITA would have the option to explore a chelating agent with three acid residues, as taught by Beckman. This is because, both Babich and Beckman teach similar concept of compounds of Formula (I) with comparable utility for cancer imaging and treatment, and to arrive at the claimed invention. Therefore, it would have been obvious to a POSITA to modify the teachings of Babich and Beckman in view of DiMagno’s disclosure to arrive at the claimed invention, because their combined teachings describe using a non-natural amino-acid peptide as a therapeutic composition for imaging and treating cancer.
Response to Arguments
Applicant argues that because the prior art, particularly Babich, does not teach or suggest thioamide linkage, thus there is no reasonable expectation that a POSITA would arrive at the claimed thioamide containing compounds. Applicant’s argument is not persuasive. While Babich and Beckman do not explicitly disclose a thioamide linkage, however, DiMagno (page 6, [0047]) discloses thioamide substitution in place of an amide bond, including the advantage associated with such substitution to improve stability against in vivo proteolytic degradation. Therefore, the combined teachings of Babich and Beckman in view of DiMagno provide both the structural modification (amide to thioamide replacement) and the rational for making such modification.
Furthermore, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, Applicant should consider the combined teachings of the prior art as a collective disclosure for the obviousness rejection, rather than on differences found in any single prior art.
Conclusion
Therefore, claims 3-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622