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 .
Election/Restrictions
Upon reconsideration group V, drawn to a kit comprising a pharmaceutical composition is grouped with group II, a pharmaceutical composition. Thus, group V is withdrawn and group II includes claims 14 and 18. Applicant's election with traverse of group I and the species featuring oxalic acid,1,2 diamino cyclohexane, succinic acid and aminomethyl coumarin in the reply filed on 4/3/2026 is acknowledged. The traversal is on the ground(s) that each invention is drawn to a single general inventive concept of a platinum metal chelate. This is not found persuasive because the examiner broke unity using the rationale that the inventive concept, a platinum metal chelate, does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-7 (unelected species, elected compound features amino methyl coumarin which is not recited among the active agents listed) and 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species or invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 and 8-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Li et al. “Current Developments in Pt(IV) Prodrugs Conjugated with Bioactive Ligands”, Bioinorganic Chemistry and Applications Volume 2018, cited by applicants. The following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Li reviews the state of the art in Pt(IV) anticancer prodrugs conjugated with bioactive ligands and other ligands including oxalic acid,1,2 diamino cyclohexane, succinic acid (three of the four elected ligands), the bioactive ligands included tamoxifen, a known agent for treating cancer (meeting claims 2-4) and ligands targeting glucose transporters (meeting claim 5), the bioactive ligands were bound by functional groups (O-C=O-CHR) within the scope of P in claim 11. See entire disclosure, especially Fig 1, 7-19, page 12 left col last ¶-rt col. last ¶. Regarding the functional limitation or property that P and L are axial ligands released from the complex after irradiation and converted to functional molecule D, it follows that since the linkages between Pt (IV) and bioactive are within the scope of the claims they will be capable of releasing bioactive under irradiation. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure or composition as that which is claimed, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01 [R-3] II.
Claim(s) 1-5 and 8-13 is/are rejected under 35 U.S.C. 102a1 as being anticipated by CN 108743963, English translation provided by examiner.
CN discloses anticancer Pt(IV) conjugates featuring oxalic acid,1,2 diamino cyclohexane, succinic acid (three of the four elected ligands) and galactose-modified hydroxyalkyl starch (considered to read on ligands for targeting glucose transporters). See entire disclosure, especially abstract, Fig. 1,2, drawings at [0048] and claims. The galactose modified starch was bound by functional groups (O-C=O-CHR) within the scope of P in claim 11. Regarding the functional limitation or property that P and L are axial ligands released from the complex after irradiation and converted to functional molecule D, it follows that since the linkages between Pt (IV) and bioactive are within the scope of the claims they will be capable of releasing bioactive under irradiation. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure or composition as that which is claimed, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01 [R-3] II.
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.
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) 1-5 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., cited above, in view of Sakar et al. (US 2018/0312534).
Li is disclosed above. Li is silent with respect to the use of the amino-methyl coumarin group (circled below) in applicants elected species of:
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Sakar is used primarily for its disclosure that Pt was well known before the time of applicants’ invention to be capable of binding with 7-Amino-4-methylcoumarin, an optical reporter molecule via a linker which includes HNC(O)O. See abstract, [0192]-[0194],[0207] and claims.
Since both references are generally related in their teachings of platinum conjugates and Li teaches several different active compounds bound to Pt, one of ordinary skill in the art would have a high expectation of success in substituting the platinum (IV) conjugates of Li with 7-Amino-4-methylcoumarin through the linkage HNC(O)O. Reason to make such a substitution would be to image and diagnose the tumor being treated. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 1-5 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 108743963, cited above, in view of Sakar et al. (US 2018/0312534).
CN is disclosed above. CN is silent with respect to the use of the amino-methyl coumarin group (circled below) in applicants elected species of:
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Sakar is used primarily for its disclosure that Pt was well known before the time of applicants’ invention to be capable of binding with 7-Amino-4-methylcoumarin, an optical reporter molecule via a linker which includes HNC(O)O. See abstract, [0192]-[0194],[0207] and claims.
Since both references are generally related in their teachings of platinum conjugates, one of ordinary skill in the art would have a high expectation of success in substituting at least some of the platinum (IV) conjugates of CN with 7-Amino-4-methylcoumarin through the linkage HNC(O)O. Reason to make such a substitution would be to image and diagnose the tumor being treated. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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