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 .
Amendments
Applicants amendments to the claims filed 8/12/2026 have been entered. Any objection\rejections from the previous office action filed 5/12/2026 not addressed below has been withdrawn.
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) 1,4-5,9,12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., cited previously, in view of Sakar et al. (US 2018/0312534), cited previously. This modified rejection was necessitated by amendment.
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.
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.
Regarding the new limitation in claim 1 that the metal complex is reduced by irradiation to release functional molecule D, it follows since Li teaches all of applicants claimed invention expect for the specific drug the metal complex will feature this property. Additionally, since be combination Li and Sakar teach the exact same compound, it follows any property recited is merely the natural result that would occur when the references are combined to produce the elected compound.
Claim(s) 1,4-5,9,12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 108743963, cited previously, in view of Sakar et al. (US 2018/0312534). This modified rejection was necessitated by amendment.
CN teaches 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.
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.
Regarding the new limitation in claim 1 that the metal complex is reduced by irradiation to release functional molecule D, it follows since CN teaches all of applicants claimed invention expect for the specific drug the metal complex will feature this property. Additionally, since be combination CN and Sakar teach the exact same compound, it follows any property recited is merely the natural result that would occur when the references are combined to produce the elected compound.
Response to Arguments
Applicant's arguments filed 8/12/2026 have been fully considered but they are not persuasive.
Applicants assert the new functional limitation that the complex is reduced by high-energy rays distinguishes the claims from Li and CN.
As noted above in the modified rejections since the compounds of Li and CN are substantially the same except for the active the examiner has good reason to believe they will feature this property of the compound. Regardless, it follows since by combination Li or CN with Sakar teach the exact same compound any property recited is merely the natural result that would occur when the references are combined to produce the elected compound.
Applicants assert their compounds show unexpected ability of being reduced under irradiation to provide a therapeutic benefit as shown in their examples
If applicants are attempting to make an allegation of unexpected results their remarks are inadequate. Applicants in order to establish an unexpected result must provide a comparison to the closest prior art, such as Li or CN, with data not mere allegation. An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). “A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference.” In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential. See MPEP 716.02(e).
Furthermore, applicants examples are for very specific metal complexes with specific ligands and active agents which are not considered to be commensurate in scope with the range of compounds encompassed in the claims. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). See MPEP 716.02d.
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 JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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
