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
Applicant's election with traverse of group I, claims 1-8 and 11 in the reply filed on 5/8/2026 is acknowledged. The traversal is on the ground(s) that the groups are properly combinable and would not constitute a serious search burden to consider together. This is not found persuasive because search burden being undue is a moot argument for lack of unity issue. Undue search burden is not an issue in a lack of unity.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 8 is objected to because of the following informalities: the chemical structures are too faint and difficult to read. Appropriate correction is required.
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) 1,4,6-7 and 11 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bhushan et al. (US 2014/0073780), cited by applicants.
Bhushan discloses dual modality breast cancer diagnostic agents featuring Gd-DOTA chelate (meeting claims 6-7) bound through a linker to an IR dye:
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, within the scope of claim 1. See entire disclosure, especially abstract, figures and claims. Regarding claims 4 and 11, the portion on the dye above
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and the linkages drawn between the chelate and dye within Bhushan are within the scope claim 4 and the broadly claimed linkage groups.
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) 1-8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. "Anti-tumor metastasis via platelet inhibitor combined with photothermal therapy under activatable fluorescence/magnetic resonance bimodal imaging guidance", ACS Applied Materials & Interfaces, Vol. 13, 2021, pp. 19679-19694, cited by applicants, in view of Bhushan et al. (US 2014/0073780).
Zhang teaches bimodal imaging agents IR780-Cys-DOTA-GD. See entire disclosure, including abstract and Fig. 1. Zhang further teaches dyes including ICG, IRdye820 and IR780 (same dye elected by applicants) were well known before the time of the claimed invention and noted such dyes were useful in photodynamic mediated therapy and show attractive advantages including real time imaging to monitor drug delivery. See page 19680 left col 1st ¶. Thus, substitution of IRDye780 for IRDye820 would be obvious to one of ordinary skill as they are listed as functional art equivalents. It is obvious to those skilled in the art to substitute one known equivalent for another. The reason for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose. See In re Omeprazole Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . . error in [the] conclusion that it would have been obvious to one skilled in the art to substitute one ARC [alkaline reactive compound] for another.”).
Zhang does not teach the linkage group claimed.
However as noted above Bhushan teaches similar bimodal dye MRI contrast agents featuring the linkage
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, as well as alkyl linkage groups between the chelate and dye. To select the alkyl group elected (decane) would be obvious to one of ordinary skill it is simply a homolog to the linkages taught by Zhang and Bhushan. The claimed compounds are so closely related structurally to the homologous compounds of the reference as to be structurally obvious therefore in the absence of any unobviousness or unexpected properties. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Since the two references are related in their teachings of bimodal dye MRI contrast agents one of ordinary skill in the art would have a high expectation of success in substituting various linkages between the dye and chelate. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). 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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