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
Claims 13,18,31 and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim Note that D was not present in applicants elected species from their response filed 6/24/2024 and the examiner extended the search to a compound that also did not contain D, see office action page 3 mailed 8/7/2024. Since these amended claims now require D, an unelected species, they are considered withdrawn. Note independent claim 11 does not require the presence of D.
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) 11,15-17,21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hernandez et al. “Preventing Radiobleaching of Cyanine Fluorophores Enhances Stability of Nuclear/NIRF Multimodality Imaging Agents” Theranostics 2017, Vol. 7, Issue 1, in view of Han et al. “Ultra pseudo-Stokes shift near infrared dyes based on energy transfer”, J. Han et al. / Tetrahedron Letters 54 (2013) 502–505, cited previously, for the reasons set forth in the previous office action filed 4/23/2025.
Claim(s) 11,15-17,21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xiao et al. “Heptamethine cyanine based 64Cu-PET probe PC-1001 for cancer imaging: Synthesis and in vivo evaluation”, Nuclear Medicine and Biology 40 (2013) 351–360, cited previously, in view of Han et al., cited above in view of Price et al. “Matching chelators to radiometals for radiopharmaceuticals”, Chem. Soc. Rev., 2014, 43, 260-290, for the reasons set forth in the previous office action filed 4/23/2025.
Response to Amendment
The declaration under 37 CFR 1.132 filed 8/25/2025 is insufficient to overcome the rejection of claims 11,15-17,21 and 22 based upon the obviousness rejection over the combination of Hernandez and Han and the combination of Xia and Price as set forth in the last Office action because: the opinion type of declaration by applicant is unpersuasive.
Applicant asserts that one of ordinary skill in the art would not have reasonably predicted the superior properties with respect to Near Infrared Radiation-Cherenkov luminescence imaging (NIR-CLI) of the claimed compound. Applicants assert the references fail to mention NIR-CLI combination imaging. Applicants assert Xiao and Hernandez make constructs to absorb in the NIR region of 800 nm and there would be no reason to select a chromophore in UV/Blue region such as B, which is not used in standard optical imagining. Applicants have another reason to use component B to make a BC construct that is Cherenkov radiation light emitting.
The opinion that applicants present is unpersuasive for two main reasons, the first is the pending claims under examination are not drawn to a specific method of imaging via NIR-CLI. The examiner only needs to determine the patentability of the compound claimed which contains A,B and C. The examiner explained how the prior art cited teaches in combination the same compound claimed and presented a prima fascia case of obviousness. Since by combination the compound produced by either the combination of Hernandez and Han and the combination of Xia and Price is the same it follows any property claimed, such as the compounds’ ability to image using NIR-CLI will necessarily be the same and capable of the same use. Second the examiner can use another reason to combine the references besides applicants reasons why the inventor selected the parts of the conjugate A,B and C. The examiner did not combine the references to meet the invented use or property that the compounds can be used for NIR-CLI imaging. As noted in the prior action the reason to substitute B from Han into the conjugates of Hernandez or Xiao stem from the noted advantages of the fluorophore absorber emitter conjugate in imaging, namely favorable imaging properties due to large pseudo-Stokes shift, high energy efficiency (>94%) and excellent FEFs.
Response to Arguments
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive.
Applicants assert with respect to Hernandez that the compound taught within, RDC018, contains D (vector) between A and C, excluded by the claimed structure. Applicants assert Han does not cure this purported deficiency.
Applicants broadly claimed divalent linkage groups does not exclude amino acids such as those in RDC018, present between DTA and cyanine dye. The amino acid functional groups between A and C are within the scope of the linkages claimed.
Applicants reiterate the assertions already addressed in the response to amendment above. The examiner incorporates his response above.
With respect to Xiao, Han and Price, applicants assert the primary reference Xiao does not mention B, Han does not teach A and D, Price does not teach B or C and none of the references report Cherenkov study.
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). Clearly as noted in the previous action Xiao is silent with respect to use of a cyanine-hydroxycoumarin fluorophore acceptor and emitter as claimed and in the elected species for B and C, which is why it was combined with the secondary references to pick up these features. The secondary references were not used to pick up any other limitations except for what was not present in the primary reference. With regard to Cherenkov study, the claims under examination are drawn to a compound and not a method of imaging. The examiner only needs to meet the claimed compound and any properties or intended use of the compound will be considered met by the same compound as it will feature the same properties and be capable of the same use. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. See MPEP 2106 [R-6] pages 2100-6 through 2100-8.
Applicants reiterate their assertion in the declaration that the claimed combination is counterintuitive since no one performs standard imaging techniques in the UV/blue region. Consequently, applicants assert one of ordinary skill could not predict the surprising properties of the claimed invention with respect to optical imaging. Applicants assert the examiner improperly picked and chose the elements from Xiao and Han and did not provide motivation as the proposed modification would be unsatisfactory for their intended purpose.
The examiner has rebutted this assertion in the above response to amendment and incorporates his response here. The examiner can use another reason to combine the references besides applicants reasons why the inventor selected the parts of the conjugate A,B and C. The examiner did not combine the references to meet the intended use or property that the compounds can be used for NIR-CLI imaging. As noted in the prior action the reason to substitute B from Han into the conjugates of Hernandez or Xiao stem from the noted advantages of the fluorophore absorber emitter conjugate in imaging, namely favorable imaging properties due to large pseudo-Stokes shift, high energy efficiency (>94%) and excellent FEFs. Thus, the examiner has provided a strong reason why one of ordinary skill would modify Xiao and have a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAMES W ROGERS/Primary Examiner, Art Unit 1618