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Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/19/2026.
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) 6-10 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kang et al. “A preliminary study for the development of cleavable linkers using activatable fluorescent probes targeting leucine aminopeptidase†”, Analyst, 2022, 147, 5386, cited IDS.
Kang discloses a method to develop and study enzyme cleavable linkers (including p-amino benzyl, meeting claim 9) with fluorescent probes, including xanthene derivatives within the scope of claim 10, the bound fluorophore was non-fluorescent until released by tumor specific peptidase in cells as shown below:
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. See entire disclosure, especially abstract and Fig. 1.
Claims 6-9 s/are rejected under 35 U.S.C. 102a1 as being anticipated by Shi et al. (US 6,287,821).
Shi discloses nucleotide analogues with 3-pro-fluorescent fluorophore reporter, including rhodamine, a xanthene derivative, the reporter exhibited greater fluorescence when uncoupled from the enzyme degradable linker used to bind it to the nucleotide. See entire disclosure, especially abstract and calms 1,5-6 and 49. Naturally enzymatic degradation during the experiment is performed in the cell or outside a cell. Regardless Shi clearly discloses monitoring the activity of enzyme within cells. See ¶ bridging col 13-14. Naturally by monitoring fluorescence and enzyme activity as disclosed within Shi the effectiveness of linker to be cleaved is also being verified as claimed. Note claim 9 is merely further limiting an optional component (spacer) in claim 6.
Claims 6-9 s/are rejected under 35 U.S.C. 102a1 as being anticipated by Miller, OPTIMIZATION OF ADC LINKERS: DESIGN AND EVALUATION OF A FRET-BASED ADC LINKER-LIBRARY, THESIS Submitted in partial fulfillment of the requirement for
Honors Thesis in Biochemistry in Harpur College of Arts and Sciences of Binghamton University State University of New York 2020.
Miller discloses optimization of Antibody-Drug conjugate (ADC) linkers by attaching the linkers to be studied to a fluorophore dye, including Oregon Green, a xanthene derivative, subjecting it to enzymatic degradation and using FRET-based assay for evaluating linker stability in vitro. See entire disclosure, especially abstract, page 13 last ¶, Conclusion bridging pages 22-23 and Fig 2. Note claim 9 is merely further limiting an optional component (spacer) in claim 6.
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) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller, cited above, in view of Quin et al. “Efficacious fluorescence turn-on probe for
high-contrast imaging of human cells overexpressing quinone reductase activity”, Chem. Commun.,2017, 53,783.
Miller is disclosed above. Miller while teaching use of xanthene derivative Oregon Green is silent with respect to the Xanthene derivatives of claim 10.
Quin is used only for its disclosure that Xanthene derivatives within the scope of claim 10 were already well known before the time of the claimed invention, the compound is shown below:
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, once attached through the amide linkage the fluorophore on the left is within the scope of the claims when X and R are NH2. See entire disclosure, especially abstract and Fig. 1. The free fluorophore displayed intense fluorescent reporter signature.
Since Miller already teaches use of Xanthene derivatives one of ordinary skill in the art would have a high expectation of success in substituting the fluorophore of Quin into the primary reference. Reason to make such a substation 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. Additionally, the intense fluorescence of the reporter groups Quin would be expected to be advantageous in the field of fluorescent imaging/assay. 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) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shi et al, cited above, in view of Quin et al., cited above.
Shi is disclosed above. Shi while teaching use of xanthene derivative Oregon Green is silent with respect to the Xanthene derivatives of claim 10.
Quin is used only for its disclosure that Xanthene derivatives within the scope of claim 10 were already well known before the time of the claimed invention, the compound shown below:
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, once attached through the amide linkage the fluorophore on the left is within the scope of the claims when X and R are NH2.. See entire disclosure, especially abstract and Fig. 1. The free fluorophore displayed intense fluorescent reporter signature.
Since Shi already teaches use of Xanthene derivatives one of ordinary skill in the art would have a high expectation of success in substituting the fluorophore of Quin into the primary reference. Reason to make such a substation 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. Additionally, the intense fluorescence of the reporter groups Quin would be expected to be advantageous in the field of fluorescent imaging/assay. 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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