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 .
Response to Arguments
Applicant's arguments, filed June 12, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Drawings
Applicants amended the drawings filed June 12, 2026, the issues identified in the April 1, 2026 Office Action have been fully resolved. Therefore, the drawings received on June 12, 2026 are acceptable.
Claim Rejections - 35 USC § 103
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.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Dyes and Pigments, 2020; cited on IDS filed June 8, 2023) in view of Sampedro et al. (Angewandte Chemie International Edition, 2018).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 1, 2026 and those set forth herein.
Applicant argues that the combination of Zhang and Sampedro fails to teach or suggest all the elements of claims 1 and 7, and that it would not be obvious to a person of ordinary skill in the art to combine Zhang and Sampedro to arrive at the claimed invention because the claimed invention achieves superior and unexpected results. Applicant argues that the cap-BDP exhibits significantly increased fluorescence intensity after irradiation that is four times the intensity before irradiation. Applicant argues that upon the addition of calcium, the IC50 value of cap-BDP against 4T1 cells decreases, showing that it further induces apoptosis via calcium influx. Applicant argues that the nano-photosensitizer of claim 7 also possesses superior and unexpected results, specifically that the cap-BDP-NPs extend the in vivo clearance half-life, allowing long circulation and drug enrichment at the tumor site.
This argument is unpersuasive. As discussed in the Office Action mailed April 1, 2026, the combination of Zhang and Sampedro teaches and suggests all the elements of instant claims 1 and 7. Zhang teaches BDP derivatives for photodynamic therapy (ABSTRACT; page 2, Scheme 1; page 4, Fig. 1) and Sampedro teaches that attaching a capsaicin group to a BDP core can enhance antitumor activity (Abstract; page 17235, scheme 1). A person of ordinary skill in the art, seeking to improve the antitumor efficacy of a known photosensitizer, would have a clear motivation and reasonable expectation of success to replace the terminal group of the BDP of Zhang with the capsaicin of Sampedro. Therefore, the combination of these teachings to substitute one known element for another would have been obvious to one of ordinary skill in the art, thereby rendering claims unpatentable. Because Sampedro already teaches that a cap-BDP conjugate can yield enhanced activity, an increase in optical or biological activity upon combining these elements is entirely within the reasonable expectation of success.
Applicant’s assertions of unexpected results fail to satisfy the requisite legal criteria established under MPEP § 716.02. Objective evidence of unexpected results must be supported by appropriate evidentiary showing, direct comparative data, and must be commensurate in scope with the claims. Applicant has failed to meet this burden based on the following criteria.
First, the alleged results are predictable, not truly unexpected. To establish unexpected results, the foaming or enhancement must significantly exceed what a person having ordinary skill in the art would have reasonably anticipated. A four-fold increase in fluorescence intensity represents a predictable quantitative enhancement (a matter of degree) rather than an entirely new, qualitative chemical mechanism that was un-anticipatable by the prior art. The reduction in the IC50 value of cap-BDP in the presence of calcium is merely the predictable, cumulative result of combining the known phototoxicity of the BDP core with the known calcium-dependent cytotoxicity of capsaicin. It is a well-established principle that capsaicin stimulates TRPV2 channels, triggering intracellular calcium influx, and subsequent cell apoptosis. Regarding the cap-BDP-NPs of claim 7, formulating hydrophobic organic compounds or photosensitizers into self-assembled nanoparticles using amphiphilic block polymers is a standard, routine technique in drug delivery, as taught by Zhang (page 2, col. 1, ¶ 2; page 2, 2.6. Preparation of SNBDP nanoparticles). Such nano-formulations inherently extend the clearance half-life and accumulate in tumors. Because the underlying compound (cap-BDP) lacks patentable novelty and non-obviousness, applying a standard drug delivery method to achieve predictable pharmacokinetic improvements cannot impart independent patentability to dependent claim 7.
Second, Applicant fails to provide direct comparison with the closest prior art (Zhang and Sampedro individually or in a baseline combination). The evidence of unexpected results must involve a direct, side-by-side comparison between the claimed invention and the closest prior art. Without a direct comparison showing that the actual performance of the claimed compound is significantly better that what would be predicted from a simple additive effect of Zhang and Sampedro, the showing is insufficient to rebut the obviousness.
Third, the results are not commensurate in scope with the claims. To effectively rebut a rejection of obviousness, the disclosure or evidence of unexpected results must be commensurate in scope with the claims to which the evidence is applied. Broad claims 1 and 7 encompass a wide genus of potential derivatives, formulations, and applications. However, Applicant’s arguments rely on narrow, specific examples such as testing against a single cell line, 4T1. The limited experimental data does not establish that the entire claimed genus would exhibit the same allegedly unexpected properties.
Further, arguments or conclusory statements in the remarks section of a response do not take the place of evidence in the record. Allegations of unexpected results must be explicitly set forth in the originally filed specification or presented in a formal, signed declaration/affidavit accompanied by actual data. Absent the submission of such proper objective evidence, Applicant’s remarks remain mere unsubstantiated allegations that cannot overcome the rejection.
Accordingly, because the combination of teachings to substitute one known element for another would have been obvious to one of ordinary skill in the art, and because the Applicant has not provided sufficient objective evidence to demonstrate unexpected results, the rejection is maintained.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (Dyes and Pigments, 2020; cited on IDS filed June 8, 2023) and Sampedro et al. (Angewandte Chemie International Edition, 2018) as applied to instant claims 1 and 7 above, and further in view of Ye et al. (Advanced Materials, 2018).
This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed April 1, 2026 and those set forth herein.
Applicant argues that claim 1 and its dependent claim 8 are allowable over the combined teachings of Zhang, Sampedro, and Ye because the references fail to teach or suggest the capsaicin-derived photosensitizer of claim 1.
This argument is unpersuasive. As discussed above and in the Office Action mailed April 1, 2026, combined teachings of Zhang and Sampedro render claim 1 obvious, and claim 8 remains obvious over Zhang and Sampedro further in view of Ye.
Conclusion
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 JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G 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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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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