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 without traverse of Group I in the reply filed on February 4, 2026 is acknowledged.
Drawings
FIG. 2 is object because the X-axis lacks descriptive label and unit of measurement. Without this label, the technical significance of the data points and the relationship between the variables cannot be understood, failing to provide a clear understanding of the claimed invention.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
The use of the term Fluo-8® which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
On page 24, line 19, “ZnPc (
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Φ )” should be clarified.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites “use of the nano-photosensitizer” but the claim does not clearly define whether the claimed subject matter is directed to a process, machine, manufacture, or composition of matter. The specification also fails to provide sufficient structural or procedural limitations that would allow one of ordinary skill in the art to determine the statutory class of the claimed invention. Because the statutory class of the claimed invention is unclear, the metes and bounds of the claim cannot be determined with reasonable certainty.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 10 does not fall within at least one of the four categories of patent eligible subject matter. The claim is directed to the use of the nano-photosensitizer, which is not defined as a process, machine, manufacture, or composition of matter as recited in 35 USC § 101. Accordingly, the claimed invention is not directed to patent-eligible subject matter.
Appropriate correction and/or amendment is required.
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; cited on PTO-892).
Regarding claim 1, Zhang discloses a diiodo-substituted boron-dipyrromethene (BDP or BODIPY), termed SNBDP, for photodynamic therapy (ABSTRACT; page 2, Scheme 1; page 4, Fig. 1). The structure of SNBDP is substantially similar to that of a capsaicin-derived photosensitizer, termed cap-BDP, of instant claim 1, differing only in the group connected to the phenyl oxygen of the compound. SNBDP contains a 1-hexanol group, whereas cap-BDP contains a capsaicin group (vanillylamine group). Regarding claim 7, Zhang discloses that the SNBDP nanoparticles (NPs) can be prepared by the self-assembly of SNBDP and an amphiphilic triblock copolymer (poloxamer, F127) in water (page 2, col. 1, ¶ 2; page 2, 2.6. Preparation of SNBDP nanoparticles).
Zhang does not disclose the structure of BDP containing a capsaicin group.
Sampedro discloses that capsaicin exhibits analgesic properties and antitumor activity in various cell types (Abstract). Sampedro discloses that the antitumor effect of capsaicin can be improved based on the enhancement of its aggregation propensity in aqueous media by covalent attachment of a BODIPY dye (Abstract; page 17235, scheme 1).
It would have been obvious to a person for ordinary skill in the art before the effective filling date of the claimed invention to substitute the 1-hexanol group in the SNBDP of Zhang with a capsaicin group to improve its activity as a photosensitizer. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Sampedro teaches capsaicin can be attached to a BODIPY for enhanced antitumor activity. Further, a person of ordinary skill in the art would have been motivated to use the photosensitizer containing a capsaicin group in order to inhibit the cancer cell proliferation and migration by activating the transient receptor potential vanilloid 1 (TRPV1) or targeting antiapoptotic proteins in tumor cells. Accordingly, applying the teaching of Sampedro to the nano-photosensitizer of Zhang constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 1 obvious.
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; cited on PTO-892) as applied to instant claims 1 and 7 above, and further in view of Ye et al. (Advanced Materials, 2018; cited on PTO-892).
Zhang and Sampedro are discussed above.
Neither Zhang nor Sampedro discloses that the amphiphilic block polymer is polyethylene glycol-b-polycaprolactone (PEG-b-PCL), polyethylene glycol-polyglutamic acid, poly2-(diisopropylamino)ethyl methacrylate, or polyethylene glycol-polybenzyl glutamate.
Ye discloses BDP-based conjugated photosensitizers (abstract). Ye discloses that the conjugated photosensitizer NPs can be prepared using PEG-b-PCL copolymer to achieve efficient cancer phototherapy (page 2, col. 2, ¶ 3; page 9, col. 1, ¶ 3).
It would have been obvious to a person for ordinary skill in the art before the effective filling date of the claimed invention to substitute the F127 in the nano-photosensitizer of Zhang and Sampedro with PEG-b-PCL to improve stability of the photosensitizer. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Ye teaches that PEG-b-PCL copolymer can be used to encapsulate the photosensitizer for achieving efficient cancer phototherapy. Further, a person of ordinary skill in the art would have been motivated to select polymers considering their properties such as stability and drug release time, based on the specific requirements of the intended application. Accordingly, applying the teaching of Ye to the nano-photosensitizer of Zhang and Sampedro constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 8 obvious.
Claim 10 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; cited on PTO-892) as applied to instant claims 1 and 7 above, and further in view of Jin et al. (ACS Applied Materials & Interfaces, 2018; cited on PTO-892).
Sampedro is discussed above.
In addition to the teachings of Zhang discussed above, Zhang discloses that the SNBDP NPs can kill the cancer cells upon light irradiation (page 2, col. 1, ¶ 2).
Neither Zhang nor Sampedro discloses that the treatment of triple negative breast cancer (TNBC).
Jin discloses that a conjugated polymer-based photosensitizer NP can be used for theranostics of TNBC (ABSTRACT). Jin discloses that conjugated polymer photosensitizer NPs showed great potential in photodynamic therapy of TNBC (page 10644, 4. CONCLUSION).
It would have been obvious to a person for ordinary skill in the art before the effective filling date of the claimed invention to use the nano-photosensitizer of Zhang and Sampedro in the preparation of drugs for the light-induced treatment of TNBC. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Jin teaches that polymer-based photosensitizer NPs can be used to treat TNBC effectively. Further, a person of ordinary skill in the art would have been motivated to use the nano-photosensitizer for the treatment of various cancers for a broader range of applications. Accordingly, applying the teaching of Jin to the nano-photosensitizer of Zhang and Sampedro constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 10 obvious.
Conclusion
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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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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