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 .
Receipt is acknowledged of IDS filed on 05/08/2025.
Claims 1-21 are pending.
Claims 10-21 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I and Species A-B in the reply filed on 08/24/2026 is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12578273B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent teaches a compound comprising BODIPY (claim 1), which is a boron-dipyrromethen-derived compound and is also a dye.
Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12064482B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent teaches a compound comprising BODIPY (claim 1), which is a boron-dipyrromethen-derived compound and is also a dye.
Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 18 of U.S. Patent No. 7705040B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent teaches a compound comprising a boron-dipyrromethene
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(claim 1), which is a boron-dipyrromethen-derived compound and acridine orange which is a dye (claim 18).
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/966,507 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending Application recites a composition comprising BODIPY (claim 2) which is a boron-dipyrromethen-derived compound and is also a dye.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18/737,027 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending Application recites a composition comprising BODIPY (claim 14) which is a boron-dipyrromethen-derived compound and is also a dye.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of copending Application No. 18/566,778 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending Application recites a composition comprising BODIPY (claim 22) which is a boron-dipyrromethen-derived compound and is also a dye.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 17/850,720 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending Application recites a composition comprising a boron-dipyrromethen-derived compound, specifically 1,3,5,7-tetramethyl -8-hydroxymethyl pyrromethene fluoroborate (claim 3), which is also a dye.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LIN (A dual-responsive nanocapsule via disulfideinduced self-assembly for therapeutic agent delivery. Chemical Science. 2016.).
Regarding claim 1, LIN teaches a boron-dipyrromethene derived compound (scheme 1a) and a dye, such as ICG (abstract). Note, BODIPY, also shown as BDP, is boron-dipyrromethene. Lin specifically used BDP-NC (page 1847, paragraph 3).
Regarding claim 3-6, LIN teaches using ICG (abstract), which is a near-infrared cyanine dye that has sulfate groups (Applicant’ specification page 2, paragraph 1).
Regarding claim 7, The composition is a nanocapsule, which is a specific type of nanoparticle (abstract).
Regarding claim 8 and 9, The ICG concentration a 9.2 wt% (page 1850, paragraph 2). This means the BPD compound was roughly 90 wt%.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over LIN (A dual-responsive nanocapsule via disulfideinduced self-assembly for therapeutic agent delivery. Chemical Science. 2016.) in view of LV (Upconversion-like Photolysis of BODIPY-Based Prodrugs via a One-Photon Process. JACS. 2019.).
LIN teaches Applicant’s invention as discussed above. Lin further teaches the composition can be used for imaging and drug delivery (abstract) and the composition is photocleavable (page 1849, paragraph 2).
Lin does not teach using boron-dipyrromethene-chlorambucil.
Regarding claim 2, LV teaches a BODIPY composition that comprises chlorambucil, which is an anticancer drug (page 17483, paragraph 2). The composition can be in a nanoparticle (page 17484, paragraph 5). The composition is photocleavable (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate chlorambucil. The person of ordinary skill in the art would have been motivated to make those modifications, because the composition in LIN is explicitly described as being able to deliver drugs and delivering an anticancer drug such as chlorambucil would allow the composition to be used for both imaging and treatment, and reasonably would have expected success because the references are in the same field of endeavor, such as photocleavable BODIPY nanoparticle compositions that are for drug delivery.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
