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 08/05/2024.
Claims 1, 3, 5-10, 13-14, 16-17, 21-25, 27-29, 31 and 35-41 are pending.
Claims 2, 4, 11, 12, 15, 18-20, 26, 30, 32, 33 and 34 are cancelled.
Claims 35-41 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, Species A and Species B in the reply filed on 09/03/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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.
Claims 3 and 5 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.
In regard to claim 3, it is unclear why the terms “S0” and “T1” are in parenthesis. Thus, it is unclear if this is a limitation in the claim or just a preferred embodiment.
In regard to claim 5, it is unclear why the term “T1” is in parenthesis. Thus, it is unclear if this is a limitation in the claim or just a preferred embodiment.
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, 3, 5-10, 13, 14, 16, 17, 21-25, 27-29 and 31 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 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 recites: A composition, comprising: a photosensitizer; a cleavable moiety that accepts triplet-triplet energy transfer from the photosensitizer in a higher energy state to cause cleavage of the cleavable moiety; and a releasable moiety releasable from the composition upon cleavage of the cleavable moiety, wherein the composition does not comprise an annihilator,
wherein
the photosensitizer is platinum II tetraphenyl tetrabenzoporphyrin (PtTPBP),
the composition comprises a therapeutically-effective amount of a prodrug, the prodrug comprising the cleavable moiety and the releasable moiety, wherein the prodrug is BODIPY-CAB represented by the following structural formula
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(claim 1).
The photosensitizer has an excitation wavelength of 625 nm (claim 4), which is about 650 nm, which instant claim 9 defines as NIR wavelength.
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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, 3, 5-10, 13, 24, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over ASKES (Red Light-Triggered CO Release from Mn2(CO)10 Using Triplet Sensitization in Polymer Nonwoven Fabrics. JACS. 2017.) in view of SASAKI (Studies on near-infrared-to-visible photon upconversion materials. Kyushu University Institutional Repository. 2021.).
Regarding claim 1, ASKES teaches a composition, comprising: a photosensitizer, such as palladium(II) tetraphenyltetrabenzoporphyrin (PS) (abstract and page 15292, paragraph 2) capable of singlet-to-triplet (S-T) activation; a cleavable moiety, such as Mn2(CO2)10 (abstract and page 15292, paragraph 2), to accept triplet-triplet energy transfer from the photosensitizer in a higher energy state to cause cleavage of the cleavable moiety; and a releasable moiety, such as CO, which releases upon cleavage of Mn2 (abstract and page 15292, paragraph 2). The composition does not comprise an annihilator.
ASKES does not teach using a photosensitizer that is activated at a near- infrared (NIR) wavelength.
SASAKI teaches using the photosensitizer Os(bptpy)22+ that is activated at 730 nm, which is at NIR (page 128, paragraph 1). Os(bptpy)22+ goes from a single state to a triple state which is advantageous for reducing the energy loss of triplet sensitization (page 41, paragraph 1), which means it can utilize lower energy light and have a highly efficient conversion.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate Os(bptpy)22+ which activates at NIR wavelength. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Os(bptpy)22+ and palladium(II) tetraphenyltetrabenzoporphyrin are functional equivalents of photosensitizers that include transition metal-porphyrins commonly used in the pharmaceutical industry. Furthermore, Os(bptpy)22+ goes from a single state to a triple state which is advantageous for reducing the energy loss of triplet sensitization which is more efficient and can utilize a lower energy light and ASKES teaches that Ideally, a clinician would better use red to near-infrared (NIR) light (page 15292, paragraph 1).
Regarding claim 3, SASAKI teaches that Os(bptpy)22+ goes directly from a singlet (S0) state to a triplet (T1) state (figure 2-2, page 35) and ASKES teaches the cleavable moiety accepts the triplet energy (figure 1).
Regarding claim 5, ASKES teaches that the triplet state of the photosensitizer is high than the triplet state of the cleavable moiety (figure 1).
Regarding claim 6, ASKES teaches the photosensitizer comprises palladium(II) tetraphenyltetrabenzoporphyrin (abstract), which is a transition metal-porphyrin.
Regarding claim 7-8, SASAKI teaches using the photosensitizer Os(bptpy)22+ (page 128, paragraph 1).
Regarding claim 9, SASAKI teaches using the photosensitizer Os(bptpy)22+ that is activated at 730 nm, which is at NIR (page 128, paragraph 1).
Regarding claim 10, SASAKI teaches using the photosensitizer Os(bptpy)22+ that is activated at 730 nm, which is at NIR (page 128, paragraph 1) and is about 690 nm.
Regarding claim 13, ASKES teaches using Mn2(CO)10 which when cleaved releases CO, which reads on prodrug. Controlled CO delivery has raised interest because it leads to positive effects on inflammation and wound healing, has a strong cell-protective action, can be used to eradicate microbes, and can relax smooth muscles to lower blood pressure (page 15292, paragraph 1).
Regarding claim 24-25, Note, the prior art’s composition would have the same chemical/physical properties of “wherein at least about 80% of the cleavable moiety is released” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise.
Regarding claim 27-29, ASKES teaches that the composition can be put into a carrier material, such as polymer fabric (page 15294, paragraph 3).
Claims 1, 3, 5-10, 13, 14, 21, 24, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over ASKES (Red Light-Triggered CO Release from Mn2(CO)10 Using Triplet Sensitization in Polymer Nonwoven Fabrics. JACS. 2017.) and SASAKI (Studies on near-infrared-to-visible photon upconversion materials. Kyushu University Institutional Repository. 2021.) in view of SLANINA (In Search of the Perfect Photocage: Structure−Reactivity Relationships in meso-Methyl BODIPY Photoremovable Protecting Groups. JACS. 2017).
ASKES and SASAKI teach Applicant’s invention as discussed above.
ASKES and SASAKI do not teach where the cleavable moiety is BODIPY.
Regarding claim 14 and 21, SLANINA teaches a photoactive composition that has a cleavable moiety, such as BODIPY, that releases a cargo (abstract). The BODIPY has the general formula of
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(abstract), which reads on BODIPY and the structure of instant claim 21. Using this structure of BODIPY allowed for a high release rate of the leaving group (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having BODIPY as the cleavable moiety. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for a high release rate of the cargo upon photo activation, and reasonably would have expected success because the references are in the same field of endeavor, such as photocleaved compositions for releasing cargo.
Claims 1, 3, 5-10, 13, 14, 16, 17, 21-25, 27-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over ASKES (Red Light-Triggered CO Release from Mn2(CO)10 Using Triplet Sensitization in Polymer Nonwoven Fabrics. JACS. 2017.), SASAKI (Studies on near-infrared-to-visible photon upconversion materials. Kyushu University Institutional Repository. 2021.) and SLANINA (In Search of the Perfect Photocage: Structure−Reactivity Relationships in meso-Methyl BODIPY Photoremovable Protecting Groups. JACS. 2017) in view of HUANG (Expanding Anti-Stokes Shifting in Triplet–Triplet Annihilation Upconversion for In Vivo Anticancer-Prodrug Activation. Angew Chem Int Ed Engl. 2017.).
ASKES, SASAKI and SLANINA teach Applicant’s invention as discussed above.
ASKES, SASAKI and SLANINA do not teach where the released moiety is chlorambucil.
Regarding claims 16 and 17, HUANG teaches a composition, comprising: a photosensitizer, such as 9-phenylacetylene anthracene (PEA) capable of singlet-to-triplet (S-T) activation at a near- infrared (NIR) wavelength (scheme 1 and page 4, paragraph 3); a cleavable moiety, such as BODIPY derivative (BDP) (page 4, paragraph 3), such as to accept triplet-triplet energy transfer from the photosensitizer in a higher energy state to cause cleavage of the cleavable moiety; and a releasable moiety, such as an anticancer drug, chlorambucil (abstract and page 4, paragraph 3) releasable from the composition upon cleavage of the cleavable moiety.
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 chlorambucil is an alternative cargo to be released and is an anticancer drug, which will allow the composition to be used for cancer treatment, and reasonably would have expected success because the references are in the same field of endeavor, such as light triggered compositions, that comprise a photosensitizer, a cleavable moiety and a therapeutic agent that is released.
Regarding claims 22 and 23, if chlorambucil is added to the BODIPY structure taught above it would create the structure in instant claim 23 shown as
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.
Regarding claim 31, Regarding claim 31, HUANG teaches the composition can be added into nanoparticles with diameter of 218 nm, which is less than 1mm (page 3, paragraph 4).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a nanoparticle. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because nanoparticle and polymer fabric are functional equivalents of carriers commonly used in the pharmaceutical industry.
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
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