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 .
Information Disclosure Statement
The information disclosure statement filed 11/7/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because some the references cited are not provided in English, a translation of the abstract alone is insufficient for the examiners full consideration. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Election/Restrictions
Applicant's election with traverse of group II claims 27-32 and the species NCA-2 in the reply filed on 5/7/2026 is acknowledged. Upon reconsideration the examiner has withdrawn the species requirement for selection of a specific compound as these groups are considered to have unity. The traversal is on the ground(s) that the groups are related to product and process of making. Applicants also noted that Desmet does not break unity as the reference does not suggest a polyamino-acid shell produced from a compound of general structure I. This is not found persuasive because the reference used to break unity merely needs to be related to the same general field of the invention and does not necessarily have to teach all of the exact elements as in a 102 type of rejection. Applicants’ argument regarding the claims are related to product and process of making is unclear, as these groups are restrictable under PCT practice.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-26 and 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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) 27,30 and 32 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bazylinska et al. “Novel Multilayer IR-786-loaded Nanocarriers for Intracellular Delivering: Characterization, Imaging, and Internalization in Human Cancer Cell Lines”, Chem. Lett. 2012, 41, 13541356, cited by applicants.
Bazylinkska discloses nanocapsules containing the cyanine dye IR-786, the nanocapsule comprising a shell produced from amino acids that are considered derivable from the compound of general structure I, in addition to emulsifier and oil (considered to read on surfactant and/or carrier or excipient) in an oil in water emulsion. See entire disclosure, especially abstract, ¶ bridging pages 1354-1355, Fig. 1 and table 1.
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) 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bazylinska et al., cited above, in view of Roschger et al. (US 6,008,350).
Bazylinska is cited above. The reference is silent with respect to NIR absorber of general structure II or III, required components of claims 18-19 and by dependency pending claims 28-29 and 31.
Roschger is used only for its disclosure that cyanine dyes within the scope for the pending claims were already well known before the time of the claimed invention, including:
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. See entire disclosure, especially abstract, examples C2,C5-C7 and claims.
Since Bazylinska already teaches use of a cyanine dyes one of ordinary skill in the art would have a very high expectation of success in using other cyanine dyes such as C2 in Roschger. The reason for specifying it 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. 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) 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs et al. “Polypeptide Nanoparticles Obtained from Emulsion Polymerization of Amino Acid N-Carboxyanhydrides”, Journal of the American Chemical Society 2019 141 (32), 12522-12526, cited IDS in view of Bazylinska et al., cited above, in view of Roschger et al. (US 6,008,350).
Jacobs teaches polypeptide nanoparticles obtained from aqueous emulsion polymerization of amino acid N-Carboxyanhydrides within the scope of general formula I with surfactant, forming the following polymeric shell:
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. See entire disclosure, especially abstract, ¶ bridging pages 12522 and 12523 and scheme 1.
Jacobs while teaching the nanoparticles can act as carriers for active compounds is silent with respect to the claimed NIR absorber.
Bazylinska and Roschger are disclosed above and are used here for their combined disclosures that cyanine dyes were known to be encapsulated by polyamino acid capsules before the time of the claimed invention. As noted above Roschger teaches cyanines within the scope of general formula II and III.
Since Jacobs teaches amino acid shell nanocapsules and Bazylinska teaches that polyamino acid microcapsules could encapsulate cyanine dyes one of ordinary skill in the art would have a very high expectation of success in adding cyanine dyes such Cy2 into the primary reference. Reason to make such a substitution would be to visualize delivery of the nanocapsules of Jacobs within the subject. 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
ny 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