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 .
Claims 1, 2, 6, 7, 10, 11, 16-19, 21, 27, 28, 32 and 33 are presented for examination.
Claims 22-26 are withdrawn from examination.
Election/Restriction
Applicant's election with traverse of Group I, claims 1, 2, 6, 7, 10, 11, 17-19, 21, 27, 28, 32 and 33 in the reply filed on 10/27/2025 is acknowledged. The traversal is on the ground(s) that Applicant submits “that a serious burden has not been placed on the Office to consider all of the claims in a single application. A review of the subject matter set forth in the claims would have an overlapping search. Further, 37 C.F.R. § 1.475(b)(3) establishes that "[a]n international or a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to a product, a process specially adapted for the manufacture of the said product, and a use of the said product." This is not found persuasive because Peyman (US 20190030190) teaches polydopamine nanoparticles containing ani-VEGF agents. See Paras [0022[, [0102], [0110] and [0344]. The ocular composition is taught in Para [0328]. Therefor the claim of the instant application lack unity of invention, considering that the shared technical feature is not a special technical feature as it does not contribute over the prior art . Furthermore, applicant’s attention is drawn to the following factors:
(a)the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due their recognized divergent subject matter;
(c) the inventions have acquired a different field of search (for example searching different classes/subclasses or electronic resources, or employing different search queries);
(d) the prior at applicable to one invention would not likely be applicable to another invention;
(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112 first paragraph.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/27/2025.
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.
Claim(s) 1, 2, 6-7, 10, 11, 16-19, 21, 27, 28, 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (WO 2019/0030190) in view of Amoozgar et al. (US 20170266123) and further in view of Jarrett et al. (US 20160331738) and Zhu et al. (A novel thermo-sensitive hydrogel-based on poly(N-isopropylacrylamide)/ hyaluronic acid of ketoconazole for ophthalmic delivery).
The claims are drawn to an ocular therapeutic composition comprising: a population of polydopamine (PDA) nanoparticles; wherein each polydopamine
Regarding claim 1, Peyman teaches polydopamine nanoparticles containing ani-VEGF agents. See Paras [0022[, [0102], [0110] and [0344]. Peyman teaches the method of delivery to the eye may be by injection, eye drops, ointments, sprays or other applications. See Para [0173].
Regarding claim 2, Peyman does not teach the claimed average particle size. However, Amoozgar teaches coated nanoparticles for drug delivery. See par [0002]. The use of polyamine-coated polymeric nanoparticles is taught in Para [0036] and [0037]. The particle size is taught to be from 10 nm to about 800 nm. See Para [0086].
Regarding claim 6, Peyman teaches the use of an antibody attached to the nanoparticles. See the abstract, Para [0015] and claim 1. Additionally, Jarrett teaches that The therapeutic agent may comprise a macromolecule, for example an antibody or antibody fragment. See Para [0116]. Jerrett teaches ranibizumab and panitumumab as monoclonal antibody. See Para [0121].
Regarding claim 7, Peyman does not teach the claimed specific anti-VEGF compounds. However, Jarrett teaches a drug delivery composition comprising hydrogels as used for various medical conditions, and includes hydrogels formed in an eye with extended drug release times. See the abstract. Jarrett teaches that The therapeutic agent may comprise a macromolecule, for example an antibody or antibody fragment. The therapeutic macromolecule may comprise a VEGF inhibitor. Examples of VEGF inhibitors are ranibizumab, aflibercept and bevacizumab. See Para [0116].
Regarding claim 10, Jerrett teaches that the therapeutic agent may comprise a kinase inhibitor. See Para [0121]. Jarrett teaches that gefitinib, ranibizumab, pegaptanib, sorafenib, dasatinib, sunitinib, erlotinib , nilotinib, lapatinib, panitumumab and vandetanib are considered to be kinase inhibitors. See Para [0121].
Regarding claim 11, Jerrett teaches the use of axitinib, sorafenib, lapatinib and pazopanib as VEGF inhibitors. See Para [0115].
Regarding claim 16, Amoozgar teaches coated nanoparticles for drug delivery. See para [0002]. The use of polyamine-coated polymeric nanoparticle is taught in Para [0036] and [0037].
Regarding claim 17, Peyman teaches that nanoparticles may be conjugated with various physiologic biomolecules to enhance or facilitate cell penetration. Examples of such compounds include, but are not limited to, carbohydrates, cholesterol, glutathione, collagen, chitosan, alginate, fibrin, fibrinogen, cellulose, starch, collagen, dextran, dextrin, fragments and derivatives of hyaluronic acid. See Para [0184].
Regarding claim 19, Peyman teaches polydopamine nanoparticles containing ani-VEGF agents. See Paras [0022[, [0102], [0110] and [0344] Peyman teaches the method of delivery to the eye may be by injection, eye drops, ointments, sprays or other applications. See Para [0173]. Peyman does not teach the composition polydopamine in a hyaluronic acid hydrogel. However, Jerrett teaches the use of the claimed anti-VEGF have been previously used in a hydrogel having sodium hyaluronate. See Examples 1-7.
Regarding claim 21, Jerrett teaches the use of the claimed anti-VEGF in a hydrogel form having sodium hyaluronate. Jerrett does not teach the use of poly(N-isopropylacrylamide) grafted sodium hyaluronate hydrogel. However, Zhu et al., teach the use of poly(N-isopropylacrylamide) hyaluronic acid as a hydrogel used in ophthalmic formulations. See the abstract. The substitution of one ophthalmic active ingredient for another in a hydrogel would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
Regarding claim 27, Peyman teaches polydopamine nanoparticles containing ani-VEGF agents. See Paras [0022[, [0102], [0110] and [0344]. Peyman teaches that the method of delivery to the eye may be by injection, eye drops, ointments, sprays or other applications. See Para [0173]. The release of PDA nanoparticles upon exposure to a reactive oxygen is the inherent property of the composition of Peyman, which reads on polydopamine nanoparticles in combination with anti-VEGF compounds. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), wherein the court states, "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 28, Peyman does not teach the claimed average particle size. However, Amoozgar teaches coated nanoparticles for drug delivery. See par [0002]. The use of polydopamine-coated polymeric nanoparticle is taught in Para [0036] and [0037]. The particle size is taught to be 10 nm and about 800 nm. See Para [0086].
Regarding Claim 32, Peyman teaches polydopamine nanoparticles containing ani-VEGF agents. See Paras [0022[, [0102], [0110] and [0344]. Peyman teaches the method of delivery to the eye may be by injection, eye drops, ointments, sprays or other applications. See Para [0173].
Regarding claim 33, Peyman does not teach the use of the specific VEGF inhibitors. However, Jerrett teaches that the therapeutic agent comprise a VEGF inhibitor. See Para [0116]. Jarrett teaches ranibizumab, bevacizumab and aflibercept as VEGF Inhibitors. See Para [0116].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617