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.
The amendments and remarks filed on 05/04/2026 have been received and entered.
Response to Arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that None of “options for the nanoparticles in Peyman even suggests using polydopamine nanoparticles. The person of ordinary skill would struggle to find any expectation of success at even arriving at a selection of one of the types of nanoparticles described in Peyman, given the vast selection of options, let alone arriving at polydopamine nanoparticles, which are not described. None of Amoozgar, Jarrett, and Zhu make up for the deficiencies identified for Peyman. Amoozgar, like Peyman, and as admitted by the Office, merely describes particles coated with polydopamine, not polydopamine particles. Jarrett describes a hydrogel system that can deliver anti-VEGF; since this system is materially very different from those described in Peyman and Amoozgar, it is not clear why the skilled person would turn to Jarrett when seeking to modify the teachings of these references”. It is the examiner’s position that Peyman in Para [0102] teaches that Particles may be coated with or linked to, e.g., folate, polydopamine, etc. so that these molecules are targeted intracellularly, extracellularly, to a cell membrane, to a specific cellular site or organelle, etc. Furthermore, Peyman in Para [0344] teaches that In one embodiment, the nanoparticles contain other agents. Peyman teaches that other agents may be included, e.g., stem cells, immunomodulators, anti-vascular endothelial growth factor (VEGF) agents, anti-integrin agents, anti-inflammatory agents, such as fasudil, antibiotics, etc. Therefore, Peyman teaches the use of polydopamine as a coating or linked to nanoparticles. The use of antibody [abstract] or anti-VEGF [0344] is also taught by Peyman. Additionally, Amoozgar teaches coated nanoparticles for drug delivery. See para [0002]. The use of polydopamine-coated polymeric nanoparticles is taught in Para [0036] and [0037]. Applicant in his remarks argues that amoozegar describes “particles coated with polydopamine, not polydopamine particles”. It is the examiner’s position that since the claims of the instant application use the phrase “comprising”, such phrase permits the addition of other ingredients, such as a polymer. Additionally, some of the claims of the instant application are drawn to the use of a polymer and hydrogel. Furthermore, Peyman teaches the use of polydopamine being linked to anti-VEGF agents. Jarrett is relied upon to teach 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]. Such teachings indicates that the use of hydrogel for delivering the claimed VEGF inhibitors as old and well known. There is no evidence of record that polydopamine linked VEGF inhibitors can not be delivered by hydrogel taught by Jarrett. Zhu is relied upon to show that the use of poly(N-isopropylacrylamide) hyaluronic acid as a hydrogel used in ophthalmic formulations as old and well known.
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 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).
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 polydopamine-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 polydopamine-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 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].
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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