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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 23 July 2025 is acknowledged.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 July 2025.
Claims 1-14 are under current consideration.
Claim Objections
Claim 5 is objected to because of the following informalities: a period is missing at the end of the claim. Appropriate correction is required.
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.
Claim 5 is 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.
The term “severe” in claim 5 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear to what extent the conjunctivitis must be impacting the subject to be “severe”.
Regarding claim 5, the phrase "including, but not limited to", as well as the use of parentheses, render the claim indefinite because it is unclear whether the limitations following the phrase or in the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, the use of the word “and” in line 2 and “or” in line 3 renders the claim indefinite in that it is not clear whether all or one of the listed conditions must be met. For purposes of compact prosecution, it is interpreted herein as if only one condition is required.
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) 1, 4-5, and 7-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Badylak et al. (WO 2018/204848 A1; published 08 November 2018).
Regarding claim 1, Badylak et al. discloses locally administering to an eye of a subject a therapeutically effective amount of isolated nanovesicles derived from an extracellular matrix (claim 1), reading on the claimed administration to a subject in need thereof an effective amount of a composition comprising one or more biological scaffold materials, wherein the subject has glaucoma (claim 10) or retinal ganglion cell degeneration caused by injury (claim 13), reading on the claimed treating of an ocular injury, disease or disorder in a subject.
Further regarding claim 1, although Badylak et al. does not explicitly disclose that the composition increases IL-4 production as claimed, since the composition and method of Badylak et al. as discussed above are at least substantially identical to the claimed method and composition therein, such IL-4 production property is presumed to be inherent in the composition and method of Badylak et al. as discussed above per MPEP 2112(V), given that compositions that are physically the same must have the same properties per MPEP 2112.01(II), and thus methods that are substantially identical that use such compositions necessarily must result in the same properties.
Regarding claim 4, Badylak et al. discloses that the subject has retinal ganglion cell degeneration caused by injury (claim 13) or has inflammatory optic neuropathy (claim 15), reading on the claimed recitation that the subject has suffered an ocular injury or suffers from an inflammatory ocular disease or disorder.
Regarding claim 5, Badylak et al. discloses that the subject has autoimmune optic neuropathy (claim 16) reading on the claimed recitation that the subject has autoimmune ocular inflammatory disease.
Regarding claim 7, Badylak et al. discloses isolated nanovesicles derived from an extracellular matrix (claim 1), reading on the claimed composition comprising a biocompatible scaffold that comprises a biomaterial.
Regarding claim 8, Badylak et al. discloses isolated nanovesicles (claim 1), reading on the claimed composition comprising a plurality of particles.
Regarding claim 9, Badylak et al. discloses isolated nanovesicles (claim 1), reading on the claimed particles having a mean particle size of 50 µm or less.
Regarding claim 10, Badylak et al. discloses locally administering to an eye of a subject a therapeutically effective amount of isolated nanovesicles derived from an extracellular matrix (claim 1), reading on the claimed composition administered to an eye of the subject, and the formulation is usually an injectable fluid (page 11 lines 30-32; page 24 lines 15-21; Examples), reading on the claimed fluid composition.
Regarding claim 11, Badylak et al. discloses locally administering to an eye of a subject a therapeutically effective amount of isolated nanovesicles derived from an extracellular matrix (claim 1), reading on the claimed composition administered to an eye of the subject, and exemplary methods include eye drops (page 24 lines 28-30), reading on the claimed drops to an eye.
Regarding claim 12, Badylak et al. discloses subconjunctival administration route and via injection (page 24 lines 22-34), reading on the claimed subconjunctival injection administration.
Regarding claim 13, Badylak et al. discloses extracellular matrix from urinary bladder (claim 4), reading on the claimed urinary bladder matrix scaffold.
Regarding claim 14, Badylak et al. discloses additional therapeutic agents in the same composition (page 26 lines 1-2), reading on the claimed additional therapeutic agents.
Claim(s) 1-9 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al. (WO 2016/178586 A2; published 10 November 2016).
Regarding claim 1, Patel et al. discloses a method of repairing corneal tissue of a subject comprising administering a collagen composition to a corneal tissue site of the subject thereby providing repair of the corneal tissue (claim 52), reading on the claimed method of treating in a subject comprising administering to the subject a composition comprising one or more biological scaffold materials, wherein the subject is affected by a corneal infection or corneal wound (claim 58), reading on the claimed ocular injury, disease or disorder in a subject.
Further regarding claim 1, although Patel et al. does not explicitly recite “an effective amount” as claimed, the administration of the composition of Patel et al. results in repair of the corneal tissue as discussed above, and thus the administration in the method of Patel et al. as discussed above inherently includes an effective amount of the composition in order to successfully achieve such result of successful repair of the corneal tissue (see also Examples in Patel et al.).
Further regarding claim 1, although Patel et al. does not explicitly disclose that the composition increases IL-4 production as claimed, since the composition and method of Patel et al. as discussed above are at least substantially identical to the claimed method and composition therein, such IL-4 production property is presumed to be inherent in the composition and method of Patel et al. as discussed above per MPEP 2112(V), given that compositions that are physically the same must have the same properties per MPEP 2112.01(II), and thus methods that are substantially identical that use such compositions necessarily must result in the same properties.
Regarding claim 2, Patel et al. discloses a method of repairing corneal tissue of a subject comprising administering a collagen composition to a corneal tissue site of the subject thereby providing repair of the corneal tissue (claim 52), reading on the claimed method of treating in a subject comprising administering to the subject a composition comprising one or more biological scaffold materials, wherein the subject is affected by a corneal infection or corneal wound (claim 58), reading on the claimed ocular injury, disease or disorder in a subject, wherein the collagen composition is a gel (paragraph [00165]), reading on the claimed recitation of gel, wherein the collagen composition comprises an extracellular matrix component (claim 53), reading on the claimed one or more extracellular matrix materials.
Further regarding claim 2, although Patel et al. does not explicitly recite “an effective amount” as claimed, the administration of the composition of Patel et al. results in repair of the corneal tissue as discussed above, and thus the administration in the method of Patel et al. as discussed above inherently includes an effective amount of the composition in order to successfully achieve such result of successful repair of the corneal tissue (see also Examples in Patel et al.).
Further regarding claim 2, although Patel et al. does not explicitly disclose that the composition increases IL-4 production as claimed, since the composition and method of Patel et al. as discussed above are at least substantially identical to the claimed method and composition therein, such IL-4 production property is presumed to be inherent in the composition and method of Patel et al. as discussed above per MPEP 2112(V), given that compositions that are physically the same must have the same properties per MPEP 2112.01(II), and thus methods that are substantially identical that use such compositions necessarily must result in the same properties.
Regarding claim 3, Patel et al. discloses a method of repairing corneal tissue of a subject (claim 52), reading on the claimed subject in need of cornea repair.
Regarding claim 4, Patel et al. discloses that the subject is affected by a corneal infection or corneal wound (claim 58), reading on the claimed ocular injury.
Regarding claim 5, Patel et al. discloses dry eye treatment (paragraph [00199]), reading on the claimed dry eye syndrome.
Regarding claim 6, Patel et al. discloses dry eye treatment (paragraph [00199]), reading on the claimed dry eye disease.
Regarding claim 7, Patel et al. discloses a collagen composition (claim 52), reading on the claimed composition comprising a biocompatible scaffold comprising a biomaterial.
Regarding claim 8, Patel et al. discloses the that compositions may include nanoparticles (paragraph [00184]), reading on the claimed plurality of particles.
Regarding claim 9, Patel et al. discloses the that compositions may include nanoparticles (paragraph [00184]), reading on the claimed particles having a mean particle size of 50 µm or less.
Regarding claim 14, Patel et al. discloses that the collagen composition also comprises a therapeutic agent (claim 53), reading on the claimed additional therapeutic agent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617