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 .
DETAILED ACTION
Final Rejection
Review of Claim Status
Claims 1, 4-5, 7-10, 13, 18-19, 22, 26, 29-30, 35, 37, 40, 42-44 were pending.
Upon amendment entry, Claims 26, 29-30, 35, 37, 40 and 42-43 are withdrawn.
Upon amendment entry, Claims 2-3, 6, 11-12, 14-17, 20-21, 23-25, 27-28, 31-34, 36, 38-39, 41, 45 are cancelled.
Upon amendment entry, Claim 46 is newly added.
Claims 1, 4-5, 7-10, 13, 18-19, 22, 44 and 46 are pending examination.
Priority Status
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Information Disclosure Statement
All references have been considered in the two (2) IDS(s) filed 11/05/2025 unless marked with a strikethrough.
Examiner Responses to Arguments/Amendments
The issues raised in the Office Action mailed 11/03/2025, are addressed below:
I. Claim Amendments –
Upon amendment entrance, Claim 1 was modified with new limitation:
“A corneal preservation composition comprising i) an effective amount of an anti-oxidant comprising one or more of ubiquinol, MitoQ, vitamin E, vitamin C, ascorbate-2- phosphate, idebenone, pyrroloquinoline quinone (PQQ), N-Acetyl-L-cysteine (NAC), palmitate, reduced glutathione, or a C14-C18 saturated fatty acid, and ii) isolated cornea or corneal tissue.”
II. Claim Rejections under 35 U.S.C. § 112 –
In view of Applicant’s amendment, the rejection on Claim 19 under 35 U.S.C. § 112 “because it is uncertain whether the narrower ranges are merely exemplary or mandatory” are acknowledged; the rejection is withdrawn.
III. Response to Arguments 35 USC § 102 –
Applicant' s arguments, filed 11/05/2025, with respect to the claims have been fully considered and they are persuasive for the following reason(s):.
Applicant argues: “Qin describes eye-drop formulations intended for in vivo administration to treat dry-eye disease (Qin, Abstract). Contrary to the Examiner's assertion at page 4 of the Office Action, nothing in Qin teaches or even suggests ex vivo immersion of donor corneal tissue. Qin is instead directed to daily ophthalmic dosing in patients.
Claim 1 is directed to a formulation expressly designed for ex vivo corneal tissue preservation. As amended, the composition of claim 1 now includes isolated cornea or corneal tissue. Accordingly, Qin fails to disclose the claimed corneal preservation composition and cannot anticipate claim 1.”
Examiner agrees. In response to applicant's argument that the references fail to show certain features of the invention, as amended, the composition of claim 1 includes the additional limitation of isolated cornea or corneal tissue. This additional limitation directed to a corneal preservation composition which includes isolated cornea or corneal tissue is not supported by the Qin.
Therefore, the 35 USC § 102 rejection has been withdrawn.
The 35 USC § 102 rejection is withdrawn because Applicant amended independent Claim 1 with an additional limitation.
Hence, this necessitated a new rejection.
IV. New Rejections –
Applicant’s amendment necessitated the new ground(s)
of rejection presented in this Office Action.
Claim Interpretation
For amended Claim 1, upon searching the Instant Specification, there is no guidance provided to direct one in the art to Applicant’s meaning of “isolated cornea” or “isolated cornea tissue.” It is also unclear from Applicant’s specification, what is required an “isolated corneal tissue.” Under Broadest Reasonable Interpretation, “isolated corneal tissue” is such material separated from the patient and processed for laboratory work.
Clarification is necessary.
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.
Graham v. Deere, Test for Obviousness
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.
Joint Inventors
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, 4-5, 7-10, 13, 18, 19, 22, 44 and 46 are rejected under 35 U.S.C. 103 as obvious over US 2020/0138742 Al (hereinafter “App’742”) and in view of WJ Armitage (Transfus Med Hemother. 2011;38(2):143-147; hereinafter “Armitage”) and as referenced by J.P. Craig (Ocul Surf. 2017 Jul;15(3):276-283; hereinafter “Craig”).
With respect to Claim 1: App’742 teaches a corneal preservation composition (abstract) comprising i) an effective amount of an antioxidant (abstract). App’742 further teaches an “embodiment of the invention provides a composition comprising an antioxidant (para. [0053]-[0055]; antioxidants: ubiquinol, linoleic acid; lipid-soluble antioxidants: omega-3 fatty acids, vitamin D, vitamin E),”
App’742 teaches in para. [0089], the corneal composition for the eye “includes retaining tears, lubricating the ocular surface (ocular surface includes the tear film, corneal and conjunctival epithelia, limbal stem cells, and eyelids, as referenced by Craig - on pg. 278, section 5.3 ocular surface), forming a smooth spherical surface of an eye ball to acquire excellent vision, protecting the ocular surface, and capturing and removing pathogens and debris. For this reason, it is effective to increase goblet cells in ophthalmic applications.”
Though App’742 teaches: 1. A corneal composition in the field of ophthalmic therapy (paras. [0001], [0004]), 2. The corneal composition can be used in keratoconjunctivitis sicca and corneal ulcer (an open sore on your cornea) treatment, and 3. The composition of the invention can also be used in dry eye (keratoconjunctivitis sicca) which affects the cornea, it fails to teach the isolated cornea or corneal tissue.
Armitage teaches for use of viable corneal endothelium (corneal tissue), the “monolayer of cells lines the inner surface of the cornea and its primary function is to maintain corneal transparency by controlling the hydration of the collagenous stromal layer. Since human corneal endothelial cells do not readily proliferate, preservation of the endothelium is a primary aim of methods of corneal storage.”
Armitage further teaches donor selection, tissue quality, organ culture, hyperthermia, corneal preservation & storage (pg. 145, Hypothermia - the principle underlying storage of cells). It also teaches “cells are extracted from the limbal region between the cornea and the sclera, and they are used in the treatment of ocular surface disease where the corneal epithelium is defective.”
Therefore, it would be obvious to one in the art, to use the combination of Armitage’& App’742 for corneal preservation since corneal tissue preservation compositions are needed for treating ocular diseases. This is done through maintaining the structural integrity, transparency, and viability of donor corneal tissue for transplantation. These solutions (eye banking - as mentioned in Armitage), allow for the safe storage of corneas, increasing the availability of suitable donor tissue to combat infections, injuries, and degenerative diseases.
App’742 continues teaching the following:
Claims 4-5: App’742 teaches wherein the fatty acid is “omega-3 fatty acids (DHA, EPA, and the like), vitamin D (calciferols), vitamin E (tocopherol and tocotrienols), and the like (para. [0055]).”
Claims 7-9: App’742 teaches wherein the composition comprising one or more carriers (para. [0076]-[0078]); as used in the application "carrier" refers to a diluent, adjuvant, excipient, or vehicle administered with a therapeutic agent”…the use of a macrocyclic compound such as cyclodextrin reads on the claim for a carrier). App’742 further teaches wherein the composition is
γ
-cyclodextrin. (para. [0078]).
Claim 10: App’742 teaches “an antioxidant solubilized by clathration unexpectedly improved a dry eye symptom compared to the same antioxidant dissolved in an organic solvent (para. [0065]); this reads on the claim of solubilized ubiquinol since as stated in the prior art ubiquinol is listed under the antioxidants that can be readily solubilized).
Claim 13: App’742 teaches further comprising a full thickness cornea, a partial thickness cornea or corneal endothelium (para. [0115])“Corneal diseases can affect the cornea's thickness, and dry eye disease (DED) is one such condition. Dry eye can lead to corneal thinning, particularly in the superior region, or in some cases, thickening due to edema or inflammatory.”
Claim 18: App’742 teaches wherein the anti-oxidant and the carrier form complexes (para. [0007]: In one embodiment of the invention, it is characterized in that an antioxidant is clathrated; para. [0209], Claims 23-24).
Claim 19: ‘App’742 teaches cyclodextrin based compositions which are within the range of “up to about 1000 nm” at paragraph [0079] for example.
Claims 22 and 44: App’742 teaches wherein the concentration of the complexes comprises about 0.1 µM to about 150 µM (paras. [0138]-[0142]: Example 1: eye drops for dry-eye giving a final concentration of 100 μM).
Claim 46: App’742 teaches wherein the corneal tissue comprises corneal endothelium, corneal epithelium, conjunctival epithelium, lens epithelium or lens (para. [0089]). App’742 teaches the corneal composition for the eye includes retaining tears, lubricating the ocular surface (ocular surface includes the tear film, corneal and conjunctival epithelia, limbal stem cells, and eyelids as referenced by on pg. 278, section 5.3 ocular surface), forming a smooth spherical surface of an eye ball to acquire excellent vision, protecting the ocular surface, and capturing and removing pathogens and debris. For this reason, it is effective to increase goblet cells in ophthalmic applications.
Conclusions
Claim(s) 1, 4-5, 7-10, 13, 18-19, 22, 44 and 46 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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