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, & 3-15 are pending and examined below.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive. Applicant argues that the prior art, Sharifi, does not teach an artificial corneal endothelial sheet. The examiner agrees that Sharifi does not teach an artificial corneal endothelial sheet, however, the examiner respectfully directs the applicant to the 103 rejection that was made with Sharifi in view of Daphna for the teaching of the artificial corneal endothelial sheet. Furthermore, the “artificial” tissue should act as the native tissue and therefore would have the same properties as the cornea and a person skilled in the art would easily conceive of grafting the material from Sharifi to an artificial corneal endothelial sheet. Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the claims remains rejected.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, & 3-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharifi et al. (US 20210322645 A1) hereinafter, Sharifi, in view of Daphna et al. (US 20190209377 A1), hereinafter, Daphna.
Regarding claim 1, Sharifi teaches wherein
a material (gelatin with glycidyl methacrylate (GELGYM), ¶0010) having an adhesion-increase function (¶0055) is attached with the surface of said artificial corneal endothelial sheet after adhesion-increase treatment (¶0056);
said adhesion-increase treatment includes obtaining a methacrylate functionalized modified polyamino high-molecular polymer by an epoxy-amine ring-opening reaction of polyamino polymer and glycidyl methacrylate (covalent functionalization of gelatin with glycidyl methacrylate through an epoxide ring opening reaction, ¶0055), and
performing surface modification of said artificial corneal endothelial sheet by photo-initiated free radical polymerization reaction (¶0065);
said adhesion-increase treatment comprises the following steps:
Step 1) putting an adhesion-increase functional material into distilled water, stirring until dissolved, and forming a solution with a concentration of 0.08-0.14g/mL;
Step 2) adding 1.0-2.0 mL of glycidyl methacrylate to the solution in Step 1);
Step 3) placing the mixed solution of Step 2) at 40-70 0C for 4-8 h;
Step 4) dialyzing in distilled water to remove unreacted glycidyl methacrylate and oligomer by the 12 -14 kDa cut-off dialysis tube, and vacuum freeze-drying to obtain solid white foam;
Step 5) putting 100.0-300.0mg of solid white foam of Step 4) into 2.0-6.OmL of distilled water and completely dissolving to obtain a mixture;
Step 6) soaking the artificial endothelial sheet in the mixture of Step 5) and adding 6.0-10.0 µL of 10% DMPA solution;
Step 7) placing the mixture of Step 6) under a UV lamp with a wavelength of 365 nm for 20- 60min, and continuously stirring the mixture during irradiation;
Step 8) washing with distilled water to obtain artificial corneal endothelial sheet with adhesion- increase treatment (methods, ¶0176-0178).
According to the specification, Applicant says “the adhesion-increase treatment includes obtaining a methacrylate modified polyamino polymer by an epoxy-amine ring-opening reaction of polyamino high-molecular polymer and glycidyl methacrylate…” (page 2 lines 5-7) and “the adhesion-increase functional material is polyamino polymer, selected from one or more of gelatin, chitosan, and serum albumin” (page 3 lines 19-20) to increase the adhesion, therefore since the prior art teaches methacrylate modified polyamino polymer by an epoxy-amine ring-opening reaction of polyamino high-molecular polymer and glycidyl methacrylate (¶0055-0065) and the engineered scaffold is formed through covalent functionalization of gelatin with glycidyl methacrylate (¶0010), the result of the process steps is met.
Furthermore, regarding claim 1, the claimed phrase “said adhesion-increase treatment comprises the following steps:
Step 1) putting an adhesion-increase functional material into distilled water, stirring until dissolved, and forming a solution with a concentration of 0.08-0.14g/mL;
Step 2) adding 1.0-2.0 mL of glycidyl methacrylate to the solution in Step 1);
Step 3) placing the mixed solution of Step 2) at 40-70 0C for 4-8 h;
Step 4) dialyzing in distilled water to remove unreacted glycidyl methacrylate and oligomer by the 12 -14 kDa cut-off dialysis tube, and vacuum freeze-drying to obtain solid white foam;
Step 5) putting 100.0-300.0mg of solid white foam of Step 4) into 2.0-6.OmL of distilled water and completely dissolving to obtain a mixture;
Step 6) soaking the artificial endothelial sheet in the mixture of Step 5) and adding 6.0-10.0 µL of 10% DMPA solution;
Step 7) placing the mixture of Step 6) under a UV lamp with a wavelength of 365 nm for 20- 60min, and continuously stirring the mixture during irradiation;
Step 8) washing with distilled water to obtain artificial corneal endothelial sheet with adhesion- increase treatment” is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Sharifi does not teach a high-adhesion artificial corneal endothelial sheet. However, Daphna teaches improving adhesion of an ocular implant to corneal tissue by forming an implant adhesive layer on the ocular implant (abstract, Daphna)
a high-adhesion artificial corneal endothelial sheet (10 is a hydrophobic pseudo-endothelial implant, Fig. 1, Daphna).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sharifi by incorporating a high-adhesion artificial corneal endothelial sheet as taught by Daphna in order to form a corneal adhesive layer on a posterior surface of a posterior portion of the corneal tissue, the corneal adhesive layer having greater adhesive strength than a rest of the corneal tissue (abstract, Daphna).
Regarding claim 3, Sharifi teaches
wherein the mass ratio of said adhesion-increase functional material, distilled water, glycidyl methacrylate in Step 1) and Step 2) is (4-7): 50: (1-2) (since the prior art teaches the adhesion increase function material, deionized water, and glycidyl methacrylate, the result of the process steps is met, ¶0176-0178).
Regarding claim 4, Sharifi teaches
wherein said adhesion-increase functional material is polyamino polymer, selected from one or more of gelatin, chitosan, serum albumin (gelatin, ¶0010).
Regarding claim 5, Sharifi teaches
wherein said artificial corneal endothelial sheet is acrylate-like material, selected from one or more of hydroxyethyl methacrylate / methyl methacrylate copolymer, polymethyl methacrylate, poly(hydroxyethyl methacrylate), acrylic acid hydrogel, methacrylic acid hydrogel (methyl methacrylate, ¶0193).
Regarding claim 6, Sharifi teaches
wherein said artificial corneal endothelial sheet has a light transmittance of 79% -85% (400nm-800nm) (250-850 nm, ¶0038).
Regarding claim 7, Sharifi teaches a method of increasing the adhesion of an artificial corneal endothelial sheet, wherein, the method comprises the following steps:
Step 1) putting an adhesion-increase functional material into distilled water, stirring until dissolved, and forming a solution with a concentration of 0.08-0.14g/mL;
Step 2) adding 1.0-2.0 mL of glycidyl methacrylate to the solution in Step I);
Step 3) placing the mixed solution of Step 2) at 40-70 0C for 4-8 h;
Step 4) dialyzing in distilled water to remove unreacted glycidyl methacrylate and oligomer by the 12 -14 kDa cut-off dialysis tube, and vacuum freeze-drying to obtain solid white foam;
Step 5) putting 100.0-300.0mg of solid white foam of Step 4) into 2.0-6.OmL of distilled water and completely dissolving to obtain a mixture;
Step 6) soaking the artificial endothelial sheet in the mixture of Step 5) and adding 6.0-10.0 µL of 10% DMPA solution;
Step 7) placing the mixture of Step 6) under a UV lamp with a wavelength of 365 nm for 20- 60min, and continuously stirring the mixture during irradiation;
Step 8) washing with distilled water to obtain artificial corneal endothelial sheet with adhesion- increase treatment (methods, ¶0176-0178).
According to the specification, Applicant says “the adhesion-increase treatment includes obtaining a methacrylate modified polyamino polymer by an epoxy-amine ring-opening reaction of polyamino high-molecular polymer and glycidyl methacrylate…”( page 2 lines 5-7) and “the adhesion-increase functional material is polyamino polymer, selected from one or more of gelatin, chitosan, and serum albumin” (page 3 lines 19-20) to increase the adhesion, therefore since the prior art teaches methacrylate modified polyamino polymer by an epoxy-amine ring-opening reaction of polyamino high-molecular polymer and glycidyl methacrylate (¶0055-0065) and the engineered scaffold is formed through covalent functionalization of gelatin with glycidyl methacrylate (¶0010), the result of the process steps is met.
Sharifi does not teach a high-adhesion artificial corneal endothelial sheet. However, Daphna teaches
a high-adhesion artificial corneal endothelial sheet (10 is a hydrophobic pseudo-endothelial implant, Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sharifi by incorporating a high-adhesion artificial corneal endothelial sheet as taught by Daphna in order to form a corneal adhesive layer on a posterior surface of a posterior portion of the corneal tissue, the corneal adhesive layer having greater adhesive strength than a rest of the corneal tissue (abstract, Daphna).
Regarding claim 8, Sharifi teaches
wherein the mass ratio of said adhesion-increase functional material, distilled water, glycidyl methacrylate in Step 1) and Step 2) is (4-7): 50: (1-2) (since the prior art teaches the adhesion increase function material, deionized water, and glycidyl methacrylate, the result of the process steps is met, ¶0176-0178).
Regarding claim 9, Sharifi teaches
wherein said adhesion-increase functional material is polyamino polymer, selected from one or more of gelatin, chitosan, serum albumin (gelatin, ¶0010);
the material of said artificial corneal endothelial sheet is acrylate-like material, selected from one or more of hydroxyethyl methacrylate / methyl methacrylate copolymer, polymethyl methacrylate, poly(hydroxyethyl methacrylate), acrylic acid hydrogel, methacrylic acid hydrogel (methyl methacrylate, ¶0193).
Regarding claim 10, Sharifi teaches use of said artificial corneal endothelial sheet according to claim 1 in preparing medical instruments for relieving or treating corneal endothelial injury, corneal endothelial dysfunction, corneal endothelial decompensation (for corneal applications, ¶0056, ¶0108, ¶0114-0119, ¶0173).
Regarding claim 11, Sharifi teaches use of said artificial corneal endothelial sheet according to claim 1 in preparing medical instruments for relieving or treating patients with corneal thickness abnormality, corneal transparency degradation, corneal edema, vision decline or loss, eye dryness and pain resulting from corneal endothelial decompensation (for corneal applications, ¶0056, ¶0108, ¶0114-0119, ¶0173).
Regarding claim 12, Sharifi teaches
wherein said medical instruments are graft, patch or kit (patch, ¶0217).
Regarding claim 13, Sharifi teaches use of said method of increasing the adhesion of an artificial corneal endothelial sheet according to claim 7 in preparing medical instruments for relieving or treating corneal endothelial injury, corneal endothelial dysfunction, corneal endothelial decompensation (for corneal applications, ¶0056, ¶0108, ¶0114-0119, ¶0173).
Regarding claim 14, Sharifi teaches use of said method of increasing the adhesion of an artificial corneal endothelial sheet according to claim 7 in preparing medical instruments for relieving or treating patients with corneal thickness abnormality, corneal transparency degradation, corneal edema, vision decline or loss, eye dryness and pain resulting from corneal endothelial decompensation (for corneal applications, ¶0056, ¶0108, ¶0114-0119, ¶0173).
Regarding claim 15, Sharifi teaches
wherein said medical instruments are graft, patch or kit (patch, ¶0217).
Conclusion
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.
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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