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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Response to Amendment
The amendment filed 01/27/2026 has been entered. Claims 60-82 and 84-85 remain pending. Claims 70 and 73-75 remain withdrawn from consideration. New claims 86-92 have been added and are pending. Claim 83 has been cancelled.
Response to Arguments
Regarding the rejection of claim 60 under Marmo, a new secondary reference, US 20140377326 A1 (hereafter –Niu--), has been brought in to illustrate that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the corneal onlay comprise of gelatin methacrylate (Gel-MA), as it is a known component of the formation of a hydrogel scaffold with the addition of chemical cross-linking agents EDC and NHS, as taught by Niu (see paragraph [0033]).
Regarding the argument that Marmo does not have an identical structure and function as claimed and therefore the limitation “wherein said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then (b) removing said cells prior to graftation” must be given more weight, the Examiner disagrees. As mentioned before, even though Marmo is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Marmo is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Marmo has binding sites on the surface, ECM, and collagen of the onlay (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098], see also paragraph [0065]). Additionally, even though Marmo is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Marmo’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0014]-[0017], see also Abstract, see also paragraph [0098]). The argument that because the modifications to promote attachment to these cells are “after the cultured cells have been developed into a layer of epithelial cells” is not relevant to the apparatus of the prior art reading the apparatus as claimed.
Similarly, regarding the rejection of claim 60 under Peyman, a new secondary reference, US 20140377326 A1 (hereafter –Niu--), has been brought in to teach that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the corneal onlay comprise of gelatin methacrylate (Gel-MA), as it is a known component of the formation of a hydrogel scaffold with the addition of chemical cross-linking agents EDC and NHS, as taught by Niu (see paragraph [0033]).
Similarly, regarding the argument that Marmo does not have an identical structure and function as claimed and therefore the limitation “wherein said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then (b) removing said cells prior to graftation” must be given more weight, the Examiner disagrees. As mentioned before, even though Peyman is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Peyman is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Peyman is disclosed to be able to be coated with collagen on the implant (see paragraph [0306]). Additionally, even though Peyman is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Peyman’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0186] and [0256]). The argument that because the modifications to promote attachment to these cells are “after the cultured cells have been developed into a layer of epithelial cells” is not relevant to the apparatus of the prior art reading the apparatus as claimed.
Applicant's arguments against the 103 rejection of claim 76 have been fully considered but they are not persuasive. The “deficiency” of Marmo that is argued to make this rejection invalid, being that the product by process limitation should be given more weight has been addressed above, and the other deficiency, being that Marmo or Peyman lack the materials collagen methacrylate (ColMA) and gelatin methacrylate (GelMA) is not relevant as these materials are not claimed in claim 76. The rejection is sustained.
Claim Rejections - 35 USC § 102
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.
Claims 76-77, 79-80, 82, and 85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20210093884 A1 (hereafter –Peyman--).
Regarding Claim 76, Peyman discloses a corneal onlay graft for treating either or both keratoconus and visual impairment (see Figure 2C below, see also paragraph [0214]), comprising or coated by: at least one member of group B, consisting of at least one type of biological polymer (see paragraph [0306]); wherein said onlay is crosslinked to form a transparent hydrogel (see paragraph [0186]); wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) [and/or] [N-hydroxysuccin-imide (NHS)] (see paragraph [0183] denoting that the cross-linking agent of the corneal onlay could be “EDC” or N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC)). The “or” clause is not limiting as the limitation only requires either N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) OR N-hydroxysuccin-imide (NHS).
The limitation “said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then removing said cells prior to graftation” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Peyman is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Peyman is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Peyman has collagen on the onlay (see paragraph [0306]). Additionally, even though Peyman is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Peyman’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0186] and [0256]).
PNG
media_image1.png
213
595
media_image1.png
Greyscale
Regarding Claim 77, Peyman discloses the onlay graft of claim 76, wherein said graft is comprising or coated by at least one member of group A, consisting of biocompatible synthetic materials (see paragraph [0214]).
Regarding Claim 79, Peyman discloses the onlay graft of claim 76, wherein said at least one member of group B consists at least one of the following: collagen, ColMA, recombinant mammals' collagen, ColMA, gelatin, GelMA, and any mixture or combination thereof (see paragraph [0306]).
Regarding Claim 80, Peyman discloses the onlay graft of claim 76, coated by one or more of the following: collagen, recombinant human collagen, laminin fibronectin or a combination thereof (see paragraphs [0195], [0274]-[0276], [0306], and [0521]).
Regarding Claim 82, Peyman discloses the onlay graft of claim 76, wherein said Onlay is made by one or more techniques selected from the group consisting of molding, 3D-printing, laser-ablating and a combination thereof (see paragraph [0320]).
Regarding Claim 85, Peyman discloses the onlay graft of claim 76, wherein said graft is comprising or coated by at least one member of group C, consisting of at least one type of protein (see paragraphs [0257] and [0521]).
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.
Claims 60-69 and 71-72 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060241751 A1 (hereafter –Marmo--), in view of US 20140377326 A1 (hereafter –Niu--).
Regarding Claim 60, Marmo discloses a corneal onlay graft for treating either or both Keratoconus and visual impairment (see Abstract and paragraph [0010]), comprising or coated by: at least one member of group B consisting of at least one type of biological polymer (see paragraphs [0073] - [0075]).
The limitation “said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then removing said cells prior to graftation” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Marmo is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Marmo is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Marmo has binding sites on the surface, ECM, and collagen of the onlay (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098], see also paragraph [0065]). Additionally, even though Marmo is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Marmo’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0014]-[0017], see also Abstract, see also paragraph [0098]).
Marmo fails to disclose wherein said group B consists at least one of the following: collagen methacrylate (ColMA), gelatin methacrylate (GelMA), and any mixture of combination thereof.
Niu discloses a corneal endothelial composition for implantation into the eye (see Abstract, see also paragraphs [0056], [0059], [0111] and [0112]). Niu teaches the corneal onlay comprising gelatin methacrylate (Gel-MA) (see paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the corneal onlay comprise of gelatin methacrylate (Gel-MA), as it is a known component of the formation of a hydrogel scaffold with the addition of chemical cross-linking agents EDC and NHS, as taught by Niu (see paragraph [0033]).
Regarding Claim 61, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said graft is comprising or coated by at least one member of group A, consisting of biocompatible synthetic materials (see paragraph [0070]).
Regarding Claim 62, Marmo as modified by Niu discloses the onlay graft of claim 61, wherein said group A consists at least one of the following: HEMA, HEA, MAA, MMA, MPC, PEG, PCL, PVA and any mixture or combination thereof (see paragraph [0074]).
Regarding Claim 63, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said at least one member of group B is mixed with at least one of the following: collagen, recombinant mammals' collagen, gelatin, elastin, and any mixture or combination thereof (see paragraphs [0017], [0071], and [0085]).
Regarding Claim 64, Marmo as modified by Niu discloses the onlay graft of claim 60, coated by one or more of the following: collagen, laminin fibronectin or a combination thereof (see paragraphs [0017] and [0071], see also paragraph [0085] denoting collagen).
Regarding Claim 65, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said Onlay is made in a method consisting of incorporating one or more of the following: limbal stem cells and epithelial cells, on its anterior surface (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098]).
Regarding Claim 66, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said Onlay is made by one or more techniques selected from the group consisting of molding, 3D-printing, laser-ablating and a combination thereof (see paragraph [0018] regarding molding, and see paragraphs [0078] and [0088] and regarding using laser ablation).
Regarding Claim 67, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said Onlay comprises sub-micron sized pores (see paragraphs [0087] and [0088], specifically see paragraph [0087] denoting that the pores can extend through the lens from the anterior to posterior surface and that the indentations that have the pores may be provided over the entire lens, then see paragraph [0069] denoting that the lens has an edge thickness of about 0 micrometers in a preferred embodiment, meaning that if the pores are provided over the entire lens, that the pores would extend through the 0 micrometer section of the lens, making the pores have to be under 1 micrometer in size (sub-micron)).
Regarding Claim 68, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said Onlay is coated by recombinant human collagen (see paragraph [0071]).
Regarding Claim 69, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein one or more of the following is true: a. said onlay has an optical refractive index that is similar to the native corneal stroma, to avoid light scattering and/or reflections (see paragraphs [0066], [0068], [0073], and [0078]); b. said onlay is marked for orientation purposes by a laser engraving, mechanical pressure, pigmented ink, or a combination thereof (see paragraph [0066] denoting that a ballast can be built in to assist with orientation, falling into the mechanical pressure category).
Regarding Claim 71, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein at least one of the following is true: a. said lenticule is configured for a spherical refractive correction in the range between about -10 diopters to about 15 diopters (see paragraph [0067]); b. said lenticule has a non-spherical shape for astigmatism vision correction (see paragraphs [0080] and [0081]); c. said lenticule has a shape for patient-tailored vision correction (see paragraphs [0080] and [0081]); d. said lenticule has an optical refractive index which is similar to native corneal stroma, to avoid light scattering and/or reflections (see paragraphs [0066], [0068], [0073], and [0078]); g. said lenticule is configured to make possible the migration of corneal stroma cells (see paragraph [0069]).
Regarding Claim 72, Marmo as modified by Niu discloses the onlay graft of claim 60, wherein said graft is comprising or coated by at least one member of group C, consisting of at least one type of protein (see paragraphs [0075], [0087], and [0089]).
Claims 60-61, 63-64, 66, and 72 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210093884 A1 (hereafter –Peyman--), in view of US 20140377326 A1 (hereafter –Niu--).
Regarding Claim 60, Peyman discloses a corneal onlay graft for treating either or both Keratoconus and visual impairment (see Figure 2C below, see also paragraph [0214]), comprising or coated by: at least one member of group B consisting of at least one type of biological polymer.
The limitation “said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then removing said cells prior to graftation” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Peyman is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Peyman is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Peyman has collagen on the onlay (see paragraph [0306]). Additionally, even though Peyman is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Peyman’s end product does result in epithelial cells that were derived from stem cells placed on the lens, as structurally claimed (see paragraphs [0186] and [0256]).
PNG
media_image1.png
213
595
media_image1.png
Greyscale
Peyman fails to disclose wherein said group B consists at least one of the following: collagen methacrylate (ColMA), gelatin methacrylate (GelMA), and any mixture of combination thereof.
Niu discloses a corneal endothelial composition for implantation into the eye (see Abstract, see also paragraphs [0056], [0059], [0111] and [0112]). Niu teaches the corneal onlay comprising gelatin methacrylate (Gel-MA) (see paragraph [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the corneal onlay comprise of gelatin methacrylate (Gel-MA), as taught by Niu, as it is a known component of the formation of a hydrogel scaffold with the addition of chemical cross-linking agents EDC and NHS, as taught by Niu (see paragraph [0033]).
Regarding Claim 61, Peyman as modified by Niu discloses the onlay graft of claim 60, wherein said graft is comprising or coated by at least one member of group A, consisting of biocompatible synthetic materials (see paragraph [0214]).
Regarding Claim 63, Peyman as modified by Niu discloses the onlay graft of claim 60, wherein said at least one member of group B is mixed with at least one of the following: collagen, recombinant mammals' collagen, gelatin, elastin and any mixture or combination thereof (see paragraphs [0017], [0071], [0085], and [0306]).
Regarding Claim 64, Peyman as modified by Niu discloses the onlay graft of claim 60, coated by one or more of the following: collagen, laminin fibronectin or a combination thereof (see paragraph [0306]).
Regarding Claim 66, Peyman as modified by Niu discloses the onlay graft of claim 60, wherein said Onlay is made by one or more techniques selected from the group consisting of molding, 3D-printing, laser-ablating and a combination thereof (see paragraph [0320]).
Regarding Claim 72, Peyman as modified by Niu discloses the onlay graft of claim 60, wherein said graft is comprising or coated by at least one member of group C, consisting of at least one type of protein (see paragraphs [0257] and [0521]).
Claims 76-82 and 84-92 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060241751 A1 (hereafter –Marmo--), in view of US 20210093884 A1 (hereafter –Peyman--).
Regarding Claim 76, Marmo discloses a corneal onlay graft for treating either or both keratoconus and visual impairment (see Abstract and paragraph [0010]), comprising or coated by: at least one member of group B, consisting of at least one type of biological polymer (see paragraph [0085]), wherein one or more of the following is true: a. said Onlay has an optical refractive index that is similar to the native corneal stroma, to avoid light scattering and/or reflections (see paragraphs [0066], [0068], [0073], and [0078]); b. said Onlay is marked for orientation purposes by a laser engraving, mechanical pressure, pigmented ink, or a combination thereof (see paragraph [0066] denoting that a ballast can be built in to assist with orientation, falling into the mechanical pressure category).
The limitation “said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then removing said cells prior to graftation” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Marmo is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Marmo is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Marmo has binding sites on the surface, ECM, and collagen of the onlay (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098], see also paragraph [0065]). Additionally, even though Marmo is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Marmo’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0014]-[0017], see also Abstract, see also paragraph [0098]).
Marmo fails to disclose wherein said onlay is crosslinked to form a transparent hydrogel; wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) and/or N-hydroxysuccin-imide (NHS).
Peyman discloses a corneal onlay that is crosslinked (see annotated Figure 2C below, see also paragraph [201]). Peyman teaches wherein said onlay is crosslinked to form a transparent hydrogel (see paragraph [0186]); wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) [and/or] [N-hydroxysuccin-imide (NHS)] (see paragraph [0183] denoting that the cross-linking agent of the corneal onlay could be “EDC” or N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC)). The “or” clause is not limiting as the limitation only requires either N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) OR N-hydroxysuccin-imide (NHS).
PNG
media_image1.png
213
595
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the corneal onlay of Marmo to have been crosslinked to form a transparent hydrogel, wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) and/or N-hydroxysuccin-imide (NHS), as doing so would strengthen the donor cornea as taught by Peyman (see paragraph [0182]).
Regarding Claim 77, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said graft is comprising or coated by at least one member of group A, consisting of biocompatible synthetic materials (see paragraph [0070]).
Regarding Claim 78, Marmo as modified by Peyman discloses the onlay graft of claim 77, wherein said group A consists at least one of the following: HEMA, HEA, MAA, MMA, MPC, PEG, PCL, PVA and any mixture or combination thereof (see paragraph [0074]).
Regarding Claim 79, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said at least one member of group B consists at least one of the following: collagen, ColMA, recombinant mammals' collagen, ColMA, gelatin, GelMA, and any mixture or combination thereof (see paragraphs [0017], [0071], and [0085]).
Regarding Claim 80, Marmo as modified by Peyman discloses the onlay graft of claim 76, coated by one or more of the following: collagen, recombinant human collagen, laminin fibronectin or a combination thereof (see paragraphs [0017] and [0071], see also paragraph [0085] denoting collagen).
Regarding Claim 81, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said Onlay is made in a method consisting of incorporating one or more of the following: limbal stem cells and epithelial cells, on its anterior surface (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098]).
Regarding Claim 82, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said Onlay is made by one or more techniques selected from the group consisting of molding, 3D-printing, laser-ablating and a combination thereof (see paragraph [0018] regarding molding, and see paragraphs [0078] and [0088] and regarding using laser ablation).
Regarding Claim 84, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein at least one of the following is true: a. said lenticule is configured for a spherical refractive correction in the range between about -10 diopters to about 15 diopters (see paragraph [0067]); b. said lenticule has a non-spherical shape for astigmatism vision correction (see paragraphs [0080] and [0081]); c. said lenticule has a shape for patient-tailored vision correction (see paragraphs [0080] and [0081]); d. said lenticule has an optical refractive index which is similar to native corneal stroma, to avoid light scattering and/or reflections (see paragraphs [0066], [0068], [0073], and [0078]); g. said lenticule is configured to make possible the migration of corneal stroma cells (see paragraph [0069]); [and h. said lenticule at least partially blocks UV light] (this limitation is not required, as the preamble of this claim only requires one of the limitations to be true).
Regarding Claim 85, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said graft is comprising or coated by at least one member of group C, consisting of at least one type of protein (see paragraphs [0075], [0087], and [0089]).
Regarding Claim 86, Marmo discloses a corneal onlay graft for treating either or both keratoconus and visual impairment (see Abstract and paragraph [0010]), comprising or coated by: at least one member of group B, consisting of at least one type of biological polymer (see paragraph [0085]), wherein at least one of the following is true: a. said lenticule is configured for a spherical refractive correction in the range between about -10 diopters to about 15 diopters (see paragraph [0067]); b. said lenticule has a non-spherical shape for astigmatism vision correction (see paragraphs [0080] and [0081]); c. said lenticule has a shape for patient-tailored vision correction (see paragraphs [0080] and [0081]); d. said lenticule has an optical refractive index which is similar to native corneal stroma, to avoid light scattering and/or reflections (see paragraphs [0066], [0068], [0073], and [0078]); g. said lenticule is configured to make possible the migration of corneal stroma cells (see paragraph [0069]).
The limitation “said onlay is made by (a) prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells on its anterior surface, and then removing said cells prior to graftation” is being treated as a product by process limitation. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Marmo is silent as to the process of removing the cells prior to graftation, the end result of the process of making the device of Marmo is the same as claimed, as the sole purpose of removing the cells in the Instant Application is to “produce binding sites and/or ECM and/or collagen for better and faster epithelization after grafting” (see paragraph [0088]), and Marmo has binding sites on the surface, ECM, and collagen of the onlay (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098], see also paragraph [0065]). Additionally, even though Marmo is silent as to the process of prematurating one or more of the following: seeding stem cells; limbal stem cells; epithelial cells, Marmo’s end product does result in epithelial cells that were derived from stem cells placed on the anterior surface of the lens, as structurally claimed (see paragraphs [0014]-[0017], see also Abstract, see also paragraph [0098]).
Marmo fails to disclose wherein said onlay is crosslinked to form a transparent hydrogel; wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) and/or N-hydroxysuccin-imide (NHS).
Peyman discloses a corneal onlay that is crosslinked (see annotated Figure 2C below, see also paragraph [201]). Peyman teaches wherein said onlay is crosslinked to form a transparent hydrogel (see paragraph [0186]); wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) [and/or] [N-hydroxysuccin-imide (NHS)] (see paragraph [0183] denoting that the cross-linking agent of the corneal onlay could be “EDC” or N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC)). The “or” clause is not limiting as the limitation only requires either N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) OR N-hydroxysuccin-imide (NHS).
PNG
media_image1.png
213
595
media_image1.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill of the art before the effective filing date of the invention for the corneal onlay of Marmo to have been crosslinked to form a transparent hydrogel, wherein the crosslinking of the onlay is by N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) and/or N-hydroxysuccin-imide (NHS), as doing so would strengthen the donor cornea as taught by Peyman (see paragraph [0182]).
Regarding Claim 87, Marmo as modified by Peyman discloses the onlay graft of claim 86, wherein said graft is comprising or coated by at least one member of group A, consisting of biocompatible synthetic materials (see paragraph [0070]).
Regarding Claim 88, Marmo as modified by Peyman discloses the onlay graft of claim 87, wherein said group A consists at least one of the following: HEMA, HEA, MAA, MMA, MPC, PEG, PCL, PVA and any mixture or combination thereof (see paragraph [0074]).
Regarding Claim 89, Marmo as modified by Peyman discloses the onlay graft of claim 76, wherein said at least one member of group B is mixed with at least one of the following: collagen, recombinant mammals' collagen, gelatin, and any mixture or combination thereof (see paragraphs [0017], [0071], and [0085]).
Regarding Claim 90, Marmo as modified by Peyman discloses the onlay graft of claim 86, coated by one or more of the following: collagen, laminin fibronectin or a combination thereof (see paragraphs [0017] and [0071], see also paragraph [0085] denoting collagen).
Regarding Claim 91, Marmo as modified by Peyman as modified by Niu discloses the onlay graft of claim 86, wherein said Onlay is made in a method consisting of incorporating one or more of the following: limbal stem cells and epithelial cells, on its anterior surface (see paragraphs [0014] - [0017], see also the Abstract, see also paragraph [0098]).
Regarding Claim 92, Marmo as modified by Peyman discloses the onlay graft of claim 86, wherein said Onlay is made by one or more techniques selected from the group consisting of molding, 3D-printing, laser-ablating and a combination thereof (see paragraph [0018] regarding molding, and see paragraphs [0078] and [0088] and regarding using laser ablation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774