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.
Response to Amendment
The amendment filed 06/06/2026 has been entered. Claims 60-80, 82, and 84-92 remain pending. Claims 70 and 73-75 remain withdrawn from consideration. Claims 81 has been cancelled.
Response to Arguments
Applicant’s arguments with respect to claim 60 have been considered but are moot because the new grounds of rejection do not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the arguments about the limitations of prematuring the epithelial cells and either limbal stems or stem cells, the Examiner holds the stance that 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]).
Claim Objections
Claim 60 is objected to because of the following informalities: "wherein said group B consists collagen methacrylate (ColMA)" should read as "wherein said group B consists of collagen methacrylate (ColMA)". Appropriate correction is required.
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]).
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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 WO 2015032985 A1 (hereafter --Griffith--).
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 of collagen methacrylate (ColMA).
Griffith discloses an implant that could be an intraocular lens or a cornea (see Abstract, see page 14, lines 26-29), as well the implant being comprised of collagen based hydrogels that’s can be crosslinked with EDC (see page 3, lines 26-30, see also page 7, lines 6-20). Griffith teaches the implant hydrogel having an option of comprising collagen methacrylate (ColMA) (see page 8 lines 21-31, see also page 10, lines 6-8).
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 taught by Griffith that cross-linking reactivity of the first natural polymer is enhanced by the incorporation of methacrylate and/ or acrylate groups along its triple helical chain, which render it reactive towards nucleophilic attacks via Michael addition reaction, and in addition, by being susceptible of radical formation under low-energy UV light irradiation, methacrylate groups offer another synthetic route to bridge collagen helices with a series of hydrophilic compounds (non-zero crosslinking), making the method presented herein very versatile for the synthesis of collagen/ CMP-based hydrogels (see page 10, lines 12-19). Additionally, 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), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 61, Marmo as modified by Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 WO 2015032985 A1 (hereafter --Griffith--).
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 epithelial cells and one or more of the following: stem cells or limbal stem cells on the anterior surface of said corneal onlay graft, 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 epithelial cells on the one or more of the following: stem cells or limbal stem 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]).
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Peyman fails to disclose wherein said group B consists of collagen methacrylate (ColMA).
Griffith discloses an implant that could be an intraocular lens or a cornea (see Abstract, see page 14, lines 26-29), as well the implant being comprised of collagen based hydrogels that’s can be crosslinked with EDC (see page 3, lines 26-30, see also page 7, lines 6-20). Griffith teaches the implant hydrogel having an option of comprising collagen methacrylate (ColMA) (see page 8 lines 21-31, see also page 10, lines 6-8).
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 taught by Griffith that cross-linking reactivity of the first natural polymer is enhanced by the incorporation of methacrylate and/ or acrylate groups along its triple helical chain, which render it reactive towards nucleophilic attacks via Michael addition reaction, and in addition, by being susceptible of radical formation under low-energy UV light irradiation, methacrylate groups offer another synthetic route to bridge collagen helices with a series of hydrophilic compounds (non-zero crosslinking), making the method presented herein very versatile for the synthesis of collagen/ CMP-based hydrogels (see page 10, lines 12-19). Additionally, 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), since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 61, Peyman as modified by Griffith 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 Griffith 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 Griffith 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 Griffith 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 Griffith 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 76-80, 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: 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), and c. said onlay comprises pores (see paragraph [0088]); and 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]).
The limitation “said onlay is made by (a) prematurating epithelial cells and one or more of the following: stem cells or limbal stem cells on the anterior surface of said corneal onlay graft, 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 epithelial cells on the one or more of the following: stem cells or limbal stem 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 comprises sub-micron sized pores, as well as 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)), as well as teaches wherein said onlay comprises sub-micron sized pores (see paragraph [0364] denoting the pores can be 1 micron, see also paragraph [0372] denoting there can be 0.2 to 3 micron sized holes in the implant). The “or” clause is not limiting as the limitation only requires either N-(3-dimethylaminopropyl)-N'-ethylcarbodiimide (EDC) OR N-hydroxysuccin-imide (NHS).
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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]), and 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 sub-micron sized pores, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
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 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 corneal onlay graft is configured for a spherical refractive correction in the range between about -10 diopters to about 15 diopters (see paragraph [0067]); b. said corneal onlay graft has a non-spherical shape for astigmatism vision correction (see paragraphs [0080] and [0081]); c. said corneal onlay graft has a shape for patient-tailored vision correction (see paragraphs [0080] and [0081]); d. said corneal onlay graft 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 corneal onlay graft is configured to make possible the migration of corneal stroma cells (see paragraph [0069]).
The limitation “said onlay is made by (a) prematurating epithelial cells and one or more of the following: stem cells or limbal stem cells on the anterior surface of said corneal onlay graft, 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 epithelial cells on the one or more of the following: stem cells or limbal stem 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).
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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 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
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 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.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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