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 08/31/2026 has been entered. Claims 1-21, 23-26, 28, and 31-41 remain pending in the application. Claims 1-16 remain withdrawn from consideration. Claims 22, 27, 29, and 30 have been cancelled. Claim 41 has been added.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/31/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The material of the mold is now taught by a new reference, US 20190270264 A1 (hereafter –Chen--). 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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 17-18, 23, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over US 20060241751 A1 (hereafter –Marmo--), in further view of US 20190270264 A1 (hereafter –Chen--).
Regarding Claim 17, Marmo discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraph [0063]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]); wherein said method comprising steps of
a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of (see paragraphs [0074] and [0088]); collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0074]); and,
b. producing the lenticule graft by a method including molding (see paragraph [0088]), wherein said molding is provided by designated tool, having the predefined geometry and surface roughness (see paragraph [0088]).
Marmo fails to disclose wherein said tool is made of a material selected from a group consisting of glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof. Marmo however discloses wherein said tool is made of a material selected from a group consisting of composite material, and also discloses that the molds of Marmo are not limited to the listed materials (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Chen discloses a method for preparing corneal lenses (see Abstract), using a designated tool for molding (see paragraph [0011]). Chen teaches wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof (see paragraphs [0011] and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof, 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 18, Marmo as modified discloses the method of claim 17, additionally comprising step of providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting Keratocytes and/or stem cells and any combination thereof (see paragraphs [0018], [0064] and [0085]).
Regarding Claim 23, Marmo as modified discloses the method of claim 17, characterized by a step of molding of a collagen solution (see paragraph [0088]).
Regarding Claim 34, Marmo as modified discloses the method of claim 17, comprising a step of ablating said lenticule by laser to shape and size (see paragraph [0088] denoting that the lends may be shaped through ablation).
Claims 17, 19, 21, 23, 25, 26, 31, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over US 20140142200 A1 (hereafter --Duan--), in view of US 20060241751 A1 (hereafter –Marmo--), in even further view of US 20190270264 A1 (hereafter –Chen--).
Regarding Claim 17, Duan discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0012] and [0041]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraphs [0019], [0041], and [0046] denoting the lenticle can replace cornea and be placed as a corneal onlay, inlay, or underlay); wherein said method comprising steps of
a. providing at least one portion of said lenticule to comprise or to be coated by at least one collagen solution selected from a group consisting of collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0019] and [0041]); and,
b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see paragraphs [0012], [0013], [0016], [0019], [0041]), wherein said method additionally comprises a step of lyophilizing said collagen solution prior to said step of crosslinking said collagen solution (see paragraphs [0016], [0019], and [0042]).
Duan fails to disclose herein said molding is provided by designated tool, having the predefined geometry and surface roughness and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Marmo discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraph [0063]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]); wherein said method comprising steps of:
a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of (see paragraphs [0074] and [0088]); collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0074]); and,
b. producing the lenticule graft by a method including molding (see paragraph [0088]).
Marmo teaches wherein said molding is provided by designated tool, having the predefined geometry and surface roughness (see paragraph [0088]), and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said molding is provided by designated tool, having the predefined geometry and surface roughness, as taught by Marmo, as by doing so could enable the method to utilize a mold (tool) wherein one or more pores to permit nutrients and liquid and gas to flow to the cell culture (see paragraph [0088]).
Duan further fails to disclose wherein said tool is made of a material selected from a group consisting of glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Chen discloses a method for preparing corneal lenses (see Abstract), using a designated tool for molding (see paragraph [0011]). Chen teaches wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof (see paragraphs [0011] and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof, 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 19, Duan as modified discloses the method of claim 17, characterized by step of molding a collagen solution, and crosslinking the same to form a transparent hydrogel (see paragraphs [0012], [0013], [0016], [0019], [0041]).
Regarding Claim 21, Duan as modified discloses the method of claim 17, characterized by a step of centrifuging collagen solution (see paragraph [0016], [0019], and [0042]).
Regarding Claim 23, Duan as modified discloses the method of claim 17, characterized by a step of molding of said collagen solution (see paragraphs [0012], [0013], [0016], [0019], [0041]).
Regarding Claim 25, Duan as modified discloses the method of claim 19, wherein said crosslinking is provided by admixing EDC and/or NHS molecules to said collagen solution (see paragraph [0016], [0042], and [0044]).
Regarding Claim 26, Duan as modified discloses the method of claim 19, wherein said crosslinking is provided in a controlled temperature and humidity (see paragraphs [0043], [0073], and [0120]).
Regarding Claim 31, Duan as modified discloses the method of claim 19, wherein said collagen solution is provided to form hydrogel with an optical refractive index which is similar to the native corneal stroma (see paragraph [0047]), thereby configured to avoid light scattering and/or reflections (see paragraph [0012]).
Regarding Claim 41, Duan as modified discloses the method of claim 17, wherein said method additionally comprises a step of lyophilizing said collagen solution prior to said step of crosslinking said collagen solution (see paragraphs [0016], [0019], and [0042]).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over US 20060241751 A1 (hereafter –Marmo--), in view of US 20190270264 A1 (hereafter –Chen--), as applied to claim 17 above, and in even further view of US 20140142200 A1 (hereafter --Duan--).
Regarding Claim 41, Marmo as modified discloses the method of claim 17.
Marmo fails to disclose wherein said method additionally comprises a step of lyophilizing said collagen solution prior to said step of crosslinking said collagen solution.
Duan discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0012] and [0041]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraphs [0019], [0041], and [0046] denoting the lenticle can replace cornea and be placed as a corneal onlay, inlay, or underlay); wherein said method comprising steps of a. providing at least one portion of said lenticule to comprise or to be coated by at least one collagen solution selected from a group consisting of collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0019] and [0041]); and, b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see paragraphs [0012], [0013], [0016], [0019], [0041]). Duan teaches wherein said method additionally comprises a step of lyophilizing said collagen solution prior to said step of crosslinking said collagen solution (see paragraphs [0016], [0019], and [0042]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to further comprise a step of lyophilizing said collagen solution prior to said step of crosslinking said collagen solution, as by doing so would produce dry, uniform, collagen powder with greatly reduced small molecule contaminants, as collagen solutions prepared from such collagen powder have very precise, repeatable collagen concentrations and reaction properties that are essential to two-stage (and more generally, multi-stage) crosslinking methods (see paragraph [0015]).
Claim 17-20, 24-25, 31, 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200337830 A1 (hereafter –Peyman--), in view of US 20060241751 A1 (hereafter –Marmo--), and in further view of US 20190270264 A1 (hereafter –Chen--).
Regarding Claim 17, Peyman discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0127] and Abstract), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0110] and Abstract); wherein said method comprising steps of
a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraphs [0150], [0153], and [0154]); and,
b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see Abstract and paragraph [0111-0114]).
Peyman fails to disclose herein said molding is provided by designated tool, having the predefined geometry and surface roughness and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Marmo discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraph [0063]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]); wherein said method comprising steps of a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of (see paragraphs [0074] and [0088]); collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0074]); and, b. producing the lenticule graft by a method including molding (see paragraph [0088]).
Marmo teaches wherein said molding is provided by designated tool, having the predefined geometry and surface roughness (see paragraph [0088]), and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said molding is provided by designated tool, having the predefined geometry and surface roughness, as taught by Marmo, as by doing so could enable the method to utilize a mold (tool) wherein one or more pores to permit nutrients and liquid and gas to flow to the cell culture (see paragraph [0088]).
Peyman further fails to disclose wherein said tool is made of a material selected from a group consisting of glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Chen discloses a method for preparing corneal lenses (see Abstract), using a designated tool for molding (see paragraph [0011]). Chen teaches wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof (see paragraphs [0011] and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof, since it has been held to be within the general skill of a worker in the art to select a known material (and therefore material stiffness (elastic modulus)) 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 18, Peyman as modified discloses the method of claim 17, additionally comprising step of providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting Keratocytes and/or stem cells and any combination thereof (see paragraphs [0110]).
Regarding Claim 19, Peyman as modified discloses the method of claim 17, characterized by step of molding a collagen solution (see Abstract, see paragraph [0018]), and crosslinking the same to form a transparent hydrogel (see paragraph [0110], [0152], and [0157]).
Regarding Claim 20, Peyman as modified discloses the method of claim 17, characterized by step of concentrating collagen solution to a predefined value in the range of about 1 to about 15% w/w (see paragraphs [0203] and [0204]).
Regarding Claim 24, Peyman as modified discloses the method of claim 19, wherein said crosslinking is provided by admixing photo initiator to said collagen solution and applying light on it (see paragraph [0022], [0106]).
Regarding Claim 25, Peyman as modified discloses the method of claim 19, wherein said crosslinking is provided by admixing EDC and/or NHS molecules to said collagen solution (see paragraph [0107]).
Regarding Claim 31, Peyman as modified discloses the method of claim 19, wherein said collagen solution is provided to form hydrogel with an optical refractive index which is similar to the native corneal stroma (see paragraph [0174]), thereby configured to avoid light scattering and/or reflections (see paragraph [0151]).
Regarding Claim 34, Peyman as modified discloses the method of claim 17, comprising step ablating said lenticule graft by laser to shape and size (see paragraph [0125] denoting that the lends may be shaped through ablation).
Regarding Claim 35, Peyman as modified discloses the method of claim 34, comprising scanning said lenticule graft by an OCT (see paragraph [0204]), simultaneously to said step of ablating, hence forming a closed-loop feedback mechanism (see paragraph [0221]).
Regarding Claim 36, Peyman as modified discloses the method of claim 34, wherein said laser system comprises excimer and/or a femtosecond laser (see paragraphs [0125] and [0146]).
Regarding Claim 37, Peyman as modified discloses a method of grafting an intrastromal corneal lenticule graft as defined in claim 17, comprising a step of using a laser system, including an Excimer Laser and/or a femtosecond laser (see paragraph [0025]).
Regarding Claim 38, Peyman as modified discloses the method of claim 37, comprising a step of shaping said intrastromal lenticule graft, by means of laser within patient's cornea, after grafting the same (see paragraph [0125]).
Regarding Claim 39, Peyman as modified discloses the method of claim 37, comprising step of optimizing depth and position within the cornea, which was optimized based on OCT scans and mechanical properties measurement of the cornea (see paragraph [0221]).
Regarding Claim 40, Peyman as modified discloses the method of claim 37, wherein said grafting said lenticule graft is provided before or after crosslinking a collagen solution (see paragraph [0110], [0152], and [0157]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over US 20140142200 A1 (hereafter --Duan--), in view of US 20060241751 A1 (hereafter –Marmo--), in further view of US 20190270264 A1 (hereafter –Chen--), as applied to claim 31 above, in view of US 7476398 B1 (hereafter –Doillon--).
Regarding Claim 32, Duan as modified discloses the method of claim 31.
Duan fails to disclose wherein at least one of the following is held true:
a. said solution is configured to form a hydrogel characterized by elastic modulus ranging between about 5OkPA to about 13MPa;
c. said solution is configured to form a hydrogel characterized with permeability to glucose, oxygen and proteins which is at least about 50% of the permeability of native corneal stroma tissue;
d. said solution is configured to form a hydrogel which at least partially blocks UV light.
Doillon discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see Abstract, see also claim 1), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see column 5, lines 14-18, see also column 5, lines 30-40, see also ); wherein said method comprising steps of a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see column 5, lines 41-59) and, b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see column 4, lines 12-15, see also column 7, lines 50-53, see also column 9, lines 22-31).
Doillon teaches wherein at least one of the following is held true: a. said solution is configured to form a hydrogel characterized by elastic modulus ranging between about 50kPA to about 13MPa (see column 3, lines 33-40). [b. said solution is configured to form a hydrogel characterized with permeability to glucose, oxygen and proteins which is at least about 50% of the permeability of native corneal stroma tissue; c. said solution is configured to form a hydrogel which at least partially blocks UV light.]
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the solution of Duan to be configured to form a hydrogel characterized by elastic modulus ranging between about 50kPA to about 13MPa, since it has been held to be within the general skill of a worker in the art to select a known material (and therefore material stiffness (elastic modulus)) on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 17, 19, 26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200046884 A1 (hereafter –Griffith--), in view of US 20060241751 A1 (hereafter –Marmo--), in further view of US 20190270264 A1 (hereafter –Chen--).
Regarding Claim 17, Griffith discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0021] and [0091]) configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0075], [0218], and [0256]); wherein said method comprising steps of a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of (see paragraph [0081]); collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0081]); and, b. processing the lenticule graft by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see paragraph [0027]).
Griffith fails to disclose wherein said molding is provided by designated tool, having the predefined geometry and surface roughness and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Marmo discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraph [0063]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]); wherein said method comprising steps of a. providing at least one portion of said lenticule graft to comprise or to be coated by at least one collagen solution selected from a group consisting of (see paragraphs [0074] and [0088]); collagen, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0074]); and, b. producing the lenticule graft by a method including molding (see paragraph [0088]).
Marmo teaches wherein said molding is provided by designated tool, having the predefined geometry and surface roughness (see paragraph [0088]), and wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said molding is provided by designated tool, having the predefined geometry and surface roughness, as taught by Marmo, as by doing so could enable the method to utilize a mold (tool) wherein one or more pores to permit nutrients and liquid and gas to flow to the cell culture (see paragraph [0088]).
Griffith further fails to disclose wherein said tool is made of a material selected from a group consisting of glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof.
Chen discloses a method for preparing corneal lenses (see Abstract), using a designated tool for molding (see paragraph [0011]). Chen teaches wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof (see paragraphs [0011] and [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method to include wherein said tool is made of a material selected from a group consisting of glass or PP, and any combination thereof, since it has been held to be within the general skill of a worker in the art to select a known material (and therefore material stiffness (elastic modulus)) 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 19, Griffith as modified discloses the method of claim 17, characterized by step of molding a collagen solution (see Abstract, paragraph [0027], and [0180]), and crosslinking the same to form a transparent hydrogel (see paragraphs [0173], [0164], [0180], and [0113]).
Regarding Claim 26, Griffith as modified discloses the method of claim 19, wherein said crosslinking is provided in a controlled temperature and humidity (see paragraphs [0173], [0164], [0180], and [0113]).
Regarding Claim 28, Griffith as modified discloses the method of claim 19 wherein said crosslinking is provided in a controlled gas mixture environment, other than air (see paragraphs [0173], [0164], [0180], and [0113]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337830 A1 (hereafter –Peyman--) in view of US 20060241751 A1 (hereafter –Marmo--), in further view of US 20190270264 A1 (hereafter –Chen--), as applied to claim 17 above, in view of US 5067961 A (hereafter --Kelman--).
Peyman fails to disclose characterized by step of centrifuging collagen solution. Kelman discloses a corneal implant and method of preparing said implant (see Abstract). Kelman teaches characterized by step of centrifuging collagen solution (see column 2, lines 36-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further include centrifuging collagen solution, as by doing so would enable recovering the fibrous fractions of the collagen to form the implant (see column 2, lines 36-45).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337830 A1 (hereafter –Peyman--) in view of US 20060241751 A1 (hereafter –Marmo--), in further view of US 20190270264 A1 (hereafter –Chen--), as applied to claim 19 above, in view of US 20190307551 A1 (hereafter --Peyman #2--).
Regarding Claim 33, Peyman as modified discloses the method of claim 19.
Peyman fails to disclose additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof.
Peyman #2 discloses a corneal implant and method of preparing said implant (see Abstract). Peyman #2 teaches additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof (see paragraph [0568]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof, as Peyman #2 teaches that doing so would promote ease of implantation (see paragraph [0568]).
Conclusion
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
