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 .
Formal Matters
Receipt of Applicant’s response, dated 10/23/2025, is acknowledged.
Claims 1-6, 8-11, and 20-28 are pending.
Claims 7 and 12-19 are canceled.
Claims 1, 5-6, and 9 are amended.
Claims 1-6, 8-11, and 20-28 are under consideration in the instant Office action.
OBJECTIONS/REJECTIONS WITHDRAWN
Claim Objections
The objections to claims 1, 6, and 9 set forth in the Office action dated 07/25/2025 are hereby withdrawn in light of Applicant’s amendments to the claims. The objection to claim 7 set forth in the Office action dated 07/25/2025 is hereby withdrawn in light of Applicant’s cancelation of claim 7.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 7 set forth in the Office action dated 07/25/2025 is hereby withdrawn in light of Applicant’s cancelation of claim 7.
OBJECTIONS/REJECTIONS MAINTAINED
Claim Objections
Claim 5 remains objected to because “support membrane” in line 2 should be amended to “synthetic support membrane” in order to improve the consistency and readability of the claims.
Applicant states in Remarks dated 10/23/2025 that claim 5 has been amended as suggested in the Office action dated 07/25/2025, however, only one recitation of “support membrane” has been amended, not both.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 8-9, 11, and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over Niu et al (WO 2013/040559 A1, published 3/21/2013, cited in IDS dated 1/27/2023) in view of Kearns et al (J. Mater. Sci.: Mater. Med., (2017), 28, 124, published 7/13/2017, cited in IDS dated 1/27/2023) and Butler et al (US 5,902,745 A, published 05/11/1999, cited in Notice of References Cited dated 07/25/2025) as evidenced by International Polymer Engineering (“Why is ePTFE used so extensively to create medical and dental implants?”, cited in Notice of References Cited dated 12/06/2024).
Niu et al teach corneal endothelial compositions comprising a transparent hydrogel scaffold and a single layer of cultured corneal endothelial cells on the surface of the scaffold, wherein the hydrogel scaffold comprises at least one biopolymer and at least one synthetic polymer, for the restoration of the corneal endothelial cell layer as well as the creation for tissue engineered construct for use in corneal endothelium transplantation (e.g., Abstract, Page 2 Lines 6-9, Page 13 Lines 18-19).
The at least one biopolymer is selected from the group consisting of hyaluronan, chitosan, alginate, collagen, dextran, pectin, carrageenan, polylysine, gelatin, and agaros, and is preferably gelatin (e.g., Abstract, Page 2 Lines 15-18).
The at least one synthetic polymer includes, but are not limited to, (meth)acrylate-oligolactide-PEO-oligolactide-(meth)acrylate, poly(ethylene glycol) (PEO), poly(propylene glycol) (PPO), PEO-PPO-PEO copolymers (Pluronics), poly(phosphazene), poly(methacrylates), poly(N-vinylpyrrolidone), PL(G)A-PEO-PL(G)A copolymers, poly(ethylene imine), and poly(ethyl glycol) diacrylate (e.g., Page 2 Lines 19-25, Page 12 Lines 25-32).
Because damage to the corneal endothelium, the inner most layer of the cornea, leads to cloudy and blurred vision, the requirement for optical transparency is important to the hydrogel scaffold as it is used in a method of corneal transplantation (e.g., Page 5 Lines 29-30, Page 12 Line 34- Page 13 Line 2). A hydrogel scaffold comprising gelatin may have 95% transparency within the visible light scope and have a porous structure which allows for the diffusion of nutrients and metabolites (e.g., Page 13 Lines 11-14).
The hydrogel scaffold provides a surface suitable for adherence and proliferation of cells and provides mechanical stability and support (e.g., Page 7 Lines 19-21). Hydrogels can be modified with fibronectin, laminin, vitronectin, or, for example, RGD for surface modification, which can promote cell adhesion and proliferation on one side of the hydrogel (e.g., Page 13 Lines 27-29, Figure 6). For example, a hydrogel scaffold comprising gelatin cross-linked with EDC (i.e., 1-ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride) and NHS (N- hydroxysuccinimide) can be further modified with the attachment of RGD motifs to improve cell attachment (e.g., Page 2 Lines 32-33, Page 4 Line 32-Page 5 Line 1, Figure 6). Incorporation of heparin into a hydrogel scaffold comprising gelatin improves cell proliferation (e.g., Page 6 Lines 6-8).
While the shape of the transparent hydrogel scaffold is not particularly limited as long as it can carry a corneal endothelial cell layer and is suitable for transplantation, a sheet form is preferable. In the preferred embodiment, the transparent hydrogel scaffold is a sheet of a thickness of 100-300 μm (Page 24 Lines 28-31). It is preferable that the cell layer contained on the scaffold is a monolayer because this is a characteristic of the corneal endothelial cell layer of living organisms (i.e., corneal endothelial cells possess the functional ability to form a single-cell thick layer ("monolayer") on the inner surface of the cornea) (e.g., Page 9 Lines 16-18, Page 25 Lines 11-15).
Niu et al do not teach the transparent hydrogel scaffold having a toughness of 30 KJ/m3 or being at least substantially free of air (instant claim 1), nor that the synthetic polymer may be at least one of expanded polytetrafluoroethylene (ePTFE) and expanded polyethylene (instant claim 9) or being wetted out (instant claim 20).
These deficiencies are made up for in the teaching of Kearns et al and Butler et al.
Kearns et al teach a scaffold comprising an ePTFE-based substrate and a monolayer of primary human retinal pigment epithelial (RPE) cells for subretinal transplantation (e.g., Abstract). Kearns et al teach that biostability, porosity, and suitable mechanical strength for surgical handling are critical for the design of a suitable cell transplanting device (e.g., Introduction Par. 2), and that ePTFE has many of these required properties (e.g., Introduction Par. 3). ePTFE is necessarily biologically inert as evidenced by “Why is ePTFE used so extensively to create medical and dental implants?” (See Pages 3, 11).
Butler et al teach ePTFE materials, including ePTFE films that can be uniaxially, biaxially, or multiaxially oriented, in the form of a laminate of two or more layers of ePTFE film, the ePTFE laminate having a thickness of preferably less than 50 microns and most preferably less than about 5 microns (e.g., Col. 8 Lines 18-30, 48-54). Butler et al teach that an opaque ePTFE material can be rendered essentially translucent to transparent when wet with liquid water by using wetting agents or surfactants adsorbed onto the surfaces and into the void, or porous, spaces of an ePTFE material (e.g., Col. 11 Lines 8-12). This can be achieved by immersing the ePTFE material in ethanol to coat the surfaces of the material and fill the pores, or void spaces, with the ethanol. The ethanol-saturated ePTFE material is then immersed in a very dilute aqueous solution of a wetting agent to displace the ethanol from the surfaces and the pores. When, for example, 0.001% polyvinyl alcohol in saline (w/v) is used as the very dilute aqueous solution of a wetting agent, spontaneous dewetting of the ePTFE is prevented/limited, which in turn prevents/limits the evolution of air bubbles and renders the normally opaque ePTFE material essentially translucent to transparent (e.g., Col. 10 Lines 51-59, Col. 11 Lines 16-26).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use the ePTFE laminate that has been rendered essentially translucent to transparent taught by Butler et al as the synthetic polymer in the transparent hydrogel scaffold of Niu et al. One of ordinary skill in the art would have been motivated to do so because Kearns et al teach advantages of using ePTFE in subretinal transplantation applications due to advantageous properties of ePTFE including biostability, porosity, and suitable mechanical strength for surgical handling and Butler et al teach how to make an ePTFE material having a thickness of preferably less than 50 microns and most preferably less than about 5 microns that is essentially translucent to transparent, for which the attributes of being thin and transparent are both important for the applications taught by Niu et al. There would have been a reasonable expectation of success because the transparent hydrogel scaffold of Niu et al is compatible with synthetic polymers, and ePTFE is a synthetic polymer taught as compatible with scaffolds for use in cell transplantation technology for eye tissue (teaching of Kearns et al) that can be produced in a thin, essentially translucent to transparent form (teaching of Butler et al).
The modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al comprising gelatin as biopolymer and the essentially translucent to transparent ePTFE laminate may result in 95% transparency within the visible light scope and the laminate ePTFE is essentially translucent to transparent, which renders obvious a measured optical transparency of at least 85% (instant claim 1). Rendering the ePTFE material to be essentially translucent to transparent in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al prevents/limits the evolution of air bubbles, which renders obvious being at least substantially free of air (instant claim 1).
The modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al being a sheet of a thickness of 100-300 μm overlaps and renders obvious the range of thickness of the reinforced biopolymer of ‘about 100 μm or less’ (instant claim 1). Further, the specification defines “about” as meaning plus or minus 10% of the stated value, see Par. [00029]. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The instant claims regarding ‘the synthetic support membrane being imbibed with the biopolymer’ are product-by-process claims (instant claims 1, 20, and 25) and therefore the product is given patentable weight, not the process by which the product is made. “[Elven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. 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 Thorne, 777 F.2d 695, 698, 227 USPQ S64, 966 (Fed. Cir. 1985)). Therefore, the instant claims that recite ‘the synthetic support membrane being imbibed with the biopolymer’ are being examined to the extent of the resulting reinforced biopolymer comprising the synthetic support membrane and the biopolymer.
The modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al having a toughness of at least 30 KJ/m3 is not explicitly taught by Niu et al, Kearns et al, or Butler et al. However, all of Niu et al, Kearns et al, and Butler et al teach strength of their scaffolds. Niu et al teach in an example regarding the experimental procedure for producing a transparent gelatin hydrogel cultured with human corneal endothelial cells and its characterization that "the gelatin [hydrogel] sheet has a proper mechanical strength and flexibility, ensuring the [gelatin] hydrogel sheet is easily handled during the surgical implantation. The mechanical property of gelatin hydrogel is greatly influenced by the cross-linking time and the amount of cross-linking agent" (Example 1, Page 26 Lines 30-33). Kearns et al teach that mechanical strength is a critical factor for the design of a suitable cell transplanting device and that ePTFE is a suitable material to use because of its mechanical strength (e.g., Introduction Par. 2 and 3). Butler et al teach that ePTFE is characterized by properties including high tensile strength and that the ePTFE laminate is a thin, high tensile strength reinforcing film having tensile strength in multiple directions (e.g., Col. 8 Lines 18-20 and 31-37, Col. 10 Lines 9-11).
Because the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al is the same as the reinforced biopolymer of the instant claims, i.e., comprises gelatin as biopolymer and the essentially translucent to transparent ePTFE laminate as synthetic polymer wherein the scaffold comprising gelatin may result in 95% transparency and the laminate ePTFE is essentially translucent to transparent, the evolution of air bubbles is prevented/limited, and the scaffold has a thickness of 100-300 μm, the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al would necessarily have a toughness of at least 30 KJ/m3. Further, as evidenced by the specification, strength and toughness of the reinforced biopolymer is provided by the synthetic support membrane, see Par. [0045], and the synthetic polymer in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al is identical to the synthetic support membrane of the instant claims, i.e., ePTFE having a thickness of most preferably less than about 5 microns that was ‘wetted out’. "Products of identical chemical composition cannot have mutually exclusive properties" (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." (Id. at 1195-96, 112 USPQ2d at 1952). But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020).
Because the synthetic polymer in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al is the same as the synthetic support membrane of the instant claims, i.e., ePTFE having a thickness of most preferably less than about 5 microns that was ‘wetted out’, the synthetic polymer in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al necessarily goes from ‘uncollapsed’ to ‘collapsed’ as a result of the ‘wetting out process’ and necessarily is ‘collapsed’ to about 1 micron thick (instant claims 21-23 and 26-28). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Therefore, the modified transparent hydrogel scaffold of Niu et al, Kearns et al and Butler et al comprising gelatin as biopolymer and the essentially translucent to transparent ePTFE laminate as synthetic polymer, wherein the surface of the scaffold can support a single layer of cultured corneal endothelial cells, and wherein surface modification promotes cell adhesion and proliferation on one side of the hydrogel renders obvious instant claims 1-4, 8-9, 11, and 20-28.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Niu et al (as cited above) in view of Kearns et al (as cited above) and Butler et al (as cited above) as evidenced by International Polymer Engineering (as cited above) as applied to claims 1-4, 8-9, 11, and 20-28 above, and further in view of Vohra et al (Eur. J. Vasc. Surg., 1991, 5, 93-103, cited in IDS dated 1/27/2023).
The teachings of Niu et al, Kearns et al, and Butler et al have been described supra.
None of Niu et al, Kearns et al, or Butler et al teach a layer of the biopolymer occurring on each side of the synthetic polymer and the synthetic polymer being approximately centrally located between two layers of the biopolymer (instant claim 5) or a layer of the biopolymer on only one side of the synthetic polymer being configured to support a cellular monolayer (instant claim 6).
These deficiencies are made up for in the teachings of Vohra et al.
Vohra et al teach an ePTFE graft coated with fibronectin that support an endothelial cell monolayer (e.g., Par. 8-9 of Discussion). The fibronectin-coated ePTFE graft is better for adherence of endothelial cells than untreated ePTFE (See Adherence studies of Results).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use fibronectin-coated ePTFE laminate in the modified transparent hydrogel scaffold of Niu et al. One of ordinary skill in the art would have been motivated to do so because Vohra et al teach that fibronectin-coated ePTFE better supports the adherence of endothelial cells than ePTFE. There would have been a reasonable expectation of success because, similar to Niu et al and Kearns et al, Vohra et al also teach scaffolds for use in cell transplantation technology for eye tissue and the transparent hydrogel scaffold of Niu et al is taught as compatible with fibronectin (see supra).
The modified transparent hydrogel scaffold of Niu et al in view of Kearns et al, Butler et al, and Vohra et al comprising fibronectin-coated ePTFE renders obvious instant claim 5 because the fibronectin (i.e., a biopolymer of instant claim 2) coating implies that the biopolymer occurs, in approximately equal layers, on both sides of the ePTFE.
The modified transparent hydrogel scaffold of Niu et al in view of Kearns et al, Butler et al, and Vohra et al comprising fibronectin-coated ePTFE renders obvious instant claim 6 because the modified transparent hydrogel scaffold is configured to support a cellular monolayer on one side of the hydrogel to be consistent with the inner surface of the naturally occurring cornea being configured to support a monolayer of corneal endothelial cells (see supra).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Niu et al (as cited above) in view of Kearns et al (as cited above) and Butler et al (as cited above) as evidenced by International Polymer Engineering (as cited above) as applied to claims 1-4, 8-9, 11, and 20-28 above, and further in view of Gore (US 3,953,566 A, published 4/27/1976, cited in IDS dated 1/27/2023).
The teachings of Niu et al, Kearns et al, and Butler et al have been described supra.
None of Niu et al, Kearns et al, or Butler et al teach the synthetic polymer as a biaxially oriented ePTFE membrane having a crystallinity index of at least 94% and a matrix tensile strength in both the longitudinal and transverse directions of at least about 600 MPa.
This deficiency is made up for in the teaching of Gore.
Gore teaches an ePTFE membrane, wherein the ePTFE is biaxially oriented ePTFE with high porosity and high strength (e.g., Column 1 Lines 32-34, Column 2 Lines 7-15, Example 3). When strength is maximized, the matrix tensile strength is in excess of 689 MPa (e.g., Column 4 Lines 29-43).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use biaxially oriented ePTFE with a tensile strength in excess of 689 MPa taught by Gore as synthetic polymer in the modified transparent hydrogel scaffold of Niu et al. One of ordinary skill in the art would have been motivated to do so in order to provide a transparent hydrogel scaffold with even greater strength, for which stability is an important attribute for the transparent hydrogel scaffold of Niu et al (supra). There would have been a reasonable expectation of success because the transparent hydrogel scaffold of Niu et al is compatible with synthetic polymers, and ePTFE is a synthetic polymer taught as compatible with scaffolds for use in and improvements to cell transplantation technology for eye tissue (teaching of Kearns et al) that can be produced in a form with even greater strength (teaching of Gore).
With respect to the crystallinity index of at least 94%, because the biaxially oriented ePTFE with a tensile strength in excess of 689 MPa of Gore is identical to that claimed and is produced by the same method as the biaxially oriented ePTFE claimed, the crystallinity index of at least 94% would have been necessarily present. As evidenced by the specification, the instantly claimed ePTFE is prepared according to the methodology of Gore, see par. [00038]. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Additionally, because the biaxially oriented ePTFE with a tensile strength in excess of 689 MPa of Gore is identical to that claimed and is produced by the same method as the biaxially oriented ePTFE claimed, the scaffold comprising the ePTFE support along with the biopolymer having the same optical transparency and thickness of about 100 μm or less of Niu et al, Kearns et al and Gore would necessarily have a toughness of at least 30 KJ/m3.
The modified corneal endothelial compositions of Niu et al in view of Kearns et al and Gore comprising biaxially oriented ePTFE with a tensile strength in excess of 689 MPa as the synthetic polymer in the scaffold render obvious instant claim 10.
Response to Applicant’s Arguments
Applicant’s arguments filed on 10/23/2025 have been considered.
Applicant argues that amended claim 1 now recites “the synthetic support membrane is fully imbibed with the biopolymer”, and that “fully imbibed” is not a product-by-process limitation but has a structural meaning in this context as evidenced by Par. [0058] of the instant specification. Applicant argues that Niu et al disclose a scaffold composition where the biopolymers and synthetic polymers are chemically cross-linked, which is fundamentally different from a “fully imbibed” composition as claimed, i.e., the cross-linking process described in Niu et al creates chemical bonds between the materials, whereas the claimed “fully imbibed” structure represents a distinct physical state where the biopolymer completely saturates the synthetic support membrane and does not require chemical cross-linking.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, the Examiner notes that amended claim 1 does not recite “the synthetic support membrane is fully imbibed with the biopolymer” and that this limitation is recited in dependent claim 25. Further, the Examiner disagrees that Par. [0058] of the instant specification provides evidence of structural meaning of “fully imbibed”, i.e., Par. [0058] correlates air expulsion from the synthetic support membrane to a wetting out process that occurs prior to the synthetic support membrane being imbibed with a biopolymer and defines “fully imbibed” as meaning that the reinforced biopolymer is imbibed with the biopolymer and is free or substantially free of air. The Examiner cannot find support in the instant specification for Applicant’s remark that “the claimed “fully imbibed” structure represents a distinct physical state where the biopolymer completely saturates the synthetic support membrane and does not require chemical cross-linking”. Without a specific definition being present in the instant specification for “imbibed”, the term is interpreted by its general meaning, i.e., taken up/incorporated, and this limitation of the instant claims is interpreted by the structure resulting from the synthetic support membrane “imbibed” with the biopolymer. The argument regarding the cross-linking taught by Niu et al being fundamentally different from the composition claimed has been fully considered by the Examiner but is not found persuasive because the biopolymer of the instant invention may be cross-linked as evidenced by Par. [0045] of the instant specification.
Applicant argues that relying on the disclosure of Butler et al of a processing step where air bubbles are removed from the ePTFE material during a wetting process constitutes impermissible hindsight because it represents one step in a process, not a final result and the final result of Butler et al is a dried material, not an end product that is “at least substantially free of air” as claimed. Applicant argues that relying on the disclosure of Butler et al of wetting an ePTFE material as reading onto the “collapsed” limitation of claims 20, 23, 26, and 28 is improper inherency analysis and does not provide adequate evidence for such inherency. Applicant argues that using Butler et al’s process on Niu et al’s hydrogel scaffold has no expectation of success as there is no motivation to combine these references and the references operate in different technical fields with different objectives, i.e., Niu et al focus on corneal endothelial compositions while Butler et al address ePTFE materials with different structural requirements and processing methods.
The above arguments have been fully considered by the Examiner but are not found persuasive because, as can be seen in the maintained grounds of rejection of claims 1-4, 8-9, 11, and 20-28 under 35 USC 103 above, there did exist motivation for a person of ordinary skill in the art to look to the teachings of Kearns et al and Butler et al from the teaching of Niu et al, i.e., a person of ordinary skill in the art would have been motivated to use the ePTFE laminate that has been rendered essentially translucent to transparent taught by Butler et al as the synthetic polymer in the transparent hydrogel scaffold of Niu et al because Kearns et al teach advantages of using ePTFE in subretinal transplantation applications due to advantageous properties of ePTFE including biostability, porosity, and suitable mechanical strength for surgical handling and Butler et al teach how to make an ePTFE material having a thickness of preferably less than 50 microns and most preferably less than about 5 microns that is essentially translucent to transparent, for which the attributes of being thin and transparent are both important for the applications taught by Niu et al. Further, a reasonable expectation of success would have been expected because the transparent hydrogel scaffold of Niu et al is compatible with synthetic polymers, and ePTFE is a synthetic polymer taught as compatible with scaffolds for use in cell transplantation technology for eye tissue (teaching of Kearns et al) that can be produced in a thin, essentially translucent to transparent form (teaching of Butler et al). Applicant is reminded that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). The arguments regarding that relying on the disclosure of Butler et al of a processing step where air bubbles are removed from the ePTFE material during a wetting process constitutes impermissible hindsight and that relying on the disclosure of Butler et al of wetting an ePTFE material as reading onto the “collapsed” limitation of claims 20, 23, 26, and 28 is improper inherency analysis and does not provide adequate evidence for such inherency have been fully considered by the Examiner but are not found persuasive because Par. [0058] of the instant specification correlates air expulsion from the synthetic support membrane to a wetting out process that occurs prior to the synthetic support membrane being imbibed with a biopolymer and correlates an ePTFE membrane having a thickness of about 5 microns prior to wetting out to the ePTFE membrane collapsing to a thickness of about 1 micron. Because the synthetic polymer in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al is the same as the synthetic support membrane of the instant claims, i.e., ePTFE having a thickness of most preferably less than about 5 microns that was ‘wetted out’, the synthetic polymer in the modified transparent hydrogel scaffold of Niu et al, Kearns et al, and Butler et al necessarily goes from ‘uncollapsed’ to ‘collapsed’ as a result of the ‘wetting out process’ and necessarily is ‘collapsed’ to about 1 micron thick. Further, the essentially translucent to transparent ePTFE laminate in the modified transparent hydrogel scaffold of Niu et al, Kearns et al and Butler et al, wherein the evolution of air bubbles is prevented/limited, meets the limitation of instant claim 1 of “the reinforced biopolymer…is at least substantially free of air” (See maintained rejection of claims 1-4, 8-9, 11, and 20-28 over Niu et al in view of Kearns et al and Butler et al under 35 USC 103 above for more details).
Conclusion
No claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619