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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 92, 96 and 100 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 92, 96 and 100, the limitation “disposed in discrete regions” renders the claim indefinite because it is unclear which regions are considered discrete regions.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4, 6, 9, 10, 13, 64, 69-71, 73-74, 77-78 and 91-94 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Bowmann et al. (US 4482516), and Cully et al. (US 2018/0125632).
Regarding claims 1 and 13, Lentz teaches a biocompatible membrane composite comprising:
a first layer having first solid features (nodes) with a first solid feature spacing (internodal spacing), wherein a majority of the first solid feature spacing of the first solid features is less than about 50 microns (refer [0040] disclosing “The outer structure, defined by outer tube 12, has a smaller microporous structure, with IND of about 15-35 microns and a substantial fibril density”); and
a second layer having second solid features (nodes) with a second solid feature spacing (internodal spacing), wherein a majority of the second solid feature spacing of the second solid features is greater than about 50 microns (refer [0039] disclosing “As shown in FIG. 3, the resulting composite structure has an inner surface defined by inner tube 14 which exhibits an IND of between 40 and 100 microns, spanned by a moderate number of fibrils”).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Lentz discloses (in [0032]) that “Tubes having a large IND (greater than 40 microns) generally exhibit long term patency as the larger pores promote cell endothelization along the inner blood contacting surface. Tubes having lower IND (less than 40 microns) exhibit inferior healing characteristics, however they offer superior radial tensile and suture retention strengths desirable in a vascular graft. The present invention provides a composite tubular structure which promotes long term patency of the graft by providing for enhanced cell endothelization along the inner surface while exhibiting enhanced strength due to the presence of the outer layer”. Lentz establishes that selection of internodal spacing is a result effective variable. It would have been obvious to one of ordinary skill in the art to select the layers having desired internodal spacing to promote cell endothelization in one layer and achieve radial tensile and suture retention strength in the second layer. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Lentz does not disclose relative dimensions of the nodes such as claimed a representative minor axis, a representative major axis, and a solid feature depth, wherein at least two of the representative minor axis, the representative major axis, and the solid feature depth are greater than about 5 microns.
Bowmann teaches porous PTFE material suitable for use in medical field (Refer Colum 1 – Lines 9-14). Bowmann discloses that the PTFE article have larger nodes and longer fibrils, and that different microstructures are obtained depending on whether the article has been uniaxially stretched, biaxially stretched, or sequentially stretched first in one direction followed by stretching in a second direction (refer Column 4 – Lines 1-19). Bowmann also discloses nodes having average width of about 17 microns and average height of about 102 microns (refer column 16 – Lines 16-29, table 4, table 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible membrane of Lentz to include nodes having at least two of the representative minor axis, the representative major axis, and the depth being greater than about 5 microns to provide membrane with higher strength as taught by Bowmann.
Lenz further teaches a reinforcing component comprising woven or non-woven textile (refer [0053]). Lenz does not teach that the reinforcing component has a stiffness greater than a combined stiffness of the first layer and the second layer.
Cully teaches an implantable device having multiple layers of ePTFE (refer fig. 2 disclosing layers 212 and 214, or 222 and 224). Cully also teaches a reinforcing component providing support and allow also allow for optimizing or tailoring the bulk device stiffness through the specific design and/or geometry of the patterns of the structural spacers within the cell encapsulation device (Refer [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible device of modified Lenz to include reinforcing component having a stiffness greater than a combined stiffness of the first layer and the second layer to provide support, prevent deformation and deflection while retaining device cross sectional thickness as taught by Cully.
Regarding claim 2, modified Lentz teaches limitations of claim 1 as set forth above. Bowmann discloses that different microstructures are obtained depending on whether the article has been uniaxially stretched, biaxially stretched, or sequentially stretched first in one direction followed by stretching in a second direction (refer Column 4 – Lines 1-19). It would have been obvious to one of ordinary skill in the art to modify the membrane making conditions to achieve desired microstructure. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, modified Lentz teaches limitations of claim 1 as set forth above. Cully teaches that outer layers of ePTFE have a thickness of 0.25 mil to 1.15 mil (about 6.35 microns to 29.21 microns) (refer table 1).
Regarding claim 6, modified Lentz teaches limitations of claim 1 as set forth above, Lentz further teaches that wherein at least one of the first solid features of the first layer and the second solid features of the second layer are connected by fibrils (Refer fig. 3, [0032]) and the fibrils are deformable (deformability of the ePTFE fibrils is inherent in the graft of Lentz).
Regarding claim 9, modified Lentz teaches limitations of claim 1 as set forth above, Lentz further teaches that the biocompatible membrane composite has thereon a surface coating comprising one or more members selected from antimicrobial agents, antibodies, pharmaceuticals and biologically active molecules (Refer [0053], [0054]).
Regarding claim 10, modified Lentz teaches limitations of claim 1 as set forth above. Lentz further teaches that at least one of the first layer and the second layer is a fluoropolymer membrane (refer abstract).
Regarding claim 64, modified Lentz teaches limitations of claim 1 as set forth above. Lentz teaches that the biocompatible membrane is implantable vascular graft (Refer abstract).
Regarding claim 69 and 77, Lentz teaches a biocompatible membrane composite comprising:
a first layer having first solid features (nodes) with a first solid feature spacing (internodal spacing), wherein a majority of the first solid feature spacing of the first solid features is less than about 50 microns (refer [0040] disclosing “The outer structure, defined by outer tube 12, has a smaller microporous structure, with IND of about 15-35 microns and a substantial fibril density”); and
a second layer having second solid features (nodes) with a second solid feature spacing (internodal spacing), wherein a majority of the second solid feature spacing of the second solid features is greater than about 50 microns (refer [0039] disclosing “As shown in FIG. 3, the resulting composite structure has an inner surface defined by inner tube 14 which exhibits an IND of between 40 and 100 microns, spanned by a moderate number of fibrils”).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Lentz discloses (in [0032]) that “Tubes having a large IND (greater than 40 microns) generally exhibit long term patency as the larger pores promote cell endothelization along the inner blood contacting surface. Tubes having lower IND (less than 40 microns) exhibit inferior healing characteristics, however they offer superior radial tensile and suture retention strengths desirable in a vascular graft. The present invention provides a composite tubular structure which promotes long term patency of the graft by providing for enhanced cell endothelization along the inner surface while exhibiting enhanced strength due to the presence of the outer layer”. Lentz establishes that selection of internodal spacing is a result effective variable. It would have been obvious to one of ordinary skill in the art to select the layers having desired internodal spacing to promote cell endothelization in one layer and achieve radial tensile and suture retention strength in the second layer. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Lentz does not disclose relative dimensions of the nodes such as claimed a representative minor axis, a representative major axis, and a solid feature depth, wherein the representative minor axis is about 3 microns to 20 microns.
Bowmann teaches porous PTFE material suitable for use in medical field (Refer Colum 1 – Lines 9-14). Bowmann discloses that the PTFE article have larger nodes and longer fibrils, and that different microstructures are obtained depending on whether the article has been uniaxially stretched, biaxially stretched, or sequentially stretched first in one direction followed by stretching in a second direction (refer Column 4 – Lines 1-19). Bowmann also discloses nodes having average width of about 17 microns and average height of about 102 microns (refer column 16 – Lines 16-29, table 4, table 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible membrane of Lentz to include nodes having the representative minor axis being about 3 microns to 20 microns to provide membrane with higher strength as taught by Bowmann.
Lenz further teaches a reinforcing component comprising woven or non-woven textile (refer [0053]). Lenz does not teach that the reinforcing component has a stiffness greater than a combined stiffness of the first layer and the second layer.
Cully teaches an implantable device having multiple layers of ePTFE (refer fig. 2 disclosing layers 212 and 214, or 222 and 224). Cully also teaches a reinforcing component providing support and allow also allow for optimizing or tailoring the bulk device stiffness through the specific design and/or geometry of the patterns of the structural spacers within the cell encapsulation device (Refer [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible device of modified Lenz to include reinforcing component having a stiffness greater than a combined stiffness of the first layer and the second layer to provide support, prevent deformation and deflection while retaining device cross sectional thickness as taught by Cully.
Regarding claim 70, modified Lentz teaches limitations of claim 69 as set forth above. Cully teaches that outer layers of ePTFE have a thickness of 0.25 mil to 1.15 mil (about 6.35 microns to 29.21 microns) (refer table 1).
Regarding claim 71, modified Lentz teaches limitations of claim 69 as set forth above, Lentz further teaches that wherein at least one of the first solid features of the first layer and the second solid features of the second layer are connected by fibrils (Refer fig. 3, [0032]) and the fibrils are deformable (deformability of the ePTFE fibrils is inherent in the graft of Lentz).
Regarding claim 73, modified Lentz teaches limitations of claim 69 as set forth above, Lentz further teaches that the biocompatible membrane composite has thereon a surface coating comprising one or more members selected from antimicrobial agents, antibodies, pharmaceuticals and biologically active molecules (Refer [0053], [0054]).
Regarding claim 74, modified Lentz teaches limitations of claim 69 as set forth above. Lentz further teaches that at least one of the first layer and the second layer is a fluoropolymer membrane (refer abstract).
Regarding claim 78, modified Lentz teaches limitations of claim 69 as set forth above. Lentz teaches that the biocompatible membrane is implantable vascular graft (Refer abstract).
Regarding claim 91, modified Lentz teaches limitations of claim 1 as set forth above. Cully further teaches that the two sheets of membrane/film each have a thickness of about 100 microns (refer [0110]).
Regarding claim 92, modified Lentz teaches limitations of claim 1 as set forth above. Cully indicates that the reinforcing component is disposed in discrete regions (refer fig. 2).
Regarding claim 93, modified Lentz teaches limitations of claim 1 as set forth above. Cully teaches that incorporating bio-absorbable components into a cell encapsulation device helps to facilitate ease of implantation, and that the bio-absorbable material is much stiffer at colder temperatures and softens at higher temperatures (e.g., body temperature once implanted) so that the bio-absorbable material becomes more conformable and compliant after implantation. As a result the longitudinal strength formed of a bio-absorbable material may allow a clinician to place the cell encapsulation device in a patient with less effort and trauma to the host, and upon implantation, the bio-absorbable material becomes more conformable and compliant (refer [0102]).
Regarding claim 94, modified Lentz teaches limitations of claim 1 as set forth above. Cully further teaches that one or both of the first and second composite layers is or includes a bio-absorbable material. The bio-absorbable material may be formed as a solid (molded, extruded, or crystals), a self-cohered web, a raised webbing, or a screen (refer [0101]).
Regarding claim 95, modified Lentz teaches limitations of claim 69 as set forth above. Cully further teaches that the two sheets of membrane/film each have a thickness of about 100 microns (refer [0110]).
Regarding claim 96, modified Lentz teaches limitations of claim 69 as set forth above. Cully indicates that the reinforcing component is disposed in discrete regions (refer fig. 2).
Regarding claim 97, modified Lentz teaches limitations of claim 69 as set forth above. Cully teaches that incorporating bio-absorbable components into a cell encapsulation device helps to facilitate ease of implantation, and that the bio-absorbable material is much stiffer at colder temperatures and softens at higher temperatures (e.g., body temperature once implanted) so that the bio-absorbable material becomes more conformable and compliant after implantation. As a result the longitudinal strength formed of a bio-absorbable material may allow a clinician to place the cell encapsulation device in a patient with less effort and trauma to the host, and upon implantation, the bio-absorbable material becomes more conformable and compliant (refer [0102]).
Regarding claim 98, modified Lentz teaches limitations of claim 1 as set forth above. Cully further teaches that one or both of the first and second composite layers is or includes a bio-absorbable material. The bio-absorbable material may be formed as a solid (molded, extruded, or crystals), a self-cohered web, a raised webbing, or a screen (refer [0101]).
Claim(s) 7 and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Bowmann et al. (US 4482516) and Cully et al. (US 2018/0125632) as applied to claims 1 and 69 above, and further in view of Kinsley et al. (US 2013/0231733A1).
Regarding claims 7 and 72, modified Lentz teaches limitations of claims 1 and 69 as set forth above. Lentz does not teach that the second layer having a second thickness of about 30 microns to 200 microns.
Kinsley teaches a biocompatible composite membrane having multiple layers of ePTFE, wherein the layers having thickness of 0.029 mm (29 microns) and 0.069 mm (69 micron) (refer fig. 12).
Selecting membrane layers thickness in the composite of modified Lentz would have been an obvious matter of design choice to one of ordinary skill in the art because Kinsley discloses that it is known in the art.
Claim(s) 11, 65, 75, and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Bowmann et al. (US 4482516) and Cully et al. (US 2018/0125632) as applied to claims 1 and 69 above, and further in view of Tu et al. (US 4816339).
Regarding claims 11, 65, 75 and 79 modified Lentz teaches limitations of claims 1 and 69 as set forth above. Modified Lentz does not teach that the second layer is a spunbound non-woven polyester material.
Tu teaches a multi-layer shaped articles, including medical implants such as vascular grafts produced from materials including polyester (refer column 2 – lines 20-35). Tu also teaches use of non-woven fibers (refer column 4 – lines 3-12).
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use spunbound non-woven polyester material as second layer because Tu discloses that use of nonwoven polyester material is known in the art.
Regarding claim 65, modified Lentz teaches limitations of claim 1 as set forth above. Modified Lentz does not teach that the biocompatible membrane comprises hydrophilic coating thereon.
Tu teaches a multi-layer shaped articles, including medical implants such as vascular grafts (abstract). Tu also teaches providing a hydrophilic tissue-compatible porous layer which promotes the elasticity, strength and saturability for the whole composite (column 3 – Lines 61-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the membrane of modified Lentz to provide a hydrophilic coating to promote elasticity, strength and saturability for the whole composite as taught by Tu.
Claim(s) 80, 82, 83, 85-86, 88-90, and 99-102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Tu et al. (US 4816339) and Cully et al. (US 2018/0125632).
Regarding claims 80 and 88, Lentz teaches a biocompatible membrane composite comprising:
a first layer having first solid features (nodes) with a first solid feature spacing (internodal spacing), wherein a majority of the first solid feature spacing of the first solid features is less than about 50 microns (refer [0040] disclosing “The outer structure, defined by outer tube 12, has a smaller microporous structure, with IND of about 15-35 microns and a substantial fibril density”); and
a second layer having second solid features (nodes) with a second solid feature spacing (internodal spacing), wherein a majority of the second solid feature spacing of the second solid features is greater than about 50 microns (refer [0039] disclosing “As shown in FIG. 3, the resulting composite structure has an inner surface defined by inner tube 14 which exhibits an IND of between 40 and 100 microns, spanned by a moderate number of fibrils”).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Lentz discloses (in [0032]) that “Tubes having a large IND (greater than 40 microns) generally exhibit long term patency as the larger pores promote cell endothelization along the inner blood contacting surface. Tubes having lower IND (less than 40 microns) exhibit inferior healing characteristics, however they offer superior radial tensile and suture retention strengths desirable in a vascular graft. The present invention provides a composite tubular structure which promotes long term patency of the graft by providing for enhanced cell endothelization along the inner surface while exhibiting enhanced strength due to the presence of the outer layer”. Lentz establishes that selection of internodal spacing is a result effective variable. It would have been obvious to one of ordinary skill in the art to select the layers having desired internodal spacing to promote cell endothelization in one layer and achieve radial tensile and suture retention strength in the second layer. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Lentz does not teach that the second layer is a spunbound non-woven polyester material.
Tu teaches a multi-layer shaped articles, including medical implants such as vascular grafts produced from materials including polyester (refer column 2 – lines 20-35). Tu also teaches use of non-woven fibers (refer column 4 – lines 3-12).
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use spunbound non-woven polyester material as second layer because Tu discloses that use of nonwoven polyester material is known in the art.
Lenz further teaches a reinforcing component comprising woven or non-woven textile (refer [0053]). Lenz does not teach that the reinforcing component has a stiffness greater than a combined stiffness of the first layer and the second layer.
Cully teaches an implantable device having multiple layers of ePTFE (refer fig. 2 disclosing layers 212 and 214, or 222 and 224). Cully also teaches a reinforcing component providing support and allow also allow for optimizing or tailoring the bulk device stiffness through the specific design and/or geometry of the patterns of the structural spacers within the cell encapsulation device (Refer [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible device of modified Lenz to include reinforcing component having a stiffness greater than a combined stiffness of the first layer and the second layer to provide support, prevent deformation and deflection while retaining device cross sectional thickness as taught by Cully.
Regarding claim 82, modified Lentz teaches limitations of claim 80 as set forth above. Cully teaches that outer layers of ePTFE have a thickness of 0.25 mil to 1.15 mil (about 6.35 microns to 29.21 microns) (refer table 1).
Regarding claim 83, modified Lentz teaches limitations of claim 80 as set forth above, Lentz further teaches that wherein at least one of the first solid features of the first layer and the second solid features of the second layer are connected by fibrils (Refer fig. 3, [0032]) and the fibrils are deformable (deformability of the ePTFE fibrils is inherent in the graft of Lentz).
Regarding claim 85, modified Lentz teaches limitations of claim 80 as set forth above, Lentz further teaches that the biocompatible membrane composite has thereon a surface coating comprising one or more members selected from antimicrobial agents, antibodies, pharmaceuticals and biologically active molecules (Refer [0053], [0054]).
Regarding claim 86, modified Lentz teaches limitations of claim 80 as set forth above. Lentz further teaches that at least one of the first layer and the second layer is a fluoropolymer membrane (refer abstract).
Regarding claim 89, modified Lentz teaches limitations of claim 80 as set forth above. Lentz teaches that the biocompatible membrane is implantable vascular graft (Refer abstract).
Regarding claim 90, modified Lentz teaches limitations of claim 1 as set forth above. Tu also teaches providing a hydrophilic tissue-compatible porous layer which promotes the elasticity, strength and saturability for the whole composite (column 3 – Lines 61-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the membrane of modified Lentz to provide a hydrophilic coating to promote elasticity, strength and saturability for the whole composite as taught by Tu.
Regarding claim 99, modified Lentz teaches limitations of claim 80 as set forth above. Cully further teaches that the two sheets of membrane/film each have a thickness of about 100 microns (refer [0110]).
Regarding claim 100, modified Lentz teaches limitations of claim 80 as set forth above. Cully indicates that the reinforcing component is disposed in discrete regions (refer fig. 2).
Regarding claim 101, modified Lentz teaches limitations of claim 80 as set forth above. Cully teaches that incorporating bio-absorbable components into a cell encapsulation device helps to facilitate ease of implantation, and that the bio-absorbable material is much stiffer at colder temperatures and softens at higher temperatures (e.g., body temperature once implanted) so that the bio-absorbable material becomes more conformable and compliant after implantation. As a result the longitudinal strength formed of a bio-absorbable material may allow a clinician to place the cell encapsulation device in a patient with less effort and trauma to the host, and upon implantation, the bio-absorbable material becomes more conformable and compliant (refer [0102]).
Regarding claim 102, modified Lentz teaches limitations of claim 80 as set forth above. Cully further teaches that one or both of the first and second composite layers is or includes a bio-absorbable material. The bio-absorbable material may be formed as a solid (molded, extruded, or crystals), a self-cohered web, a raised webbing, or a screen (refer [0101]).
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Tu et al. (US 4816339) and Cully et al. (US 2018/0125632) as applied to claim 80 above, and further in view of Bowmann et al. (US 4482516).
Regarding claim 81, modified Lentz teaches limitations of claim 80 as set forth above. Modified Lentz does not disclose relative dimensions of the nodes such as claimed a representative minor axis, a representative major axis, and a solid feature depth, wherein the representative minor axis is about 3 microns to 20 microns.
Bowmann teaches porous PTFE material suitable for use in medical field (Refer Colum 1 – Lines 9-14). Bowmann discloses that the PTFE article have larger nodes and longer fibrils, and that different microstructures are obtained depending on whether the article has been uniaxially stretched, biaxially stretched, or sequentially stretched first in one direction followed by stretching in a second direction (refer Column 4 – Lines 1-19). Bowmann also discloses nodes having average width of about 17 microns and average height of about 102 microns (refer column 16 – Lines 16-29, table 4, table 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the biocompatible membrane of modified Lentz to include nodes having the representative minor axis being about 3 microns to 20 microns to provide membrane with higher strength as taught by Bowmann.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Tu et al. (US 4816339) and Cully et al. (US 2018/0125632) as applied to claim 80 above and further in view of Kinsley et al. (US 2013/0231733A1).
Regarding claim 84, modified Lentz teaches limitations of claim 80 as set forth above. Lentz does not teach that the second layer having a second thickness of about 30 microns to 200 microns.
Kinsley teaches a biocompatible composite membrane having multiple layers of ePTFE, wherein the layers having thickness of 0.029 mm (29 microns) and 0.069 mm (69 micron) (refer fig. 12).
Selecting membrane layers thickness in the composite of modified Lentz would have been an obvious matter of design choice to one of ordinary skill in the art because Kinsley discloses that it is known in the art.
Response to Arguments
Applicant’s arguments, see remarks, filed 05/20/2026, with respect to the rejection(s) of claim(s) 1 and 16 under 35 USC 103 as being unpatentable over Lentz et al. (US 2004/0193242), in view of Bowmann et al. (US 4482516), and rejection of claim 80 over Lentz et al. (US 2004/0193242), in view of Tu et al. (US 4816339) have been fully considered and are persuasive, in particular that the cited prior arts fail to teach reinforcing component having a stiffness greater than a combined stiffness of the first layer and the second layer. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lentz et al. (US 2004/0193242), in view of Bowmann et al. (US 4482516) and Cully et al. (US 2018/0125632) for claims 1 and 69; and Lentz et al. (US 2004/0193242), in view of Tu et al. (US 4816339) and Cully et al. (US 2018/0125632) for claim 80. Refer claim rejections above.
Conclusion
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/PRANAV N PATEL/ Primary Examiner, Art Unit 1777
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