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 .
Status of Claims
This office action is responsive to the amendment filed on 12/05/2025. As directed by the amendment: claims 3, 11-13, 16-18 and 21 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-21 are presently pending in this application, and currently examined in the Office Action.
Terminal Disclaimer
The terminal disclaimer filed on 12/05/2025 is NOT accepted because the person who signed the terminal disclaimer is not the applicant, patentee or an attorney or agent of record; see response dated 12/16/2025 for details.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-3, 5, 6, 9-11, 14-16, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US PG Pub. 2010/0233115), as previously disclosed, hereinafter Patel, in view of Sanders (US PG Pub. 2003/0171053), as previously disclosed.
Regarding claim 1, Patel discloses a vascular repair patch/membrane for repairing damage in a blood vessel wall, comprising a polymeric substrate having an abluminal surface and a luminal surface, wherein the vascular repair patch/membrane is substantially planar in form and conformable so as to conform to an inner vascular wall, and wherein length and width of the abluminal surface and luminal surface are substantially larger than thickness of the vascular repair patch/membrane, and wherein the length is defined as the direction of abluminal and luminal surfaces parallel to the flow axis when the abluminal surface is secured to the inner vascular wall, and the width is perpendicular to the length ([0006]; [0027], Line 1; [0035], Lines 9-12; [0083]; [0086], Lines 1-4; [0174]; [0175] & [0177]); wherein the polymeric substrate comprises a first polymer filament layer interfaced with a second polymer filament layer, illustrated in Figures 5 and 6, the first polymer filament layer comprises a plurality of polymer filaments wherein the polymer filaments are oriented in parallel with the length, and the first polymer filament layer is adjacent the luminal surface, and the second polymer filament layer comprises a plurality of polymer filaments which are oriented randomly, and the second polymer filament layer is adjacent the abluminal surface and the abluminal surface is configured for securement to the inner vascular wall ([0062]; [0077]; [0086], Lines 1-4; [0091], Lines 8-10; [0196] & [0208], Lines 5-7); but does not specifically disclose the polymeric substrate having a Young's modulus in a range of from 0.5 to 3.0 MPa, however it is stated that the vascular repair patch/membrane “can be configured to resemble the physical tissue structure at the area of treatment” ([0103], Lines 1-3) and that having the patch/membrane resemble physical properties of the target tissue enhances growth of that tissue ([0103], Lines 5-6), and further discloses throughout the specification that target tissue/tissue to be treated/repaired can be blood vessels ([0035], Lines 9-12; [0187], Lines 1-6; [0198], 2nd to Last Line & [0213]).
Sanders teaches that the Young's modulus of a blood vessel is 0.001 GPa, which converts to 1 MPa (Table 1 of Sanders). Thus, in view of the teachings of Sanders, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the Young's modulus, of the vascular repair patch of Patel, to be in the range of from 0.5 to 3.0 MPa, specifically around 1 MPa, since this is a known physical property/Young's modulus of a blood vessel, as taught by Sanders; and having the vascular repair patch resemble the physical property/Young's modulus of a target tissue, i.e. a blood vessel, enhances growth of the tissue and aids in repair/healing, as taught by Patel.
Regarding claims 2 and 3, Patel in view of Sanders disclose the vascular repair patch according to claim 1, wherein Patel further teaches the abluminal surface comprises a securement adapted to secure the abluminal surface to the inner vascular wall, the securement being a physical securement (Patel: [0205], 3rd to Last Line; [0208], Line 6 & [0247]).
Regarding claim 5, Patel in view of Sanders disclose the vascular repair patch according to claim 1, wherein Patel further teaches the polymer filaments of the first polymer filament layer are oriented with a standard deviation of no more than 18º, and the polymer filaments of the second polymer filament layer are oriented with a standard deviation of at least 63º (Patel: [0077], Lines 10-13 & [0111], Lines 14-23).
Regarding claim 6, Patel in view of Sanders disclose the vascular repair patch according to claim 5, wherein Patel further teaches the polymer filaments of the first and second polymer filament layers have an average filament diameter in a range of from 1 to 20mm, and the diameters of the filament diameters of at least one of the first and second polymer filament layers form a bimodal distribution with one peak in a range of from 0.2 to 2 mm and a second peak in a range of from 2.5 to 10mm (Patel: [0169]; [0171]; [0181] & [0182]).
Regarding claim 9, Patel in view of Sanders disclose the vascular repair patch according to claim 6, wherein Patel further teaches the first polymer filament layer and the second polymer filament layer form the bimodal distribution (Patel: [0171], Lines 1-2 – to clarify, it is stated that the filament/fiber diameters can vary between layers).
Regarding claim 10, Patel in view of Sanders disclose the vascular repair patch according to claim 9, wherein Patel further teaches the first polymer filament layer has polymer filaments with an average diameter of the one peak in the range of from 0.2 to 2mm and the second polymer filament layers has polymer filaments of the second peak in the range of from 2.5 to 10mm (Patel: [0181] & [0182]).
Regarding claim 11, Patel in view of Sanders disclose the vascular repair patch according to claim 10, wherein Patel further teaches the polymer filaments of at least one of the first and second polymer filament layers comprise polycaprolactone (PCL) and a second bioabsorbable polymer selected from the group consisting of polylactic acid (PLA), poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), poly- DL-lactic acid (PDLLA), polyglycolic acid (PGA), polyglycolide (PG), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-caprolactone) (PGCL), poly(L-lactide-co-caprolactone) (PLLA- co-CL), poly(D-lactide-co-caprolactone) (PDLA-co-CL), and poly(DL-lactide-co-caprolactone) (PDLLA-co-CL) - (Patel: [0030] – [0032]).
Regarding claim 14, Patel in view of Sanders disclose the vascular repair patch according to claim 13, wherein Patel further teaches the first polymer filament layer of the vascular repair patch comprises one or more extracellular matrix compounds selected from collagen, elastin, fibronectin, laminins, vitronectin, and/or hyaluronic acid (Patel: [0212]); and though it is not specifically disclosed that the extracellular matrix compounds are in an areal amount of from 1mg/cm2 to 50mg/cm2, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate concentration for the extracellular matrix compounds, including from 1mg/cm2 to 50mg/cm2, based on intended use and/or patient need; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 15, Patel in view of Sanders disclose the vascular repair patch according to claim 14, wherein Patel further teaches the second polymer filament layer comprises a thrombogenic agent, i.e. fibrin (Patel: [0030], Line 9; [0122], Line 8 & [0149], Line 7); and though it is not specifically disclosed that the thrombogenic agent is in an areal amount of from 0.5mg/cm2 to 100mg/cm2, this parameter is deemed to be a mere matter of normal design choice, not involving a novel inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate concentration for the thrombogenic agent, including from 0.5mg/cm2 to 100mg/cm2, based on intended use and/or patient need; and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05).
Regarding claim 16, Patel in view of Sanders disclose the vascular repair patch according to claim 1, wherein Patel further teaches the polymer filaments of at least one of the first and second polymer filament layers comprise polycaprolactone (PCL) and a second bioabsorbable polymer selected from the group consisting of polylactic acid (PLA), poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), poly- DL-lactic acid (PDLLA), polyglycolic acid (PGA), polyglycolide (PG), poly(lactic-co-glycolic acid) (PLGA), poly(glycolide-co-caprolactone) (PGCL), poly(L-lactide-co-caprolactone) (PLLA- co-CL), poly(D-lactide-co-caprolactone) (PDLA-co-CL), and poly(DL-lactide-co-caprolactone) (PDLLA-co-CL) - (Patel: [0030] – [0032]).
Regarding claim 19, Patel discloses a vascular repair patch/membrane for repairing damage in a blood vessel wall, comprising a polymeric substrate having an abluminal surface and a luminal surface, wherein the vascular repair patch/membrane is substantially planar in form and conformable so as to conform to an inner vascular wall, and wherein length and width of the abluminal surface and luminal surface are substantially larger than thickness of the vascular repair patch/membrane, and wherein the length is defined as the direction of abluminal and luminal surfaces parallel to the flow axis when the abluminal surface is secured to the inner vascular wall, and the width is perpendicular to the length ([0006]; [0027], Line 1; [0035], Lines 9-12; [0083]; [0086], Lines 1-4; [0174]; [0175] & [0177]); wherein the polymeric substrate comprises a first polymer filament layer interfaced with a second polymer filament layer, illustrated in Figures 5 and 6, the first polymer filament layer comprises a plurality of polymer filaments wherein the polymer filaments are oriented in parallel with the length, and the first polymer filament layer is adjacent the luminal surface, and the second polymer filament layer comprises a plurality of polymer filaments which are oriented randomly, and the second polymer filament layer is adjacent the abluminal surface and configured so as that the abluminal surface comprises a securement adapted to secure the abluminal surface to the inner vascular wall ([0062]; [0077]; [0086], Lines 1-4; [0091], Lines 8-10; [0196]; [0205], 3rd to Last Line; [0208], Lines 5-7 & [0247]); and wherein the polymer filaments of the first and second polymer filament layers have an average filament diameter in a range of from 1 to 20mm, and the filament diameters of at least one of the first polymer filament layer and the second polymer filament layers form a bimodal distribution with one peak in a range of from 0.2 to 2mm and a second peak in a range of from 2.5 to 10mm (Patel: [0169]; [0171]; [0181] & [0182]); but does not specifically disclose the polymeric substrate having a Young's modulus in a range of from 0.5 to 3.0 MPa, however it is stated that the vascular repair patch/membrane “can be configured to resemble the physical tissue structure at the area of treatment” ([0103], Lines 1-3) and that having the patch/membrane resemble physical properties of the target tissue enhances growth of that tissue ([0103], Lines 5-6), and further discloses throughout the specification that target tissue/tissue to be treated/repaired can be blood vessels ([0035], Lines 9-12; [0187], Lines 1-6; [0198], 2nd to Last Line & [0213]).
Sanders teaches that the Young's modulus of a blood vessel is 0.001 GPa, which converts to 1 MPa (Table 1 of Sanders). Thus, in view of the teachings of Sanders, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the Young's modulus, of the vascular repair patch of Patel, to be in the range of from 0.5 to 3.0 MPa, specifically around 1 MPa, since this is a known physical propriety of a blood vessel, as taught by Sanders; and having the vascular repair patch resemble physical properties of a target tissue, i.e. a blood vessel, enhances growth of the tissue and aid in repair/healing, as taught by Patel.
Regarding claim 20, Patel in view of Sanders disclose the vascular repair patch according to claim 19, wherein Patel further teaches the first polymer filament layer has polymer filaments with an average diameter of the one peak in the range of from 0.2 to 2mm and the second polymer filament layers has polymer filaments of the second peak in the range of from 2.5 to 10mm (Patel: [0181] & [0182]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Sanders as applied to claim 3 above, and further in view of Priewe et al. (US PG Pub. 2014/0257348), as previously disclosed, hereinafter Priewe.
Regarding claim 4, Patel in view of Sanders disclose the vascular repair patch according to claim 3, but do not specifically teach the physical securement is a plurality of microneedles.
However, Priewe teaches a repair patch (20) comprising a plurality of microneedles (28/40), illustrated in Figures 3, 4c, 4e and 4f, the microneedles aid in securing the patch to tissue with enhanced resistance to shear and peel forces ([0015], Lines 1-4 & [0018]).
In view of the of the teachings of Priewe, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the physical securement means, on the abluminal surface of the polymeric substrate of the vascular repair patch of Patel in view of Sanders, to comprise a plurality of microneedles, in order to aid in securing the vascular repair patch to tissue with enhanced resistance to shear and peel forces, as taught by Priewe.
Claims 7, 8, 12, 13, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Sanders as applied to claims 6, 11 and 16 above, and further in view of Franco et al. (Preparation and characterization of electrospun PCL/PLGA membranes and chitosan/gelatin hydrogels for skin bioengineering applications; J Mater Sci: Mater Med: 22:2207-2217; 2011), hereinafter Franco.
Regarding claims 7 and 8, Patel in view of Sanders disclose the vascular repair patch according to claim 6, wherein Patel teaches the filament diameters of the layers can vary within the layers (Patel: [0171], Lines 1-2), but does not specifically disclose the first and second polymer filament layers each form a bimodal distribution such that first polymer filaments have an average diameter of the one peak in the range of from 0.2 to 2mm and second polymer filaments with an average diameter of the second peak in the range of from 2.5 to 10mm for each of the first and second polymer filament layers.
However, Franco teaches a polymeric filament substrate, wherein the diameters of the polymer filaments form a bimodal distribution with one peak in the range of from 0.2 to 2 m and a second peak in the range of from 2.5 to 10 m, illustrated in Figures 1c2 and 1b2, such a distribution optimizes the substrate for tissue engineering applications (pg. 2211, Section 3.1.1 & pg. 2215, 1st Column, Lines 1-4).
In view of the teachings of Franco, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the filament diameters, of each of the first and second polymer filament layers of the vascular repair patch of Patel in view of Sanders, to form a bimodal distribution with one peak in the range of from 0.2 to 2m and a second peak in the range of from 2.5 to 10m, in order to optimize the filament layers for tissue engineering applications, as taught by Franco.
Regarding claims 12 and 13, Patel in view of Sanders disclose the vascular repair patch according to claim 11, wherein Patel teaches PCL is present in the polymer filaments and the second bioabsorbable polymer is PLGA (Patel: [0030]); but does not specifically disclose the PCL is in amount of at least 50wt% PCL and the second bioabsorbable polymer/PLGA is present in an amount up to 50wt%.
However, Franco teaches a polymeric filament substrate comprising 80wt% PCL and 20wt% PLGA; such a composition results in strong mechanical properties and good biocompatibility (Abstract, Lines 1-11 & pg. 2208, Section 2.2.1, Line 9).
In view of the teachings of Franco, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the polymer filaments, of the first and second polymer filament layers of the vascular repair patch of Patel in view of Sanders, to comprise at least 50wt%, specifically 80wt%, PCL and up to 50wt%, specifically 20wt%, PLGA, since this composition results in strong mechanical properties and good biocompatibility; and 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 (see MPEP 2144.07).
Regarding claims 17 and 18, Patel in view of Sanders disclose the vascular repair patch according to claim 16, wherein Patel teaches PCL is present in the polymer filaments and the second bioabsorbable polymer is PLGA (Patel: [0030]); but does not specifically disclose the PCL is in amount of at least 50wt% PCL and the second bioabsorbable polymer/PLGA is present in an amount up to 50wt%.
However, Franco teaches a polymeric filament substrate comprising 80wt% PCL and 20wt% PLGA; such a composition results in strong mechanical properties and good biocompatibility (Abstract, Lines 1-11 & pg. 2208, Section 2.2.1, Line 9).
In view of the teachings of Franco, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the polymer filaments, of the first and second polymer filament layers of the vascular repair patch of Patel in view of Sanders, to comprise at least 50wt%, specifically 80wt%, PCL and up to 50wt%, specifically 20wt%, PLGA, since this composition results in strong mechanical properties and good biocompatibility; and 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 (see MPEP 2144.07).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5, 6, 14-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,944,723. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a vascular repair patch comprising a polymeric substrate which comprises a first polymer filament layer comprising a plurality of polymer filaments, wherein the polymer filaments are oriented in parallel; and a second polymer filament layer comprising a plurality of polymer filaments wherein the polymer filaments are oriented randomly; wherein the polymer filaments of the first and second polymer filament layers comprise at least 50wt % polycaprolactone (PCL) and up to 50wt % poly(lactic-co-glycolic acid) (PLGA), wherein the PLGA has a lactide:glycolide ratio of 80:20 to 20:80; the polymer filaments of the first and second polymer filament layers have an average filament diameter in a range of from 1 to 20 µm, and diameters of the polymer filaments of at least one of the first and second polymer filament layers form a bimodal distribution with one peak in a range of from 0.2 to 2 µm and a second peak in a range of from 2.5 to 10 µm; the polymeric substrate has a Young's modulus in a range of from 0.5 to 3.0 MPa; the polymer filaments of the first polymer filament layer are oriented with a standard deviation of no more than 18°, and the polymer filaments of the second polymer filament layer are oriented with a standard deviation of at least 63°; the second polymer filament layer has an average porosity of from 40 to 60%; the vascular repair patch has a total thickness in a range of from 50 µm to 500 µm, and the second polymer filament layers independently has a thickness in a range of from 20 µm to 200 µm; the first polymer filament layer of the vascular repair patch comprises one or more extracellular matrix compounds in an areal amount of from 1µg/cm² to 50µg/cm², based on a surface area of the first major surface of the vascular repair patch, and wherein the one or more extracellular matrix compounds are selected from collagen (particularly collagen types I and II), elastin, fibronectin, laminins, VE-cadherin, vitronectin, integrins, heparan sulfate, chondroitin sulfate, ketaran sulfate, hyaluronic acid, and peptide sequences selected from example Arg-Gly-Asp (RGD), Arg-Glu-Asp-Val (REDV), Tyr-Ile-Gly- Ser-Arg (YIGSR); the second polymer filament layer comprises one or more thrombogenic agents selected from tissue factor (TF, or Factor III), Factor VII, Factor X and Fibrin; and the second polymer filament layer comprises the one or more thrombogenic agents in an areal amount of from 0.5µg/cm² to 100ug/cm², based on a surface area of the second major surface of the vascular repair patch.
Allowable Subject Matter
Claim 21 would be allowable if the Double Patenting rejection, set forth above, was overcome by filing a proper e-Terminal Disclaimer.
The following is a statement of reasons for the indication of allowable subject matter: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches a vascular repair patch comparing a polymeric substrate having a first polymer filament layer, comprise of a plurality of parallel oriented polymer filaments, and a second polymer filament layer, comprised of a plurality of randomly oriented polymer filaments; wherein the second polymeric filament layer has an average porosity of 40% to 60%, in addition to all the other structural limitations set forth in independent claim 21.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claims 1 and 19, as being unpatentable over the prior art of Patel and Sanders, stating “Patel in view of Sanders also does not disclose that the surface adjacent the layer comprising the randomly orientated filaments is configured for securement to the inner vascular wall”, and further states that Patel teaches away from the layer comprising the randomly orientated filaments being configured for securement to the inner vascular wall. Examiner respectfully disagrees with Applicant’s assertions. The parameter of the surface adjacent the layer comprising the randomly orientated filaments is configured for securement to the inner vascular wall is a functional/intended use parameter, which in device/apparatus claims such as claims 1 and 19, is considered to the extent that it further defines the claimed structure of the final device; the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art, and if the prior art structure is capable of performing the intended use, i.e. the surface adjacent the randomly orientated filaments layer being able to be secured to the inner vascular wall, then it meets the claim (see MPEP 2114). Furthermore, though Patel may teach placing the surface adjacent the parallel orientated/aligned filaments layer in contact with tissue, this does not teach away from the device/repair patch being able to, i.e. having the structural ability to, be implanted such that the surface adjacent the randomly orientated filaments layer can be secured to the inner vascular wall. Nowhere in the entire disclosure of Patel is there any mention, or detailing, of the device/repair patch having any kind of physical/structural limitation(s) which would prevent it from being implanted such that the surface adjacent the randomly orientated filaments layer could be secured to the inner vascular wall. The fact that Patel discloses another functional/intended use of the device/repair patch does not, in anyway, actually teach away from the structure of the device/repair patch, of Patel, being able to meet the claimed functional/intended use parameter of the surface adjacent the randomly orientated filaments layer being able to be secured to the inner vascular wall.
Applicant further goes on to argue that “Patel does not teach the use of a subrationally planar patch for treating defects in blood vessels”. Again, Examiner respectfully disagrees with Applicant’s assertions. Patel clearly discloses the device can be a “membrane”, which “refers to an object that is essentially flat, or planer in shape” (Patel: [0083]). Patel further clearly states the device can be used “as tissue substitutes and/or tissue regeneration matrices for wounds and/or defects in biological tissues including…blood vessels” (Patel: [0187], Lines 1-6). Applicant also argues that “Patel provides no guidance as to how to achieve the Young's modulus required by claims 1 and 19”. Applicant is reminded that independent claims 1 and 19 are rejected by the prior art of Patel in view of Sanders, and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references (See MPEP 2145). Furthermore, Patel discloses that the vascular repair patch/membrane “can be configured to resemble the physical tissue structure at the area of treatment” (Patel: [0103], Lines 1-3), that having the patch/membrane resemble physical properties of the target tissue enhances growth of that tissue (Patel: [0103], Lines 5-6), and discloses throughout the specification that target tissue/tissue to be treated/repaired can be a blood vessel (Patel: [0035], Lines 9-12; [0187], Lines 1-6; [0198], 2nd to Last Line & [0213]). Additionally, the secondary reference of Sanders is used to teach that the Young's modulus of a blood vessel is 0.001 GPa, which converts to 1 MPa (Table 1 of Sanders). Thus, in view of the teachings of Sanders, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the Young's modulus, of the vascular repair patch of Patel, to be in the range of from 0.5 to 3.0 MPa, specifically around 1 MPa, since this is a known physical property/Young's modulus of a blood vessel, as taught by Sanders. Therefore, the rejections of independent claims 1 and 19, as being unpatentable over the prior art of Patel and Sanders, are deemed to be proper since all the structural limitations set forth in the claims are taught; hence, the rejections stand.
Conclusion
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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/DINAH BARIA/Primary Examiner, Art Unit 3774