DETAILED ACTION
Claims 1-17, 26-35 are currently pending. Claims 1-11, 13-17, 26-29, 32-35 are currently under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/2026 has been entered.
Withdrawn Rejections
The prior rejection of Claims 28 and 32 under 112(b) is withdrawn in light of Applicant’s arguments to clearly define thickness of the reinforcement layer is greater than the sum of the thickness of the first protection membrane and thickness of the second protection membrane, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 02/25/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 02/25/2026, it is noted that claims 1, 28 and 32 have been amended and claims 33-35 are newly added. No new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 1-11, 13-17, 26-29, 32 and 35 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.
Claim 1 and 28: The term “substantially an entire extent of” in claims 1 and 28 is a relative term which renders the claim indefinite. The term “substantially an entire extent of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “substantially an entire extent of” does not have clear metes and bounds as to what substantially requires, what percentage of surface is required to be coated to meet the instant limitation. Claims 2-11, 13-17, 26-27, 29, 32 and 35 are further rejected as not curing the ambiguity of the amount of surface required to be coated. Claims 33-34 are not rejected as they specifically define the % of the coating and thus cure the ambiguity of “substantially”.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 embraces the alternative of the reinforcement layer has i) a thickness of from 25 um to 500 um, wherein instant claim 1 contains limitation (ii) the reinforcement layer has an average thickness ranging from 25 um to 500 um, thus claim 8 does not further limit the thickness of the reinforcement layer as limitation 8(i) is the same thickness limitation as 1(ii).
Claim 10 contains the limitation of “wherein the intermediate layer has: (i) an average thickness of from 0.1 um to 100 um; or…”. Instant claim contains limitation of wherein the first protection membrane has a thickness ranging from 10um to 250um, wherein the intermediate membrane comprises the first protection membrane. Thus claim 10 contains a lower limit for the thickness of the intermediate layer, which is not possible due to the thickness of the first protection layer required by instant claim 1 and thus is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-4, 7-8, 11, 13-17, 26-29 and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296322 (previously applied) and US 2018/0206982 (previously applied) US 2009/0112309 and US 2005/0261543.
Regarding claims 1, 28 and 33-35, the limitation of an anti-fouling implantable material comprising a reinforcement layer comprising plurality of polymeric filaments comprising a filament polymer, the reinforcement layer having a first surface and an opposing surface; an intermediate layer comprising a first protection membrane having a first surface facing and disposed over the first surface of the reinforcement layer, the first protection membrane comprising a protective polymer and an outer layer comprising anionic polymer grafted onto an exposed surface of the intermediate layer is met by the ‘322 publication teaching a prosthetic heart valve including a plurality of synthetic polymeric leaflets comprising a base polymer and a polymeric coating at least partially disposed over the base polymer, wherein the polymeric coating include polymerized units of a monomer comprising a zwitterionic group (abstract). Figure 1 demonstrates polymeric filaments comprising a first and opposing second surface (Figure 1) wherein the leaflet includes a plurality of fibers [0021]. A polymeric coating of zwitterionic pendant groups is disposed over a base polymer ([0047], [0082]) wherein zwitterionic pendant groups are grafted on the surface of a base polymer [0092].
Regarding the limitation of wherein the first surface of the reinforcement layer is attached to the first surface of the first protection membrane over substantially an entire extent of the first surface of the first protection membrane is met by the ‘322 publication teaching fibers form the leaflet wherein the fibers are formed into a woven or a non-woven fibrous matrix. Multiple fiber material can be formed simultaneously by one or more apparatuses [0101] wherein the leaflet can be made of material that includes a plurality of fibers embedded in a base polymer that is composed of at least one zwitterionic polymer. The fiber extends the direction and a plurality of undulations and the circumferential direction, radial direction and direction along at least a portion of an edge profile of the leaflet [0087]. Thus the fibers are taught as extending in all directions of the leaflet wherein the fibers may be formed into a woven matrix, thus meeting the limitation of “substantially an entire extent” or greater than 50% of the first surface.
Regarding claims 1, 27 and 32, the limitation of wherein the reinforcement layer has an average thickness ranging from 25 um to 500 um and wherein the reinforcement layer has a thickness that is more than twice than a thickness of the first protection membrane and second is met by the ‘322 publication teaching the fibers have a diameter of at least 1 micron and diameter ranges could be 1 to 5 microns [0088]. The base polymer is taught to have a thickness of 50 to about 1000 nanometers [0092]. As MPEP 2144.05 recites “where 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 optimization”.
Regarding claims 3-4, the limitation of wherein the filament polymer comprises a poly(ethylene terephthalate) is met by the ‘322 publication teaches the fibers include but are not limited to polymer such as polyethylene terephthalate (PET) [0089].
Regarding claims 7-8, the limitation of wherein the polymeric filaments have an average diameter of from 0.001 um to 2000 um is met by the ‘322 publication teaching fibers have a diameter of at least one micron, specifically 1-50 microns [0088].
Regarding claim 11 and 13-14, the limitation of wherein the ionic polymer is anionic, cationic or zwitterionic, specifically MPC and thickness of from 0.001 um to 25um is met by the ‘322 publication teaching zwitterionic modified to include a zwitterionic pendant group by grafting having a surface thickness of 50 to 1000 nanometers [0092] wherein the zwitterionic monomer is 2-methacryloyloxyethyl phosphorylcholine ([0080], Formula 7).
Regarding claim 15-17, the limitation of wherein the implantable medical device comprises a prosthetic heart valve is met by the ‘322 publication teaching a heart valve [0093] comprising a plurality of leaflets.
Regarding claims 26 and 28, the limitation of further comprises a second protection membrane attached to at least a portion of the opposing surface of the reinforcement layer, the second protection membrane comprising a second protection polymer, wherein the second protective polymer of the second protection membrane has the same or different chemical composition than the first protective polymer is met by the ‘322 publication teaching each leaflet has a base polymer and a polymer coating at least partially disposed over the base polymer (abstract) wherein the plurality of fibers are embedded in the base polymer ([0021]-[0022], [0044]). The polymer is taught as applied by e.g. dip coating [0050]. It would have been obvious to one of ordinary skill in the art that the fibers would be fully coated on both sides, with the coating fully covering the fibers as the coating is taught to be applied at least partially disposed as a coating by the method such as dip coating and the fibers are taught as being embedded in the base polymer.
The ‘322 publication does not specifically teach the elected species wherein the polymeric filaments are twisted into yarn fibers comprising a plurality of polymeric filaments wherein the yarn fibers are subsequently knitted to form a knitted material (claims 1-2, 29).
The ‘322 publication does not specifically teach first protection membrane and each of the first and second protection membrane has an average thickness ranging from 10 um to 250 um (claim 1).
The ‘982 publication teaches prosthetic heart valves include a frame having a plurality of strut members (abstract). The fabric having a woven layer and plush pile layer including a plurality of pile yarns [0010]. Woven or knitted fabrics are taught wherein yarns are formed of polymers such as PET which may be woven ([0098], [0102]). The prosthetic valve can include an outer covering made of woven fabric (e.g. PET fabric). The yarns are taught to be twisted ([0126], [0146]).
The ’543 publication teaches implantable, artificial ventricular assist device. The device includes a circumferential, flexible inner wall membrane covering the inner circumferential opening (abstract). The anti-thrombogenic coating can include segmented polyurethane or 2-methacryloyloxyethyl phosphorylcholine polymer [0012]. The entire interior blood containing surface of pump including the thermoplastic elastomer forming a coating on the disk and further forming the membrane are coated with an anti-thrombogenic material. The anti-thrombogenic coating is approximately 20 micron thick layer of an anti-thrombogenic material, such as segmented polyurethane or 2-methacryloxyloxyethyl phosphorylcholine (MPC) polymer.
The ‘309 publication teaches polymer leaflets which are coated with biocompatible material to reduce the thrombogenic effects and to increase durability of CBHV wherein the leaflets are polyester weave as a core material and are coated with SIBS (abstract, claim 29-38).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (polymeric filaments formed of PET, protection layer and outer ionic polymer comprising MPC) from within the prior art disclosure of the ‘322 publication, to arrive at the instantly claimed antifouling implantable material “yielding no more than one would have expected from such an arrangement”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form twisted fibers and knit to form the heart valve material as taught by the ‘322 publication because the ‘982 publication teaches that it was known to use twisted PET filaments to form a knitted fabric for a prosthetic valve and the ‘322 publication is directed to PET filaments. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘322 publication teaches woven fiber matrix formed of PET filaments and the ‘982 publication specifically teaches twisted PET filaments and knitting or weaving to form a heart valve material, thus the ‘322 publication and the ‘982 publication are both directed to PET filaments which are used to form heart valve materials. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success to form the leaflet taught by the ’322 publication as a woven polymeric fabric which is fully coated as the ‘322 publication teaches the PET filaments may form a woven fibrous matrix and the ‘309 publication teaches a woven fabric heart valve which is coated, thus making it obvious to form a coated PET woven matrix.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the coating thickness for anti-thrombotic coatings taught by the ‘543 publication and the coating thickness taught by the ‘322 publication and optimize to obtain the desired results as the ‘543 publication teaches about 20 micron thick MPC polymer coating on a blood containing device and the ‘322 publication teaches 50-1000 nm anti-thrombotic coating including MPC on a blood contacting medical device wherein the coating thickness is taught to be optimized to obtain the desired bulk properties and benefits such as reduced thrombotic response. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the thickness of the MPC containing coating as the ’322 publication and the ‘543 publication teach two known coating thickness of MPC on blood containing device wherein the amount is taught as optimizable by the use of “about” language and the desires to obtain the desired bulk properties. As MPEP 2144.05 recites “where 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 optimization”.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296322, US 2018/0206982, US 2009/0112309 and US 2005/0261543 as applied to claims 1-4, 7-8, 11, 13-17, 26-29 and 32-35 above, and further in view of US 2016/0296323 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-4, 7-8, 11, 13-17, 26-29 and 32-35 are taught by the ‘322 publication, the ‘982 publication, the ‘309 publication and the ‘543 publication.
The ‘322 publication does not specifically teach wherein the protective polymer comprises the elected polycarbonate polyurethane (claim 9) wherein the intermediate layer has a durometer Shore hardness of from 10A to 80A (claim 10).
The ‘323 publication teaches a prosthetic heart valve leaflet including a plurality of electrospun fibers at least partially embedded in a polymer matrix. The plurality of fibers includes polyisobutylene urethane copolymer (abstract). The polymer matrix includes polyisobutylene urethane copolymer having a durometer from about 60A toa bout 55D shore hardness [0009]. The electrospun fibers include polyethylene terephthalate (PET) [0007]. The polymeric matrix can be made of various biostable and/or biocompatible polymeric material. The polymer matrix can be made of an elastomer polymer. Suitable polymer matrix material can include copolymers. Various polyurethanes can be used to construct the polymeric matrix such as polyurethanes with soft segments such as polycarbonate and polyisobutylene [0055]. In some cases, a polymer matrix of an exemplary composite material provided herein can be made of polyisobutylene urethane copolymer having a durometer of about 55D or from about 60A to about 55D shore hardness [0059]. In some cases, a zwitterionic polymer includes a backbone with a zwitterionic group [0070].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a polycarbonate polyurethane for the base polymer taught by the ‘322 publication because the ‘322 publication teaches base polymers include polyisobutylene polyurethane and the ‘323 publication teaches the interchangeability of soft segments of polyisobutylene and polycarbonate for a polyurethane copolymer. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘322 publication and the ‘323 publication are both directed to hear valve materials including filaments and a matrix/base polymer that is formed of polyurethane copolymers. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a known hardness of the matrix polymer as taught by the ‘323 publication and optimize for the base polymer of the ‘323 publication because the ‘323 publication teaches known shore hardness of materials used in combination with PET filaments to form heart valves.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296322, US 2018/0206982, US 2009/0112309 and US 2005/0261543 as applied to claims 1-4, 7-8, 11, 13-17, 26-29 and 32-35 above, and further in view of US 2,998,296 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-4, 7-8, 11, 13-17, 26-29 and 32-35 are taught by the ‘322 publication, the ‘982 publication, the ‘309 publication or the ‘543 publication.
The combination of references does not specifically teach a core and shell surrounding the core of the filament wherein the shell polymer is hydroxylated poly(ethylene terephthalate) (claims 5-6).
The ‘296 patent teaches alkaline treatment of polyethylene terephthalate filaments to improve processing in textile machines (column 1, lines 1-10). The fibers with which the present invention concerned are fiber forming polyesters that are chemically reactive with alkaline solutions including PET. The filaments are subjected to drawing operation to give it high strength and reduce shrinkage (column 1, lines 25-35). The PET spun into yarn. The fibers are subjected to alkali treatment to improve the hydrolyze the polymeric polyethylene terephthalate. The nature of such treatment provides certain physical properties such as tenacity (column 1, lines 35-50). Threads treated in the present manner have reduced intrafilamentary figuration and glide easily long each other (column 1, lines 65-70) and have improved processability in the combing machine (column 2, lines 1-10). The treatment is taught to modify the surface (column 2, lines 10-20). Thus the treated surface is considered the “shell” and the untreated inner fiber the “core”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to treat the PET filaments taught by the ‘322 publication with an alkaline solution to obtain partially hydrolyzed PET filaments because the ‘296 patent teaches treatment of PET filaments was well known at the time of the invention. One of ordinary skill in the art before the filing date of the claimed invention would have been motivated to treat the PET filaments with the alkaline solution as the ‘296 patent teaches obtaining a hydrolyzed surface resulting in easer glide during processing and improved processing and tenacity. One of ordinary skill in the art before the filing date of the claimed invention would have been motivated to do so as the ‘982 publication teaches processing filaments into a woven or knitted fabric, wherein the ‘296 patent teaches improved processibility of the treatment filaments.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘322 publication (Edelman) in view of the ‘982 publication (Haivatov)
Applicant points to Figure 1 of the instant specification. Applicant argues the ‘322 publication Fig 4 depicts a material that includes a four fiber embedded in a base polymer. They do not disclose the attachment relationship now recited in claim 1, namely a protection membrane having its own first surface facing and disposed over a reinforcement layer first surface, with attachment over substantially an entire extent of the protection membrane as shown in figure 1. Applicant argues ‘322 publication illustrates a leaflet body in which four fibers are embedded within the base polymer. The fibers 405 are clearly not attached to a surface of the polymer over substantially an entire extend of the surface of the polymer. The base polymer 402 is the primary structurant component of the leaflet and dedicates the overall strength, durability and compressibility. The fibers are intended to provide a desired amount of elasticity.
In response, the ‘322 publication teaching fibers form the leaflet wherein the fibers are formed into a woven or a non-woven fibrous matrix. Multiple fiber material can be formed simultaneously by one or more apparatuses [0101] wherein the leaflet can be made of material that includes a plurality of fibers embedded in a base polymer that is composed of at least one zwitterionic polymer. The fiber extends the direction and a plurality of undulations and the circumferential direction, radial direction and direction along at least a portion of an edge profile of the leaflet [0087]. Thus the fibers are taught as extending in all directions of the leaflet wherein the fibers may be formed into a woven matrix, thus meeting the limitation of “substantially an entire extent” or greater than 50% of the first surface. Applicant is additionally referred to the 112(b) rejection above newly applied.
Applicant argues the limitation of the first protection membrane has an average thickness ranging from 10um to 250 um wherein the ‘322 publication teaches 50 to 1000 nm [0092].
In response, the ’543 publication teaches implantable, artificial ventricular assist device (abstract). The anti-thrombogenic coating can include segmented polyurethane or 2-methacryloyloxyethyl phosphorylcholine polymer [0012]. The anti-thrombogenic coating is approximately 20 micron thick layer of an anti-thrombogenic material, such as segmented polyurethane or 2-methacryloxyloxyethyl phosphorylcholine (MPC) polymer. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the coating thickness for anti-thrombotic coatings taught by the ‘543 publication and the coating thickness taught by the ‘322 publication and optimize to obtain the desired results as the ‘543 publication teaches about 20 micron thick MPC polymer coating on a blood containing device and the ‘322 publication teaches 50-1000 nm anti-thrombotic coating including MPC on a blood contacting medical device wherein the coating thickness is taught to be optimized to obtain the desired bulk properties and benefits such as reduced thrombotic response. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the thickness of the MPC containing coating as the ’322 publication and the ‘543 publication teach two known coating thickness of MPC on blood containing device wherein the amount is taught as optimizable by the use of “about” language and the desires to obtain the desired bulk properties. As MPEP 2144.05 recites “where 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 optimization”.
Applicant argues the reliance on the ‘982 publication does not cure the deficiencies of the ‘322 publication wherein the textile is a covering disposed around a valve frame, not as an anti-fouling implantable material which a reinforcement layer is attached over substantially an entire extent. The ‘982 publication covering is described and shown as external textile component positioned about a valve frame. Applicant argues the ‘982 publication primary function is to help form a seal the prosthetic valve against the surrounding anatomy. In contrast to the fabric overing 112 in forming the prosthetic leaflet material are selected to inhibit or at least minimize tissue ingrowth. Sealing devices for prosthetic valves and leaflets for prosthetic valves have very different functional properties.
In response, the ‘322 publication teaches the use of PET filaments. The ‘982 publication teaches that it was known to use twisted PET filaments to form a knitted fabric for the prosthetic valve. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘322 publication teaches woven fiber matrix formed of PET filaments and the ‘982 publication specifically teaches twisted PET filaments and knitting or weaving to form a heart valve material, thus the ‘322 publication and the ‘982 publication are both directed to PET filaments which are knitted or woven and are used to form heart valve materials. Thus the ’322 publication teaches woven fabric from PET filaments and the ‘982 publication teaches specific PET knitted or woven fabrics known to be used in medical devices.
Applicant argues claims 2-17, 26-27 and 33 depend from 1 and thus should be allowable for the same reasons.
In response, Applicant’s arguments regarding claim 1 are addressed as first presented.
Applicant argues ‘322 publication does not teach or suggest the attachment extent feature. The ‘322 publication discloses structure almost entirely composed of a polymer base layer with a few fibers embedded. The ‘982 does not cure these deficiencies.
In response, the ‘322 publication teaching fibers form the leaflet wherein the fibers are formed into a woven or a non-woven fibrous matrix. Multiple fiber material can be formed simultaneously by one or more apparatuses [0101] wherein the leaflet can be made of material that includes a plurality of fibers embedded in a base polymer that is composed of at least one zwitterionic polymer. The fiber extends the direction and a plurality of undulations and the circumferential direction, radial direction and direction along at least a portion of an edge profile of the leaflet [0087]. Thus the fibers are taught as extending in all directions of the leaflet wherein the fibers may be formed into a woven matrix, thus meeting the limitation of “substantially an entire extent” or greater than 50% of the first surface. Applicant is additionally referred to the 112(b) rejection above newly applied.
Applicant argues the ‘323 publication does not cure the deficiencies of the ‘322 publication and the ‘982 publication.
In response, Applicant’s arguments regarding the ‘322 publication and the ‘982 publication are addressed as first presented.
Applicant argues the ‘296 patent does not cure the deficiencies of the ‘322 publication and the ‘982 publication.
In response, Applicant’s arguments regarding the ‘322 publication and the ‘982 publication are addressed as first presented.
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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