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 . Claims included in the prosecution are claims 1-6 and 10-16.
Applicants' arguments, filed 05/13/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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 2 fails to further limit claim 1 since claim 1 limits the solvent-sensitive substrate to certain polymers by specifying specific polymers for the warp yarn and the weft yarn and claim 2 broadens the scope by reciting additional polymers, for example rubbers.
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.
1. Claims 1-5, 10, 11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (US 2020/0188098, Jun. 18, 2020) (hereinafter Alkhatib) in view of Winner et al. (US 2019/0231511, Aug. 1, 2019) (hereinafter Winner) and De Bont et al. (US 2022/0023501, Jan. 27, 2022) (hereinafter De Bont).
Alkhatib discloses wherein polymer-containing fabric materials (i.e., claimed solvent-sensitive substrate) that may be used for construction of medical devices (¶ [0007]. The fabric may be used for the leaflets of prosthetic heart valves (abstract). The polymeric fabric materials include uncoated and coated fabrics. The fabric materials include polyurethanes, polypropylene, or combinations thereof (¶ [0008]). The term “fabric” refers to a polymer-fiber containing material having yarns (i.e., fibers) (¶ [0100]). The fabric may be formed from various weaving techniques. “Weft” refers to fibers that extend along the width of the fabric, while “warp” refers to fibers that extend along the length of the fabric (¶ [0112]). Figures 10 and 11 is a plan view of the warp and weft weave patterns (¶ [0036] and [0027]). The polymeric fabric may be coated with at least one polymer layer to form a coated fabric. “Coated” means that the fabric has a polymer applied to at least a portion of it after the fabric has been formed. In some embodiments, the polymer coating may provide improved or altered properties to the fabric relative to the uncoated fabric. These altered properties may include adjusting the porosity of the fabric (¶ [0010]). The polymers which may be used for the coating include all of those previously identified for use for the fabric. In addition, in some embodiments, the polymer coating can be bioabsorbable, biodegradable, and/or bioerodible (¶ [0011]). The fabric may be engineered to have certain mechanical properties. Other fabric properties that may be sought include a specific anisotropy (¶ [0106]). Different portions of the surface could be coated with different thicknesses and/or different number of layers of polymer. This can be done to provide a coated fabric with areas of greater or lesser porosity (¶ [0127]). The coating could include an active pharmaceutical ingredient. The coating may include anti-oxidants (¶ [0116]). Very thin polymer layers may be applied to simply fill the open pores in the fabric (i.e., meeting an integrated interphase boundary in which the coating infiltrates the solvent-sensitive substrate) (¶ [0119]). The coated fabric may also include intermediate materials or layers intended to improve adhesion between the polymer layers and the fabric layers (i.e., meeting a non-integrated interface boundary in which the coating is free of intermixing with or infiltration into the solvent-sensitive substrate) (¶ [0122]). The porosity of the fabric may allow cells to flow through a prosthetic heart valve (¶ [0103]). A pre-prepared film may be laminated to one or more surfaces of the fabric (¶ [0014]).
Alkhatib differs from the instant claims insofar as not disclosing wherein the coating comprises poly(glycerol sebacate) urethanes (i.e., a polyester copolymer of a polyol and a polyacid).
However, Winner discloses textiles for endovascular and other medical applications (abstract). The textile includes a resorbable coating (¶ [0022]). Suitable coating materials include poly(glycerol sebacate urethane) (¶ [0031]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Alkhatib discloses wherein the polymer coating may comprise polyurethanes and is bioabsorbable and biodegradable. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated poly(glycerol sebacate urethane) as a polymer coating since it is a known and effective polymer coating material as it is a polyurethane and is resorbable as taught by Winner.
The combined teachings of Alkhatib and Winner do not teach the warp yarn having an elastic modulus of 2 MPa to 15 MPa and comprising polyurethane; and the weft yarn having an elastic modulus of 75 MPa to 125 MPa and comprising polypropylene.
However, De Bont discloses a medical implant component comprising a composite biotextile (abstract). In an embodiment, the warp strands consist of UHMWPE and the weft strands consist of another polymer like a polyester such as PET, alternatively weft strands consist of UHMWPE and warp strand of PET. Such fabrics may show anisotropic properties, like different strength and/or elongation in warp vs weft direction (¶ [0059]). By using different strands as warp versus weft, a woven fabric with anisotropic properties may be formed, reflecting for example typical properties of some natural tissue material, like in leaves of a heart valve (¶ [0047]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the warp and weft fiber to be of different polymers since Alkhatib discloses wherein the fabric may have a specific anisotropy and by using different strands as warp versus weft, a woven fabric with anisotropic properties may be formed as taught by De Bont.
In regards to the warp yarn being polyurethane and the weft yarn being polypropylene, Alkhatib discloses wherein polyurethane and polypropylene are both suitable fabric materials. Therefore, when making different strands of warp versus weft, it would have been obvious to one of ordinary skill in the art to have used polyurethane for one strand and polypropylene for other strand.
In regards to the warp yarn having an elastic modulus of 2 MPa to 15 MPa and the weft yarn having an elastic modulus of 75 MPa to 125 MPa, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at a fabric with the warp yarn and weft yarn having the claimed elastic modulus based on the specific anisotropy desired since different elongation in weft and warp directions causes anisotropic properties as taught by De Bont. 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 experimentation. See MPEP 2144.05(II)(A).
2. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (US 2020/0188098, Jun. 18, 2020) (hereinafter Alkhatib) in view of Winner et al. (US 2019/0231511, Aug. 1, 2019) (hereinafter Winner), De Bont et al. (US 2022/0023501, Jan. 27, 2022) (hereinafter De Bont), and further in view of Quincy, III et al. (US 2007/0141929, Jun., 21, 2007) (hereinafter Quincy, III).
The teachings of Alkhatib, Winner, and De Bont are discussed above. Alkhatib, Winner, and De Bont do not teach wherein the coating is a conformal coating maintaining porosity of the anisotropic textile.
However, Quincy, III discloses a substrate that contains an exothermic coating (abstract). To maintain porosity of the substrate, it may sometimes be desired to apply the exothermic coating so as to cover less than 100% and in some embodiments from about 10% to about 80% of the areas of one or more surfaces of the substrate. For instance, in one particular embodiment, the exothermic coating is applied to the substrate in a preselected pattern (¶ [0037]).
Alkhatib discloses wherein the porosity of the fabric allows cells to flow through a prosthetic heart valve. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the coating such that porosity of the fabric is maintained motivated by the desire to allow cells to flow through. One of ordinary skill in the art would have had a reasonable expectation of success since applying a coating in a preselected pattern allows maintaining of porosity as taught by Quincy, III.
3. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (US 2020/0188098, Jun. 18, 2020) (hereinafter Alkhatib) in view of Winner et al. (US 2019/0231511, Aug. 1, 2019) (hereinafter Winner), De Bont et al. (US 2022/0023501, Jan. 27, 2022) (hereinafter De Bont), and further in view of Kresslein et al. (US 2018/0161185, Jun. 14, 2018) (hereinafter Kresslein).
The teachings of Alkhatib, Winner, and De Bont are discussed above. Alkhatib, Winner, and De Bont do not teach wherein an electro-spun mesh is disposed on the fabric.
However, Kresslein discloses medical devices having a lattice framework. The lattice framework may comprise a plurality of interconnected polymeric electrospun fiber members (abstract). The medical device may include a polymeric electrospun mesh contacting at least two of the interconnected members and having a pore size. In certain embodiments, the polymeric electrospun mesh may extend over one or both ends of the medical device. Such a medical device may be used, for example, as an occlusion device or for the treatment of an aneurysm (¶ [0011]).
Alkhatib discloses wherein the fabric may be coated with at least one polymer layer and wherein a pre-prepared film may be laminated to one or more surfaces of the fabric. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have coated the fabric of Alkhatib with electrospun mesh since it is a known and effective pre-prepared film for medical devices and it has the additional property of causing a medical device to be useful as an occlusion device or for the treatment of an aneurysm as taught by Kresslein.
4. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib et al. (US 2020/0188098, Jun. 18, 2020) (hereinafter Alkhatib) in view of Winner et al. (US 2019/0231511, Aug. 1, 2019) (hereinafter Winner), De Bont et al. (US 2022/0023501, Jan. 27, 2022) (hereinafter De Bont), and further in view of Wagner et al. (US 2014/0135898, May 15, 2014) (hereinafter Wagner).
The teachings of Alkhatib, Winner, and De Bont are discussed above. Alkhatib, Winner, and De Bont do not teach wherein the coating is formed with hexamethylene diisocyanate.
However, Wagner discloses implantable medical devices including a polymeric layer and a non-porous silicon coating (abstract). In certain embodiments, an additional non-silicone may be applied to the graft (¶ [0060]). The additional coating may comprise one or more polyurethanes. The polyurethanes each comprise a soft segment and a hard segment. The hard segment is comprised of a diisocyanate, such as hexamethylene diisocyanate (¶ [0061]).
As discussed above, it would have been obvious to one of ordinary skill in the art to have incorporated poly(glycerol sebacate urethane) as a polymeric coating of Alkhatib. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the poly(glycerol sebacate urethane) with hexamethylene diisocyanate since the prior art does not teach how to form this compound and hexamethylene diisocyanate is a known and effective compound to form polyurethanes as taught by Wagner.
Response to Arguments
Applicant argues that De Bont does not disclose or suggest combining weft or the type recited in claim 1 with warp of the type recited in claim 1.
The Examiner does not find Applicant’s argument to be persuasive. As this is a 103 obviousness rejection, no one prior art reference is required to teach each and every claim limitation. Therefore, the claim limitation does not need to be teach solely by De Bont. As discussed in the rejection, it would have been prima facie obvious to one of ordinary skill in the art to have formulated the warp and weft fiber to be of different polymers since Alkhatib discloses wherein the fabric may have a specific anisotropy and by using different strands as warp versus weft, a woven fabric with anisotropic properties may be formed as taught by De Bont. In regards to the warp yarn being polyurethane and the weft yarn being polypropylene, Alkhatib discloses wherein polyurethane and polypropylene are both suitable fabric materials. Therefore, when making different strands of warp versus weft, it would have been obvious to one of ordinary skill in the art to have used polyurethane for one strand and polypropylene for other strand. In regards to the warp yarn having an elastic modulus of 2 MPa to 15 MPa and the weft yarn having an elastic modulus of 75 MPa to 125 MPa, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at a fabric with the warp yarn and weft yarn having the claimed elastic modulus based on the specific anisotropy desired since different elongation in weft and warp directions causes anisotropic properties as taught by De Bont. 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 experimentation. See MPEP 2144.05(II)(A). As such, Applicant’s argument is unpersuasive.
Conclusion
Claims 1-6 and 10-16 are rejected.
Claims 7-9 and 17-21 have been withdrawn.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
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/TRACY LIU/Primary Examiner, Art Unit 1614
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