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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on 7/21/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election (with traverse) of Species A3 and B2 is acknowledged. The traversal is on the grounds that the species are unnecessarily extensive. This is not found persuasive because the figures/ descriptions the different species are mutually exclusive species with mutually exclusive characteristics that are not obvious variants of each other since the figures/ descriptions are disclosing features which are alternatives to each other and are not combinable. If the applicant believes that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one species would disclose the other since they are obvious variants of each other.
Claim(s) 7-8, 10, 13, 19 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/21/2026.
Claim Objections
Claim(s) 2, 4, 11-12, 14 is/are objected to because of the following informalities:
Within claim 2, line 5: a semicolon is missing after “75D”;
Within claim 4, line 1: a comma is missing after “1”;
Within claim 4, line 3: “thereof, and wherein” should be replaced with --thereof; wherein-- (for grammatical purposes);
Within claim 4, line 4: “yarn wherein” should be replaced with --yarn; wherein-- (for grammatical purposes);
Within claim 4, line 5: “polymer, and wherein” should be replaced with --polymer; and wherein-- (for grammatical purposes);
Within claim 11, line 1: a comma is missing after “1”;
Claim 11 is missing the period at the end of the claim
Within claim 12, line 1: a comma is missing after “11”;
Within claim 15, line 1: a comma is missing after “4”;
Appropriate correction is required.
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.
Claim(s) 14-17 is/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.
Within claim 14, line 2: Applicant claims, “a multi-component yarn”; it is unclear, and therefore indefinite, if this is the in addition to OR a redefinition of the first/ second yarns (within claim 1 and 4).
Claim(s) 15 recites the limitation "the warp direction" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the warp direction" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the third yarn" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 9 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Felix et al. (US 2021/0393389 A1).
With respect to claim 1:
Felix et al. discloses a textile (material of implantable prosthesis 20), as can be seen in figs. 1-3, comprising:
a first yarn (each first filament 82), as can be seen in fig. 8, comprising one or more filaments comprising a first polymer (polypropylene) (paragraphs [0070, 0078, 0080]);
one or more additional yarns (each second filament 86), as can be seen in fig. 8, comprising a composition and/or properties different from the first yarn (each first filament 82) (due to the differences in diameter) (paragraphs [0070, 0078, 0080]);
wherein the first yarn (each first filament 82) exhibits an elasticity higher (due to the smaller filament size) than an elasticity of the one or more additional yarns (each second filament 86) (paragraphs [0078, 0080]); wherein
the textile (material of implantable prosthesis 20) exhibits an ultimate elongation of about 50% to about 700% (paragraph [0010]) and is shape-adapting and biocompatible (conforming the muscle implanted thereon) (paragraph [0009]), and wherein the textile (material of implantable prosthesis 20) is configured to be inserted and/or implanted in a subject's body (paragraph [0009]).
With respect to claim 9:
Wherein the one or more filaments of the first yarn (each first filament 82) is melt-spun (PLEASE NOTE: Claim 9 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a polymer yarn. Manufacturing steps such as melt-spinning are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
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.
Claim(s) 1-3, 9, 11, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 6342068 B1) in view of Davidson (US 2008/0021547 A1).
With respect to claim 1:
Thompson discloses the invention substantially as claimed. Specifically, Thompson discloses a textile (material of layers 44-48), as can be seen in figs. 1, 3-7, comprising:
a first yarn (one of structural strands 32) comprising one or more filaments comprising a first polymer (polyurethane monofilament) (column 6, lines 21-34 and column 6, line 63-column 7, line 3);
one or more additional yarns (textile strands 42 within inner layer 42 OR outer layer 46) comprising a composition and/or properties different (are much finer having higher compliance and may not be elastic) from the first yarn (one of structural strands 32) (column 7, lines 21-60);
wherein the first yarn (one of structural strands 32) exhibits an elasticity higher (has elasticity) than an elasticity (may not be elastic) of the one or more additional yarns (textile strands 42 within inner layer 42 OR outer layer 46) (column 6, lines 21-34 and column 7, lines 47-60); wherein
the textile (material of layers 44-48) is shape-adapting and biocompatible (conforming to the latticework 35), and wherein the textile (material of layers 44-48) is configured to be inserted and/or implanted in a subject's body (on a stent) (column 7, lines 61-67).
However, Thompson is silent concerning the ultimate elongation of the textile (material of layers 44-48) (with it specifically being about 50% to about 700%).
Davidson teaches an implantable prosthetic heart valve comprising a sealing element (sewing ring) comprising a textile. The textile is made of polyurethane yarns (fibers) and has an ultimate elongation of about 50% to about 700% (100-1000%) which allows the textile to match the properties of arterial (not just heart) tissue (paragraphs [0005, 0010-0012]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the textile (material of layers 44-48), as disclosed by Thompson, such that it has an ultimate elongation of about 50% to about 700% (100-1000%), as taught by Davidson et al., as the two structures are made from the same structure/ materials (yarns of polyurethane) and adjusting the ultimate elongation to about 50% to about 700% (100-1000%), as taught by Davidson et al., allows the best matching of arterial tissue properties.
With respect to claim 2:
Wherein the first polymer (polyurethane monofilament), as disclosed by Thompson, comprises a thermoplastic polyurethane (TPU), a polyurethane (PU) (column 6, line 63-column 7, line 3), a thermoplastic elastomer (TPE), an elastomeric polyolefin, polybutylene terephthalate (PBT), silicone-based elastomer, or a combination thereof; and/OR wherein the first polymer has a durometer from about 75A to about 75D and/OR wherein the first polymer has an ultimate tensile strength between about 4500 psi to about 8000 psi.
With respect to claim 3:
Wherein the one or more additional yarns (textile strands 42 within inner layer 42 OR outer layer 46), as disclosed by Thompson, comprise a polyolefin, a polyester, a polyurethane (column 7, lines 47-60), a thermoplastic polyurethane, a polyamide, or a combination thereof.
With respect to claim 9:
Wherein the one or more filaments of the first yarn (one of structural strands 32), as disclosed by Thompson, is melt-spun (column 6, lines 21-34 and column 6, line 63-column 7, line 3). (PLEASE NOTE: Claim 9 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a polymer yarn. Manufacturing steps such as melt-spinning are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 11:
Wherein the textile (material of layers 44-48), as disclosed by Thompson, has a woven construction (must be woven to have a “tight weave”) (column 7, lines 61-67).
With respect to claim 20:
Thompson discloses the invention substantially as claimed. Specifically, Thompson discloses an implantable prosthetic valve (prosthesis 18), as can be seen in figs. 1, 3-7, comprising:
an annular frame (one of the structural strands 32 of latticework 35 OR radiopaque strands of latticework 35) having an inflow end, an outflow end, and a longitudinal axis (as can be seen in figs. 1, 3-7); wherein the annular frame (one of the structural strands 32 of latticework 35 OR radiopaque strands of latticework 35) is configured to expand and collapse (column 7, lines 61-67 OR column 13, lines 8-17); and
a sealing element secured to the frame (one of the structural strands 32 of latticework 35), wherein the sealing element comprises a textile (material of layers 44-48) having a knitted, woven (must be woven to have a “tight weave”) (column 7, lines 61-67), or braid (abstract) construction and comprising:
a textile (material of layers 44-48), as can be seen in figs. 1, 3-7, comprising:
a first yarn (one of the other structural strands 32) comprising one or more filaments comprising a first polymer (polyurethane monofilament) (column 6, lines 21-34 and column 6, line 63-column 7, line 3);
one or more additional yarns (textile strands 42 within inner layer 42 OR outer layer 46) comprising a composition and/or properties different (are much finer having higher compliance and may not be elastic) from the first yarn (one of the other structural strands 32) (column 7, lines 21-60);
wherein the first yarn (one of the other structural strands 32) exhibits an elasticity higher (has elasticity) than an elasticity (may not be elastic) of the one or more additional yarns (textile strands 42 within inner layer 42 OR outer layer 46) (column 6, lines 21-34 and column 7, lines 47-60); wherein
the textile (material of layers 44-48) is shape-adapting and biocompatible (conforming to the latticework 35), and wherein the textile (material of layers 44-48) is configured to be inserted and/or implanted in a subject's body (on a stent) (column 7, lines 61-67).
However, Thompson is silent concerning the ultimate elongation of the textile (material of layers 44-48) (with it specifically being about 50% to about 700%).
Davidson teaches an implantable prosthetic heart valve comprising a sealing element (sewing ring) comprising a textile. The textile is made of polyurethane yarns (fibers) and has an ultimate elongation of about 50% to about 700% (100-1000%) which allows the textile to match the properties of arterial (not just heart) tissue (paragraphs [0005, 0010-0012]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the textile (material of layers 44-48), as disclosed by Thompson, such that it has an ultimate elongation of about 50% to about 700% (100-1000%), as taught by Davidson et al., as the two structures are made from the same structure/ materials (yarns of polyurethane) and adjusting the ultimate elongation to about 50% to about 700% (100-1000%), as taught by Davidson et al., allows the best matching of arterial tissue properties.
Claim(s) 1, 9, 11-12, 18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen et al. (US 2012/0168022 A1) in view of Davidson (US 2008/0021547 A1) (as evidenced by “PET – Density -Strength – Melting Point – Thermal Conductivity” and “Polyethylene – Density -Strength – Melting Point – Thermal Conductivity”).
With respect to claim 1:
Rasmussen et al. discloses the invention substantially as claimed. Specifically, Rasmussen et al. discloses a textile (woven fabric 620), as can be seen in fig. 6, comprising:
a first yarn (first material 110 of composite yarn 100 made up of polyethylene terephthalate fibers) comprising one or more filaments comprising a first polymer (made up of polyethylene terephthalate fibers) (paragraphs [0024-0027]);
one or more additional yarns (second material 114 of some of the composite yarns 100 made up of polyethylene fibers) comprising a composition and/or properties different from the first yarn (first material 110 of composite yarn 100 made up of polyethylene terephthalate fibers) (paragraphs [0024-0027]);
wherein the first yarn (first material 110 of composite yarn 100 made up of polyethylene terephthalate fibers) exhibits an elasticity higher than an elasticity of the one or more additional yarns (second material 114 of some of the composite yarns 100 made up of polyethylene fibers) (paragraph [0027]) (polyethylenene terephthalate has a higher young’s modulus/ elasticity than polyethylene as evidenced by “PET – Density -Strength – Melting Point – Thermal Conductivity” and “Polyethylene – Density -Strength – Melting Point – Thermal Conductivity”);
wherein the textile (woven fabric 620) is shape-adapting and biocompatible, and wherein the textile (woven fabric 620) is configured to be inserted and/or implanted in a subject's body (paragraphs [0034-0036]).
However, Rasmussen et al. is silent concerning the ultimate elongation of the textile (material of layers 44-48) (with it specifically being about 50% to about 700%).
Davidson teaches an implantable prosthetic heart valve comprising a sealing element (sewing ring) comprising a textile. The textile has an ultimate elongation of about 50% to about 700% (100-1000%) which allows the textile to match the properties of arterial (not just heart) tissue (paragraphs [0005, 0010-0012]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the textile (woven fabric 620), as disclosed by Rasmussen et al., such that it has an ultimate elongation of about 50% to about 700% (100-1000%), as taught by Davidson et al., as the two structures are made from the same structure (polymer yarns) and adjusting the ultimate elongation to about 50% to about 700% (100-1000%), as taught by Davidson et al., allows the best matching of arterial tissue properties.
With respect to claim 9:
Wherein the one or more filaments of the first yarn (first material 110 of composite yarn 100), as disclosed by Rasmussen et al., is melt-spun. (PLEASE NOTE: Claim 9 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a polymer yarn. Manufacturing steps such as melt-spinning are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 11:
Wherein the textile (woven fabric 620), as disclosed by Rasmussen et al., has a woven construction (paragraph [0029]).
With respect to claim 12:
Wherein the woven construction, as disclosed by Rasmussen et al., comprises a plain weave, derivatives of plain weave, a rib weave, a basket weave, a twill weave, a satin weave, a dobby weave, a jacquard weave, an extra yarn weave, a pique weave, a double cloth textile, a crepe weave, a leno weave, a pile weave, a triaxial weave, or a combination thereof (paragraph [0029]).
With respect to claim 18:
Wherein the textile (woven fabric 620), as disclosed by Rasmussen et al. as modified by Davidson (as discussed above with respect to claim 1), a high elastic recovery (in order to mimic the natural arterial tissue) (Rasmussen et al. paragraphs [0008, 0010]). However, neither Rasmussen et al. nor Davidson explicitly recited the elastic recovery of the textile (woven fabric 620) to be at least 80%. However, Rasmussen et al. specifically discloses the textile (woven fabric 620)to have a high elastic recovery in order to mimic the natural arterial tissue (Rasmussen et al. paragraphs [0008, 0010]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the elastic recovery of the textile (woven fabric 620) to be at least 80% as this is result effective variables that contribute to the ability of the material to conform/ mimic the motion of the natural tissue 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 and modifying the percentage of elastic recovery, as taught and suggested by Rasmussen et al., would allow for the textile (woven fabric 620) to be conform/ mimic the motion of the natural tissue after implantation. In re Aller, 105 USPQ 233.
With respect to claim 20:
Rasmussen et al. discloses the invention substantially as claimed. Specifically, Rasmussen et al. discloses and implantable prosthetic valve (stent graft 600), as can be seen in fig. 6, comprising:
an annular frame (stent/ support structure) having an inflow end, an outflow end, and a longitudinal axis; wherein the annular frame stent/ support structure) is configured to expand and collapse (paragraph [0036]); and
a sealing element (woven fabric 620) secured to the frame (stent/ support structure), wherein the sealing element (woven fabric 620) comprises a textile (woven fabric 620) having a knitted, woven, or braid construction (paragraph [0036]) and comprising:
a first yarn (first material 110 of composite yarn 100) comprising one or more filaments comprising a first polymer (paragraphs [0024-0027]);
one or more additional yarns (second material 114 of composite yarn 100) comprising a composition and/or properties different from the first yarn (first material 110 of composite yarn 100) (paragraphs [0024-0027]);
wherein the first yarn (first material 110 of composite yarn 100 made up of polyethylene terephthalate fibers) exhibits an elasticity higher than an elasticity of the one or more additional yarns (second material 114 of some of the composite yarns 100 made up of polyethylene fibers) (paragraph [0027]) (polyethylenene terephthalate has a higher young’s modulus/ elasticity than polyethylene as evidenced by “PET – Density -Strength – Melting Point – Thermal Conductivity” and “Polyethylene – Density -Strength – Melting Point – Thermal Conductivity”);
wherein the textile (woven fabric 620) is shape-adapting and biocompatible, and wherein the textile (woven fabric 620) is configured to be inserted and/or implanted in a subject's body (paragraphs [0034-0036]).
However, Rasmussen et al. is silent concerning the ultimate elongation of the textile (material of layers 44-48) (with it specifically being about 50% to about 700%).
Davidson teaches an implantable prosthetic heart valve comprising a sealing element (sewing ring) comprising a textile. The textile has an ultimate elongation of about 50% to about 700% (100-1000%) which allows the textile to match the properties of arterial (not just heart) tissue (paragraphs [0005, 0010-0012]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the textile (woven fabric 620), as disclosed by Rasmussen et al., such that it has an ultimate elongation of about 50% to about 700% (100-1000%), as taught by Davidson et al., as the two structures are made from the same structure (polymer yarns) and adjusting the ultimate elongation to about 50% to about 700% (100-1000%), as taught by Davidson et al., allows the best matching of arterial tissue properties.
Allowable Subject Matter
Claim(s) 4-6 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 14-17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 4:
A textile (as required by claim 1) further comprising: an about 5 to about 1000 denier second yarn (comprising the specific list of polymers: polyester, nylon, polyolefin, or combinations thereof). (Note: Although the second material 114 of the other of the composite yarns 100, as disclosed by Rasmussen et al., has the required size and elasticity in relation to the first yarn (as required by claim 4); the second material 114 of the other of the composite yarns 100, as disclosed by Rasmussen et al., is made from a different polymer with different material properties which appear to teach away from being replaced with the specific polymer(s) as required by claim 4.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
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