DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 01/22/2026.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 62/529,394 and 62/635,451, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the two provisional applications mentioned above do not provide support for at least the following limitations in the independent claims: a fluoroelastomer layer configured to bond the inner layer to the metal middle layer. The disclosures do not set forth or establish that this was adequately supported via written description as of their filing dates. Accordingly, the effective filing date of the current claims is 07/05/2018, the filing date of 16/028,172, of which the current application is a CON of 17/071,745 and 17/071,745 is a CON of said 16/028,172.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 01/22/2026, with respect to the rejection(s) of claim(s) 1/15/18 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 7,049,380 B1 to Chang et al.
Claim Rejections - 35 USC § 103
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 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) 1-2, 4-14, 15-17, and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0317301 A1 to Quadri et al. (hereinafter “Quadri”) (previously of record) in view of US 7,049,380 B1 to Chang et al. (hereinafter “Chang”).
Regarding claim 1, Quadri discloses (see abstract; Figs. 1-10; and [0114]-[0165]) a delivery system (10) for delivering an expandable implant to a body location (see [0114]), the delivery system comprising: an outer sheath assembly (22) comprising an outer shaft having an outer lumen and a proximal end and a distal end (see Figs. 2/4/6/8), wherein the outer sheath assembly comprises an implant retention area (16) configured to retain the expandable implant in a compressed configuration (see [0116]), wherein the outer sheath assembly comprises a capsule (58 + 60) at the distal end, the capsule adapted to provide both compression resistance and flexibility (see [0152]/[0153]/[0159]) and comprising: an outer polymer layer (82) comprised of a flexible material configured to provide tensile and elongation properties (ePTFE, see [0152]-[0153], corresponds to ePTFE disclosed in Applicant's spec. at [0169] which has these material properties), a metal middle layer (hypotube 150) located on a radially inner surface of the outer polymer layer (see Fig. 9 and [0153]-[0155]), and an inner liner (82) located on a radially inner surface of the metal middle layer (see Fig. 9 and [0153]), wherein the metal middle layer is a metal hypotube configured to provide radial strength and compression resistance (see Fig. 9 and [0153]-[0155]).
Quadri further discloses (claim 2) the expandable implant (70, see Fig. 3), wherein the expandable implant comprises an inner frame (72), an outer frame (80), a valve body (see Fig. 3), and one or more skirts (81) (see Fig. 3 and [0120]-[0121]); (claim 4) wherein the expandable implant is a prosthetic replacement heart valve for a native mitral valve (see [0114]); (claim 5) wherein the delivery system includes a shaft assembly (12) comprising a proximal end (11) and a distal end (13), and wherein a handle (14) is coupled to the proximal end of the shaft assembly (see Fig. 1 and [0116]); (claim 6) wherein the outer polymer layer comprises an elastomer (ePTFE, see [0152]/[0153]); (claim 7) wherein the inner liner comprises extruded PTFE (see [0152]-[0153], the limitation "extruded" is being treated as a product by process limitation. As set forth in MPEP 2113, “Even 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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of extruding imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation "extruded" is given little patentable weight); (claim 8) wherein the inner liner wraps around a distal end of the capsule and is in contact with a radially outer surface of the outer polymer layer (see Fig. 9); (claim 9) further comprising a fluorinated ethylene polymer layer located between the inner liner and the metal layer (see [0158]-[0163]); (claim 10) wherein the outer polymer layer comprises ePTFE (see [0152]-[0153]); (claim 11) wherein the inner liner comprises pre-axially compressed PTFE (see [0152]-[0153], the limitation "pre-axially compressed" is being treated as a product by process limitation. As set forth in MPEP 2113, “Even 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 in 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). Examiner notes since there was no evidence provided by the applicant that the process of pre-axially compressing imparts a structural difference onto the end product of the claimed invention that is not present in the prior art, the limitation "pre-axially compressed" is given little patentable weight); (claim 12) further comprising one or more fluorinated ethylene polymer sections located between the outer polymer layer and the metal middle layer to provide radial strength when the expandable implant is under compression (see [0158]-[0163]); (claim 13) wherein the inner liner is extended and inverted at the distal end in order to cover the distal end of the capsule as well as an outer diameter of a portion of the outer polymer layer (see [0152]-[0153] and Fig. 9); (claim 14) wherein the inner liner is PTFE, which resists radial expansion and decreases friction with the expandable implant (see [0152]-[0153]).
With respect to claim 1, Quadri fails to specifically disclose a fluoroelastomer layer configured to bond the inner liner to the metal middle layer, but note that Quadri discloses that the device can comprise a variety of biocompatible layers presented as an intermediate layer in the device (see [0159]-[0160]), that the inner liner comprises PTFE (see [0152]-[0153]), and that the layers can be attached via a variety of different techniques (see [0164]). Chang discloses (see abstract and Col. 3, lines 3-65), in the same field of endeavor of fluoroelastomers for medical devices, a fluoroelastomer (perfluoromethyl vinyl ether “PMVE” is a known fluoroelastomer, see Col. 3, lines 1-2) configured to bond materials such as PTFE together (see Col. 3, lines 24-29) for the purpose of providing excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits, when bonding components of a medical device together (see Col. 4, lines 18-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Quadri’s device by using a fluoroelastomer bonding layer as taught by Chang in order to bond the inner liner to the metal middle layer by providing a bonding material which provides excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits.
Regarding claim 15, Quadri discloses (see abstract; Figs. 1-10; and [0114]-[0165]) a delivery system (10) for delivering an expandable implant to a body location (see [0114]), the delivery system comprising: an outer sheath assembly (22) comprising an outer shaft (see Figs. 2/4/6/8) having an implant retention area (16) configured to retain the expandable implant in a compressed configuration (see [0116]), wherein the outer sheath assembly comprises a capsule (58 + 60) adapted to provide both compression resistance and flexibility (see [0152]/[0153]/[0159]), the capsule comprising: an outer polymer layer (82) comprised of a flexible material configured to provide tensile and elongation properties (ePTFE, see [0152]-[0153], corresponds to ePTFE disclosed in Applicant's spec. at [0169] which has these material properties), a metal middle layer (hypotube 150) located on a radially inner surface of the outer polymer layer (see Fig. 9 and [0153]-[0155]), an inner liner (82) located on a radially inner surface of the metal middle layer (see Fig. 9 and [0153]).
Quadri further discloses (claim 16) wherein the delivery system includes a shaft assembly (12) comprising a proximal end (11) and a distal end (13), and wherein a handle (14) is coupled to the proximal end of the shaft assembly (see Fig. 1 and [0116]); and (claim 17) wherein the inner liner wraps around a distal end of the capsule and is in contact with a radially outer surface of the outer polymer layer (see Fig. 9).
With respect to claim 15, Quadri fails to specifically disclose a fluoroelastomer layer configured to bond the inner liner to the metal middle layer, but note that Quadri discloses that the device can comprise a variety of biocompatible layers presented as an intermediate layer in the device (see [0159]-[0160]), that the inner liner comprises PTFE (see [0152]-[0153]), and that the layers can be attached via a variety of different techniques (see [0164]). Chang discloses (see abstract and Col. 3, lines 3-65), in the same field of endeavor of fluoroelastomers for medical devices, a fluoroelastomer (perfluoromethyl vinyl ether “PMVE” is a known fluoroelastomer, see Col. 3, lines 1-2) configured to bond materials such as PTFE together (see Col. 3, lines 24-29) for the purpose of providing excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits, when bonding components of a medical device together (see Col. 4, lines 18-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Quadri’s device by using a fluoroelastomer bonding layer as taught by Chang in order to bond the inner liner to the metal middle layer by providing a bonding material which provides excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits.
Regarding claim 18, Quadri discloses (see abstract; Figs. 1-10; and [0114]-[0165]) a delivery system (10) for delivering an expandable replacement valve to a native heart valve (see [0114]), the delivery system comprising: an outer sheath assembly (22) comprising a capsule (58 + 60) forming an outer lumen having an implant retention area (16)configured to retain the expandable replacement valve in a compressed configuration (see [0116]), the capsule comprising: an outer polymer layer (82) comprised of a flexible material (ePTFE, see [0152]-[0153], corresponds to ePTFE disclosed in Applicant's spec. at [0169] which has these material properties); a metal middle layer (hypotube 150) located on a radially inner surface of the outer polymer layer (see Fig. 9 and [0153]-[0155]); an inner liner (82) located on a radially inner surface of the metal middle layer (see Fig. 9 and [0153]), wherein the metal middle layer is configured to provide radial strength and compression resistance (see Fig. 9 and [0153]-[0155]).
Quadri further discloses (claim 19) the expandable implant (70, see Fig. 3), wherein the expandable implant comprises an inner frame (72), an outer frame (80), a valve body (see Fig. 3), and one or more skirts (81) (see Fig. 3 and [0120]-[0121]); and wherein the expandable implant is a prosthetic replacement heart valve for a native mitral valve (see [0114]); and (claim 20) a fluorinated ethylene polymer layer located between the inner liner and the metal layer (FEP tube, see [0158]-[0163]).
With respect to claim 18, Quadri fails to specifically disclose a fluoroelastomer layer configured to bond the inner liner to the metal middle layer, but note that Quadri discloses that the device can comprise a variety of biocompatible layers presented as an intermediate layer in the device (see [0159]-[0160]), that the inner liner comprises PTFE (see [0152]-[0153]), and that the layers can be attached via a variety of different techniques (see [0164]). Chang discloses (see abstract and Col. 3, lines 3-65), in the same field of endeavor of fluoroelastomers for medical devices, a fluoroelastomer (perfluoromethyl vinyl ether “PMVE” is a known fluoroelastomer, see Col. 3, lines 1-2) configured to bond materials such as PTFE together (see Col. 3, lines 24-29) for the purpose of providing excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits, when bonding components of a medical device together (see Col. 4, lines 18-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Quadri’s device by using a fluoroelastomer bonding layer as taught by Chang in order to bond the inner liner to the metal middle layer by providing a bonding material which provides excellent biocompatibility, high tensile strength, high clarity, high abrasion resistance, and adequate elasticity, among other benefits.
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Quadri in view Chang, as applied to claim 1 above, and further in view of US 2011/0022157 A1 to Essinger (hereinafter “Essinger”) (previously of record).
The combination of Quadri and Chang discloses the invention substantially as claimed as discussed above, however, with respect to claim 3, Quadri/Chang fails to specifically disclose wherein the one or more skirts comprise an outer skirt and an inner skirt. Essinger discloses, in the same field of endeavor of heart valves, the known use of an outer skirt and an inner skirt on the frame of a heart valve (see [0069]-[0071]) for the purpose of providing a covering for a least a portion of an outer surface of the valve component via an inner skirt to serve as a sealing member between the stent and the valve and for providing a covering for at least a portion of the outer surface of the stent via an outer skirt to serve as a sealing member between the stent and the native anatomy (see [0071]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Quadri's device (as modified by Chang abov) with the inner and outer skirts taught by Essinger in order to provide coverings which serve as sealing members between the stent and the valve and between the stent and the native anatomy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the attached PTO-892 Notice of References cited for additional relevant prior art disclosing multi-layer constructions of sheaths/capsules which comprise fluoroelastomers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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