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, claims 1-33, 45-49 in the reply filed on 11/24/2025 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)).
Claims 35-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 7, 15, 18, 19, 21, 22, 31-34 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. Claims 7, 15, 18, 19, 21, 22, 31-34 refer to acronyms PCU, PGS, and/or PCL without specifying the material the acronym stands for either in the claim itself or a previous claim that these claims depend from. This renders the scope of the claim unclear as the precise meaning of the acronym is not sated in the claims.
Claim Rejections - 35 USC § 102
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)(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.
Claims 17, 23, 25-28, 49 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shang et al. Pub. No.: US 2020/0138573).
For claim 17, Shang et al. (hereinafter, Shang) discloses a heart valve replacement comprising:
a tubular body portion 12 comprising an inflow end, an outflow end and a central portion arranged between said inflow and outflow ends, defining a longitudinal direction of the valve replacement and having an inner wall region (e.g., fig. 4B);
a valve 14 comprising at least one leaflet 40attached to the inner wall region of the central portion, each one of said leaflets being movable between a closing position and an opening position of the valve,
wherein the tubular body portion 12 comprises a combination of a biostable polymer and a biodegradable polymer (e.g., para. 166) such that the tubular body is configured to allow in-growth of tissue of a host after implantation (e.g., para. 166) and to increase its diameter concomitantly with surrounding organ structures of the host (e.g., abstract),
wherein the valve comprises entirely biostable polymer (e.g., para. 133) and is secured to the biostable polymer of the tubular body portion (e.g., para. 166).
For claim 23 Shang discloses the heart valve replacement of claim 17, wherein the at least two leaflets each have sufficient height to maintain the competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 25, Shang discloses the heart valve replacement of claim 17, wherein the at least two leaflets each have sufficient height of coaptation to maintain competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 26, Shang discloses the heart valve replacement of claim 17, wherein the at least two leaflets each have sufficient length of the free edge to maintain competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 27, Shang discloses a valve attached to the inner wall of the tubular body (e.g., fig. 4B). Use of sintering is considered a product-by-process limitation which does not alter the structure of the resultant product; thus, the attached valve and tubular body of Shang meets the claim.
For claim 28, Shang discloses the heart valve replacement of claim 17, wherein the valve is growth compatible (abstract).
For claim 49, Shang discloses a heart valve replacement comprising:
a tubular body portion 12 comprising an inflow end, an outflow end and a central portion arranged between said inflow and outflow ends, defining a longitudinal direction of the valve replacement and having an inner wall region (e.g., fig. 4B);
a valve 14 comprising at least one leaflet 40 attached to the inner wall region of the central portion, each one of said leaflets being movable between a closing position and an opening position of the valve,
wherein the tubular body portion 12 comprises a combination of a biostable polymer and a biodegradable polymer (e.g., para. 166) such that the tubular body is configured to allow in-growth of tissue of a host after implantation (e.g., para. 166) and to increase its diameter concomitantly with surrounding organ structures of the host (e.g., abstract),
wherein the valve comprises entirely biostable polymer (e.g., para. 133) and is secured to the biostable polymer of the tubular body portion (e.g., para. 166), and further wherein the replacement is manufactured by one or more of the processes selected from the group consisting of: lyophilization, knitting, braiding, 3D printing, and a combination thereof (e.g., para. 136, weaving is considered a form of braiding).
Claim 31 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kalfa et al. (WO 2017/162645).
Kalfa et al. (hereinafter, Kalfa) discloses a heart valve replacement (e.g., abstract) comprising a porous (e.g., pg. 44 lines 6-7) electrospun (e.g., pg. 30 line 10) tube (e.g., pg. 30, line 10) comprising PCU, PGS and PCL (e.g., pg. 30 lines 10-13).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 8-16, 20-21, 24, 29-30, 45-48 are rejected under 35 U.S.C. 103 as being unpatentable over Shang et al. Pub. No.: US 2020/0138573) in view of Kalfa et al. (WO 2017/162645).
Shang discloses a heart valve replacement comprising:
a tubular body 12 having an inflow end, and outflow end and a generally cylindrical inner side wall portion extending between the inflow end and outflow end thereby forming a blood passage with a diameter (e.g., fig. 4B), and
a valve 14 defined by at least two leaflets 40, wherein each leaflets comprises first and second opposing portions and a longitudinal body therebetween, such that the first portion is secured to the inner side wall portion of said tubular body and the second portion (coaptation edge, see fig. 4B) is a free edge configured to engage corresponding second portion of an adjacent leaflet to close the valve (e.g., fig. 4B), the inter engaging portions of the leaflets being separable to open the valve,
wherein the tubular body is composed of electrospun fibers (not disclosed), and further wherein the electrospun fibers include biostable polymeric fibers and biodegradable polymeric fibers (para. 166).
As provided in italicized text above, Shang lacks disclosure of electrospun fibers. Kalfa teaches the use of electrospun fibers as suitable for a porous implantable conduit (e.g., abstract, pg. 30 lines 10-13). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided Shang with electrospun fibers as taught by Kalfa for the purpose of providing a porous structure which allows tissue ingrowth. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Shang discloses the heart valve replacement of claim 1, wherein the tubular body permits in- situ tissue regeneration such that the diameter of the tubular member increases over time after implantation (abstract).
For claim 3, Shang discloses the heart valve replacement of claim 1, wherein the biodegradable polymeric fibers comprise at least one polymer selected from the group consisting of: polycapriolactone (PCL) and polyglycerol sebacate (PGS), or a combination thereof (para. 10).
For claim 6, Shang lacks the biostable material as poly carbonate urethane ("PCU"). Kalfa teaches the use of PCU in an electrospun implantable valve, it would have been obvious to have selected the biostable material of Shang as electrospun PCU as taught by Kalfa as an obvious material suitable for use as an implanted valve conduit. This modification would have occurred using known methods and would have yielded predictable results.
For claim 8, Shang discloses a valve attached to the inner wall of the tubular body (e.g., fig. 4B). Use of sintering is considered a product-by-process limitation which does not alter the structure of the resultant product; thus, the attached valve and tubular body of Shang meets the claim.
For claim 9, Shang discloses the heart valve replacement of claim 1, wherein the valve is attached to a portion of the tubular body formed only by biostable material (e.g., para. 166).
For claim 10, Shang discloses the heart valve replacement of claim 1, wherein the at least two leaflets each have sufficient height to maintain the competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 11, While Shang does not expressly disclose the heart valve replacement of claim 1, wherein the at least two leaflets each have a height greater than the diameter of the tubular body, the prosthetic is designed for implantation and growth in pediatric patients, where the valve grows with the patient. It would have been obvious to have selected a leaflet height which is greater than the diameter of the tubular body in the smallest configuration such that the valve leaflets are sufficiently sized to accommodate patient growth.
For claim 12, Shang discloses the heart valve replacement of claim 1, wherein the at least two leaflets each have sufficient height of coaptation to maintain competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 13, Shang discloses the heart valve replacement of claim 1, wherein the at least two leaflets each have sufficient length of the free edge to maintain competency of the valve while the diameter of the tubular body increases over time (e.g., fig. 4B, abstract).
For claim 14, Shang discloses the heart valve replacement of claim 1, wherein the valve is formed entirely from biostable material (e.g., para. 133).
For claim 15, Shang lacks the heart valve replacement of claim 14, wherein the valve is formed from PCU. Kalfa teaches the use of PCU in an electrospun implantable valve, it would have been obvious to have selected the biostable material of Shang as electrospun PCU as taught by Kalfa as an obvious material suitable for use as an implanted valve conduit. This modification would have occurred using known methods and would have yielded predictable results.
For claim 16, Shang does not specify the replacement has an initial diameter of about 12 mm and a final diameter of about 24 mm, however, as Shang is allowed to grow with the patient (abstract), selection of a 12-24mm diameter is considered an obvious expedient given average human valve sizes in pediatric, adolescent, and adult patients. This modification would have occurred using known methods and would have yielded predictable results.
For claim 45, Shang discloses a method of replacing a heart valve in a host, comprising the steps of: inserting a distal end portion of a delivery sheath into a portion of a heart of a host, the delivery sheath having a heart valve replacement according to any one of claims 1 to 36 disposed within a lumen of the delivery sheath, moving the heart valve replacement distally out of the delivery sheath; and positioning the heart valve replacement within the heart of the host (e.g., para. 46).
For claim 46, Shang discloses the method of claim 45, wherein the method is a method is a method for treating the host for aortic stenosis, mitral valve stenosis, regurgitation, or tricuspid valve regurgitation (e.g., para. 4).
For claim 47, Shang discloses the method of claim 45, wherein the host is a child under the age of eighteen years old (para. 3).
For claim 48, Shang discloses the method of claim 47, wherein the living tissue of the child replaces a portion of the heart valve replacement over time (abstract).
For claim 20, Shang lacks the biostable material as poly carbonate urethane ("PCU"). Kalfa teaches the use of PCU in an electrospun implantable valve, it would have been obvious to have selected the biostable material of Shang as electrospun PCU as taught by Kalfa as an obvious material suitable for use as an implanted valve conduit. This modification would have occurred using known methods and would have yielded predictable results.
For claim 21, Shang lacks wherein the biostable polymer of the tubular body portion is poly carbonate urethane and the biodegradable biomaterial of the tubular body is PGS and PCL. Kalfa teaches the same materials, these materials are expected to have the same degradation properties.
For claim 24, while Shang does not expressly disclose the heart valve replacement of claim 1, wherein the at least two leaflets each have a height greater than the diameter of the tubular body, the prosthetic is designed for implantation and growth in pediatric patients, where the valve grows with the patient. It would have been obvious to have selected a leaflet height which is greater than the diameter of the tubular body in the smallest configuration such that the valve leaflets are sufficiently sized to accommodate patient growth.
For claim 29, Shang lacks disclosure of electrospun fibers. Kalfa teaches the use of electrospun fibers as suitable for a porous implantable conduit (e.g., abstract, pg. 30 lines 10-13). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Shang conduit with electrospun fibers as taught by Kalfa for the purpose of providing a porous structure which allows tissue ingrowth. This modification would have occurred using known methods and would have yielded predictable results.
For claim 30, Shang teaches the valve does not include electrospun fibers (no mention of electrospun fibers in the disclosure).
Allowable Subject Matter
Claims 4-5, 7 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. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Shang et al. Pub. No.: US 2020/0138573) in view of Kalfa et al. (WO 2017/162645) as applied above, however, Shang and Kalfa do not fairly teach or suggest PGS and PCL are in a ratio of between about 1:1 to 4:1; the ratio of PGS:PCL is about 3:1; or that the tube comprises about 50 weight % polycarbonate urethane, 25 weight % PGS and 25 weight % PCL.
Claims 18-19, 22 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. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Shang et al. Pub. No.: US 2020/0138573, as applied above, however, Shang does not fairly teach or suggest PGS and PCL are in a ratio of between about 1:1 to 4:1; the ratio of PGS:PCL is about 3:1; or that the tube comprises about 50 weight % polycarbonate urethane, 25 weight % PGS and 25 weight % PCL.
Claims 32-34 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. The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is Kalfa et al. (WO 2017/162645) as applied above, however, Kalfa does not fairly teach or suggest PGS and PCL are in a ratio of between about 1:1 to 4:1; the ratio of PGS:PCL is about 3:1; or that the tube comprises about 50 weight % polycarbonate urethane, 25 weight % PGS and 25 weight % PCL.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774