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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claimed invention in claim 1 recites “the supplemental valve structure extends into at least one of the inferior vena cava; and the supplemental valve being positioned in or adjacent the right atrium…” This reads on the valve being in contact with the body. Applicant is advised to change the term “extends into” to “configured to extend into” and “being positioned in or adjacent” to “configured to be positioned in or adjacent to.”
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.
Claims 1-5, 9-10, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No 2017/0165061 granted to Figulla et al (hereinafter “Figulla”).
In reference to claim 1, Figulla discloses a supplemental valve apparatus for implantation into the right atrium, comprising: a supplemental valve [e.g. Figure 1: heart valve 15]; and the supplemental valve coupled to at least one supplemental valve structure [e.g. Figure 1: support structure 11], the supplemental valve structure extends into at least one of the inferior vena cava or superior vena cava [e.g. 0037]; and the supplemental valve being positioned in or adjacent the right atrium [e.g. 0037].
In reference to claim 2, Figulla discloses wherein: the supplemental valve is a biologic valve [e.g. 0039].
In reference to claim 3, Figulla discloses wherein: the supplemental valve apparatus is positioned within the right atrium, and anchored in position by a structure extending into the inferior vena cava and into the superior vena cava [e.g. 0038].
In reference to claim 4, Figulla discloses wherein: the supplemental valve apparatus includes one or more of a jacket and/or seal(s) [e.g. Figure 1: fluid tight covering 16] to direct blood flow from the inferior vena cava and superior vena cava through the supplemental valve [e.g. 0039].
In reference to claim 5, Figulla discloses wherein: the supplemental valve apparatus is configured to enable percutaneous delivery via a delivery system [e.g. 0032 and 0041].
In reference to claim 9, Figulla discloses a method for treating a compromised tricuspid valve, comprising: a supplemental valve apparatus [e.g. heart valve prosthesis 10] including a supplemental valve [e.g. heart valve 15]; leaving the existing tricuspid valve in position [e.g. 0037]; placing a supplemental valve in or adjacent the right atrium [e.g. 0037]; maintaining the position of the supplemental valve with a structure located at least in part within the superior vena cava and/or the inferior vena cava [e.g. 0037-0038]; and directing blood flow from the superior vena cava and inferior vena cava through the supplemental valve [e.g. 0039].
In reference to claim 10, Figulla discloses wherein the supplemental valve apparatus is delivered to the desired location percutaneously [e.g. 0032].
In reference to claim 14, Figulla discloses wherein: the supplemental valve is deployed in or adjacent the right atrium, and then the supplemental valve apparatus is anchored in position [e.g. 0037-0038].
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.
Claims 6-8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Figulla in view of U.S. Patent Application Publication No 2020/0129290 granted to Ottma et al (hereinafter “Ottma”).
In reference to claim 6, Figulla discloses the supplemental valve apparatus includes a delivery system for deploying a supplemental valve into the right atrium [e.g. 0032]; the supplemental valve apparatus having a supplemental valve [e.g. 0039], an inferior vena cava leg for anchoring at least a portion of the supplemental valve apparatus in the inferior vena cava, and a superior vena cava leg, for anchoring at least a portion of the supplemental valve apparatus in the superior vena cava [e.g. 0038]. Figulla, however, fails to disclose an inner shaft; an outer shaft; and a supplemental valve apparatus positioned between the inner shaft and the outer shaft, the outer shaft configured to be retracted with respect to the inner shaft to deploy the supplemental valve apparatus. Ottma discloses a catheter system for implantation of prosthetic valves and describes an inner shaft [e.g. Figure 4: cannula 12], an outer shaft [e.g. Figure 4: sleeve 7]; and a supplemental valve apparatus positioned between the inner shaft and the outer shaft, the outer shaft configured to be retracted with respect to the inner shaft to deploy the supplemental valve apparatus [e.g. Figure 4: anchoring support 10 is located between cannula 12 and sleeve 7]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Figulla to include the inner and outer shaft and the supplemental valve apparatus located between the two as taught by Ottma, since such a modification would provide the predictable results of being able to implant the valve with minimal invasion.
In reference to claim 7, Figulla discloses the supplemental valve apparatus includes a delivery system for deploying a supplemental valve into the right atrium [e.g. 0032]; the supplemental valve apparatus having a supplemental valve [e.g. 0039], an inferior vena cava leg for anchoring at least a portion of the supplemental valve apparatus in the inferior vena cava, and a superior vena cava leg, for anchoring at least a portion of the supplemental valve apparatus in the superior vena cava [e.g. 0038]. Figulla, however, fails to disclose a distal shaft; a proximal shaft; and a supplemental valve apparatus positioned between the distal shaft and the proximal shaft, the distal shaft configured to be advanced with respect to the proximal shaft to deploy the supplemental valve apparatus. Ottma discloses a catheter system for implantation of prosthetic valves and describes a distal shaft [e.g. Figure 4: sleeve-shaped element 5]; a proximal shaft [e.g. Figure 4: sleeve 4]; and a supplemental valve apparatus positioned between the distal shaft and the proximal shaft, the distal shaft configured to be advanced with respect to the proximal shaft to deploy the supplemental valve apparatus [e.g. Figure 4: anchoring support 10 is located between cannula 12 and sleeve 7; paragraph 0062]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Figulla to include distal and proximal shaft and the supplemental valve apparatus located between the two as taught by Ottma, since such a modification would provide the predictable results of being able to implant the valve with minimal invasion.
In reference to claim 8, Figulla discloses the supplemental valve apparatus includes a delivery system for deploying a supplemental valve into the right atrium [e.g. 0032]; the supplemental valve apparatus having a supplemental valve [e.g. 0039], an inferior vena cava leg for anchoring at least a portion of the supplemental valve apparatus in the inferior vena cava, and a superior vena cava leg, for anchoring at least a portion of the supplemental valve apparatus in the superior vena cava [e.g. 0038]. Figulla, however, fails to disclose a distal shaft; a proximal shaft; an outer shaft; and a supplemental valve apparatus positioned between the distal shaft and the proximal shaft, the distal shaft configured to be advanced with respect to the proximal shaft to deploy the supplemental valve apparatus. Ottma discloses a catheter system for implantation of prosthetic valves and describes a distal shaft [e.g. Figure 4: sleeve-shaped element 5]; a proximal shaft [e.g. Figure 4: sleeve 4]; an outer shaft [e.g. Figure 4: sleeve 7]; and a supplemental valve apparatus positioned between the distal shaft and the proximal shaft, the distal shaft configured to be advanced with respect to the proximal shaft to deploy the supplemental valve apparatus [e.g. Figure 4: anchoring support 10 is located between cannula 12 and sleeve 7; paragraph 0062]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Figulla to include distal, proximal, and outer shaft and the supplemental valve apparatus located between the two as taught by Ottma, since such a modification would provide the predictable results of being able to implant the valve with minimal invasion.
In reference to claims 11-13, Figulla discloses a method for treating a compromised tricuspid valve but fails to disclose the supplemental valve apparatus is deployed at least in part by advancing a distal shaft and retracting an outer shaft. Ottma discloses a catheter system for implantation of prosthetic valves and describes a valve apparatus being deployed at least in part by retracting an outer shaft [e.g. 0060] and the valve apparatus being deployed at least in part by advancing a distal shaft [e.g. 0062]. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Figulla to have the supplemental valve apparatus deployed at least in part by advancing a distal shaft and retracting an outer shaft as taught by Ottma, since such a modification would provide the predictable results of implanting the valve with minimal invasion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NADIA AHMAD MAHMOOD whose telephone number is (571)270-3975. The examiner can normally be reached Monday-Friday 8am-4pm.
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/NADIA A MAHMOOD/Primary Examiner, Art Unit 3796