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 without traverse of Group I, Species B, and sub-species 1 in the reply filed on 6/12/2026 is acknowledged. Claims 28-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/12/2026. The requirement is still proper and is therefore made FINAL.
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 4, 17, and their dependent claims 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). Claims 4 and 17 recite that each of the first and second anchor points comprising the medial and the lateral trigone and an area having a radius of 3 mm surrounding each of the medial and lateral trigones. This language positively recites a part of the human anatomy. Appropriate correction is required. It is recommended that the Applicant use functional language to overcome the present rejection.
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 16 and its dependent claims 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. Claim 16 recites a first anchor point and a second anchor point. It is unclear if these elements are intended to be the same anchor points as those recited in claim 15. Appropriate correction is required.
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)(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.
Claim(s) 1, 7-9, 12, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLean et al. (WO 2019/045910 A1; hereinafter “McLean”).
McLean discloses the following regarding claim 1: a mitral valve repair apparatus, comprising a frame (704) having an annulus section (central section), an atrial section (upper section) extending from a superior aspect of the frame (Figs. 7B-7C), and a ventricle section (lower section) extending from an inferior aspect of the frame (Figs. 7B-7C); a posterior leaflet (714) having one or more scallops (curved, end portions) connected to the frame (Figs. 7A-7B) such that the one or more scallops extend from the frame for coaptation against a native anterior leaflet when the frame is deployed (Figs. 7A-7B; paras. 000115-000116); at least one arm member (702B) connected to the frame such that the at least one arm member extends laterally in a curved configuration configured to approximate a curvature of a native mitral annulus when the frame is deployed (Figs. 7A-7C); and an anchoring leg (720) connected to the frame such that the anchoring leg extends in a superior direction from a posterior side of the frame (Figs. 7B-7C) and defines a capture region between the anchoring leg and the posterior side where the capture region is sized to receive at least a portion of a native posterior leaflet in an elongated state when the frame is deployed (Fig. 7C; paras. 000115-000118).
McLean discloses the following regarding claim 7: the apparatus of claims 1, wherein at least a portion of the mitral valve repair apparatus comprises a membrane or fabric layer (708).
McLean discloses the following regarding claim 8: the apparatus of claim 1, wherein the one or more scallops comprise a P1, P2, and P3 scallop each connected to the frame (paras. 00076, 000102-000105).
McLean discloses the following regarding claim 9: the apparatus of claim 1, wherein the posterior leaflet has a width configured to span an arc length of between 0 to 100% of the native posterior leaflet (Figs. 7A-7C).
McLean discloses the following regarding claim 12: the apparatus of claim 1, wherein the anchoring leg has a width sized for introduction between a chordae tendinea bundle of a lateral papillary muscle and a chordae tendinea bundle of a medial papillary muscle of a subject (Fig. 7C; paras. 000115-000118).
McLean discloses the following regarding claim 14: the apparatus of claim 1, wherein the anchoring leg comprises a first leg attachment (left side attachment point) connected to a first portion of the frame (Figs. 7A-7B) and a second leg attachment (right side attachment point) connected to a second portion of the frame (Figs. 7A-7B) such that the anchoring leg has a middle section (central portion) defining a radially outward bend (Figs. 7A-7B).
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) 2-6 and 15-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean in view of Gabbay (Pub. No.: US 2003/0199975 A1).
Regarding claims 2-6, McLean discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the at least one arm member comprising a first arm and a second arm each extending laterally from the frame. Gabbay teaches that it is well known in the art that a mitral valve repair device comprises a first arm (struts of elements 556) and a second arm (struts of elements 558) each extending laterally from the frame (Figs. 17-19; paras. 0101-0104). The first arm member comprises a first anchor point (attachment point of elements 556) and the second arm member (attachment point of elements 558) comprises a second anchor point where each anchor point is configured to align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject (Figs. 17-19, where the size and the shape of the anchor points allow them to be fully capable of being positioned such that they align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject). Gabbay further teaches that each of the first and second anchor points have a size and a shape that can cover the medial and the lateral trigone area and an area having a radius of 3 mm surrounding each of the medial and lateral trigones (Figs. 17-19). The first and second anchor points of Gabbay each comprise an opening (open spaces of elements 554 located at the anchor points) for accommodating a position of the medial and the lateral trigones (Figs. 17-19); and the first and second anchor points each comprise a slot (open spaces of elements 554 located adjacent the anchor points) for accommodating the position of the medial and the lateral trigones (Figs. 17-19). This configuration facilitates the device to more securely grip the surrounding tissue when implanted (paras. 0101-0104). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the arm of McLean to have the configuration taught by Gabbay, in order to more securely grip the surrounding tissue when implanted. Such a modification would be made with a reasonable expectation of success.
McLean teaches the following regarding claim 15: a mitral valve repair apparatus, comprising a frame (704) having an annulus section (central section), an atrial section (upper section) extending from a superior aspect of the frame (Fig. 7B), and a ventricle section (lower section) extending from an inferior aspect of the frame (Fig. 7B); a posterior leaflet (714) having one or more scallops (rounded edge portions) connected to the frame such that the one or more scallops extend from the frame for coaptation against a native anterior leaflet when the frame is deployed (Figs. 7A-7B; paras. 000115-000116); and an anchoring leg (720) connected to the frame such that the anchoring leg extends in a superior direction from a posterior side of the frame (Figs. 7B-7C) and an apex (Fig. 7A) of the anchoring leg defines a bend angle which curves away from the frame when deployed (Figs. 7A-7C), wherein the anchoring leg and the posterior side define a capture region therebetween which is sized to receive at least a portion of a native posterior leaflet in an elongated state when the frame is deployed (Fig. 7C; paras. 000115-000118).
Regarding claims 15-19, McLean further teaches an arm member (702B). However, it does not explicitly recite a first arm and a second arm each extending laterally from the frame. Gabbay teaches a first arm member (struts of elements 556) connected to a first portion of the frame and a second arm member (struts of elements 558) connected to a second portion of the frame such that the first arm member and the second arm member each extend laterally in a curved configuration opposite to one another to each approximate a curvature of a native mitral annulus when the frame is deployed frame (Figs. 17-19; paras. 0101-0104). A first anchor point (attachment point of elements 556) is located along the first arm member (Figs. 17-19) and a second anchor point (attachment point of elements 558) is located along the second arm member (Figs. 17-19). The first anchor point and the second anchor point are each positioned to coincide with a respective first tissue location and a second tissue location (Figs. 17-19). The first arm member comprises a first anchor point (interpreted to be the same element as that of claim 15) and the second arm member comprises a second anchor point (interpreted to be the same element as that of claim 15) where each anchor point is configured to align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject (Figs. 17-19, where the size and the shape of the anchor points allow them to be fully capable of being positioned such that they align respectively with or in proximity to a medial and a lateral trigone of a left atrium of a subject). Each of the first and second anchor points that can cover the medial and the lateral trigone and an area having a radius of 3 mm surrounding each of the medial and lateral trigones (Figs. 17-19). The first and second anchor points each comprise an opening (open spaces of elements 554 located at the anchor points) for accommodating a position of the medial and the lateral trigones (Figs. 17-19); and the first and second anchor points each comprise a slot (open spaces of elements 554 located adjacent the anchor points) for accommodating the position of the medial and the lateral trigones (Figs. 17-19). This configuration facilitates the device to more securely grip the surrounding tissue when implanted (paras. 0101-0104). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the arm of McLean to have the configuration taught by Gabbay, in order to more securely grip the surrounding tissue when implanted. Such a modification would be made with a reasonable expectation of success.
McLean teaches the following regarding claim 20: the apparatus of claims 15, wherein at least a portion of the mitral valve repair apparatus comprises a membrane or fabric layer (708).
McLean teaches the following regarding claim 21: the apparatus of claim 15, wherein the one or more scallops comprise aP1, P2, and P3 scallop each connected to the frame (paras. 00076, 000102-000105).
McLean teaches the following regarding claim 22: the apparatus of claim 15, wherein the posterior leaflet has a width configured to span an arc length of between 0 to 100% of the native posterior leaflet (Fig. 7A-7C).
Regarding claims 23-24 and 26, McLean, as modified by Gabbay, teaches the limitations of the claimed invention, as described above. However, they do not explicitly recite the widths of the posterior leaflet and the anchoring leg. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal widths of the posterior leaflet and the anchoring leg needed to achieve the desired results and to properly fit a particular patient’s anatomy. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the widths of the posterior leaflet and the anchoring leg, would have been obvious at the time of applicant's invention in view of the teachings of McLean and Gabbay. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
McLean teaches the following regarding claim 25: the apparatus of claim 15, wherein the anchoring leg has a width sized for introduction between a chordae tendinea bundle of a lateral papillary muscle and a chordae tendinea bundle of a medial papillary muscle of a subject (Fig. 7C; paras. 000115-000118).
McLean teaches the following regarding claim 27: the apparatus of claim 15, wherein the anchoring leg comprises a first leg attachment (left side attachment point) connected to a first portion of the frame (Figs. 7A-7B) and a second leg attachment (right side attachment point) connected to a second portion of the frame such that the anchoring leg has a middle section (central section) defining a radially outward bend (Figs. 7A-7B).
Claim(s) 10-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean.
McLean discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the widths of the posterior leaflet and the anchoring leg. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal widths of the posterior leaflet and the anchoring leg needed to achieve the desired results and to properly fit a particular patient’s anatomy. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the widths of the posterior leaflet and the anchoring leg, would have been obvious at the time of applicant's invention in view of the teachings of McLean. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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