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 .
Response to Arguments
In view of the amendments filed on 9/5/2025, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection of claim 11 is moot. The antecedent basis issue of claim 16 has not been corrected; and therefore, the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection of claim 16 has been maintained.
Applicant’s arguments with respect to claim(s) 1-9, 12-23, and 25-29 have been considered, but are moot in view of the new grounds of 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.
Claims 16, 27, and their 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 the limitation "the interstage." Claim 27 recites the limitation “the tissue frame.” There is insufficient antecedent basis for these limitations in the claims. 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) 1-2, 4-5, 7, 9, 12-13, 16-20, 23, and 25-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oba et al. (Pub. No.: US 2016/0310268 A1; hereinafter “Oba”).
Oba discloses the following regarding claim 1: a prosthetic valve comprising: a support structure (e.g., Figs. 9-13) including: a leaflet frame (322); and an anchor frame (302) coupled to the leaflet frame (Figs. 9-31); and one or more leaflets (328) coupled to the leaflet frame (Figs. 9-13); and a tissue cutting element (318) coupled to the support structure (Figs. 9-13) such that relative movement between the leaflet frame and the anchor frame transitions the tissue cutting element from a non-cutting state (compressed state) to an active state (expanded state) in which the tissue cutting element is configured to cut tissue (as the leaflet and the anchor frames are moved into a fully expanded state) (paras. 0009-0016).
Oba discloses the following regarding claim 2: the prosthetic valve of claim 1, wherein the tissue cutting element includes at least two tissue cutting elements (Figs. 9-13).
Oba discloses the following regarding claim 4: the prosthetic valve of claim 1, wherein the tissue cutting element is configured to be held proximate the support structure in the non-cutting state (in the collapsed state) and to project away from the support structure in the active state (in the expanded state) (paras. 0009-0016).
Oba discloses the following regarding claim 5: the prosthetic valve of claim 1, wherein the tissue cutting element has one or more cutting edges that are sufficiently sharp that the one or more cutting edges are operable to cut through tissue promptly (para. 0103).
Oba discloses the following regarding claim 7: the prosthetic valve of claim 1, wherein: the tissue cutting element extends a length from the leaflet frame to a free end (Figs. 9-13); and the tissue cutting element includes one or more cutting edges that extend for less than the length of the tissue cutting element (Figs. 9-13; para. 0103).
Oba discloses the following regarding claim 9: the prosthetic valve of claim 1, wherein the tissue cutting element has a first cutting edge facing a first direction (at upper end of barb) and a second cutting edge facing a second direction (at lower end of barb) different than the first direction (Figs. 12-13).
Oba discloses the following regarding claim 12: the prosthetic valve of claim 1, wherein the support structure is configured to retain the tissue cutting element in the non-cutting state prior to deployment of the support structure (paras. 0009-0016).
Oba discloses the following regarding claim 13: the prosthetic valve of claim 1, wherein the tissue cutting element is configured to grasp and retain tissue in addition to cutting tissue (paras. 0075, 0103).
As best interpreted, Oba discloses the following regarding claim 16: the prosthetic valve of claim 1, wherein the interstage (cover) comprises a polymer membrane (paras. 0084, 0101-0105).
Oba discloses the following regarding claim 17: the prosthetic valve of claim 1, wherein the prosthetic valve is configured to replace a native mitral valve and the tissue to be cut is that of an anterior leaflet of the native mitral valve (para. 0101, where the shape and configuration of the valve is fully capable of these functions).
Oba discloses the following regarding claim 18: the prosthetic valve of claim 1, wherein the one or more leaflets are flexible leaflets and, formed of synthetic material (paras. 0106, 0155).
Oba discloses the following regarding claim 19: the prosthetic valve of claim 1, wherein the tissue cutting element is a single-edged cutting element (interpreted as the entire cutting edge of the barb) (Figs. 9-13).
Oba discloses the following regarding claim 20: the prosthetic valve of claim 1, wherein the tissue cutting element is a double-edged cutting element (interpreted as the upper cutting edge and the lower cutting edge of the barb) (Figs. 9-13).
Oba discloses the following regarding claim 23: a method of delivering the prosthetic valve of claim 1 to a treatment site, the method comprising: positioning the prosthetic valve at the treatment site (paras. 0101-0103); engaging the cutting element with native leaflet tissue at the treatment site to cut and grasp the native leaflet tissue (paras. 0016, 0072-0075, 0103).
Oba discloses the following regarding claim 25: the method of claim 23, wherein the native leaflet tissue is not cut at a time the tissue cutting element is first engaged with the native leaflet tissue (paras. 0016, 0072-0075, 0103, the engagement is interpreted as the time when the barbs are expanding, but before they fully penetrate the surrounding tissue).
Oba discloses the following regarding claim 26: the method of claim 23, wherein the native leaflet tissue is cut at a time the tissue cutting element is first engaged with the native leaflet tissue (paras. 0016, 0072-0075, 0103, the engagement is interpreted as the time when the barbs have fully expanded and penetrated the surrounding tissue).
Oba discloses the following regarding claim 27: the prosthetic valve of claim 1, wherein the tissue cutting element extends from the tissue frame (interpreted as the support frame) (Figs. 9-13).
Oba discloses the following regarding claim 28: the prosthetic valve of claim 1, wherein the tissue cutting element extends from the anchor frame (Figs. 9-13).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Drasler et al. (US Pat. No. 6,287,335 B1; hereinafter “Drasler”).
Oba discloses the limitations of the claimed invention, as described above. Oba further teaches the relative movement between the anchor frame and the leaflet frame including expanding the leaflet frame from a compressed state to an intermediate state prior to full expansion; and expanding the leaflet frame from the intermediate state to a fully expanded state (paras. 0009-0016). However, it does not explicitly recite two neighboring frame elements of the leaflet frame releasing the tissue cutting element thereby transitioning it from the non-cutting state to the active state. Drasler teaches that it is well known in the art that stent support structures comprise two neighboring frame elements (370) of the leaflet frame releasing the tissue cutting element (250) thereby transitioning it from the non-cutting state to the active state (Figs. 11A-11D; col. 44, lines 57- col. 45, lines 54), for the purpose of protecting the tissue cutting element and holding it away from the patient’s tissue until its desired deployment site. It would have been obvious to one having ordinary skill in the art to modify the device of Oba to comprise the tissue cutting element configuration, taught by Drasler, in order to protect the tissue cutting element and hold it away from the patient’s tissue until its desired deployment site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 6, 8, 14, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Dunham et al. (WO 2019/183372 A1; hereinafter “Dunham”).
Regarding claims 6 and 8, Oba discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the tissue cutting element has one or more cutting edges that are relatively dull such that the one or more cutting edges are operable to cut through tissue by eroding through the tissue over an extended period of time; and the tissue cutting element being configured as an electrosurgical cutting element. Dunham teaches that it is well known in the art that stent support structures comprise the tissue cutting element (202, 204) has one or more cutting edges that are relatively dull such that the one or more cutting edges are operable to cut through tissue by eroding through the tissue over an extended period of time (paras. 0041-0045), for the purpose of better controlling the penetration rate of the prosthesis into the surrounding tissue. Dunham further teaches that the tissue cutting element is configured as an electrosurgical cutting element (paras. 0041-0045). It would have been obvious to one having ordinary skill in the art to modify the device of Oba to comprise the tissue cutting elements, taught by Dunham, in order to better control the penetration rate of the prosthesis into the surrounding tissue. Such a modification would be made with a reasonable expectation of success.
Regarding claim 14, Oba discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the tissue cutting element formed of material that is at least one of bioresorbable and biocorrodible. Dunham teaches that it is well known in the art the tissue cutting element is formed of material that is at least one of bioresorbable and biocorrodible (para. 0043), for the purpose of utilizing the material’s degradation properties and assist in healing the surrounding tissue. It would have been obvious to one having ordinary skill in the art to modify the material of the tissue cutting element of Oba according to the teachings of Dunham, in order to utilize the material’s degradation properties and assist in healing the surrounding tissue. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Regarding claim 29, 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 period of time needed for the tissue cutting element to properly cut the surrounding tissue and achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the period of time needed for the tissue cutting element, would have been obvious at the time of applicant's invention in view of the teachings of Oba and Dunham. 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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba in view of Bruchman et al. (Pub. No.: US 2014/0172083 A1; hereinafter “Bruchman”).
Oba discloses the limitations of the claimed invention, as described above. However, it does not recite the tissue cutting element being elastically deformable so as to be self-expanding under spring bias forces to project away from the support structure. Bruchman teaches that it is well known in the art that stent support structures and their components are elastically deformable so as to be self-expanding under spring bias (paras. 0102-0105), for the purpose of allowing the device to be more easily expanded at its implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of Oba to comprise self-expanding components, as taught by Bruchman, in order to allow the device to be more easily expanded at its implantation site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oba.
Oba discloses the limitations of the claimed invention, as described above. However, it is silent as the radius of curvature of the cutting edge of the tissue cutting element. 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 radius of curvature of the cutting edge of the tissue cutting element needed to properly cut the surrounding tissue and achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the radius of curvature of the cutting edge of the tissue cutting element, would have been obvious at the time of applicant's invention in view of the teachings of Oba. 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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