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 .
Drawings
The drawings were received on 4/20/26. These drawings are acceptable.
Response to Arguments
Applicant’s arguments, see page 2 of remarks (pg 11 of response), filed 4/20/26, with respect to the claim recitation of “window” lacking written support have been fully considered and are persuasive. The 112(a) rejection of claims 121-140 has been withdrawn. However, while Applicant's arguments pertaining to the “window” recitation pertaining to support of the intended feature have been fully considered but they are not persuasive regarding clarity. Applicant contends that several paragraphs of the specification with different features together define the limitation of “windows” that was questioned by the examiner as not properly described in the specification of which was rejected under 112 (a). While, the examiner has a better understanding of the intended feature to be claimed, no sufficient description or definition was provided by the use of the term “windows” and thus one does not know the boundaries of the claimed window.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). It is noteworthy, that the limitation at issue is never used in the specification. MPEP 2173.05(a) III. States Until the meaning of a term or phrase used in a claim is clear, a rejection under 35 U.S.C. 112 (b) is appropriate.
In addition the comments pertaining to the issue of the recitation “valve sealing cover… configured to prevent flow through the valve frame” see page 3 of remarks (pg 12 of response), filed 4/20/26, with respect to the claim lacking clarity for flow blockage have been fully considered and are persuasive in view of the amendment to claim 121. However, as already mentioned, the claim (s) still lack clarity for “window” and is being presented under a 112 (b) rejection.
Applicant’s arguments with respect to claim(s) 121 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 121-140 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “window” in claims 121-127, 129, 130, 132, 133 is used by the claim to mean “gap or opening,” while the accepted meaning is “hole in structure provided with surrounding framework.” The term is indefinite because the specification does not clearly redefine the term. No where is the term used or a structure with an opening disposed therein to define a window. Applicant is trying to claim some arbitrary space about the structures of the apparatus.
Claims 127 and 132 respectively recite the limitations "the plurality of leaflets" and “three leaflets” in the claims, but claim 121 had recited both (artificial) leaflets and native leaflets. There is insufficient antecedent basis for these limitations in the claims to know for sure which is meant, the (artificial) or native.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 121-124,138,139 are rejected under 35 U.S.C. 103 as being unpatentable over Naor et al. (CN 108463189) in view of LV et al. (WO 2018/077144). Fig. 13A shows a prosthetic heart valve device for treating a deficient native atrioventricular valve of a heart comprising a native atrium, a native annulus and a native ventricle, the prosthetic heart valve device comprising: an expandable valve frame 530 forming an annular flow path extending in an axial direction, the expandable valve frame comprising: an inflow region; a mid-region connected to the inflow region; an outflow region connected to the mid-region; a plurality of leaflets 1310 mounted to the expandable valve frame to control flow through the annular flow path. Figs. 19A,19B shows a valve sealing cover 1905 extending across the inflow region and the outflow region and configured to prevent paravalvular flow through a wall of the expandable valve frame. Fig. 12B shows an anchoring structure 1210 configured to surround the expandable valve frame i.e. 1201 (note Fig. 13A did not detail with a reference number the outer frame, but note the specification mentioned the internal valve frame) . Fig. 13E shows how anchoring structure connects to the expandable valve frame via a plurality of connection elements 1320. Fig. 2A shows how the anchoring structure 205 comprising: an atrial region configured to be positioned within the native atrium 102 of the heart; an annular region configured to surround the expandable valve frame, positioned within the native annulus 103 of the heart; a ventricular region configured to be positioned within the native ventricle 108 of the heart. Fig. 2B shows the placement of the anchoring structure 205 with an annular region and a ventricular region with ventricular structure 211. It is noted that Naor et al. disclose (pages 17,20 of translation) anchor sealing cover extending over the anchoring structure to prevent paravalvular flow through the anchoring structure, see i.e. Figs. 10A-D. However, Naor et al. did not explicitly disclose the ventricular region comprising a plurality of ventricular conformance structures wherein spacing between the plurality of connection elements form at least one window defined between adjacent ventricular conformance structures of the anchoring structure and sized to allow a native valve leaflet to move freely therethrough without contact with the anchoring structure when the prosthetic heart valve device is in a radially expanded state in accordance with a native valve leaflet. LV et al. show (Fig. 8d) a plurality of ventricular conformance structures 514, 515 wherein spacing between the plurality of connection elements form at least one window defined between adjacent ventricular conformance structures of the anchoring structure (page 15 of translation) and sized to allow a native valve leaflet to move freely therethrough without contact with the anchoring structure when the prosthetic heart valve device is in a radially expanded state in accordance with a native valve leaflet. It would have been obvious to provide at least one window formed from spacing between connection elements and adjacent ventricular conformance structures of the anchoring structure as taught by LV et al. in the prosthetic valve of Naor et al. such that it aids in stabilizing the prosthetic device, see LV page 15 of translation. With respect to claims 122,123 it is inherent the at least one window per LV et al. forms a void within the anchoring structure to avoid blood flow obstruction and defines a space between adjacent connection elements that allows blood to flow therethrough. Regarding claim 124, it is inherent the at least one window per LV et al. forms a gap in a ventricular region of the anchoring structure that is configured to not push against the native valve leaflet when the prosthetic heart valve device is expanded. Regarding claim 138, Naor et al. disclose (pages 12,22 of translation) the prosthetic heart valve device is configured to controllably transition between a radially compressed state configured for delivery, and a radially expanded state configured for implantation. Regarding claim 139, Naor further disclose (page 5 of translation) the expandable valve frame, together with the plurality of leaflets mounted thereto, is configured to transition between a blood-flow permitting state and a blood-flow preventing state.
Claim(s) 140 is rejected under 35 U.S.C. 103 as being unpatentable over Naor et al. (CN 108463189) in view of LV et al. (WO 2018/077144) as applied to claim 121 above, and further in view of Freudenthal (WO 2014026870). Naor et al. in view of LV et al. is explained supra. However, Naor et al. in view of LV et al. did not explicitly detail that the inflow region has a first stiffness; the mid-region has a second stiffness; and the outflow region has a third stiffness. Freudenthal teaches (Figs. 10,11) that a prosthetic heart valve frame is configured with the inflow region has a first stiffness; the mid-region has a second stiffness; and the outflow region has a third stiffness. It would have been obvious to one of ordinary skill in the art to provide a different stiffness in the inflow, outflow and middle region of the prosthetic valve as taught by Freudenthal in the valve of Naor et al. as modified by LV et al. such that one can be flexible in implanted states and during delivery, see pages 4,5,20 of translation of Freudenthal.
Allowable Subject Matter
Claims 125,128,129 and 136 if combined together with claim 121 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
Prosecution Insights