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 .
Status of Claims
This office action is responsive to the amendment filed on 08/04/2026. As directed by the amendment: claims 1 and 4 have been amended, no claims have been cancelled and no new claims have been added. Thus, claims 1-20 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1, 2, 8, 9, 13, 14 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann et al. (US PG Pub. 2022/0257367), as previously disclosed, hereinafter Neumann.
Regarding claims 1, 2 and 19, Neumann discloses a prosthetic heart valve (700), illustrated in Figures 29 and 30, and a method of radially expanding the prosthetic heart valve, wherein the prosthetic heart valve (700) comprises a link (712) extending along an axial direction; and a radially expandable frame (702) comprising a plurality of struts (704) comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes/junctions; a first pivot node/junction comprising a first pivot pin (732), attached to the link (712), and extending through apertures in first inner and outer struts (704) to pivotally connect the first inner and outer struts (704); and a second pivot node/junction comprising a second pivot pin (730) extending through apertures in second inner and outer struts (704) to pivotally connect the second inner and outer struts (704), wherein the second pivot node/pin (730) is slidably connected to, and configured to move relative to, the link (712) via an axial slot (738) in the link, along the axial direction, via member (716); and radially expanding the radially expandable frame (700) from a radially retracted orientation to a radially expanded orientation while the second pivot node/pin translates relative to, and slidably connected to, the link (712) in the axial direction, via member (716), illustrated in Figures 29-32 ([0279]; [0383] & [0386] – [0389]).
Regarding claims 8 and 9, Neumann discloses the prosthetic heart valve of claim 1, wherein the plurality of pivot nodes/junctions further comprises an intermediate pivot node, comprising an intermediate pivot pin (30), positioned between the first pivot node (at pin 732/16) and the second pivot node (at pin 730/14) and extending through apertures (114) third outer and inner struts (704/28) to pivotally connect the third inner and outer struts (704/28), illustrated in Figures 1, 4, 29 and 30 ([0279] & [0383]).
Regarding claim 13, Neumann discloses the prosthetic heart valve of claim 1, further comprising a plurality of leaflets (22), wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint (24) that is connected to the second pivot node (30), wherein the commissural joint is configured to move together with the second pivot node relative to the link (34) along the axial direction, illustrated in Figure 1 ([0275] & [0384], Lines 1-4).
Regarding claim 14, Neumann discloses the prosthetic heart valve of claim 13, further comprising a skirt at least partially circumscribing an interior area defined by the radially expandable frame, the plurality of leaflets each comprise a margin of attachment to the skirt, wherein the skirt is mounted relative to the radially expandable frame ([0277] & [0384], Lines 1-4).
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 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann.
Regarding claim 3, Neumann discloses the prosthetic heart valve of claim 2, and though it is not specifically disclosed that the first pivot pin extends through an aperture in the link to attach the first pivot node to the link, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way to attach the first pivot pin to the link, including the link having an aperture for the first pivot pin to extend through, since this is an art equivalent means for attaching a pivot pin to the link.
Regarding claim 18, Neumann discloses the prosthetic heart valve of claim 14, and though it is not specifically disclosed that the first pivot pin extends through an aperture in the skirt to directly attach the skirt to the first pivot node, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way to attach the skirt, including the skirt having an aperture for the first pivot pin to extend through, since this is an art equivalent means for attaching a skirt to a frame of a heart valve. Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the skirt being attached by having an aperture for the first pivot pin to extend through, as opposed to being attached another way, i.e. without an aperture.
Response to Arguments
Applicant's arguments filed 08/04/2026 have been fully considered but they are not persuasive. Applicant argues the rejection of independent claim 1 as being unpatentable over the prior art of Neumann, stating that the newly added parameter of the second pivot node being slidably connected to the link via an axial slot in the link is not taught by Neumann. Examiner respectfully disagrees with Applicant’s assertion. As detailed in the rejection section, Neumann teaches the second pivot node/pin (730) slidably connected to the link (712) via an axial slot (738) in the link, by member (716), illustrated in Figures 31 and 32 ([0390]). It is to be noted, that the limitation that made, and still makes, claim 4 allowable is that “the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link”. Thus, the rejection of independent claim 1, as it currently stands, is deemed to be proper since Neumann teaches all the structural limitations set forth in the claim; hence, the rejection stands.
Allowable Subject Matter
Claims 4-7, 10-12, 15-17 and 20 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.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 09/24/2026
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