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 Objections
Claim 12 is objected to because of the following informalities:
In line 4, “third inner strut plurality of inner struts” should be changed to “third inner strut of the plurality of inner struts”
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 14, 15, 19, and 20 respectively of copending Application No. 18/625,399 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims disclose the same subject matter except that the copending application refers to the presently claimed “link axis” and an “axial direction”.
Claims 1, 8, 9, 11, 12, 13, 14, 15, 16, 17, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 8, 9, 13, 14, 15, 18, and 19 respectively of copending Application No. 18/533,327 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims disclose the same subject matter except that the copending application refers to the presently claimed “link axis” and an “axial direction”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1, 8, 9, 11-15, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neumann et al. (US 2022/0257367).
Regarding claim 1, Neumann discloses a prosthetic heart valve (700, FIG 29-40, [0383-0400]) comprising: a link (712) extending along a link axis (FIG 30); and a radially expandable frame (702) comprising: a plurality of struts (704) comprising a plurality of inner struts (Struts angled in a downward direction and having full line hash marks in FIG 30) pivotally attached to a plurality of outer struts (struts angled in an upward direction and having dots markings in FIG 30) at a plurality of pivot nodes (Pivot point as shown by pins, [0383 and 0387]); a first pivot node (Node formed at 732, FIG 31, [0388]) of the plurality of pivot nodes pivotally connecting a first inner strut of the plurality of inner struts to a first outer strut of the plurality of outer struts at the first pivot node (732 forms an pivot point of attachment for the struts and is pivotable relative to 712), and the first pivot node is attached to the link (FIG 31 and 32); and a second pivot node of the plurality of pivot nodes (Pivot point forms at 730, FIG 30-32) pivotally connecting a second inner strut of the plurality of inner struts to a second outer strut of the plurality of outer struts at the second pivot node ([0387]), and the second pivot node is slidably connected to the link (Because 716 slides relative to link 712, [0387-0389]), wherein the second pivot node is configured to move relative to the link along the link axis (The node at 730 moves relative to 712 as 716 slides therein, FIGs 29-30 and 31-32 show the movement).
Regarding claim 8, Neumann discloses the first pivot node comprises a first pivot pin extending through an aperture of the first inner strut and an aperture of the first outer strut to pivotally connect the first inner strut to the first outer strut ([0388] “a fastener 732 (e.g., a rivet or pin). The fastener 732 is affixed to and extends radially from the outer member 712 through corresponding apertures at a junction of two overlapping struts 704 and can serve as a pivot pin around which the two struts 704 can pivot relative to each other and the outer member 712. A nut (such as nut 562 described previously) can be mounted on each fastener 732 to retain the fastener within the corresponding apertures”), and the second pivot node comprises a second pivot pin extending through an aperture of the second inner strut and an aperture of the second outer strut to pivotally connect the second outer strut to the second inner strut ([0387] “The fastener can be, for example, a rivet or a pin. As shown, in some embodiments, the fastener 730 can extend through corresponding apertures at a junction of two overlapping struts 704 of frame 702 and can serve as a pivot pin around which the two struts 704 can pivot relative to one another and the inner member 716. In some embodiments, an end cap or nut can be disposed over and end portion of the fastener 730, such as nut 562 described above”).
Regarding claim 9, Neumann discloses the first pivot pin extends through an aperture in the link to attach the first pivot node to the link (732 forms a rivet which comprises an aperture to receive the pivot pin).
Regarding claim 11, Neumann discloses the link comprises an axial slot (738, FIG 31-32) extending along the link axis, and the second pivot pin extends through the axial slot to slidingly connect the second pivot node to the link ([0390]).
Regarding claim 12, Neumann discloses the plurality of pivot nodes further comprises an intermediate pivot node (Middle of the three axial aligned nodes shown in FIG 29-30) positioned between the first pivot node and the second pivot node (FIG 29-30) to pivotally connect a third outer strut of the plurality of outer struts to a third inner strut plurality of inner struts at the intermediate pivot node (The respective two struts attached to the third node define a third inner and outer strut).
Regarding claim 13, Neumann discloses the intermediate pivot node comprises an intermediate pivot pin extending through an aperture of the third inner strut and an aperture of the third outer strut to pivotally connect the third inner strut to the third outer strut (a pin is shown as projecting through the struts and understood to comprise respective apertures, [0383]).
Regarding claim 14, Neumann discloses a plurality of leaflets (22, FIG 1, [0275 and 0407]), wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint (24/26) that is connected to the second pivot node (At least by mechanical assembly of the device), wherein the commissural joint is configured to move together with the second pivot node relative to the link along the link axis (Because 26 is attached to 34 which is slidable relative to 36, equivalent to the link of the device of 700).
Regarding claim 15, Neumann discloses an inner skirt at least partially circumscribing an interior area defined by the radially expandable frame ([0277 and 0384]), the plurality of leaflets each comprise a margin of attachment to the inner skirt (By being assembly to the frame), wherein the inner skirt is mounted relative to the radially expandable frame ([0277 and 0384]).
Regarding claim 18, Neumann a method of radially expanding the prosthetic heart valve of claim 1, comprising radially expanding the radially expandable frame from a radially retracted orientation (FIG 30) to a radially expanded orientation (FIG 29) while the second pivot node translates relative to the link along the link axis while being slidably connected to the link (as 730 slides towards 712 and shown in the movement of arrow 734 in FIG 32, [0385 and 0389]).
Regarding claim 19, Neumann the prosthetic heart valve further comprises a plurality of leaflets (22, FIG 1, [0275 and 0407]), wherein two leaflets of the plurality of leaflets are connected to each other at a commissural joint (24/26), and radially expanding the radially expandable frame axially translates second pivot node together with the commissural joint relative to the link (Because 26 is attached to 34 which is slidable relative to 36, equivalent to the link of the device of 700).
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.
Claim(s) 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann et al. (US 2022/0257367) in view of Dvorsky et al. (US 2022/0280295).
Regarding claim 2-5, Neumann discloses the invention substantially as claimed, as set forth above for claims 1.
Neumann is silent regarding each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments, and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments wherein an inflection location between adjacent curved segments of the sinusoidal series of curves segments of another inner strut of the plurality of inner struts is pivotally connected to an inflection location between adjacent curved segments of the sinusoidal series of curved segments of another outer strut of the plurality of outer struts at another pivot node of the plurality of pivot nodes, wherein the radially expandable frame is configured to be radially expanded to radially expanded orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding convex surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding convex surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts, and wherein the radially expandable frame is configured to be radially retracted to a radially retracted orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding concave surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding concave surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts.
However, Dvorsky teaches in the same field of endeavor a prosthetic heart valve (300, FIG 8-9, [0091]) comprising a plurality of inner struts (308a) and a plurality of inner struts (308b) attached at a plurality of pivot notes (located at apertures 312, FIG 9), and further wherein each inner strut of the plurality of inner struts comprises a sinusoidal series of curved segments (324 and 326, FIG 9), and each outer strut of the plurality of outer struts comprises a sinusoidal series of curved segments (324 and 326, [0099-0101]) wherein an inflection (328) location between adjacent curved segments of the sinusoidal series of curves segments of another inner strut of the plurality of inner struts is pivotally connected to an inflection location between adjacent curved segments of the sinusoidal series of curved segments of another outer strut of the plurality of outer struts at another pivot node of the plurality of pivot nodes (328 forms at least one of the pivot nodes,[0099-0104]) , wherein the radially expandable frame is configured to be radially expanded to radially expanded orientation (Such as FIG 8) where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding convex surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts (Convex segments 324 of each respective strut are oriented in the same direction such that the corresponding surfaces are adjacent to one another, FIG 8), and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding convex surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts (Concave segments 326 are similarly arranged such that they align with adjacent strut segments), and wherein the radially expandable frame is configured to be radially retracted to a radially retracted orientation where convex surfaces of the sinusoidal series of curved segments of each inner strut of the plurality of inner struts each face a corresponding concave surface of the curved segment of a corresponding adjacent inner strut of the plurality of inner struts, and convex surfaces of the sinusoidal series of curved segments of each outer strut of the plurality of outer struts each face a corresponding concave surface of the curved segment of a corresponding adjacent outer strut of the plurality of outer struts (When the frame is collapsed to the radially retracted orientation, the concave and convex segments remain positioned in the same manner relative to one another due to the pivot node attachment points). Dvorsky further teaches an embodiment where linear struts are used (FIG 2A-4)
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the linear struts of Neumann with the sinusoidal struts taught by Dvorsky, for the purpose of substituting a strut shape commonly known in the art with the additional benefit of providing the frame with additional resistance against buckling or other deformation during expansion or use of the prosthetic valve ([0100]).
Regarding claims 6-7, Neumann/ Dvorsky disclose the invention substantially as claimed, as set forth above for claim 2. Neuamnn further discloses an outer skirt at least partially circumscribing an outer periphery defined by the radially expandable frame ([0277 and 0384]), wherein the outer skirt is mounted relative to the radially expandable frame ([0277]), wherein the outer skirt is directly attached to the plurality of outer struts and/or the plurality of inner struts with a plurality of sutures ([0277] “outer skirts can be mounted to the frame using sutures, an adhesive, welding, and/or other means for attaching the skirts to the frame”).
Claim(s) 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Neumann et al. (US 2022/0257367) in view of Barash et al. (US 2019/0105153).
Regarding claim 16, Neumann disclose the invention substantially as claimed, as set forth above for claim 15.
Neumann is silent regarding the inner skirt is directly attached to the link without a direct attachment to the radially expandable frame, wherein the inner skirt is indirectly attached to the radially expandable frame by the link.
However, Barash teaches a prosthetic heart valve frame (2100, FIG 52, [0327]) wherein a link (2130, [0331]) is provided with a plurality of apertures (2142) configured to receives sutures ([0332]). Further, Neumann discloses attaching the inner skirt to the frame using sutures ([0277]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the link of Neumann to comprise the apertures taught by Barash, for the purpose of providing an attachment point for the inner skirt to be attached to the frame using sutures. In the device as modified, the inner skirt is directly attached to the link without a direct attachment to the radially expandable frame (by being sutures to apertures in the link), wherein the inner skirt is indirectly attached to the radially expandable frame by the link.
Regarding claim 17, Neumann disclose the invention substantially as claimed, as set forth above for claim 15.
Neumann is silent regarding the first pivot pin extends through an aperture in the inner skirt to directly attach the inner skirt to the first pivot node.
However, Barash teaches a prosthetic heart valve frame (1900, FIG 46, [0313]) wherein an inner skirt (1940) is directly attached to a pivot node (1715) via a pivot pin extending through an aperture of the inner skirt ([0318] discloses “the connection of the inner struts 1712 and outer struts 1714 at junctions 1715 may be used to help secure the skirt to the inner frame sub-assembly 1710, such as by passing the projections 1716 through corresponding slits or openings in the skirt”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the inner skirt of Neumann to be attached to the frame at the pivot nodes by the pivot pin being received within an aperture of the skirt, as taught by Barash, for the purpose of utilizing a technique commonly known in the art for attaching the skirt to the frame.
Regarding claim 20, Neumann disclose the invention substantially as claimed, as set forth above for claim 19. Neumann further discloses the prosthetic heart valve further comprises a skirt at least partially circumscribing an interior area defined by the radially expandable frame ([0277 and 0384]), the plurality of leaflets each comprise a margin of attachment to the skirt (By being assembly to the frame).
Neumann is silent regarding an attachment location of the skirt is movably mounted to the link and wherein radially expanding the radially expandable frame translates that attachment location of the skirt relative to the link.
However, Barash teaches a prosthetic heart valve frame (2100, FIG 52, [0327]) wherein a link (2130, [0331]) is provided with a plurality of apertures (2142) configured to receives sutures ([0332]). Further, Neumann discloses attaching the inner skirt to the frame using sutures ([0277]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the link of Neumann to comprise the apertures taught by Barash, for the purpose of providing an attachment point for the inner skirt to be attached to the frame using sutures. In the device as modified, an attachment location of the skirt is movably mounted to the link and radially expanding the radially expandable frame translates that attachment location of the skirt relative to the link (because the skirt is slidable and pivotable relative to the sutures being used to attach it to the link).
Allowable Subject Matter
Claim 10 is 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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