DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 11,446,140. Although the claims at issue are not identical, they are not patentably distinct from each other because the application claim is merely broader than the patent claim. Here, all of the elements of application claim 1 are found in patent claim 6. The differences between the claims is that the patent claim includes many more elements and thus is much more specific. Thus the invention of claim 6 of the patent is in effect a “species” of the “generic” invention of application claim 1. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 1 is anticipated by patent claim 6, the claims are not patentably distinct.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 17-18, 20 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Rowe et al. (Pub. No.: US 2009/0319037).
Rowe et al. (hereinafter, Rowe) discloses a method for implanting a transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve in a connection channel (abstract), having a circumferential connection channel wall structure, between an atrial chamber and a ventricular chamber of a heart (abstract), the transcatheter atrio-ventricular valve prosthesis comprising an inner device 480 to be disposed in an interior of the connection channel (fig. 26), the inner device having a circumferential support structure which is radially expandable (fig. 23-26), and having a valve attached to the circumferential support structure (para. 102), and an outer device 441 to be disposed on an exterior of the connection channel (fig. 26), wherein the outer device at least partly extends around the inner device at a radial distance to the inner device (fig. 26), and wherein the inner and outer devices form a securing mechanism for securing the circumferential connection channel wall structure therebetween (fig. 27, para. 105), the method comprising: forwarding a catheter to a ventricular chamber of a heart (fig. 19); forwarding a wire 443 through the catheter to the ventricular chamber and guiding the wire around the circumferential connection wall structure (fig. 23); forwarding a catching wire 462, provided with a catching mechanism 460, through the catheter to the ventricular chamber of the heart (fig. 23-24); catching a free end of the wire with the mechanism and drawing the free end into the catheter to thereby allow the wire to form a contractible loop for providing the outer device around the circumferential connection wall structure (para. 101); forwarding the inner device into the interior of the connection channel (fig. 25); and radially expanding the inner device and radially contracting the loop to secure the circumferential connection channel wall structure therebetween (fig. 25-26).
For claim 18, Rowe discloses the method of claim 17, wherein the catching mechanism 460 is one of a catching snare and a catching basket (locking member is considered a snare, e.g., fig. 38).
For claim 20, Rowe discloses the method according to claim 17, wherein the catheter for forwarding the catching wire is forwarded to the ventricular chamber via an arterial retrograde approach entering the heart cavity over the aorta or via a venous access and through a puncture through the inter atrial septum (trans-septal approach) or via a puncture through the apex of the heart (trans-apical approach) or via a puncture through the atrial wall from outside the heart (trans-apical, see fig. 23-26).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-8, 11-16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe et al. (Pub. No.: US 2009/0319037) in view of Barone (Pub. No.: US 2010/0145438)
Rowe discloses a transcatheter atrio-ventricular valve prosthesis for functional replacement of an atrio-ventricular valve in a connection channel (abstract), having a circumferential connection channel wall structure, between an atrial chamber and a ventricular chamber of a heart (abstract), comprising:
an inner device 480 configured to be disposed in an interior of the connection channel, the inner device having a circumferential support structure which is radially expandable (e.g., fig. 23-26), and having a valve attached to the circumferential support structure (e.g., para. 102), wherein the circumferential support structure of the inner device is of tubular shape and extends along an axis and has two axial ends (e.g., fig. 36), and
an outer device 441 configured to be disposed on the exterior of the connection channel (e.g., fig. 23-26), wherein the outer device is configured to at least partly extend around the inner device at a radial distance to the inner device, and wherein the inner and outer devices are configured to form a securing mechanism for securing the circumferential connection channel wall structure therebetween (e.g., para. 103),
wherein the outer device is configured to form a ring, for extending circumferentially around the circumferential connection channel walt structure, between and at a distance to the axial ends of the inner device (fig. 23-26), and
the circumferential support structure of the inner device comprises an outer circumferential groove, and the ring of the outer device is configured to be aligned to the outer circumferential groove (not disclosed).
As detailed in italicized text above, Rowe lacks an outer circumferential groove on the inner device aligned with the ring of the outer device. Barone teaches providing an inner heart valve prosthesis with a circumferential groove 41 in order to retain a ring-shaped outer device 33 (fig. 6-8). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided Rowe with a circumferential groove as taught by Barone for the purpose of providing a complementary recess to retain the ring within the groove to prevent the ring from dislocating during leaflet motion in the cardiac cycle. This modification would have occurred using known methods and would have yielded predictable results.
For claim 2, Barone teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1 wherein the circumferential groove 41, in cross-section, has a width corresponding to the cross- sectional dimension of the ring or slightly greater than the cross-sectional dimension of the ring so that the circumferential connection channel wall structure can be clamped by the ring against opposing lateral walls of the circumferential groove (e.g., fig. 8).
For claim 3, Rowe teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1 wherein the outer device further comprises an anchor member (para. 109) having one or more anchor parts (e.g., umbrella-shaped barbs) to penetrate into the circumferential connection channel wall structure at a position at or close to the ring (para. 109), the anchor member comprising an eye, through which the ring extends to thereby be anchored on the circumferential connection channel wall structure at the position at or close to the ring by the anchor member (para. 109). It would have been obvious to one of ordinary skill in the art to interconnect the barbs of paragraph 106 with the ring using an eye as an obvious expedient to connect the two components together.
For claim 4, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is made of a mesh-like structure (e.g., fig. 26).
For claim 5, Barone teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is provided with a compressible material 56 arranged on and around the outer periphery of the circumferential support structure (fig. 13). It would have been obvious to include compressible material with the Rowe implant in order to provide a sealing material with the outer ring.
For claim 6, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the ring of the outer device is one of an open ring or a closed ring (e.g., fig. 27, closed ring).
For claim 7, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the ring is made of an elastic wire material (para. 94).
For claim 8, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device is formed as a clamp in the form of an open ring (para. 108).
For claim 11, Barone teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer surface of the circumferential support structure of the inner device is free of projections, with the circumferential groove being formed as a radially inwardly deepened recess in the circumferential support structure (e.g., fig. 12).
For claim 12, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure is radially expandable to be able to exert an active outward radial force against the inner periphery of the circumferential connection channel wall structure and/or wherein the outer device is contractible to be able to exert an active inward radial force against the outer periphery of the circumferential connection channel wall structure (para. 103-105).
For claim 13, Rowe discloses the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the circumferential support structure and/or the outer device are formed from a shape-memory material (para. 49, 94).
For claim 14, Rowe teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of staples arranged around the periphery of the inner device, each staple having a base member configured to extend at a radial distance to the inner device at a radial outer side of the inner device to thereby clamp the circumferential connection channel wall structure radially between the base member and the inner device, and each staple having penetration legs for radially penetrating the circumferential connection channel wall structure and engaging the inner device (para. 109). Use of staples with penetration legs are considered an obvious expedient to the “spring-loaded clamps, anchoring members having one or more hook or umbrella-shaped barbs, clasps, or other such clamping or fastening mechanisms.”
For claim 15, Rowe teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of clips (para. 109) arranged around the periphery of the inner device, each clip being of U-shape with a U-base portion and two U-leg portions, wherein an outer leg portion of the U- leg portions is configured to extend along and at a radial distance to the inner device at an outer side thereof, and an inner leg portion of the U-leg portions is configured to extend along and on an inner side of the inner device, wherein the U-leg portions are configured to radially clamp the circumferential connection channel wall structure and the inner device therebetween, wherein the clips may be arranged at an axial end of the circumferential support structure, and wherein the clips may be arranged at the other axial end of the circumferential support structure (para. 109). Use of u-base and U-leg clips is considered an obvious expedient to the “spring-loaded clamps, anchoring members having one or more hook or umbrella-shaped barbs, clasps, or other such clamping or fastening mechanisms.”
For claim 16, Rowe teaches the transcatheter atrio-ventricular valve prosthesis according to claim 1, wherein the outer device further comprises a plurality of arms (para. 109) extending around an outer periphery of the inner device at a radial distance thereto, to clamp the circumferential connection channel wall structure radially between the arms and the inner device (para. 109), each arm, starting from a free end thereof, is configured to extend in parallel and at a radial distance to the inner device to thereby form a corresponding radial gap therebetween for receiving the circumferential connection channel wall structure therein for clamping the circumferential connection channel wall between the respective arm and the inner device (para. 109), and each arm is configured to extend towards the inner device and is fixedly connected to the inner device, for example at an axial end of the circumferential support structure of the inner device, wherein the arms may be arranged at the other axial end of the circumferential support structure (this language is specified as optional in the claim). Rowe’s clamps are fully capable of engaging the heart valve. Use of arms is considered an obvious expedient to the “spring-loaded clamps, anchoring members having one or more hook or umbrella-shaped barbs, clasps, or other such clamping or fastening mechanisms.”
Claims 9-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe et al. (Pub. No.: US 2009/0319037) in view of Barone (Pub. No.: US 2010/0145438) and Rowe et al. (Pub. No.: US 2009/0276040).
Rowe in view of Barone is explained supra, however, the Rowe inner device lacks a tubular funnel portion that corresponds to a funnel shape of the connection channel. Rowe ‘040 teaches a tubular funnel shape to fit contours of the native mitral valve (abstract). Thus it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified inner device 480 to include a tubular funnel shape as taught by Rowe ‘040 for the purpose of better fitting the native anatomy of the mitral valve. This modification would have occurred using known methods and would have yielded predictable results. For claim 10, Rowe ‘404 includes a funnel shape at one of the axial ends of the inner device.
Claims 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rowe et al. (Pub. No.: US 2009/0319037) in view of Tuval (Pub. No.: US 2008/0071361).
For claim 19, Rowe does is silent as to whether the method is carried out on a beating heart. Rowe’s implantation procedure occurs using a minimally invasive approach through a trans-apical approach (e.g., fig. 23-26). Tuval teaches a trans-apical prosthetic heart valve implantation which occurs on a beating heart (para. 574). It would have been highly obvious to one of ordinary skill in the art to have performed Rowe’s method on a beating heart as taught by Tuval in order to reduce complications due to stopping the heart. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774