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 .
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 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8 and 11-20 of U.S. Patent No. 10,966,709. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are overlapping in scope as discussed below.
Claim 21 is rejected over claim 1 of U.S. Patent No. 10,966,709 which discloses a suture attachment catheter configured to repair a heart valve by inserting a suture in a valve leaflet of a beating heart of a patient, comprising: a generally flexible catheter body having a proximal end, a distal end; a suture attachment assembly proximate the distal end of the catheter body, the suture attachment assembly including: a proximal clamping jaw disposed adjacent the distal end of the catheter body; a rail having a proximal portion and distal portion, the proximal portion configured to be selectively longitudinally slideable with respect to the proximal clamping jaw; and a distal clamping jaw hingedly attached to the distal portion of the rail; a control handle operable attached to the proximal end of the catheter body, the control handle including: a rail actuator configured to selectively longitudinally slide the rail with respect to the proximal clamping jaw; and a jaw actuator configured to selectively pivot the distal clamping jaw between a first position for delivery of the suture attachment assembly into the heart and a second position for capturing a valve leaflet between the proximal clamping jaw and the distal clamping jaw.
Claim 22 is rejected over claim 2 of U.S. Patent No. 10,966,709.
Claim 23 is rejected over claim 3 of U.S. Patent No. 10,966,709.
Claim 24 is rejected over claim 6 of U.S. Patent No. 10,966,709.
Claim 25 is rejected over claim 7 of U.S. Patent No. 10,966,709.
Claim 26 is rejected over claim 8 of U.S. Patent No. 10,966,709.
Claim 27 is rejected over claim 11 of U.S. Patent No. 10,966,709.
Claim 28 is rejected over claim 12 of U.S. Patent No. 10,966,709.
Claim 29 is rejected over claim 13 of U.S. Patent No. 10,966,709.
Claim 30 is rejected over claim 14 of U.S. Patent No. 10,966,709.
Claim 31 is rejected over claim 15 of U.S. Patent No. 10,966,709.
Claim 32 is rejected over claim 16 of U.S. Patent No. 10,966,709.
Claim 33 is rejected over claim 17 of U.S. Patent No. 10,966,709.
Claim 34 is rejected over claim 18 of U.S. Patent No. 10,966,709.
Claim 35 is rejected over claim 19 of U.S. Patent No. 10,966,709.
Claim 36 is rejected over claim 20 of U.S. Patent No. 10,966,709.
Claim 37 is rejected over claim 1 of U.S. Patent No. 10,966,709.
Claim 38 is rejected over claim 1 of U.S. Patent No. 10,966,709.
Claim 39 is rejected over claim 1 of U.S. Patent No. 10,966,709.
Claims 21, 24, 25, 32-34, 37 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10, 11, 12 17 and 18 of U.S. Patent No. 11,612,389. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are overlapping in scope as discussed below. Examiner notes the method steps as recited are inherent in the operation of the device.
Claim 21 is rejected over claim 1 of U.S. Patent No. 11,612,389 which discloses a device or method of repairing a heart valve by inserting a suture in a valve leaflet of a beating heart of a patient, comprising: a generally flexible catheter body having a proximal end and a distal end into a vasculature of the patient; intravascularly accessing an interior of the heart with a suture attachment assembly operably attached to the distal end of the catheter body, the suture attachment assembly including a rail defining a portion of a clamping jaw, a distal clamping jaw hingedly operably attached to the rail, and a proximal clamping jaw operably attached to the rail; positioning the suture attachment assembly adjacent to a moving heart valve leaflet of the heart; operating a jaw actuator disposed on a control handle operably attached to the proximal end of the catheter body to selectively slide one of the proximal clamping jaw and the distal clamping jaw with respect to the other to adjust a distance between the proximal clamping jaw and the distal clamping jaw; capturing the heart valve leaflet between the proximal clamping jaw and the distal clamping jaw; and operating a needle actuator disposed on the control handle to slide a needle from within the catheter body to penetrate the heart valve leaflet to insert a suture through the heart valve leaflet.
Claim 24 is rejected over claim 17 of U.S. Patent No. 11,612,389.
Claim 25 is rejected over claim 18 of U.S. Patent No. 11,612,389.
Claim 32 is rejected over claim 10 of U.S. Patent No. 11,612,389.
Claim 33 is rejected over claim 11 of U.S. Patent No. 11,612,389.
Claim 34 is rejected over claim 12 of U.S. Patent No. 11,612,389.
Claim 37 is rejected over claim 6 of U.S. Patent No. 11,612,389.
Claim 38 is rejected over claim 6 of U.S. Patent No. 11,612,389.
Claims 21, 24, 25, 28, 32, 33, 34, 37 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10, 11, 12, 27 and 19 of U.S. Patent No. 10,588,620. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are overlapping in scope as discussed below.
Claim 21 is rejected over claim 1 of U.S. Patent No. 10,588,620 which discloses a suture attachment catheter configured to repair a heart valve by inserting a suture in a valve leaflet of a beating heart of a patient, comprising: a generally flexible catheter body having a proximal end, a distal end; a suture attachment assembly proximate the distal end of the catheter body, the suture attachment assembly including: a proximal clamping jaw disposed adjacent the distal end of the catheter body; a rail having a proximal portion and distal portion, the proximal portion configured to be selectively longitudinally slideable with respect to the proximal clamping jaw; and a distal clamping jaw hingedly attached to the distal portion of the rail; a control handle operable attached to the proximal end of the catheter body, the control handle including: a rail actuator configured to selectively longitudinally slide the rail with respect to the proximal clamping jaw; and a jaw actuator configured to selectively pivot the distal clamping jaw between a first position for delivery of the suture attachment assembly into the heart and a second position for capturing a valve leaflet between the proximal clamping jaw and the distal clamping jaw.
Claim 24 is rejected over claim 17 of U.S. Patent No. 10,588,620.
Claim 25 is rejected over claim 19 of U.S. Patent No. 10,588,620.
Claim 28 is rejected over claim 1 of U.S. Patent No. 10,588,620.
Claim 32 is rejected over claim 10 of U.S. Patent No. 10,588,620.
Claim 33 is rejected over claim 11 of U.S. Patent No. 10,588,620.
Claim 34 is rejected over claim 12 of U.S. Patent No. 10,588,620.
Claim 37 is rejected over claim 6 of U.S. Patent No. 10,588,620.
Claim 38 is rejected over claim 6 of U.S. Patent No. 10,588,620.
Claims 21-28 and 31-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 6, 7, 9, 12 and 15-20 of U.S. Patent No. 12,137,897. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are overlapping in scope as discussed below. Examiner notes the method steps as recited are inherent in the operation of the device.
Claim 21 is rejected over claim 1 of U.S. Patent No. 12,137,897 which discloses a suture attachment catheter configured to repair a heart valve by inserting a suture in a valve leaflet of a beating heart of a patient, comprising: a generally flexible catheter body having a proximal end and a distal end; a suture attachment assembly proximate the distal end of the catheter body, the suture attachment assembly including: a proximal clamping jaw disposed adjacent the distal end of the catheter body; a rail having a proximal portion and distal portion, the proximal portion configured to be selectively longitudinally slideable with respect to the proximal clamping jaw; and a distal clamping jaw hingedly attached to the distal portion of the rail; a control handle operable attached to the proximal end of the catheter body, the control handle including: a rail actuator configured to selectively longitudinally slide the rail with respect to the proximal clamping jaw; and a jaw actuator configured to selectively pivot the distal clamping jaw between a first position for delivery of the suture attachment assembly into the heart and a second position for capturing a valve leaflet between the proximal clamping jaw and the distal clamping jaw.
Claim 22 is rejected over claim 2 of U.S. Patent No. 12,137,897.
Claim 23 is rejected over claim 3 of U.S. Patent No. 12,137,897.
Claim 24 is rejected over claim 6 of U.S. Patent No. 12,137,897.
Claim 25 is rejected over claim 7 of U.S. Patent No. 12,137,897.
Claim 26 is rejected over claim 9 of U.S. Patent No. 12,137,897.
Claim 27 is rejected over claim 12 of U.S. Patent No. 12,137,897.
Claim 28 is rejected over claim 2 of U.S. Patent No. 12,137,897.
Claim 31 is rejected over claim 15 of U.S. Patent No. 12,137,897.
Claim 32 is rejected over claim 16 of U.S. Patent No. 12,137,897.
Claim 33 is rejected over claim 17 of U.S. Patent No. 12,137,897.
Claim 34 is rejected over claim 18 of U.S. Patent No. 12,137,897.
Claim 35 is rejected over claim 19 of U.S. Patent No. 12,137,897.
Claim 36 is rejected over claim 20 of U.S. Patent No. 12,137,897.
Claim 37 is rejected over claim 1 of U.S. Patent No. 12,137,897.
Claim 38 is rejected over claim 1 of U.S. Patent No. 12,137,897.
Claim 39 is rejected over claim 1 of U.S. Patent No. 12,137,897.
Allowable Subject Matter
Claims 21-39 are rejected on the ground of nonstatutory double patenting as presented above, but would be allowable if a proper terminal disclaimer is filed and if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 40 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.
The following is a statement of reasons for the indication of allowable subject matter:
Zentgraf US 2009/0105751 teaches a suture attachment catheter configured to repair a heart valve by inserting a suture in a valve leaflet of a beating heart of a patient, comprising a catheter body 104 (figure 1a) having a proximal end and a distal end; a suture attachment assembly operably attached to the distal end of the catheter body (figure 1a), the suture attachment assembly including: a proximal clamping jaw 128 disposed adjacent the distal end of the catheter (figure 4d), a rail 176 (figure 5d) having a proximal portion and a distal portion, the proximal portion configured to be selectively longitudinally slideable with respect to the proximal clamping jaw (figures 4b, 4d, distal jaw extended); a distal clamping jaw 124 attached to the distal portion of the rail (figure 5d), a control handle operably attached to the proximal end of the catheter (Figure la; 106), the control handle including: a rail actuator 174.
However, Zentgraf does not specifically teach the catheter body being generally flexible, the distal clamping jaw being hingedly attached to the rail, or a flexible member extending from a jaw actuator through the catheter body to a distal surface of the clamping jaw, the jaw actuator selectively moves the flexible member to pivot the distal clamping jaw.
Adams US 6179195 teaches a fastening catheter device comprising: a generally flexible catheter body (figure 1; 4) having a proximal end and a distal end; a distal assembly including: a proximal clamping jaw 12a disposed adjacent a distal end of the catheter body (figure 1), a rail 20a,b being selectively longitudinal slideable with respect to the proximal clamping jaw (figure 3a); a distal clamping jaw 16 hingedly operably attached to the distal portion of the rail (figure 3a), a control handle 6 operably attached to the proximal end of the catheter (figure 2), the control handle including: a jaw actuator connected to the clamping jaw.
However, Adams is intended to be used in conjunction with an endoscope. Thus, the hinged attachment of the distal clamping jaw is provided to allow for better visibility through the endoscope. Zentgraf is not intended to be used with an endoscope or any type of scope given it is delivered to the heart and includes its own imaging or monitoring system for confirming the clamping of tissue. Therefore, no motivation could be found to incorporate the hinged attachment of the distal clamping jaw or the flexible shaft.
Rosenbluth et al. US 5312423 discloses a ligation device, comprising a distal jaw 29 that is pivotably connected to catheter 10, a flexible member 82 pulls the distal jaw end 30 to pivot relative to the rail 28.
However, Rosenbluth et al. fails to disclose a suture attachment catheter configured to insert a suture in a valve leaflet, the distal jaw being slideable with the rail or a rail actuator.
Hooven US 2002/0091382 discloses an ablation device, the device having a slideable distal jaw 16 (figure 34).
However, the distal jaw is not hingedly attached to a distal portion of the rail, or a jaw actuator having a flexible member extending therefrom through the catheter body to a distal surface of the distal clamping jaw for pivoting the distal clamping jaw.
Burkhart et al. US 2009/0062819 discloses a suture passer, a distal jaw 10b being hingedly attached to a distal portion of a rail (figure 7).
However, the rail is not longitudinally slideable with respect to a proximal jaw, or comprise a rail actuator, or flexible member extending from a jaw actuator through the catheter body to a distal surface of the distal clamping jaw for pivoting the distal clamping jaw.
The prior art of record, as well as the prior art at large, alone or in combination, fails to remedy those deficiencies listed above.
Conclusion
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771