DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Claims 13-28 are pending in the application. Claims 1-12 are cancelled. Claims 13-28 are rejected.
Information Disclosure Statement
Per MPEP §609.02(II)(2), the information from the parent application(s) has been considered. “A listing of the information need not be resubmitted in the continuing application unless the applicant desires the information to be printed on the patent.”
Claim Objections
Claims 21-28 are objected to because of the following informalities:
Claim 21 recites “actuating the suture the suture lock to hold…” in line 9 of the claim. This is believed to be a typographical error. For the purposes of examination, this limitation is being interpreted as “actuating Appropriate correction is required.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 13-28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Loulmet (US PG Pub 2011/0011917) in view of Kaye et al. (US PG Pub 2008/0288060).
Regarding claim 13, Loulmet teaches a method of repairing a heart valve (see paragraph [0031]) in a beating heart of a patient (See paragraphs [0004]-[0006]), comprising:
intravascularly inserting a deployment catheter (200) into the beating heart of the patient to a position adjacent a mitral valve leaflet (See Figs. 2-3; paragraphs [0042] and [0045]-[0046]);
inserting a suture (400) through the mitral valve leaflet with the deployment catheter (See Figs. 6, 9, and 10; paragraphs [0032], [0037]-[0038]);
inserting an anchor catheter (1100) into the beating heart of the patient to insert an anchor device (402) adjacent a left ventricle of the heart such that the suture extends from the mitral valve leaflet to the anchor device (See Figs. 6, 9, 10; paragraphs [0033], [0041]);
adjusting a tension of the suture to achieve proper valve function (See paragraphs [0037]-[0038] by sliding the suture through an open space within the anchor device (See Figs. 17D-17I; paragraph [0058]); and
locking the suture at the anchor device at the tension that achieves proper valve function (See paragraphs [0038] and [0058]-[0061]).
Loulmet does not explicitly teach locking the suture at the anchor device is achieved by rotating a portion of the anchor to clamp the suture by eliminating the open space within the anchor device. Loulmet teaches the fastener may be secured “in any suitable way” such as by crimping (See paragraph [0061]).
Kaye teaches an advantageous suture locking device (7) featuring and inner member (13) and outer member (12) having complementary screw threads and a void therein for receiving the sutures (See paragraphs [0046]-[0047]). Kaye teaches the locking device securely holds the sutures in the desired location but also allows for the release of the sutures to “facilitate adjustment of the valve constriction device after implantation” (See paragraph [0045]).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the threaded locking device as taught by Kaye for the crimped locking device of Loulmet since the threaded locking device of Kaye allows for post-implantation adjustment thereby ensuring proper valve function is achieved.
Regarding claim 14, modified Loulmet teaches the method of claim 13 above and further teaches withdrawing the anchor catheter from the body with the anchor device engaged with the suture in the heart. (See Paragraphs [0066]-[0069]).
Regarding claim 15, modified Loulmet teaches the method of claim 13 above and further teaches inserting the suture through the anchor device prior to inserting the anchor catheter into the body. (See paragraph [0050]. Note that since the suture is attached to the anchor, they are inserted as one unit into the catheter and then into the body).
Regarding claim 16, modified Loulmet teaches the method of claim 13 above but does not explicitly teach that inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.
Loulmet does teach a secondary anchor (700) which slides along the suture to allow for precise placement in the desired tissue location (See Figs. 7, 8A; paragraph [0052]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the first anchor (402) of Loulmet to be slidable along the suture (as is the case for second anchor 700) rather than fixedly secured to the suture since being able to slide the anchor along the suture allows the surgeon more control and precision to place the anchor in the desired tissue location.
Regarding claim 17, modified Loulmet teaches the method of claim 13 above and further teaches inserting a cutting catheter (1400) having a cutting tool (1402) (See Fig. 14) to adjacent the anchor device after locking the suture and cutting the suture adjacent the anchor device with the cutting tool (See Figs. 14-16C; paragraph [0062])
Regarding claim 18, modified Loulmet teaches the method of claim 13 above and further teaches the step of inserting a suture (4020) through the mitral valve leaflet with the deployment catheter includes:
capturing a heart valve leaflet (4040) with a clamping mechanism (jaw member 4048) of the deployment catheter (See Figs. 8G-8K; paragraphs [0055]-[0056] note that 4058 is a compact single delivery instrument); and
inserting the suture (4020) through the heart valve leaflet with a needle (4022) of the deployment catheter. (See paragraphs [0050] and [0055]-[0068]).
Regarding claim 19, modified Loulmet teaches the method of claim 13 above and further teaches rotating a portion of the anchor causes the portion of the anchor to move longitudinally relative to the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 20, modified Loulmet teaches the method of claim 19 above and further teaches the longitudinal movement of the portion of the anchor device eliminates the open space within the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 21, Loulmet teaches a method of repairing a heart valve (see paragraph [0031]) in a beating heart of a patient (See paragraphs [0004]-[0006]), comprising:
intravenously advancing a deployment catheter (200) into the left ventricle of beating heart of the patient through a septum in the heart (See Figs. 1-3; paragraphs [0042] and [0045]-[0046]);
inserting a suture (400) through the mitral valve leaflet with the deployment catheter (See Figs. 6, 9, and 10; paragraphs [0032], [0037]-[0038]);
inserting an anchor catheter (1100) into the heart to insert an anchor device (402) adjacent the left ventricle such that the suture extends from the mitral valve leaflet to the anchor device (See Figs. 6, 9, 10; paragraphs [0033], [0041]), the anchor device including a suture lock (fastener 1104) (See paragraph [0058]);
adjusting a tension of the suture to achieve proper valve function (See paragraphs [0037]-[0038]); and
actuating the suture lock to hold the suture at the tension that achieves proper valve function (See paragraphs [0038] and [0058]-[0061]).
Loulmet does not explicitly teach actuating the suture lock includes causing the suture lock to rotate. Loulmet teaches the fastener may be secured “in any suitable way” such as by crimping (See paragraph [0061]).
Kaye teaches an advantageous suture locking device (7) featuring and inner member (13) and outer member (12) having complementary screw threads and a void therein for receiving the sutures (See paragraphs [0046]-[0047]). Kaye teaches the locking device securely holds the sutures in the desired location but also allows for the release of the sutures to “facilitate adjustment of the valve constriction device after implantation” (See paragraph [0045]).
It would have been obvious to one of ordinary skill in the art at the time of invention to substitute the threaded locking device as taught by Kaye for the crimped locking device of Loulmet since the threaded locking device of Kaye allows for post-implantation adjustment thereby ensuring proper valve function is achieved.
Regarding claim 22, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches rotation of the suture lock causes the suture lock to move longitudinally relative to the anchor device. (See Kaye Figs. 8A & 8B; paragraphs [0045]-[0047]).
Regarding claim 23, modified Loulmet teaches the method as required by claim 22 as set forth above and further teaches the suture lock moves longitudinally from an initial position (See Kaye Fig. 8A) to a final position at which the suture is held at the tension that achieves proper valve function. (See Kaye Fig. 8B; paragraphs [0045]-[0047]).
Regarding claim 24, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches withdrawing the anchor catheter from the body with the anchor device engaged with the suture in the heart. (See Paragraphs [0066]-[0069]).
Regarding claim 25, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches inserting the suture through the anchor device prior to inserting the anchor catheter into the body. (See paragraph [0050]. Note that since the suture is attached to the anchor, they are inserted as one unit into the catheter and then into the body).
Regarding claim 26, modified Loulmet teaches the method as required by claim 21 as set forth above but does not explicitly teach that inserting the anchor device adjacent the left ventricle includes advancing the anchor device along the suture to adjacent the left ventricle.
Loulmet does teach a secondary anchor (700) which slides along the suture to allow for precise placement in the desired tissue location (See Figs. 7, 8A; paragraph [0052]).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify the first anchor (402) of Loulmet to be slidable along the suture (as is the case for second anchor 700) rather than fixedly secured to the suture since being able to slide the anchor along the suture allows the surgeon more control and precision to place the anchor in the desired tissue location.
Regarding claim 27, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches inserting a cutting catheter (1400) having a cutting tool (1402) (See Fig. 14) to adjacent the anchor device after locking the suture and cutting the suture adjacent the anchor device with the cutting tool (See Figs. 14-16C; paragraph [0062])
Regarding claim 28, modified Loulmet teaches the method as required by claim 21 as set forth above and further teaches the step of inserting a suture (4020) through the mitral valve leaflet with the deployment catheter includes:
capturing a heart valve leaflet (4040) with a clamping mechanism (jaw member 4048) of the deployment catheter (See Figs. 8G-8K; paragraphs [0055]-[0056] note that 4058 is a compact single delivery instrument); and
inserting the suture (4020) through the heart valve leaflet with a needle (4022) of the deployment catheter. (See paragraphs [0050] and [0055]-[0068]).
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 and 24-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,974,920. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘920 patent requires a method of repairing a heart valve in a beating heart of a patient including the steps of intravenously advancing a deployment catheter into a left ventricle through a septum of the heart, inserting a suture through a mitral leaflet with the deployment catheter; inserting an anchor catheter into the heart to insert an anchor adjacent the left ventricle such that the suture extends from the mitral leaflet to the anchor, the anchor including a suture lock, adjusting tension of the suture for proper valve function and actuating the suture lock to hold the suture at a tension that achieves proper valve function where actuating the suture lock incudes causing the suture lock to rotate.
For applicant’s convenience, a chart showing the correlating claims is included below.
Claims of the instant application (18/640248)
Corresponding claims of Patent No. 11,974,920
21
7
24
8
25
9
26
10
27
11
28
12
Claims 13-20, 22 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,974,920 in view of Kaye et al. (US PG Pub 2008/0288060). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘920 patent requires a method of repairing a heart valve in a beating heart of a patient including the steps of intravenously advancing a deployment catheter into a left ventricle through a septum of the heart, inserting a suture through a mitral leaflet with the deployment catheter; inserting an anchor catheter into the heart to insert an anchor adjacent the left ventricle such that the suture extends from the mitral leaflet to the anchor, the anchor including a suture lock, adjusting tension of the suture for proper valve function and actuating the suture lock to hold the suture at a tension that achieves proper valve function where actuating the suture lock incudes causing the suture lock to rotate.
The ‘920 patent is silent as to the particular form of the locking device and does not explicitly require locking the suture at the anchor device is achieved by rotating a portion of the anchor to clamp the suture by eliminating the open space within the anchor device as required by instant claims 13 and 20 or rotation of the suture lock causes the suture lock to move longitudinally relative to the anchor device as required by instant claims 19 and 22 or the suture lock moves longitudinally from an initial position to a final position at which the suture is held at the tension that achieves proper valve function as required by instant claim 23.
Kaye teaches an advantageous suture locking device (7) featuring and inner member (13) and outer member (12) having complementary screw threads and a void therein for receiving the sutures (See paragraphs [0046]-[0047]). Kaye teaches the locking device securely holds the sutures in the desired location but also allows for the release of the sutures to “facilitate adjustment of the valve constriction device after implantation” (See paragraph [0045]).
It would have been obvious to one of ordinary skill in the art at the time of invention to use the threaded locking device as taught by Kaye in the method as required by the ‘920 patent since the threaded locking device of Kaye allows for post-implantation adjustment thereby ensuring proper valve function is achieved.
For applicant’s convenience, a chart showing the remaining correlating claim limitations is included below.
Claims of the instant application (18/640248)
Corresponding claims of Patent No. 11,974,920
13
1, 7
14
2, 8
15
3, 9
16
4, 10
17
5, 11
18
6, 12
Conclusion
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/R.S.H/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774