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 .
DETAILED ACTION
Election/Restrictions
Applicant timely traversed the restriction requirement in the reply filed on 07/08/2026 with the election of Claims 1-11, Figs. 3A-3D. Therefore, claims 6-8 and 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Thus, claims 1-5 and 9-11 are presently pending in this application.
Applicants’ election with traverse is acknowledged. The traversal is on the grounds that Figs. 3A-3B are not patentably distinct from Fig. 5 and therefore should be examined together. This is not found persuasive because the embodiment in Figs. 3A-3B is a mutually exclusive species with mutually exclusive characteristics that are not obvious variants of the embodiment in Fig. 5 since Figs. 3A-3B are directed to a distinct guard member different from disc shape intersection in Fig. 5. If the applicants believe that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one would disclose the other since they are obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS’s have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “110” has been used to designate both “guard member” and “toroid tube”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 9 recites the limitation "intersection”. There is insufficient antecedent basis for this limitation in the claim.
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 1, 5 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (2005/0004668) “Aklog” in view of Tsukashima et al. (2012/0123531) “Tsukashima”.
Regarding claim 1, Aklog discloses a system 145 (Fig. 4D; par. 0086) for treating prolapse, flail, or billow of at least one leaflet of a native heart valve (abstract and Figs. 20A-20F), the system comprising: an annuloplasty ring 124 configured for deployment using a delivery device (the annuloplasty ring 124 is fully capable of performing this intended use as shown in Figs. 20A-20F using a catheter for delivery), and a guard member 146 (Fig. 4D) comprising a plurality of struts 150 coupled to a juncture (annular ring 148; Fig. 4D; par. 0090) at one end and coupled to the annuloplasty ring 124 at another end (Fig. 4D), the guard member 146 configured for deployment using the delivery device (the guard member is fully capable of performing this intended use); wherein a first strut and a second strut of the of plurality of struts together extend across the annuloplasty ring to prevent prolapse, flail, or billow of the at least one leaflet of the native heart valve (Fig. 4D and par. 0090 disclose the struts 150 together extend across the ring 124).
Aklog is silent regarding the annuloplasty ring comprising a plurality of anchors configured to be selectively deployed to secure the annuloplasty ring to a heart valve annulus of the native heart valve. However, Tsukashima teaches a similar annuloplasty ring 100 (Fig. 1) comprising a plurality of anchors 104 configured to be selectively deployed to secure the annuloplasty ring to a heart valve annulus of the native heart valve (Fig. 1 and par. 0052). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the annuloplasty ring in Aklog to include a plurality of anchors configured to be selectively deployed to secure the annuloplasty ring to a heart valve annulus of the native heart valve, as taught and suggested by Tsukashima, for securely attaching the annuloplasty ring to the valve annulus (par. 0052).
Regarding claim 5, Aklog discloses wherein the juncture comprises a central strut (central annular ring 148; Fig. 4D).
Regarding claim 9, as best understood, Aklog discloses wherein intersection is configured to be grasped by a plurality of graspers extending from the delivery device to engage the guard member with the delivery catheter (the delivery device is not positively recited in claim 1, therefore, the intersection 148 is fully capable of performing the intended use of being configured to be grasped by a plurality of graspers extending from the delivery device to engage the guard member with the delivery catheter; furthermore, Figs. 20A-20F disclose a delivery catheter).
Regarding claims 10-11, Aklog discloses the guard member is configured to transition from a restrained position corresponding to a restrained shape to an unrestrained position corresponding to an unrestrained shape and wherein each strut of the plurality of struts is configured to twist about a longitudinal axis of such strut (par. 0112 discloses the struts, which includes the guard member 146, made of shape memory material which would allow the guard member and the struts to perform the intended use of being configured to transition from a restrained position corresponding to a restrained shape to an unrestrained position corresponding to an unrestrained shape and to twist about a longitudinal axis of such strut).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Aklog et al. (2005/0004668) “Aklog” in view of Tsukashima et al. (2012/0123531) “Tsukashima” further in view of Morris et al. (2015/0351903) “Morris”.
Regarding claims 2-4, Aklog in view of Tusukashima discloses the claimed invention of claim 1; except for plurality of couplers, each coupler of the plurality of couplers coupled to a respective strut of the plurality of struts and configured to couple the respective strut to the annuloplasty ring and wherein each coupler of the plurality of couplers is sized and configured to conform to a surface of the annuloplasty ring and the delivery device comprises a first delivery catheter configured to deliver the annuloplasty ring and a second delivery catheter configured to deliver the guard member.
However, Aklog discloses a plurality of couplers 332 (Fig. 17A), each coupler of the plurality of couplers coupled to a respective strut 324 of the plurality of struts and configured to couple the respective strut to the annuloplasty ring 322 (Figs. 17-17A) and the delivery device comprises a first delivery catheter configured to deliver the annuloplasty ring and a second delivery catheter configured to deliver the guard member (the delivery device is not positively recited in claim 1; the annuloplasty ring and the guard member and fully capable of performing the intended use of being delivered by a first and second delivery catheter).
Furthermore, Morris discloses wherein each coupler of the plurality of couplers 114 is sized and configured to conform to a surface of a ring 110 (flexible ribs 114 conform to the ring surface; par. 0116; Fig. 10C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system in Aklog in view of Tsukashima to include plurality of couplers, each coupler of the plurality of couplers coupled to a respective strut of the plurality of struts and configured to couple the respective strut to the annuloplasty ring and wherein each coupler of the plurality of couplers is sized and configured to conform to a surface of the annuloplasty ring and the delivery device comprises a first delivery catheter configured to deliver the annuloplasty ring and a second delivery catheter configured to deliver the guard member, as taught and suggested by Aklog and Morris, for detachably engaging the guard member to the ring facilitated by resilient material.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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