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 . Claims 14-24 are pending and examined below. Claims 1-13 & 25 is/are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group II: claims 14-24 in the reply filed on 05/01/2026 is acknowledged. The requirement is therefore made FINAL.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 14-24 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation " the mitral valve annulus" in line 1 from the bottom of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 16, 17, and 18 recites the limitation "the step of" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation “the medial trigon” and “the lateral trigon” in lines 2-23. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the steps of" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the elongated third member” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same or different third member from claim 14 from which claim 23 depends from. For the purpose of examination, they are considered the same.
All dependent claims are likewise rejected.
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) 14-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz et al. (US 20170189187 A1) hereinafter, Ruiz, in view of Call et al. (US 20130190863 A1) hereinafter, Call.
Regarding claim 14, Ruiz teaches
a method for performing an annuloplasty procedure (abstract, Ruiz), the method comprising:
introducing a catheter (46, Fig. 2, Ruiz) into a left atrium of a heart (38, Fig.2, Ruiz);
deploying a first member (501, Fig. 3, Ruiz) from the catheter; anchoring the first member to an anterior side (74, Fig. 3, Ruiz) of a mitral valve (56, Fig. 2, Ruiz) in the left atrium (38, Fig. 2, Ruiz), the first member (501, Fig. 3, Ruiz) having a first flexible tensile member attached (94, Fig. 3, Ruiz);
deploying a second member (502, Fig. 3, ¶0039, Ruiz) from the catheter; anchoring the second member (502, Fig. 3, Ruiz) to the anterior side (74, Fig. 3, Ruiz) of the mitral valve (56, Fig. 2, Ruiz) in the left atrium (38, Fig. 2, Ruiz), the second member having a second flexible tensile member (82, Fig. 3, Ruiz) attached;
deploying a third member (see annotate Fig. 3 below, Ruiz) from the catheter, anchoring the third member to a posterior side (66, Fig. 3, Ruiz) of the mitral valve in the left atrium; and
applying tension to the first and the second tensile members (82, 94, see annotated Fig. 3 below, Ruiz) to draw the first member and the second member toward the third member, thereby bringing the posterior side and the anterior side of the mitral valve annulus into closer approximation (posterior annulus is pulled toward the anterior annulus, ¶0039, Ruiz).
Ruiz discloses all three members, tensile members, and anchoring the members to the anterior and posterior side. The examiner is interpreting the claim to not have a specific order (MPEP 2111.01 II). It is improper to read a specific order of steps into method claims. Furthermore, Ruiz discloses that various changes and modifications may be made to adapt a particular situation (¶0046, Ruiz) therefore, it would be obvious to modify the order of sides to which the members are deployed and anchored.
Ruiz does not teach the third member slidably tracks over the first and the second flexible tensile members. However, Call teaches methods of repairing the mitral valve and reducing mitral regurgitation (abstract, Call)
wherein the third member slidably tracks over the first and the second flexible tensile members (162 & 170, see annotated Fig. 14 below, Call).
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 teachings of Ruiz by incorporating the teaching above as taught by Call in order to reduce mitral regurgitation when the physician pulls proximally on the tensile members (¶0050, Call).
Regarding claim 15, Ruiz teaches
wherein the first member (501, Fig. 3, Ruiz) is deployed from the catheter (46, Fig. 2, Ruiz) with the first flexible tensile member pre-attached (anchor elements coupled by the at least one tensile member, ¶0010, Ruiz), and wherein the second member (502, Fig. 3, Ruiz) is deployed from the catheter with the second flexible tensile member pre-attached (anchor elements coupled by the at least one tensile member, ¶0010, Ruiz).
Regarding claim 16, Ruiz teaches
wherein the step of applying tension to the first and the second tensile members comprises deploying a first lock (lock member, ¶0030, Ruiz) over the first tensile member and deploying a second lock (98, Fig. 3, ¶0040, Ruiz) over the second tensile member.
Regarding claim 17, Ruiz does not specifically disclose cutting the tensile members. However, Call teaches
further comprising the step of cutting the first tensile member proximal to the first lock and cutting the second tensile member proximal to the second lock (tensile members cut to appropriate length, ¶0050, Figs, 15 & 17D, Call).
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 teachings of Ruiz by incorporating the teaching above as taught by Call in order to cut to an appropriate length and sufficiently tension the tensile members such that the anterior and posterior leaflets coapt and mitral regurgitation is reduced or eliminated (¶0050, Call).
Regarding claim 18, Ruiz teaches
wherein the step of applying tension to the first and the second tensile members comprises applying tension independently to the two separate tensile members (pulling on the respective proximal end portions of the tensile members, ¶0039, Ruiz).
Regarding claim 19, Ruiz teaches
wherein the first member is anchored toward a medial side of the mitral valve and the second member is anchored toward a lateral side of the mitral valve (Figs. 2-3, Ruiz).
Regarding claim 20, Ruiz teaches
wherein the first member has at least one anchor within proximity of the medial trigon and the second member has at least one anchor within proximity of the lateral trigon (Figs. 2-3, ¶0034 & ¶0036, Ruiz).
Regarding claim 21, Ruiz teaches
wherein at least one of the steps of anchoring the first member and the second member comprises attaching at least two separate anchors by screwing the separate anchors into the mitral valve annulus (Figs. 2-3, ¶0034 & ¶0036, Ruiz).
Regarding claim 22, Ruiz teaches
wherein a dimensional reduction of the mitral valve annulus in an anterior-posterior direction can be different on the lateral side and the medial side (¶0038, Ruiz).
Claim(s) 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz in view of Call and further in view of Dahlgren et al. (US 20110082538 A1) hereinafter, Dahlgren.
Regarding claim 23, Ruiz does not teach the third member has an elongated shape. However, Dahlgren teaches an implantable device (e.g., annuloplasty implant) (abstract, Dahlgren)
wherein the third member (2402b, Fig. 23U, Dahlgren) has an elongated shape, and wherein the method further comprises rotating the elongated third member into a desired position before anchoring it to the posterior side of the mitral valve annulus (segments may be moved with respect to one another, ¶0225, Dahlgren).
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 teachings of Ruiz and Call by incorporating the teaching above as taught by Dahlgren in order to be delivered percutaneously in a first configuration while assuming a structure in a second configuration that is sufficiently rigid to affect a shape of the tissue orifice in a desired manner (¶0225, Dahlgren).
Regarding claim 24, Ruiz teaches
wherein the first member, the second member and the third member are each deployed from the catheter with at least one anchor lead attached (2330, Fig. 23U, Dahlgren).
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 teachings of Ruiz and Call by incorporating the teaching above as taught by Dahlgren in order to advance fasteners to secure the implant member to the annulus (¶0251, Dahlgren).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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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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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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