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 2-3, 7, 11, 13, 17, & 21-37 are pending and examined below.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/20/2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 08/20/2025 , with respect to the rejection(s) of claim(s) 1-7, 10-13, 15-18, and 22 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McNiven. Please see the rejection below.
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.
Claims 2-3, 7, 11, 13, 17, & 21-37 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 2 recites the limitation “the interventional device” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation “the valve tissue” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation “the actuator rod” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation “the grasping assembly” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation “movement the rod” in line 2. It is unclear if there is a missing word to clarify this limitation.
Claim 25 recites the limitation “the distal assembly” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation “the proximal assembly” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation “a shaft” in line 2. It is unclear is this is the same or different shaft from claim 27. For the purpose of examination, it is regarded as the same shaft.
Claim 37 recites the limitation “the valve tissue” in line 12. There is insufficient antecedent basis for this limitation in the claim.
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) 2-3, 11, 13, 23-28, 31-32, 34, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNiven et al. (US 20180021134 A1).
Regarding claim 23, McNiven teaches
a repair device (100, Fig. 3) configured for repair of a valve (¶0025), the repair device comprising:
a proximal grasping assembly (118a-c, Fig. 3) and a distal grasping assembly (108a-c, Fig. 3), each of which is movable between a first position (contained in the distal end of the catheter, ¶0034) and a second position (expanded condition, Fig. 3, ¶0021),
the distal grasping assembly and the proximal grasping assembly having a predetermined spaced apart relationship configured to define a grasping space therebetween (space between 118a-c and 108a-c, Fig. 3) configured to receive the valve tissue (Fig. 6); and
a lock (124a-c & 126a-c, Fig. 4, ¶0031) having an open configuration allowing movement of both the proximal grasping assembly and the distal grasping assembly (¶0031), the lock further having a binding configuration which prevents movement of the proximal grasping assembly and the distal grasping assembly (124a-c & 126a-c, Fig. 4, ¶0031).
Regarding claim 2, McNiven teaches
wherein the lock (124a-c & 126a-c, Fig. 4, ¶0031) comprises a first locking plate (flat portions of 124a, Fig. 4).
Regarding claim 3, McNiven teaches
wherein the lock (124a-c & 126a-c, Fig. 4) is disposed proximal (Fig. 4) the proximal grasping assembly (118a-c, Fig. 3), wherein the lock is biased toward one of the binding configuration and the open configuration (¶0033).
Regarding claim 11, McNiven teaches
wherein the lock comprises a first locking plate (flat portions of 124a, Fig. 4) and a second locking plate (flat portions of 124b, Fig. 4), each being biased toward the binding configuration (Fig. 4).
Regarding claim 13, McNiven teaches
wherein the lock comprises a lock control (130, Fig. 4) configured to selectively release the first locking plate and the second locking plate and allow the first locking plate and the second locking plate to transition to the binding configuration (¶0033).
Regarding claim 24, McNiven teaches
a repair device (100, Fig. 3) configured for repair of a valve (¶0025), the repair device comprising:
a proximal grasping assembly (118a-c, Fig. 3) and a distal grasping assembly (108a-c, Fig. 3), each of which is movable between a first position (contained in the distal end of the catheter, ¶0034) and a second position (expanded condition, Fig. 3, ¶0021),
the distal grasping assembly and the proximal grasping assembly are attached to a shaft (distal portion of 102, Fig. 3) in a predetermined spaced apart relationship configured to define a grasping space therebetween (space between 118a-c and 108a-c, Fig. 3) to receive valve tissue (Fig. 6) when each the proximal grasping assembly and the distal grasping assembly are in the second position (Fig. 6), wherein
both the distal grasping assembly and the proximal grasping assembly are configured to rotate relative to the shaft at the same time (¶0034);
a rod (102, Fig. 3) operatively connected to the shaft (distal portion of 102, Fig. 3), the actuator rod being configured such that movement of the rod moves both the proximal grasping assembly and the distal grasping assembly (¶0034); and
a lock (124a-c & 126a-c, Fig. 4, ¶0031) connected to the actuator rod (102, Fig. 3), the lock being configured to selectively move between an open configuration and a binding configuration (124a-c & 126a-c, Figs. 3-4, ¶0031), wherein, in the open configuration, the lock is configured to allow translation of the actuator rod, further wherein, in the binding configuration, the lock is configured to prevent movement of the proximal grasping assembly and the distal grasping assembly (124a-c & 126a-c, Figs. 3-4, ¶0031).
Regarding claim 25, McNiven teaches
further comprising a rod (102, Fig. 3) operably connected to the grasping assembly and the distal grasping assembly (108a-c, Fig. 3), wherein movement the rod rotates both the proximal grasping assembly and the distal assembly (¶0034).
Regarding claim 26, McNiven teaches
wherein the proximal grasping assembly (118a-c, Fig. 3) and the distal grasping assembly (108a-c, Fig. 3) are pivotally attached to the rod (102, Fig. 3).
Regarding claim 27, McNiven teaches
wherein the distal grasping assembly and the proximal assembly (118a-c, Fig. 3) are joined by a shaft (distal portion of 102, Fig. 3).
Regarding claim 28, McNiven teaches
wherein each proximal grasping assembly (118a-c, Fig. 3) and distal grasping assembly (108a-c, Fig. 3) being joined such that a shaft (distal portion of 102, Fig. 3) acts as a hinging point (Fig. 3).
Regarding claim 31, McNiven teaches
wherein both the distal grasping assembly (108a-c, Fig. 3) and the proximal grasping assembly (118a-c, Fig. 3) are configured to rotate relative to the shaft (distal portion of 102, Fig. 3, ¶0034).
Regarding claim 32, McNiven teaches
wherein translation of the rod (102, Fig. 3) controls rotation of both the proximal grasping assembly (118a-c, Fig. 3) and the distal grasping assembly (108a-c, Fig. 3) about the hinging point.
Regarding claim 34, McNiven teaches
further comprising: a proximal leg (straight portion of 118a-c towards the distal end, Fig. 3) pivotally connected to the rod (102, Fig. 3) and joined to the proximal grasping assembly (joined at the bend on 118a-c, Fig. 3); and a distal leg (112a-c, Fig. 3) pivotally connected to the rod (102, Fig. 3) and joined to the distal grasping assembly (108a-c, Fig. 3).
Regarding claim 37, McNiven teaches
a repair system configured for repair of a regurgitant tricuspid valve (¶0025), the repair system comprising:
a delivery system (¶0026), comprising:
a sheath (103, Fig. 3);
a delivery catheter (¶0026) disposed within the sheath (103, Fig. 3) so as to be translatable within the sheath (103, Fig. 3, ¶0026); and
a repair device (100, Fig. 3), including:
a proximal grasping assembly (118a-c, Fig. 3) and a distal grasping assembly (108a-c, Fig. 3), each of which is movable between a first position and a second position (contained in the distal end of the catheter, ¶0034),
the distal grasping assembly and the proximal grasping assembly having a predetermined spaced apart relationship configured to define a grasping space therebetween (space between 118a-c and 108a-c, Fig. 3) to receive the valve tissue (Fig. 6); and
a lock (124a-c & 126a-c, Fig. 4, ¶0031) disposed proximal (Fig. 4) the proximal grasping assembly (118a-c, Fig. 3), the lock (124a-c & 126a-c, Figs. 3-4, ¶0031) having an open configuration allowing movement of both the proximal grasping assembly (118a-c, Fig. 3) and the distal grasping assembly (108a-c, Fig. 3),
the lock (124a-c & 126a-c, Figs. 3-4, ¶0031) further having a binding configuration which prevents movement of the proximal grasping assembly (118a-c, Fig. 3) and distal grasping assembly (108a-c, Fig. 3), wherein
the sheath (103, Fig. 3) is configured to be selectively retractable relative to the delivery catheter to expose at least a portion of the repair device (100, Fig. 3) and enable the distal grasping assembly (108a-c, Fig. 3) and the proximal grasping assembly (118a-c, Fig. 3) to move toward the second configuration (¶0030, 0032, 0034, & 0036).
Claim(s) 7, 29-30, 33, & 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over McNiven in view of Wahr et al. (US 20020183787 A1) hereinafter, Wahr.
Regarding claim 7, McNiven teaches a first locking plate (flat portions of 124a-c, Fig. 4) but does not teach the first locking plate being configured to cooperate with a leaf spring. However, Wahr teaches a device for sealing a patent foramen ovale in the heart (abstract, Wahr)
the first locking plate (32, Fig. 11, Wahr) being configured to cooperate with a leaf spring (32a, Fig. 11, Wahr).
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 McNiven by incorporating a leaf spring as taught by Wahr in order to fix anchor 14 with respect to tether 16 (¶0061, Wahr).
Regarding claim 29, McNiven does not teach upon the rod being translated longitudinally the proximal grasping assembly and the distal grasping assembly move in opposite directions. However, Wahr teaches
wherein upon the rod (16, Fig. 12, Wahr) being translated longitudinally the proximal grasping assembly (14, Fig. 12, Wahr) and the distal grasping assembly (12, Fig. 12, Wahr) move in opposite directions relative to the shaft.
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 McNiven by incorporating the teaching above as taught by Wahr in order to allow right atrial anchor 14 to be moved relative to tether 16 (0060, Wahr).
Regarding claim 30, McNiven teaches
wherein each proximal grasping assembly (118a-c, Fig. 3, McNiven) and distal grasping assembly (108a-c, Fig. 3, McNiven) being joined to the shaft (distal portion of 102, Fig. 3, McNiven) such that shaft acts as a hinging point (Fig. 3, McNiven).
Regarding claim 33, McNiven does not teach upon the rod being translated longitudinally the proximal grasping assembly and the distal grasping assembly move in opposite directions. However, Wahr teaches
wherein upon the rod (16, Fig. 12, Wahr) being translated longitudinally the proximal grasping assembly (14, Fig. 12, Wahr) and the distal grasping assembly (12, Fig. 12, Wahr) move in opposite directions relative to the shaft.
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 McNiven by incorporating the teaching above as taught by Wahr in order to allow right atrial anchor 14 to be moved relative to tether 16 (¶0060, Wahr).
Regarding claim 35, McNiven teaches
wherein distal translation of the rod (102, Fig. 3, McNiven) relative to the shaft moves distal leg (112a-c, Fig. 3, McNiven) distally. McNiven does not teach the distal grasping assembly to rotate about the hinge point thereby rotating away from the shaft to the first position. However, Wahr teaches
causing the distal grasping assembly (12, Fig. 15, Wahr) to rotate about the hinge point thereby rotating away from the shaft to the first position (Fig. 15, Wahr).
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 McNiven by incorporating the teaching above as taught by Wahr because this is a preferred position of the arms in a delivery position (¶0075, Wahr).
Regarding claim 36, McNiven teaches
wherein distal translation of the rod relative to the shaft moves the proximal leg (straight portion of 118a-c towards the distal end, Fig. 3, McNiven) distally. McNiven does not teach the proximal grasping assembly to rotate about the hinge point thereby rotating away from the shaft to the first position. However, Wahr teaches
causing proximal grasping assembly (14, Fig. 15, Wahr) to rotate about the hinge point thereby rotating away from the shaft to the first position (Fig. 15, Wahr).
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 McNiven by incorporating the teaching above as taught by Wahr because this is a preferred position of the arms in a delivery position (¶0075, Wahr).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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