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 .
Response to Arguments
The amendments, dated 12/15/2025, have overcome:
The rejection of claim(s) 1, 3-5, 7-12, 20 under 35 U.S.C. 102(a)(1) based on Basude et al. (US 2020/0383782 A1 – as previously cited);
The rejection of claim(s) 2, 13-19 under 35 U.S.C. 103 based on Basude et al. (US 2020/0383782 A1 – as previously cited) and (Cao (US 2018/0185154 A1 – as previously cited);
The rejection of claim(s) 6 under 35 U.S.C. 103 based on Basude et al. (US 2020/0383782 A1 – as previously cited) and Metchik et al. (US 2019/0069991 A1 – as previously cited);
The aforementioned rejections have been withdrawn.
Claim Objections
Claim(s) 12 is/are objected to because of the following informalities:
Within claim 12, line 3: “canter” should be replaced with --center--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 7-8, 20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Powell et al. (US 2006/0229708 A1).
With respect to claim 1:
Powell et al. discloses a fixation device, as can be seen in figs. 32-33C, for engaging heart valve leaflets, comprising:
a center member (central shaft 1122) with a first end (closer to the top of the page in fig. 33C), an opposite second end (closer to the bottom of the page in figs. 33C), and a length extending therebetween (paragraph [0146]);
wherein the center member (central shaft 1122) includes a first set of radially extending projections on a first side of the center member and a second set of radially extending projections on a second side of the center member opposite the first side (teeth on the sides of the central shaft 1122) (paragraph [0146]);
wherein the first set of radially extending projections are spaced apart a fixed distance from the second set of radially extending projections (the central shaft 1122 does not change shape, as such the teeth thereon will maintain a constant distance therebetween);
first and second arms (articulating jaw arms 1120) each having a first free end (closer to the top of the page in fig. 33C) and an opposite second end (at the connection with the central shaft 1122), the second end (at the connection with the central shaft 1122) of each arm extending from the second end of the center member (central shaft 1122), as can be seen in fig. 33C, the first and second arms (articulating jaw arms 1120) biased in a first position adjacent the center member (central shaft 1122), as can be seen fig. 33C, and moveable to a second position spaced apart from the center member (central shaft 1122), as can be seen in fig. 33A (paragraphs [0149-0150]); and
an actuator (stabilizers 1112) configured to move the first and second arms (articulating jaw arms 1120) from the first position, as can be seen fig. 33C, to the second position, as can be seen in fig. 33A (paragraph [0150]).
With respect to claim 2:
Wherein the center member (central shaft 1122) and the first and second arms (articulating jaw arms 1120) are a monolithic structure (as can be seen in figs. 32-33C the aforementioned structures are shown as a single component without any lines/ seams denoting breaks therein, as such is considered to be monolithic).
With respect to claim 4:
Wherein when in the first position, as can be seen fig. 33, at least a first portion of each of the first and second arms (articulating jaw arms 1120) is in contact with the first set and the second set of radial projections (teeth on the sides of the central shaft 1122) (Please note: the “when” is being treated as “is configured to/ is capable of”; the double jaw grasper (1113) is capable of/ configured to be delivered to the heart through the central lumen (1111) with the double jaw grasper (1113) closed, such that the actuator (stabilizers 1112) is not between the first and second arms (articulating jaw arms 1120) and the center member (central shaft 1122) (thereby having a smaller delivery profile) resulting in at least a portion of the first and second arms (articulating jaw arms 1120) being in contact with the first set and the second set of radial projections (teeth on the sides of the central shaft 1122) (paragraphs [0144]).)
With respect to claim 5:
Wherein the first end of the center member (end of central shaft 1122 closer to the top of the page in fig. 33C) includes a connection element configured to be removably connected to a catheter shaft (delivery device therefore) (as the double jaw grasper (1113) maybe used to permanently grasp the valve leaflets (due to the at least temporarily grasp language) there inherently must be a connection element between the delivery device therefore and the first end of the center member (end of central shaft 1122 closer to the top of the page in fig. 33C) where it is connected, as seen in fig. 32) (paragraphs [0146-0148]).
With respect to claim 7:
Wherein the first and second arms (articulating jaw arms 1120) are independently actuatable (paragraph [0146]).
With respect to claim 8:
Wherein the actuator (stabilizers 1112) is removable (paragraph [0150]).
With respect to claim 20:
Powell et al. discloses a fixation device, as can be seen in figs. 32-33C, for engaging heart valve leaflets, comprising:
a center member (central shaft 1122) with a first end (closer to the top of the page in fig. 33C), an opposite second end (closer to the bottom of the page in figs. 33C), and a length extending therebetween (paragraph [0146]);
a first set of radially extending projections on a first side of the center member and a second set of radially extending projections on a second side of the center member opposite the first side (teeth on the sides of the central shaft 1122) (paragraph [0146]);
wherein the first set of radially extending projections are spaced apart a fixed distance from the second set of radially extending projections (the central shaft 1122 does not change shape, as such the teeth thereon will maintain a constant distance therebetween);
first and second arms (articulating jaw arms 1120) extending from the second end of the center member (end of central shaft 1122 closer to the bottom of the page in fig. 33C), the first and second arms (articulating jaw arms 1120) biased in a first position adjacent the center member (central shaft 1122), as can be seen fig. 33C, and moveable to a second position spaced apart from the center member (central shaft 1122), as can be seen in fig. 33A (paragraphs [0149-0150]); and
a removable actuator (stabilizers 1112) configured to move the first and second arms (articulating jaw arms 1120) from the first position, as can be seen fig. 33C, to the second position, as can be seen in fig. 33A (paragraph [0150]), wherein the actuator (stabilizers 1112) is configured to actuate the first and second arms (articulating jaw arms 1120) independently (paragraph [0146]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Powell et al. (US 2006/0229708 A1) in view of Metchik et al. (US 2019/0069991 A1).
With respect to claim 6:
Powell et al. discloses the invention substantially as claimed, as discussed above. However, Powell et al. does not disclose the connection element (connection means between the double jaw grasper (1113) used to permanently grasp the valve leaflets and the delivery device therefore which will deliver/ push it thru the conduit (1108)) to include threading.
Metchick et al. discloses an implantable prosthetic device that includes a spacer member with a plurality of anchor members coupled thereto to be disposed between leaflets of a native valve (paragraph [abstract]). The prosthetic device is coupled to a delivery device therefor by a threaded connection element (distal end portion 512b) has an external thread mating with an internal thread of the (226) of the spacer member (paragraphs [0096-0097]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the threaded connection element, as taught by Wetchik et al., for the undisclosed connection element between the first end of the center member (end of central shaft 1122 closer to the top of the page in fig. 33C) of the double jaw grasper (1113) and the delivery device therefore, as disclosed by Powell et al., as the courts have found prima facie obviousness where modification requires combining prior art elements according to a known method to yield predictable results (see MPEP 2143). (In this case - the predictable result is the threaded connection would provide a more secure connection therebetween in order to reduce the possibility of premature/ unintended deployment during delivery and recoverability of the double jaw grasper (1113) should repositioning be required.)
Allowable Subject Matter
Claim(s) 9-19 is/are 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: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 9:
A fixation device (as required by claim 1 and 8) wherein the actuator comprises first and second wires each removable connected to the first and second arms (respectively). (PLEASE NOTE: The aforementioned claim subject matter is in direct contrast the actuator (stabilizers 1112), as disclosed by Powell et al., which although has separate structures/ wires to actuate the respective arms, these actuators/ wires is/ are not removable connected first and second arms – nor does Powell et al. appear to be capable of functioning/ being positioned with a modification thereto.)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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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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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/Primary Examiner, Art Unit 3774
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