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 .
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.
Claim(s) 1-6 and 9-16 and 20 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Hine et al. (Pub. No.: US 2021/0106839 A1); hereinafter referred to as “Hine”.
Regarding claims 1 and 11, Hine discloses a biostimulator (e.g. see figure 2 element 100, [0041]), comprising: a housing (e.g. see figure 2 element 120, [0056]-[0060]) having an electronics compartment (e.g. see figure 2 element 112, [0100]) containing pacing circuitry (e.g. see figure 10 element 210, [0105]); a fixation guide (e.g. see figure 2 element 122, [0056]-[0060]) mounted on the housing and including a guide passage (e.g. see [0056], “elongate body of the inner catheter 122 may define a lumen”); and a fixation element (e.g. see figure 2 element 110, [0046]-[0051]) movable through the guide passage from an undeployed state to a deployed state (e.g. see figures 20-22), wherein in the undeployed state a fixation tip of the fixation element is within the guide passage (e.g. see figure 20), and wherein in the deployed state the fixation tip extends out of the guide passage (e.g. see figure 22).
Regarding claims 2, 12, and 18, Hine discloses in the undeployed state a fixation axis of the fixation element is parallel to a housing axis of the housing (e.g. see figure 14 steps 304 and 306, figures 20-22).
Regarding claims 3, 13, and 19, Hine discloses in the deployed state a fixation axis of the fixation element is orthogonal to a housing axis of the housing (e.g. see figure 14 steps 304 and 306, figures 20-22).
Regarding claims 4 and 14, Hine discloses a pacing electrode (e.g. see figure 9 elements 150, 152, 154, 156, [0100], [0106]) electrically coupled to the pacing circuitry (e.g. see [0105]) and extending along a pacing axis, wherein in the undeployed state the pacing axis is parallel to a housing axis of the housing, and wherein in the deployed state the pacing axis is orthogonal to the housing axis (e.g. see figure 14 steps 304 and 306, figures 20-22).
Regarding claim 5, Hine discloses the pacing electrode is movable relative to the fixation element (e.g. see [0121]).
Regarding claim 6, Hine discloses the pacing electrode (e.g. see figure 9 elements 150, 152, 154, 156, [0100], [0106]) and the fixation element (e.g. see figure 9 element 110, [0046]-[0051]) are coaxial.
Regarding claim 9, Hine discloses the guide passage (e.g. see [0056], “elongate body of the inner catheter 122 may define a lumen”) extends through a guide body of the fixation guide from a proximal guide end of the fixation guide to a lateral guide wall of the fixation guide (e.g. see figure 2 element 122, [0056]-[0060]).
Regarding claims 10, 15, and 20, Hine discloses the fixation element (e.g. see figure 2 element 110, [0046]-[0051]) extends helically through the guide passage to the fixation tip (e.g. [0096], “the fixation element 140 includes a helix to screw in or out of the septal wall of the patient's heart 10 in response to rotation of the fixation member 110).
Regarding claim 16, Hine discloses the invention (see the rejection for claim 1 above) and further discloses in the deployed state the fixation tip extends into the interventricular septal wall (e.g. see figures 20-22).
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) 7 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine in view of Tze et al. (Pub. No.: US 2023/0381501 A1); hereinafter referred to as “Tze”.
Regarding claims 7 and 17, Hine discloses the device making a 90 degree turn (e.g. see figures 8 and 20-22) but is silent as to the fixation guide includes a hinge movably connecting a distal guide portion to a proximal guide portion, wherein the distal guide portion is mounted on the housing, and wherein the proximal guide portion includes the guide passage. Tze teaches it is known to use such a modification as set forth in [0045], figure 3 element 190 to allow the flexible bending of the lead body 110 at that location without transferring unacceptable forces to the CSP electrodes, e.g., unacceptable forces that result in lead electrode dislodgement or injury to the myocardium at the implantation location resulting in an unstable or elevated pacing threshold (e.g. see [0045]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a hinge at the bend as taught by Tze in the system/method of Hine, since said modification would provide the predictable results of allowing the flexible bending of the lead body 110 at that location without transferring unacceptable forces to the CSP electrodes, e.g., unacceptable forces that result in lead electrode dislodgement or injury to the myocardium at the implantation location resulting in an unstable or elevated pacing threshold.
Regarding claim 18, Hine discloses in the undeployed state a fixation axis of the fixation element is parallel to a housing axis of the housing (e.g. see figure 14 steps 304 and 306, figures 20-22).
Regarding claim 19, Hine discloses in the deployed state a fixation axis of the fixation element is orthogonal to a housing axis of the housing (e.g. see figure 14 steps 304 and 306, figures 20-22).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hine in view of Feldmann et al. (Pub. No.: US 2007/0129782 A1); hereinafter referred to as “Feldmann”.
Regarding claim 8, Hine discloses the fixation guide includes an inner guide wall surrounding the guide passage (e.g. see [0056], “elongate body of the inner catheter 122 may define a lumen”) but is silent as a protrusion extends inward from the inner guide wall to engage the fixation element. Feldmann teaches it is known to use such a modification as set forth in [0044]-[0045], figures 2-4 elements 18, 18’, 18’’ to engage the fixation helix in order to cause axial movement of fixation helix 10 when the helix is rotated around its longitudinal axis (e.g. see [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a protrusion to rotate the helix at the bend as taught by Feldmann in the system/method of Hine, since said modification would provide the predictable results of engaging the fixation helix in order to cause axial movement of fixation helix when the helix is rotated around its longitudinal axis.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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