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
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.
Claims 1, 2, 4-5 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. US 2020/0306547.
Regarding claim 1: Liu discloses a biostimulator (“pacing device 20”, 0071) comprising;
a housing 22/22a/22b (figures 3, 6, 17 and 21) having a longitudinal axis A (figure 6), the housing containing electronics (“enclosing electronic components”, paragraph 0082, also figure 3 demonstrates that the electronic components are within housing portion 22a);
a fixation element 50 (figures 3, 6, 17 and 21) coupled to the housing 22/22a/22b (figures 3, 6, 17 and 21), wherein the fixation element 50 extends about the longitudinal axis; and
a pacing element 24 (“distal extension”, figures 3, 6, 17 and 21) coupled to the housing, wherein the pacing element includes a strain relief 77 (“strain relief”, figure 6, 17 and 21) surrounding a flexible conductor 70/72 (figure 3), and wherein a stiffness of the strain relief decreases in a distal direction (paragraphs 0117-118 “flexibility that changes along its length” and “distally extending taper” as is seen in figure 17 the strain relief is thicker at the proximal end and more narrow at a distal end thus decreasing in stiffness distally).
Regarding claim 2: Liu discloses that the flexible conductor 72 (figure 3) extend from modules 56, 58, 60, 62, 64 to one or more electrodes 26-36 (paragraph 0099), this is a typical conductor and considered to be a cable.
Regarding claim 4: Liu discloses that the fixation element 50 (figure 6) includes a helical fixation element (paragraphs 0020 and 0068).
Regarding claim 5: Liu discloses that the fixation element can include tines (paragraphs 0068 and 0084).
Regarding claim 13: Liu discloses a biostimulator (“pacing device 20”, 0071) comprising;
a housing 22/22a/22b (figures 3, 6, 17 and 21) having a longitudinal axis A (figure 6), the housing containing electronics (“enclosing electronic components”, paragraph 0082, also figure 3 demonstrates that the electronic components are within housing portion 22a);
a pacing element 24 (“distal extension”, figures 3, 6, 17 and 21) coupled to the housing, wherein the pacing element 24 includes a flexible conductor 72 (figure 3) extending between the electronics compartment 22a (figure 3) and a distal pacing tip (conductor 72 connects to electrodes 30/32/34/36, electrode 36 is considered to be at a distal tip, figure 2), wherein the pacing element includes a strain relief 77 (“strain relief”, figure 6, 17 and 21) surrounding a flexible conductor 72 (figure 3), and wherein a stiffness of the strain relief decreases in a distal direction (paragraphs 0117-118 “flexibility that changes along its length” and “distally extending taper” as is seen in figure 17 the strain relief is thicker at the proximal end and more narrow at a distal end thus decreasing in stiffness distally).
Regarding claim 14: Liu discloses that the flexible conductor 72 (figure 3) extend from modules 56, 58, 60, 62, 64 to one or more electrodes 26-36 (paragraph 0099), this is a typical conductor and considered to be a cable.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. US 2020/0306547 in view of Sommer et al. US 2010/0331938.
Regarding claim 3: Liu discloses the claimed invention however Liu does not disclose a tubular braid with a tubular braid lumen. Sommer however teaches of a reinforcement member which extends axially on the outer surface of a lead body, this would maintain the conductor within the braided lumen (abstract). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a tubular braid, as taught by Sommer, in order to add reinforcement to the lead.
Regarding claim 15: Liu discloses the claimed invention however Liu does not disclose a tubular braid with a tubular braid lumen. Sommer however teaches of a reinforcement member which extends axially on the outer surface of a lead body, this would maintain the conductor within the braided lumen (abstract). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a tubular braid, as taught by Sommer, in order to add reinforcement to the lead.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. US 2020/0306547 in view of Zhu US 2010/0082086.
Regarding claim 6: Liu discloses the claimed invention however Liu does not disclose a nosecone. Zhu however teaches of stimulation lead 10 which includes a nose cone 2 (figure 1). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include a nose cone, as taught by Zhu, in order to connect with a stylus to advance the lead (paragraph 0046).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. US 2020/0306547 in view of Haasl et al. US 2018/0264274.
Regarding claim 7: Liu discloses the claimed invention however Liu doesn’t disclose that the pacing element includes a helical electrode which is coupled to the flexible conductor. Note that Liu does disclose electrodes coupled to the flexible conductor (figure 3). Haasl however teaches of a similar device which includes a distal extension with fixation features 44 (figure 2) at the distal end of the distal extension. Although figure 2 shows tines, Haasl teaches that these can be tines or a helical coil (paragraph 0064). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include distal helical coils on the distal end of the pacing element, as taught by Haasl, in order to secure the extension to the tissue.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. US 2020/0306547 in view of Rothstein et al. US 2012/0191169.
Regarding claim 16: Liu discloses the claimed invention including the pacing element. However Liu does not disclose a helical electrode having a distal pacing tip on the pacing element. Rothstein however teaches of a distal helix electrode 228 (figure 7) which is at the end of a lead. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include a distal helical electrode, as taught by Rothstein, in order to fix the electrode to the tissue.
Claims 8-11 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. US 2020/0306547 in view of Zhang et al. US 2021/0228888.
Regarding claim 17: Liu discloses a biostimulator (“pacing device 20”, 0071) comprising;
a housing 22a (figures 3, 6, 17 and 21) having a longitudinal axis A (figure 6), the housing containing electronics (“enclosing electronic components”, paragraph 0082, also figure 3 demonstrates that the electronic components are within housing portion 22a);
a fixation element mount 22b (figures 3, 6, 17 and 21) coupled to the housing 22a (figures 3, 6, 17 and 21), and
a fixation element 50 (figure 5) partially embedded in the fixation element 22b mount (figure 5) radially inward of the mount surface, wherein the fixation element extends helically about the longitudinal axis (figure 5).
Liu therefore discloses the claimed invention, however Liu does not disclose that the fixation element mount is tapered. Zhang however teaches of a feedthrough assembly 112 (figure 2) which includes helix mount 114 which is tapered at the distal end of the mount 114. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include a tapered helix mount, as taught by Zhang, in order to electrically isolate the distal electrode (paragraph 0051). Liu therefore discloses the claimed invention, however Liu does not disclose that the fixation element mount is tapered. Zhang however teaches of a feedthrough assembly 112 (figure 2) which includes helix mount 114 which is tapered at the distal end of the mount 114. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include a tapered helix mount, as taught by Zhang, in order to electrically isolate the distal electrode (paragraph 0051).
Regarding claims 8-10: Liu discloses the claimed invention including a fixation element mount 22b (figures 3, 6, 17 and 21) coupled to the housing 22a (figures 3, 6, 17 and 21). Liu further discloses a fixation element 50 (figure 5) partially embedded in the fixation element 22b mount (figure 5) radially inward of the mount surface, wherein the fixation element extends helically about the longitudinal axis (figure 5). Liu therefore discloses the claimed invention, however Liu does not disclose that the fixation element mount is tapered. Zhang however teaches of a feedthrough assembly 112 (figure 2) which includes helix mount 114 which is tapered at the distal end of the mount 114. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu to include a tapered helix mount, as taught by Zhang, in order to electrically isolate the distal electrode (paragraph 0051).
Regarding claim 11: Liu/Zhang discloses the claimed invention however Liu/Zhang does not disclose a spiral ramp with the fixation helix mounted in the spiral ramp. Zhang however further teaches of a flange 270, the flange extends helically about the longitudinal axis (paragraph 0059) and the fixation helix is mounted to the flange (paragraph 0058). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu/Zhang to include a spiral ramp, as taught by Zhang in order to mount the helical fixation member.
Regarding claim 18: Liu disclose that the fixation element 50 (figure 3) includes a helical fixation element (paragraph0084) with turns embedded in housing 22b which is considered to be a fixation element mount.
Regarding claim 19: Liu/Zhang discloses the claimed invention however Liu/Zhang does not disclose a spiral ramp with the fixation helix mounted in the spiral ramp. Zhang however further teaches of a flange 270, the flange extends helically about the longitudinal axis (paragraph 0059) and the fixation helix is mounted to the flange (paragraph 0058). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Liu/Zhang to include a spiral ramp, as taught by Zhang in order to mount the helical fixation member.
Regarding claim 20: Liu discloses that the strain relief 77 (figure 6) which extends distally (figure 17), this strain relief section 77 surrounds and encapsulates the distal extension 24 as well as the conductor 70.
Allowable Subject Matter
Claim 12 is 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: Claim 12 recites a radial protrusion to grip the strain relief. This limitation in combination with all of the limitations of claim 1 appears to be unique.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796