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
Applicant’s arguments, see Applicant’s Response, filed 12/29/2025, with respect to the rejection of claims1-16 under Shiroff et al. US 2014/0350653 in view of DiGiore et al. US 2013/0105071 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 Therefore, the rejection has been withdrawn.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 Swendson et al. US 4,651,751.
Applicant argues on page 9: “Nowhere does DiGiore teach or suggest that the helical section 702 of the multi-lumen conductor guide comprises conductors that are maintained in a tightly would configuration for enhancing fatigue-resistance at helical section 702, much less conductors that transition from the tightly wound configuration towards a straight configuration within a transition portion, as recited by claim 1, as amended.” The DiGiore reference, in light of the claim amendments, is now replaced with the Swendson et al. US 4,651,751 et al. reference. However, it is noted that the language “for enhanced fatigue-resistance” is not structural, this is functional language that does not require any specific structure other than being helical. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
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 1-4 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shiroff et al. US 2014/0350653 previously cited in view of Swendson et al. US 4,651,751.
Regarding claims 1 and 8: Shiroff discloses a neuromuscular electrical stimulation lead (abstract) comprising; a lead body (figure 1) with a proximal region 12 (figure 1), a distal region 14 (figure 1) and a fatigue-resistant zone 20/31 (“strain relief”, figures 1 and 2) which is between the proximal and distal regions; the lead is configured to be implanted adjacent to nervous tissue associated with a lumber spine for stimulation of tissue (paragraph 0029); electrodes 16/33 (figures 1-2) on the distal region 14 (figure 1) and conductors 13/32 (figures 1-2) electrically coupled to the electrodes and extending through the lead body from the distal region to the proximal region (paragraph 0030); the conductors 13/32 are comprised of individual strands (“plurality of insulated wires”, paragraph 0036). Shiroff further discloses that the fatigue-resistant zone 31/43 (“strain relief”, figures 2-3) has a helical configuration of individual wires wound in a coiled configuration (“helical”, paragraph 0036), the fatigue-resistant zone is disposed at locations within the patient that experience shear forces caused by movement (abstract, paragraphs 0008, 0044), this is considered to be a fatigue-resistant zone.
Therefore, Shroffs discloses the claimed invention however Shiroff does not specifically disclose individual conductors are in a straight configuration outside of the fatigue-resistant zone, with the strands of the conductor maintaining the coil configuration and gradually transitioning towards the straight configured in a semi-coiled configured with a transition portion outside of the fatigue resistant zone.
Swendson however teaches of a pacing catheter 11 (figure 1) which includes leads 29 (figures 1, 2a, 2b, and 3a) operably connected to electrodes 35/62 (figures 1, 2a, 2b, and 3a). In this configuration the inner conductor 17 (figures 1, 2a, 2b, and 3a) is connected to distal electrode 62 (figures 1, 2a, 2b, and 3a) and the outer conductor 25 (figures 1, 2a, 2b, and 3a) is connected to electrode 35 (figures 1, 2a, 2b, and 3a) to form a bipolar lead (column 3, line 58 through column 4 line 12, and column 5 line 15). With particular attention to figure 3a, the inner conductor 17 (figure 3a) is in a straight configuration within insulative sheath 43 (“the first section is straight”, column 4, line 19), the second section labeled the transition section 39 (figure 3a) transitions from the straight configuration into coils 45 (figure 3a), the transition section then shifts into a tightly coiled distal section 41 (figure 3a). Swendson teaches that the flexibility of the lead including the inner conductor increases from the straight configuration (being the least flexible) to the tightly coiled distal section (being the most flexible), see column 4 lines 52-67. Therefore Swendson teaches of the flexible zone, considered to be the distal tightly coiled region 41 (figure 3a) which gradually transitions in the transition region 39 towards a straight and section 37. It is made of the record that the fatigue resistant zones are considered to be the most flexible portion of the lead. It is further noted that figure 3a of Swendson closely resembles applicants figure 2a. Further, as is known, anything that is more flexible is also less likely to fatigue.
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It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Shroffs to include a first straight section which is the least flexible or most rigid portion of the lead, a transition section which transitions from straight to coiled to a third section which is tightly coiled and the most flexible, as taught by Swendson, in order to control the flexibility of the lead.
Regarding claim 2: Shiroff discloses an insulative sheath 15 (figure 1) which extends from the proximal region 12 (figure 1) to the distal region 14 (figure 1), the conductors are within the sheath (paragraph 0015).
Regarding claim 3: Shiroff/ Swendson discloses the claimed invention, however Shiroff/ Swendson does not specifically discloses multiple fatigue-resistant zones. Swendson however, teaches of both an inner conductor 17 (figure 1) and an outer conductor 25 (figure 1). The outer conductor 25 (figure 1) includes contiguous coils 31 and axially spaced coils 33 (column 4, lines 1-12). This creates an additional fatigue resistant/flexible region about the spaced apart coils 33. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Shiroff/ Swendson to include multiple flexible regions, as taught by Swendson, in order to create flexibility.
Regarding claim 4: Shiroff discloses that the wires are individually insulated (paragraph 0036).
Regarding claim 7: Shiroff/ Swendson discloses the claimed invention it is inherent to the design of Swendson that the length of the wire which is helically wound is longer than the length of the wire which is straight.
Regarding claims 9-13: Shiroff discloses a first fixation element 19a (figure 1) and a second fixation element 19b (figure 1) coupled to the lead body, 19a is proximal to at least one electrode, 19b is distal to 19a and an electrode is between 19a and 19b (figures 12). Shiroff further discloses that 19a is angled towards the distal end and 19b is angled towards the proximal end which places the tissue between the two anchors and is considered to be in a sandwich configuration (figures 1-2). Note that this is the same configuration as is seen in applicants figure 1. The lead is deployed between muscle layers (abstract) for restoring muscle function associated with lumbar spine stability (paragraph 0029). The language found in claim 13 is considered to be functional language and/or intended use language. The electrodes of Shiroff are capable of this specific site of stimulation. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises stimulation electrodes.
Regarding claims 14-16: Shiroff discloses a system (figure 1) which includes an IPG 8 (figure 1, paragraph 0030) as well as a lead 10 (figure 1), the lead is coupled to the IPG, the individual conductors 13 are connected to the internal components of the IPG, as is known in the art. The IPG delivers stimulation to the tissue, which is neuromuscular stimulation which includes the stimulation of nerves (abstract).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shiroff et al. US 2014/0350653 previously cited in view of Swendson et al. US 4,651,751 and further in view of Shoberg et al. US 2017/0312500.
Regarding claims 5-6: Shiroff/Swendson discloses the claimed invention however Shiroff/Swendson does not specifically disclose each conductor including multiple wires and/or seven wires. Shoberg however teaches of an electrode assembly which includes cable conductors which include seven filars (paragraph 0026). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Shiroff/Swendson to include multiple filars or seven filars, as taught by Shoberg, in order to use a bundled filar cable.
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 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