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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/20/2026 has been entered.
Amendment
This action is in response to the Amendment filed on 5/20/2026.
Claims 1-25 are pending.
Claims 1-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim 22-25 are being examined.
Response to Arguments
Applicant's arguments with respect to claims 22-25 have been considered but are not persuasive.
Rejections under 35 U.S.C. 103 - Ryu et al (U.S. Patent Number: US 7,848,821 B1, hereinafter “Ryu”, cited in IDS filed 07/30/2024) in view of Bonde et al (U.S. Patent Application Publication Number: US 2007/0255368 A1, hereinafter “Bonde”) and Silipo et al (U.S. Patent Number: US 8,442,620 B2, hereinafter “Silipo”, cited in IDS filed 07/30/2024), and in further view of Jiang et al (U.S. Patent Application Publication Number: US 2016/0045747 B2, hereinafter “Jiang”- PREVIOUSLY CITED)
Independent claims 22 and 25 have been amended to recite “
“wherein a portion of the conductive distal anchor protrudes from the lumen of the introducing needle, forming a bend over a first edge of the terminal opening of the introducing needle to be held in an area between an inner surface of the introducing sheath and an outer surface of the introducing needle.”
Applicant argues that the interpretation provided in the office action mailed on 2/23/2026 ignores the structural relationship between the claimed components.
Since in Claim 22, the conductive distal anchor is held in an area between an inner surface of the introducing sheath and an outer surface of the introducing needle, this defines a "nested" or "sandwiched" configuration. They argue that Ryu (Figs. 7-12) teaches a push tube (90) that abuts the proximal side of a hook (45). The hook in Ryu is located entirely distal to the push tube. There is no disclosure in Ryu-or any of the secondary references-of an anchor that is bent back over the edge of a needle to be held between that needle and an outer sheath. This structural difference provides a critical technical advantage. As disclosed in the Specification (p. 23), the claimed arrangement protects the delicate open-coiled helical structure from stress and metal fatigue during insertion. Ryu's system, designed for heart tissue using stiffer wires, does not face or solve the problem of protecting fracture-prone helical coils during high-force percutaneous insertion through muscle and fascia. They argue that there is no motivation to combine Ryu with the other references to arrive at the claimed structure. If a person of ordinary skill in the art (PHOSITA) were to bend Ryu's hook back over the edge of the push tube (90), it would likely disable the primary function of Ryu's device, which relies on the distal end of the tube (100) pushing against the hook to drive it into tissue (Ryu: col. 6, lines 20-30).
The examiner respectively disagrees with the applicant’s arguments for the following reasons.
The claims as recited are directed to a system (therefore apparatus claims) that comprise inter alia:
a lead comprising an insulated body and a conductive distal anchor;
an introducing needle comprising an inner lumen configured to contain the lead, and wherein the introducing needle comprises a distal portion forming a terminal opening;
an introducing sheath comprising an inner lumen configured to contain the introducing needle and the conductive distal anchor of the open-coiled stimulation lead and wherein the introducing sheath comprises a distal portion of the introducing sheath forming a terminal opening of the introducing sheath; and
wherein a portion of the conductive distal anchor protrudes from the lumen of the introducing needle, forming a bend over a first edge of the terminal opening of the introducing needle to be held in an area between an inner surface of the introducing sheath and an outer surface of the introducing needle.
The claim as recited recites the limitation “to be held…” can be interpreted as an intended use limitation. However as clearly shown in the reproduced figure below, Ryu teaches the distal anchor forming a bend over a first edge of the terminal opening of the introducing needle to be held in an area between an inner surface of the introducing sheath and an outer surface of the introducing needle as claimed.
Ryu teaches a lead comprising an insulated lead body (e.g. 50 Figs.7-12, Col. 5 lines 61-62) a conductive distal anchor (e.g. 50, 50a-50d Figs. 7-12, col. 5, lines 61-67: insulated lead body 50 comprising electrode distal end 35 and conductive distal anchor 45 for delivering electrical current);
an introducing needle (e.g. 90 Figs. 7-12; col. 5, lines 50-53: push tube) comprising an inner lumen (e.g. 95 Fig 7-12) configured to contain the lead (e.g. 50 Figs. 7-11), and wherein the introducing needle comprises a distal portion forming a terminal opening (e.g. 100 Fig. 7-12 Col. 6 lines 5-30 col. 6, lines 20-29; col. 7, line 62-col. 8, line 6);
an introducing sheath (e.g. 25 Figs. 7-12; col. 5, line 53), comprising an inner lumen configured to contain the introducing needle (e.g. 90 Figs. 7-12).
The tines 45 protrude from the lumen of the needle 90 as seen in Fig. 7 shows two tines however fig. 23 shows that the tine can be a single hook feature too and therefore the conductive distal anchor protrudes from the lumen 95 of the introducing needle, forming a bend (as shown by A) over a first edge of the terminal opening 100 of the introducing needle 90 to be held in an area between an inner surface (as shown by B) of the introducing sheath 25 and an outer surface (as shown by C) of the introducing needle 90.
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Therefore, applicant’s arguments are not persuasive and the rejection is maintained.
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.
Claims 22, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al (U.S. Patent Number: US 7,848,821 B1, hereinafter “Ryu”, cited in IDS filed 07/30/2024) in view of Bonde et al (U.S. Patent Application Publication Number: US 2007/0255368 A1, hereinafter “Bonde”) and Silipo et al (U.S. Patent Number: US 8,442,620 B2, hereinafter “Silipo”, cited in IDS filed 07/30/2024), and in further view of Jiang et al (U.S. Patent Application Publication Number: US 2016/0045747 B2, hereinafter “Jiang”- PREVIOUSLY CITED).
Regarding claims 22, 24 and 25, Ryu teaches a system for testing, positioning, introducing and deploying a lead for percutaneous peripheral nerve stimulation, the system comprising:
a lead comprising an insulated lead body (e.g. 50 Figs.7-12, Col. 5 lines 61-62) a conductive distal anchor (e.g. 50, 50a-50d Figs. 7-12, col. 5, lines 61-67: insulated lead body 50 comprising electrode distal end 35 and conductive distal anchor 45 for delivering electrical current);
an introducing needle (e.g. 90 Figs. 7-12; col. 5, lines 50-53: push tube) comprising an inner lumen (e.g. 95 Fig 7-12) configured to contain the lead (e.g. 50 Figs. 7-11), and wherein the introducing needle comprises a distal portion forming a terminal opening (e.g. 100 Fig. 7-12 Col. 6 lines 5-30 col. 6, lines 20-29; col. 7, line 62-col. 8, line 6);
an introducing sheath (e.g. 25 Figs. 7-12; col. 5, line 53), comprising an inner lumen configured to contain the introducing needle (e.g. 90 Figs. 7-12) and the conductive distal anchor (e.g. 45/45a-d Figs. 7-12) of the stimulation lead ( e.g. 50/50a-d Figs. 7-12) and wherein the introducing sheath comprises a distal portion of the introducing sheath forming a terminal opening of the introducing sheath (Figs. 7-12 show the introducing sheath 25 comprises a distal end 20, which comprises a terminal opening that permits deployment of the introducing needle and stimulation lead out of the inner lumen 40 and out the distal end 20; col. 6, lines 20-29; col. 7, line 62-col. 8, line 6);
As discussed above, Ryu further teaches the tines 45 protrude from the lumen of the needle 90 as seen in Fig. 7 shows two tines however fig. 23 shows that the tine can be a single hook feature too and therefore the conductive distal anchor protrudes from the lumen 95 of the introducing needle, forming a bend (as shown by A in the reproduced figure) over a first edge of the terminal opening 100 of the introducing needle 90 to be held in an area between an inner surface (as shown by B in the reproduced figure) of the introducing sheath 25 and an outer surface (as shown by C in the reproduced figure) of the introducing needle 90.
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Ryu does not specifically teach that the insulated lead body comprises an open-coiled structure with a central void which promotes tissue ingrowth.
In a similar field of endeavor, Bonde teaches an implantable medical electrical lead for applying electrical stimulation energy and further teaches an insulated lead body (e.g. 44 Fig. 3) comprises an open-coiled structure (e.g. [0028]: an electrically non-conductive material 42 covering a section of the wire 40, the wire coil 40 can be closely wound as shown, or in alternative embodiments, individual windings of the wire coil 40 can be longitudinally spaced. The coiled nature of the wire 40 can further be continued along a majority of the wire's length) with a central void (e.g. 52 Fig.3 [0028]: the coil configuration generates or defines an internal passage 52) which to provide strain relief. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the insulated lead body in the teachings of Ryu to have an open coiled structure as taught by Bonde in order to provide the predictable results of providing strain relief and further the textured surface of the coiled insulated lead body and the internal passage will promote tissue growth.
Further Silipo teaches that it is known in the art of fixation leads having an integrated electrode to include a fixation shape appropriate for the medical application, such as a bent barb or tine 220 similar to Ryu’s (Silipo’s Figs. 1A-1B), which can alternatively be an open-coiled helical shape 220’ also having a bent end (Silipo’s Figs. 2A-2B), which provide the same purpose of engagement and fixation into target tissue (col. 5, line 58-col. 6, line 8; col. 8, lines 20-42). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive distal anchor of Ryu in view of Bonde to have a bent anchoring shape as shown by any of Ryu or Silipo and including an open-coiled helical shape, for the purpose of providing the fixation shape appropriate for fixation at the tissue site based on the desired medical application. (Note: for the sake of compact prosecution, Silipo’s teachings are being included in the rejection to show an open coiled bent anchor).
Further Ryu teaches that a plurality of stimulation leads may be retained by the introducing needle that is retained by the introducing sheath, for different purposes, such as for positioning a plurality of conductive distal anchors in different implantation sites (50a-d above refer to a plurality of stimulation leads; the different stimulation leads may be deployed in a staggered manner so that their respective conductive distal anchors engage different tissue sites, col. 7, lines 21-36). Ryu is relied upon to teach that it is reasonable to include an introducing sheath comprising an introducing needle comprising a plurality of deployable structures within the introducing needle, teaching that the introducing sheath is configured to contain a series of tubular nesting components, which comprises the deployable conductive distal anchor. However Ryu does not teach a testing needle with an inner lumen and wherein a distal portion of the testing needle comprises one or more bevels and wherein the testing needle comprises an outer diameter configured to be received by the inner lumen of the introducing sheath, wherein the testing needle is configured for electrical stimulation testing prior to introduction of the lead, and wherein the testing needle and the introducing needle are not received by the introducing sheath concurrently, such that the testing needle is removed from the introducing sheath prior to insertion of the introducing needle.
In a similar field of endeavor, Jiang teaches that it is well known to use an introducer sheath, a stylet and a beveled testing needle (i.e. foramen needle Fig. 9) for localization of a target and subsequent implantation of the lead wherein the testing needle comprises an inner lumen (i.e. [0099]: The foramen needle and stylet are used for locating the correct sacral foramen or implant lead and subsequent acute stimulation testing, therefore the foramen needle has a lumen for the stylet) an outer diameter configured to be received by an inner lumen of an introducing sheath (i.e. introducer), wherein the testing needle and the introducing needle (i.e. directional guide) are not received by the introducing sheath concurrently (e.g. [0099], Fig. 9). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Ryu in view of Bonde and Silipo to further include a testing needle for electrical stimulation testing prior to introduction of the lead as taught by Jiang and wherein the testing needle and the introducing needle are not received by the introducing sheath concurrently, such that the testing needle is removed from the introducing sheath prior to insertion of the introducing needle (i.e. push tube) in order to provide the predictable results of being able to accurately determine the target location. (Note: as discussed in the office action mailed on 9/2/2025, the claims are directed to an apparatus that comprises the claimed elements and the order of introduction, testing and removal of the testing needle and lead is intended use, furthermore the claims do not recite any specific dimensions for the claimed elements).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al (U.S. Patent Number: US 7,848,821 B1, hereinafter “Ryu”, cited in IDS filed 07/30/2024) in view of Bonde et al (U.S. Patent Application Publication Number: US 2007/0255368 A1, hereinafter “Bonde”) and Silipo et al (U.S. Patent Number: US 8,442,620 B2, hereinafter “Silipo”, cited in IDS filed 07/30/2024), and Jiang et al (U.S. Patent Application Publication Number: US 2016/0045747 B2, hereinafter “Jiang”- PREVIOUSLY CITED) and in further view of Marnfeldt et al (U.S. Patent Application Publication Number: US 2005/267555 A1, hereinafter “Marnfeldt”- PREVIOUSLY CITED).
Regarding claim 23, Ryu in view of Bonde and Silipo and Jiang teach the claimed invention as discussed above, but does not specifically teach that the distal portion of the introducing needle comprises one or more bevels.
Marnfeldt teaches that it is well known for engagement tools for implantable medical devices to have beveled edges (e.g. 310 Fig 3A). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the introducing needle (i.e. push tube) of Ryu to have beveled edges as shown by the needle 310 of Marnfeldt’s teachings of in order to provide the predictable results of easily conforming to the feature 75 of the electrode 10 of Ryu (e.g. Figs 4-6) and being able to easily navigate through the tissue.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pohndorf et al (U.S. Patent Number: US 5776178, hereinafter “Pohndorf”) teaches an implantable medical lead comprising insulated lead body that comprises an open-coiled structure with a central void and an open coiled anchor (e.g. Fig. 2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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