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Claim Status: Claims 14-31 are pending; Claims 18-29 have been withdrawn from consideration as they are directed to a non-elected invention.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 17, 2025 has been entered.
Response to Arguments
With respect to Double Patenting rejection, Applicant has filed the terminal disclaimer; therefore, the double patenting rejections have been withdrawn.
With respect to 35 U.S.C. 103 rejection, Applicant’s arguments with respect to claims 14 and 30 have been considered but are moot because the new ground of rejection has been made necessitated by amendments.
Response to Amendment
With respect to claim objection, Applicant’s amendment has overcome the objection.
Terminal Disclaimer
The terminal disclaimer filed on December 20, 2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 11,745,011 and US 11,103,697 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Election/Restrictions
Applicant’s election without traverse of claims 14-17, in the reply filed on July 17, 2025 is acknowledged.
Claim Interpretation
“Helical lead” (as first recited in line 2 of claim 14) is given the broadest reasonable interpretation, that “helical” is a descriptive property of the lead. Examiner interprets the limitation to mean that helical refers to the physical structure of the lead body, and that the lead body is helically coiled or spiraled so that the lead may be referred to as a helical lead. For example, the exterior of the lead body may be ribbed along at least a portion of its length, with the ribbing in a helically spiraling configuration. Under the broadest reasonable interpretation, the limitation is not limited to the open-coiled configuration shown in Applicant’s Fig. 1, element “130”.
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-AlA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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 14-17 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Bonde et al (US 9,561,053 B2, hereinafter “Bonde”) in view of Lee et al (US 9,427,574 B2, hereinafter “Lee”,), Mamo et al (US 2005/0240238 A1, hereinafter “Mamo”), Perryman et al (US 2016/0361535 A1, hereinafter “Perryman”) (all cited in the IDS filed 09/01/2023), and Soltis et al. (US 2003/0144722).
Regarding claim 14, Bonde shows a system comprising a stimulation lead 108 comprising a distal anchor (Fig. 10, lead 108 with fixation tines 112 at its distal end, col. 16, lines 31-40). As discussed in the citation of Bonde, the fixation feature allows fixation into tissue for correct placement and prevent movement. Bonde further shows the stimulation lead having a proximal end 16A in communication with the stimulus generator unit (Fig. 2A), so that the stimulus generator unit is in electrical communication with electrodes 114A-114D at the distal end of the lead (col. 16, lines 21-23). Since the tines 112 anchor conductive electrodes 114 of the distal end of lead 108 (col. 16, lines 31-40), Examiner considers Bonde to show that the lead comprises a conductive distal anchor.
Bonde further shows the system comprising a needle assembly comprising an “inner sheath” 154/166 (cannula depicted in Figs. 15A-15B) having an outer circumference and defining a cavity 158/170 (the outer surface of the cannula, col. 20, lines 25-36). Bonde shows at least one test electrode positioned along the outer circumference and electrically communicating with the stimulus generator unit to deliver test stimulation at one or more desired positions to allow secure repositioning of the assembly before final positioning and removal of the cannula to then deploy the fixation tines and anchor the lead in one of the desired positions by fixation into tissue (Fig. 15A-15B, 17, 18; col. 3, line 47-col. 4, line 28; col. 19, line 23-col. 20, line 59; col. 21, lines 13-36, fixation to encourage tissue to hold onto the tines). Although Bonde does not explicitly refer to the tubular structure of the cannula as a sheath, Examiner broadly considers the cannula to be structurally equivalent to a sheath, for having a cavity for carrying a lead within. Regarding retention of the fixation tines during delivery and positioning of the lead, Lee explicitly teaches a lead comprising similar tines that encourage tissue fixation (Fig. 6A-12B and 14A, showing fixation tines comprising an added compound for promoting tissue ingrowth to prevent lead migration, col. 21, lines 26-52), wherein correct placement is further shown by restraining the fixation tines using an outer sheath in order to maneuver the lead through a tunnel of tissue into a desired position (col. 19, lines 38-62). As cited, Lee describes the retention within sheath as a delivery configuration, and then allowing fixation in tissue as the deployed configuration. Thus there is obvious motivation to one having ordinary skill in the art before the effective filing date of the claimed invention combine Bonde and Lee to show restraining fixation tines within an “inner sheath” for maneuvering and positioning the lead during placement, and then deploying the lead from the sheath to allow the tines to deploy and affix at the placement site.
Bonde and Lee lack explicitly showing that this assembly is further completely carried within a bore defined by an outer sheath having an outer circumference. Mamo explicitly teaches that it is known in the art to provide a double -sheathed delivery method for a fixation lead, wherein an inner sheath is completely carried within an outer sheath, for the purpose of dilating a delivery path in order to safely maneuver a lead assembly through a delicate and tortuous pathway for positioning within a patient before fixation therein, wherein the use of a dilator minimizes tissue disruption and prevents displacement of the lead during delivery (Figs. 3a-5a; para. 0074-0077). As taught by Mamo, dilators 42 can be provided in sequence to achieve a desired dilation (para. 0074), for delivery and placement of a needle, lead or catheter assembly carried within (para. 0073-0074), so that the dilator is considered to show multiple sheaths as needed for carrying the lead assembly. Although the lead contained therein comprises the electrically conductive components, Mamo is relied upon to show a motivation for carrying the lead within an inner sheath which is wholly carried within an outer sheath until deployment of the fixation feature (Figs. 4 and 5a). Mamo thus teaches a benefit for providing an outer sheath having an outer circumference and defining a bore for the inner sheath to be completely carried therein. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added the addition of an outer sheath as taught by Mamo, and provided the shown double-sheathed method for safely dilating a tissue pathway, for improving the ability to maneuver through a tunnel of tissue as discussed by Bonde and Lee above.
After the modification of Bonde and Lee in view of Mamo, it would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to reposition the location of the test electrode as needed, in order to effectively test for desired positioning locations, such as modifying the test electrode to be positioned to an outer sheath retaining the needle assembly elements described. Thus it would have been obvious to have applied Mamo’s teaching to Bonde’s outer sheath and maintained the testing electrode on the outer sheath to maintain the test mode shown at the one or more desired positions, while safely dilating the one or more desired positions for ultimate deployment of the lead carried within an inner sheath carried within the outer sheath. The modification in view of Mamo provides an improvement to Bonde’s outer sheath by allowing safe dilation in a tortuous pathway while allowing testing for placement of the lead contained therein.
Regarding the claimed feature that the lead remains carried with the inner sheath during positioning and testing of the needle assembly until the lead is deployed, the combination in view of Mamo’s use of dilators is relied upon to teach additional sheath structures that can guide the already sheathed lead (as taught by Lee, for retention of the fixation tines until deployment of the lead and deployment of the fixation tines, col. 19, lines 38-46), so that the lead is properly pushed into positioning before fixation can occur. Examiner relies upon this combination to show that the lead is carried as needed within the inner sheath so that proper positioning and testing of the needle assembly can occur before the lead is deployed, which then affixes the lead into the tissue site and encourages tissue growth to retain said lead. The claim language remains broad to include that the lead is carried within the multiple sheaths until final retention of the lead in tissue, since it is still being positioned but not yet fixed into place.
The combination of Bonde, Lee, and Mamo renders obvious the lead carried within an inner sheath of a needle assembly, wherein the lead is carried within the inner sheath during positioning and testing of the needle assembly until the lead is deployed, above. The combination lacks expressly describing that said lead has a body with a helical configuration, thereby defining the lead as a helical lead. The combination teaches fixation of the lead at the distal end, using the distal anchor elements, above. Perryman teaches that it is known to provide fixation means along the body of the lead, wherein the fixation means is shown to be a Dacron cuff comprising an open-coiled structure (Fig. 5, para. 0085, showing a basic Dacron cuff 508; Figs. 7-8, showing that the Dacron cuff has a spiral configuration 708a, 808a, para. 0095 and 0100, wherein Perryman describes this spiral feature as promoting tissue ingrowth for anchoring). Perryman lacks expressly describing the spiral configuration as a helical configuration, but it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a helical format of a spiral, since such spiral shapes are known, and it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See /n re Dailey, 149 USPQ 47 (CCPA 1976).
It would have been an obvious modification to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination above to include anchoring means along the body of the lead, such as helically spiraled Dacron cuffs taught by the modification of Perryman, to encourage fixation of the lead at the desired position. It would have therefore been obvious to retain the body of the lead within the inner sheath, as previously discussed, until the lead can be deployed so that the plurality of fixation means, including the helical Dacron cuffs on the body of the lead, are secured during positioning until deployment of the lead for the enhanced fixation of the lead when a fixation site has been selected. The modification to add the Dacron cuffs on the body of the lead, to thereby define the lead as a helical lead, would have been to enhance tissue in growth in the coils and prevent lead migration along the length of the lead and not just the distal end where the distal anchors are located.
Bonde, Lee, Mamo, and Perryman are silent regarding the helical open-coiled lead comprising a conductive distal anchor, wherein the distal anchor is formed from an electrically conductive material.
However, Soltis discloses a medical electrode assembly (abstract) and teaches a helical open-coiled lead comprising a conductive distal anchor, wherein the distal anchor is formed from an electrically conductive material (para. [0009], conductive helical anchor electrode lead or fixation electrode, para. [0025], fig. 1, screw helix 20 or other fixation mechanism; para. [0024], It will be understood by those skilled in the art that the lead body of the present invention may be used in a wide variety of implantable leads including, but not limited to, neurostimulation leads, pacing leads, cardiac sensing leads, defibrillation leads, and other leads as will be recognized by those skilled in the art), wherein the helical open-coiled lead is carried with the inner sheath until the helical lead is deployed (para. [0014], [0015], the screw helix retracted or extended, fig. 2A, fig. 2B).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bonde as modified by Lee, Mamo, and Perryman, by adding a helical open-coiled lead comprising a conductive distal anchor, wherein the distal anchor is formed from an electrically conductive material, wherein the helical open-coiled lead is carried with the inner sheath until the helical lead is deployed, as taught by Soltis, for the purpose of active fixation of electrodes to a target location using screw helix (para. [0004]).
Regarding claim 15, Bonde shows a “plunger” release mechanism and spacer arrangement that pushes the cannula off of the needle (Abstract; col. 1, lines 37-56; col. 2, lines 15-26; col. 12, lines 53-60), comprising spacers that reliably engage the release mechanism until deployment to retract and remove the cannula (col. 14, line 54-col. 15, line 3). It would have been an obvious modification to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied this plunger to the inner sheath so that selective movement of the plunger may move the outer sheath and helical lead in concert to deploy the distal end for anchoring at the fixation site.
Regarding claim 16, Bonde shows a lock to restrict movement of the plunger prior to deploying the lead (col. 14, line 54-col. 15, line 3). Bonde therefore renders obvious the claimed feature of a lock to restrict movement of the plunger prior to deploying the helical lead.
Regarding claim 17, Bonde shows a plurality of test electrodes positioned on the outer circumference of a sheath at spaced-apart intervals (Figs. 15A-15B). Bonde shows that the test electrodes allow repositioning of the lead before removal of the cannula via use of the plunger to deploy the fixation tines at one of the desired positions (col. 3, line 47-col. 4, line 28; col. 19, line 23-col. 20, line 59; col. 21, lines 13-36). In view of the modifications discussed above, to rearrange components to provide effective testing and placement of the lead, wherein the test electrode is arranged on the outer sheath, it would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to rearrange the plurality of test electrodes so that the helical lead may comprise at least one of those electrodes to cooperate with test electrodes and associate a desired position with one of the at least one test electrode, for effective positioning of the needle assembly and selection of a fixation site to deploy the lead. It would have therefore been obvious to have the plunger cooperate with the needle assembly to deploy the helical lead at the desired position according to results of the test electrodes of the lead and needle assembly outer sheath.
Regarding Claim 30, Claim 30 is rejected under substantially the same basis as claim 14.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Bonde et al (US 9,561,053 B2, hereinafter “Bonde”) as modified by Lee et al (US 9,427,574 B2, hereinafter “Lee”,), Mamo et al (US 2005/0240238 A1, hereinafter “Mamo”), Perryman et al (US 2016/0361535 A1, hereinafter “Perryman”) (all cited in the IDS filed 09/01/2023), and Soltis et al. (US 2003/0144722) and further in view of Meadows et al. (US 2003/0120323).
Regarding Claim 31, Bonde as modified by Lee, Mamo, Perryman, and Soltis discloses the claimed invention substantially as set forth in claim 30.
Bonde discloses that the conductive distal anchor comprises electrodes to electrically stimulate the tissue site (col. 19, lines 35-52), but is silent regarding any of the electrodes being a monopolar electrode.
However, Meadows discloses a spinal cord stimulator system (abstract) and teaches stimulation channels that are either monopolar or bipolar configurations (para. [0188], [0123], [0114], [0113]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Bonde as modified by Lee, Mamo, Perryman, and Soltis, by configuring the electrode to be a monopolar electrode, as taught by Meadows, for the purpose of controlling the polarity, amplitude, rate, pulse width and channel through which the current stimulus pulses are provided (para. [0123]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 9, 2025Examiner, Art Unit 3792