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 Amendment
This office action is responsive to the amendment filed on March 13, 2025. As directed by the amendment: no claim(s) have been amended, no claim(s) have been cancelled, and no claim(s) have been added. Thus, claims 1-22 are currently pending in the application.
Response to Arguments
It is noted, that Examiner Hough, has inherited this case from Examiner Littich, and has given full faith and credit to that examiner’s stance and search. However, the Examiner does welcome the applicant to contact Examiner Hough for an interview if they deem it necessary.
Applicant's arguments filed March 13, 2025 have been fully considered but they are not persuasive. The applicant principally argues that the prior art does not teach the limitation “a grounding system having a member extending through the holder to engage a grounding lead” and that one skilled in the art would not combine Rabinovitz with Mathur. The examiner respectfully disagrees. The applicant argues that majority of the outer perimeter or the EPG in Mathur is exposed and thus no holes would be needed to access the EPG. The prior art Mathur discloses in Figs. 2 and 12c-f, [0095]-[0096] that there is a lead extension 22 connected to the proximal lead connector 24 that allows a grounded neurostimulation therapy cable set. Which establishes that there is a desire for a grounding system in Mathur, and the prior art Rabinovitz discloses a different grounding system. Furthermore, the applicant argues that Rabinovitz does not disclose a member that extends through the holder and that a hole is not a member. The examiner would like to note that it is cited in the office action that Rabinovitz discloses the use of cerebrospinal fluid as the grounding agent that extends through an opening 236 and engages the grounded exterior of the stimulator. The basis of Rabinovitz as discloses in the abstract, [0005] and [0025] is that the bodily fluid act to both conveniently and reliable ground the system. Therefore, the examiner is not convinced and the rejection is maintained.
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.
Claims 1, 2, 5-8, 12, & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mathur, P. (hereinafter Mathur; US PGPub. No. 2017/0239483) and further in view of Rabinovitz B. (hereinafter Rabinovitz, US PGPub No. 2020/0391022).
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In regard to claim 1, Mathur teaches: a holder (12) having a depression (area bounded by 13, and the interior surfaces of 14, & 15 in FIG. 9A) to hold the therapy device (40, unlabeled in 9A) within a holder wall ( The surface partially enclosed by elements 13, 14, & 15); a biasing system (unlabeled spring-clip affixation mechanism [0091]) configured to engage the therapy device ([0091], 40, unlabeled in FIG. 9A) within the holder (12) to provide a selected holding force ([0091] a spring clip affixation device 12 for releasably securing external pulse generator 40 to the patient.) of the therapy device within the holder . . . wherein the holder is configured to be held relative (figure 10, elements 60 and 61 [0091-0092]) to subject for a selected period of time. Mathur does not teach: a grounding system having a member extending through the holder to engage a grounding lead.
Rabinovitz teaches a holder (212) having a depression (216) to hold the therapy device (14) within a holder wall (214o, 215i, 216sw); and a grounding system having a member (236 and paragraph [0033], cerebrospinal fluid extends through an opening 236 and engages the grounded exterior of the stimulator, 14) extending through the holder to engage a grounding lead. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the grounding system of Rabinovitz. Such a modification would have the predictable result of grounding the stimulator for proper operation (Rabinovitz [0025]).
In regard to claim 2, Mathur and Rabinovitz substantially teach the of claim 1. Mathur additionally teaches (FIG. 10)a pouch (61) configured to hold the holder (12) relative to the subject (60).
In regard to claim 5, Mathur and Rabinovitz substantially teach the invention of claim 1. Mathur additionally teaches: wherein the biasing system further comprises: a holding member ([0090] the EPG mounting portion includes two pairs of tabs, a first pair of tabs 14 and a second pair of tabs 15 with retention features, each pair of tabs adapted to fittingly engage with corresponding features in the outer housing 41 of EPG 40 so as to securely mount EPG 40 to the substrate); and a biasing member (unlabeled spring for spring clip affixation) configured to bias the holding member toward the depression ( The surface whose boundaries are partially defined by the surface 13 and the holding members 14 & 15).
In regard to claim 6, Mathur and Rabinovitz substantially teach the invention of claims 1 and 5. Mathur and Rabinovitz additionally teach: The system of Claim 5, further comprising: a stimulation system (Mathur 40, Rabinovitz 14) held within the depression (Mathur 13, Rabinovitz 216) at least in part by the biasing system (Mathur [0091] discussed above, 14 &15).
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In regard to claim 7, Mathur and Rabinovitz substantially teach the invention of claim 1. Rabinovitz additionally teaches: The system of Claim 1, further comprising: a cover (215) configured to cover at least a portion of the holder (214); wherein the holder includes at least one passage (217) to receive the therapy device (unlabeled leads, 14); wherein the cover is configured to cover at least a portion of the therapy device when received within the holder. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include a cover that covers at least a portion of a therapy device with at least one passage to receive the therapy device of Rabinovitz. Such a modification would have the predictable result of better securing the stimulation device within a holder.
In regard to claim 8, Mathur teaches a holder (12) having a depression (surface defined by 13, and interior, red-filled sections of 14 and 15 as discussed above) to hold the therapy device (40, unlabeled in figure 9A) within a holder wall; a compression member (14 & 15) configured to engage the therapy device (40) within the holder (12) to provide a selected holding force ([0091] a spring clip affixation device 12 for releasably securing external pulse generator 40 to the patient.) of the therapy device within the holder; . . . wherein the holder is configured to be held relative (figure 10, elements 60 and 61) to subject for a selected period of time. Mathur does not teach: a grounding system having a member extending through the holder to engage a grounding lead.
Rabinovitz teaches a holder (212) having a depression (216) to hold the therapy device (14) within a holder wall (214o, 215i, 216sw); and a grounding system having a member (236 and paragraph [0033], cerebrospinal fluid extends through an opening 236 and engages the grounded exterior of the stimulator, 14) extending through the holder to engage a grounding lead. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the grounding system of Rabinovitz. Such a modification would have the predictable result of grounding the stimulator for proper operation (Rabinovitz [0025]).
In regard to claim 12, Mathur and Rabinovitz substantially teach the invention of claim 8. Mathur further teaches, in figure 10, a pouch (61) configured to hold the holder (12) relative to the subject (60).
In regard to claim 15, Mathur and Rabinovitz substantially teach the invention of claim 8 as discussed above. Rabinovitz additionally teaches: a cover (215) configured to cover at least a portion of the holder (214); wherein the holder includes at least one passage (216, 217) to receive the therapy device (14); wherein the cover is configured to cover at least a portion of the therapy device when received within the holder. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include a cover that covers at least a portion of a therapy device with at least one passage to receive the therapy device of Rabinovitz. Such a modification would have the predictable result of better securing the stimulation device within a holder.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mathur, P. and further in view of Rabinovitz and Gehman S., et. al. (hereinafter Gehman, USPGPub No. 2013/0060115).
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In regard to claim 16, Mathur teaches a holder (12) having (i) a depression (surface defined by 13, and interior sections of 14 & 15 as discussed above) adapted to receive the therapy device (40, element unlabeled in figure 9A) within a holder wall and . . . a holding member (14, & 15) configured to engage the therapy device (40, unlabeled in figure 9A) within the holder (12) to provide a selected holding force ([0091] a spring clip affixation device 12 for releasably securing external pulse generator 40 to the patient.) of the therapy device (40) within the holder. . . wherein the holder is configured to be held relative (figure 10, elements 60 and 61) to subject for a selected period of time. Mathur does not teach: (ii) a projection (14 & 15) extending from the holder wall to at least partially enclose the depression; . . . and does not teach: a grounding system having a member extending through the holder to engage a grounding lead.
Gehmen teaches (Gehmen FIG. 1, holster 20 with an extension projecting over a depression) a projection extending from the holder wall to at least partially enclose the depression. Rabinovitz teaches a holder (212) having a depression (216) to hold the therapy device (14) within a holder wall (214o, 215i, 216sw); and a grounding system having a member (236 and paragraph [0033], cerebrospinal fluid extends through an opening 236 and engages the grounded exterior of the stimulator, 14) extending through the holder to engage a grounding lead. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the ground system extending through the holder to engage a grounding lead as in Rabinovitz and include a projection extending from a holder was as in Gehman. Such a modification would have the predictable result of securing the stimulation device within a holder (Gehman) and grounding the stimulator for proper operation (Rabinovitz).
Claims 3, 4, 13, & 14, are rejected under 35 U.S.C. 103 as being unpatentable over Mathur and further in view of Rabinovitz and Covidien (hereinafter Covidien; Covidien Service Manual, Force FX Electrosurgical Generator C revision 02/2011 P.N. 1012637)
In regard to claim 3, Mathur in view of Rabinovitz substantially teaches the invention of claim 1, but fails to teach: a ground biasing assembly having an electrically conductive member; an electrically conducting biasing member configured to bias the electrically conductive member toward the depression; a set screw configured to hold the member in electrical contact with at least a portion of the ground biasing assembly. Covidien teaches a ground biasing assembly having an electrically conductive member (page 9-4, element 3), an electrically conducting biasing member (page 9-4, element 6) configured to bias the electrically conductive member toward the depression; (page 9-4, element 1) a set screw (page 9-4, elements 6 16) configured to hold the member (3) in electrical contact with at least a portion of the ground biasing assembly (1, 3, 6, and 16).At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the ground biasing system of Covidien for electron return (grounding) to the cathode terminal of a battery or the ground. Such a modification would have the predictable result of better securing a robust ground in a stimulation device, for benefits including safety and reference measurements (Rabinovitz [0025] “As those skilled in the art will appreciate, many functional neurosurgical implants (as described below) require grounding to operate properly (for example, taking accurate impedance measurements) . . . ”
In regard to claim 4, Mathur, Rabinovitz, and Covidien substantially teach the invention of claim 3. Covidien additionally teaches the ground biasing assembly has a cylinder (page 9-4, element 6) configured to hold the electrically conductive member (page 9-4, element 3) and the electrically conducting biasing member (page 9-4, element 6) and the member is held in electrical contact (page 9-4, element 16) with the cylinder.
In regard to claim 13, Mathur in view of Rabinovitz substantially teach the invention of claim 8, but fails to teach: a ground biasing assembly having an electrically conductive member; an electrically conducting biasing member configured to bias the electrically conductive member toward the depression; a set screw configured to hold the member in electrical contact with at least a portion of the ground biasing assembly. Covidien teaches a ground biasing assembly having an electrically conductive member (page 9-4, element 3), an electrically conducting biasing member (page 9-4, element 6) configured to bias the electrically conductive member toward the depression; (page 9-4, element 1) a set screw (page 9-4, elements 6 16) configured to hold the member (3) in electrical contact with at least a portion of the ground biasing assembly (1, 3, 6, and 16At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the features of the enclosed implantable stimulation device holder of Rabinovitz and to include the ground biasing system of Covidien for electron return (grounding) to the cathode terminal of a battery or the ground. Such a modification would have the predictable result of better securing a robust ground in a stimulation device, for benefits including safety and reference measurements (Rabinovitz [0025] “As those skilled in the art will appreciate, many functional neurosurgical implants (as described below) require grounding to operate properly (for example, taking accurate impedance measurements) . . . ”In regard to claim 14, Mathur, Rabinovitz, and Covidien substantially teach the invention claimed as discussed above. Covidien additionally teaches the ground biasing assembly has a cylinder (page 9-4, element 6) configured to hold the electrically conductive member (page 9-4, element 3) and the electrically conducting biasing member (page 9-4, element 6) and the member is held in electrical contact (page 9-4, element 16) with the cylinder.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Mathur and further in view of Rabinovitz, Gehman, and Covidien.
In regard to claim 20, Mathur and Rabinovitz substantially teach the invention claimed as discussed above. Neither Mathur nor Rabinovitz teach: a ground biasing assembly having an electrically conductive member; an electrically conducting biasing member configured to bias the electrically conductive member toward the depression; a set screw configured to hold the member in electrical contact with at least a portion of the ground biasing assembly. Covidien teaches a ground biasing assembly having an electrically conductive member (page 9-4, element 3), an electrically conducting biasing member (page 9-4, element 6) configured to bias the electrically conductive member toward the depression; (page 9-4, element 1) a set screw (page 9-4, elements 6 16) configured to hold the member (3) in electrical contact with at least a portion of the ground biasing assembly (1, 3, 6, and 16).At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the ground biasing system of Covidien for electron return (grounding) to the cathode terminal of a battery or the ground. Such a modification would have the predictable result of better securing a robust ground in a stimulation device, for benefits including safety and reference measurements (Rabinovitz [0025] “As those skilled in the art will appreciate, many functional neurosurgical implants (as described below) require grounding to operate properly (for example, taking accurate impedance measurements) . . . ”In regard to claim 21, Mathur, Rabinovitz, and Covidien substantially teach the invention of claims 20 and 16 discussed above. Covidien additionally teaches the ground biasing assembly has a cylinder (page 9-4, element 6) configured to hold the electrically conductive member (page 9-4, element 3) and the electrically conducting biasing member (page 9-4, element 6) and the member is held in electrical contact (page 9-4, element 16) with the cylinder. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the ground biasing system of Covidien for electron return (grounding) to the cathode terminal of a battery or the ground. Such a modification would have the predictable result of better securing a robust ground in a stimulation device, for benefits including safety and reference measurements (Rabinovitz [0025] “As those skilled in the art will appreciate, many functional neurosurgical implants (as described below) require grounding to operate properly (for example, taking accurate impedance measurements) . . . “ .
In regard to claim 22, Mathur, Rabinovitz, and Covidien substantially teach the invention of claims 20 and 16 discussed above. Rabinovitz additionally teaches: The system of Claim 20, further comprising: a cover (215) configured to cover at least a portion of the holder (214); wherein the holder includes at least one passage (216, 217) to receive the therapy device (14); wherein the cover is configured to cover at least a portion of the therapy device when received within the holder. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to include the features of the enclosed implantable stimulation device holder of Rabinovitz. Such a modification would have the predictable result of better securing the stimulation device within a holder held in a pouch relative to a subject.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Mathur and further in view of Rabinovitz and Bachus, K. (hereinafter Bachus; US PGPub. No. 2012/0310371).
In regard to claim 9, Mathur in view of Rabinovitz substantially teach the invention of claim 8, but fails to teach threaded member configured to be driven toward the depression; wherein a passage is formed within a wall of the holder to allow access of a driver to drive the threaded member. Bachus teaches: the compression member (2300 & 2400) further comprises: a threaded member (2200) configured to be driven toward the depression (2104, the interior concave surface); wherein a passage is formed within a wall of the holder (2106 in 2100 (visible in Fig 6.) to allow access of a driver to drive the threaded member. The embodiment in Bachus is for retention of a worn medical device. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to possess the features of the enclosed implantable stimulation device holder of Rabinovitz, and to have further modified the retention system with a threaded member to direct a compression member towards the depression. Such a modification would have the predictable result of better securing a stimulation device within a holder held in a pouch relative to a subject.
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In regard to claim 10, Mathur, in view of Rabinovitz, and Bachus substantially teach the invention of claim 9. Bachus additionally teaches a holding reinforcing member ([0079] a circumferential groove may be added for axial retention, i.e. 2504) to increase a holding power of the threaded member (2200) relative to the wall (the wall of the holder, 2100, unlabeled). The embodiment in Bachus is for retention of a worn medical device configured to be retained by spring loaded mechanisms.. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to possess the features of the enclosed implantable stimulation device holder of Rabinovitz, and to have further modified the retention system with a threaded member to direct a compression member towards the depression, the depression being a dimple or a groove such as to enhance retention. Such a modification would have the predictable result of better securing a stimulation device within a holder held in a pouch relative to a subject.
In regard to claim 11, Mathur, in view of Rabinovitz, and Bachus substantially teach the invention of claim 9 as discussed above. Mathur and Rabinovitz additionally teach: The system of Claim 9, further comprising: a stimulation system (Mathur 40, Rabinovitz 14) held within the depression (Mathur 13 interior surfaces of the clips 14 and 15, Rabinovitz 216) at least in part by the biasing system (Mathur [0089] the EPG mounting portion includes two pairs of tabs, a first pair of tabs 14 and a second pair of tabs 15 with retention features, each pair of tabs adapted to fittingly engage with corresponding features in the outer housing 41 of EPG 40 so as to securely mount EPG 40 to the substrate).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mathur and further in view of Rabinovitz, Gehman, and Bachus, K.
In regard to claim 17, Mathur, in view of Rabinovitz and Gehman substantially teach the invention of claim 16 as discussed above. Mathur, Rabinovitz, and Gehman fail to teach: The system of Claim 16, wherein the holding member comprises at least one of (1) a threaded member configured to be driven toward the depression, (2) biasing system, or (3) combinations thereof. Bachus teaches: the holding member (2300 & 2400) comprises at least one of (1) a threaded member (2200) configured to be driven toward the depression (2104), (2) biasing system (2106, 2200, 2300, & 2400), or (3) combinations thereof. The embodiment in Bachus is for retention of a worn medical device. At the effective date of filing of this invention, it would have been obvious for one of ordinary skill in the art to have modified the external pulse generator of Mathur to possess the features of the enclosed implantable stimulation device holder of Rabinovitz, with a tab projecting over a depression (Gehman), and to have further modified the retention system with a threaded member to direct a compression member towards the depression. Such a modification would have the predictable result of better securing a stimulation device within a holder held in a pouch relative to a subject.
In regard to claim 18, Mathur, Rabinovitz, and Bachus substantially teach the invention claimed as discussed above. Mather additionally teaches: the biasing system further comprises a holding member (12) and a biasing member (unlabeled spring-clip affixation mechanism) configured to bias the holding member toward the depression (13, interior surfaces of the clips 14 & 15).
In regard to claim 19, Mathur, Rabinovitz, and Bachus substantially teach the invention claimed as discussed above. Mathur and Rabinovitz additionally teach: The system of Claim 9, further comprising: a stimulation system (Mathur 40, Rabinovitz 14) held within the depression (Mathur 13, interior surfaces of tabs 14 and 15, Rabinovitz 216) at least in part by the biasing system (Mathur [0089] the EPG mounting portion includes two pairs of tabs, a first pair of tabs 14 and a second pair of tabs 15 with retention features, each pair of tabs adapted to fittingly engage with corresponding features in the outer housing 41 of EPG 40 so as to securely mount EPG 40 to the substrate).
Conclusion
THIS ACTION IS MADE FINAL. 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 JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough August 19, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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