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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/05/2026 has been entered.
Response to Arguments
Claim Rejections - 35 USC § 103
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Regarding arguments to claim 10, specifically to the amendment including wherein the plurality of electrodes includes a first group of one or more electrodes arranged on a ventral surface of the paddle body, the ventral surface being directed towards the neural target, newly cited reference Hou (US 20160206873 A1 – hereinafter Hou) teaches a similar method of stimulating a neural target in a spinal cord by an implanted paddle electrode assembly (abstract – “The present disclosure provides methods and systems for neurostimulation at the tract of Lissauer”), comprising stimulation electrodes 408 implanted and located on a paddle on its ventral surface towards the neural target (spinal tract of Lissauer 300), as depicted in figure 5.
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Since the reference of Parker (US 20180228547 A1 – hereinafter Parker) and Hou both teach within the field of methods for stimulating a neural target in a spinal cord by an implanted paddle electrode assembly, with stimulation electrodes, one of ordinary skill in the art would have then found obvious to the combination of Parker and its stimulation electrodes, to incorporate the ventral stimulation electrode configuration as taught by Hou to predictably result in stimulating neural targets for therapy purposes (Hou paragraph 0036). Parker further teaches Parker a second group of one or more electrodes arranged on a dorsal surface of the paddle body facing in the opposite direction to the ventral surface (figure 14a, sense electrodes 1456 and 1458 are on the dorsal surface) and away from the ventral side as visible in figure 14a, as stated in the rejection below.
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Regarding claim 10’s amendment including wherein the second group of one or more electrodes arranged on the dorsal surface of the paddle body comprises a reference electrode of the one or more measurement electrodes, the reference electrode selected so as to function as an indifferent electrode, specifically arguments that the reference electrode does not function as an indifferent electrode, it is reminded that “[w]hen the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process”, In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986), see MPEP 2112.02. Since Parker discloses the same structural element as required by claim 10 (i.e. reference electrode 8), Parker is considered to inherently function similarly as an indifferent electrode as in claim 10’s reference electrode. Therefore, it is maintained that the combination of figure 14a of Parker with the reference electrode 8 of figure 3 of Parker as stated in the rejection below sufficiently satisfies the claim.
Election/Restrictions
Applicant’s election without traverse of Group II: claims 10-16 in the reply filed on May 12, 2025 was acknowledged. Claims 1-9 and 17-31 are withdrawn.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. AU2022900196, filed on February 02, 2022.
Information Disclosure Statement
The information disclosure statements filed March 27, 2024 and May 03, 2024 have been considered by the Examiner.
Claim Interpretation
According to MPEP 2112.02, a prior art device anticipates a claimed process if the device carries out the process during normal operation. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). Furthermore, where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Furthermore, the employment of the claimed steps must inherently produce the same intended results else the claims are incomplete for failing to recite a critical aspect of the invention.
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.
Claim(s) 10-12, 14, 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parker (US 20180228547 A1 – hereinafter Parker) (cited previously) in view of Hou (US 20160206873 A1 – hereinafter Hou) [NEW].
Re. claim 10, Parker teaches a method of stimulating a neural target in the spinal cord by an implanted paddle electrode assembly (figure 14a shows an embodiment of paddle electrode array 1450 positioned to directly stimulate the spinal cord 1480), the paddle electrode assembly comprising a plurality of electrodes arranged on a paddle body (figure 14a, paddle 1450 contains stimulation electrodes 1452 and sense electrodes 1456 and 1458),
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the method comprising:
providing stimulation energy to the first subset of one or more stimulation electrodes to stimulate the neural target (paragraph 0095 – “Simultaneously, the chosen stimulus electrode 1452 directly stimulates the spinal cord 1480”);
and measuring a response of the neural target, the response evoked from the neural target by the stimulation energy, from using the second subset of one or more measurement electrodes (paragraph 0095 – “Sense electrodes 1456 and 1458 sense the resultant neural activity produced from 1490 and 1452, as it continues to propagate rostrally”).
The paddle electrode embodiment of figure 14a of Parker does not explicitly teach selecting from the plurality of electrodes, a first subset of electrodes comprising one or more stimulation electrodes, and selecting, from the plurality of electrodes, a second subset of electrodes comprising one or more measurement electrodes.
Parker teaches in the embodiment of figures 1-2 selecting, from the plurality of electrodes, a first subset of electrodes (figure 2, electrode selection module 126 allows the device to select which electrodes of electrode array 150 to activate as stimulation electrodes and sense electrodes, paragraph 0056 – “Electrode selection module 126 switches the generated pulses to the appropriate electrode(s) of electrode array 150, for delivery of the current pulse to the tissue surrounding the selected electrode. Measurement circuitry 128 is configured to capture measurements of neural responses sensed at sense electrode(s) of the electrode array as selected by electrode selection module 126”);
and selecting, from the plurality of electrodes, a second subset of electrodes (figure 2, electrode selection module 126 allows the device to select which electrodes of electrode array 150 to activate as sense electrodes, paragraph 0059 – “…any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8”).
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Since figures 1-2 and 14a are embodiments of the same invention, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of figure 14a to incorporate the electrode selection as taught by the embodiment of figures 1-2 and paragraphs 0056-0059 since such modification would predictably result in stimulating and sensing evoked compound action potentials (ECAPs) at a target site, as well as “for therapeutic purposes which in the case of spinal cord stimulator for chronic pain is to create paraesthesia at a desired location” (Parker paragraph 0058).
Parker further teaches a second group of one or more electrodes arranged on a dorsal surface of the paddle body facing in the opposite direction to the ventral surface (figure 14a, sense electrodes 1456 and 1458 are on the dorsal surface as visibly shown in figure 14a with its visible sense electrodes).
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The embodiment of Parker in figure 14a further fails to teach wherein the second group of one or more electrodes arranged on the dorsal surface of the paddle body comprises a reference electrode of the one or more measurement electrodes, the reference electrode selected so as to function as an indifferent electrode.
Parker teaches in figure 3, an embodiment of an implanted spinal cord stimulator comprising an electrode assembly 150 which includes a reference electrode 8, alongside a measurement electrode 6, stimulation electrode 2.
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying stimulation paddle 1450 of Parker figure 14a, to incorporate the reference electrode 8 next to the measurement electrode as taught by Parker figure 3, since such modification would still predictably result in producing consistent current delivery to a patient.
Parker teaches the stimulation electrodes 1452 in figure 14a as stated above, but does not explicitly teach wherein the plurality of electrodes includes a first group of one or more electrodes arranged on a ventral surface of the paddle body, the ventral surface being directed towards the neural target.
Hou teaches a similar method of stimulating a neural target in a spinal cord by an implanted paddle electrode assembly (abstract – “The present disclosure provides methods and systems for neurostimulation at the tract of Lissauer”). Hou further teaches a stimulation paddle 400 (figure 4),
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and wherein the plurality of electrodes includes a first group of one or more electrodes arranged on a ventral surface of the paddle body, the ventral surface being directed towards the neural target (figure 4 show the paddle 400 comprising stimulation electrodes 408 arranged on a ventral surface of the paddle body and the ventral surface being directed towards the neural target, or implanted in the spinal tract of Lissauer 300 in figure 5; paragraph 0036 – “Lead assembly 400 is implanted such that stimulating electrodes 408 are positioned to stimulate dorsal column 306 for therapy purposes…”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the paddle of Parker, specifically the stimulation electrode arrangement, to incorporate the ventral surface electrode configuration as taught by Hou, since such modification would predictably result in stimulating neural targets for therapy purposes (Hou paragraph 0036).
Re. claim 11, the combination of Parker and Hou (hereinafter the combined invention) further teaches wherein the second group of one or more electrodes arranged on a dorsal surface of the paddle body comprises the second subset of electrodes (Parker figure 14a teaches two sense electrodes 1456-1458, which would be positioned on the dorsal side of the body 1450 as per claim 10 rejection stated above).
Re. claim 12, Parker of the combined invention further teaches wherein the second group of electrodes includes at least two electrodes (figure 14a, two sense electrodes 1456-1458).
Re. claim 14, Parker of the combined invention further teaches wherein the first subset of electrodes is selected based on a relative position of the first subset of electrodes and the neural target (paragraph 0057 – “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver a current pulse to surrounding tissue including nerve 180…”).
Re. claim 32, Hou of the combined invention further teaches wherein at least one of the stimulation electrodes is located on the ventral surface of the paddle body (figure 4 show the paddle 400 comprising stimulation electrodes 408 arranged on a ventral surface of the paddle body and the ventral surface being directed towards the neural target, or implanted in the spinal tract of Lissauer 300 in figure 5; paragraph 0036 – “Lead assembly 400 is implanted such that stimulating electrodes 408 are positioned to stimulate dorsal column 306 for therapy purposes…”).
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Re. claim 33, Parker of the combined invention further teaches wherein the at least one ventral surface stimulation electrode (Parker paragraph 0057 – “Electrode selection module 126 selects a stimulation electrode 2 of electrode array 150 to deliver a current pulse to surrounding tissue including nerve 180”) and reference electrode are selected based on their relative position (Parker paragraph 0059 – “To this end, any electrodes of the array 150 may be selected by the electrode selection module 126 to serve as measurement electrode 6 and measurement reference electrode 8”).
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parker (US 20180228547 A1 – hereinafter Parker) in view of Hou (US 20160206873 A1 – hereinafter Hou) [NEW] and Soin (US 10857364 B1 – hereinafter Soin) (cited previously).
Re. claim 13 the combination of Parker and Hou (hereinafter the combined invention) teaches the claimed invention as stated above except wherein the second subset of electrodes is selected based on a relative position of the second subset of electrodes and the first subset of electrodes.
Soin teaches a neuromodulation system and method with feedback optimized electrical field generation for stimulating target tissue of a patient (Soin abstract), comprising a paddle lead 18 with two subset of electrodes 30 implanted to a target tissue in the spine (Soin figures 4-5), and further teaches wherein the second subset of electrodes is selected based on a relative position of the second subset of electrodes and the first subset of electrodes (any two of electrodes 30 can be selected based on their different positions, including their distances and orientations. For example, in column 14 lines 50-60: “In addition, and as described further below, a specific electrode 30 and/or one or more pairs or other combinations of electrodes 30 can be selected to optimize and maximize the strength or intensity of the electric field in the target tissue 12 to provide optimal therapeutic results and/or to control the strength of the electric field in the target tissue 12 to prevent discomfort to the patient 14 and damage to the target tissue 12. For example, specific electrodes 30 or pairs or other combinations of electrodes 30 having different distances from and/or different orientations… “).
Soin and the combined invention both teach spinal stimulation systems with electrode selection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation system/method of the combined invention, particularly the electrode selection of Parker, to incorporate the electrode selection as taught by Soin since such modification of Parker in view of Soin would predictably result to optimize and maximize the strength or intensity of the electric field/stimulus in the target tissue to provide optimal therapeutic results and/or to control the strength of the electric field/stimulus in the target tissue to prevent discomfort to the patient (Soin column 14 lines 54-57).
Re. claim 15, the combination of Parker and Hou (hereinafter the combined invention) teaches the claimed invention as stated above except the method further comprising selecting the second subset of electrodes to maximize a distance between any one electrode of the first subset of electrodes and any one electrode of the second subset of electrodes.
Soin teaches a neuromodulation system and method with feedback optimized electrical field generation for stimulating target tissue of a patient (Soin abstract), comprising a paddle lead 18 with electrodes 30 implanted to a target tissue in the spine (Soin figures 4-5), and further teaches selecting the second subset of electrodes to maximize a distance between any one electrode of the first subset of electrodes and any one electrode of the second subset of electrodes (any two of electrodes 30 can have their electric field intensities maximized by their different distances. For example, Soin column 14 lines 50-60: “In addition, and as described further below, a specific electrode 30 and/or one or more pairs or other combinations of electrodes 30 can be selected to optimize and maximize the strength or intensity of the electric field in the target tissue 12 to provide optimal therapeutic results and/or to control the strength of the electric field in the target tissue 12 to prevent discomfort to the patient 14 and damage to the target tissue 12. For example, specific electrodes 30 or pairs or other combinations of electrodes 30 having different distances from and/or different orientations… “).
Soin and the combined invention both teach spinal stimulation systems with electrode selection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation system/method of the combined invention, particularly the electrode selection of Parker, to incorporate the electrode selection as taught by Soin since such modification would predictably result to optimize and maximize the strength or intensity of the electric field in the target tissue to provide optimal therapeutic results and/or to control the strength of the electric field in the target tissue to prevent discomfort to the patient (Soin column 14 lines 54-57).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Parker (US 20180228547 A1 – hereinafter Parker) in view of Hou (US 20160206873 A1 – hereinafter Hou) [NEW], and further in view of Esteller (US 20190099602 A1 – hereinafter Esteller) (cited previously).
Re. claim 16, the combination of Parker and Hou (hereinafter the combined invention) teaches the claimed invention as stated above except selecting, from the plurality of electrodes, a third subset of electrodes, based on the measured response of the neural target; and providing stimulation energy to the third subset of electrodes to stimulate the neural target, wherein the third subset of electrodes comprises at least one electrode that is not a member of the first subset of electrodes.
Esteller teaches a similar spinal cord stimulator (Esteller paragraph 0036) with a paddle lead (figure 1A) and teaches selecting, from the plurality of electrodes, a third subset of electrodes, based on the measured response of the neural target (figure 14 shows an ECAP algorithm 124a, step 232 which chooses one of three electrode configurations that has the best ECAP features for stimulation after assessing ECAP features for each electrode configuration in step 230, with electrode configurations 1-3 shown)
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providing stimulation energy to the third subset of electrodes to stimulate the neural target (figure 12B shows ECAP algorithm 124a in box 186 to provide stimulation)
and wherein the third subset of electrodes comprises at least one electrode that is not a member of the first subset of electrodes (figure 14 shows all three electrode configurations including at least one electrode that is not a member of the others, including electrode configuration 3 having electrodes 2 and 6 absent in electrode configuration 1).
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Esteller and the combined invention both teach spinal stimulation systems with electrode selection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stimulation system of the combined invention to incorporate the third electrode configuration stimulation as taught by Esteller since such modification would predictably result in adjusting stimulation therapy to treat patients and achieve good therapeutic results (Esteller paragraph 0089).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Bradley (US 20150012068 A1) [NEW] teaches a system for delivering stimulation to a nerve site comprising an indifferent reference electrode (paragraph 0295 – “The indifferent electrode 1390 is used as a reference for the measurement of the action potentials”).
DiGiore (US 8494653 B2) teaches a paddle electrode configuration with ventral and dorsally located electrodes (figures 3-11).
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796