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 filed 4/20/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that nowhere do any of these paragraphs in Boggs disclose applying electrical stimulation to the least one occipital nerve to provide relief of pain in a distribution of the at least one occipital nerve and in one or more region(s) of referred pain outside the distribution of the at least one occipital nerve, 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, then it meets the claim.
Election/Restrictions
Claims 61, 65, 96-106, 114-115, 120-126, and 130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/16/2025.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 66-68, 71-79, 86-94, and 111-112 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al (US Publication 2017/0361089) in view of Crosby et al (WO 2021/016616).
Referring to Claim 66, Boggs, II et al teaches a system for relief of pain, the system comprising: a percutaneous lead configured for insertion into a posterior neck inferior to a nuchal ridge targeting at least one occipital nerve (e.g. Paragraphs [0029]-[0031], [0097] and [0101]; and Figures 1a, and 1b); at least one electrode formed on the percutaneous lead configured to be positioned at a therapeutically effective distance from the at least one occipital nerve (e.g. Paragraphs [0045]-[0046]); an electrical stimulation device operatively coupled to the percutaneous lead and configured to apply electrical stimulation through the at least one electrode to the at least one occipital nerve to provide relief of pain in a distribution of the at least one occipital nerve and in one or more region(s) of referred pain outside the distribution of the at least one occipital nerve by modulating activity at a point of convergence of the at least one occipital nerve and one or more non-targeted nerve(s) innervating the region of referred pain (e.g. Paragraphs [0031] and [0045]-[0046]), wherein the electrical stimulation comprises a first parameter selected from a group consisting of: frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and waveform shape (e.g. Paragraphs [0100] and [0103]), wherein the electrical stimulation comprises a second parameter selected from a group consisting of: frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and waveform shape, wherein the first parameter is amplitude and the second parameter is pulse duration (e.g. Paragraphs [0100] and [0103]),. However, Boggs, II et al does not disclose wherein an optimal amplitude and pulse duration are selected by increasing the amplitude until discomfort is produced, then decreasing the amplitude and correspondingly increasing the pulse duration to maximize activation of target fibers innervating the region of pain without activating non-target fibers.
Crosby et al teaches that it is known to use wherein an optimal amplitude and pulse duration are selected by increasing the amplitude until discomfort is produced, then decreasing the amplitude and correspondingly increasing the pulse duration to maximize activation of target fibers innervating the region of pain without activating non-target fibers as set forth in page 3 last bullet in paragraph [0006] and claim 9 to provide to maximize activation of target fibers innervating the region of pain without activating non-target fibers to reduce unwanted side effects. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with wherein an optimal amplitude and pulse duration are selected by increasing the amplitude until discomfort is produced, then decreasing the amplitude and correspondingly increasing the pulse duration to maximize activation of target fibers innervating the region of pain without activating non-target fibers as taught by Crosby et al, since such a modification would provide the predictable results of to maximizing activation of target fibers innervating the region of pain without activating non-target fibers to reduce unwanted side effects.
Referring to Claim 67, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the percutaneous lead is configured to be inserted a length inside a body to produce tissue ingrowth such that the percutaneous lead is resistant to migration during movement of a head and neck (e.g. Paragraph [0070]).
Referring to Claim 68, Boggs, II et al in view of Crosby et al teaches the system of claim 67, wherein the percutaneous lead is an open coil lead (e.g. Paragraph [0074]).
Referring to Claim 71, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the percutaneous lead comprises one or more anchoring structures (e.g. Paragraph [0071]).
Referring to Claim 72, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the at least one electrode is positioned outside of a central nervous system (e.g. Paragraph [0070]).
Referring to Claim 73, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the percutaneous lead is configured for insertion into a portion of the body that is proximal to the region of pain (e.g. Paragraphs [0045]-[0046]).
Referring to Claim 74, Boggs, II et al in view of Crosby et al teaches the system of claim 73, wherein the electrical stimulation occurs proximal to the region of pain (e.g. Paragraphs [0045]-[0046]).
Referring to Claim 75, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the at least one occipital nerve is selected from a group consisting of: greater occipital nerve, lesser occipital nerve, third occipital nerve, C2 nerve, C3 nerve, C2 medial branch nerve, C3 medial branch nerve, cervical plexus (e.g. Paragraph [0101]).
Referring to Claim 76, Boggs, II et al in view of Crosby et al teaches the system of claim 75, wherein the at least one occipital nerve is selected from a group that comprises at least one distal branch of a selected nerve or nerves (e.g. Paragraph [0101]).
Referring to Claim 77, Boggs, II et al in view of Crosby et al teaches the system of claim 75, wherein the at least one electrode is positioned proximal to a point on the at least one occipital nerve at which one or more nerve fibers branch off from the at least one occipital nerve to innervate distal structures in the region of pain (e.g. Paragraphs [0045]-[0046]).
Referring to Claim 78, Boggs, II et al in view of Crosby et al teaches the system of claim 75, wherein the at least one electrode is positioned along the at least one occipital nerve wherein comfortable sensations are generated only in the region of pain or an area immediately surrounding the region of pain (e.g. Paragraph [0101]).
Referring to Claim 79, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein stimulation of the at least one occipital nerve creates comfortable sensations in a distribution of the at least one occipital nerve and does not generate sensations in a distribution of the one or more non-targeted nerve that innervates the region of referred pain (e.g. Paragraph [0101]).
Referring to Claim 86, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the electrical stimulation activates target large diameter fibers in the at least one occipital nerve (e.g. Paragraphs [0045]-[0046]).
Referring to Claim 87, Boggs, II et al in view of Crosby et al teaches the system of claim 86, wherein the stimulation prevents activation of non-target small diameter fibers in the at least one occipital nerve (e.g. Paragraph [0067]).
Referring to Claim 88, Boggs, II et al in view of Crosby et al teaches the system of claim 87, wherein the stimulation prevents activation of non-target fibers in cutaneous tissue, subcutaneous tissue, and muscles proximate to the at least one occipital nerve (e.g. Paragraph [0067]).
Referring to Claim 89, Boggs, II et al in view of Crosby et al teaches the system of claim 88, wherein the stimulation prevents activation of non-target fibers in rotatores, semispinalis cervicis, semispinalis capitis, splenius cervicis, splenius capitis, multifidus, oblique capitis inferior, or trapezius muscles (e.g. Paragraph [0067]).
Referring to Claim 90, Boggs, II et al in view of Crosby et al teaches the system of claim 66, except wherein the at least one electrode is formed integrally at a distal end of the lead.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to wherein the at least one electrode is formed integrally at a distal end of the lead, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (see MPEP 2144.04(V)(B)).
Referring to Claim 91, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the at least one electrode is not at a distal end (e.g. Paragraph [0078]). However, does not explicitly disclose wherein the at least one electrode is formed integrally on a portion of the lead. It would have been obvious to one of ordinary skill in the art at the time the invention was made to wherein the at least one electrode is formed integrally on a portion of the lead, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. (see MPEP 2144.04(V)(B)).
Referring to Claim 92, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the percutaneous lead is configured for insertion into the posterior neck inferior to the nuchal ridge targeting at least one occipital nerve at one or more of C2 lamina, C2 lateral articular pillar, C2/C3 joint, C3 lamina, C3 lateral articular pillar, or between an obliquus capitis inferior muscle and semispinalis cervicis muscle (e.g. Paragraph [0101]).
Referring to Claim 93, Boggs, II et al in view of Crosby et al teaches the system of claim 92, wherein an entry site of the percutaneous lead is at least spinal levels inferior to a target location and the percutaneous lead is inserted along a non-intersecting trajectory to achieve the therapeutically effective distance from the at least one occipital nerve (e.g. Paragraphs [0045]-[0046] and [0101]).
Referring to Claim 94, Boggs, II et al in view of Crosby et al teaches the system of claim 93, wherein the entry site is located inferior to a hairline to facilitate placement of bandaging materials over the entry site (e.g. Paragraph [0096]).
Referring to Claim 111, Boggs, II et al in view of Crosby et al teaches the system of claim 93, wherein the entry site is located inferior to a hairline (e.g. Paragraph [0096]).
Referring to Claim 112, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the percutaneous lead is inserted along a non-intersecting trajectory generally from inferior to superior to achieve the therapeutically effective distance from the at least one occipital nerve (e.g. Paragraphs [0045]-[0046]).
Claim(s) 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al (US Publication 2017/0361089) in view of Crosby et al (WO 2021/016616) as applied above, and further in view of Andresen et al (US Patent 10,149,976).
Referring to Claim 69, Boggs, II et al in view of Crosby et al teaches the system of claim 67, except wherein the length to be inserted inside the body is greater than or equal to 4 cm.
Andresen et al teaches that it is known to use the length to be inserted inside the body is greater than or equal to 4 cm as set forth in Column 15 lines 58-61 to provide the lead being inserted into a position that reaches target fibers. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with the length to be inserted inside the body is greater than or equal to 4 cm as taught by Andresen et al, since such a modification would provide the predictable results of the lead being inserted into a position that reaches target fibers.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Boggs, II et al with the length to be inserted inside the body is greater than or equal to 4 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 70, 80, 81, 95, and 113 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boggs, II et al (US Publication 2017/0361089) in view of Crosby et al (WO 2021/016616) as applied above, and further in view of Kast et al (US Publication 2015/0209578).
Referring to Claim 70, Boggs, II et al in view of Crosby et al teaches the system of claim 67, except wherein the length is at least three-times greater than a length of the at least one electrode.
Kast et al teaches that it is known to use the length is at least three-times greater than a length of the at least one electrode as set forth in Figure 1D, electrode 7A to provide adequate length to provide an electrode that is adequate to reach the target location, without being so large as to activate non-target fibers. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with the length is at least three-times greater than a length of the at least one electrode as taught by Kast et al, since such a modification would provide the predictable results of adequate length to provide an electrode that is adequate to reach the target location, without being so large as to activate non-target fibers.
In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Boggs, II et al with the length is at least three-times greater than a length of the at least one electrode, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Referring to Claim 80, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the point of convergence is a trigeminocervical complex (e.g. Paragraph [0092] greater occipital nerve). However, Boggs, II et al does not explicitly disclose the one or more non-targeted nerve is a branch of a trigeminal nerve.
Kast et al teaches that it is known to use at least one non-targeted nerve is a branch of a trigeminal nerve as set forth in Paragraph [0025] (targeting the occipital nerve branch) to provide a more targeted therapy based on the patient’s conditions without causing discomfort. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with at least one non-targeted nerve is a branch of a trigeminal nerve as taught by Kast et al, since such a modification would provide the predictable results of a more targeted therapy based on the patient’s conditions without causing discomfort.
Referring to Claim 81, Boggs, II et al in view of Crosby et al teaches the system of claim 80, except wherein the region of referred pain is one or more of a parietal, temporal, frontal, frontotemporal, retroorbital, supraorbital, and auricular regions.
Kast et al teaches that it is known to use wherein the region of referred pain is one or more of a parietal, temporal, frontal, frontotemporal, retroorbital, supraorbital, and auricular regions as set forth in Paragraph [0030] (cervicogenic headaches) to provide improved versatility of the device in treating patient pain and improving patient quality of life. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with wherein the region of referred pain is one or more of a parietal, temporal, frontal, frontotemporal, retroorbital, supraorbital, and auricular regions as taught by Kast et al, since such a modification would provide the predictable results of improved versatility of the device in treating patient pain and improving patient quality of life.
Referring to Claim 95, Boggs, II et al in view of Crosby et al teaches the system of claim 93, wherein the percutaneous lead is inserted along a non-intersecting trajectory to achieve the therapeutically effective distance from the at least one occipital nerve (e.g. Paragraphs [0045]-[0046]). However, Boggs, II et al does not explicitly disclose the entry site is at a midline. Kast et al teaches that it is known to use the entry site is at a midline as set forth in Paragraphs [0039] to provide reduce the amount of tissue being disturbed by entering further away from and tunneling the device into location. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with the entry site is at a midline as taught by Kast et al, since such a modification would provide the predictable results of reduce the amount of tissue being disturbed by entering further away from and tunneling the device into location.
Referring to Claim 113, Boggs, II et al in view of Crosby et al teaches the system of claim 963, wherein the lead is coiled (e.g. Figure 2 and Paragraph [0031]). However, Boggs, II et al does not disclose the entry site is at a midline and the percutaneous lead is inserted along a non-intersecting trajectory generally from medial to lateral.
Kast et al teaches that it is known to use the entry site is at the midline and the lead is inserted along a non-intersecting trajectory generally from medial to lateral as set forth in Paragraphs [0039] and Figure 1A, paddle 17A and to provide improved lead treatment and placement accuracy. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Boggs, II et al, with the entry site is at a midline and the percutaneous lead is inserted along a non-intersecting trajectory generally from medial to lateral as taught by Kast et al, since such a modification would provide the predictable results of improved lead treatment and placement accuracy.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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