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 Objections
Claim 61 is objected to because of the following informalities: Claim 61 is both cancelled and withdrawn. The examiner assumes that cancelling claim 61 was a typographical error and should have remained consistent with the previous claim set having claims 1-60 cancelled. The examiner assumes claim 61 stands as withdrawn as presented in the current claim set. Appropriate correction is required.
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 9/16/2025 is acknowledged.
Claims 61, 65, 96-106, 114-115, 120-126, and 130 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 108, and 111-113 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 108 recites the limitation "the muscles" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 111 and 113 recites the limitation "the entry site" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 112 and 113 recites the limitation "the coiled lead" in line 1 (claim 112) and line 2 (claim 113). There is insufficient antecedent basis for this limitation in the claim.
Claim 112 recites the limitation "the midline" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 108, 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 the 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 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 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 the 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 the 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 the 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 the 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 108, Boggs, II et al in view of Crosby et al teaches the system of claim 66, wherein the muscles include one or more of the rotatores, multifidus, semispinalis cervicis, semispinalis capitis, splenius cervicis, splenius capitis, obliquus capitis inferior, or trapezius (e.g. Paragraph [0067]).
Referring to Claim 111, Boggs, II et al in view of Crosby et al teaches the system of claim 66, 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 coiled 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 at least one 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 the midline. Kast et al teaches that it is known to use the entry site is at the 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 the 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 66, 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 the midline and the coiled 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 the midline and the coiled 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
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