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 11/5/2025 have been fully considered but they are not persuasive.
Applicant argues that the Whitehurst reference does not disclose the claim language found in claim 1 which recites “causing modulation of one or more nerve(s) innervating a region outside of a region innervated by the at least one occipital nerve”. This language is found in claim 1, lines 10-11.
Whitehurst discloses stimulation applied to nerves arising from the C1-C4 cervical spinal cord. This includes the greater occipital nerve, lesser occipital nerve, third occipital nerve, auricular nerves, transverse cervical nerves and supraclavicular nerves (paragraph 0059). The electrodes are implanted in the upper cervical spine (paragraph 0063-64) which is disclosed to be C1-C4 (paragraph 0059). Claim 2 of Whitehurst also requires stimulation of the upper cervical spinal nerves including the occipital nerves as well as the great auricular nerves, the transverse cervical nerves and the supraclavicular nerves.
As is known the occipital nerves arise from the C2 and C3 spinal nerves. The occipital nerves mainly carry sensory fibers which supply sensory input to the posterior and lateral scalp including the skin of the external ear. The third occipital nerve provides motor innervation to the semispinalis capitis muscle. i
The first spinal nerve C1, known as the suboccipital nerve, and is purely motor and lacks sensory fibers. The anterior root of C1 innervates the neck and suboccipital muscles and the posterior root and does not contribute to skin innervation. Some fibers of the C1 join with the hypoglossal nerve and help to stimulate the geniohyoid and thyroid. ii
The forth spinal nerve C4 controls upper should motion and is one of the nerves that controls the diaphragm. This nerve supplies sensation to the neck, shoulders and upper arms. iii
Therefore by Whitehurst is stimulating C1 and C4 both of which have nerves which innervate regions outside of the regions that are innervated by the C2 and C3 nerves which are the occipital nerves. The fact that Whitehurst is claiming stimulation of nerves which are not the occipital nerve and include the great auricular nerves, the transverse cervical nerves and the supraclavicular nerves demonstrates that Whitehurst is clearly stimulating nerves which will innervate regions outside of the nerves innervated by the occipital nerves. For instance the supraclavicular nerves innervate the upper chest and shoulder, which is clearly out of the area of the occipital nerves even when all three occipital nerves are considered.
The claim rejections are not withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2005/0102006 in view of Boggs II et al. US 2017/0361089 and further in view of McGee et al. US 2016/0213927. All references previously cited.
Regarding claim 1: Whitehurst discloses inserting a percutaneous lead 150 (figure 2) comprising electrodes 152 (four electrodes are carried on the lead, paragraph 0063 and figure 2) into a posterior neck (back of the neck is disclosed in paragraph 0059) inferior to a nuchal ridge targeting occipital nerves (as can be seen in figures 2 and 5, the lead and electrodes are implanted in a posterior/back of the neck below/inferior to the skull and/or nuchal ridge, nerves that are targeted include the greater occipital nerve 130, lesser occipital nerve 132 and third occipital nerve 134 (figure 1) also paragraph 0059); positioning the electrode a therapeutically effective distance from the occipital nerve (electrodes 152 are located adjacent both branches of the greater occipital nerve and both branches of the third occipital nerve 134” paragraph 0091). The electrodes are positioned proximally to the occipital nerve and branches thereof (paragraph 0059). Whitehurst therefore discloses the claimed invention however Whitehurst is silent as to the therapeutic distance being between 0.5-3cm, this is the distance between the electrode and the target neural tissue. Boggs II however teaches of a similar invention and teaches that the optimal distance between the electrode on a lead and the target nerve tissue is between 0.1-50mm / 0.1-5cm. Boggs II further teaches that this enables preferred activation of target nerve fibers (paragraph 0067). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst to include placing the lead at an optimal distance of between 0.1-50mm / 0.1-5cm, as taught by Boggs II, in order to preferentially activate target nerve fibers in the occipital nerves while avoiding activation of motor fibers (paragraph 0024). In applicants response it is argued that Whitehurst does not discuss activation of large diameter nerve fibers. Boggs II also does not specifically discuss large diameter nerve fibers. However, the omission of any discussion from Whitehurst and/or Boggs II does not indicate or confirm that Whitehurst and/or Boggs II are not activating large diameter nerve fibers preferentially. However, the interest of compact prosecution, McGee teaches that selective stimulation of large diameter motor fibers while avoiding small diameter sensory fibers includes multiple factors such as electrode design and shape, location of electrode and pattern of stimulation (paragraph 0079). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/Boggs II to include selective stimulation of large diameter nerve fibers, as taught by McGee, in order to selectively control stimulation while avoiding stimulation side effects.
Regarding claims 2-3: Whitehurst discloses the claimed invention however Whitehurst does not specifically disclose that the length of the lead facilitates tissue ingrowth to resist migration and an open coil lead. Boggs II however teaches of preventing migration using a coiled structure to prevent migration along the length (paragraph 0070 and 0076). It therefore would have been obvious to one of ordinary skill in the art at the time the invention as filed to modify Whitehurst to include a coiled structure which prevents migration along the length of the lead, as taught by Boggs II, in order to reduce the rates of lead replacement and removal.
Regarding claim 6: Whitehurst discloses anchoring structures (paragraph 0064).
Regarding claim 7: Whitehurst disclose that the leads are outside the CNS (figures 2 and 5, paragraph 0064).
Regarding claims 8-9: Whitehurst discloses that the lead 150 (figure 2) is configured for insertion into a portion of the body proximal to the region of referred pain (paragraph 0062) and stimulation occurs proximal to the referred pain region (paragraph 0024 the origin of the headache is in the cervical spine, pain is felt in the head stimulation occurs in the cervical spine area which is proximal to the referred pain).
Regarding claims 10-11: Whitehurst discloses that stimulation is to the greater occipital nerve, lesser occipital nerve, third occipital nerve and branches of these nerves (paragraph 0059) which necessary incudes distal branches.
Regarding claim 14: Whitehurst discloses targeting specific neural populations and excluding other neural populations which is considered to be comfortable sensations generated only in the painful regions (paragraph 0069). It is also noted that this language does not require any additional method step.
Claims 4-5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2005/0102006 in view of Boggs II et al. US 2017/0361089 and further in view of McGee et al. US 2016/0213927 and further in view of Kast et al. US 9,427,572. All references previously cited.
Regarding claim 4: Whitehurst/Boggs II/McGee discloses the claimed invention however Whitehurst/Boggs II/McGee does not specifically disclose that the length of the lead is greater than 4 cm. Kast however teaches of a lead that is no greater than 6 inches (column 1, lines 60-67), this would include lengths from 0-6 inches or 0-15.24 cm, which is greater than 4 cm. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/Boggs II/McGee to include a lead of greater than 4cm as taught by Kast, in order to stimulate nerves int eh C1-C4 region (column 3, line13).
Regarding claim 5: Whitehurst discloses electrodes 153 (figure 3) and leads 150, the lead is clearly at least 3x’s longer than each electrode in this depiction.
Regarding claim 19: Whitehurst discloses inserting a percutaneous lead 150 (figure 2) comprising electrodes 152 (four electrodes are carried on the lead, paragraph 0063 and figure 2) into a posterior neck (back of the neck is disclosed in paragraph 0059) inferior to a nuchal ridge targeting occipital nerves (as can be seen in figures 2 and 5, the lead and electrodes are implanted in a posterior/back of the neck below/inferior to the skull and/or nuchal ridge, nerves that are targeted include the greater occipital nerve 130, lesser occipital nerve 132 and third occipital nerve 134 (figure 1) also paragraph 0059); positioning the electrode a therapeutically effective distance from the occipital nerve (electrodes 152 are located adjacent both branches of the greater occipital nerve and both branches of the third occipital nerve 134” paragraph 0091). The electrodes are positioned proximally to the occipital nerve and branches thereof (paragraph 0059). The remainder of the claim language, not specifically addressed, is specific to intended use and or desired results. Whitehurst disclose targeting neural populations while excluding non-targeted neural populations (paragraph 0069) in order to increase activity in some neural populations while decreasing neural activity in other populations. Whitehurst therefore discloses the claimed invention however Whitehurst is silent as to the therapeutic distance being between 0.5-3cm, this is the distance between the electrode and the target neural tissue. Boggs II however teaches of a similar invention and teaches that the optimal distance between the electrode on a lead and the target nerve tissue is between 0.1-50mm / 0.1-5cm. Boggs II further teaches that this enables preferred activation of target nerve fibers (paragraph 0067). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst to include placing the lead at an optimal distance of between 0.1-50mm / 0.1-5cm, as taught by Boggs II, in order to preferentially activate target nerve fibers in the occipital nerves while avoiding activation of motor fibers (paragraph 0024). Whitehurst/Boggs II therefore discloses the claimed invention however Whitehurst/Boggs II does not specifically (as discussed above) discuss the preferential stimulation of large diameter nerve fibers as well as modulating amplitude and pulse duration. McGee teaches that selective stimulation of large diameter motor fibers while avoiding small diameter sensory fibers includes multiple factors such as electrode design and shape, location of electrode and pattern of stimulation (paragraph 0079). McGee further teaches of varying amplitude and pulse duration in order to modify stimulation intensity (paragraph 0081). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/Boggs II to include selective stimulation of large diameter nerve fibers as well as modulating pulse amplitude and duration, as taught by McGee, in order to selectively control stimulation as well as stimulation intensity while avoiding stimulation side effects.
Claims 23-26 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2005/0102006 in view of Boggs II et al. US 2017/0361089 and further in view of McGee et al. US 2016/0213927 and further in view of Kim et al. US 2006/0052837. All references previously cited.
Regarding claims 23-24: Whitehurst/Boggs II/McGee discloses the claimed invention however Whitehurst/Boggs II/McGee does not specifically disclose targeting large diameter A-alpha and A-beta fibers while not targeting smaller diameter A-delta and C fibers. Kim however teaches of setting stimulation levels to preferentially activate large diameter A-alpha and A-beta fibers over small diameter c-fibers (paragraph 0081). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Whitehurst/Boggs II/McGee to include selectively stimulating A-alpha and A-beta fibers while avoiding c-fibers, as taught by Kim, in order to leave motor nerves unstimulated (Kim paragraph 0082).
Regarding claim 25: The muscle tissue in the vicinity of the occipital nerve is inherently includes the muscles listed in the claim language.
Regarding claim 26: Whitehurst discloses electrodes 152 and 152’ (figure 3), as can be seen in the drawing at least 6 of the electrodes are spaced away from the distal end of the lead.
Regarding claim 28: Whitehurst discloses stimulation of any nerve from C1-C4 (paragraph 0031) which would necessarily allow for configuration for insertion into the posterior neck targeting any of the claimed structures.
Regarding claim 29: Whitehurst disclose implantation of the SCU 110 (“control unit” figure 2) into the mastoid area 142 (figure 2) of the skull 140 (figure 2). It is known that the C1 vertebra is located below/inferior to the base of the skull. Whitehurst further discloses that the electrode leads 150 are attached to the SCU and then run within a surgically created recess or groove to the nerves of the upper cervical spine (paragraph 0062). Further, Whitehurst discloses stimulation is applied to nerves ranging from C1-C4 locations (paragraph 0059) therefore the lead is disclosed as being percutaneously implanted at least 2 levels above C4 prior to tunneling of the lead to the location along C3 or C4.
Regarding claim 30: Whitehurst, figure 2 demonstrates the skull as well as the implant location. The lead and stimulation unit are both inferior to the frontal hairline above the eyes.
Regarding claim 31: Whitehurst discloses that the lead 150 is inserted at an entry site (see the claim 29-30 rejections) and it is at a midline of the stimulator 110.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst et al. US 2005/0102006 in view of Boggs II et al. US 2017/0361089 and further in view of McGee et al. US 2016/0213927 and further in view of Kim et al. US 2006/0052837 and further in view of Yu US 2016/0166828. All references previously cited.
Regarding claim 27 as understood: Whitehurst/Boggs II/McGee/Kim discloses the claimed invention. However it is unclear if Whitehurst/Boggs II/McGee/Kim discloses that a distal end of the electrode is outside the therapy area while the electrode is within the therapy area. Figures 17A-B of Yu demonstrate electrodes on a lead which are partially within the field of treatment while. It therefore would have been obvious to one of ordinary skill in the art to include an electrode partially within the therapy area and partially outside the therapy area, as taught by Yu, in order to reconfigured the electrodes for stimulation if migration occurs (paragraphs 0027 and 0087).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i https://www.kenhub.com/en/library/anatomy/occipital-nerves
ii https://www.imaios.com/en/e-anatomy/anatomical-structures/spinal-nerve-c1-133586468#
iii https://my.clevelandclinic.org/health/articles/22278-cervical-spine