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 .
Priority
Claims 1-20 are deemed to have an effective filing date of May 23, 2022 as the provisional application does not appear to provide support for stimulation “according to at least one stimulation protocol based on an upper airway patency hysteresis parameter.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 507.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 571, 575, 1164A, and 1164B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: Paragraph [0097] on page 16 of the originally-filed specification begins: “Fig. 3C is a diagram on an example arrangement 575 comprising some … attributes as example 500 in Fig. 3C”. The reference to the same figure does not make sense.
Appropriate correction is required.
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.
Claim 19 is 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 19, line 2, recites “the first stimulation protocol”. However, claims 18 and 1 from which claim 19 depends recites “at least one stimulation protocol”. It is unclear whether “the first stimulation protocol” refers to “at least one stimulation protocol” or another protocol. Thus, the scope of claim 19 is indefinite.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1, 11-13 and 16-17 are rejected under 35 U.S.C. 102 (a)(1) as anticipated by US Patent Application Publication No. 2019/0009093 to Ni et al. (hereinafter referred to as “Ni”), or, in the alternative, under 35 USC 103 as obvious over Ni in view of US Patent Application Publication No. 2012/0109249 to Tehrani et al. (hereinafter referred to as “Tehrani”).
Regarding claim 1, Ni discloses a method comprising: applying electrical stimulation, via at least one stimulation element, to upper airway patency-related tissue (e.g., paragraph [0017]: stimulation electrode portion 45 is positioned in contact with a desired nerve, such as they hypoglossal nerve to stimulate the nerve) according to at least one stimulation protocol based on an upper airway patency hysteresis parameter (e.g., abstract: stimulation protocol determination system automatically selects a stimulation protocol based on an upper airway flow limitation; paragraphs [0016]: applying stimulation in intervals or periods during targeted portions of the respiratory cycle which maintains and/or increases upper airway patency while preventing collapse of the upper airway; [0030]-[0035]: stimulation protocol determination module senses an indication of an upper airway flow limitation that detects and tracks when a flow limitation is present in the upper airway of a patient including the degree and/or duration of flow limitation where the upper airway flow limitation includes a respiratory phase parameter). Ni differs from the claimed invention in that it does not use the term “hysteresis”. However, the instant specification does not provide a special definition for “hysteresis”. Paragraph [0123] of the instant specification indicates that method of stimulation based on an upper airway patency hysteresis parameter includes sensing respiratory information and implementing the timing of the stimulation based on the sensed respiratory information such as respiratory phase information. Thus, the upper airway flow limitation of Ni is an upper airway patency hysteresis parameter.
However, if the respiratory phase information of Ni, is not considered an upper airway patency hysteresis parameter, Tehrani teaches, in a related art: therapeutic stimulating in combination with stimulation of auxiliary respiratory nerves or muscles in the upper airway (see abstract), that stimulation during inspiration (a respiratory phase) in accordance with a protocol of the invention may also increase upper airway hysteresis so that the resulting tidal flow is greater than the intrinsic normal flow and peak flow is maintained near normal peak flow to avoid upper airway closure. That is, Tehrani teaches that a flow limitation is an upper airway patency hysteresis parameter, as well as that it was known in the stimulation of the airway art to base stimulation protocol on an upper airway patency hysteresis parameter. Accordingly, one of ordinary skill in the art would have modified the method of Ni to base its protocol on an upper airway patency hysteresis parameter that was known in the art as taught by Tehrani, and because the combination would have yielded a predictable result.
With respect to claim 11, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 1, wherein the upper airway patency hysteresis parameter represents a degree and a duration of upper airway patency for the upper airway patency-related tissue following at least one stimulation period of the at least one stimulation protocol (e.g., Ni paragraphs [0031]: flow limitation parameter detects and tracks when a flow limitation is present in the upper airway of a patient, as well as the degree and/or duration of flow limitation; and [0074]: an additional stimulation burst on top of a baseline level of stimulation is applied at the beginning of the inspiratory phase implies that the inspiratory phase is detected following a baseline level of stimulation).
As to claim 12, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 1, wherein the upper airway patency hysteresis parameter comprises an upper airway patency hysteresis reference (e.g., paragraph [0043] of Ni: in order to recognize a flow limitation, the method uses as a reference point a normal beathing pattern).
With respect to claim 13, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 12, wherein the upper airway patency hysteresis reference is based on at least one of: a historical patient-specific average patency hysteresis effect (e.g., paragraphs [0043]-[0044] of Ni: in some embodiments, the method uses the particular breathing pattern of a specific patient); and a multiple patent average patency hysteresis effect (e.g., paragraphs [0043]-[0044] of Ni: variances may exist from patient-to-patient so it will be understood that the normal breathing pattern is representative implies that the normal breathing pattern may be derived from multiple patients).
As to claim 16, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 11, wherein the upper airway patency-related tissue comprises a genioglossus-based patency tissue (e.g., paragraphs [0017], [0023], [0026] of Ni: stimulation of the hypoglossal nerve to restore airway patency and thereby reduce or eliminate apnea events).
With respect to claim 17, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 16, wherein the genioglossus-based patency tissue comprises at least one of a hypoglossal nerve (e.g., paragraphs [0017], [0023], [0026] of Ni: stimulation of the hypoglossal nerve to restore airway patency and thereby reduce or eliminate apnea events) and a genioglossus muscle innervated by the hypoglossal nerve (e.g., paragraphs [0030]-[0033] of Tehrani: airway related muscles are stimulated/activated; and paragraphs [0069] and [0071] of Tehrani: electrode 51 may stimulate upper airway muscles or hypoglossal nerve where stimulation of the hypoglossal nerve stimulates/activates upper airway muscles to open the airway passage). Accordingly, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani so that a genioglossus muscle (upper airway muscle that opens the airway passage) is innervated by the hypoglossal nerve in view of the teachings of Tehrani that such was a known stimulation protocol to open the airway passage and because the combination would have yielded a predictable result.
Claims 2-10, 14-15, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ni, either alone or in combination with Tehrani as applied to claim 1 above, and further in view of US Patent Application Publication No. 2008/0103545 to Bolea et al. (hereinafter referred to as “Bolea”).
With respect to claim 2, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 1, but does not expressly disclose that the upper airway patency-related tissue comprises an ansa cervicalis-related nerve. However, Bolea, in a related art: methods for nerve stimulation for obstructive sleep apnea (OSA) therapy, teaches that suitable nerve stimulation sites include the hypoglossal nerve (e.g., Fig. 12, sites A, B, C, and E and paragraphs [0085]-[0086] of Bolea) and an ansa cervicalis-related nerve (e.g., Fig. 12, site D and paragraph [0085] of Bolea). Accordingly, one of ordinary skill in the art would have recognized the benefits of stimulating an ansa cervicalis-related nerve to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, to stimulate an ansa cervicalis-related nerve in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
As to claim 3, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 2, wherein the ansa cervicalis-related nerve comprises a superior root portion (e.g., paragraph [0086] and Fig. 12 of Bolea, superior root of ansa cervicalis). Accordingly, one of ordinary skill in the art would have recognized the benefits of stimulating an ansa cervicalis-related nerve comprising a superior root portion to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to stimulate an ansa cervicalis-related nerve comprising a superior root portion in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
With respect to claim 4, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 3, wherein the superior root portion innervates at least one of a sternothyroid muscle, a sternohyoid muscle, and an omohyoid muscle (e.g., paragraphs [0082], [0086], and [0089] of Bolea: the sternohyoid muscle is innervated by the ansa cervicalis nerve). Accordingly, one of ordinary skill in the art would have recognized the benefits of innervating the sternohyoid muscle by stimulating an ansa cervicalis-related nerve distal of the superior nerve root to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to stimulate an ansa cervicalis-related nerve distal of the nerve root (and thus, stimulating that as well) to innervate the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
As to claim 5, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 3, wherein the upper airway patency-related tissue comprises at least one nerve portion extending distally from the superior root portion and innervating at least one of the sternothyroid muscle, the sternohyoid muscle, and the omohyoid muscle (e.g., paragraphs [0082], [0086], and [0089] of Bolea: the sternohyoid muscle is innervated by an electrode placed at or near the ansa cervicalis nerve to stimulate/activate the same). Accordingly, one of ordinary skill in the art would have recognized the benefits of innervating the sternohyoid muscle by stimulating an ansa cervicalis-related nerve distal of the superior nerve root to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to stimulate an ansa cervicalis-related nerve distal of the nerve root (and thus, stimulating that as well) to innervate the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
With respect to claim 6, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 1, wherein the upper airway patency-related tissue comprises at least one of a plurality of infrahyoid strap muscles, which comprise at least one of a sternothyroid muscle, a sternohyoid muscle, and an omohyoid muscle (e.g., paragraphs [0082], [0086], and [0089] of Bolea: the sternohyoid muscle is innervated by an electrode placed at or near the ansa cervicalis nerve to stimulate/activate the same). Accordingly, one of ordinary skill in the art would have recognized the benefits of innervating the sternohyoid muscle by stimulating an upper airway patency-related tissue to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to stimulate an upper airway patency-related tissue to innervate the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
As to claim 7, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 3, comprising: applying the electrical stimulation to the at least one infrahyoid strap muscle (e.g., paragraphs [0082], [0086], and [0089] of Bolea: the sternohyoid muscle is innervated by placing an electrode at or near the ansa cervicalis nerve to stimulate the same). Accordingly, one of ordinary skill in the art would have recognized the benefits of innervating the sternohyoid muscle by stimulating a distal end of an ansa cervicalis-related nerve at the sternohyoid muscle as shown in Fig. 12 to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to stimulate a distal end of an ansa cervicalis-related nerve and thus, stimulating/innervating the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
With respect to claim 8, Ni, either alone or in combination with Tehrani, in combination with Bolea discloses/teaches the method of claim 7, the applying comprises: transcutaneously applying the electrical stimulation to the at least one infrahyoid strap muscle (e.g., Figs. 51 D-K and paragraphs [0294]-[0297] of Bolea: an external neurostimulator system inductively coupled to an internal/implanted receiver to provide stimulation to the patient; and paragraphs [0082], [0086], and [0089] of Bolea: the sternohyoid muscle is innervated by placing an electrode at or near the ansa cervicalis nerve to stimulate the same). Accordingly, one of ordinary skill in the art would have recognized the benefits of innervating the sternohyoid muscle by stimulating a distal end of an ansa cervicalis-related nerve at the sternohyoid muscle as shown in Fig. 12 to treat OSA in view of the teachings of Bolea. One of ordinary skill in the art would have further modified the stimulation of the sternohyoid muscle to be down transcutaneously or inductively coupled electrical energy for stimulation in view of the teachings of the external neurostimulator of Bolea above. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to transcutaneously apply electrical to the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea) in view of the teachings of Bolea that such was known in the stimulation therapy art for treating OSA, and because the combination would have yielded a predictable result.
As to claim 9, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 8, comprising: removably securing the stimulation element externally of, and relative to, a neck region (Figs. 51 C-K and paragraph [0295] of Bolea: transmitter coil 912 is carried by an adhesive patch 924 that may be placed on the skin in the neck area (Fig. 51C); transmitter coil 912 is carried by an under-chin strap 926 worn by the patient (Fig. 51E); transmitter coil 912 may be carried by a neck strap 928 worn by the patient (Fig. 51F); and paragraphs [0296]-[0297]: transmitter coils 912 are located on each side of a neck pillow 938, which is particularly beneficial for bilaterial stimulation – where the adhesive patch, under-chin strap, neck strap, and pillow are removably secured to a neck region of the patient). Accordingly, one of ordinary skill in the art would have recognized the benefits of removably securing an external neurostimulator to a neck region of a patient as shown in Figs. 51C-F and K of Bolea to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to removably secure an external neurostimulator to a neck region of a patient in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea) in view of the teachings of Bolea that such was known in the stimulation therapy art for treating OSA, and because the combination would have yielded a predictable result.
With respect to claim 10, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 7, comprising: implanting the stimulation element subcutaneously within a neck region to be in stimulating relation to the at least one infrahyoid strap muscle (e.g., paragraphs [0082], [0085]-[0086], and [0089]-[0090] of Bolea: the sternohyoid/infrahyoid muscle is stimulated/innervated by implanting an electrode at or near the ansa cervicalis nerve or the electrode may be placed directly in the muscles innervated by the target nerves to stimulate the same). Accordingly, one of ordinary skill in the art would have recognized the benefits of implanting the stimulation electrode/element subcutaneously within a neck region to be in stimulating relation to the sternohyoid muscle as shown in Fig. 12 to treat OSA in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, in view of Bolea to implant an electrode subcutaneously within a neck region to be in stimulating relation to the sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
As to claims 14-15, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 11, but does not expressly teach that the upper airway patency-related tissue comprises infrahyoid-based, upper airway patency tissue comprising at least one of the ansa cervicalis-related nerve and at least one infrahyoid strap muscle innervated by the ansa cervicalis-related nerve. However, Bolea, in a related art: methods for nerve stimulation for obstructive sleep apnea (OSA) therapy, teaches an electrode may be placed at an ansa cervicalis-related (ANC) nerve and/or intramuscular electrodes may be placed directly in the muscle (sternohyoid) innervated by the ANC nerve (e.g., Fig. 12, site D and paragraphs [0085]-[0086] of Bolea). Accordingly, one of ordinary skill in the art would have recognized the benefits of stimulating an ansa cervicalis-related nerve to treat OSA and innervating an infrahyoid strap muscle (sternohyoid muscle) by the ANC in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani, to stimulate an ansa cervicalis-related nerve and innervate a sternohyoid muscle in order to treat OSA and control upper airway patency (see paragraph [0048] of Bolea), and because the combination would have yielded a predictable result.
With respect to claim 18, Ni, either alone or in combination with Tehrani, discloses/teaches the method of claim 1, but does not expressly teach that the upper airway patency-related tissue comprises at least one of an infrahyoid-based, upper airway patency tissue and a genioglossus-based patency tissue. Ni does disclose stimulating one or more nerves that affect upper airway dilation (e.g., paragraphs [0002] and [0016]), and a stimulation electrode in contact with a desired nerve, such as a hypoglossal nerve (e.g., paragraph [0017]). Bolea teaches, in a related art: methods for nerve stimulation for obstructive sleep apnea (OSA) therapy, activating a genioglossus muscle via stimulating the hypoglossal nerve (e.g., paragraph [0047] of Bolea); and stimulating an infrahyoid-based upper airway patency tissue (e.g., Fig. 12, sternohyoid muscle and paragraphs [0086] and [0089]-[0090]: co-activating sites A+C+D by implanting a first electrode on a hypoglossal never proximal of a branch innervating the genioglossus muscle (at site A) and another electrode on a branch of an ansa cervicalis nerve distal of the nerve root and innervating the sternohyoid at site D). Accordingly, one of ordinary skill in the art would have recognized the benefits of stimulating both one of an infrahyoid-based, upper airway patency tissue (sternohyoid muscle) and a genioglossus-based patency tissue (genioglossus muscle) in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani so that the upper airway patency-related tissue comprises the sternohyoid muscle and a genioglossal muscle to treat OSA in view of the teachings of Bolea, and because the combination would have yielded a predictable result.
As to claim 19, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 18, wherein the at least one stimulation element comprises a first stimulation element (e.g., paragraphs [0085]-[0086] of Bolea: nerve electrode may be placed at the target nerve(s) and/or intramuscular electrodes may be placed directed in the muscles(s) innervated by the target nerve(s)), and wherein applying the stimulation via the first stimulation protocol comprises: performing the stimulation of the infrahyoid-based patency tissue via the first stimulation element without stimulating the genioglossus-based patency tissue (e.g., paragraph [0086] of Bolea: electrodes are at site C, which does not stimulate the genioglossus muscle, and site D, which stimulates the sternohyoid muscle (an infrahyoid-based patency tissue and does not stimulate the genioglossus muscle). Accordingly, one of ordinary skill in the art would have recognized the benefits of stimulating both one of an infrahyoid-based, upper airway patency tissue (sternohyoid muscle) and a genioglossus-based patency tissue (geniohyoid muscle) in view of the teachings of Bolea. Consequently, one of ordinary skill in the art would have modified the method of Ni, either alone or in combination with Tehrani so that the at least one stimulation element comprises a first stimulation element and stimulation is applied via a first stimulation protocol performing stimulation of the sternohyoid muscle and another genioglossus-based patency tissue (geniohyoid muscle) to treat OSA in view of the teachings of Bolea, and because the combination would have yielded a predictable result.
With respect to 20, Ni, either alone or in combination with Tehrani, in view of Bolea discloses/teaches the method of claim 18, wherein the at least one stimulation protocol comprises a first stimulation protocol including a series of stimulation cycles with each stimulation cycle comprising alternating stimulation periods and non-stimulation periods (e.g., paragraphs [0150] and [0153] of Bolea: series of stimulation cycles alternating between small and large diameter fibers of a nerve implies alternating stimulation periods and non-stimulation periods between small and large fibers to reduce muscle fatigue), and comprising: applying the electrical stimulation, via the first stimulation protocol and the first stimulation element, to the infrahyoid-based patency tissue via at least one of: a first closed loop mode including timing the stimulation periods relative to sensed respiratory phase information and based on the hysteresis patency parameter (e.g., paragraphs [0223]-[0224] of Bolea: extracted waveform and event data may be used for therapy tracking and/or closed loop therapy control where sensed respiratory data may be used to determine therapeutic efficacy and to control stimulus in a closed loop fashion by , for example, increasing stimulus intensity during periods of increased apnea and hypopnea occurrence … or data may be used to turn stimulus on or to turn stimulus off); and a first open loop mode including timing the stimulation periods without reference to respiratory phase information and based on the hysteresis patency parameter (alternative feature, not required). Accordingly, one of ordinary skill in the art would have recognized the benefits of a stimulation protocol including a series of stimulation cycles with each cycle comprising alternating stimulation periods and non-stimulation periods, and the benefits of applying the electrical stimulation to the target nerves via a closed loop mode including timing the stimulation periods relative to sensed respiratory phase information and based on the hysteresis patency parameter in view of the teachings of Bolea. Accordingly, one of ordinary skill in the art would have modified further the method of Ni, either alone or in combination with Tehrani, in view of Bolea to include a first stimulation protocol as set forth in claim 20 to reduce muscle fatigue, to apply the electrical stimulation to the sternohyoid nerve as it is one of the targets nerves taught by Bolea to treat OSA, and to apply the electrical stimulation via a closed loop mode according to the first alternative of claim 20 in view of the teachings of Bolea that such was a well-known protocol in the medical arts, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2020/0147376 to Dieken et al. is directed to a method for delivering, via a first stimulation element, stimulation to an upper airway patency-related nerve to cause contraction of upper airway patency-related muscle where the stimulation can be performed via an open loop stimulation without the use of any sensory feedback of any kind relative to the stimulation, or, the stimulation could be performed based on sensed respiratory information (e.g., abstract and paragraphs [0086]-[0087]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792