DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/28/2026 has been entered.
Regarding the claims submitted with the RCE filed on 7/28/2026; all of the claims previously examined have been cancelled and new claims 60-74 have been added. The previous examined claims were device/systems claims whereas the claims pending are methods claims. Applicant is advised that the cancelling of previously examined claims in favor of new claims which switch between system/device claims to methods claims can result in restriction by original presentation. However, due to expedited prosecution the claims will be examined as submitted however applicant is advised that this can result in the claims not being examined in favor of a restriction by original presentation.
Claim Objections
Claim 60 recites “the first and the electrical signals”, this should read “the first and the second electrical signals”.
Claim 61 recites “a third electrical to target site”. This should read “a third electrical signal to a target site”.
Claims 67 and 68 each depend from claim 1, which has been cancelled. These claims should be amended to depend from claim 60.
Claim 63 is objected to under 37 CFR 1.75 as being a duplicate of claim 62. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claims 60-74 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.
Regarding claim 60: line 1 recites “improving obstructive sleep apnea (OSA)” in line 7 recites “improving the patient’s sleep disordered breathing”. Sleep apnea is a specific type of sleep disordered breathing and is considered to be a narrow recitation followed by a more broad recitation of sleep disordered breathing. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation sleep disordered breathing, and the claim also recites obstructive sleep apnea which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 61, line 1 recites “a third electrical”, it is unclear what the third electrical is in reference to however this should likely read “a third electrical signal”.
Claim 65 recites “wherein the efferent fiber is a pharyngeal nerve plexus or branch thereof.” This language is indefinite because an efferent fiber or efferent fibers are a part of a nerve and it is not clear how a fiber or fibers can be a nerve plexus (considered to be a network of nerves) or branch. The efferent fiber(s) may be a part of the pharyngeal nerve plexus or branch but it is unclear how it is the pharyngeal nerve plexus or branch.
The remainder of the claims, not specifically addressed above, are also rejected in that all claims depend from claim 60.
Claim Rejections - 35 USC § 102
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.
Claims 60-64 and 68-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verzal et al. US 2024/0252824i.
Regarding claim 60: Verzal discloses a method of improving OSA (paragraph 0059, “the sleep disordered breathing may comprise obstructive sleep apnea”) comprising:
delivering a first electrical signal to a target site of an ansa cervicalis 315 (figure 2) innervating the sternothyroid muscle to activate the sternothyroid muscle (paragraph 0062);
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delivering a second electrical signal to a phrenic nerve (paragraphs 0564, 0566-0567 and 0694-0695) innervating a diaphragm to activate the diaphragm (0566 and 0925); and
improving the patient’s sleep disordered breathing via delivery of electrical signals. This language is considered to be directed towards an intended outcome and does not further specify any method steps, Verzal discloses treating sleep disordered breathing (paragraph 0098) and therefore this is teaching improving sleep disordered breathing.
Regarding claim 61: Verzal discloses delivering a third electrical signal to a target site of the ansa cervicalis 352 (paragraph 0065) innervating a sternohyoid muscle 354 to activate the sternohyoid muscle 354 (figure 2, paragraph 0062).
Regarding duplicate claims 62-63: Verzal discloses delivering a forth electrical signal to a target site of the ansa cervicalis 332 (paragraph 0065) innervating an omohyoid muscle 334 (figure 2) to activate the omohyoid muscle (figure 2, paragraph 0062).
Regarding claim 64: Verzal discloses delivering a fifth electrical signal to a hypoglossal nerve 305 (figure 2) to stimulate the hypoglossal nerve 305 to activate a genioglossus muscle 304 (figure 2, paragraph 0062).
Regarding claims 68 and 70: Verzal discloses sensing a severity of OSA (paragraphs 0836, 0842, 0843 and 1160-1161), the severity of OSA is broadly interpreted to be a respiratory state, Verzal further discloses that sensed respiratory information includes inspiratory and expiratory phases (paragraph 0123).
Regarding claim 69: Verzal discloses delivering either a first or second electrical signal in response to the sensed physiological parameter (paragraphs 0756, 0836 and 0842).
Regarding claims 71-72: Verzal discloses that sensed respiratory information includes inspiratory and expiratory phases (paragraph 0123).
Regarding claim 73: Verzal discloses sensing sleep stage (paragraph 0651).
Regarding claim 74: Verzal discloses delivering stimulation based on the severity of OSA (paragraphs 0653, 0756, 0836, 0842, 0843).
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.
Claims 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al. US 2024/0252824 in view of Bolea et al. US 2008/0103545.
Regarding claim 65: Verzal discloses a sixth electrical signal to a glossopharyngeal nerve (paragraphs 0800, 0811 and 0956-0957). Although the remainder of the claim language can be considered intended use/outcome, in order to expedite prosecution the following rejection is made. Verzal therefore discloses stimulating the glossopharyngeal nerve, however Verzal does not disclose stimulating efferent fibers to activate a stylopharyngeus muscle. Bolea, however teaches of an OSA treatment (title and abstract) which stimulates efferent fibers of the glossopharyngeal nerve to target the stylopharyngeus muscle (paragraph 0094). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Verzal to include targeting the efferent fibers of the glossopharyngeal nerve to activate the stylopharyngeus muscle, as taught by Bolea, in order to control patency of the upper airway (Bolea, paragraph 0093).
Regarding claim 66: Verzal/Bolea discloses the claimed invention and Bolea specifically discloses stimulation of efferent fibers of the glossopharyngeal nerve to activate the stylopharyngeus muscle. Claim 66 provides no specific step not found in claim 65 only an intended outcome, therefore it is rejected with claim 65.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Verzal et al. US 2024/0252824 in view of Kent US 2019/0117966.
Regarding claim 67: Verzal discloses the claimed invention however, Verzal does not disclose stimulating the pharyngeal nerve plexus to activate palatoglossus and palatopharyngeus muscles. Kent however, teaches of a sleep apnea device and method (paragraph 0003) which activates both the palatoglossus and palatopharyngeus muscles to improve sleep disorders by stimulating the pharyngeal plexus which branches from the hypoglossal nerve (paragraph 0012). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Verzal to include stimulating the pharyngeal nerve plexus to activate palatoglossus and palatopharyngeus muscles, as taught by Kent, in order to improve SBD.
Conclusion
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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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i Regarding the Verzal disclosure, the date relied upon as a date acceptable for prior art rejections is the Provisional Application (63/191,172) date of May 21, 2021 which is before applicants earliest priority date of 8/25/2021. The earliest priority date of 8/25/2021 is also a provisional date for provisional application 63/236,774.
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