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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 53-68) in the reply filed on 12/8/2025 is acknowledged. The traversal is on the grounds that the examiner has not established that there would be a serious search burden and the applicant submits that there are dependent claims which link the groups.
This is not found persuasive because independent claim 53 which is directed to a method for stimulating via at least one stimulation element, at least one fiber of a glossopharyngeal nerve of a patient to promote upper airway patency is distinct from the apparatus claim 69 that is directed to a device comprising a control portion (which is interpreted as a controller) configured to stimulate, via at least one stimulation element, at least one glossopharyngeal-related tissue. The device of the apparatus claim 69 from Group II comprises a control portion that is broadly recited and is required to be only capable of stimulating the glossopharyngeal related tissue and could be used to stimulate any other portion of the body as stated in the restriction requirement mailed on 10/6/2025. No additional limitations have been provided to limit the controller of device to stimulate the glossopharyngeal related tissue as claimed in independent claim 69 or the stylopharyngeus muscle or to specific fibers of the glossopharyngeal nerve or related tissue as claimed in the dependent claims 70-72. Therefore there would be serious search burden if the restriction is not required.
Thus the requirement is still deemed proper and is therefore made FINAL.
Claims 69-72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/8/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “stimulation element” interpreted as a nerve cuff electrode in claims 53 and 63.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 53-68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bolea et al (U.S. Patent Application Publication Number: US 2008/0103545 A1, hereinafter “Bolea”).
Regarding claims 53 and 63-66, Bolea teaches a method, comprising:
selectively stimulating, via at least one stimulation element, at least one fiber of a glossopharyngeal nerve (or glossopharyngeal-related tissue as claimed in claims 63-65) of a patient to promote upper airway patency (e.g. [0093]: The glossopharyngeal nerve GN (cranial nerve IX) innervates the stylopharyngeus, which functions to dilate the lateral walls of the pharynx. However, since the glossopharyngeal nerve GN is a multi-function nerve with both afferent and efferent fibers, one or more of the fiber selective stimulation means described in greater detail below may be used to facilitate targeting the fibers that innervate only the stylopharyngeus, Fig. 27, [0145]: Electrode 2700 may be oriented on the nerve it is implanted on in any suitable manner, such as, for example, according to the direction of intended stimulation, where it may be desired to stimulate efferent (motor) fibers of a nerve, such as, while avoiding stimulation to afferent (sensory) fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located distally of cathode electrode contact 2703, with distal and proximal designations based on the relative location of the electrode contact on the nerve. Alternatively, in circumstances where it may be desired to stimulate afferent fibers of a nerve while avoiding stimulation of efferent fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located proximally of cathode electrode contact 2703).
Regarding claims 54-56 and 67, Bolea teaches selectively stimulating comprises:
stimulating the at least one fiber while not stimulating other fibers at a target location of the glossopharyngeal nerve (as claimed in claim 54) (e.g. [0093]: The glossopharyngeal nerve GN (cranial nerve IX) innervates the stylopharyngeus, which functions to dilate the lateral walls of the pharynx. However, since the glossopharyngeal nerve GN is a multi-function nerve with both afferent and efferent fibers, one or more of the fiber selective stimulation means described in greater detail below may be used to facilitate targeting the fibers that innervate only the stylopharyngeus) and
stimulating the at least one fiber at a target location of the glossopharyngeal nerve to stimulate efferent fibers of the glossopharyngeal nerve while not stimulating afferent fibers of the glossopharyngeal nerve (as claimed in claim 55) (e.g. Fig. 27, [0145]: Electrode 2700 may be oriented on the nerve it is implanted on in any suitable manner, such as, for example, according to the direction of intended stimulation, where it may be desired to stimulate efferent (motor) fibers of a nerve, such as, while avoiding stimulation to afferent (sensory) fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located distally of cathode electrode contact 2703, with distal and proximal designations based on the relative location of the electrode contact on the nerve.) and
stimulating the at least one fiber at a target location of the glossopharyngeal nerve to stimulate select afferent fibers of the glossopharyngeal nerve while not stimulating efferent fibers and other afferent fibers of the glossopharyngeal nerve (as claimed in claim 56)(e.g. Fig. 27, [0145]: Alternatively, in circumstances where it may be desired to stimulate afferent fibers of a nerve while avoiding stimulation of efferent fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located proximally of cathode electrode contact 2703).
Regarding claims 62, 64 and 65, Bolea teaches the at least one fiber comprises an efferent fiber of the glossopharyngeal nerve and selectively stimulating the at least one fiber of the glossopharyngeal nerve comprises selectively activating upper airway patency-related muscle selected from a group consisting of: at least one stylopharyngeus muscle; at least one pharyngeal constrictor muscle; and a combination thereof (e.g. [0093]: The glossopharyngeal nerve GN (cranial nerve IX) innervates the stylopharyngeus, which functions to dilate the lateral walls of the pharynx. However, since the glossopharyngeal nerve GN is a multi-function nerve with both afferent and efferent fibers, one or more of the fiber selective stimulation means described in greater detail below may be used to facilitate targeting the fibers that innervate only the stylopharyngeus, e.g. Fig. 27, [0145]: Electrode 2700 may be oriented on the nerve it is implanted on in any suitable manner, such as, for example, according to the direction of intended stimulation, where it may be desired to stimulate efferent (motor) fibers of a nerve, such as, while avoiding stimulation to afferent (sensory) fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located distally of cathode electrode contact 2703, with distal and proximal designations based on the relative location of the electrode contact on the nerve.)
Regarding claim 57, Bolea teaches that afferent fibers are usually larger diameter fibers and efferent fibers are usually lower diameters fibers and selectively stimulating comprises selectively stimulating differing diameter fibers of a nerve, by using a suitable configuration for the electrodes (e.g. [0146]) or using waveform pulse widths (e.g. [0156]) and therefore they teach stimulating efferent fibers and at least one afferent fiber of the glossopharyngeal nerve, while not stimulating other afferent fibers of the glossopharyngeal nerve as claimed. (Note: the claim does not recite any specific waveform parameters to selectively stimulate efferent and specific afferent fibers while not stimulating other afferent fibers as claimed).
Regarding claim 58-61, Bolea teaches the at least one fiber comprises an afferent fiber of the glossopharyngeal nerve and selectively stimulating the afferent fiber of the glossopharyngeal nerve (e.g. [0093]) further comprises inducing a physiologic response and thereby causing at least one of maintaining and increasing upper airway patency (claim 58) and the physiologic response is associated with a reflex opening activity. associated with upper airway patency (claim 59) and comprises at least one of: recruiting mechanoreceptors; and recruiting chemoreceptors (claim 60) and wherein the physiologic response causes at least one of: reflex opening of the upper airway; and priming of a sensory pathway associated with upper airway patency and reflex opening of the upper airway (claim 61) (e.g. Figs. 12 A-D, [0093]: nerve stimulation sites are shown for effecting muscles controlling patency of the upper airway, since the glossopharyngeal nerve GN is a multi-function nerve with both afferent and efferent fibers, one or more of the fiber selective stimulation means described in greater detail below may be used to facilitate targeting the fibers that innervate only the stylopharyngeus, [0145]: where it may be desired to stimulate afferent fibers of a nerve while avoiding stimulation of efferent fibers of the nerve, the electrode 2700 may be oriented on the nerve in a manner such that anode electrode contact 2702 is located proximally of cathode electrode contact 2703 [0094]: mechanoreceptors which detect pressure changes in a patient's upper airway associated with its collapse and institute a physiological response to re-open the patient's upper airway. Therefore, stimulation of specific afferent fibers may result in triggering a reflex response that causes upper airway dilation by activating several muscles groups).
Regarding claim 68, as discussed above Bolea teaches selectively stimulating the afferent or efferent fibers of the glossopharyngeal nerve while avoiding the stimulation of efferent or afferent fibers respectively (e.g. [0093]: GN is a multi-function nerve with both afferent and efferent fibers, one or more of the fiber selective stimulation means described in greater detail below may be used to facilitate targeting the fibers that innervate only the stylopharyngeus, [0145]) and therefore they that the stimulating causes, without activating at least one of coughing and trachea closure, activating the stylopharyngeus muscle without activating at least one of coughing and trachea closure (Note: Applicant’s own disclosure states that to avoid or mitigate activating reflex activity of coughing and/or closing of the trachea in response to selective stimulation at target location the methods may specifically select afferent fibers and/or efferent fibers to be stimulated, while other afferent and/or efferent fibers are not stimulated).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Karell (U.S. Patent Application Publication Number: US 2009/0012573 A1, hereinafter “Karell”) teaches a stimulator comprising electrodes and a control unit adapted to provide electrical stimulation intraorally and/or intranasally to a patient for improved breathing (e.g. abstract, Fig.1).
Boggs, II et al (U.S. Patent Application Publication Number: US 2011/0093032 A1, hereinafter “Boggs”) teaches systems and methods comprising an electrical pulse generator system, which may be external to or implanted in an animal body, to provide therapeutically effective electrical stimulation to maintain or improve airway patency by the stimulation of target nerve(s) or their branches using one or more leads and one or more electrodes implanted in, on, around, or near the target nerve(s) wherein the target nerves to be stimulated to maintain or improve upper airway patency, preferably through upper airway muscle reflex activation, are the glossopharyngeal nerve (e.g. abstract).
Lattner et al (U.S. Patent Number: US 6212435, hereinafter “Lattner”) teaches an intraoral electromuscular stimulation device and method to treat a breathing disorder comprising a first and second electrode, a first support member that maintains the first electrode, a sensor that detects a respiratory parameter of a patient and a control unit receives the signal from the sensor, distinguishes between inspiration and expiration, and initiates an electrical stimulation at a stimulation time prior to onset of inspiration and continues stimulation through a portion of inspiration at a level sufficient to induce muscle contraction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792