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 .
Amendment
This action is in response to the Amendment filed on 6/5/2026.
Claims 53-72 are pending.
Claims 53-68 are examined.
Claims 69-73 are withdrawn.
Response to Arguments
Applicant's arguments with respect to claims have been considered.
Claim Interpretations under 35 U.S.C. 112 (sixth paragraph)
Applicant has amended the independent claims to recite "stimulation electrode arrangement" to clarify the subject matter and therefore the "stimulation electrode arrangement" is not interpreted under § 112, six paragraph.
Claim Rejections under 35 U.S.C. 102- Bolea et al., U.S. Publication No. 2008/0103545.
Applicant has amended independent claims 53 and 63 to now recite:
selectively stimulating via a stimulation electrode arrangement an afferent fiber of a glossopharyngeal nerve of a patient to promote upper airway patency.
Independent claim 53 recites “selectively stimulating, via at least one stimulation electrode arrangement, an afferent fiber of a glossopharyngeal nerve of a patient to promote upper airway patency.
Similar amendments have been made to independent claim 63
Upon further search and consideration, the claims are rejected as discussed in the current office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 55 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 55 recites “wherein selectively stimulating comprises stimulating the afferent fiber and an efferent fiber at a target location of the glossopharyngeal nerve, while not stimulating other fibers of the glossopharyngeal nerve.
Nerves comprise afferent or efferent fibers. The afferent fibers conduct signals towards the central nervous system and efferent fibers carry signals away from the central nervous system. Therefore, there is no support for “stimulating an efferent and afferent fiber at the glossopharyngeal nerve while not stimulating afferent other fibers of the glossopharyngeal nerve. “
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 53-68 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 53 recites selectively stimulating an efferent fiber of a glossopharyngeal nerve and Claim 55 recites “wherein selectively stimulating comprises stimulating the afferent fiber and an efferent fiber at a target location of the glossopharyngeal nerve, while not stimulating afferent other fibers of the glossopharyngeal nerve”. Independent claim 63 similarly recite stimulating an afferent fiber of the glossopharyngeal nerve and dependent claim 66 recites stimulating an afferent and an efferent fiber of the glossopharyngeal nerve. Therefore, it is unclear as to what fibers are being stimulated. Is it efferent or afferent or both fibers?
Claim 55 recites “wherein selectively stimulating comprises stimulating the afferent fiber and an efferent fiber at a target location of the glossopharyngeal nerve, while not stimulating other fibers of the glossopharyngeal nerve. Nerve fibers comprise afferent or efferent with the afferent fibers bringing signals towards the central nervous system and efferent fibers carrying signals away from the central nervous system. Therefore, it is unclear as to what “other fibers of the glossopharyngeal nerve” are being referred to in this claim.
The dependent claims inherit the deficiencies..
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 53-56, 58-61, 63-66 and 68 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pitts (U.S. Patent Application Publication Number: US 2002/0049479A1, hereinafter “Pitts”).
Regarding claims 53 and 55, Pitts teaches a method, comprising:
selectively stimulating, via at least one stimulation electrode arrangement (e.g. [0013]: The electrode is capable of conducting selected electrical stimulation generated by the stimulator and delivering the selected electrical stimulation during a selected time of day.), an afferent fiber or efferent fiber (as claimed in claim 55) of a glossopharyngeal nerve of a patient to promote upper airway patency (e.g. Title, [0013]: the electrode is placed near enough to the glossopharyngeal nerve that stimulation effects glossopharyngeal branches (efferent and/or afferents), thus inducing muscle tone in the airway muscle fiber served by the stimulated branch of the glossopharyngeal., [0025],[0030]claim 10,[0029]: stimulation frequency is 0.001Hz to 100Hz similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]). Therefore, since Pitts teaches the claimed stimulation frequency and the claimed implantation location, they teach selective stimulation of an afferent fiber of a glossopharyngeal nerve as claimed.
Regarding claim 54, Pitts teaches wherein selectively stimulating comprises stimulating the afferent fiber while not stimulating other select fibers at a target location of the glossopharyngeal nerve and without activating at least one of coughing and trachea closure, and wherein the stimulation electrode arrangement comprises a stimulation electrode connected to a pulse generator (e.g. [0025]: low intensity stimulation to maintain tone, [0029]: stimulation frequency is 0.001H to 100Hz similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]).
Regarding claim 56, Pitts teaches selectively stimulating comprises stimulating the afferent 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 which are unrelated to promoting upper airway patency (e.g. [0025]: low intensity stimulation to maintain tone, [0029]: stimulation frequency is 0.001H to 100Hz similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]).
Regarding claims 58-61, Pitts teaches the electrode is placed near enough to the glossopharyngeal nerve that stimulation effects glossopharyngeal branches (efferent and/or afferents), thus inducing muscle tone in the airway muscle fiber served by the stimulated branch of the glossopharyngeal (e.g. Title, [0013], claim 10) and further teaches a low intensity stimulation (e.g. [0025],[0030]) with a stimulation frequency of 0.001H to 100Hz (e.g. [0029]) similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]). Therefore, since Pitts teaches the implantation location, low intensity stimulation and a stimulation frequency that overlaps the claimed range, Pitts teaches the claimed limitations (as recited in claims 58-61) of selectively stimulating the afferent fiber of the glossopharyngeal nerve further comprises inducing a physiologic response that comprises at least one of: recruiting mechanoreceptors; and recruiting chemoreceptors and thereby causing at least one of maintaining or increasing upper airway patency and wherein the physiologic response is associated with a reflex opening activity associated with upper airway patency and the physiologic response causes at least one of: reflex opening of the upper airway via the recruiting of the mechanoreceptors; and priming of a sensory pathway associated with upper airway patency and reflex opening of the upper airway via recruiting of the chemoreceptors (Note: the claims do not recite any additional limitations that preclude the teachings of Pitts).
Regarding claims 63, 64 and 66, Pitts teaches a method, comprising:
inducing a physiological response by selectively stimulating, via at least one stimulation electrode arrangement (e.g. [0013]: The electrode is capable of conducting selected electrical stimulation generated by the stimulator and delivering the selected electrical stimulation during a selected time of day), an afferent fiber or efferent fiber (as claimed in claim 64) of a glossopharyngeal nerve of a patient to promote upper airway patency,
wherein the physiological response comprises at least one of:
reflex opening of the upper airway; and
priming of a sensory pathway associated with upper airway patency (e.g. Title, [0013]: the electrode is placed near enough to the glossopharyngeal nerve that stimulation effects glossopharyngeal branches (efferent and/or afferents), thus inducing muscle tone in the airway muscle fiber served by the stimulated branch of the glossopharyngeal., [0025],[0030]claim 10,[0029]: stimulation frequency is 0.001Hz to 100Hz similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]). Therefore, since Pitts teaches the claimed stimulation frequency and the claimed implantation location, they teach selective stimulation of an afferent fiber of a glossopharyngeal nerve as claimed.
Regarding claim 65, Pitts teaches the stimulation electrode arrangement comprises a stimulation electrode connected to a pulse generator (e.g. [0019]) and inducing the physiologic response occurs without activating at least one of coughing and trachea closure (e.g. [0025]: low intensity stimulation to maintain tone, [0029]: stimulation frequency is 0.001H to 100Hz similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159]).
Regarding claim 68, Pitts teaches the claimed invention as discussed above and since they teach a low intensity stimulation to maintain tone (e.g. [0025]) and a stimulation frequency of 0.001H to 100Hz ([0029]) similar to “the stimulation energy level of between about 2 Hz to about 100 Hz ” as disclosed in the current application in paragraph [0159], they teach stimulating causes, at least one of: activating the stylopharyngeus muscle without activating at least one of coughing and trachea closure; activating at least one pharyngeal constrictor muscle without activating at least one of coughing and trachea closure; and priming of a sensory pathway associated with upper airway patency and reflex opening of the upper airway without activating at least one of coughing and trachea closure as claimed.
Claim Rejections - 35 USC § 103
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 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 55, 62 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Pitts (U.S. Patent Application Publication Number: US 2002/0049479A1, hereinafter “Pitts”) in view of Wilsons (U.S. Patent Application Publication Number: US 2012/0253249A1, hereinafter “Wilson”).
Regarding claim 55, Pitts teaches the claimed invention as discussed above except for selectively stimulating comprises stimulating: an efferent fiber of the glossopharyngeal nerve as timed with respiration information; and the afferent fiber of the glossopharyngeal nerve using a stimulation energy level below a threshold which is applied independent of the respiration information.
In a similar field of endeavor, Wilson teaches current steering by using stimulation waveforms that contain features allowing for selective stimulation using current steering, directionally selective stimulation of efferent or afferent fibers, selectivity for stimulating axons of a particular diameter, or features designed to block transmission of undesired bioelectric activity (e.g. [0041], [0078]: Stimulation location, amplitude, and/or waveform may be adjusted in a closed-loop based on current respiratory conditions such as respiratory phase, or based on conditions relayed by the apnea monitoring and detection module 1104 in response to previous stimulation. Stimulation waveforms may also contain features allowing for selective stimulation using current steering, directionally selective stimulation of efferent or afferent fibers, selectivity for stimulating axons of a particular diameter, or features designed to block transmission of undesired bioelectric activity).Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Pitts to use a closed loop stimulation and current steering techniques as taught by Wilson in order to provide the predictable results of providing a more targeted stimulation therapy.
Regarding claim 62, Pitts teaches the claimed invention as discussed above and teaches delivering low level stimulation to branches of the ninth cranial (glossopharyngeal) nerve that innervate motor units of the tongue and other pharyngeal muscles and therefore they teach activating an upper airway patency-related muscle selected from a group consisting of: a stylopharyngeus muscle; and a pharyngeal constrictor muscle; and a combination thereof. They do not specifically teach selectively stimulating an efferent fiber of the glossopharyngeal nerve.
In a similar field of endeavor, Wilson teaches current steering by using stimulation waveforms that contain features allowing for selective stimulation using current steering, directionally selective stimulation of efferent or afferent fibers, selectivity for stimulating axons of a particular diameter, or features designed to block transmission of undesired bioelectric activity (e.g. [0041], [0078]).Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Pitts to use current steering techniques to further select efferent fibers as taught by Wilson in order to provide the predictable results of providing a more targeted stimulation therapy
Regarding claim 67, Pitts teaches the claimed invention as discussed above and while the teach selective stimulation of an afferent fiber of the glossopharyngeal nerve as discussed above, they do not specifically teach not stimulating other select fibers at a target location of the glossopharyngeal nerve.
In a similar field of endeavor, Wilson teaches current steering by using stimulation waveforms that contain features allowing for selective stimulation using current steering, directionally selective stimulation of efferent or afferent fibers, selectivity for stimulating axons of a particular diameter, or features designed to block transmission of undesired bioelectric activity (e.g. [0041], [0078]).Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Pitts to use current steering techniques to select efferent fibers while not stimulating other select fibers as taught by Wilson in order to provide the predictable results of providing a more targeted stimulation therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zabara (U.S. Patent Number: US 5540734, hereinafter “Zabara”) teaches a method comprising the steps of attaching at least one electrode to afferents a patient's glossopharyngeal nerve, and applying modulating electric signals to the glossopharyngeal nerve through the at least one electrode (e.g. Claim 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).
Applicant's amendment necessitated the new grounds 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 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
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