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 .
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 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.
Status of Claims
Claims 10-29 are pending and under consideration for patentability; claims 1-9 were cancelled and claims 10-29 were added as new claims via a Preliminary Amendment dated 01 May 2025.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 06 March 2025 has been acknowledged and considered by the Examiner.
Claim Objections
Claims 10, 26, and 28 are objected to because of the following informalities.
Claims 10, 26, and 28 contain minor typographical and/or grammatical errors.
Claim 10, line 3: Applicant is advised to change “a stimulation element to” to “a stimulation element configured to”
Claim 26, line 5: Applicant is advised to change “a stimulation element to” to “a stimulation element configured to”
Claim 28, line 3: Applicant is advised to change “a stimulation element to” to “a stimulation element configured to”
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-22 and 25-29 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Bolea et al. (US 2015/0224307 A1).
Regarding claim 10, Bolea describes a device for treating obstructive sleep apnea ([0006]) comprising
a sensing element 70 configured to sense physiologic information
a stimulation element 60 configured to stimulate an upper airway patency-related nerve ([0051])
a pulse generator 50 comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0049])
wherein the stimulation element, the sensing element, and the pulse generator are configured to be implantable in a head-and-neck region of a patient ([0050])
Regarding claim 11, Bolea describes wherein the stimulation element comprises at least one stimulation electrode 64 and a first lead 62 supporting the at least one stimulation electrode ([0049], figure 1).
Regarding claim 12, Bolea describes wherein the pulse generator is connected to the first lead (figure 1).
Regarding claim 13, Bolea describes wherein the sensing element comprises at least one sensor 74 and a second lead 72 supporting the at least one sensor ([0049], figure 1).
Regarding claim 14, Bolea describes wherein the pulse generator is connected to the second lead (figure 1).
Regarding claim 15, Bolea describes wherein the sensed physiologic information comprises respiratory phase information ([0049]).
Regarding claim 16, Bolea describes wherein the respiratory phase information comprises inspiratory phase information and/or expiratory phase information ([0009], [0113]).
Regarding claim 17, Bolea describes wherein the control portion is configured to generate the stimulation signal in an open loop mode without synchronizing stimulation to the sensed respiratory phase information ([0013], [0127]).
Regarding claim 18, Bolea describes wherein the control portion is configured to generate the stimulation signal in a closed loop manner by synchronizing stimulation to at least a portion of the sensed respiratory phase information ([0051], [0127]).
Regarding claim 19, Bolea describes wherein the sensing element comprises an accelerometer ([0017], [0120]).
Regarding claim 20, Bolea describes wherein the sensed physiologic information comprises sleep disordered breathing behavior information ([0023]), and wherein the control portion is configured to cause initiation, termination, and/or adjustment of the stimulation to treat obstructive sleep apnea based on the SDB behavior information ([0127]).
Regarding claim 21, Bolea describes wherein the SDB behavior information comprises sleep quality information ([0146], [0156]).
Regarding claim 22, Bolea describes wherein the sleep quality information comprises an apnea-hypopnea index ([0055]).
Regarding claim 25, Bolea describes wherein the upper airway patency-related nerve comprises a hypoglossal nerve ([0050]).
Regarding claim 26, Bolea describes a device for treating obstructive sleep apnea ([0006]) comprising
a sensing element 70 configured to sense physiologic information including respiratory information ([0049]), the respiratory information comprising inspiratory phase information and expiratory phase information ([0009], [0113])
a stimulation element 60 to stimulate an upper airway patency-related nerve ([0051])
a pulse generator 50 comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0049])
a lead 62 extending outwardly from a housing of the pulse generator to support the stimulation element in a spaced apart position relative to the housing ([0049], figure 1)
wherein the stimulation element, the sensing element, the pulse generator, and the lead are configured to be implantable in a head-and-neck region of a patient ([0050])
Regarding claim 27, Bolea describes wherein the sensing element is configured to be implanted at a first implant location in the head-and-neck region of the patient and the stimulation element is configured to be implanted at a second implant location in the head-and-neck region of the patient spaced apart from the first implant location ([0058], figure 2).
Regarding claim 28, Bolea describes a device for treating obstructive sleep apnea ([0006]) comprising
a sensing element 70 configured to sense physiologic information
a stimulation element 60 configured to stimulate an upper airway patency-related nerve ([0051])
a pulse generator 50 comprising a control portion configured to generate a stimulation signal applied via the stimulation element ([0049])
a first lead 62 connecting the pulse generator to the stimulation element
a second lead 72 connecting the pulse generator to the sensing element
wherein the stimulation element, the sensing element, the pulse generator, the first lead, and the second lead are configured to be implantable in a head-and-neck region of a patient ([0050])
Regarding claim 29, Bolea describes wherein the sensing element is configured to be implanted at a first implant location in the head-and-neck region of the patient and the stimulation element is configured to be implanted at a second implant location in the head-and-neck region of the patient spaced apart from the first implant location ([0058], figure 2).
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.
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 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Bolea in view of Dieken et al. (WO 2017/184753 A1).
Regarding claim 23, Bolea describes the device of claim 10 but does not explicitly disclose wherein the sensed physiologic information comprises posture information and wherein the control portion is configured to sense an awake state or a sleep state of the patient based on the posture information. However, Dieken also describes a device for treating obstructive sleep apnea ([0039]), including sensing physiologic information in the form of posture information and using a control program configured to sense an awake state or a sleep state of a patient based on the posture information ([0110], [0126]). As Dieken is also directed towards treating obstructive sleep apnea and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to measure posture information and deduce a patient’s sleep state, in a manner similar to that described by Dieken, when using the device described by Bolea, as doing so advantageously allows the resulting device to modify the stimulation settings based on the patient’s sleep state.
Regarding claim 24, Dieken describes wherein the control portion is configured to adjust a stimulation therapy level based on the sensed awake state or sleep state ([0195], [0217]).
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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