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 II, drawn to the system for sensing accelerometer data and/or providing neurostimulation therapy, Species D, and Species B2, in the reply filed on 8/12/26 is acknowledged. The traversal is on the ground(s) that, for Species set 1, species C-E are not mutually exclusive. This is found persuasive and the requirement for election of species amongst Set 1 is withdrawn. For the restriction and Species Set 2, no arguments were provided therefor.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/12/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
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.
Claim(s) 20-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheiner et al. (US 2020/0282215 A1, hereinafter Scheiner).
For claim 20, Scheiner discloses a system (Figs 1,2,5,6,11) ([0022-0091]), comprising inter alia:
a first housing (15) configured for implantation in an anterior cervical region of a patient (Figs 1,2,5,6,11) ([0022-0091]);
a first electrode lead (30) coupled to the first housing and configured to be disposed in a submandibular region (Figs 1,2,5,6,11) ([0022-0091]) (especially Fig 1 and [0026-0027]), wherein at least one electrode on the first electrode lead is configured to be disposed at or near a first branch of a hypoglossal nerve of the patient (Figs 1,2,5,6,11) ([0022-0091]) (especially Fig 1 and [0026-0027]);
an accelerometer (86) configured to provide a sensor signal (Figs 1,2,5,6,11) ([0022-0091]) (especially [0032,0075,0081]) that includes information about (1) a patient response to a first electrostimulation therapy that is provided to the patient using the at least one electrode (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]), wherein the first electrostimulation therapy is configured to treat a sleep disorder or breathing disorder of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]), (2) a respiration of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]), and (3) a physiologic status characteristic of the patient, the physiologic status characteristic including information about one or more of an orientation, activity level, heart rate, or pulse characteristic of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); and
a processor circuit (80,50) configured to provide an indication of a breathing disorder status for the patient based on the patient response, the respiration, and the physiologic status characteristic of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 21, Scheiner discloses the system of claim 20, wherein the processor circuit is configured to:
determine the patient response to the first electrostimulation therapy using a first sampled portion of the sensor signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]);
determine the respiration of the patient using a second sampled portion of the sensor signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); and
determine the physiologic status characteristic of the patient using a third sampled portion of the sensor signal to determine the physiologic status characteristic of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]);
wherein the first, second, and third sampled portions of the sensor signal correspond to non-overlapping time intervals (treatment, respiration detection, and physiologic status over time) (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 22, Scheiner discloses the system of claim 20, wherein the processor circuit is configured to adjust the first electrostimulation therapy based on the indication of the breathing disorder status (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 23, Scheiner discloses the system of claim 20, wherein respective portions of the sensor signal correspond to the information about the respiration of the patient and the physiologic status characteristic of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 24, Scheiner discloses a system for sensing physiologic status information using an implanted sensor (Figs 1,2,5,6,11) ([0022-0091]), the system comprising inter alia:
an accelerometer (86) configured for implantation at or in an anterior cervical region of a patient and configured to provide a first sensor signal (Figs 1,2,5,6,11) ([0022-0091]) (especially [0032,0075,0081]);
a processor circuit (80,50) configured to:
process a first portion of the first sensor signal to identify first physiologic status information about the patient, wherein the first physiologic status information includes first respiration cycle information (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]);
process a second portion of the first sensor signal to identify second physiologic status information about the patient, wherein the second physiologic status information includes non-respiration information, and wherein the first and second portions of the first sensor signal are non-overlapping or partially overlapping in time (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); and
a therapy delivery circuit (84) configured to provide a neurostimulation therapy to the patient based on the first and second physiologic status information (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 25, Scheiner discloses the system of claim 24, wherein the therapy delivery circuit is configured to provide a quantitative indication (sleep score) of a progression of a breathing disorder or sleep disorder of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 26, Scheiner discloses the system of claim 24, wherein the first portion of the first sensor signal comprises information about timing characteristics of one or more inspiration and exhalation phases of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 27, Scheiner discloses the system of claim 26, wherein the second portion of the first sensor signal comprises information about activity level, posture, and pulse characteristics of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 28, Scheiner discloses the system of claim 27, wherein the respective non-overlapping portions of the first sensor signal correspond to the information about the activity level, the posture, and the pulse characteristics of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 29, Scheiner discloses the system of claim 28, wherein the pulse characteristics comprises information about a heart rate of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 30, Scheiner discloses the system of claim 24, wherein the processor circuit is configured to: apply a first signal filter to the first sensor signal to isolate respiration information from noise and yield a first filtered signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); determine an envelope characteristic of the first filtered signal to yield an envelope signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); apply a pattern matching algorithm to the envelope signal to yield a first respiration signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); and provide the first respiration cycle information based on a comparison of the first respiration signal to one or more specified threshold values (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 31, Scheiner discloses the system of claim 30, wherein parameters of the first signal filter and parameters of the pattern matching algorithm are based on information about the patient acquired from or during a sleep study of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 32, Scheiner discloses the system of claim 30, wherein the processor circuit is configured to process the second portion of the first sensor signal to identify at least an activity level, a posture, or one or more pulse characteristics of the patient (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
For claim 33, Scheiner discloses the system of claim 32, wherein the processor circuit is configured to: apply a second filter to isolate the second physiologic status information from noise and yield a second filtered signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); determine an envelope characteristic of the second filtered signal (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]); and provide the information about the activity level, the posture, or one or more pulse characteristics of the patient based on a comparison of the envelope characteristic of the second filtered signal to one or more specified threshold values (Figs 1,2,5,6,11) ([0022-0091, especially 0069-0087]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring neurostimulation therapy based on sensed physiologic status.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
