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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 21, 2025 has been entered.
Response to Amendment
The amendment filed October 21, 2025 has been entered. Examiner acknowledges Applicant’s cancellation of claim 18.
Claims 1-17 and 19-21 are pending.
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 limitation(s) is/are:
“energy conversion element” first recited in claim 2.
"stimulation element" first recited in claim 8.
The claim limitation "energy conversion element" uses the term “element” 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. The generic placeholder is modified by functional language (“sensing respiratory effort information of the patient via the energy conversion element”). The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for “energy conversion element” is provided in examples in Figs. 4A-6, i.e., a piezoelectric, capacitive, and electromagnetic energy conversion devices.
The claim limitation "stimulation element" uses the term “element” 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. The generic placeholder is modified by functional language (“to apply stimulation energy to an upper-airway-patency- related nerve of the patient”). The generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. The corresponding structure for “stimulation element” is provided in Paragraph 0071: “In some examples, the stimulation lead 674 includes a stimulation element 676 (e.g. electrode portion, such a cuff electrode) and extends from the medical device 675 so that the stimulation element 676 is positioned in contact with a desired nerve 673 to stimulate nerve 673 for restoring upper airway patency.”
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 § 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 2-16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Tehrani et al. (US 20060167523 A1) (hereinafter – Tehrani) (disclosed by Applicant) in view of
Ward et al. (US 20090036975 A1) (hereinafter – Ward) in further view of
Kellogg et al. (US 7498681 B1) (hereinafter – Kellogg).
Re. Claim 2: Tehrani teaches a method comprising:
locating a physiological sensor within a patient's body in contact with native tissue that moves in response to respiratory effort (Paragraph 0057: “The stimulator 20 further comprises one or more sensors configured to sense one or more physiologic parameters. For example one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters… These sensors may be incorporated with electrode leads 21, 22, 31, 32, 41, 42 or may be separately implanted or otherwise coupled to the subject”).
While Tehrani teaches sensing respiratory effort information of the patient via the located physiological sensor (see previous citation), Tehrani does not teach the invention wherein
the self-powered physiological sensor including an energy conversion element;
sensing respiratory effort information of the patient via the energy conversion element of the located self-powered physiological sensor without receiving or using power from a power source external to the energy conversion element.
The term “self-powered” is understood in light of Applicant’s Paragraph 0071:
“… including a passive, direct mechanical- to-electrical energy conversion element (e.g. 20, 110, 300, 400, 500, 610, etc.) and/or associated processing, storage, energy harvesting elements, etc. Therefore, despite the presence of lead 677, the sensor portion 680 does not receive power from medical device 675.”
Therefore, a “self-powered” sensor is interpreted as requiring, at minimum (see “and/or” in above citation) a passive, direct mechanical-to-electrical energy conversion element. Additionally, it is clear that in the context provided by Applicant’s Paragraph 0075, the power source 106 of control unit 100 of Tehrani (Fig. 2) is considered an external source to sensors previously described.
Ward teaches analogous art in the technology of self-powered implantable devices (Abstract). Ward further teaches a piezoelectric stent applicable to cardiovascular and respiratory phenomena (Paragraph 0060), wherein the piezoelectric materials forming the device allows for the device to have energy harvesting capabilities (Paragraph 0051; Fig. 9) or “self-powering” capabilities (Paragraphs 0028, 0038, 0068). Thus, the piezoelectric device of Ward is understood to not receive or use power from a power source external to the energy conversion element of the piezoelectric elements.
It would have been obvious to one having skill in the art before the effective filing date to have modified the sensors of Tehrani to instead utilize the piezoelectric sensors taught by Ward, the motivation being that doing so removes the need to receive power from an external power source (Paragraph 0038).
Tehrani as modified by Ward further teaches the invention comprising delivering a signal indicative of the respiratory effort information from the self-powered physiological sensor to a separate device (Examiner notes that sensors of the combination of Tehrani as modified by Ward are now considered self-powered; Fig. 2, as described in Paragraph 0066: “. Thus the inputs 101, 102 comprise a plurality of inputs, each input corresponding to one of the electrodes or sensors;” additionally or alternatively, Fig. 2: telemetry circuit 106; Paragraph 0065: “The telemetry circuit is also configured to transmit… modulated sensed and/or accumulated data such as sensed EMG activity, sensed flow or tidal volume correlated activity, sensed nerve activity, sensed responses to stimulation, sensed position information, sensed movement information and episode counts or recordings”).
Ward, in teaching further detail regarding the modification of Tehrani, further teaches operating the self-powered physiological sensor to directly convert mechanical energy, received at the energy conversion element via movement of the native tissue in contact with the self-powered physiological sensor, to electrical energy, wherein the delivered signal indicative of the respiratory effort information is based upon the electrical energy (Figs. 2, 5-9; Examiner notes that pressure signals shown would be respiratory signals when utilized in the invention of Tehrani).
Tehrani as modified by Ward but does not teach the invention wherein the step of operating includes at least one of:
operating the self-powered physiological sensor to electromagnetically convert mechanical energy of electrical energy, or
operating the self-powered physiological sensor to capacitively convert mechanical energy to electrical energy.
Kellogg teaches analogous art in the technology of devices which produce an electrical signal in response to mechanical forces (Abstract). Kellogg further teaches the invention wherein the step of operating includes at least one of:
operating the self-powered physiological sensor to electromagnetically convert mechanical energy of electrical energy (Abstract: “Electromechanical devices that generate an electrical signal in response to an external source of mechanical vibrations can operate as a sensor of vibrations and as an energy harvester for converting mechanical vibration to electrical energy. The devices incorporate a magnet that is movable through a gap in a ferromagnetic circuit, wherein a coil is wound around a portion of the ferromagnetic circuit”), or
operating the self-powered physiological sensor to capacitively convert mechanical energy to electrical energy.
It would have been obvious to one having skill in the art before the effective filing date to have modified the respiratory implant of Tehrani as modified by Ward to additionally include electromagnetic mechanical energy to electrical energy conversion mechanism as taught by Kellogg, the motivation being that doing so provides another modality through which energy can be harvested from the surrounding environment (i.e., electromagnetically), as well as another method of attaining motion data (i.e., vibration data) potentially indicative of respiratory effort.
Re. Claim 3: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention wherein the self-powered physiological sensor is configured and located to detect a respiratory pattern (see sensors of Tehrani as modified by Ward in rejection of claim 2; Paragraph 0057: “For example one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters…”).
Re. Claim 4: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 3. Tehrani further teaches the invention wherein the respiratory pattern is selected from the group consisting of inspiration, expiration, and respiratory pause (Fig. 4A-4D: tidal volume used to identify inspiration points; Paragraph 0058: “An EMG signal may be used or other sensed activity may also correspond with either tidal volume or airflow and may be used to identify different portions of a respiration cycle. An example of such signal processing or analysis is described in more detail herein with reference to a sensed respiration correlated signal, such as an EMG, flow or tidal volume correlated signal, in FIGS. 16A-16D”).
Re. Claim 5: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention wherein the respiratory effort information is a waveform (Fig. 4A-14B, 16B-16D: see waveforms sensed).
Re. Claim 6: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention wherein the step of locating includes implanting the self- powered physiological sensor in a subcutaneous, non-vascular location (Paragraph 0057: “The stimulator 20 further comprises one or more sensors configured to sense one or more physiologic parameters. For example one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters… These sensors may be incorporated with electrode leads 21, 22, 31, 32, 41, 42 or may be separately implanted or otherwise coupled to the subject”).
Re. Claim 7: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention further comprising:
treating sleep disordered breathing by the patient based upon the respiratory effort information (Fig. 15: initialization based on respiration parameters; Paragraph 0116: therapy of the device is delivered based on respiration parameters; Paragraph 0118: therapy is intended to treat obstructive sleep apnea).
Re. Claim 8: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 7. Tehrani further teaches the invention further comprising:
implanting a medical device within the patient, including a stimulation element of the medical device located to apply stimulation energy to an upper-airway-patency- related nerve of the patient; and
operating the medical device to deliver stimulation to the upper-airway-patency-related nerve based upon the respiratory effort information
(Paragraph 0060: “The control unit 100 is implanted subcutaneously within the patient, for example in the chest region on top of the pectoral muscle. The control unit may be implanted in other locations within the body as well. The control unit 100 is configured to receive sensed nerve electrical activity from the electrode assemblies 21, 22, (31, 32, 41, 42) corresponding to respiratory effort or other respiration related parameters of a patient. The control unit 100 is also configured to receive information corresponding to other physiological parameters as sensed by other sensors. The control unit 100 delivers stimulation to the nerves 15, 16 or diaphragm as desired in accordance with the invention;” Paragraph 0079: discussion of upper airway patency control).
Re. Claim 9: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention further comprising:
monitoring sleep disordered breathing by the patient based upon the respiratory effort information (Paragraph 0124: “Stimulation may be provided at various times during sleep or various sleep stages or sleep transitions, including but not limited to, for example: prior to sleep, at sleep onset, upon detection of dropping tidal volume, upon detection of transition into REM or non-REM or during REM or non-REM sleep, or upon changes in breathing patterns, including but not limited to breathing rate”).
Re. Claim 10: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention wherein the self-powered physiological sensor is located to sense a small scale bodily movement of a portion of a patient involved in respiration (Paragraph 0057: “For example one or more sensors such as an accelerometer or movement sensor may sense information regarding movement pattern of the diaphragm muscles, intercostal muscles, and rib movement and thus determine overall respiratory activity and patterns. An electrode or electrodes may be used to sense the EMG of the diaphragm to determine respiration parameters;” Examiner notes that sensing electrical activity arising from muscle activity can also be considered sensing of small scale bodily movement since such movement arises from nervous stimulation of muscles).
Re. Claim 11: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 10. Tehrani further teaches the invention wherein the small scale bodily movement is selected from the group consisting of motion, pressure, and strain (see citation in rejection of claim 10).
Re. Claim 12: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 10. Tehrani further teaches the invention wherein the small scale bodily movement is selected from the group consisting of an apnea event and a regular respiratory cycle (Figs. 4A-4C: detected variations in tidal volume from small scale bodily movement sensors identify apnea events from regular respiratory cycles).
Re. Claim 13: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Tehrani further teaches the invention wherein the native tissue is in continuity with pleura of a lung of the patient (Fig. 1: electrode assemblies 21, 22 are implanted in diaphragm muscles; see substitution of such sensors with those of Ward).
Re. Claim 14: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. The modification of Tehrani by Ward to include the sensor of Ward does not discuss operating the self-powered physiological sensor to store power generated solely by the self-powered physiological sensor in response to movement of the native tissue.
Such an aspect is also taught by Ward (Paragraph 0038: “Even in embodiments in which a battery becomes part of the stent, advantageously this battery is charged by the electrical output produced by the piezoelectric material and thus inductive charging or recharging of the battery is not necessary”).
Thus, it would have been obvious to one having skill in the art before the effective filing date to have modified Tehrani as modified by Ward and Kellogg to further include storing power generated by the self-powered sensor and components therefor as taught by Ward in another embodiment, the motivation being that doing so enables excess energy to be stored when needed in cases where self-powered energy is insufficient.
Additionally or alternatively, combining two adjacent embodiments within the same reference has been considered by the courts to be obvious. As per Boston Scientific Scimed, Inc. v. Cordis Corp., "[c]ombining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness."
Re. Claim 15: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Ward, in teaching further detail related to the incorporated sensor, further teaches that the sensor also conforms the self-powered sensor to the native tissue (Fig. 2: see conformation of stent to artery tube – Examiner notes that this would be applied to respiratory organs when incorporated in the device of Tehrani).
Re. Claim 16: Tehrani as modified by and Kellogg teaches the invention according to claim 15. Ward, in teaching further detail related to the incorporated sensor, further teaches the invention wherein the self-powered physiological sensor comprises a flexible, resilient material (Paragraph 0058: “The piezoelectric polymers and polymer composites are flexible, and can conform to various shapes such as tubes. They have densities similar to water and living tissues, and are chemically inert, which makes them suitable for implantation;” Paragraph 0066: “The materials for use in the stents are flexible and lightweight, therefore they will not result in patient discomfort nor will they interfere with the regular function of arteries and other vessels”).
Re. Claim 19: Tehrani as modified by Ward teaches the invention according to claim 2. Ward, in teaching further detail related to the incorporated sensor, also teaches the invention wherein the self-powered physiological sensor includes a piezoelectric element (Abstract; Title).
Re. Claim 20: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2. Kellogg further teaches the invention wherein the step of operating comprises operating the self-powered physiological sensor to electromagnetically convert mechanical energy to electrical energy (see citations of rejection of claim 1).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over:
Tehrani et al. (US 20060167523 A1) (hereinafter – Tehrani) (disclosed by Applicant) in view of
Ward et al. (US 20170328931 A1) (hereinafter – Ward) in further view of
Kellogg et al. (US 7498681 B1) (hereinafter – Kellogg) in further view of
Marquez et al. (US 20170258585 A1) (hereinafter – Marquez).
Re. Claim 17: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 15, but does not teach the invention wherein the self-powered physiological sensor comprises a shape-memory material.
Marquez teaches analogous art in the technology of implantable sensor devices (Paragraph 0007). Marquez further teaches a self-powered device (Paragraph 0025) including a piezoelectric sensor integrated into a stent which may comprise nitinol (i.e., a known shape memory alloy) (Paragraph 0009).
It would have been obvious to one having skill in the art before the effective filing date to have modified Tehrani as modified by Ward and Kellogg to further include the stent comprising nitinol as taught by Marquez, the motivate being that shape memory alloys allow the stent to be deformed into a particular configuration suitable for navigating implantation procedures, and thereafter regain a configuration suitable for the implant location.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over:
Tehrani et al. (US 20060167523 A1) (hereinafter – Tehrani) (disclosed by Applicant) in view of
Ward et al. (US 20170328931 A1) (hereinafter – Ward) in further view of
Kellogg et al. (US 7498681 B1) (hereinafter – Kellogg) in further view of
Kim et al. (US 20140210313 A1) (hereinafter – Kim).
Re. Claim 21: Tehrani as modified by Ward and Kellogg teaches the invention according to claim 2, but does not teach the invention wherein the step of operating comprises operating the self-powered physiological sensor to capacitively convert mechanical energy to electrical energy.
Kim teaches analogous art in the technology of self-powered devices (Abstract). Kim further teaches a sensor which converts mechanical energy to electrical energy via a change in capacitive ( Figs. 5A-8C: capacitive voltage sensing in response to vibration/pressure; Paragraph 0046: “As is apparent from the graphs of FIGS. 8A to 8C, a change of capacitance is highly sensitive to an external force. Thus, the energy harvesting device 10 may be effectively used as a touch sensor. Furthermore, since the energy harvesting device 10 having the self-powered touch sensor utilizes electrical energy generated in the energy generation layer 13 (e.g., self-generated electrical energy), a separate external power source for measuring the capacitance is not required”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the respiratory implant of Tehrani as modified by Ward and Kellogg to additionally include self-powered capacitive sensors to convert mechanical energy to electrical energy as taught by Kim, the motivation being that doing so provides another modality through which energy can be harvested from the surrounding environment (i.e., capacitively), as well as another method of attaining motion data (i.e., pressure) indicative of respiratory effort.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner notes that the concept of self-powered sensors which convert mechanical energy to electrical energy either capacitively or electromagnetically does not appear to be novel.
Conclusion
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/JUSTIN XU/ Examiner, Art Unit 3791