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 .
Response to Arguments
Applicant’s amendments merit new grounds for rejection under 35 U.S.C. § 112(a) and an objection to the specification as filed, as the additional subject matter appears to lack written description and therefore be considered new matter.
Applicant's arguments filed 2/25/2026 have been fully considered but they are not persuasive.
Applicant 1st argues on page 9 that “Jung does not disclose determining a stimulation parameter based on information received from a sensor in response to an electrical signal being delivered to an energy emitter of a cannula. Further, Jung does not disclose delivering stimulation including the determined stimulation parameter from a structure configured to be inserted into a lumen of the cannula”.
The examiner is not persuaded. [0046] of Jung discloses “As shown, the stimulus controller 100 may comprise an adaptive feed-forward Pattern Generator/Pattern Shaper (PG/PS) assembly (46, 48) within a closed loop implementation, to control respiratory muscle movement using electrical stimulation after incomplete or complete paraplegia in human and animal models (including but not limited to rodents). This adaptive closed-loop ventilatory controller 100 can automatically customize and continually update stimulation parameters to achieve a desired breathing pattern with a fixed frequency and movement amplitude”. The closed loop in [0046] will be in response to emitted energy as the loop will keep iterating in a closed loop fashion. Each additional loop is “in response” to the previous loop.
Applicant 2nd argues on page 9 that “The Office Action acknowledges Bonde does not disclose determining a stimulation parameter based on information received from a sensor. Office Action, p. 4. Therefore, Bonde necessarily cannot disclose determining a stimulation parameter based on information received in response to electrical energy delivered from a cannula, or delivering stimulation including the determined stimulation parameter from a structure configured to be inserted into a lumen of the cannula”.
The examiner is not persuaded. Bonde discloses in [0102]-[0104] that the electrode placement/location can be determined in response to the stimulation from the energy emitters on the external cannula. This is what the applicant discloses in [0146].
Applicant 3rd argues on pages 9-10 that “Tehrani generally discloses a control unit configured to receive information from one or more sensors. Tehrani, para. [0131]. However, Tehrani does not disclose determining a stimulation parameter based on information received from the sensor in response to the electrical signal delivered to the energy emitter of a cannula. Further, Tehrani does not disclose delivering stimulation including the determined stimulation parameter from a structure configured to be inserted into a lumen of the cannula”.
The examiner agrees with this assessment. However, this argument is unpersuasive as Tehrani is not relied upon to teach the argued claim language. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification should provide support for the most recent claim amendment.
The energy emitter 1056 of figure 10B disclosed in [0146] of the applicant’s printed publication (Pub. No.: US 2022/0266007 A1) is for location purposes only, not timing as claimed in claim 27 or duration, a pulse width, a frequency, an amplitude, or a combination thereof as claimed in claim 48. [0154] of the applicant’s printed publication references energy emitter 1056 but does not clarify the application of energy emitter. The applicant’s most recent applicant remarks does not outline where the amendment is actually supported.
The examiner cannot find support in the applicant’s specification for the energy emitter 1056 on the external cannula being used for any application other than location. [0067]-[0071] of the applicant’s printed publication (Pub. No.: US 2022/0266007 A1) use the phrase “energy emitter”, but it describes the stimulation lead, not the emitter on the cannula. Figures 9A, 9B, [0121], [0122], [0134] refer to cannulas but there is no mention of an external cannula with an energy emitter used in the same manner as the control unit steps. Original claim 21 (not elected for prosecution) (directed towards a method for positioning a stimulation lead) has a cannula with an energy emitter but it is not used for timing as claimed in claim 27 or duration, a pulse width, a frequency, an amplitude, or a combination thereof as claimed in claim 48. Original claim 26 (not elected) claims the stimulation parameters are determined in response to the signals from the stimulation lead, not in response to signals from the energy emitter on the cannula.
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.
Claims 27 and 48 are 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.
The applicant has amended claim 27 include “determine a stimulation parameter based on information received from the sensor in response to the electrical signal delivered to the energy emitter, wherein the stimulation parameter includes a timing of a stimulation signal” and has amended claim 48 to include “determine a stimulation parameter based on information received from the sensor in response to the electrical signal delivered to the energy emitter, wherein the stimulation parameter includes a duration, a pulse width, a frequency, an amplitude, or a combination thereof”. The applicant has also amend claims 27 and 48 to include the subject matter from claim 29 which states “a cannula including an energy emitter, a proximal end, a distal end, and a plurality of apertures between the proximal end and the distal end; a stimulation lead comprising a plurality of electrodes, wherein the stimulation lead is configured to be inserted in a lumen of the cannula such that each aperture of the plurality of apertures aligns with an electrode of the plurality of electrodes”. This corresponds to figure 10B element 1056.
The energy emitter 1056 of figure 10B disclosed in [0146] of the applicant’s printed publication (Pub. No.: US 2022/0266007 A1) is for location purposes only, not timing as claimed in claim 27 or duration, a pulse width, a frequency, an amplitude, or a combination thereof as claimed in claim 48. [0154] of the applicant’s printed publication references energy emitter 1056 but does not clarify the application of energy emitter. It further does not help that the applicant’s most recent submission does not outline where the amendment is actually supported.
The examiner cannot find support in the applicant’s specification for the energy emitter 1056 on the external cannula being used for any application other than location. [0067]-[0071] of the applicant’s printed publication (Pub. No.: US 2022/0266007 A1) use the phrase “energy emitter”, but it describes the stimulation lead, not the emitter on the cannula. Figures 9A, 9B, [0121], [0122], [0134] refer to cannulas but there is no mention of an external cannula with an energy emitter used in the same manner as the control unit steps. Original claim 21 (not elected for prosecution) (directed towards a method for positioning a stimulation lead) has a cannula with an energy emitter but it is not used for timing as claimed in claim 27 or duration, a pulse width, a frequency, an amplitude, or a combination thereof as claimed in claim 48. Original claim 26 (not elected) claims the stimulation parameters are determined in response to the signals from the stimulation lead, not in response to signals from the energy emitter on the cannula. In the next applicant response, the applicant should state where the subject matter is supported in the specification or originally filed claims.
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.
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: “control unit” in claims 27 and 48.
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. [0086] of the applicant’s printed publication states “The control unit 1001 may include all of the electronics, software, and functioning logic necessary to perform the functions described herein”.
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
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.
Claim(s) 27-28, 30-33, 41-44 and 48-54, is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonde et al. (Pub. No.: US 2008/0269740 A1); hereinafter referred to as “Bonde”, in view of Jung (Pub. No.: US 2016/0287877 A1) and Van Venrooij et al. (Pub. No.: US 2002/0183817 A1); hereinafter referred to as “Van Venrooij”.
Regarding claim 27, Bonde discloses a system for stimulating tissue comprising: a cannula (e.g. see figure 15 element 154, [0103]) including an energy emitter (e.g. see element 160, [0103]-[0104]); a stimulation lead (e.g. see figure 2A element 16A, figure 10 element 108); a sensor (e.g. see [0039], “sensing circuit”); and a control unit (e.g. see figure 2A, element 28) configured to: deliver an electrical signal to the energy emitter (e.g. see [0102]-[0104]); and deliver a stimulation signal, to tissue, via one or more electrodes of the plurality of electrodes (e.g. see figure 2A element 26A-26D, [0042]) (NOTE: Bonde discloses in [0102]-[0104] that the electrode placement/location can be determined in response to the stimulation from the energy emitters on the external cannula. This is what the applicant discloses in [0146]).
Bonde discloses the invention but is silent as to determining a stimulation parameter based on information received from the sensor in response an electrical signal delivered to an energy emitter, wherein the stimulation parameter includes a timing of a stimulation signal. Jung teaches it is known to use such a modification as set forth in figure 3 [0046]-[0050] (Note: [0046] of Jung discloses “As shown, the stimulus controller 100 may comprise an adaptive feed-forward Pattern Generator/Pattern Shaper (PG/PS) assembly (46, 48) within a closed loop implementation, to control respiratory muscle movement using electrical stimulation after incomplete or complete paraplegia in human and animal models (including but not limited to rodents). This adaptive closed-loop ventilatory controller 100 can automatically customize and continually update stimulation parameters to achieve a desired breathing pattern with a fixed frequency and movement amplitude”. The closed loop in [0046] will be in response to emitted energy as the loop will keep iterating in a closed loop fashion. Each additional loop is “in response” to the previous loop. [0050] discloses “The role of the pattern generator 46 may be to provide general timing information for producing a given cyclic breathing pattern (i.e., it provides an oscillatory signal at the desired movement frequency). The output signal of pattern generator 46 may be adaptively customized by the pattern shaper 48 to determine the specific stimulation pattern used to activate the muscle 50” and “The pattern shaper 48 may generate the stimulus control signal sent to the electrodes implanted within the muscles and/or nerves for controlling the breathing pattern of the patient, where the stimulus control signal may include the frequency, amplitude, the pulse width, the inter-pulse interval (time between each stimulus pulse), the charge balance, and/or the inter-pulse gap (or delay) between the negative and positive phases of each stimulus pulse”) to provide an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart (e.g. see [0045], and also [0006] and [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use closed loop, feedback driven adjustment of stimulation timing as taught by Jung in the system of Bonde, since said modification would provide the predictable results of adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart.
Bonde and Jung disclose the claimed invention but are silent as to the stimulation lead includes a plurality of electrodes; the cannula includes a plurality of apertures between a proximal end and a distal end of the cannula; and the stimulation lead is configured to be inserted in a lumen of the cannula such that each aperture of the plurality of apertures aligns with an electrode of the plurality of electrodes. Van Venrooij teaches that it is known to use such a modification as set forth in figures 7 and 8, [0066] to provide directional application of electrical stimulation current which yields more effective localization of electrical stimulation and reduced electrical stimulation of brain tissue adjoining a desired brain target (e.g. see [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use apertures for electrode exposure as taught by Van Venrooij in the system of Bonde and Jung, since said modification would provide the predictable results of directional application of electrical stimulation current which yields more effective localization of electrical stimulation and reduced electrical stimulation of brain tissue adjoining a desired brain target.
Regarding claim 28, Bonde discloses the stimulation lead is a transcutaneous lead or a subcutaneous lead (e.g. see figure 1 element 16, [0037]).
Regarding claim 30, Bonde discloses the energy emitter is located at a distal end of the cannula (e.g. see [0103]).
Regarding claim 31, Bonde discloses the cannula comprises a radiopaque marker, a portion of the cannula is detectable via ultrasound, or both (e.g. see [0041], [0111]).
Regarding claim 32, Bonde discloses the cannula comprises an orientation indicator (e.g. see [0041]), the control unit is wearable (e.g. see figure 1), the stimulation lead comprises a reversible anchoring mechanism (e.g. see [0089]), or a combination thereof.
Regarding claims 33 and 54, Bonde discloses sensing electrical activity (e.g. see [0039]) but does not explicitly disclose sensing impedance. Jung teaches it is known to use such a modification as set forth in [0036], [0040] to provide detection of real-time physiological changes of the user (e.g. see [0041] and [0050]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use impedance sensing for the feedback loop as taught by Jung in the system of Bonde, since said modification would provide the predictable results of detection of real-time physiological changes of the user.
Regarding claim 41, Bonde discloses the cannula includes a lumen, and the lead has a diameter less than a diameter of the lumen of the cannula (e.g. see figure 15 element 158, [0102]-[0108]).
Regarding claim 42, Bonde discloses the invention but is silent as to the control unit is further configured to determine a first lung volume based on the signal from the sensor, and determine the stimulation parameter based on the first lung volume. Jung teaches it is known to use such a modification as set forth in figure 3 [0046]-[0050] to provide an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart (e.g. see [0045], and also [0006] and [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine a first lung volume based on the signal from the sensor, and determine the stimulation parameter based on the first lung volume as taught by Jung in the system of Bonde, since said modification would provide the predictable results of an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart.
Regarding claim 43, Bonde discloses the invention but is silent as to determining the stimulation parameter based on the first lung volume includes: determining a second lung volume; comparing the second lung volume to the first lung volume; and determining the stimulation parameter based on the comparison of the second lung volume to the first lung volume. Jung teaches it is known to use such a modification as set forth in [0026], [0047]-[0048] and figure 9 to provide an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart (e.g. see [0045], and also [0006] and [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine the stimulation parameter based on the first lung volume includes: determining a second lung volume; comparing the second lung volume to the first lung volume; and determining the stimulation parameter based on the comparison of the second lung volume to the first lung volume as taught by Jung in the system of Bonde, since said modification would provide the predictable results of an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart.
Regarding claim 44, Bonde discloses the invention but is silent as to determining the stimulation parameter based on the first lung volume includes: comparing the first lung volume to a pre-determined value or a calculated value; and determining the stimulation parameter based on the comparison of the first lung volume to the pre-determined value or the calculated value. Jung teaches it is known to use such a modification as set forth in [0026], [0047]-[0048] and figure 9 to provide an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart (e.g. see [0045], and also [0006] and [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to determine the stimulation parameter based on the first lung volume includes: comparing the first lung volume to a pre-determined value or a calculated value; and determining the stimulation parameter based on the comparison of the first lung volume to the pre-determined value or the calculated value. as taught by Jung in the system of Bonde, since said modification would provide the predictable results of an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart.
Regarding claim 48, Bonde discloses the claimed invention (see the rejection for claim 27) but is silent as to determining a stimulation parameter based on information received from the sensor, wherein the stimulation parameter includes a duration, a pulse width, a frequency, an amplitude, or a combination thereof; and deliver a stimulation signal, including the stimulation parameter, to tissue, via the stimulation lead. Jung teaches it is known to use such a modification as set forth in figure 3 [0046]-[0050] (Note: [0050] discloses “The pattern shaper 48 may generate the stimulus control signal sent to the electrodes implanted within the muscles and/or nerves for controlling the breathing pattern of the patient, where the stimulus control signal may include the frequency, amplitude, the pulse width, the inter-pulse interval (time between each stimulus pulse), the charge balance, and/or the inter-pulse gap (or delay) between the negative and positive phases of each stimulus pulse”) to provide an adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart (e.g. see [0045], and also [0006] and [0030]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use closed loop, feedback driven adjustment of stimulation timing as taught by Jung in the system of Bonde, since said modification would provide the predictable results of adaptive system that can account for muscle fatigue of the diaphragm or lung compliance changes, as well as changing metabolic demands of the heart.
Regarding claim 49, see the rejection for claim 33 above.
Regarding claim 50, see the rejection for claim 27 above.
Regarding claims 51-53, see the rejection for claims 42-44 above.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonde, Jung, and Van Venrooij as applied to claim 27 above, and further in view of Tehrani et al. (Pub. No.: US 2011/0288609 A1); hereinafter referred to as “Tehrani”.
Regarding claim 45, Bonde, Jung, and Van Venrooij disclose the claimed invention but are silent as to an external respiratory support device configured to provide positive pressure ventilation, wherein the control unit is further configured to determine the timing of the positive pressure ventilation and the timing of the delivery of the stimulation signal. Tehrani teaches that it is known to use such a modification as set forth in [0242], [0275], [0279] to minimize and prevent lung collapse and ventilator-associated pneumonia while maintaining the diaphragm muscle tone (e.g. see [0278] and [0279]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use positive pressure ventilation coordinated with the electrical stimulation as taught by Tehrani in the system of Bonde, Jung, and Van Venrooij, since said modification would provide the predictable results of minimizing and preventing lung collapse and ventilator-associated pneumonia while maintaining the diaphragm muscle tone.
Claim(s) 46 and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonde, Jung, and Van Venrooij as applied to claim 27 above, and further in view of Brunner et al. (Pub. No.: US 2014/0100436 A1); hereinafter referred to as “Brunner”.
Regarding claim 46 and 47, Bonde, Jung, and Van Venrooij disclose the claimed invention but are silent as to the control unit is further configured to generate an image corresponding to the distribution of gas between lung portions and the signal from the sensor is an impedance, and the lung portions include a posterior lung region, an anterior lung region, a left lung, a right lung, or a combination thereof. Brunner teaches that it is known to use such a modification as set forth in [0005] (Brunner teaches left/right and posterior/anterior lung regions) to allow the doctor or athlete to evaluate lung function in real-time (e.g. see [0005]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use impedance sensing to generate lung gas distribution imaging in different lung regions as taught by Brunner in the system of Bonde, Jung, and Van Venrooij, since said modification would provide the predictable results of allowing the doctor or athlete to evaluate lung function in real-time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pianca et al. (Patent No.: US 7,033,326 B1) (e.g. see column 9 line 50 through column 10 line 3 which discloses an external cannula with an energy emitter and an internal stimulation lead).
Applicant's amendment necessitated the new ground(s) 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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