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 .
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: “a non-invasive therapeutic stimulation unit”, “a clock unit”, and “a control unit” in claim 1 and a “a pacing unit” in claim 6. NOTE: The specification seems to imply the “a non-invasive therapeutic stimulation unit” is a stimuli generator and “a clock unit”, “a control unit”, and “a pacing unit” are logic/processing circuitry.
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 § 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 1-3, 6-10, 12-15, and 18-21 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. In particular, the applicant’s printed publication states:
“[0030] The proposed medical device may be provided so as to be locked to or actuated in dependence on a physiological cycle corresponding to a relatively slow physiological rhythm, e.g. is having a frequency in the range of around 0.03 Hz to 0.5 Hz, in particular of 0.1 Hz to 0.35 Hz. Physiological cycles with a slow physiological rhythm have been identified as favorable for the therapeutic treatment effect. However, the present invention and the effects interlinked therewith are not limited to such slow physiological cycles.”
Thus, there seems to be support for 0.03 Hz to 0.5 Hz, but not 0.3 Hz to 0.5 Hz as claimed.
Response to Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11 that Francois only discloses a clock signal and not a reference clock signal. The examiner is not persuaded. The stimulation in [0057]-[0059], [0066]-[0069] is coordinated with breathing patterns ([0066]) and/or inhalation/exhalation phases ([0057]-[0059], [0066]-[0069]). Said breathing pattens and/or inhalation/exhalation phases may be interpreted as “reference” signals as they are not the sensed signal itself, but instead are a derived phase/classification. In particular, breathing patterns associated with cough, quiet breathing, breathing patterns associated with speaking ([0066]) and inhalation/exhalation ([0057]-[0059], [0066]-[0069]) are a derivative of the sensed signal. Thus the examiner may interpret the phases in [0057]-[0059], [0066]-[0069] as “reference” clock signals.
Regarding the limitation “physiological condition of the patient having a physiological rhythm in a range of 0.3 Hz to 0.5 Hz”, the examiner is citing Yun et al. (Pub. No.: US 2019/0240468 A1); hereinafter referred to as “Yun”. This appears to be new subject matter as dependent claim 18 discloses 0.07 Hz to 0.16 Hz, not 0.3 Hz to 0.5 Hz. Also, please see the 112 rejection.
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) 1-3, 6-10, 12-15, and 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al. (Pub. No.: US 2014/0142652 A1); hereinafter referred to as “Francois”, in view of Yun et al. (Pub. No.: US 2019/0240468 A1); hereinafter referred to as “Yun”.
Regarding claim 1, Francois discloses a medical device for stimulating neurons of a patient to suppress a pathologically synchronous activity of the neurons (e.g. see [0067], “contraction of at least some of the lower external intercostal muscles (located in intercostal spaces 7 and below) is blocked while contraction of at least some of the lower internal intercostal muscles (located in intercostal spaces 7 and below) is stimulated”), comprising: a non-invasive therapeutic stimulation unit (e.g. see [0049]-[0056]) configured to administer a plurality of stimuli to a patient's body which is configured to suppress the pathologically synchronous activity, a clock unit (e.g. see processing/logic circuitry disclosed in [0081]-[0084] and [0057]-[0059], [0066]-[0069] for the inhalation/exhalation timing. The timing of the inhalation and exhalation will read on “clock signal”. The applicant discloses this in claim 4) configured to generate at least one reference clock signal related to a reference physiological cycle of a patient, and a control unit (e.g. see [0081]-[0084], “controller”) configured to control operation of the medical device in dependence on the at least one reference clock signal such that the non-invasive therapeutic stimulation unit is actuated in a first operating mode during a first phase of the at least one reference clock signal and in a second operating mode which differs from the first operating mode during a second phase of the at least one reference clock signal (e.g. see [0057]-[0059], [0066]-[0069]), wherein the reference physiological cycle is a breathing cycle which comprises at least one of an inhalation phase, a breath holding phase, an exhalation phase and a pause phase (e.g. see [0057]-[0059], [0066]-[0069]), and wherein the control unit is configured to control operation of the non-invasive therapeutic stimulation unit such that stimulation parameters are adjusted and controlled in dependence on the at least one reference clock signal (e.g. see [0057]-[0059], [0066]-[0069]).
Francois discloses the claimed invention but is silent as to the patient having a physiological rhythm in a range of 0.3 Hz to 0.5 Hz. Yun teaches that it is known to use such a modification as set forth in [0088]-[0089] to provide modulation of the subject's autonomic nervous system (e.g. see [0087]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to treat a patient with a physiological rhythm in a range of 0.33 Hz to 0.67 Hz as taught by Yun in the system/method of Francois, since said modification would provide the predictable results of modulation of the subject's autonomic nervous system. According to MPEP 2144.05(I), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding claim 2, Francois discloses the plurality of stimuli comprises at least one of acoustic stimuli, tactile stimuli, vibratory stimuli, vibrotactile stimuli, visual stimuli, electrical stimuli and, or thermal stimuli, and wherein the stimulation unit is configured to selectively and intermittently administer the plurality of stimuli (e.g. see [0049]-[0056], [0073]-[0078]).
Regarding claim 3, Francois discloses the at least one reference clock signal comprises a repeating sequence of at least two subsequent phases (e.g. see [0057]-[0059], [0066]-[0069]).
Regarding claim 6, Francois discloses a pacing unit which is configured to provide guidance for a physiological cycle of the patient, wherein the control unit is configured to operate the pacing unit in dependence on the at least one reference clock signal (e.g. see processing/logic circuitry disclosed in [0081]-[0084] and [0057]-[0059], [0066]-[0069] for the inhalation/exhalation timing).
Regarding claim 7, Francois discloses the at least one reference clock signal has a cycle frequency in a slow breathing range (e.g. see [0081]-[0084], [0057]-[0059], [0066]-[0069]).
Regarding claim 8, Francois discloses the pacing unit is configured to provide non-invasive guidance stimuli to the patient's body for providing guidance for an activity or physiological cycle of the patient, wherein the non-invasive guidance stimuli comprises at least one of visual stimuli, acoustic stimuli, tactile stimuli, vibratory stimuli, vibrotactile stimuli, electrical stimuli, transdermal electrical stimuli transdermal magnetic stimuli, transcranial electrical stimuli, transcranial magnetic stimuli, or electrical tongue stimuli, and wherein the non-invasive guidance stimuli are configured to guide or instruct the patient to perform an activity (e.g. see [0049]-[0056], [0073]-[0078]).
Regarding claim 9, Francois discloses the control unit is configured to actuate the stimulation unit in dependence on a predetermined actuation pattern (e.g. see [0081]-[0084], “controller”, [0057]-[0059], [0066]-[0069]).
Regarding claim 10, Francois discloses a sensor unit (e.g. see [0036]-[0048]) configured to monitor an actual physiological cycle of the patient, wherein the clock unit is configured to generate a recorded clock signal being indicative of the actual physiological cycle in dependence on monitoring data obtained by the sensor unit (e.g. see [0081]-[0084], [0057]-[0059], [0066]-[0069]).
Regarding claim 12, Francois discloses the first operating mode and the second operating mode of the stimulation unit differ in at least one of a stimulation modality, a frequency of the stimuli to be administered, stimulation elements to be actuated, stimulation amplitude, a stimulation pattern, a stimulation region at the patient's body to which the stimuli are to be administered, or stimuli intensity (e.g. see [0054]-[0055]).
Regarding claim 13, Francois discloses the control unit is configured to, based on a recorded clock signal, determine a parameter quantifying a characteristic of an actual cycle, and wherein the control unit is configured to control operation of the medical device in dependence on a comparison of the parameter with a threshold or a threshold range (e.g. see [0066]).
Regarding claim 14, Francois discloses the control unit is configured to actuate the stimulation unit if the parameter has reached the threshold range and to stop actuation of the stimulation unit if the determined parameter lies outside the threshold range (e.g. see [0066]).
Regarding claim 15, Francois discloses the control unit is configured to provide information to the patient being indicative of a result of the comparison of the parameter with the threshold (e.g. see [0066]).
Regarding claim 18, Francois discloses the claimed invention but is silent as to the slow breathing range is in a range of 0.07 Hz to 0.16 Hz. Yun teaches that it is known to use such a modification as set forth in [0088] to provide modulation of at least a portion of the subject's autonomic nervous system (e.g. see [0087]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a slow breathing range as taught by Yun in the system/method of Francois, since said modification would provide the predictable results of modulation of at least a portion of the subject's autonomic nervous system.
Regarding claim 19, Francois discloses the predetermined actuation pattern is not dependent on the at least one reference clock signal (e.g. see [0081]-[0084], [0057]-[0059], [0066]-[0069]).
Regarding claim 20, Francois discloses the clock unit is configured to generate a reference clock signal which refers to a reference condition of the patient, wherein the clock unit is configured to generate a recorded clock signal being indicative of an actual activity or an actual physiological cycle of the patient, and wherein the control unit is configured to actuate the stimulation unit in dependence on the reference clock signal or the recorded clock signal (e.g. see [0081]-[0084], [0057]-[0059], [0066]-[0069]).
Regarding claim 21, Francois discloses the control unit is configured to actuate the stimulation unit according to a predefined actuation pattern if the parameter lies outside the threshold range and to actuate the stimulation unit in dependence on the recorded clock signal if the parameter has reached the threshold range (e.g. see [0081]-[0084], [0057]-[0059], [0066]-[0069]).
Allowable Subject Matter
Claim 22 is allowed as it contains the allowable subject matter from claim 16 (and intervening claims 13 and 10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Simon et al. (Pub. No.: US 2013/0184792 A1) (e.g. see [0279]) and Gelfand (Patent No.: US 9,987,488 B1) (e.g. see figures 2 and 4, column 7 lines 43-57 and column 9 line 49 through column 10 line 19).
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
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights