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 without traverse of Group I (claims 1-4, 9, 10, 16 and 20-28) and Species A (spontaneous respiration impulse sensor; claims 10 and 22) in the reply filed on 12/3/2025 is acknowledged. Claims 29-32, 27 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Therefore, claims 16, 29-32, 37 and 38 are withdrawn from consideration, leaving claims 1-4, 9, 10 and 20-28 pending examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “throughflow control actuator” in claim 21 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 16 is objected to because of the following informalities: the proper status identifier for this claim should be “withdrawn”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “to reduce it again in the expiration phase” should be “to reduce the strength of the stimulation signal in the expiration phase”. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: “on the basis of” should be “based on”. Appropriate correction is required.
Claim Interpretation
Regarding limitations related to the respiration of a living being, and inherent properties/characteristics of such respiration, e.g. the course of a respiratory cycle, the exhalation phase, the inspiratory reserve volume, the lungs, etc., the examiner considers these to be inherent properties of a living being who by definition is breathing/respiring. Therefore, according to MPEP 2173.05(e), it would not be appropriate to reject these terms as lacking antecedent basis. Similarly, the strength of the stimulation signal is an inherent property/characteristic of any/all stimulation signals, i.e. every stimulation signal has an amplitude/strength.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 4, 9, 10, 21, 22 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
[Claim 3] The limitation “at which level the muscle contraction generated by stimulation signals is greater than zero, but at least so high that up to 75% of the inspiratory reserve volume is still present in the lungs at the end of the exhalation” is indefinite. Specifically, “greater than zero” and “at least so high” both relate to a minimum level, however “but” refers to something contrasting/different, which creates confusion. For examination purposes, the examiner interprets this limitation as “…greater than zero, and at least so high…”
[Claim 4] The term “the characteristics of the respiratory cycle” lack antecedent basis. While the examiner understands the respiratory cycle includes a countless amount of inherent/implicit characteristics, it’s unclear which and how many of these characteristics are required by this limitation. For examination purposes, any characteristic of the respiratory cycle will read on this limitation.
[Claims 9 and 10] These two claims are written as wherein clauses that recite a method step “wherein current measured values of… are determined continuously by” which creates confusion as to what is structurally required by these claims. As currently written, this appears to be a statement of fact explaining how certain values can be determined. MPEP 2173.05(g) states “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. If it is applicant’s intention that a sensor is specifically required, the examiner recommends positively reciting such a sensor, e.g. the electrostimulation device according to claim 1, further comprising at least one sensor configured to…
Additionally, in relation specifically to claim 10, the limitation “as a function of the measured values of the spontaneous respiration impulses, in particular in a manner synchronized with the spontaneous respiration impulses” improperly recites a broad limitation “as a function of the measured values of the spontaneous respiration impulses” and a narrower limitation “in a manner synchronized with the spontaneous respiration impulses” in the same claim. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the narrower language is considered not required.
[Claim 21] The limitation “the volumetric flow of the air stream” lacks antecedent basis.
[Claim 22] The term “the spontaneous respiration impulse sensor” lacks antecedent basis. It appears as if this claim should depend on claim 10.
[Claim 28] The limitation “alternately stimulate purely thoracic breathing, purely abdominal breathing or a combination thereof” is indefinite, as it’s unclear what “alternately” refers to in this context. First and foremost, the “or” makes it clear that only one of these options (purely thoracic breathing, purely abdominal breathing or a combination) is required. However, if only one option is required, e.g. purely thoracic breathing, it’s unclear how such an option can be “alternately” stimulated. Second, it’s unclear what is meant by alternately stimulating a combination of thoracic breathing and abdominal breathing. Additionally, it’s unclear how a combination of purely thoracic breathing and purely abdominal breathing can exist, as the combination, by definition, cannot include of “purely” thoracic breathing or “purely” abdominal breathing, as both are required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 9, 10, 20 and 22-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0261747 to Schuler et al.
[Claim 1] Schuler discloses an electrostimulation appliance (Figs. 2-4 and 6) for stimulating one or more nerves and/or muscles of a living being with electrically, electromagnetically and/or magnetically generated stimulation signals, comprising:
a) at least one signal output device (treatment member 24) through which electrically, electromagnetically and/or magnetically generated stimulation signals can be fed into at least one nerve and/or one muscle (at least Pars 0087-89 and 0097; see also Background Section); and
b) at least one control device (control module 22) which is configured to activate the at least one signal output device in such a way that the stimulation signals output by the at least one signal output device are able to generate muscle contractions in the living being, by which the respiration of the living being can be influenced in a targeted manner (at least Pars 0108 and 0121)
[Claim 2] Schuler discloses a control device configured to modify the strength of the stimulation signal (at least Pars 0081 and 0108-123, with particular emphasis on Par 0081). The examiner contends that modification can only occur in two ways, i.e. “in several steps and/or uniformly”, therefore Schuler inherently teaches at least one of these ways, as there are no other possibilities.
[Claim 3] As discussed in Par 0012 of Schuler, the claimed effect seemingly relates to “normal quite breathing”, therefore implicitly/inherently Schuler teaches a control device configured to keep the strength of the stimulation signal at an increased level to cause “normal breathing” (see at least Pars 0081 and 0108-123, with particular emphasis on Pars 0081 and 0108). It is noted that Par 0108 explicitly teaches controlling the “respiration rates and depth of inhalation” and therefore reads on the claim language, as the controller is at least capable of operating in the claimed manner to provide the claimed effect; see MPEP 2114 (“computer-implemented functional claim limitations may narrow the functionality of the device, by limiting the specific structure capable of performing the recited function”). If applicant disagrees, see alternative 103 below.
[Claim 4] As made clear in Pars 0081 and 0108-123, Schule discloses a control device configured to control provide at least one of the claimed effects, e.g. control depth of respiration, control characteristics of the respiratory cycles, perform targeted excitation of the respiratory nerves and/or control the respiratory state to an increased value.
[Claims 9, 10 and 22] Schuler discloses as least one spontaneous respiration impulse sensor (signal sensor 21 or respiration sensor 32; see at least Pars 0086 and 0015-116) which detects/measures the spontaneous respiration impulses, i.e. breathing events, of the living being, these measured values (neuro-electrical coded signals or "waveform signals") are supplied to the control device to control/modify the electrical stimulation (at least Pars 0073-83).
[Claim 20] Schuler explicitly discloses increasing the strength, i.e. amplitude, of the stimulation signal (Par 0081). It’s also clear from Par 0012 that contraction of the diaphragm causes inspiration, therefore the amplitude of the stimulation signal must be greater during inspiration, i.e. to cause contraction of the diaphragm, then in expiration. If applicant disagrees, see alternative 103 below.
[Claim 23] Schuler discloses that the electrostimulation system can be used in conjunction with “mechanical respiration support” (Par 0113) and “augmented by oxygen administration” (Par 0114). The examiner considers this a control device capable of being connected to a ventilator; see MPEP 2114. If applicant disagrees, see alternative 103 below.
[Claim 24] Schuler discloses a control device configured to store characteristics of one or more respiratory cycles (at least Pars 0080-83 and 0094)
[Claims 25-26] Schuler discloses a control device that controls respiration rates and depth of inhalation (Par 0108). The examiner takes the position that this encompasses deep inhalations and partial exhalations, as the controller is configured to apply the specific electrical stimulation that causes these effects; see MPEP 2114. If applicant disagrees, see alternative 103 below.
[Claim 27] Schuler discloses a control device that is configured to stimulate secretion mobilization (at least Pars 0017 and 0110-113)
[Claim 28] Schuler discloses the specific nerves that control respiration, specifically the intercostal nerves innervate the intercostal muscles, i.e. muscles between the ribs responsible for thoracic breathing, and phrenic nerves innervate the diaphragm, i.e. muscle responsible for abdominal breathing (Par 0014). Par 108 makes it clear that the signals can be sent to both of these nerves to control each/both of these muscles independently of each other (“rhythmic operation of the diaphragm and/or the intercostal muscles to inspire and expire air”)
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 3, 20, 25, 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0261747 to Schuler et al.
Schuler is discussed above and specifically teaches controlling the respiration rate and depth of inhalation of a patient by controlling the movements/contractions of the diaphragm and intercostal muscles (Par 0108) by modifying the strength/amplitude and rate of the applied electrical stimulation/signals (Par 0081). The reference is silent to the specific timing or strength of the applied signals or the effects caused in the patient, as claimed. If it is determined that the controller of Schuler is not capable of providing such claimed effects, the examiner considers this to be an optimization of a result effective variable and obvious to try, as Schuler makes it clear that the control device is configured to control any/all respiration rates and depths of inhalation, as well as the overall control of muscles that cause breathing. Therefore, it would have been obvious to one of ordinary skill in the art to try different strengths, e.g. increasing and decreasing the amplitude of the applied electrical stimulation/signals, at different times during the respiratory cycle, including during inspiration and/or expiration, as routine experimentation of a result effective variable to specifically achieve different respiration rates, depths of inhalation or breathing actions/patterns.
Claims 21 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Schuler as applied to claim 1 above, and further in view of US 2016/0310730 to Martins et al.
As discussed above, in relation to claim 23, Schuler explicitly considers using the electrical stimulation system in conjunction, i.e. to augment, mechanical respiration support devices, but fails to explicitly teach a control device that is connected to a ventilator or controlling a through control actuator to control the airflow to a patient. However, in the same field of endeavor, Martins (Fig. 28) discloses a system including an electrical stimulation device (2813) and ventilator (2802) and controller (2814) that controls both the electrical stimulation and valves/air-flow provided by the ventilator (Pars 0256-263, especially Pars 0256 and 0263). Therefore, it would have been obvious to one of ordinary skill in the art to modify the controller of Schuler to specifically interface with and control the ventilator, as taught by Martins, as a known configuration for a system that controls both electrical stimulation and a ventilator. It is emphasized that the combination of an electrical stimulation device and ventilator is explicitly contemplated by Schuler, Martins merely teaches/depicts a known configuration or design for such a combined system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796