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
Regarding the claim and drawing objections, applicant’s amendments have overcome these objections and they are hereby withdrawn.
Regarding the 112b rejections, applicant’s amendments have overcome these rejections and they are hereby withdrawn. However, applicant’s amendments have created new 112b rejections; see below.
Regarding the 102 rejection, applicant’s amendments have overcome this rejection and it is hereby withdrawn. Specifically, the examiner agrees that Schuler (alone) fails to teach the newly claimed interface. However, such an interface is taught by the combination of Schuler and Martins (as detailed in the rejection of previous dependent claims 21 and 23); see explanation below.
Regarding the 103 rejection of Schuler and Martins, applicant’s arguments have been fully considered but are not persuasive. The examiner maintains that Schuler’s disclosure that the disclosed electrostimulation system can be used in conjunction with “mechanical respiration support” (Par 0113) and “augmented by oxygen administration” (Par 0114) is sufficient motivation for a POSITA to look for combined/integral system that combines ventilation and electrical stimulation, as known in the art and taught by Martins. Applicant’s arguments are mere conclusory statements and general opinions from counsel without any support/evidence. It is emphasized that Schuler itself provides the motivation for a POSITA to look for combined electrical stimulation and ventilation systems by expressly teaching that the treatment provided by the electrostimulation system of Schuler can be enhanced or augmented with mechanical respiration support or oxygen administration (Pars 0113-114). Clearly, Schuler contemplates/encompasses using ventilation in combination with electrical stimulation, but is merely silent to the specifics/details related to the control of such a combined system. However, this explicit teaching of both ventilation and electrical stimulation would lead a POSITA to look to known combined ventilation and electrical stimulation systems, such as the system taught by Martins. Martins, which explicitly teaches a combined ventilation and electrical stimulation system, discloses the claimed interface, and it would be obvious to modify Schuler with this interface in order to properly control both electrical stimulation and ventilation, which is explicitly contemplated by Martins. Therefore, applicant’s arguments are not persuasive.
In response to applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
"A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
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 9, 10, 23 and 41 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.
[Claims 9 and 10] These claims recites a “sensor configured to determine continuously…”. It’s unclear if/how the functional language of “configured to determine continuously…” serves to further limit the structure of the sensor. It is emphasized that a sensor merely senses, i.e. gathers data/information, but is not responsible for determining a condition, let alone continuously determining a condition. 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.” The examiner contends that as long as the prior art teaches a respiration sensor, the claim language is met, as such a sensor is capable of the functional language; MPEP 2114.
[Claim 23] This claim recites “wherein the control device is connectable via an interface to a ventilator which is configured to ventilate the living being by generating variable positive pressure and/or negative pressure, wherein the control device is configured for data exchange with a control device of the ventilator”, however it’s unclear if the interface recited in claim 23 is the same or different than the interface now recited in claim 1. If it’s the same interface it should be preceded by “the” or “said”. Furthermore, if it is the same interface, it’s unclear if/how this claim serves to further limit the independent claim, as the independent claim already requires “an interface configured to connect the at least one control device to a positive-pressure ventilation device configured to ventilate the living being by generating variable positive pressure and/or negative pressure, wherein the at least one control device is configured for data exchange with a control device of the positive-pressure ventilation device”. Seemingly this claim should be deleted, as the subject matter recited in this claim already appears in the independent claim.
[Claim 41] The phrase “its interface” is indefinite, as it’s unclear if this is the same interface referred to in claim 1 or a different interface. If it’s the same interface it should be referred to as “the” or “said” interface. For examination purposes, this is interpreted as the same interface recited in claim 1.
Additionally, it’s unclear if a positive-pressure ventilation device and a control of the positively-pressure ventilation device are positively required, i.e. it’s unclear if the scope of the claim actually requires the particular ventilation device and an associated controller or merely an interface that is configured to connect to such a hypothetical/imaginary/unclaimed ventilation device and a control device (of the electrostimulation device) that is configured to exchange data with a ventilation controller. The independent claim makes it clear that the ventilation device and an associated controller are not actually required, only an interface that is configured to connect with a ventilation device and an electrostimulation controller that is configured for data exchange with a ventilation controller, however the current dependent claim confuses the issues, as it seems to actually/positively require such a ventilation device and ventilation controller. Therefore, the scope/breadth of the claim, i.e. what is structurally required, is unclear/indefinite. For examination purposes, the examiner takes the position that the claimed “electrostimulation appliance” (see preamble) does not include/require a positive-pressure ventilation device or a control device of a positive-pressure ventilation device, as these are merely functional limitations, i.e. intended uses, of the interface and at least one control device.
Lastly, “the control device of the electrostimulation appliance” lacks antecedent basis. It seems as if this is attempting to refer to the “at least one control device” in claim 1, but it’s unclear as there are now two control devices recited in claim 1 (“at least one control device” and “a control device of the positively-pressure ventilation device”). It’s imperative that applicant keep claim terms consistent throughout the entire claim set to avoid confusion.
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 1-4, 9, 10, 20, 22-28 and 41 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.
[Claims 1, 23 and 41] 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).
Schuler discloses that the electrostimulation system can be used in conjunction with “mechanical respiration support” (Par 0113) and “augmented by oxygen administration” (Par 0114), but fails to explicitly teach “an interface configured to connect the at least one control device to a positive-pressure ventilation device configured to ventilate the living being by generating variable positive pressure and/or negative pressure, wherein the at least one control device is configured for data exchange with a control device of the positive-pressure ventilation device”. 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). Specifically, Martins discloses an interface (communication between mechanical ventilator 2812 and stimulator 2813; at least Pars 0258 “wirelessly or via a wired-line connection”) configured to connect the control device (processor 2814) to a positive-pressure ventilation device (2802) configured to ventilate the living being by generating variable position pressure and/or negative pressure (Inherently how a mechanical ventilator operates; see also Par 0256 “The tracheal tube assembly 2808 generally includes one-way valves for controlling one-way flow from the inspiratory conduit 2806 to the patient 101 and from the patient 101 to the expiratory conduit 2807”), wherein the at least one control device is configured for data exchange with a control device of the positive-pressure ventilation device (at least Pars 0258-263 discuss the data exchange between the processor 2814 and the ventilator 2802; e.g. via adapter 2810, directly from the mechanical ventilator or from sensors). Therefore, it would have been obvious to one of ordinary skill in the art to modify the controller of Schuler to specifically include the 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, including an interface and control device that allows data exchange between these two systems (electrical stimulator and ventilator).
[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.
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.
[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). The examiner contends that the sensors taught by Schuler are at the very least capable of providing the claimed function, as they are seemingly the same sensors disclosed by applicant. MPEP 2114 states… "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
[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 above, in relation to claim 3.
[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 above, in relation to claim 3.
[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”). If applicant disagrees, see alternative 103 above, in relation to claim 3.
Conclusion
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 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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