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 invention I in the reply filed on 4 August 2025 is acknowledged.
Claims 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4 August 2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
control unit, first recited in claim 1 (microcontroller with motor controller, a gate driver, and one or more field effect transistors – p. 4 of the specification as filed).
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 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.
Claim 22 is 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 22 refers to “the sequence of rotational speed setpoints”; there is no antecedent basis for this limitation in the claim. Claim 1 defines a set of setpoints, but does not indicate this set as having any particular order such that even if referring to the set it is not clear how one might identify a “next” value in the set. Clarification is 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.
Claim(s) 1-6, 8-14, 16-18, 20-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pompilio (US 2013/0150747).
Regarding claim 1, Pompilio discloses a system for evaluating the respiratory function of an individual using forced oscillation technique oscillometry (paragraph [0001]), comprising:
a blower (paragraph [0027])comprising a casing (element 12, figure 1), an impeller mounted for rotation within the casing (element 11), and a motor configured to, during operation, rotate the impeller (element 10);
a ventilation interface (element 21; paragraph [0028]);
a connecting member defining a passageway in fluid communication with the blower and the ventilation interface (figures 1, 2 – see element 13); and
a control unit (element 20) communicatively coupled to the motor (paragraph [0033]) and configured to control a rotational speed of the impeller to meet a set of rotational speed setpoints for the impeller so that the blower produces a time-varying pressure waveform in the passageway, the time-varying pressure waveform including a sinusoidally-varying pressure fluctuation to be superimposed on a respiratory flow of the patient by way of the ventilation interface (paragraph [0039]), and an offset pressure selected to maintain a positive air pressure in the passageway during operation of the system (paragraph [0039]).
Regarding claim 2, Pompilio further discloses that the control unit is further configured to control the rotational speed of the impeller to meet the set of rotational speed setpoints by generating a control input based on a desired air pressure with the passageway (paragraph [0038]), and a known relationship between the rotational speed of the impeller and an air pressure produced by the blower (paragraph [0033], [0034]); and
the motor is configured so that the motor varies the rotational speed of the impeller in response to the control input (paragraph [0033], [0038], [0039]).
Regarding claim 3, Pompilio further discloses that the control input is a single-frequency signal (paragraph [0039], a sinusoidal signal).
Regarding claim 4, Pompilio further discloses that the control input is a multi-frequency signal (paragraph [0039], sum of sinusoids).
Regarding claim 5, Pompilio further discloses that the controller is further configured to generate the control input by combining at least a first and a second signal (paragraphs [0032], [0033], signals from sensors 16 and 17).
Regarding claim 6, an amplitude, a phase, and a waveform of a pressure signal are inherently different than a respective amplitude, phase, and waveform of a flow signal.
Regarding claim 8, as the sinusoidal variation is imposed on the offset pressure, the offset pressure must inherently be “substantially constant” at least in comparison, absent any more specific limitations defining “substantially”.
Regarding claim 9, Pompilio further discloses that a maximum pressure amplitude of the time varying pressure waveform is “about” 0.1 cm H2O to about 2 cm H2O (paragraphs [0039]-[0040])
Regarding claim 10, Pompilio further discloses an outlet port in fluid communication with the passageway in the connecting member, and an ambient environment around the system (paragraph [0027]).
Regarding claim 11, Pompilio further discloses that the outlet port has a length of about zero to about three inches (paragraph [0027]).
Regarding claim 12, Pompilio further discloses that the passageway and the outlet port form an airflow pathway between the ventilation interface and the ambient environment around the system (paragraph [0027]); and the system the further comprises an obstruction located within the outlet port and configured to partially restrict a passage of air from the airflow pathway and to the ambient environment (see figure 2).
Regarding claim 13, Pompilio further discloses that the obstruction is at least one of: a plate having one or more orifices formed therein and a mesh screen (see figure 2).
Regarding claim 14, Pompilio further discloses that the outlet port is configured so that a total resistance of the system to normal tidal breathing of the individual is about 1 cm H2O/L/s or less (paragraph [0041]).
Regarding claim 16, Pompilio further discloses that the control unit is further configured to calculate an impedance of a respiratory system of the individual based on a measured pressure and a measured volumetric flowrate of the air within the passageway (paragraph [0003], [0013], [0021]).
Regarding claim 17, Pompilio further discloses that the ventilation interface comprises at least one of a mouthpiece, a facemask, an endotracheal tube, a tracheal tube, a tracheostomy adapter, a tubing adapter, and a connection to a standard ventilatory interface (paragraph [0028]).
Regarding claim 18, Pompilio further discloses that the control unit comprises a microcontroller (paragraph [0033]).
Regarding claim 20, Pompilio further discloses that the control unit is further configured to implement a first feedback loop to control the rotational speed of the impeller to meet the set of rotational speed setpoints for the impeller (paragraphs [0013], [0021], [0036]-[0038]).
Regarding claim 21, Pompilio further discloses that the control unit is further configured to implement a second feedback loop to update the one or more rotational speed setpoints to achieve a target pressure for air within the passageway (paragraph [0021], accelerating and decelerating the rotational velocity as needed; paragraph [0038]).
Regarding claim 22, Pompilio further discloses that the control unit is further configured to implement the second feedback loop to at least one of: update the one or more rotational speed setpoints to a “next value” in the sequence of rotational speed setpoints; and compensate for changes in an actual pressure of the air within the passageway due to respiration of the individual (paragraph [0021], [0033], [0038], [0045]).
Regarding claim 23, Pompilio further discloses that the control unit is further configured to update the second feedback loop based a difference between the target pressure for the air within the passageway and a measurement of an actual pressure of the air within the passageway (paragraph [0038]).
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.
Claim(s) 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pompilio.
Regarding claim 24, Pompilio does not explicitly teach an update frequency of the first feedback loop being greater than an update frequency of the second feedback loop; however, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (see MPEP 2144.05(II)). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have tried updating the first feedback loop more frequently than the second as part of routine experimentation to achieve an optimized delivery of the desired small-amplitude pressure stimuli while still allowing the patient to comfortably spontaneously breathe.
Regarding claim 25, Pompilio further discloses that the update frequency of the second feedback loop is “sufficient” to permit the impeller to stabilize at each of the setpoints (paragraphs [0038]-[0042]; the Examiner notes that the claim does not indicate how long the impeller must be held at any given setpoint, such that any achieving of a desired setpoint is thus “stabilizing” at that setpoint for some period of time).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pompilio in view of Mahadevan (US 2015/0128947).
Regarding claim 7, Pompilio does not explicitly disclose that the offset pressure is about 0.5 cm H2O to about 40 cm H2O. Mahadevan teaches a system for evaluating the respiratory function of an individual using forced oscillation technique oscillometry (paragraph [0033]), comprising a blower (paragraph [0019]), a ventilation interface (paragraph [0021]), a connecting member defining a passageway in fluid communication with the blower and the ventilation interface (element 40); and a control unit communicatively coupled to the motor (element 20) and configured to control a rotational speed of the blower so that the blower produces a pressure waveform in the passageway including a pressure fluctuation to be superimposed on a respiratory flow of the patient by way of the ventilation interface (paragraph [0033]-[0034], forced oscillation), and a positive pressure of about 0.5 cm H2O to about 40 cm H2O (paragraph [0020]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Pompilio with the control unit configured to deliver an offset pressure of about 0.5 cm H2O to about 40 cm H2O, as taught by Mahadevan, in order to allow comfortable breathing.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pompilio in view of Maksym (US 2015/0119743).
Pompilio does not disclose that the control unit is further configured to control the rotational speed of the impeller to produce pseudorandom noise within the passage, though Pompilio does disclose that the control unit is configured to control the rotational speed of the impeller to improve measurement quality (paragraph [0021]). Maksym teaches a device for evaluating respiratory function used forced oscillation technique oscillometry (para [0002]), wherein the device is configured to produce pseudorandom noise to the airway of a subject (para [0165]-[0166]). Accordingly, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the control unit of Pompilio such that it is further configured to control the rotational speed of the impeller to produce pseudorandom noise within the passage, as taught by Maksym, in order to provide a more complex signal for better exploring the patterns or mechanisms of frequency dependence of respiratory impedance in health and disease.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pompilio in view of Burton (US 2009/0301482).
Regarding claim 19, Pompilio further discloses that the microcontroller comprises a motor controller (paragraph [0033]); Pompilio does not disclose specifics of the electrical components of the control unit, particularly a gate driver communicatively coupled to the motor controller and one or more field effect transistors communicatively coupled to the gate driver and configured to provide electrical current to the motor of the blower. Burton teaches a motor controller for a respiratory blower (Abstract) comprising a gate driver (FPGA, para [0111]; see Table 1: FPGA is field programmable gate array, para [0127]) communicatively ·coupled to the motor controller (para [0111]) and one or more field effect transistors (para [0070]; table 1, metal oxide semiconductor field effect transistor) communicatively coupled to the gate driver (para [0111]) and configured to provide electrical current to the motor of the blower (para [0070]). Accordingly, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the control unit of Pompilio such that it comprises a gate driver communicatively coupled to the motor controller and one or more field effect transistors communicatively coupled to the gate driver and configured to provide electrical current to the motor of the blower, as taught by Burton, in order to provide the appropriate electrical components to allow for controlling the blower.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791