Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment
This office action is responsive to an amendment filed on 2/26/2026. As directed by the amendment, claims 1-2, 8, 11-12, 14-15, and 25 were amended, no claims were cancelled, and new claim 28 was added. Thus, claims 1-28 are presently pending in this application.
Priority
Regarding claims 5-6 and 18-19, it is noted that the applicant’s priority claim to provisional application 61/171606 is not supported by the subject matter of the provisional application. An “assessment of accuracy of the calculated resistance and compliance values” (claims 5 and 18) is not disclosed within 61/171606. Therefore, claims 5-6 and 18-19 will be assigned an effective filing date of 4/22/2010.
Claim Interpretation- 35 USC § 112 – Sixth Paragraph/35 USC § 112(f)
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.
At present, no claims are interpreted under 35 USC 112(f).
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 7-9, 11, 20-22, and 24 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 pre-AIA the applicant regards as the invention.
Regarding claim 7, the limitation “a PEEP control parameter” (line 2) is unclear if the PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 1, line 10.
Regarding claim 8, the limitation “a preset PEEP control parameter” (line 2) is unclear if the preset PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 1, line 10.
Regarding claim 11, the limitation “a preset PEEP control parameter” (line 2) is unclear if the preset PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 1, line 10.
Regarding 20, the limitation “a PEEP control parameter” (lines 1-2) is unclear if the PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 14, line 8.
Regarding claim 21, the limitation “a preset PEEP control parameter” (line 2) is unclear if the preset PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 14, line 8.
Regarding claim 24, the limitation “a preset PEEP control parameter” (lines 1-2) is unclear if the preset PEEP control parameter is the same as, or part of or different from “one or more control parameters” being claimed in claim 14, line 8.
Any remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 7-16, and 20-28 are rejected under 35 U.S.C. 102(b) as being anticipated by Wenkebach et al (2003/0196663).
Regarding claim 1, Wenkebach discloses a respiratory treatment apparatus for estimating respiratory resistance and compliance based on measures of flow and pressure comprising ([0014] discloses a respirator that has sensors for measure pressure and flow; [0006] discloses calculating resistance and compliance based on the pressure and flow readings): one or more sensors to generate signals representative of flow and pressure ([0014] discloses pressure and flow sensors); and a processor, coupled with the one or more sensors ([0014] discloses an evaluating and control unit to determine resistance and compliance, which would require a processor), the processor being configured to control: detecting a portion of expiration of a breathing cycle from data of the flow signal ([0006] discloses taking measurements during a first disturbed phase of expiration and a second undisturbed phase of expiration); and calculating a resistance value and compliance value with flow, pressure and volume measures that correspond to the detected portion of expiration ([0006] discloses calculating resistance and compliance based on the pressure and flow readings as well as volume. [0018] discloses the basic equation used, which includes pressure, flow, and volume and is very similar to the applicant’s equation disclosed in [0123]), adjusting one or more control parameters for controlling operation of the respiratory treatment apparatus based on the calculated resistance value and compliance value ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value and resistance value as seen in the formula of [0018]).
Regarding claim 2, Wenkebach discloses the detected portion of expiration begins at an initiation of an expiration cycle and ends when an expired tidal volume for the expiration cycle exceeds a limit in a range of about 85 to 90 percent ([0006] discloses two phases of expiration in which data is taken. These two phases would cover the claimed “portion of expiration”, furthermore, relatively, the detected portion (including first phase and second phase of expiration) of expiration would be “at” an initiation of an expiration cycle, the term “at” is defined as “near”, the term “at” is defined as “used as a function word to indicate presence or occurrence in, on, or near”, see Merriam-Webster.com, alternatively, even if the term “at” is being defined as being on the initiation of an expiration cycle, Wenkebach discloses in [0006] that the brief disturbance of the breathing gas supply taking place during a first phase of expiration, the airway pressure PAW and the breathing gas flow d/dt V are measured before and during the disturbance, which would include on an initiation of the expiration when the time “before” disturbance occurs on the initiation of expiration).
Regarding claim 3, Wenkebach discloses the calculating comprises a multiple linear regression process with data representing the flow, pressure and volume measures ([0018] discloses a formula that serves as the basis for multiple linear regression).
Regarding claim 7, Wenkebach discloses the processor is further configured to control determining a PEEP control parameter based on a plurality of compliance values determined by the calculating of the processor ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value as seen in the formula of [0018]).
Regarding claim 8, Wenkebach discloses the processor controls a repeated change to a preset PEEP control parameter during which a plurality of pressure and flow measures are determined, and wherein the plurality of compliance values are determined based on the plurality of pressure and flow measures ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value as seen in the formula of [0018]).
Regarding claim 9, Wenkebach discloses the determining of the PEEP control parameter comprises detecting an inflection point from data representing the plurality of compliance values ([0011] discloses increase respiration pressure if PMUS value is positive and decrease respiration pressure if PMUS value is negative. The point at which the PMUS value is zero is considered and “inflection point” and the point at which the respiratory pressure should be set. This helps to avoid “ventilator fighting” by the patient. See [0016]).
Regarding claim 10, Wenkebach discloses the processor is further configured to control determining a maximum pressure support limit based on a plurality of compliance values determined by the calculating of the processor ([0011]-[0012], and [0016], setting the respiratory pressure support to a level such that PMUS is zero is considered “determining the maximum pressure support limit”).
Regarding claim 11, Wenkebach discloses the processor controls a repeated change to a preset PEEP control parameter during which a plurality of pressure and flow measures are determined, and wherein the plurality of compliance values are determined based on the plurality of pressure and flow measures ([0011]-[0012] discloses repeatedly changing the respiration pressure to obtain a PMUS value of zero. This repeated changing is based on repeatedly calculating the compliance values during the expiration cycle).
Regarding claim 12, Wenkebach discloses the determining of the maximum pressure support limit comprises detecting an inflection point from data representing the plurality of compliance values ([0011] discloses increase respiration pressure if PMUS value is positive and decrease respiration pressure if PMUS value is negative. The point at which the PMUS value is zero is considered and “inflection point” and the point at which the respiratory pressure should be set. This helps to avoid “ventilator fighting” by the patient. See [0016]).
Regarding claim 13, Wenkebach discloses a flow generator, coupled with the processor, to generate a flow of breathable gas at pressures above atmospheric to a patient interface based on control signals from the processor ([0014] discloses a respirator and a control unit. The respirator would have a “flow generator” that is controlled by the control unit).
Regarding claim 14, Wenkebach discloses a method for estimating respiratory resistance and compliance based on measures of flow and pressure comprising: generating, with one or more sensors, signals representative of flow and pressure ([0014] discloses pressure and flow sensors); and detecting, in a processor, a portion of expiration of a breathing cycle from data of the flow signal ([0014] discloses an evaluating and control unit to determine resistance and compliance, which would require a processor. [0006] discloses taking measurements during a first disturbed phase of expiration and a second undisturbed phase of expiration); and calculating, in the processor, a resistance value and compliance value with flow, pressure and volume measures that correspond to the detected portion of expiration ([0006] discloses calculating resistance and compliance based on the pressure and flow readings as well as volume. [0018] discloses the basic equation used, which includes pressure, flow, and volume and is very similar to the applicant’s equation disclosed in [0123]), adjusting, in the processor, one or more control parameters for controlling operation of a respiratory treatment apparatus based on the calculated resistance value and compliance value ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value and resistance value as seen in the formula of [0018]).
Regarding claim 15, Wenkebach discloses the detected portion of expiration begins at an initiation of an expiration cycle and ends when an expired tidal volume for the expiration cycle exceeds a limit in a range of about 85 to 90 percent ([0006] discloses two phases of expiration in which data is taken. These two phases would cover the claimed “portion of expiration”, furthermore, relatively, the detected portion (including first phase and second phase of expiration) of expiration would be “at” an initiation of an expiration cycle, the term “at” is defined as “near”, the term “at” is defined as “used as a function word to indicate presence or occurrence in, on, or near”, see Merriam-Webster.com, alternatively, even if the term “at” is being defined as being on the initiation of an expiration cycle, Wenkebach discloses in [0006] that the brief disturbance of the breathing gas supply taking place during a first phase of expiration, the airway pressure PAW and the breathing gas flow d/dt V are measured before and during the disturbance, which would include on an initiation of the expiration when the time “before” disturbance occurs on the initiation of expiration).
Regarding claim 16, Wenkebach discloses the calculating comprising a multiple linear regression process with data representing the flow, pressure and volume measures ([0018] discloses a formula that serves as the basis for multiple linear regression).
Regarding claim 20, Wenkebach discloses determining, in the processor a PEEP control parameter based on a plurality of compliance values determined by the calculating of the processor ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value as seen in the formula of [0018]).
Regarding claim 21, Wenkebach discloses repeatedly, changing, in the processor, a preset PEEP control parameter during which a plurality of pressure and flow measures are determined, and wherein the plurality of compliance values are determined based on the plurality of pressure and flow measures ([0012] discloses controlling the pressure of respiration based on the PMUS value. The PMUS value is determined in part by the compliance value as seen in the formula of [0018]).
Regarding claim 22, Wenkebach discloses the determining of the PEEP control parameter comprises detecting an inflection point from data representing the plurality of compliance values ([0011] discloses increase respiration pressure if PMUS value is positive and decrease respiration pressure if PMUS value is negative. The point at which the PMUS value is zero is considered and “inflection point” and the point at which the respiratory pressure should be set. This helps to avoid “ventilator fighting” by the patient. See [0016]).
Regarding claim 23, Wenkebach discloses determining, in the processor, a maximum pressure support limit based on a plurality of compliance values determined by the calculating of the resistance value and compliance value ([0011]-[0012], and [0016], setting the respiratory pressure support to a level such that PMUS is zero is considered “determining the maximum pressure support limit”).
Regarding claim 24, Wenkebach discloses repeatedly changing a preset PEEP control parameter during which a plurality of pressure and flow measures are determined, and wherein the plurality of compliance values are determined based on the plurality of pressure and flow measures ([0011]-[0012] discloses repeatedly changing the respiration pressure to obtain a PMUS value of zero. This repeated changing is based on repeatedly calculating the compliance values during the expiration cycle).
Regarding claim 25, Wenkebach discloses the determining of the maximum pressure support limit comprises detecting an inflection point from data representing the plurality of compliance values ([0011] discloses increase respiration pressure if PMUS value is positive and decrease respiration pressure if PMUS value is negative. The point at which the PMUS value is zero is considered and “inflection point” and the point at which the respiratory pressure should be set. This helps to avoid “ventilator fighting” by the patient. See [0016]).
Regarding claim 26, Wenkebach discloses controlling, with the processor, a flow generator to generate a flow of breathable gas at pressures above atmospheric to a patient interface ([0014] discloses a respirator and a control unit. The respirator would have a “flow generator” that is controlled by the control unit).
Regarding claim 27, Wenkebach discloses controlling, with the processor, an operation of a flow generator based on the calculated resistance value and compliance value ([0014] discloses the respirator’s pressure being controlled via determining PMUS, which in turn is a function of the calculated resistance and compliance values).
Regarding claim 28, Wenkebach discloses that the detected portion of the expiration excludes data from an end of an expiration cycle (see paragraphs 0006 and the entire disclosure, the detected portion is being interpreted as the first and second phases of an expiration and therefore, would excludes data from “an end of an expiration cycle” that takes place at a later time relative to the detected portion, one that is different from the expiration cycle where the detected portion is being detected, it is noted that the claim does not mention what expiration cycle “an end of that expiration cycle” belongs to, therefore, the expiration cycle in line 2 of claim 28 can be referring to a different expiration cycle).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 4 and 17 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wenkebach.
Regarding claims 4 and 17, Wenkebach does not explicitly disclose that the resistance and compliance values are calculated in a breath-by-breath process.
However, Wenkebach does disclose performing the measurements and compliance/resistance calculations several times per minute ([0015]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the calculations on a breath-by-breath basis to give the apply the most up to date and appropriate respiratory pressure to the user. See MPEP 2144.05-Optimization within prior art conditions or through routine experimentation.
Claims 5-6 and 18-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wenkebach, as applied to claims 2 and 15 above, and further in view of Martin et al (2010/0057646).
Regarding claims 5 and 18, Wenkebach does not disclose the processor configured to control an assessment of accuracy of the calculated resistance and compliance values.
However, Martin teaches an intelligent medical learning system that uses a coefficient of determination when it makes changes to a parameter to assess the accuracy of its algorithm ([0164]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and method of Wenkebach to calculate a coefficient of determination on its calculated resistance and compliance values as taught by Martin to know the accuracy of the calculation(s).
Regarding claim 6 and 19, the modified device and method of Wenkebach has the assessment of accuracy comprising calculating a coefficient of determination and comparing it to a threshold (Martin, [0164], discloses comparing a coefficient of determination value (R2) to determine if the algorithm is accurate).
Response to Arguments
Applicant's arguments filed on 2/26/2026 have been fully considered but they are not persuasive.
The applicant on pages 8-9 of the remarks argues that the reference Wenkebach fails to disclose detecting a portion of expiration of a breathing cycle from data of the flow signal and calculating a resistance value and compliance value with flow, pressure and volume measures that correspond to the detected portion of expiration. The applicant argues that the Office Action asserts that Wenkebach discloses in paragraph [0006] “taking measurements during a first disturbed phase of expiration and a second undisturbed phase of expiration” and “calculating resistance and compliance based on the pressure and flow readings as well as volume”, however, the Office action does not establish that Wenkebach teaches or suggest calculating a resistance value and compliance value with flow, pressure and volumes measures that correspond a detected portion of expiration of a breathing cycle. Furthermore, Wenkebach describes determining resistance based on measurements taken before and during disturbance of the breathing gas supply that takes place during a first phase of expiration and determining compliance based on measurement taken during a second phase of expiration that does not include disturbance. Wenkebach does not teach or suggest that the first and second phases of expiration occur during the same breathing cycle. Indeed, the plain meaning of the phrases “a first phase of expiration” and “a second phase of expiration” suggests that the first and second phases of expiration described in Wenkebach belong to different breathing cycles and not to the same breathing cycle. Moreover, the term “phase” in the phrase “phase of expiration” is used, for example, in paragraphs [0008] and [0015] of Wenkebach in a manner consistent with each phase of expiration (e.g., the first and second) belonging to a different breathing cycle, thus, Wenkebach does not teach or suggest calculating resistance and compliance values with measures that correspond to the same detected portion of expiration within a single breathing cycle. However, the argument is not persuasive because there is no disclosure within Wenkebach that indicate that the first phase and the second phase of expiration are referring to expirations of different breathing cycles, when reading the disclosure of paragraph 0006, one having ordinary skill in the art would recognize that Wenkebach is disclosing different phases of the same expiration based on the phrase “first phase of expiration” and “a second, undisturbed phase of expiration”, Wenkebach does not disclose that the second undisturbed phase of expiration is of another expiration or a second expiration, or an expiration in another breathing cycle. Furthermore, Wenkebach discloses that there is a disturbance during a phase of expiration, therefore, there would be another portion of that same expiration is not being disturbed, and when Wenkebach discloses a second undisturbed phase of expiration, Wenkebach would be referring to the same expiration having a second undisturbed phase, reading Wenkebach as a whole, one having ordinary skill in the art would conclude that the first and second phases are part of the expiration of the same breathing cycle, therefore, for the applicant to arrive at the conclusion that the second phase of expiration is referring to another expiration in a different breathing cycle relative to the expiration where the first phase of expiration takes place would be unreasonable. Therefore, the rejection still stands.
The arguments to the newly added claim limitations in claims 1-28 has been addressed in the above rejection.
The amendments to claims 1-28 filed on 2/26/2026 overcome the 101 rejection, therefore, the 101 rejection has been withdrawn.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Blanch (CA 2362160) is cited to show a medical ventilator configured to calculate resistance and compliance based on volume, flow, and pressure within an expiratory phase.
Blanch (2005/0284476) is cited to show a ventilator configured to calculate lung compliance and resistance.
Tehrani (2011/0017214) is cited to show a ventilator configured to calculate the resistance and compliance based on flow, volume and pressure during an expiration.
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/TU A VO/Primary Examiner, Art Unit 3785
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