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 Amendment
This office action is responsive to an amendment filed on 5/27/2026. As directed by the amendment, claims 1, 3, and 40 were amended, claims 6-9, 13-28, 31-39, 43-46, 50-53, and 57-60 were cancelled, and no new claims were added. Thus, claims 1-5, 10-12, 29-30, 40-42, 47-49, 54-56, and 61 are presently pending in this application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains term that is implied, (i.e., the term “the present disclosure” in line 1 of the abstract). Correction is required. See MPEP § 608.01(b).
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.
At present, no claims are interpreted under 35 USC 112(f).
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 1-5, 10-12, 29-30, 40-42, 47-49, 54-56, and 61 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.
The limitation “determining, based on the acoustic data, that the leak is an unintentional leak; determining, based on the acoustic data, an amount of the unintentional leak; calculating, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; comparing the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimating, based on the comparing the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak” (claim 1, lines 12-19) is not supported by the original disclosure and is therefore, new matter. The disclosure fails to disclose determining, based on the acoustic data, that the leak is an unintentional leak; determining, based on the acoustic data, an amount of the unintentional leak; calculating, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; comparing the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimating, based on the comparing the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak.
The limitation “determine, based on the acoustic data, that the leak is an unintentional leak; determine, based on the acoustic data, an amount of the unintentional leak; calculate, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; compare the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimate, based on the comparison of the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak” (claim 40, lines 15-23) is not supported by the original disclosure and is therefore, new matter. The disclosure fails to disclose determine, based on the acoustic data, that the leak is an unintentional leak; determine, based on the acoustic data, an amount of the unintentional leak; calculate, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; compare the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimate, based on the comparison of the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak.
Any remaining claims are rejected for their dependency on a rejected base claim.
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 1-5, 10-12, 29-30, 40-42, 47-49, 54-56, and 61 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 1, the limitation “the calculated amount of the intentional leak” (lines 18-19) lacks proper antecedent basis.
Regarding claim 1, the limitation “a user” (lines 6-7) is unclear if the user is the same as or different from “a user” being claimed in claim 1, line 4.
Regarding claim 12, the limitation “determining an intentional leak” (line 2) is unclear if the intentional leak is the same as or different from “the intentional leak” being claimed in claim 1, lines 14 and 19.
Regarding claim 40, the limitation “the calculated amount of the intentional leak” (lines 21-22) lacks proper antecedent basis.
Any remaining claims are rejected for their dependency on a rejected base claim.
Allowable Subject Matter
Claims 1-5, 10-12, 29-30, 40-42, 47-49, 54-56, and 61 are allowable over the prior art.
The following is an examiner’s statement of reasons for indicating allowable subject matter: The closest prior art of record Holley (WO 2010091462 A1) does not specifically disclose the claimed apparatus and method as presented in the claim 1-5, 10-12, 29-30, 40-42, 47-49, 54-56, and 61.
Regarding claim 1, Holley discloses a method for acoustic detection in a respiratory treatment apparatus (abs.), comprising: receiving acoustic data associated with airflow caused by operation of a respiratory therapy system during a sleep session of a user (para. 72, the sound sensor 104 measures sound traversing within a respiratory treatment conduit 108 for analysis by the detection controller 106.); analyzing at least a portion of the acoustic data to determine a value of a parameter associated with the at least a portion of the acoustic data (para. 19, a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound); and determining an occurrence of a leak during the sleep session in response to the determined value of the parameter satisfying a condition. (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient).
Holley discloses determining the occurrence of the leak includes determining an intentional leak that is indicative of airflow venting from one or more vents associated with the respiratory therapy system (para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data). Additionally, the (para. 17, the microphone may be adapted with an endotracheal tube couple, the coupler may further include a vent). The device (para. 128, may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient). This same system would be able to analyze an “intentional leak”.
However, Holley fails to disclose the combination of generating, via a microphone communicatively coupled to a respiratory therapy system, acoustic data associated with airflow caused by operation of the respiratory therapy system during a sleep session of a user, receiving, from the microphone, the acoustic data associated with airflow caused by operation of the respiratory therapy system during the sleep session of a user; and determining, based on the acoustic data, that the leak is an unintentional leak; determining, based on the acoustic data, an amount of the unintentional leak; calculating, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; comparing the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimating, based on the comparing the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak. Therefore, to modify Holley to arrive at the claimed invention would not have been obvious, and would be based upon improper hindsight reasoning.
Regarding claim 40, Holley discloses a system comprising: a respiratory therapy device configured to generate a flow of pressurized air (Fig. 1, respiratory treatment apparatus 102); a user interface configured to aid in delivery of the flow of pressurized air to a user (Fig. 17, example mask); a conduit configured to connect the respiratory therapy device and the user interface (Fig. 1, Respiratory treatment conduit 108, para. 75 the patient at a patient end of the conduit, para. 71, the treatment apparatus includes conduits such as an endotracheal tube or supple tube and mask); a microphone (Fig. 1, sound sensor 104, para. 71, such as a microphone), a memory storing machine-readable instructions (Fig. 1, detection controller 106); and a control system including one or more processors configured to execute the machine- readable instructions to (para. 73, the controller may include integrated chips, a memory and/or other control instruction, data or information storage medium. For example, programmed instructions encompassing such a detection methodology may be coded on integrated chips in the memory of the device): generate, using the microphone, acoustic data associated with the flow of the pressurized air during a sleep session of the user (para. 19, microphone adapted for coupling with a respiratory treatment conduit to generate a measure of sound of a flow generator.); analyze at least a portion of the generated acoustic data to determine a value of a parameter associated with the generated acoustic data; (para. 19, The apparatus may also include a controller or processor configured to analyze data samples of the measure of sound from the microphone by calculation of a cepstrum with the data samples of the measure of sound); and determine an occurrence of a leak during the sleep session in response to the determined value of the parameter satisfying a condition. (para. 128, the technology may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient).
Holley discloses determining the occurrence of the leak includes determining an intentional leak that is indicative of airflow venting from one or more vents associated with the respiratory therapy system (para. 135, the leak may be identified and/or quantified by examination of cepstrum data such as comparing known stored cepstrum data representative of a leak to a current test cepstrum data). Additionally, the (para. 17, the microphone may be adapted with an endotracheal tube couple, the coupler may further include a vent). The device (para. 128, may be implemented to determine whether there is a technical problem with the patient interface including leaks and/or kinks in the system. This may also be detected by comparing current test reflection data or cepstrum data to a known reflection data or cepstrum data taken while the patient interface was in good working order and properly on a patient). This same system would be able to analyze a “intentional leak”.
However, Holley fails to disclose a system comprising a respiratory therapy device, a microphone, a control system including one or more processors configured to execute machine-readable instructions to: generate, using the microphone, acoustic data associated with the flow of the pressurized air during a sleep session of the user; and determine, based on the acoustic data, that the leak is an unintentional leak; determine, based on the acoustic data, an amount of the unintentional leak; calculate, based on an intentional leak characteristic curve, a calculated amount of the unintentional leak; compare the amount of the unintentional leak with the calculated amount of the unintentional leak; and estimate, based on the comparison of the amount of the unintentional leak with the calculated amount of the intentional leak, a total amount of the unintentional leak. Therefore, to modify Holley to arrive at the claim invention would not have been obvious and would be based upon improper hindsight reasoning.
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.
Jacquot (FR 2987274) is cited to show a curve based on intentional leak between a patient circuit and mouth of the patient.
Kelly (WO 2013/050907) is cited to show a device for detecting intentional leak.
D’Angelo (WO 2012/172491) is cited to show a device for detecting intentional leak.
Garde (WO 2013/027151) is cited to show a device for detecting intentional leak.
Kwok (2009/0205662) is cited to show a respiratory device comprising leak detection.
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/TU A VO/Primary Examiner, Art Unit 3785
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