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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 11, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on October 11, 2024 are accepted.
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 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:
Claim 1: Claim limitation “an attachment mechanism configured to attach the respiratory therapy sound capturing device to a respiratory therapy device;” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “mechanism” coupled with functional language “to attach” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “mechanism”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Claim 1: “an attachment mechanism”, refers to the specification [00053]: “include, but are not limited to, glue, adhesive, magnets, snaps, straps, VELCROTM, and/or clasp.”
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 § 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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rice et al. (US 2024/0042149 A1) (“Rice”).
Regarding claim 1, Rice discloses A respiratory therapy sound capturing device comprising (Abstract and entire document):
an attachment mechanism configured to attach the respiratory therapy sound capturing device to a respiratory therapy device (FIG. 1 and [0051] sensor housing, respiratory therapy device 122 housing and memory device housing, individual housings, combined housings, etc. attachment is implied. The sound device is attached to the therapy device to attach the sensors, see also [0103] – [0105] an attachment mechanism attaches the sensors to the respiratory device. See also [0059]);
a microphone configured to detect sound made when a user is using the respiratory therapy device and communicate the detected sound to a transceiver (FIG. 1 microphone 140 and [0053] transceiver); and
the transceiver, the transceiver being communicatively coupled to the microphone and transmit sound detected by the microphone to an external computing device (FIG. 1 microphone 140 and [0053] transceiver).
Regarding claim 2, Rice discloses The respiratory therapy sound capturing device of claim 1, further comprising: an accelerometer configured to detect at least one of motion of the respiratory therapy sound capturing device and an orientation of the respiratory therapy sound capturing device (FIG. 1, [0065] motion sensor 138).
Regarding claim 3, Rice discloses The respiratory therapy sound capturing device of claim 1, wherein the respiratory therapy device is at least one of an inhaler, a positive expiratory pressure (PEP) device, oscillating positive expiratory pressure (oPEP) device, incentive spirometer, respiratory muscle trainer (RMT), spirometer, nebulizer, and a peak flow meter ([0064]).
Regarding claim 5, Rice discloses The respiratory therapy sound capturing device of any of claim 1, wherein the respiratory therapy device includes a mouthpiece and a body and the respiratory therapy sound capturing device is configured to be placed between the mouthpiece and the body of the respiratory therapy device to capture sound the user makes when inhaling out of the mouthpiece or exhaling into the mouthpiece (FIG. 2 and associated paragraphs, face mask, user interface 124, and see [0059], sensors can be attached anywhere in the system).
Regarding claim 6, Rice discloses The respiratory therapy sound capturing device of claim 5, wherein the respiratory therapy sound capturing device further comprises: a lumen configured to allow air exhaled into mouthpiece to be communicated to the body of the respiratory therapy device and is also configured to allow air inhaled through the body of the respiratory therapy device to be communicated to the mouthpiece (FIG. 2 and associated paragraphs, face mask, user interface 124).
Regarding claim 7, Rice discloses The respiratory therapy sound capturing device of claim 1,wherein the sound detected by the microphone is sound corresponding to at least one of air moving into the respiratory therapy device, air moving out of the respiratory therapy device, a vibration of the respiratory therapy device, and an oscillation of a component air of the respiratory therapy device (FIG. 2 and associated paragraphs, face mask, user interface 124, and see [0059], sensors can be attached anywhere in the system, to include air coming in and out; see also [0067], [0158], [0161]).
Regarding claim 8, Rice discloses A system comprising (Abstract and entire document):
a respiratory therapy device (FIG. 1 and [0051], respiratory therapy device 122, and [0064]); and
a respiratory therapy sound capturing device coupled to the respiratory therapy device, the respiratory therapy sound capturing device comprising (FIG. 1 and [0051] sensor housing, respiratory therapy device 122 housing and memory device housing, individual housings, combined housings, etc. attachment is implied. The sound device is attached to the therapy device to attach the sensors, see also [0103] – [0105] an attachment mechanism attaches the sensors to the respiratory device. See also [0059]):
a microphone configured to detect sound made when a user when the user is using the respiratory therapy device and communicate the detected sound to a transceiver (FIG. 1 microphone 140 and [0053] transceiver); and
the transceiver, the transceiver being communicatively coupled to the microphone and transmit sound detected by the microphone to an external computing device (FIG. 1 microphone 140 and [0053] transceiver).
Regarding claim 9, Rice discloses The system of claim 8, wherein the respiratory therapy sound capturing device further comprises: an accelerometer configured to detect at least one of motion of the respiratory therapy sound capturing device and an orientation of the respiratory therapy sound capturing device (FIG. 1, [0065] motion sensor 138).
Regarding claim 10, Rice discloses The system of claim 8, wherein the respiratory therapy device is at least one of an inhaler, a positive expiratory pressure (PEP) device, oscillating positive expiratory pressure (oPEP) device, a peak flow meter, Incentive spirometer, and a respiratory muscle trainer device ([0064]).
Regarding claim 11, Rice discloses The system of claim 8, wherein the respiratory therapy device includes a mouthpiece and a body and the respiratory therapy sound capturing device is configured to be placed between the mouthpiece and the body of the respiratory therapy device to capture sound the user makes when inhaling out of the mouthpiece or exhaling into the mouthpiece (FIG. 2 and associated paragraphs, face mask, user interface 124, and see [0059], sensors can be attached anywhere in the system).
Regarding claim 12, Rice discloses The system of claim 11, wherein the respiratory therapy sound capturing device further comprises: a lumen configured to allow air exhaled into mouthpiece to be communicated to the body of the respiratory therapy device and is also configured to allow air inhaled through the body of the respiratory therapy device to be communicated to the mouthpiece (FIG. 2 and associated paragraphs, face mask, user interface 124).
Regarding claim 13, Rice discloses The system of claim 8, wherein the sound detected by the microphone is sound corresponding to at least one of air moving into the respiratory therapy device, air moving out of the respiratory therapy device, a vibration of the respiratory therapy device, and an oscillation of a component of the respiratory therapy device (FIG. 2 and associated paragraphs, face mask, user interface 124, and see [0059], sensors can be attached anywhere in the system, to include air coming in and out; see also [0067], [0158], [0161]).
Regarding claim 14, Rice discloses A method comprising (Abstract and entire document):
receiving, by a processor, a parameter for using a respiratory therapy device (FIG. 1 and [0051], respiratory therapy device 122, and [0064], [0050] processor and [0067] parameters);
receiving, by the processor, sound detected by a microphone when a user when the user is using the respiratory therapy device and communicate the detected sound to a transceiver (FIG. 1 microphone 140 and [0053] transceiver);
analyzing, by the processor, the received sound to determine if the received sound corresponds to use of the respiratory therapy device in a manner that is compliant with the received parameter (FIG. 1 and [0051], respiratory therapy device 122, and [0064], [0050] processor and [0067] parameters and monitoring and analyzing to generate sleep score, determine if user is sleeping in a manner according to a parameter); and
providing a result of the analysis to a display device ([0052], [0060]).
Regarding claim 15, Rice discloses The method of claim 14, wherein the analysis includes determining at least one of a number of inhales in a time period, a number of exhales in a time period, a duration of inhales in a time period, and a duration of exhales in a time period ([0067]).
Regarding claim 16, Rice discloses The method of claim 14, wherein the analysis includes determining at least one of a peak frequency and a peak amplitude detected for one or more exhalations detected during a time period ([0067]).
Regarding claim 17, Rice discloses The method of claim 14, wherein the analysis includes determining at least one of an average frequency, a peak frequency, an average amplitude, a peak amplitude, and a duration detected for one or more inhalations detected during a time period ([0067], [0158], [0161]).
Regarding claim 18, Rice discloses The method of claim 14, further comprising: determining, by the processor, a recommendation regarding how to use the respiratory therapy device responsively to the analysis; and providing, by the processor, the recommendation to the user ([0190]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rice in view of Miller et al. (US 2015/0101600 A1) (“Miller”).
Regarding claim 4, Rice discloses The respiratory therapy sound capturing device of claim 1, Rice fails to disclose wherein the attachment mechanism is an adhesive.
However, in the same field of endeavor, Miller teaches wherein the attachment mechanism is an adhesive (FIG. 2A-2C and FIG. 3 and associated paragraphs see at least [0026] and [0029] discussing attaching sensor module to respiratory device using adhesive as the interface).
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 device as taught by Rice to include wherein the attachment mechanism is an adhesive as taught by Miller to be removable for ease of cleaning (abstract, [0018]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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