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 .
This office action is in response to the preliminary amendment filed 6/20/23. As directed by the amendment: claims 1-4, 6-9, 13, 16-17, 23, 25, 31, and 37 have been amended, claims 10-12, 14-15, 18-22, 24, 27-30, 32-36, and 38-72have been cancelled, and claims 73-75 have been added. As such, claims 1-9, 13, 16-17, 23, 25-26, 31, 37, and 73-75 are pending in the instant application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “435a” has been used to designate both the temple occlusion and the headgear conduit. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 is objected to because of the following informalities: the language “a therapy session” (line 9 and 13) is objected to as a therapy session has already been set forth in claim 4; Examiner suggests amending to read –the therapy session--. Appropriate correction is required.
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: “respiratory therapy system” in claim 1, 37, and 73, “body position algorithm module” in claim 8, “body movement algorithm module” in claim 8, “respiratory therapy device” in claim 16-17.
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.
The respiratory therapy system/device is disclosed as being known elements such as a blower/compressor which generates a positive pressure flow to be sent via conduits to a patient interface (see para. 0043 of the publication of the instant application, see also Fig. 2). The body position/movement algorithm module is disclosed as instructions on computer readable/executable medium to determine body position/movement when executed by a processor (see para. 0104 and Fig. 1).
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.
Claims 5-7, 16, and 31 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.
Claim 5 recites the limitation "the therapy flow settings" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the increasing of air flow to achieve a desired headgear user interface pressure setting" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the increased air flow for an occluded headgear conduit" in line 1-2 and “the airflow for a non-occluded headgear conduit” in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the tube" in line 4 and “the one or more baseline acoustic signatures” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the acoustic data" in line 2 and “the one or more acoustic reflections” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 13, 16-17, 23, 25-26, 31, 37, and 73-75 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) abstract ideas in the form of a mental observation and/or mathematical concept. This judicial exception is not integrated into a practical application because the claims do not include significantly more than the abstract idea itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because:
Step 1
Claims 1 and its dependents set forth a process type of claim (one of the four statutory categories of claims). Claim 37 sets forth a process type of claim (one of the four statutory categories of claims). Claim 73 and its dependents set forth a system/machine type of claim (one of the four statutory categories of claims).
Step 2A, Prong 1
Each of independent claims 1, 37, and 73 recite at least one step or instruction for determining, via acoustic signature, anomalies indicative of headgear conduit occlusion, which is grouped as a mental process and/or mathematical concept (as the analysis of the acoustic signature involves mathematical concept) under the 2019 PEG. Accordingly, each of the claims recites an abstract idea.
Specifically, claims 1, 37, and 73 recites determining an acoustic signature for one or more headgear conduits (observation, which is a mental process under the 2019 PEG); and analyzing the acoustic signature for anomalies indicative of conduit occlusion (judgement or evaluation, which is a mental process and/or a mathematical concept under the 2019 PEG).
Accordingly, as indicated above, the above identified claim recites an abstract idea.
Further, the dependent claims merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed (claim 16-17 for example setting forth a respiratory therapy device which is well-known and conventional elements in the art).
Step 2A, Prong 2
The above-identified abstract idea in each independent claims 1, 37, and 73 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG because they do not include any additional elements or steps which, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. In light of the disclosure it is understood that a headgear user interface (claim 1, 37, and 73) and memory and a control system (claim 73) are generic or well-known elements in the art and which do not improve the functioning of a computer, or any other technology or technical field. Nor would the control system serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified well-known elements does not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least these reasons, the abstract idea identified above in independent claims 1, 37, and 73 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Step 2B
None of the claims include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims do not appear to include additional elements that amount to significantly more than the judicial exception. Dependent claims 16 and 17 include elements such as a respiratory therapy device, but these are well-known and conventional elements in the art and do not amount to significantly more than the abstract idea. Similarly, Applicant’s specification sets forth that a control system/processor performs the claimed method; however, such a control system/processor is reasonably construed as a generic computer device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the control system/processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
Such a recitation of a control system/processor in claim 73 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g. to obtain, manipulate or display data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the methods of claims 1 and 37 (and their dependents) are directed to applying an abstract idea (e.g., mental process and/or mathematical concept) on a general purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent claims 16-17 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR). Therefore, none of the claims amounts to significantly more than the abstract idea itself. Accordingly, claims 1, 37, and 73 (and their dependents) are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 8, 16-17, 23, 25-26, 31, 37, 73, and 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (2011/0313689) in view of Veliss et al. (2008/0060649).
Regarding claim 1, Holley discloses a method for detecting an occlusion within a respiratory therapy system (see Holley Fig. 1 showing respiratory therapy device/system, abstract for example), the method including determining an acoustic signature for one or more conduits during operation of the respiratory therapy system (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example); analyzing the determined acoustic signature to identify anomalies in the acoustic signature during operation of the respiratory therapy system and determining an identified anomaly in the acoustic signature relates to an occlusion of at least one of the one or more conduits (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example; specifically para. 0089 identifies an anomaly as being an obstruction/occlusion in the conduit, the location of the occlusion and the extent of the occlusion). Holley is silent as to providing this acoustic signature analysis of the respiratory conduit being one or more headgear conduits of a headgear user interface having plural headgear conduits; however, Veliss teaches a similar, well-known patient interface in the form of a headgear user interface having plural headgear conduits (see Veliss Fig. 1-4 to 1-6 for example and accompanying written disclosure describing these figures, headgear user interface including a connector 70 which connects to main air supply tube and plural headgear conduits 42 connected to sealing cushion interface 80). Thus 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 Holley method to be applied for determining presence/location/extent of occlusions in a conduit of a headgear user interface having plural headgear conduits, as taught by Veliss, as this would have been obvious substitution of one known element for another (type of user/patient interface).
Regarding claim 2, the modified Holley method further includes identifying the headgear user interface (see Holley para. 0021-0024, para. 0117-0123 which discloses identifying accessory/mask, modified in view of Veliss would provide for identifying the headgear user interface).
Regarding claim 3, the modified Holley method’s analyzing the acoustic signature includes comparing with one or more baseline acoustic signatures associated with the headgear user interface to identify the anomalies (see Holley para. 0030-0032, 0077, 0089).
Regarding claim 8, the modified Holley method further includes in response to determining the identified anomaly from the determined acoustic signature relates to an occlusion, (i) storing information related to a detected occlusion in the one or more headgear conduits for analysis by a body position algorithm module and/or a body movement algorithm module associated with the respiratory therapy system, and/or (ii) inputting information related to a detected occlusion in the one or more headgear conduits into a body position algorithm module and/or a body movement algorithm module associated with the respiratory therapy system (see Holley para. 0107 and 0188 for example which discloses memory and that the occlusions detected via the analysis of the acoustic signature can be saved and is thus able to be ‘for analysis by a body position algorithm module’).
Regarding claim 16, the modified Holley method is such that a total length of at least one of the one or more headgear conduits extends from a connector at one end of the one or more headgear conduits to a second end at a cushion or a frame of the headgear user interface, the connector coupling the tube conveying air from a respiratory therapy device of the respiratory therapy system to the one or more headgear conduits, the determined acoustic signature and the one or more baseline acoustic signatures being associated with at least a predefined region of the one or more headgear conduits, the predefined region being less than the total length (see Veliss Fig. 1-4 to 1-6, headgear conduits 42 connected at one end to connector 70 which connects to main air supply tube and the other end to a cushion/frame 80; Holley acoustic signature analysis providing for analysis of the regions of the headgear user interface which may become occluded, para. 0012-0020, 0030-0032, 0077, 0079-0089, 0101, 0111-0112 for example).
Regarding claim 17, the modified Holley method’s acoustic signature is based on data received from a microphone associated with the respiratory therapy system and which is coupled to a component thereof along an air pathway by the device, tube, and headgear user interface of the system (see Veliss Fig. 1-4 to 1-6, headgear conduits 42 connected at one end to connector 70 which connects to main air supply tube and the other end to a cushion/frame 80; Holley’s acoustic signature analysis for detecting occlusions provided to such a patient interface and which uses a microphone, see para. 0017-0018, 0081).
Regarding claim 23, the modified Holley method’s identified anomaly in the acoustic signature relates to one of (i) a partial occlusion of the headgear conduit or (ii) a substantially full occlusion of the conduits (see Holley para. 0019 and 0089 for example).
Regarding claim 25, the modified Holley method determination of the anomaly relates to an occlusion including comparing with plural baseline acoustic signatures associated with partial to full occlusions of the headgear conduits (see Holley para. 0019, 0030-0032, 0077, 0089).
Regarding claim 26, the modified Holley method further includes determining a degree of occlusion by comparing with the plurality of baseline signatures with the partial to full occlusions of headgear conduits (see Holley para. 0019, 0030-0032, 0077, 0089, Holley being able to determine “extend of the obstruction”).
Regarding claim 31, the modified Holley method determines the acoustic signature based on calculating a cepstrum of the acoustic data which identifies a distance associated with one or more acoustic reflections indicating a location of the identified anomaly (see Holley para. 0089).
Regarding claim 37, Holley discloses a method for detecting an occlusion within a respiratory therapy system (see Holley Fig. 1 showing respiratory therapy device/system, abstract for example), the method including determining an acoustic signature for a conduit during operation of the respiratory therapy system (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example); analyzing the determined acoustic signature to identify anomalies in the acoustic signature during operation of the respiratory therapy system and determining an identified anomaly in the acoustic signature relates to an occlusion of at least one of the one or more conduits (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example; specifically para. 0089 identifies an anomaly as being an obstruction/occlusion in the conduit, the location of the occlusion and the extent of the occlusion). Holley is silent as to providing this acoustic signature analysis of the respiratory conduit being one or more headgear conduits of a headgear user interface having plural headgear conduits; however, Veliss teaches a similar, well-known patient interface in the form of a headgear user interface having plural headgear conduits (see Veliss Fig. 1-4 to 1-6 for example and accompanying written disclosure describing these figures, headgear user interface including a connector 70 which connects to main air supply tube and plural headgear conduits 42 connected to sealing cushion interface 80). Thus 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 Holley method to be applied for determining presence/location/extent of occlusions in a conduit of a headgear user interface having plural headgear conduits, as taught by Veliss, as this would have been obvious substitution of one known element for another (type of user/patient interface).
Regarding claim 73, Holley discloses a system for detecting an occlusion within a respiratory therapy system (see Holley Fig. 1 showing respiratory therapy device/system, abstract for example) which includes a memory having stored thereon machine readable instructions (see para. 0084, 0107, 0161, 0188); a control system including one or more processors configured to execute the instructions (para. 0015, 0018-0019, 0107, 0161, 0188) to: determining an acoustic signature for one or more conduits during operation of the respiratory therapy system (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example); analyzing the determined acoustic signature to identify anomalies in the acoustic signature during operation of the respiratory therapy system and determining an identified anomaly in the acoustic signature relates to an occlusion of at least one of the one or more conduits (see para. 0012-0020, 0079-0089, 0101, 0111-0112 for example; specifically para. 0089 identifies an anomaly as being an obstruction/occlusion in the conduit, the location of the occlusion and the extent of the occlusion). Holley is silent as to providing this acoustic signature analysis of the respiratory conduit being one or more headgear conduits of a headgear user interface having plural headgear conduits; however, Veliss teaches a similar, well-known patient interface in the form of a headgear user interface having plural headgear conduits (see Veliss Fig. 1-4 to 1-6 for example and accompanying written disclosure describing these figures, headgear user interface including a connector 70 which connects to main air supply tube and plural headgear conduits 42 connected to sealing cushion interface 80). Thus 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 Holley system to be applied for determining presence/location/extent of occlusions in a conduit of a headgear user interface having plural headgear conduits, as taught by Veliss, as this would have been obvious substitution of one known element for another (type of user/patient interface).
Regarding claim 74, the modified Holley system’s control system is further configured to execute the machine-readable instructions to identify the headgear user interface (see Holley para. 0021-0024, para. 0117-0123 which discloses identifying accessory/mask, modified in view of Veliss would provide for identifying the headgear user interface).
Claim(s) 4-7, 13, and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley and Veliss as applied to claims 1 and 73 above, and further in view of Jafari et al. (2011/0209704).
Regarding claim 4, the modified Holley method is silent as to in response to determining the anomaly/occlusion, to determine a modification to air flow settings in the respiratory therapy system during a session to increase air flow to the headgear user interface; however, Jafari discloses a similar respiratory therapy system which includes modifications to therapy settings in response to occlusions (see Jafari para. 0058). Thus 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 modified Holley method to adjust therapy settings such as to achieve increased air flow, as taught by Jafari, in order to provide that the system/method is responsive to the potential detected occlusion and to provide the ventilation support during such occlusions (Jafari para. 0058).
Regarding claim 5, the modified Holley method’s modification to the settings includes increasing air flow to achieve desired headgear user interface pressure setting for the session (see Jafari para. 0058).
Regarding claim 6, the modified Holley method increasing of air flow to achieve a desired headgear user interface pressure setting includes increasing air flow, via a flow generator motor of the respiratory therapy system, based on predetermined pressure-flow relationships for (i) a headgear conduit having an occlusion, (ii) a headgear conduit that is unobstructed, or both (i) and (ii) (see Jafari para. 0058; Holley para. 0082 disclosing the blower which is a motor driven flow generator, the control of the system is based on detected presence or absence of occlusion).
Regarding claim 7, the modified Holley method’s increased air flow for the occluded headgear conduit is less than the air flow for non-occluded headgear during the therapy session (Jafari para. 0058, it being obvious to choose particular values for the airflow to obtain a predicted/desired result).
Regarding claim 13, the modified Holley method is such that in response to an implemented modification to therapy flow settings after determining the identified anomaly in the determined acoustic signature relates to an occlusion, continuing to determine acoustic signatures for the one or more headgear conduits during the therapy session using the respiratory therapy system (Holley para. 0012-0020, 0079-0089, 0101, 0111-0112; which is performed during therapy session and thus being con continuously); comparing at least one of the continued determined acoustic signatures with one or more baseline acoustic signatures associated with the one or more headgear conduits during a therapy session using the respiratory therapy system (see Holley para. 0030-0032, 0077, 0089); in response to at least one of the continued determined acoustic signatures substantially matching one or more baseline acoustic signatures relating to non-occluded headgear conduits, determining a further modification to air flow in the respiratory therapy system during a therapy session to achieve desired headgear user interface pressure settings for the respiratory therapy system (Jafari para. 0058).
Regarding claim 75, the modified Holley system is silent as to the control system configured to execute the instructions to: in response to determining the anomaly/occlusion, to determine a modification to air flow settings in the respiratory therapy system during a session to increase air flow to the headgear user interface; however, Jafari discloses a similar respiratory therapy system which includes modifications to therapy settings in response to occlusions (see Jafari para. 0058). Thus 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 modified Holley system to adjust therapy settings such as to achieve increased air flow, as taught by Jafari, in order to provide that the system/method is responsive to the potential detected occlusion and to provide the ventilation support during such occlusions (Jafari para. 0058).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holley and Veliss as applied to claim 1 above, and further in view of Komar et al. (2021/0023317).
Regarding claim 9, the modified Holley method is silent as to the determination of the anomaly/occlusion in the acoustic signature being continuous for a series of determinations over a predetermined period of time; however, Komar teaches a similar method which includes detecting an event over a series of determinations for a period of time (see Komar para. 0034). Thus 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 modified Holley method’s occlusion determination to be done over a series of determinations over a period of time, as taught by Komar, in order to prevent false occlusion determinations (see Komar para. 0034).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Chamtie et al. (2020/0282161) discloses an acoustic measurement system for clogging of respiratory interfaces, Sullivan et al. (5,245,995) discloses a CPAP treatment system which utilizes acoustic measurements for occlusions, Kwok et al. (6,044,844), Kwok et al. (2007/0246043), and Rothermel et al. (2019/0298954) disclose user interfaces with headgear and breathing conduits integrated together similar to the claimed/disclosed invention.
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/COLIN W STUART/Primary Examiner, Art Unit 3785
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