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 .
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 1, 4, 7, 8, 10, 12, 13, 22, 25, 27, 81, 83 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 1 now calls for determining “(i) a site location of a physical obstruction” and/or “(iv) a site location of the physical obstruction”. It is unclear if this is a typographical error where the intent is to find some other parameter, or merely a repetition of the same finding. Clarification is required.
Claim 22 recites “detect the acoustic reflection of the acoustic signal emitted by the acoustic device”; there is no antecedent basis for this recitation in the claim as line 2 does not define any relationship between the acoustic signal and the acoustic reflection. For the purposes of examination line 2 will be treated as though defining that the acoustic reflection is a reflection of the emitted acoustic signal; correction is required.
Claim 28 now defines that the system is configured to cause emission of the acoustic signal “after a detection of” various events. Claim 22 requires emission of the acoustic signal in order to allow evaluation of any event, such that it is not possible to limit the instructions to cause that signal to be emitted only after such evaluation. It appears this may be an additional/secondary emitting of an acoustic signal; for the purposes of examination the claim will be treated as such but clarification is required. Further, there is still no antecedent basis for “after a detection of” any event as claim 22 only recites that there is a characterization which is indicative of one of these events, but does not at any point call for detection of one of these events. Correction is required.
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, 4, 7, 8, 10, 12, 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “analyzing acoustic data”, “characterizing an occurrence of an event”, “determining…a site”, “responsive to the characterization… providing a recommendation”.
This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application because:
The recited characterization does not provide any improvement to technology; no details of performance of the characterization are recited and the result is not used in any manner beyond a nonspecific output in an unidentified format of a nonspecific message
The recited characterization is not applied or used to effect a particular treatment; the result is not used for any treatment purpose
The recited characterization does not effect any transformation or reduction of an article; it is simply manipulation of data
The recited characterization is not applied or used in any meaningful way
As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no actual elements are identified as performing any step within the abstract idea itself. The recited but unspecified “acoustic device” is recited at a high level of generality only for the insignificant extrasolution activity of data gathering, where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional. See MPEP 2106.05(d). Similarly, the claim makes reference to use of data received from a motion sensor, but does not actively involve use of the motion sensor as part of the claimed method, only the receipt of data, which is a well-understood, routine, and conventional requirement that data must be received in order to analyze that data. The task of “providing a recommendation” is also entirely disembodied and thus mental, but even if embodied it would likely be no more than the insignificant postsolution activity of outputting a result of the abstract idea (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity). As such, considered individually and as a whole, the claim elements do not amount to significantly more than the abstract idea itself. Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 4, 7, 8, 10, 12, 13 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited, as claims 4, 7, 8 and 13 are directed to aspects of the abstract characterization itself; claim 10 is ostensibly directed to the extrasolution activity of data gathering but remains entirely disembodied. Claim 12 appears to be an attempt at providing a practical application of the abstract idea, but adjusting some unidentified settings in an unidentified manner for a nonspecific therapy that does not identify how or why the adjustment is made or how it relates to the characterization is not sufficiently specific to constitute providing a practical application of the judicial exception itself.
Claims 22, 25, 27, 81, 83 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 22 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 22 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “analyze acoustic data”, “characterize an occurrence of an event”, “determine…a site”, “providing a recommendation”.
This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application because:
The recited characterization does not provide any improvement to technology; no details of performance of the characterization are recited and the result is not used in any manner beyond a nonspecific output of a nonspecific message
The recited characterization is not applied or used to effect a particular treatment; the result is not used for any treatment purpose
The recited characterization does not effect any transformation or reduction of an article; it is simply manipulation of data
The recited characterization is not applied or used in any meaningful way beyond generally linking it to a generic technological environment for its execution (“memory device”, “control system”, and “processors”) - see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions
As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The other recited elements are a nonspecific “acoustic device” used as part of the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional), and a nonspecific “motion sensor” recited at a high level of generality and also used only for extrasolution data gathering. The recited “memory device”, “control system”, and “processors” are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. As such, considered individually and as a whole, the claim elements do not amount to significantly more than the abstract idea itself.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 22 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 25, 27, 81, 83 fail to cure the deficiencies of independent claim 22 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited, as claims 25 and 27 are directed to aspects of the abstract characterization itself and claims 81 and 83 are directed to the insignificant extrasolution activity of data gathering.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 7, 8, 10, 12, 13, 22, 25, 27, 81, 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilkinson (US 2006/0037615) in view of Shelly (US 2019/0099571).
Regarding claim 1, Wilkinson discloses a method comprising:
emitting an acoustic signal into an airway of a user via an acoustic device (paragraph [0045], [0135]);
detecting, via the acoustic device, an acoustic reflection of the acoustic signal caused by one or more physical features within the airway of the user (paragraphs [0045]-[0047], [0135]);
analyzing acoustic data associated with the acoustic reflection (paragraphs [0045]-[0047], [0175)];
characterizing an occurrence of an event in the airway of the user based, at least in part, on the analyzed acoustic data, the characterization being indicative of an obstructive apnea event, a central apnea event, a mixed apnea event, or a hypopnea event in the user (paragraphs [0047], [0049], [0074]-[0075]);
responsive to the characterization indicating the occurrence of an obstructive apnea event, a mixed apnea event, or a hypopnea event, determining a site location of a physical obstruction, a site size of the physical obstruction, and/or a site shape of the physical obstruction (paragraph [0174], “Measurement of the closure”).
Wilkinson does not disclose also detecting a position of the user based on motion data from a motion sensor that detects a user position and, responsive to the characterization indicating the occurrence of an obstructive apnea event, a mixed apnea event, or a hypopnea event, providing a recommendation based at least in part on the user position.
Shelly teaches a method comprising analyzing data associated with an airway of a user during respiration and characterizing an occurrence of a physical obstruction including hypopnea, central, mixed, or obstructive apnea events in the airway based on the analyzed data (paragraph [0029]), and further teaches detecting a position of the user based on motion data from a motion sensor that detects a user position (paragraph [0028]), and, based on the characterization as including an obstructive event, providing a recommendation based at least in part on the user position (paragraph [0033], [0036]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Wilkinson and also detected the user’s position using a motion sensor and provided a recommendation based on the position, as taught by Shelly, in order to provide additional data that could be used to aid in alleviating the effects of an obstruction.
Regarding claim 4, Wilkinson further discloses that the characterization of the event can indicate an absence of a physical obstruction (paragraph [0045], “whether the airway is open or not”).
Regarding claim 7, Wilkinson further discloses determining a duration of the occurrence of the physical obstruction within the airway of the user (see figures 11a, 11b, showing the data over time).
Regarding claim 8, Wilkinson further discloses determining the duration of the occurrence of the physical obstruction by analyzing acoustic data associated with acoustic reflections of acoustic signals emitted over a period of time, the period of time including a start and end of the occurrence of the physical obstruction (see figures 11a, 11b).
Regarding claim 10, Wilkinson further discloses emitting the acoustic signal continuously during the occurrence of the event (see figures 11a, 11b).
Regarding claim 12, Wilkinson further discloses automatically changing settings of a therapy for treatment of the event in the user based on the physical obstruction (paragraph [0050]).
Regarding claim 13, Shelly’s detection of the user’s location/body is a detection of an organ (skin) of the user.
Regarding claim 22, Wilkinson discloses a system comprising:
an acoustic device for emitting an acoustic signal and detecting an acoustic reflection of the emitted acoustic signal (paragraphs [0045], [0135]);
a memory device storing machine-readable instructions and a control system including one or more processors communicatively coupled to the acoustic device (paragraph [0264]),
the control system being configured to execute the machine-readable instructions to:
detect the acoustic reflection of the acoustic signal emitted by the acoustic device into an airway of the user, the acoustic reflection being caused by one or more physical features within the airway of the user (paragraphs [0045]-[0047], [0135]),
analyze acoustic data associated with the acoustic reflection (paragraphs [0045]-[0047], [0175]), and
characterize an occurrence of an event in the airway of the user based, at least in part, on the analyzed acoustic data, the characterization being indicative of an obstructive apnea event, a central apnea event, a mixed apnea event, or a hypopnea event in the user (paragraphs [0047], [0049], [0074], [0075]); and
responsive to the characterization indicating the occurrence of an obstructive apnea event, a mixed apnea event, or a hypopnea event, determining a site location of a physical obstruction, a site size of the physical obstruction, and/or a site shape of the physical obstruction (paragraph [0174], “Measurement of the closure”).
Wilkinson does not further disclose a motion sensor for detecting a user position, wherein a position of the user is detected based on motion data from the motion sensor and, responsive to the characterization indicating the occurrence of an obstructive apnea event, a mixed apnea event, or a hypopnea event, providing a recommendation based at least in part on the user position.
Shelly teaches a system configured to analyze data associated with an airway of a user during respiration and characterizing an occurrence of a physical obstruction including hypopnea, central, mixed, or obstructive apnea events in the airway based on the analyzed data (paragraph [0029]), and further teaches detecting a position of the user based on motion data from a motion sensor in the system that detects a user position (paragraph [0028]), and, based on the characterization as including an obstructive event, providing a recommendation based at least in part on the user position (paragraph [0033], [0036]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Wilkinson and also included a motion sensor and detected the user’s position using the motion sensor and provided a recommendation based on the position, as taught by Shelly, in order to provide additional data that could be used to aid in alleviating the effects of an obstruction.
Regarding claim 25, Wilkinson further discloses that the characterization of the event can indicate an absence of a physical obstruction (paragraph [0045], “whether the airway is open or not”).
Regarding claim 27, Wilkinson further discloses that the control system is further configured to execute the machine-readable instructions to determine a duration of the occurrence of the physical obstruction within the airway of the user (see figures 11a, 11b).
Regarding claim 28, Wilkinson further discloses that the control system is further configured to execute the machine-readable instructions to emit the acoustic signal at specific monitoring times after a detection of the event (see figures 11a, 11b – the signal is also emitted after the event’s start is detected).
Regarding claim 81, Shelly further teaches that the user position includes one or more of a user location and a user orientation (paragraph [0028]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Wilkinson, as modified above, with the user position being indicative of a user location or orientation, as further taught by Shelly, in order to provide additional information of the user’s status.
Regarding claim 83, Shelly further teaches that the motion sensor is selected from a group consisting of a camera, a bed sensor, an accelerometer, a sonar sensor, and a radio frequency sensor such as an impulse-radio ultra wideband (IR-UWB) sensor (paragraph [0028]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Wilkinson, as modified above, with the motion sensor being one of a camera, a bed sensor, an accelerometer, a sonar sensor, and a radio frequency sensor such as an impulse-radio ultra wideband (IR-UWB) sensor, as further taught by Shelly, in order to provide accurate positioning information.
Response to Arguments
Applicant's arguments filed 24 November 2025 have been fully considered but they are not persuasive.
Regarding the rejection under 112 of claim 28, Applicant attempts to argue that the recitation of characterizing an occurrence of an event based on analyzed acoustic data that is associated with an acoustic reflection of an emitted acoustic signal does not require emission of an acoustic signal, apparently believing that the recited “a detection of the obstructive apnea event, central apnea event, mixed apnea event, or hypopnea event” can refer to some other detection despite being “a” detection of the event as defined as being found in claim 22. Detection of the event as performed by the device of claim 22 requires emission of an acoustic signal, such that it is not possible for the emission of the signal to only take place after the event has been detected. If the intent is to also include some other detection of an event the claims should be clearly drafted to include the device also being configured to recite this additional input and define how it relates to any other detection being performed. As presented, the claims call for the signal used to detect the event to be emitted only after that event has already been detected.
Regarding the interpretations of the claim limitations under 112f, the Examiner notes that these are not rejections under 112 as discussed by Applicant; further, Applicant argues against such interpretation because the limitations do not use the term “means” despite the MPEP making clear that equivalents to means are also subject to such interpretation, and attempts to argue that recitations of “for emitting a signal” and “storing… instructions” provide structure despite these being functions, not structure. The interpretations remain unchanged.
Regarding the rejections under 101, Applicant initially argues that the step of “characterizing an obstructive apnea or hypopnea event using received acoustic data” cannot be performed “manually by any human elements”. As this is not a limitation found in any claim, this argument is moot.
Applicant continues by asserting that no part of the Office’s 101 guidance would “support an assertion that the above quoted elements allegedly recited by Applicant’s independent claims” represent mental processes; again, as the “above quoted elements” are not recited in the claims under examination at this time, this allegation is moot.
Applicant next argues that the claims as presented provide a specific technological improvement, that being achieving detection of apneas/hypopneas and discrimination of central from obstructive events “without the ‘potential discomfort associated with the FOT method’” by the use of acoustic signals and acoustic reflections. It should be noted that the specification “must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.” MPEP 2106.05(a) One of ordinary skill in the art in the field of sleep disordered breathing would be familiar with the use of acoustic signals reflected in an airway as used for detecting apneic events and discriminating between central and obstructive events, as evidenced by Wilkinson above, and further evidenced by at least Behbehani (US 6142952), Kayyali (US 9615773), Miles (US 5353788), Holley (US 2011/0313689), Gaumond (US 6379311), and Chamtie (US 2020/0282161), such that their use alone cannot be considered an improvement in the art of respiratory monitoring. Still further, as no specifics of any of the steps of processing data obtained from these sensors have been recited in the invention as claimed, there does not appear to be any particular advantage or improvement provided by using acoustic signals in evaluating the condition of an airway that would be recognized by one of ordinary skill in the art.
Applicant continues by arguing that the “independent claims amount to ‘significantly more’ than any alleged abstract idea”; the Examiner notes that Step 2B of analysis is directed to whether the claims recite additional elements which amount to significantly more than the abstract idea, not the claims as a whole. Further, Applicant’s arguments in this section are directed to “the above-quoted elements” representing “a specific technological improvement” – as this is not what is evaluated in step 2B these remarks are moot.
Applicant next asserts that the analysis of the claims has omitted the aspect of step 2B as to whether the additional elements provide an inventive concept; as noted above, they do not. The Examiner also notes that Applicant has not provided any suggestion of what this “inventive concept” provided by the additional elements might be or which “features” allegedly “exceed” well-understood, routine, and conventional activities, such that the mere assertion that these are present is entirely unpersuasive. The claims remain rejected.
Regarding the art rejections, Applicant’s remarks directed to Kayyali are moot in light of the amendments to the claims changing their scope; these will not be further addressed.
Regarding the rejections under Wilkinson as modified by Shelly, Applicant initially argues that Shelly does not teach detecting a position of the user, pointing to Shelly paragraph [0029], which is not cited as teaching this, and omitting the citation of Shelly paragraph [0028] which does clearly teach detecting a position of the user, and then asserts that Shelly does not teach “or even suggest” using the data to “provid[e] a recommendation based on the physical obstruction and the user position”. As this limitation is not found in any claim, this argument is moot. The Examiner notes that this limitation was found in previous claim 11, but claim 1 as presented only calls for the recommendation to be based on the user position and does not incorporate all of the limitations of previous claim 11. Still further, Shelly does clearly provide recommendations based upon the user position, as cited above.
Applicant continues by presenting what appears to be a misinterpretation of how the claims have been rejected under 103 as Wilkinson as modified by Shelly and not Shelly modified by Wilkinson, asserting that Shelly does not teach or suggest the numerous limitations which are cited above and in the previous office action as being disclosed by Wilkinson; there is no need for Wilkinson to “cure” these “deficiencies” in Shelly as Shelly is not relied upon to teach these. The Examiner notes that Applicant has not presented any arguments directed to what Wilkinson is relied upon to disclose, such that the general allegation of various “deficiencies” being present in either reference is entirely unpersuasive. The claims remain rejected.
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.
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/KAREN E TOTH/Examiner, Art Unit 3791