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 .
DETAILED ACTION
In the amendment dated 16 July 2026, the following occurred: Claims 37, 52, 65, and 69 have been amended.
Claims 37-39, 41-54, 56-67, and 69-78 are pending.
Priority
This application claims priority to U.S. Patent No. 11,367,023 dated 61/780,640 dated 27 January 2017 which claims priority to PCT/US2015/043226 dated 31 July 2015 which claims priority to U.S. Provisional Patent Application No. 62/031,975 dated 01 August 2014.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 04 June 2026 and 29 July 2026 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
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 37-39, 41-54, 56-67, and 69-78 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
STEP 1
Claims 37, 52, and 65 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system, method, and computer-readable medium (“CRM”) for managing patient compliance with respiratory pressure therapy, which are within a statutory class.
STEP 2A1
The limitations of (Claim 52 being representative) receiving data concerning patient respiratory pressure therapy from a plurality of respiratory pressure therapy devices; generating, by applying a compliance model to the received data, a score for each of a plurality of patients receiving the respiratory pressure therapy, wherein each score indicates a probability that a respective patient will meet a compliance standard, and wherein the compliance standard has a minimum amount of usage per session for a fraction of a number of consecutive sessions of respiratory pressure therapy and wherein one or more parameters of the compliance model are altered between executions of the compliance model as the respiratory pressure therapy proceeds according to a predetermined schedule; grouping the plurality of patients receiving the respiratory pressure therapy into a plurality of groups based on a time-based assessment of the received data, wherein the time-based assessment evaluates a period of days that each of the plurality of patients has been on the respiratory pressure therapy; generating […information…] representing the plurality of groups, wherein the plurality of groups is displayed, each […displayed group…] corresponding to a particular group; in response to user input, receiving a user selection of one group of the plurality of groups displayed, the user selection for activation of the one group; and generating upon activation of the one group […], a […] listing [of] a subset of the patients in the one group, wherein the subset of the patients in the one group are ranked […and displayed…] according to their scores, as drafted, is a process that, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components.
The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to managing patient compliance with respiratory pressure therapy (see Spec. Para. 0002) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receive data…generate data…group data…receive data…and generate data,” as indicated supra.
That is, other than reciting a system implemented by one or more processors or a CRM having graphical displays (discussed, infra), the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the one or more processors or the CRM having graphical displays, the claims encompass a person collecting respiratory therapy data for patients, analyzing the patient data to create scores, grouping patients based on the scores, and outputting data based on the grouped scores in the manner described in the identified abstract idea, supra. The Examiner notes that Applicant has described monitoring of CPAP compliance as a product of CMS compliance standards promulgated by Medicaid (see Spec. Para. 0020). As the cited evidentiary references indicate, monitoring of CPAP usage for patients to determine whether CMS compliance standards are met is a human task performed by healthcare providers, i.e., sleep specialists (see Schwab et al. at Pg. 616; Continuous Positive Airway Pressure Devices & Accessories at Pg. 3; What Is CPAP Compliance? at Pg. 4).
Further, and as is known in the art, healthcare providers (i.e., sleep specialists) routinely monitor multiple patients for CPAP compliance at the same time (see US 2008/0114689 to Psynik et al. at Fig. 5, Para. 0051; US2015/0154380 to Duckworth at Para. 0119, 0122, 0123), thus it is a human task. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
STEP 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of one or more processors or a CRM having graphical displays that implements the identified abstract idea. The one or more processors or CRM having graphical displays are not described by the applicant and are recited at a high-level of generality (i.e., generic processors or storage device performing a generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims further recite the additional elements of a plurality of respiratory pressure therapy devices. The respiratory pressure therapy devices represent locations from which data is received, which is a form of extra-solution data gathering activity. MPEP 2106.04(d)(I) indicates that merely adding insignificant extra-solution activity to the judicial exception cannot provide a practical application. Alternatively, the respiratory pressure therapy devices merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
The claims further recite the additional elements of an array of selectable headings. The array of selectable headings (i.e., tabs) merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Given the broadest reasonable interpretation, the claim limitation of “upon activation” is interpreted as part of the rules or instructions for a person to follow, i.e., choosing to display information. In the event that this element can alternately be interpreted as an additional element outside of the abstract idea, the limitation represents extra-solution activity. MPEP 2106.04(d)(I) indicates that merely adding insignificant extra-solution activity to the judicial exception cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
STEP 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using one or more processors or a CRM having graphical displays to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a plurality of respiratory pressure therapy devices were considered to represent extra-solution data gathering activity. The Background section of Applicant’s Specification indicates that respiratory pressure therapy devices that output data are well-understood, routine, and conventional in the field. Further and for completeness, the prior art of record indicates that the receiving data from respiratory pressure therapy devices is well-understood, routine, and conventional in the field (see also, US 2008/0114689 to Psynik at Para. 0032, 0034, US 2015/0154380 to Duckworth at Para. 0127, WO 2004/110540 to Hebblewhite at Pg. 2, US 2014/0207476 to Fong at Para. 0133). Alternatively, the respiratory pressure therapy devices merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of an array of selectable headings were considered to generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Further and for completeness, the prior art of record indicates that an array of selectable headings is well-understood, routine, and conventional in the field. See US 2007/0088406 to Bennett et al. at Fig. 11, Para. 0051; US 2001/0040584 at Fig. 11, Para. 0047; US 2002/0004729 to Zak et al. at Para. 0078, Fig. 8; US 2008/0114689 to Psynik at Fig. 4A.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the claim limitation of “upon activation” was alternately interpreted extra-solution activity. The prior art of record indicates that graphical layouts displaying selectable data that is implemented “upon activation” is well-understood, routine, conventional activity in the field (see US 2008/0114689 to Psynik at Fig. 4A, WO 2004/110540 to Hebblewhite at Fig. 1, US 2016/0019351 to Ober at Fig. 11, Para. 0007, Claim 23, US 20150100327 to Kelley at Fig. 3A, 5). MPEP 2106.05(A) further indicates that well-understood, routine, and conventional activity of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 38, 39, 41-51, 53, 54, 56-64,66, 67, and 69-78 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 38, 53, 66 merely describe(s) the type of data received.
Claim(s) 39, 54, 67 merely describe(s) data that is displayed, which further defines the abstract idea.
Claim(s) 41, 42, 43, 44, 45, 46, 47, 48, 56, 57, 58, 59, 60, 61, 62, 63, 69, 70, 71, 73-78 merely describe(s) the data displayed and/or additional data that is displayed, which further defines the abstract idea.
Claim(s) 41, 42, 43, 44, 45, 46, 48, 56, 57, 58, 59, 60, 61, 62, 63, 69, 70, 71, 73-78 also include features that occur “upon activation.” As with the independent claims, this is interpreted to be part of the rules or instructions for a person to follow, i.e., choosing to display or not display information. Alternately interpreting this feature as an additional element, the feature is interpreted in the same manner as the “upon activation” feature of Claim 37 and does not provide a practical application or significantly more for the same reasons.
Claims 73-78 further recite the additional element of a graphical icon in the form of a checkbox. The icon in the form of a checkbox merely generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Further, and for completeness, the prior art of record indicates that a selectable icon in the form of a checkbox is well-understood, routine, and conventional in the field. See US 2002/0116256 to De Rafael et al. at Para. 0031; US 2015/0356662 to Poole et al. at Para. 0060; US 2009/0248702 to Schwartz et al. at Para. 0085.
Claim(s) 49, 64, 72 merely describe(s) what the score represents, which further defines the abstract idea.
Claim(s) 50, 51 positively recites the additional elements of the respiratory pressure therapy devices being part of the system. These additional elements generally link the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide a practical application or significantly more.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 37-39, 41-54, 56-67, and 69-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,367,023. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite determining compliance/usage information and displaying associated data in a manner that is an obvious variation on one another.
Claims 37-39, 41-54, 56-67, and 69-78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-36 of copending Application No. 18/828,543 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite determining compliance/usage information and displaying associated data in a manner that is an obvious variation on one another. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Double Patenting
Regarding the rejection of Claim 37-72, the Applicant has cancelled Claims 40, 55, and 68 rendering the rejection of those claims moot. Regarding the remaining claims, the Applicant requests reconsideration of the rejection or that the rejection be held in abeyance. The Examiner has reconsidered the rejections and finds it to be proper. Further, the rejection cannot be held in abeyance. See MPEP 804 (“As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated.”). Therefore, the rejection is maintained.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 37-39, 41-54, 56-67, and 69-78, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
With regard to Step 2A, Prong One, Applicant asserts that the claims are not merely directed to "managing personal behavior including following rules or instructions," as alleged in the Office Action. (Id. at 4). For example, claim 37 expressly recites " ... applying a compliance model to the received data" and further recites that " ... wherein one or more parameters of the compliance model are altered between executions of the compliance model as the respiratory pressure therapy proceeds according to a predetermined schedule." […] Repeatedly adjusting parameters of a compliance model itself is not merely "managing personal behavior or
Regarding (a), the Examiner respectfully submits that these features are part of the abstract idea. Adjusting parameters of a model is part of the rules or instructions and the Applicant has not provided any arguments as to why these cannot be part of the rules or instructions.
Like Example 39, which recites training a neural network but does not set forth or describe any mathematical relationships, calculations, formulas, or equations using words or other symbols, claim 37 of the subject application recites [various features of the claim]. […] Thus, claim 37 does not recite mathematical relationships, calculations, formulas, or equations, as claim 37 merely involves altering parameters of a compliance model between executions of the compliance model without specifying any particular mathematical relationships that are involved with regard to how this is quantified.
Regarding (b), the Examiner respectfully submits that Applicant is not claiming a neural network and thus this analogy falls on its face. Further, and as indicated in Applicant’s arguments at multiple locations, the abstract idea was not characterized as a mathematical concept and arguments directed to this are immaterial to the current rejection.
The subject application clearly identifies a problem in the field of medical therapy devices, and provides a solution that is recited in the claims.
Regarding (c), the Examiner respectfully disagrees. As has been discussed on multiple occasions, there is no technical problem and thus this test fails. Applicant is directed to previous Office Actions for discussion as to why this argument is not persuasive.
As described in the specification, a compliance model achieves this by altering parameters over time in order to improve the model itself.
Regarding (d), the Examiner respectfully submits that the model is part of the abstraction. An improved abstract idea is still an abstract idea. To the extent that Applicant is attempting to argue that the compliance model of the claim is equivalent to the machine learning improvement of Dejardens, the Examiner points out that the compliance model is not a machine learning model.
With regard to Step 2B, Applicant asserts that claim 37 clearly supplies an inventive concept beyond any alleged abstract idea. Claim 37 provides a particular solution… in a particular technological context.
Regarding (e), the Examiner respectfully disagrees. There is no technical problem as has been discussed on multiple occasions and thus this test fails. Applicant is directed to previous Office Action for discussion as to why this argument is not persuasive.
The Office Action has not shown that this ordered combination, including the adaptive alteration of compliance-model parameters between executions as therapy proceeds, is well-understood, routine, and conventional.
Regarding (f), the Examiner respectfully submits that there is no requirement that the rejection provide evidence that the abstraction is well-understood, routine, and conventional. MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).”
Finally, Applicant notes that the Memo states that "Examiners are reminded that if it is a "close call" as to whether a claim is eligible, they should only make a rejection when it is more likely than not (i.e., more than 50%) that the claim is ineligible under 35 U.S.C. 101. A rejection of a claim should not be made simply because an examiner is uncertain as to the claim's eligibility" (Memo at Page 5).
Regarding (g), the Examiner respectfully submits that Applicant’s invention is not even remotely a “close call.”
Interview Request
Applicant states: If, however, for any reason the Examiner does not believe that such action [allowance] can be taken at this time, it is respectfully requested that the Examiner telephone Applicant's attorney at (908) 738-1780 in order to overcome any additional objections which the Examiner might have.
The Examiner declines this request. The Examiner does not have any suggestions.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Bao et al. (U.S. Pre-Grant Patent Publication No. 2016/0193437) which discloses a respiratory apparatus that can be controlled via a mobile device to improve patient compliance.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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