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
The present office action represents the first action on the merits.
Claims 1-36 are pending.
Priority
This application claims priority to U.S. Patent Application No. 17/826,226 dated 27 May 2022 which 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 27 October 2025, 09 September 2025, 10 January 2025, and 04 April 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within the independent claim. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: computing summary data for each of a plurality of patients receiving the respiratory pressure therapy based on the received data from each patient’s respiratory pressure therapy device. Therapy summary data is computed from the summary data, where the summary data comprised either leak flow rates or AHI’s and respiratory pressure device usage times. A plurality of rules are applied to the therapy summary data, including a first clinical rule that compares leak flow rates or AHI’s to a first threshold and a compliance rule that compares the compliance data to a compliance standard. Each of a plurality of workflow groups corresponding to the rules are updated by adding a patient to the workflow when they meet the rule. A notification regarding the updating is sent along with a graphical layout having a selectable heading. A selection of the selectable heading is received and another graphical layout is sent having details of the patient in the workflow group.
The most remarkable prior art of record is as follows:
Psynik et al.: U.S. Pre-Grant Patent Publication No. 2008/0114689;
Schurenberg et al.: U.S. Pre-Grant Patent Publication No. 2002/0007284;
Duckworth et al.: U.S. Pre-Grant Patent Publication No. 2015/0154380;
Reiner: U.S. Pre-Grant Patent Publication No. 2011/0270623;
Pipke et al.: U.S. Pre-Grant Patent Publication No. 2015/0186602;
Dunn et al.: U.S. Patent No. 8,775,200;
Amurthur: WIPO Publication No. WO2010/104678;
Valentin et al.: Air Leak Is Associated With Poor Adherence to AutoPAP Therapy;
Ryan et al.: U.S. Pre-Grant Patent Publication No. 2010/0138232;
Papadopoulos et al.: U.S. Pre-Grant Patent Publication No. 2014/0155705;
Stroup et al.: U.S. Pre-Grant Patent Publication No. 2007/0016440;
Ober et al.: U.S. Pre-Grant Patent Publication No. 2016/00193351.
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 1-36 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.
Claims 1 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a system and method for managing patient compliance with respiratory pressure therapy, which are within a statutory category.
Step 2A1
The limitations of (Claim 20 being representative): receiving therapy data concerning patient respiratory pressure therapy; computing therapy summary data from the therapy data, the therapy summary data comprising (a) one or more leak flow rates or one or more Apnea / Hypopnea Indices (AHI's) and (b) one or more usage times for each of a plurality of patients receiving the respiratory pressure therapy; applying a plurality of rules to the therapy summary data, the plurality of rules comprising a first clinical rule and a compliance rule, the first clinical rule having a condition that compares the one or more leak flow rates or the one or more AHi' s to a first predetermined threshold, the compliance rule having a condition that compares the one or more usage times to a predetermined compliance standard; updating a plurality of workflow groups, each workflow group corresponding to one of the plurality of rules, depending on results of the respective rule applications, wherein updating the plurality of workflow groups comprises adding at least one of the patients to a workflow group of patients experiencing compliance difficulties; sending in response to updating the plurality of workflow groups, a notification for addressing the compliance difficulties; serving a first graphical layout comprising a selectable heading for each of the plurality of workflow groups; receiving a selection of the selectable heading for the workflow group of patients experiencing compliance difficulties via an interaction with the first graphical layout; and serving in response to receiving the selection of the selectable heading, a second graphical layout comprising details of one or more patients in the workflow group of patients experiencing compliance difficulties, 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.
That is, other than reciting a system implemented on/by a plurality of servers or a method implemented by one or more processors, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the plurality of servers or one or more processors, the claims encompass a person collecting respiratory therapy data for patients, analyzing the patient data to therapy summary data, applying rules that compare data to standards, updating workflow groups, and sending and receiving related data in the manner described in the identified abstract idea, supra. 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 claim recites the additional element(s) of a plurality of server or one or more processors that implements the identified abstract idea. The servers or processors are not described by the applicant and are recited at a high-level of generality (i.e., generic servers pr components thereof) such that it amounts no more than mere instructions to apply the exception using generic computers. 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 (1) a plurality of respiratory pressure therapy devices and (2) a computing device. The (1) 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. The (2) computing device merely generally links 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. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claims further recite the additional element of the data servers being “in communication” with a plurality of respiratory pressure therapy devices and/or one another and/or a computing device, which represent the transmission/receipt of data over a network. Each of these transmission/receipt steps are recited at a high level of generality (i.e., as a general means of transmitting/receiving data) and amounts to the mere transmission of data, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Given the broadest reasonable interpretation, the claim limitation of “receive a selection of [a] selectable heading” 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, this additional element does 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 element(s) of using a plurality of servers or one or more processors to perform the noted steps amounts to no more than mere instructions to apply the exception using generic computer components. 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 (1) a plurality of respiratory pressure therapy devices were considered to represent extra-solution data gathering activity and (2) a computing device which generally linked the abstract idea. 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 element of communicating data was considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the claim limitation of “receive a selection of [a] selectable heading” was alternately interpreted extra-solution activity. The prior art of record indicates that graphical layouts displaying selectable data that is implemented after “receiv[ing] a selection” 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 2-19 and 21-36 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) 2, 21 merely describe(s) the one or more details of the patient, which further defines the abstract idea.
Claim(s) 3, 4, 6, 22, 23, 25 merely describe(s) receiving and outputting data, which further defines the abstract idea.
Claim(s) 3, 4, 6, 22, 23, 25 also include features that occur “in response to receiving the selection.” 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 “in response to receiving the selection” feature of Claim 1 and does not provide a practical application or significantly more for the same reasons.
Claim 6, 25 includes the additional element of “a selectable checkbox” which represent extra-solution data gathering activity. The prior art of record indicates that “a selectable checkbox” is well-understood, routine, conventional activity in the field (see US 2015/0347413 to Brady et al. at Para. 0066; US 2010/0169888 to Hare et al. at Para. 0234; US 2002/0116256 to De Rafael at Para. 0031). MPEP 2106.05(A) further indicates that well-understood, routine, and conventional activity of use cannot provide significantly more.
Claim(s) 5, 24 merely describe(s) data about the patients, which further defines the abstract idea.
Claim(s) 7, 26 merely describe(s) how workflow groups are updated, which further defines the abstract idea.
Claim(s) 8, 11, 27, 30 merely describe(s) sending a notification, which further defines the abstract idea.
Claim(s) 9, 10, 28, 29 merely describe(s) the intended use of the notification, which further defines the abstract idea.
Claim(s) 12 merely describe(s) the arrangement of data processing (i.e., servers, which are additional elements per Claim 1), which further defines the abstract idea.
Claim(s) 13 merely describe(s) the number of data sources (i.e., respiratory pressure therapy devices, which are additional elements per Claim 1), which further defines the abstract idea.
Claim(s) 14, 15, 19, 31, 32, 36 merely describe(s) the therapy summary data, which further defines the abstract idea.
Claim(s) 16, 33 merely describe(s) the first predetermined threshold, which further defines the abstract idea.
Claim(s) 17, 18, 34, 35 merely describe(s) the predetermined compliance standard, which further defines the abstract idea.
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 1-36 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 1-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 37-72 copending Application No. 17/826,226 (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.
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:
Kimmel et al. (U.S. Patent No. 6,910,481) which discloses a system for measuring and outputting compliance data of a pressure support system.
Carter et al. (U.S. Patent No. 8,789,527) which discloses a pressure support apparatus that automatically adjusts treatment by comparing treatment set point data.
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.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683