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 Objections
Claim 14 is objected to because of the following informalities:
Claim 14 contains the limitation “wherein the determining of the arousal of the subject is based only a RIP belt signals.” The examiner has interpreted this to be read as “wherein the determining of the arousal of the subject is based only on RIP belt signals.”
Appropriate 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention details a system and method (Step 1) directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
In accordance with MPEP 2106.04, each of Claims 1-20 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of Claims 1-20 recites at least one step or instruction for determining an arousal or arousal-associated event of a subject, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). Accordingly, each of Claims 1-20 recites an abstract idea.
Specifically, Claim 1 recites
A method for determining an arousal or an arousal-associated event in a sleep study of a subject, the method comprising:
obtaining data from one or more body signals, the one or more body signals being non-brain signals; and (additional element)
determining an arousal of the subject using the data from one or more body signals. (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Similarly, Claim 16 recites,
A system for determining an arousal or arousal-associated event of a subject, the system comprising:
a receiver configured to receive one or more body signals, the one or more body signals being non-brain signals; and (additional element)
a memory storage having instructions stored thereon; and (additional element)
a processor configured to perform at least the following: and (additional element)
obtain data from one or more body signals, the one or more body signals being non-brain signals; (additional element)
determine an arousal or arousal-associated event of the subject using the data from one or more body signals. (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Lastly, Claim 19 recites,
A method of estimating an apnea-hypopnea-index (AHI) of a subject in a sleep study, the method comprising:
obtaining data from one or more body signals, the one or more body signals being non-brain signals; and (additional element)
determining an apnea-hypopnea-index (AHI) of the subject using the data from one or more body signals. (observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III))
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1, 16 and 19 (and their respective dependent claims 2-15, 17-18, and 20) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claims 1, 16 and 19), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). More specifically, the additional elements of: receiver, memory, processor and body signals data are generic and used for data gathering adding insignificant extra-solution activity to the judicial exception in independent Claims 1, 16 and 19 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 16, and 19 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., external programming device or computer as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f).
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 according to MPEP 2106.05(a). 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. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 16 and 19 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1, 16 and 19 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B per MPEP 2106.05
None of Claims 1-20 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: receiver, memory, processor and body signals data. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s instant specification, [0078] and [0131] the memory storage may include a separate memory from the processor, hardwired to the processor or physical storage media including computer hardware such as RAM, ROM, flash memory, and etc. with such generality that they are generic and commercially available. Further, in applicant’s specification [0125]-[0128] the processor may be combined with the memory and receiver to create the CPU 1001 as detailed in Fig 8 to implement the system utilizing different types of processors or operating systems and receive data from the recording devices specifically outlined in [0128] which are all generic and commercially available. Lastly, the body signal data can come from input devices as detailed in [0128] or the recording device as detailed in [0078] as Respiratory Inductive Plethysmography belts that are able to directly transmit to a processor (receiving the data) which is a generic sensor and further details in [0083] a wide array of other body signals/sensors may be used to capture the body signal data with such generality that they are generic and commercially available.
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing 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 technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for computers. 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 MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claims 1, 16 and 19 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 receive, store, or transmit 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 MPEP 2106.05(f) along with 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. See MPEP 2106.05(a) along with 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, per MPEP 2106.05(a), 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 system of Claims 1-20 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing 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 according to MPEP 2106.04(d)(2) and 2106.05(e).
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 1, 16 and 19 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). 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 according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements 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 according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, 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 according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-20 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-20 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-7, 10-13, 15 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoskuldsson (US 2019/0274586 A1), hereinafter, Hoskuldsson.
Regarding claim 1, Hoskuldsson discloses a method for determining an arousal or an arousal-associated event in a sleep study of a subject (e.g. abstract), the method comprising: obtaining data from one or more body signals, the one or more body signals being non-brain signals (e.g. [0063]; [0065]-[0067]; [0078]-[0079]); and determining an arousal of the subject using the data from one or more body signals (e.g. [0015]; [0022]; [0117]; [0276]; [0280] RERA (Respiratory Effort-Related Arousal) Fig 6 and 33).
Regarding claim 4, Hoskuldsson discloses wherein the one or more body signals are respiratory signals (e.g. [0065]-[0067]).
Regarding claim 5, Hoskuldsson discloses wherein the one or more body signals are non-cardiac body signals (e.g. [0065]-[0067]; [0078]-[0079]).
Regarding claim 6, Hoskuldsson discloses wherein the one or more body signals are indictive of a respiratory activity of the subject (e.g. [0065]-[0067]; [0078]-[0079]).
Regarding claim 7, Hoskuldsson discloses wherein the one or more body signals include respiratory inductance plethysmography (RIP) signals (e.g. [0065]-[0067] Fig 1A/B/C:31/32).
Regarding claim 10, Hoskuldsson discloses further comprising performing a prediction for each of a series of time intervals and aggregating the predictions to score an arousal event or an arousal- associated event (e.g. [0307]-[0308]).
Regarding claim 11, Hoskuldsson discloses wherein the arousal or arousal-associated event of the subject is determined without an EEG signal (e.g. [0075]-[0082] the system does not include an EEG signal).
Regarding claim 12, Hoskuldsson discloses a method of estimating an apnea-hypopnea-index (AHI) comprising the method for determining an arousal or an arousal-associated event in a sleep study of the subject according to claim 1 (e.g. abstract [0011]; [0072] Table 1).
Regarding claim 13, Hoskuldsson discloses wherein the body signals further comprise an additional body signal that is not a respiratory signal (e.g. [0078] the system can include a nasal cannula and an esophageal Pressure (Pes) catheter).
Regarding claim 15, A hardware storage device having stored thereon computer executable instructions which, when executed by one or more processors of a computer system, configure the computer system to perform the method according to claim 1 (e.g. Claim 20).
Regarding claim 19, Hoskuldsson discloses a method of estimating an apnea-hypopnea-index of a subject in a sleep study (e.g. abstract), the method comprising: obtaining data from one or more body signals, the one or more body signals being non-brain signals (e.g. [0063]; [0065]-[0067]; [0078]-[0079]); and determining an apnea-hypopnea-index (AHI) of the subject using the data from one or more body signals (e.g. abstract [0011]; [0072] Table 1).
Regarding claim 20, Hoskuldsson discloses wherein the one or more body signals include respiratory inductance plethysmography (RIP) signals (e.g. [0065]-[0067] Fig 1A/B/C:31/32).
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of Rapoport (US 7,896,812 B2)
Regarding claim 2, Hoskuldsson is silent regarding wherein determining the arousal or arousal-associated event includes using classifier to perform a classification of the of the one or more body signals.
However, Rapoport discloses a system and method for diagnosis and treatment of a breathing pattern of a patient wherein determining the arousal or arousal-associated event includes using classifier to perform a classification of the of the one or more body signals, specifically breathing/respiration signals (e.g. abstract; col 3 lines 7-9 and col 7 lines 33-53 and claim 13).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hoskuldsson to incorporate the teachings of Rapoport wherein determining the arousal or arousal-associated event includes using classifier to perform a classification of the of the one or more body signals for the purpose of utilizing a known way to determine arousal from breathing and respiration signals.
Regarding claim 3, modified Hoskuldsson discloses wherein the classifier is a neural network, an artificial neural network, a decision tree or trees, forests of decision trees, clustering, a support vector machine, a convolutional neural network (CNN), and/or a transformer neural network (e.g. Rapoport abstract; col 3 lines 7-9 and col 7 lines 33-53 and claim 13).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of Hoskuldsson (US 2015/0126879 A1), hereinafter Hoskuldsson ’15.
Regarding claim 8, Hoskuldsson is silent regarding wherein obtaining the one or more body signals include obtaining a thorax effort signal (T), the thorax effort signal (T) being an indicator of a thoracic component of the respiratory effort, and obtaining an abdomen effort signal (A), the abdomen effort signal (A) being an indicator of an abdominal component of the respiratory effort.
However, Hoskuldsson ‘15 discloses a method apparatus and system wherein obtaining the one or more body signals include obtaining a thorax effort signal (T), the thorax effort signal (T) being an indicator of a thoracic component of the respiratory effort, and obtaining an abdomen effort signal (A), the abdomen effort signal (A) being an indicator of an abdominal component of the respiratory effort. (e.g. abstract [0007]-[0009]; [0017]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system Hoskuldsson to incorporate the teachings of Hoskuldsson ’15 wherein obtaining the one or more body signals include obtaining a thorax effort signal (T), the thorax effort signal (T) being an indicator of a thoracic component of the respiratory effort, and obtaining an abdomen effort signal (A), the abdomen effort signal (A) being an indicator of an abdominal component of the respiratory effort for the purpose of utilizing the RIP belts to gather respiratory related data.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of Hoskuldsson ‘15 as applied to claim 8 above, and further in view of Hoskuldsson (US 2021/0085242 A1), hereinafter Hoskuldsson ’21.
Regarding claim 9, modified Hoskuldsson is silent regarding wherein obtaining the one or more body signals further includes obtaining a signal of an acceleration signal indicating an acceleration of a body part of the subject.
However, Hoskuldsson ‘21 discloses a system and method for determining sleep stages based on non-cardiac body signals wherein obtaining the one or more body signals further includes obtaining a signal of an acceleration signal indicating an acceleration of a body part of the subject (e.g. [0045] the sleep stage classifier can rely solely on the RIP belts or on the RIP belts and a body movement sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hoskuldsson to incorporate the teachings of Hoskuldsson ’21 wherein obtaining the one or more body signals further includes obtaining a signal of an acceleration signal indicating an acceleration of a body part of the subject for the purpose of utilizing another known way to utilize RIP belts to determine a sleep stage or arousal.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson in view of Hoskuldsson ’21.
Regarding claim 14, Hoskuldsson discloses wherein the determining of the arousal of the subject is based a RIP belt signals (e.g. [0065]-[0067] Fig 1A/B/C:31/32).
Hoskuldsson is silent regarding wherein the determining of the arousal of the subject is based only on RIP belt signals.
However, Hoskuldsson ‘21 discloses a system and method for determining sleep stages based on non-cardiac body signals wherein the determining of the arousal of the subject is based only on RIP belt signals (e.g. [0045] the sleep stage classifier can rely solely on the RIP belts or on the RIP belts and a body movement sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hoskuldsson to incorporate the teachings of Hoskuldsson ’21 wherein the determining of the arousal of the subject is based only on RIP belt signals for the purpose of utilizing another known way to utilize RIP belts to determine a sleep stage or arousal.
Claim(s) 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Hoskuldsson ’21 in view of Hoskuldsson.
Regarding claim 16, Hoskuldsson ‘21 discloses a system for determining an arousal or arousal-associated event of a subject, the system comprising: a receiver configured to receive one or more body signals (e.g. [0039] claim 11 the processor can receive the data), the one or more body signals being non-brain signals (e.g. [0002]); a memory storage having instructions stored thereon (e.g. [0039] the processor may include a memory storage); and a processor (e.g. [0039] Fig 2a:38) configured to perform at least the following: obtain data from one or more body signals, the one or more body signals being non-brain signals (e.g. [0039]; [0042]; [0045]);
Hoskuldsson ‘21 is silent regarding the system being able to determine an arousal or arousal-associated event of the subject using the data from one or more body signals.
However, Hoskuldsson discloses a system and method for non-invasively determining respiratory effort of a subject including determining an arousal of the subject using the data from one or more body signals (e.g. [0015]; [0022]; [0117]; [0276]; [0280] RERA (Respiratory Effort-Related Arousal) Fig 6 and 33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Hoskuldsson ’21 to incorporate the teachings of Hoskuldsson of determining an arousal of the subject using the data from one or more body signals for the purpose of not only determining sleep stages but more specifically an arousal or arousal-associated event (e.g. Hoskuldsson [0015]; [0022]; [0117]; [0276]; [0280] RERA (Respiratory Effort-Related Arousal) Fig 6 and 33).
Regarding claim 17, modified Hoskuldsson ‘21 discloses further comprising a first RIP belt (e.g. Hoskuldsson ‘21 [0039] Figs. 2a/b:31) and a second RIP belt (e.g. Hoskuldsson ‘21 [0039] Figs. 2a/b:32).
Regarding claim 18, modified Hoskuldsson ‘21 discloses wherein the system is configured to obtain the data from the one or more body signals by receiving a transmission, either wireless or by hardwire, of said data (e.g. Hoskuldsson ‘21 [0040]; [0196]; [0199]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough February 5, 2026
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796