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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 28, 2026 has been entered.
Status of Claims
Claims 1-9, as originally filed on November 14, 2024, were previously pending and subject to a final office action filed on January 28, 2026 (the “January 28, 2026 Final Office Action”). On July 28, 2026, Applicant filed a Request for Continued Examination in accordance with 37 CFR 1.114, where Applicant: (i) amended claims 1 and 5; (ii) canceled claims 2-4 and 6-9; and (iii) added new claims 10-26 (the “July 28, 2026 RCE”). As such, claims 1, 5, and 10-26, as recited in the July 28, 2026 RCE, are currently pending and subject to the non-final office action below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 27, 2026 is in compliance with the provisions of 37 CFR 1.97(b)(3), and has been considered by the examiner. The information disclosure statement (IDS) submitted on July 30, 2026 is in compliance with the provisions of 37 CFR 1.97(b)(4), and has been considered by the examiner.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 10-11, 35 U.S.C. § 101 Rejections Section, filed July 28, 2026, with respect to rejections of claim 1-9 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1 and 5 are maintained and the § 101 rejections of new claims 10-26 are added in this office action.
First, Applicant argues that claims 1 and 5 are directed to a “specific improvement in physiological monitoring technology, rather than an abstract idea”, by reciting “a specific technique for processing physiological motion signals to assess a physical condition”. See Applicant’s Remarks, at p. 10. Examiner respectfully disagrees. When evaluating whether claims recite an improvement to the functioning of a computer or a technical field, the disclosure 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). The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Id.
Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. In the present case, Applicant has not identified a technical problem, nor has Applicant explained the details of an unconventional technical solution expressed in the claims. For example, lines 26-28 on page 10 of Applicant’s specification state in a conclusory manner that the computer-readable program code is configured to classify phases of a respiratory cycle, including polyphasic motions within the phases and calculate energy of the polyphasic motions based on sensed information of the local acceleration sensor, where lines 28-31 on page 10 provide that the computer-readable program code is configured to classify the severity of cardiac decompensation by calculating an excessive energy index (EEi) that compares excessive energy that appears in the polyphasic motions to energy required for inspiration at a basic respiratory rate. See Applicant’s specification as filed on November 14, 2024, p. 10, lines 26-31. This description states the idea of a solution without describing the details of how that solution is accomplished, by stating in a conclusory manner that it is possible to classify polyphasic motions within the phases.
However, this is not a technical improvement, because Applicant has not identified a technical problem that the claimed invention solves, and Applicant’s claim limitations do not describe a specific way for collecting and processing the motion data or for determining a severity of cardiac decompensation. Nor does it specify how the energy associated with the identified polyphasic motion correlates to a severity of cardiac decompensation. Rather, the claimed invention leaves that decision to the operator of the device/method. Therefore, the alleged improvement is not directed to a specific improvement in the computer’s functionality, but merely states the idea of solution. For these reasons, this argument is not persuasive.
Next, Applicant argues that the claims are analogous to those held patent eligible by the Federal Circuit in CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020). See Applicant’s Remarks, at p. 10-11. Examiner respectfully disagrees. First, this case is not precedential. Second, Applicant’s claims are unlike the claims in the CardioNet case, because Applicant’s claims and specification do not describe a specific improvement to the functioning of a computer or technical field. For example, the Federal Circuit held in CardioNet that the claimed device more accurately detected the occurrence of atrial fibrillation and atrial flutter as distinct from V-TACH and other arrythmias, and allows for more reliable and immediate treatment of these two medical conditions. Further, the Federal Circuit found in CardioNet that the dependent claims recited a specific improvement by further specifying the physical features or operation of the device claimed in the independent claims.
Conversely, Applicant’s dependent claims recite further mental steps directed to determining respiratory effort and identifying multiple peaks within a single respiratory phase. Further, the PTAB determined that Applicant’s specification and similar claims in Applicant’s parent case (Application Serial No. 16/933,004) failed to provide detailed technical information concerning the device or its components. See p. 14 of the Patent Board Decision filed on October 31, 2024 in Application Serial No. 16/933,004. In particular, the PTAB found that the specification “merely describes the process and code in terms of the functions they perform and fails to specify the structure of the computer components or code. See pp. 14-15 of the Patent Board Decision filed on October 31, 2024 in Application Serial No. 16/933,004. Therefore, Applicant’s claims are unlike the claims were held to eligible in CardioNet. For these reasons, this argument is not persuasive. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 101 Section below, for further clarification and complete analysis.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 103
Applicant’s arguments, see Applicant’s Remarks, pp. 11-13, 35 U.S.C. § 103 Rejections Section, filed July 28, 2026, with respect to rejections of claims 1-9 under 35 U.S.C. § 103, have been fully considered, but they are moot in light of Applicant’s amendments to independent claims 1 and 5. Therefore, the combinations of the references previously cited in the January 28, 2026 Final Office Action, are not relied upon to teach the newly amended claim limitations in claims 1 and 5, and the § 103 rejections are hereby withdrawn in light of the amendments.
However, Examiner notes that Applicant’s amendments in the July 15, 2026 Amendment have introduced several issues under § 112(a). Consequently, all of the rejections will be reassessed if the Applicant amends the claims further.
Drawings
The drawings were received on July 28, 2026. These drawings are acceptable.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5, and 10-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites:
- "identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle".
Similarly, claim 5 recites:
- "identifying from the sensed signal a polyphasic expiratory motion during an expiratory phase of the respiratory cycle".
While Applicant’s specification provides general support for device being capable of classifying phases of a respiratory cycle [see Applicant’s specification as filed on November 14, 2024, p. 10, lines 26-31], Applicant’s specification is silent as to: (1) the non-transitory computer-readable medium storing instructions that cause the processor to: identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle; and (2) the method identifying from the sensed signal a polyphasic expiratory motion during an expiratory phase of the respiratory cycle. Therefore, Applicant’s disclosure does not provide written description support for the aforementioned limitations described in claims 1 and 5.
Matter not present on the filing date of the application in the specification, claims, or drawings that is added after the application filing is usually new matter. See MPEP §§ 2163.06 and 2163.07. These amendments (i) change the scope of the claims, and as described above, and (ii) contain subject matter which was not described in the specification in a way as to reasonably convey to one skilled in the relevant art that the inventors had possession of the claimed invention. Therefore, the limitations directed to: (1) the non-transitory computer-readable medium storing instructions that cause the processor to: identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle (as described in claim 1); and (2) the method identifying from the sensed signal a polyphasic expiratory motion during an expiratory phase of the respiratory cycle (as described in claim 5), are deemed to be new matter, because the specification does not provide written description support for them. As such, claims 1 and 5 are rejected for failing to comply with the written description requirement under 35 U.S.C. § 112(a).
Examiner further notes that the steps directed to: (1) the non-transitory computer-readable medium storing instructions that cause the processor to: identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle (as described in claim 1); and (2) the method identifying from the sensed signal a polyphasic expiratory motion during an expiratory phase of the respiratory cycle (as described in claim 5), are not described by the present Specification in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed, e.g. see MPEP § 2161.01. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement, e.g. see MPEP § 2161.01. Therefore, Applicant’s specification lacks adequate written description for these computer-implemented functional claim limitations. See MPEP § 2161.01(I).
Claims 10-26 (which individually depend on claims 1 and 5) are also rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the written description requirement for similar reasons as described in the § 112(a) new matter rejections of claims 1 and 5 above.
Claim Rejections - 35 USC § 112(b)
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 and 10-20 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 recites the limitations "a sensor configured to generate motion data indicative of respiration of the patient" in lines 2 to 3 of claim 1; and "identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle" in lines 8 to 9 of claim 1. However, there is insufficient antecedent basis for some of these limitations in the claim. See MPEP § 2173.05(e). The terms “patient” and “respiratory cycle” were not previously recited in claim 1. Examiner suggests that Applicant amend the phrases “a sensor configured to generate motion data indicative of respiration of the patient” in lines 2 to 3 of claim 1 and “identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle” in lines 8 to 9 of claim 1 to “a sensor configured to generate motion data indicative of respiration of a patient” and “identify a polyphasic expiratory motion during an expiratory phase of a respiratory cycle of the patient”, or make some other appropriate correction of course. Appropriate correction is required.
Claims 10-20 are also rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite, for similar reasons as described above in the analysis of the § 112(b) rejections applied to claim 1 (due to their individual dependencies on claim 1).
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, 5, and 10-26 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the 2019 Revised PEG
Following Step 1 of the 2019 Revised PEG, claims 1 and 10-20 are directed to a device, which is within one of the four statutory categories (i.e., a machine or apparatus). See MPEP § 2106.03. Claims 5 and 21-26 are directed to a method, which is also within one of the four statutory categories (i.e., a process). See id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 Revised PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1, 5, and 10-26 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to a without significantly more. Representative independent claims 1 and 5 include limitations that recite an abstract idea. Note that independent claim 1 cover a device, while independent claim 5 covers the matching method. Specifically, independent claim 1 recites (and independent claim 5 substantially recites) the following limitations:
A device comprising:
a. a sensor configured to generate motion data indicative of respiration of the patient;
b. a processor; and
c. a non-transitory computer-readable medium storing instructions that, when executed by the processor, cause the processor to:
i. receive the motion data;
ii. identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle;
iii. determine energy associated with the identified polyphasic motion; and
iv. determine respiratory effort based on the determined energy associated with the identified polyphasic motion; and
v. determine a severity of cardiac decompensation based on the determined respiratory effort.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., a method comprising: identifying a polyphasic expiratory motion during an expiratory phase of the respiratory cycle; determining energy associated with the identified polyphasic motion; and determining respiratory effort based on the determined energy associated with the identified polyphasic motion; and determining a severity of cardiac decompensation based on the determined respiratory effort). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claim 1 which are not underlined), the context of claims 1 and 5 encompasses a concept that is capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., a method comprising: identifying a polyphasic expiratory motion during an expiratory phase of the respiratory cycle; determining energy associated with the identified polyphasic motion; and determining respiratory effort based on the determined energy associated with the identified polyphasic motion; and determining a severity of cardiac decompensation based on the determined respiratory effort).
The aforementioned claim limitations described in claims 1 and 5 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) identifying a polyphasic expiratory motion during an expiratory phase of the respiratory cycle (i.e., a type of observation, evaluation, judgment, and/or opinion where a person can mentally identify polyphasic expiration motion on a graph of a respiratory cycle); (2) determining energy associated with the identified polyphasic motion (i.e., a type of observation, evaluation, and/or judgment where a person can manually calculate energy associated with the identified polyphasic motions using a mathematical equation); (3) determining respiratory effort based on the determined energy associated with the identified polyphasic motion (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally determine respiratory effort based on the determined energy of the identified polyphasic motion); and (4) determining a severity of cardiac decompensation based on the determined respiratory effort (i.e., a type of observation, evaluation, judgment, and/or opinion mentally determine the severity of cardiac decompensation based on the determined respiratory effort). If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(III). Accordingly, claims 1 and 5 recite an abstract idea that falls within the Mental Processes grouping of abstract ideas.
Furthermore, Examiner notes that dependent claims 10-19, 21-24, and 26 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. Examiner notes that: (1) dependent claims 20, 25, and 26 provides limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A; and (2) dependent claims 10-19 and 21-24 do not provide any limitations that are deemed to be additional elements which require further analysis under Prong Two of Step 2A.
- For example, claims 10-19 and 21-24 merely recite additional steps for calculating ratios contained in the Excessive Energy Index (EEi) or identifying data related to the respiratory cycle data (i.e., these steps are deemed to be further mental steps involving a human performing the steps mentally with the aid of pen and paper).
- Further, claim 26 includes an additional “determining” step directed to determining different polyphasic activities at different sites [on a user’s body described in the claim]. This step is deemed to be a further mental step involving a human performing this step mentally with the aid of pen and paper. However, Examiner notes that claim 26 includes a limitation that is deemed to be an additional element and requires further analysis under Prong Two of Step 2A.
Step 2A of the 2019 Revised PEG - Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h).
Following Prong Two of Step 2A of the 2019 Revised PEG, this judicial exception is not integrated into a practical application because they do not impose any meaningful limits on practicing the abstract idea. In the present case, for representative independent claim 1 (similar to claim 5), the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A device comprising (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
a. a sensor configured to generate motion data indicative of respiration of the patient (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f));
b. a processor (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)); and
c. a non-transitory computer-readable medium storing instructions that, when executed by the processor, cause the processor to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
i. receive the motion data (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f); adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving or transmitting data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d));
ii. identify a polyphasic expiratory motion during an expiratory phase of the respiratory cycle;
iii. determine energy associated with the identified polyphasic motion; and
iv. determine respiratory effort based on the determined energy associated with the identified polyphasic motion; and
v. determine a severity of cardiac decompensation based on the determined respiratory effort; and
the step directed to “sensing motion signal indicative of respiration of the patient” (as described in claim 5) (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)). However, the recitation of these limitations is made with a high-level of generality (i.e., using generic computer devices to perform the abstract mental process of: identifying a polyphasic expiratory motion during an expiratory phase of the respiratory cycle; determining energy associated with the identified polyphasic motion; and determining respiratory effort based on the determined energy associated with the identified polyphasic motion; and determining a severity of cardiac decompensation based on the determined respiratory effort), such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; and (2) adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.05(f), (g).
- The following is an example of a court decisions that demonstrates merely applying instructions by reciting a computer structure as a tool to implement the claimed invention (e.g., see MPEP § 2106.05(f)):
- A commonplace business method or mathematical algorithm being applied on a general purpose computer, e.g., see Alice Corp. Pty. Ltd. V. CLS Bank Int’l – similarly, the additional elements recited in claim 1 described in the Prong One analysis of Step 2A above, invokes general-purpose computer (i.e., the device; sensor; processor; and non-transitory computer-readable medium storing instructions that are executed by the processor) to perform the commonplace business method for sensing motion data indicative of respiration of a patient and determining a severity of cardiac decompensation based on determined respiratory effort of the patient.; and
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g., see Intellectual Ventures I LLC v. Capital One Bank (USA) – similarly, the non-transitory computer-readable medium storing instructions that are executed by the processor is an example of generic software that is used to tailor information (i.e., software used to identify a polyphasic expiratory motion during an expiratory phase of a respiratory cycle and make the determinations of: (i) energy associated with the identified polyphasic motion, (ii) respiratory effort based on the determined energy associated with the identified polyphasic motion, and (iii) severity of cardiac decompensation based on the determined respiratory effort).
- The following are examples of insignificant extra-solution activities (e.g., see MPEP § 2106.05(g)):
- Examples of Mere Data Gathering/Mere Data Outputting:
- Obtaining information about transactions using the Internet to verify credit card transactions, e.g., see CyberSource v. Retail Decisions, Inc. – similarly, the step of “receiving the motion data”, described in claim 1, is the equivalent of obtaining and transmitting data from the sensor in the device.
Thus, the additional elements in independent claims 1 and 5 are not indicative of integrating the judicial exception into a practical application. Similarly, dependent claims 10-19 and 21-24 do not recite any additional elements outside of those identified as being directed to the abstract idea described above. Examiner notes that dependent claims 20, 25, and 26 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font):
wherein the sensor is a local acceleration sensor mountable on a chest or upper abdomen of a patient, and configured for sensing local accelerations or changes in a position, including orientation or displacement of the local acceleration sensor (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 20);
wherein the sensing comprises sensing local accelerations and/or changes in sensor position, including orientation and displacement, with a local acceleration sensor mounted on a chest or abdomen of a patient (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 25); and
comprising using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the chest at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient (the Examiner submits that these additional elements amount to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) and determining different polyphasic activities at these different sites (as described in claim 26).
As such, the additional elements in claims 1, 5, 20, 25, and 26 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1, 5, and 10-26: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1, 5, and 10-26 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1, 5, and 10-26 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, with respect to integration of abstract idea into a practical application, the additional elements of claims 1, 5, 20, 25, and 26 amount to no more than: adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; and adding insignificant extra-solution activity to the judicial exception. See MPEP §§ 2106.05(f), (g). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1, 5, 20, 25, and 26, as recited, the device; sensor; processor; non-transitory computer-readable medium storing instructions; and the steps directed to: “receive the motion data”; “sensing motion signal indicative of respiration of the patient”; “wherein the sensor is a local acceleration sensor mountable on a chest or upper abdomen of a patient, and configured for sensing local accelerations or changes in a position, including orientation or displacement of the local acceleration sensor”; “wherein the sensing comprises sensing local accelerations and/or changes in sensor position, including orientation and displacement, with a local acceleration sensor mounted on a chest or abdomen of a patient”; and “comprising using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the chest at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the device; sensor; processor; non-transitory computer-readable medium storing instructions; and the steps directed to: “sensing motion signal indicative of respiration of the patient”; “wherein the sensor is a local acceleration sensor mountable on a chest or upper abdomen of a patient, and configured for sensing local accelerations or changes in a position, including orientation or displacement of the local acceleration sensor”; “wherein the sensing comprises sensing local accelerations and/or changes in sensor position, including orientation and displacement, with a local acceleration sensor mounted on a chest or abdomen of a patient”; and “comprising using local acceleration sensors, one placed on an upper sternum, close to a supra-sternal notch, another placed on a left side of the chest at a region of cardiac point of maximal impact (PMI) and another placed on a upper abdomen (epigastrium) near a diaphragm of the patient”, described in claims 1, 5, 20, 25, and 26, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant generally describes these computer components as being part of a device for continuous acquisition and analysis of respiratory dynamics. See Applicant’s specification as filed on November 14, 2024, at p. 14, lines 27-30—p. 15, lines 1-23. For example, the acceleration sensor may be “embodied in a patch and sensor unit.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 3-4. The data acquisition system and data storage and the non-transitory, computer-readable storage medium are disclosed as being part of the “hardware for data complication and filtration and continuous data analysis and comparison with past data.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 5-16. The processor is described as a “central processing unit, which may include additional channels for ECG acquisition with appropriate gain and filtering.” See Applicant’s specification as filed on November 14, 2024, p. 15, lines 9-11. These descriptions in the specification describe these additional elements as basic computer components and functions, such as well-understood, routine, and conventional computer components. Therefore, the Examiner submits that these computer components and functions represent well-understood, routine, and conventional computer components and functions which are known in the medical industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the step and feature directed to: “receive the motion data” - The following represents examples that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – the limitations directed to: “receive the motion data”, is similarly deemed to be well-understood, routine, and conventional activity in the field of monitoring and sensing respiratory data, because they also represent mere collection and transmission of data over a network (i.e., collecting and transmitting the motion data from the patient over a network).
Thus, taken alone, the additional elements of claims 1, 5, 20, 25, and 26 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1, 5, 20, 25, and 26 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 10-19 and 21-24 (which depend on claims 1 and 5 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that claims 10-19 and 21-24 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1 and 5. Dependent claims 10-19 and 21-24 merely add limitations that further narrow the abstract idea described in independent claims 1 and 5. Therefore, claims 1, 5, and 10-26 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/N.A.A./Examiner, Art Unit 3686
/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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