DETAILED ACTION
Claims 1-20 are currently pending and have been examined.
This action is in response to the amendment filed on 2/26/2026.
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 .
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11955224. The present claims and claims 1-20 of U.S. Patent No. 11955224 are both directed to a system for generating a pulmonary dysfunction nourishment program that uses respiratory volume data collected from a user, receiving, a salubrious reference, identifying a functional signature from the salubrious reference using a machine learning model, and generating a functional program as a function of the functional signature.
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 is directed to an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-10 are directed to a system (i.e., a machine); Claims 11-20 are directed to a method (i.e., a process). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A system for generating a pulmonary dysfunction nourishment program, the system comprising:
a computing device, the computing device configured to:
receive at least a respiratory volume collection relating to a user, wherein the at least respiratory volume collection comprises at least a biomarker, wherein the at least biomarker comprises a bioremnant and a volatile organic compound (VOC);
receive a salubrious reference relating to the user;
identify a functional signature as a function of the salubrious reference, wherein identifying the functional signature comprises:
receiving a conduct indicator, wherein the conduct indicator comprises an indicator index;
generating one or more conduct parameters as a function of the salubrious reference;
comparing the conduct indicator to the one or more conduct parameters to generate an indicator index; and
identifying the functional signature using a trained functional machine-learning model configured to transform at least the conduct indicator and respiratory biomarker data derived from the respiratory volume collection into a physiological wellness state representation;
wherein: the trained functional machine-learning model has been trained on training data comprising respiratory biomarker data derived from respiratory volume collections and associated physiological context data; and
the trained functional machine-learning model is constrained by the indicator index; and
generate a nourishment program as a function of the functional signature.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because receiving patient data including a salubrious reference, conduct indicators, and parameters, and determining a functional signature based on the patient data are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). 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.
Accordingly, independent claim 1 and analogous independent claim 11 recite at least one abstract idea.
Furthermore, dependent claims 2-10 & 12-20 further narrow the abstract idea described in the independent claims. Claims 2 & 12 recites an indicator index, claims 3 & 13 recite generating conduct parameters, claims 4 & 14 recite receiving the conduct indicator, claims 5 & 15 recite transmitting the nourishment program, claims 6 & 16 recite selecting a coach, claims 8 & 18 recite generating a graphical representation of the signatures; Claims 10 & 20 recite generating a nourishment program.
These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 1 and analogous independent claim 20, even when considered individually and as an ordered combination.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception 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.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
1. A system for generating a pulmonary dysfunction nourishment program, the system comprising:
a computing device, the computing device configured to:
receive at least a respiratory volume collection relating to a user, wherein the at least respiratory volume collection comprises at least a biomarker, wherein the at least biomarker comprises a bioremnant and a volatile organic compound (VOC);
receive a salubrious reference relating to the user;
identify a functional signature as a function of the salubrious reference, wherein identifying the functional signature comprises:
receiving a conduct indicator, wherein the conduct indicator comprises an indicator index;
generating one or more conduct parameters as a function of the salubrious reference;
comparing the conduct indicator to the one or more conduct parameters to generate an indicator index; and
identifying the functional signature using a trained functional machine-learning model configured to transform at least the conduct indicator and respiratory biomarker data derived from the respiratory volume collection into a physiological wellness state representation;
wherein: the trained functional machine-learning model has been trained on training data comprising respiratory biomarker data derived from respiratory volume collections and associated physiological context data; and
the trained functional machine-learning model is constrained by the indicator index; and
generate a nourishment program as a function of the functional signature.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computing device, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitations of the using a trained functional machine-learning model configured to transform data into a representation, training the machine-learning model using training data, and constraining the model by an index, the Examiner submits that these limitations attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, and do not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. (see MPEP § 2106.05(f)).
Regarding the additional limitation of receive at least a respiratory volume collection relating to a user, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of mere data gathering (see MPEP § 2106.05(d)(II)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea 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, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or 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 a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 11 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recite at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 9 and 19: These claims recite a nourishment coach that is a large language model and thus amount to mere instructions to apply an exception, because they recite no more than an idea of a solution or outcome (see MPEP § 2106.05(f)(1)).
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 10 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above regarding the additional limitations of the computing device, the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of receive at least a respiratory volume collection relating to a user, the Examiner submits that this additional limitation merely adds insignificant extra-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)) and is conventional as it merely consists of mere data gathering (see MPEP § 2106.05(d)(II)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: receive a salubrious reference relating to the user; identify a functional signature as a function of the salubrious reference, wherein identifying the functional signature comprises: receiving a conduct indicator, wherein the conduct indicator comprises an indicator index; generating one or more conduct parameters as a function of the salubrious reference; comparing the conduct indicator to the one or more conduct parameters to generate an indicator index; and identifying the functional signature using a trained functional machine-learning model configured to transform at least the conduct indicator and respiratory biomarker data derived from the respiratory volume collection into a physiological wellness state representation; wherein: the trained functional machine-learning model has been trained on training data comprising respiratory biomarker data derived from respiratory volume collections and associated physiological context data; and the trained functional machine-learning model is constrained by the indicator index; and generate a nourishment program as a function of the functional signature.
The most relevant prior art of record includes:
Javed (US20220280040) teaches to a system and method to determine symptoms of respiratory ailments is disclosed. The system includes a transceiver operable to receive data from a monitor attached to a patient. The monitor includes a plurality of sensors, each of the plurality of sensors outputting physiological data related to respiration of the patient. An analytics platform is coupled to the transceiver to analyze the physiological data to determine the occurrence of a symptom of a respiratory condition, disorder or ailment in the patient. Reddy (US20200337594) teaches to detection and identification of certain substances in the exhaled breath of a subject or person, and in particular to biomarkers for systems, methods, and devices for detecting and identifying certain substances, such as volatile organic compounds (VOCs), volatile gases (VGs), ketones, cannabis, controlled substances, pharmaceuticals, or anesthetics, in the exhaled breath of a subject or person in real-time. Courville (US20150213220) teaches to a system and associated methods are provided monitoring patient health. A composite risk score is computed based upon the relevance of a set of risk factors to a patient. The composite risk score is then used to select one of a plurality of sets of health data thresholds. Measurements that exceed thresholds of the selected set of thresholds cause an alert to be generated to prompt medical intervention.
Response to Arguments
Applicant’s arguments on pages 1-8 regarding claims 1-20 being rejected under 35 USC § 101 have been fully considered but they are not persuasive. Applicant claims that:
The claims are directed to a specific technical process for generating a physiological wellness state and do not recite a judicial exception.
The Examiner, however, asserts that the claims are clearly directed to certain methods of organizing human activity as described in the updated 101 rejection above.
The claims improve the technical field of pulmonary health assessment by using a machine-learning driven mechanism.
The Examiner further asserts that that there is no indication here that the claimed invention addresses a problem specifically arising in the realm of computer technology; the Applicant does not provide adequate evidence or technical reasoning how the process improves the efficiency of the computer, as opposed to the efficiency of the process, or of any other technological aspect of the computer. Further, the problems the invention is attempting to solve are “generating a pulmonary nourishment program”. (citing Spec. ¶ 2-3). These are not technological problems, but a problem arising in the field of medicine. The solution provided here has not been described or claimed as anything more than a generic use of existing technology performing based, purely conventional functions of a computer. Therefore, the Examiner asserts that the claims as a whole are not directed significantly more than an abstract idea.
Similar to McRo, the claims use computation in a specific way to achieve a technological result.
The Examiner asserts that the claimed invention is unlike McRo and the holding of McRo actually supports the Examiner's position. McRo held that an improvement may be one that “that improve[s] computer-related technology by allowing computer performance of a function not previously performable by a computer.” There is nothing in the Applicant’s invention that allows a computer to perform functions not previously performable by a computer. The distinction is “not previously performable by a computer.” Whether or not the claimed invention was previously known (i.e., is novel/non-obvious) is not the test. The test is where a computer could not physically perform the identified functions prior to the invention and whether the claimed invention solved this problem. This is not the case in the present invention. Furthermore, even assuming, arguendo, that the current invention achieves the improvement of, for example, providing a pulmonary nourishment program, these improvements represent improvements to the abstract idea and not technological improvements in the same vein as those recited by McRO (i.e. automating a process that previously could not be automated through specific rules, and/or no longer requiring a manual process that relies on subjective determinations).
There is no evidence establishing the additional elements in the claims are not well-understood, routine, and conventional.
The Examiner respectfully submits that the argued additional elements have been considered as an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, and does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. The machine learning elements have not been considered well-understood, routine, conventional activity and therefore analysis under the well- understood, routine, and convention test is not required.
Similar to BASCOM, the claims recite a non-conventional and non-generic arrangement of elements to achieve a technical result.
The Examiner asserts that the Applicant’s claims are not analogous to BASCOM. In BASCOM the court held that the claims amounted to statutory subject matter under step 2B because the additional elements within the claims were directed to a particular arrangement that yielded a technical improvement to the technology of filtering content. The court pointed to the disclosure of the application which explained why and how the particular claimed arrangement of these elements yielded the asserted technological improvement. No such unconventional and non-generic arrangement of otherwise known computer elements is argued with respect to the present claims, and Examiner asserts that the present claims do not satisfy the rationale provided by the court. Claim 1 for example recites a computing device receiving user parameter data and utilizing a trained machine learning model. In contrast to the claims in BASCOM however, these additional elements are not arranged in an unconventional and non-generic combination but instead are arranged, and used, in well-known, routine and conventional fashion(s). Additionally, each of these elements individually performs its well-understood, routine and conventional function. This remains true when the elements are viewed as an ordered combination. Each of the elements still performs its well-understood, routine and conventional function in relation to the other elements. The relationship between each of these elements and their respective functions remain those of generic computer devices. As such, the Examiner respectfully submits that the Applicant’s claims are not analogous to those found to be patent eligible in BASCOM.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Neumann (US20210134461) teaches to prioritizing comprehensive prognoses and generating an associated treatment instruction set, the system comprising a computing device configured to receive at least a user biological marker and select a prognosis using a classification machine-learning model and an associated diagnostic from a biological marker database
Anushiravani (US20200151516) teaches to system predicts the user's disease or disease state, if any, as well as possible future disease states, identifies triggers, determines whether a particular medication prescribed to the user is effective in managing the symptoms and/or disease or disease state and determines multiple conditions other than respiratory conditions, such as sleep disorders, sleep stages (e.g., REM stages and Deep sleep) using the collected sensory and user information.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/ Primary Examiner, Art Unit 3619
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