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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 29, 2026 has been entered.
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered but they are not persuasive.
Examiner notes that a human can receive data. Examiner notes that generating a model is not defined with any specificity in the claim and as such the BRI of the term would be well within the realm of something one of ordinary skill in the art could perform in their mind. The model is not defined or recited in any specific way, and as best understood in light of the specification it merely could just be a collection of data, which is something one can generate in their mind. Examiner notes that a human can make determinations. The claims are recited a high level of generality. No specific analysis is being done merely the claims just require some sort of determining, whatever that may be.
Per MPEP 2106.04(d)(2): “If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a “pharmaceutical composition” or that a “feed dispenser is operable to dispense a mineral supplement” are not affirmative limitations because they are merely indicating how the claimed invention might be used.” The new limitations of automatically generate(ing) a treatment recommendation for the user based on the determination are analogous to these examples from the MPEP and thus do not provide significantly more. Nothing tangible is provided. A doctor given physiological data can analyzed it and determine an appropriate treatment and thus give a patient a recommendation on treatment. The claims do not require any treatment to actually be applied.
Per MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.” The additional elements in the claim when viewed with the abstract ideas recited do not reflect any improvement. The claims are merely directed to limitations analogous to MPEP 2106.04(a)(2) III A: ”Examples of ineligible claims that recite mental processes include:• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;”. The claims do not recite any additional elements that are not considered well-understood, routine and/or conventional. As noted in the 101: The additional elements are identified as follows: ‘processor’ in claims 28, 33, 34, 37, 38, 43, 46-49; ‘receiver’ in claims 28, 43; ‘emitter’ in claims 37, 43, 48. Each of these elements are well-understood, routine, and conventional elements and as such do not provide significantly more.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The model "correlates data derived using active auscultation systems 100, 200, and/or 201 (e.g., lung resonance data and/or received acoustic signals) with ancillary and other data such as medical test data, imaging data (e.g., CT scan data, MRI scan data), medical history, geographic data, levels of pollution corresponding to a geographic location, weather, temperature, humidity, activity measured by sensors (e.g., accelerometers), and/or ad lib data entered by a user via text, email, voice commands, etc." As-Filed Specification, paragraph [0071]. This integration of multiple data sources to generate a lung model”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims do not require that all these sources of data are considered in combination. Nor do the claims even specify how these sources of data are specifically used to generate the model. Examiner notes that physicians and other medical health professionals often look at multiple data sources to develop diagnosis. Thus, given the high level of generality of the claims, this is clearly within the realm of a mental process and capabilities of a human whether in the mind or with pen and paper.
The alleged improvement is not reflected in the claims. Physiological data is known to vary across different individuals and thus, acquiring an individual’s specific physiological data is known to be required to make determinations. This is common in the medical field. It is not clear where the alleged improvement is and it is not clear how any alleged improvement is reflected in the claims.
Thus the 101 rejection remains.
Response to Amendment
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 28-51 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 28-51 are all within at least one of the four categories (claims 28-42 being methods and claims 43-51 being apparatuses).
Regarding Step 2, the independent claim 28 recites:
receiving, by a processor, an acoustic energy response from a receiver communicatively coupled to the processor and proximate to a body of a user, the acoustic energy response being responsive to acoustic energy directed into the body of the user toward a lung of the user; and
generating, by the processor, a model of the lung of the user using the received acoustic energy response, the model of the lung of the user including one or more features that represent volumes of air trapped in discrete pockets in the lung of the user after exhalation; and
determining, by the processor, based on the model, whether the user requires preventative measures, treatment administration, or any combination thereof;
automatically generating, by the processor, a treatment recommendation for the user based on the determination.
independent claim 43 recites:
an emitter configured to emit acoustic energy into a body of a user toward a lung of the user;
a receiver communicatively coupled to a processor and configured to receive an acoustic energy response that is responsive to acoustic energy emitted into the body of the user toward the lung of the user by the emitter and communicate the received acoustic energy response to the processor; and
the processor, the processor being configured to:
receive the acoustic energy response from the receiver; and
generate a model of the lung of the user using the received acoustic energy response, the model of the lung of the user including one or more features that represent volumes of air trapped in discrete pockets in the lung of the user after exhalation,
determine, based on the model, whether the user requires preventative measures, treatment administration, or any combination thereof; and
automatically generate a treatment recommendation for the user based on the determination.
The above bolded claim limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
The claimed steps of receive(ing), determine (ing), and generate(ing) can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding Step 2A (prong 2):
This judicial exceptions (abstract ideas) in claims 28-51 are not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for receive(ing), determine (ing), and generate(ing) merely invoke a computer as a tool.
The data-gathering step (receive(ing)) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for receive(ing), determine (ing), and generate(ing).
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement. MPEP 2106.04(d)(2): “If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the “treatment or prophylaxis” consideration. For example, a step of “prescribing a topical steroid to a patient with eczema” is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a “pharmaceutical composition” or that a “feed dispenser is operable to dispense a mineral supplement” are not affirmative limitations because they are merely indicating how the claimed invention might be used.” The new limitations of determining/determination…whether the user requires preventative measures, treatment administration, or any combination thereof are analogous to these examples from the MPEP and thus do not provide significantly more.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer receive(ing) and generate(ing). The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole 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 functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Regarding Step 2B:
The additional elements are identified as follows: ‘processor’ in claims 28, 33, 34, 37, 38, 43, 46-49; ‘receiver’ in claims 28, 43; ‘emitter’ in claims 37, 43, 48
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering (receiver and emitter) and computing (processor), as demonstrated by
The prior art provided by the Applicant in the IDS which disclose each of the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 37 and 48 recites additional elements at a high level of generality which are conventional in the art (in this case used for the extra-solutionary data gathering)
Claims 29-36, 38-42, 44-47, 49-51 are steps that are also abstract as a mental process through additional data gathering or analysis
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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