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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 26th, 2026 has been entered.
Claims 1-2, 4, and 8-23 remain pending in the application. Claims 1 and 13-17 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments and amendments, filed March 26th, 2026, with respect to the claim objections have been fully considered. The claim objections are withdrawn.
Applicant’s arguments and amendments, filed March 26th, 2026, with respect to the claim rejections under 35 U.S.C. 101 have been fully considered but are not persuasive.
At page 10-12, Applicant argues that claim 2 is not directed to abstract ideas because steps b and c of claim 2 cannot be performed in the human mind as these steps require processing at least three parameters and involve complex computations using PCA and machine learning algorithms through a decision tree learner and that the claim places limitations on how the PCA and decision tree learners operate to perform steps b and c. Examiner respectfully disagrees. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses a series of data with as few as three data points. See, for example, [0064, 0066, 0072]. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using three data points in the human mind or by using a pen and paper. The unsupervised multivariate principal component analyses and supervised decision tree learners are used to generally apply the abstract idea (i.e., perform the mental processes and/or mathematical concepts, “correlating, determining, utilising … estimate, predicting”) without placing any limitations on how the unsupervised multivariate principal component analysis and supervised decision tree learners operates to derive the orthogonal principal components and the Pcrit, arousal threshold, loop gain and pharyngeal muscle responsiveness measurement, and the key OSA phenotypes/endotypes. That is there is no limitations describing the decisions, computations, or rules performed (emphasis added) on the polysomnography parameters to derive the correlations and estimated key OSA phenotypes/endotypes. There is no details or limitations of computations, decisions, or rules of the covariation structure that is used to derive orthogonal principal components. In addition, the limitations would cover every mode of implementing the recited abstract idea using the unsupervised multivariate principal component analyses and supervised decision tree learners. The claim omits any details as to how the unsupervised multivariate principal component analyses and supervised decision tree learners solves a technical problem and instead recites only the idea of a solution or outcome. See MPEP 2106.05(f). Therefore, the limitations “(b) correlating, using at least one computer processor, the first series of polysomnography and anthropometric parameters with each of an upper-airway collapsibility (Pcrit), arousal threshold, loop gain and pharyngeal muscle responsiveness measurement of each subject of the collection of subjects, wherein said correlating includes applying unsupervised multivariate principal component analyses (PCA) to the first series of polysomnography and anthropometric parameters to determine a plurality of orthogonal principal components based on variation in structure of the parameters; (c) determining, using at least one computer processor, a supervised decision tree learner describing the correlation of step (b) for each of the upper-airway collapsibility (Pcrit), arousal threshold, loop gain and pharyngeal muscle responsiveness measurement, wherein the supervised decision tree learners are trained based on the plurality of orthogonal principal components; (d) utilising the supervised decision tree learners, in conjunction with a second series of polysomnography and anthropometric parameters measured for the candidate subject, to estimate key OSA phenotypes/endotypes for the candidate subject” represents no more than mere instructions to implement the abstract idea.
At pages 12-14, Applicant argues that the claims are integrated into a practical application and provides an improvement in the functioning of a computer because the claims recite numerous additional elements and define a structures computational pipeline. Examiner respectfully disagrees. 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 and mere instructions to implement the abstract idea. The additional elements of measuring a series of polysomnography and anthropometric variables and providing a clinical decision diagnostic tool are directed to insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)) , e.g., mere data gathering steps and data outputting steps necessary to perform the Abstract Idea. Furthermore, the claim confines the use of the judicial exception to the technological environment of the unsupervised multivariate principal component analyses and supervised decision tree learners by generally linking the use of the judicial exception to the recited unsupervised multivariate principal component analyses and supervised decision tree learners. The unsupervised multivariate principal component analyses and supervised decision tree learners are used to generally apply the abstract idea (i.e., perform the mental processes and/or mathematical concepts, “correlating, determining, utilising … estimate, predicting”) without placing any limitations on how the unsupervised multivariate principal component analysis and supervised decision tree learners operates to derive the orthogonal principal components and the Pcrit, arousal threshold, loop gain and pharyngeal muscle responsiveness measurement, and the key OSA phenotypes/endotypes in a non-conventional or non-generic computation. Therefore, these unsupervised multivariate principal component analyses and supervised decision tree learners do not integrate the judicial exception into a practical application. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the measuring step, computer processor, and providing step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)). Furthermore, the improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for an analysis of data. The claims do not integrate the analysis into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the processor. “Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
At pages 15-16, Applicant argues that the step of providing the target therapy to the candidate subject to treat obstructive sleep apnea, integrates the judicial exception into a practical application. Examiner respectfully disagrees. The disclosure as originally filed at the time of effective filing date of the claimed invention discloses, in para. [0024, 0029], that patients are prescribed one or more therapies. The providing the target therapy step using the determined target therapy is merely referring to the relevant pre-existing audience of doctors who used obstructive sleep apnea treatments/therapies to treat patients suffering from obstructive sleep apnea. The step of providing targeted therapies/obstructive sleep apnea treatments/therapies was known to doctors, and was well-known, routinely, and conventionally used to treat obstructive sleep apnea – as evidenced by the non-patent literature of record. A clinician knowledgeable in treating obstructive sleep apnea would have known and be capable to perform/prescribe the well-known, routine, and conventionally used treatments/therapies of obstructive sleep apnea using the targeted therapies. Therefore, the step of “providing the target therapy to the candidate subject to treat obstructive sleep apnea” is merely an instruction to “apply” the targeted therapies using well-understood, routine, or conventional techniques in the field.
Claim Rejections - 35 USC § 101
Claims 2, 4, 8-12, and 18-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 2, 22, and 23 follows.
STEP 1
Regarding claims 2, 22, and 23, the claim recites a series of steps or acts. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
correlating, using at least one computer processor, the first series of polysomnography and anthropometric parameters with each of an upper-airway collapsibility (Pcrit), arousal threshold, loop gain and pharyngeal muscle responsiveness measurement of each subject of the collection of subjects, wherein said correlating includes applying unsupervised multivariate principal component analyses (PCA) to the first series of polysomnography and anthropometric parameters to determine a plurality of orthogonal principal components based on variation in structure of the parameters;
determining, using at least one computer processor, a supervised decision tree learner describing the correlation of step (b) for each of the upper-airway collapsibility (Pcrit), arousal threshold, loop gain and pharyngeal muscle responsiveness measurement, wherein the supervised decision tree learners are trained based on the plurality of orthogonal principal components;
utilising the supervised decision tree learners, in conjunction with a second series of polysomnography and anthropometric parameters measured for the candidate subject, to estimate key OSA phenotypes/endotypes for the candidate subject; and
based on the estimated key OSA phenotypes/endotypes, predicting the likelihood of the candidate subject responding to the one or more OSA treatments to thereby provide a clinical decision diagnostic tool for obstructive sleep apnea;
determining a target therapy for the candidate subject based on the predicted likelihood of the candidate subject responding to the one or more OSA treatments using the clinical decision diagnostic tool
set forth a judicial exception.
These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion) (correlating, determining, estimate, predicting, determining) and/or mathematical concepts (including mathematical relationships, mathematical formulas or equations, and mathematical calculations) (correlating, determining, utilizing … estimate). Thus, the claim is drawn to a Mental Process and/or Mathematical Concepts, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
Claims 2, 22, and 23 recites “(a) measuring a first series of polysomnography and anthropometric parameters for a collection of subjects including at least OSA sufferers, wherein said first series of polysomnography and anthropometric parameters includes age and BMI, and at least one of: total AHI, supine AHI, nadir SaO2, non-REM AHI, supine non-REM AHI, REM AHI, arousal index, and fraction of hypopneas vs. apneas”, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The measuring of polysomnography and anthropometric parameters does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the polysomnography and anthropometric parameters, nor does the method use a particular machine to perform the Abstract Idea. Furthermore, the step of “providing the target therapy to the candidate subject to treat obstructive sleep apnea (OSA)” recited in claims 22-23 is merely an instruction to “apply” the target therapy using well-understood, routine, or conventional techniques in the field. The step of providing the target therapy was known to doctors, and was routinely and conventionally used to treat obstructive sleep apnea – as evidenced by the non-patent literature of record. A clinician knowledgeable in treating obstructive sleep apnea would have known and be capable to perform the routine and conventionally used treatments of obstructive sleep apnea using the target therapies.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
Computer processor;
(a) measuring a first series of polysomnography and anthropometric parameters for a collection of subjects including at least OSA sufferers, wherein said first series of polysomnography and anthropometric parameters includes age and BMI, and at least one of: total AHI, supine AHI, nadir SaO2, non-REM AHI, supine non-REM AHI, REM AHI, arousal index, and fraction of hypopneas vs. apneas;
providing the target therapy to the candidate subject to treat obstructive sleep apnea (OSA)
The of measuring and providing steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the measuring and providing steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., mere data gathering step necessary to perform the Abstract Idea and mere instructions to “apply” the target therapy using well-understood, routine, or conventional techniques in the field. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering, comparing activity, and treatments/therapies engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the measuring step, computer processor, and providing step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims. Claims 4, 8-12 and 18-21 are directed to more abstract ideas and/or mere instructions to “apply” the target therapy, which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Randerath WJ. Mandibular Advancement Therapy for Obstructive Sleep Apnea: Answers and (More) Questions. JAMA Intern Med. 2015;175(8):1285–1287. doi:10.1001/jamainternmed.2015.2059 directed to mandibular advancement therapy for obstructive sleep apnea.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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