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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/8/25 has been entered.
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.
Claim(s) 10-23 and 25-26 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Representative claim(s) 21 recites
21. (Currently Amended) An apparatus configured to diagnose the presence of a malady of the respiratory system f a patient, the apparatus comprising:
a microphone;
an audio interface including an analog-to-digital converter (ADC) coupled to the microphone;
a data store coupled to the ADC and configured to store a digitized audio file of patient sounds received from the audio interface;
at least one processor configured to perform operations corresponding to instructions stored in a memory, the operations comprising:
identifying a plurality of epochs based on the digitized audio file;
wherein an entirety of the digital audio signal is divided into non-overlapping epochs;
identifying a plurality of sub-segments based on the digitized audio file for each of the epochs;
processing the digitized audio file to produce a multiplicity of mel-frequency cepstral coefficients (MFCCs) signals for each of the sub-segments based on the identified epochs and the identified sub-segments;
processing the MFCCs signals for each of the sub-segments to produce a deviation from probability distribution scores for each of the MFCCs signals for each epoch;
storing a test vector for the patient in the data store;
and processing the test vector using a machine learned model to produce a malady diagnosis signal;
and generating for display via a human-machine interface a malady diagnosis to a human based on the malady diagnosis signal.
(abstract portions shown in emphasis)
Step 2A Prong One
The recitation of an apparatus comprising a microphone, processing elements for processing an audio file to determine statistical parameters, and an interface to present a result encompasses performance of the limitation in the mind but for the recitation of mere extrasolutionary activity (i.e., mere data gathering and/or nominal output to facilitate an otherwise wholly abstract statistical analysis) and otherwise nominal and generic computer elements (2019 Patent Eligibility Guidance – hereafter ‘2019 PEG’ - p. 55; see also MPEP § 2106.05(a), (d) and (g)) (i.e., processing ‘assemblies’ which are merely computerized elements to carry out the wholly abstract statistical analyses).
For example, but for the recitation of obtaining / presenting data and generic processing ‘assemblies to perform abstract limitations, the steps of ‘processing’ audio files to ‘identify’ segments, to ‘produce’ MFCC values, and to ‘produce’ and ‘store’ encompasses a clinician (mentally) reviewing an audio file (e.g., of a patient’s sleep), (mentally) segmenting and applying epochs to the data, (mentally) determining statistical parameters (MFCCs, Gaussianity, vectorizing the data), and (mentally) forming a decision as to whether the patient has OSA.
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extrasolutionary activity (and otherwise generic computing elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under step 2A prong one of the Mayo framework as set forth in the 2019 PEG.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. Claim 21 only recites additional elements of extrasolutionary activity — in particular, mere sound recording with a microphone and a broad presentation of results — and otherwise generic computing elements (i.e., processing ‘assemblies’ and broadly recited audio data handling and storage) without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 - the instant claim, for example, does not tie into a particular machine, a sufficiently particular form of data or signal collection — via the claimed data obtaining, or a sufficiently particular form of display or computing architecture / structure).
Independent claim(s) 1 and 9-10 encounter the same issues as claim(s) 21 mutatis mutandis. The method claim(s) do not even recite as much data gathering structure as claim(s) 21 and are thus as at least ineligible as claim(s) 21.
Dependent claim(s) 2-8, 11, 13-20, 23, and 25-26 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application / integration (the dependent claim(s) reciting generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea).
Dependent claim(s) 12 and 22 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extrasolutionary activity (generic data gathering and nominal display) and/or generic computing elements (storage, memory per se).
Accordingly, the claim(s) are not integrated into a practical application under step 2A prong two.
Step 2B
The claims 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 the abstract idea into a practical application, the additional elements of extrasolutionary activity (data gathering and display outputting) and generic computing elements cannot amount to significantly more than an abstract idea.
For the independent claim portions and dependent claims which provide additional elements of extrasolutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more:
2106.05(g) Insignificant Extra-Solution Activity
Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information about credit card transactions, which is recited as part of a claimed process of analyzing and manipulating the gathered information by a series of steps in order to detect whether the transactions were fraudulent. An example of post-solution activity is an element that is not integrated into the claim as a whole, e.g., a printer that is used to output a report of fraudulent transactions, which is recited in a claim to a computer programmed to analyze and manipulate information about credit card transactions in order to detect whether the transactions were fraudulent.
As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). In Flook, the Court reasoned that "[t]he notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance. A competent draftsman could attach some form of post-solution activity to almost any mathematical formula". 437 U.S. at 590; 198 USPQ at 197; Id. (holding that step of adjusting an alarm limit variable to a figure computed according to a mathematical formula was "post-solution activity"). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 79, 101 USPQ2d 1961, 1968 (2012) (additional element of measuring metabolites of a drug administered to a patient was insignificant extra-solution activity).
Examiners should carefully consider each claim on its own merits, as well as evaluate all other relevant considerations, before making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. In particular, evaluation of the particular machine and particular transformation considerations (see MPEP § 2106.05(b) and (c), respectively), the well-understood, routine, conventional consideration (see MPEP § 2106.05(d)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)) may assist examiners in making a determination of whether an element (or combination of elements) is insignificant extra-solution activity. Note, however, that examiners should not evaluate the well-understood, routine, conventional consideration in the Step 2A Prong Two analysis, because that consideration is only evaluated in Step 2B.
This consideration is similar to factors used in past Office guidance (for example, the now superseded Bilski and Mayo analyses) that were described as mere data gathering in conjunction with a law of nature or abstract idea. When determining whether an additional element is insignificant extra-solution activity, examiners may consider the following:
(1) Whether the extra-solution limitation is well known. See Bilski v. Kappos, 561 U.S. 593, 611-12, 95 USPQ2d 1001, 1010 (2010) (well-known random analysis techniques to establish the inputs of an equation were token extra-solution activity); Flook, 437 U.S. at 593-95, 198 USPQ at 197 (a formula would not be patentable by only indicating that is could be usefully applied to existing surveying techniques); Intellectual Ventures I LLC v. Erie Indem. Co., 850 F.3d 1315, 1328-29, 121 USPQ2d 1928, 1937 (Fed. Cir. 2017) (the use of a well-known XML tag to form an index was deemed token extra-solution activity). Because this overlaps with the well-understood, routine, conventional consideration, it should not be considered in the Step 2A Prong Two extra-solution activity analysis.
(2) Whether the limitation is significant (i.e. it imposes meaningful limits on the claim such that it is not nominally or tangentially related to the invention). See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715-16, 112 USPQ2d 1750, 1755 (Fed. Cir. 2014) (restricting public access to media was found to be insignificant extra-solution activity); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1242, 120 USPQ2d 1844, 1855 (Fed. Cir. 2016) (in patents regarding electronic menus, features related to types of ordering were found to be insignificant extra-solution activity). This is considered in Step 2A Prong Two and Step 2B.
(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). This is considered in Step 2A Prong Two and Step 2B.
Below are examples of activities that the courts have found to be insignificant extra-solution activity:
Mere Data Gathering:
i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989);
Some cases have identified insignificant computer implementation as an example of insignificant extra-solution activity. See e.g., Fort Props., Inc. v. Am. Master Lease LLC, 671 F.3d 1317, 1323-24, 101 USPQ2d 1785, 1789-90 (Fed. Cir. 2012); Bancorp Servs., LLC v. Sun Life Assur. Co. of Canada, 687 F.3d 1266, 1280-81, 103 USPQ2d 1425, 1434-35 (Fed. Cir. 2012). Other cases have considered these types of limitations as mere instructions to apply a judicial exception. See MPEP § 2106.05(f) for more information about insignificant computer implementation.
For claim limitations that add insignificant extra-solution activity to the judicial exception (e.g., mere data gathering in conjunction with a law of nature or abstract idea), examiners should explain in an eligibility rejection why they do not meaningfully limit the claim. For example, an examiner could explain that adding a final step of storing data to a process that only recites computing the area of a space (a mathematical relationship) does not add a meaningful limitation to the process of computing the area. For more information on formulating a subject matter eligibility rejection, see MPEP § 2106.07(a).
The extrasolutionary activity of obtaining data with a microphone and broadly ‘presenting’ results as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and activity (memory/storage, processing ‘assemblies’), MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well-understood, routine, and conventional when recited at a high level of generality
II. ELEMENTS THAT THE COURTS HAVE RECOGNIZED AS WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL ACTIVITY IN PARTICULAR FIELDS
Because examiners should rely on what the courts have recognized, or those of ordinary skill in the art would recognize, as elements that describe well‐understood, routine activities, the following section provides examples of elements that have been recognized by the courts as well-understood, routine, conventional activity in particular fields. It should be noted, however, that many of these examples failed to satisfy other considerations (e.g., because they were recited at a high level of generality and thus were mere instructions to apply an exception, or were insignificant extra-solution activity). Thus, examiners should carefully analyze additional elements in a claim with respect to all relevant Step 2B considerations, including this consideration, before making a conclusion as to whether they amount to an inventive concept.
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log);
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
v. Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
vi. A Web browser’s back and forward button functionality, Internet Patent Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015).
Accordingly, the computerized elements, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s). The claim(s) are not patent eligible under step 2B.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10-13, 19-23, and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abeyratne (US 20120004749 A1 – previously cited).
For claim 10, Abeyratne teaches A method of operating one or more processors to diagnose the presence of a malady of a respiratory system of a patient, the method comprising:
accessing a digital audio signal of sounds of the patient from a data store accessible to the one or more processors; [¶145]
forming a test vector for the patient based upon the deviations scores from the probability distribution of the acquiring a digital audio signal of sounds of the patient in an electronic storage assembly accessible to said processors; [step(s) 98]
identifying a number of epochs of the digital audio signal; [step(s) 100]
wherein an entirety of the digital audio signal is divided into non-overlapping epochs; [step(s) 100 in view of step(s) 204]
identifying a plurality of sub-segments for each of the epochs; [¶147]
for each sub-segment of each of the epochs determining an associated multiplicity of mel-frequency cepstral coefficients (MFCCs); [step(s) 110]
determining deviation scores from a probability distribution for each of the epochs in respect of each of the multiplicity of MFCCs; [step(s) 110-111]
forming a test vector for the patient based upon the deviations scores from the probability distribution of the MFCCs; [step(s) 112 in ¶150 (including a vector as for an SVM)]
applying the test vector to a pre-trained machine learned model stored in the data store to generate a malady signal indicating malady or non-malady for the patient; [step(s) 112-114]
and controlling a display responsive to the one or more electronic processors to display a message corresponding to the malady signal. [step(s) 116-118]
For claim 11, Abeyratne teaches A method according to claim 10, wherein forming of the test vector based upon the deviations scores of the MFCCs includes applying a comparator to each of the deviation scores. [¶151]
For claim 12, Abeyratne teaches A method according to claim 11, wherein the comparator comprises instructions executed by the one or more processors to implement a decision routine. [¶151]
For claim 13, Abeyratne teaches A method according to claim 12, wherein the output of the routine indicates if the deviation score is equal to or below the threshold. [¶151]
For claim 19, Abeyratne teaches A method according to claim 10, including forming the test vector on the basis of the entire digital audio signal. [¶150 use of SVM on data means forming vector for training / classifying based on entire signal]
For claim 20, Abeyratne teaches A method according to claim 10, wherein the probability distribution is a Gaussian distribution and the deviation from a probability distribution score is a non-Gaussianity Score (NGS). [step(s) 111]
For claim 21, Abeyratne teaches An apparatus configured to diagnose the presence of a malady of the respiratory system of a patient, the apparatus comprising:
a microphone; [step(s) 53, 55 in Fig. 6]
an audio interface including an analog-to-digital converter (ADC) [step(s) 51] coupled to the microphone;
a data store coupled to the ADC and configured to store a digitized audio file of patient sounds received from the audio interface; [step(s) 54]
at least one processor configured to perform operations corresponding to instructions stored in a memory, the operations comprising:
identifying a plurality of epochs based on the digitized audio file; [step(s) 100]
wherein an entirety of the digital audio signal is divided into non-overlapping epochs; [step(s) 100 in view of step(s) 204]
identifying a plurality of sub-segments based on [part of step 100 in Fig. 7 per ¶147] the digitized audio file for each of the epochs;
processing the digitized audio file to produce a multiplicity of mel-frequency cepstral coefficients (MFCCs) signals for each of the sub-segments based on the identified epochs and the identified sub-segments; [step 110 in Fig. 7]
processing the MFCCs signals for each of the sub-segments to produce a deviation from probability distribution scores for each of the MFCCs signals for each epoch; [step(s) 111 and 112]
storing a test vector for the patient in the data store; [step(s) 112 in ¶150 (including a vector as for an SVM)]
and processing the test vector using a machine learned model to produce a malady diagnosis signal; [step(s) 112-114 in Fig. 7]
and generating for display via a human-machine interface a malady diagnosis to a human based on the malady diagnosis signal. [step(s) 116, 118 in Fig. 7]
For claim 22, Abeyratne teaches A non-transitory computer readable medium bearing tangible, machine readable instructions that, when executed, cause one or more processors to perform operations corresponding to the method of claim 10. [step(s) 72 in Fig. 6]
For claim 23, Abeyratne teaches A non-transitory computer readable medium according to claim 22,
wherein the probability distribution is a Gaussian distribution and the deviation is a non-Gaussianity score (NGS). [step(s) 111]
For claim 25, Abeyratne teaches A method according to claim 10,
wherein the malady is Obstructive Sleep Apnea (OSA). [step(s) 116-118]
For claim 26, Abeyratne teaches An apparatus according to claim 21,
wherein the malady is Obstructive Sleep Apnea (OSA). [step(s) 116-118]
Response to Arguments
Applicant's 4/8/25 arguments have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7-8 that the claim(s) are eligible under step 2B. Examiner respectfully disagrees. The additional elements of the claim(s) and the claim(s) as a whole do not reflect an improvement to the technology or other form of novelty which could amount to significantly more than the identified abstract idea. Examiner agrees that step 2B is a separate consideration from step 2A prong two but, even on the merits of step 2B alone, the claim(s) do not reflect an unconventional use of either data gathering, output, nor any other form of application of the judicial exception which could amount to significantly more.
Applicant argues in remarks p. 8-9 that Abeyratne fails to teach non-overlapping epochs in ¶100 and ¶147. As an initial matter, Examiner notes that the rejection refers to step 100 and ¶147 (as now stated in the rejections with more emphasis) and not paragraph 100 (i.e., not ¶100). Further, Examiner respectfully submits that the segmentation detailed in step 100 as well as step 204 in Fig. 8 is clearly a form of non-overlapping segmentation — step 204 reciting the use of non-overlapping segments verbatim.
Applicant argues in remarks p. 9 that Abeyratne fails to teach determining MFCCs for each sub-segment as Abeyratne teaches determining MFCCs only for the voiced snoring segments. Examiner respectfully disagrees. The MFCC determination of snoring segments constitute(s), under BRI, at least some form of determining MFCCs for ‘each sub-segment’. That Abeyratne calls these sub-segments snoring segments does not constitute a failure to teach determining the MFCCs for each sub-segment.
Applicant then argues in remarks p. 9 that Abeyratne doesn’t teach a form of sub-segmentation. However, in ¶147 Abeyratne teaches the classifying of the segments using the SRS method is at least some form of sub-segmentation.
Applicant argues in remarks p. 9 that Abeyratne fails to teach determining a deviation from a distribution. Examiner respectfully disagrees. Abeyratne teaches in step 111 the determining of a non-Gaussianity index which is an express teaching of determining a deviation from a distribution.
Conclusion
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
Prosecution Insights