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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) 1-20 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) 1 recites
A method for generating an arterial blood pressure (ABP) signal, the method comprising:
generating a model using machine learning;
detecting a heart-motion-induced signal;
and transforming the heart-motion-induced signal into the ABP signal by inputting the heart-motion-induced signal into the model and using an output of the model as the ABP signal.
(abstract portions shown in emphasis)
Step 2A Prong One
The recitation of transforming a motion signal into a BP signal 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) and/or otherwise nominal and generic computer elements (2019 Patent Eligibility Guidance – hereafter ‘2019 PEG’ - p. 55; see also MPEP § 2106.05(a), (d) and (g)) (e.g., processing ‘units’).
For example, but for the recitation of obtaining/acquiring data and/or generic processing ‘units’ / functional steps to perform abstract limitations, the steps of ‘transforming’ a signal encompasses a clinician (mentally) reviewing signal data to then (mentally) transform the signal data into one or more BP values.
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extrasolutionary activity (and/or 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 1 only recites additional elements of extrasolutionary activity — in particular, a generic ‘detecting’ of a motion signal — and/or generic computing structures / elements 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/processing architecture / structure).
Independent claim(s) 18 and 20 encounter the same issues as claim(s) 1 mutatis mutandis.
Dependent claim(s) 2-6, 8-11, and 19 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).
Dependent claim(s) 7 and 12-17 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).
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/step(s) of signal detection, filtering, and display 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 units), 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 computer 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) 1-2, 5-10, 15, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khullar (US 20210117782 A1).
For claim 1, Khullar teaches A method for generating an arterial blood pressure (ABP) signal, the method comprising:
generating a model using machine learning; [use of neural network is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Khullar – see esp. abstract, ¶5]
detecting a heart-motion-induced signal; [¶5]
and transforming the heart-motion-induced signal into the ABP signal by inputting the heart-motion-induced signal into the model and using an output of the model as the ABP signal. [¶49]
For claim 2, Khullar teaches The method of claim 1 wherein the heart-motion-induced signal is a seismocardiography (SCG) signal. [¶5]
For claim 5, Khullar teaches The method of claim 1 wherein the model includes a neural network. [¶¶20-21]
For claim 6, Khullar teaches The method of claim 5 wherein the neural network is a convolutional neural network. [¶¶20-21]
For claim 7, Khullar teaches The method of claim 1 wherein:
generating the model includes analyzing an error function for determining a deviation between the ABP signal and a reference ABP signal; [¶¶36-40]
and in analyzing the error function, different weightings are applied to different signal portions of at least one of the ABP signal, the reference ABP signal, or the deviation. [filter selection in ¶40 is a form of weighting of signal portions of BP signal(s)]
For claim 8, Khullar teaches The method of claim 1 wherein the heart-motion-induced signal is detected in a contact-free manner. [Fig(s). 1 where IMUs 102-112 are on the subject’s clothes and not adhered to the subject’s chest/skin]
For claim 9, Khullar teaches The method of claim 1 further comprising:
filtering the heart-motion-induced signal to generate a filtered heart-motion-induced signal, wherein the filtered heart-motion-induced signal is inputted into the model. [¶18]
For claim 10, Khullar teaches The method of claim 1 wherein:
the heart-motion-induced signal is generated by a detection means of a device; [102-112]
and the transformation is carried out by at least one of:
a calculating means of the device, or a calculating means of another device to which the heart-motion-induced signal is transmitted. [wearable 114 in ¶15 ¶41]
For claim 15, Khullar teaches The method of claim 1 wherein the heart-motion-induced signal is the only input value of the model. [¶49; initial training via cuff in ¶¶13-16 for then subsequent determination via only IMUs in Fig(s). 5 and ¶16]
For claim 18, Khullar teaches A system for generating an arterial blood pressure (ABP) signal, the system comprising:
detection means [102-112] for detecting a heart-motion-induced signal;
and calculating means [114] for transforming the heart-motion-induced signal into the ABP signal,
wherein the calculating means includes a model generated by machine learning, [use of neural network is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Khullar – see esp. abstract, ¶5]
wherein the heart-motion-induced signal constitutes an input value to the model, [¶¶13-20 ¶49]
and wherein the ABP signal constitutes an output value of the model. [¶¶13-20 ¶49]
For claim 20, Khullar teaches A non-transitory computer-readable medium comprising instructions including:
generating a model using machine learning; [use of neural network is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Khullar – see esp. abstract, ¶5]
detecting a heart-motion-induced signal; [¶¶13-20]
and transforming the heart-motion-induced signal into an arterial blood pressure (ABP) signal by inputting the heart-motion-induced signal into the model and using an output of the model as the ABP signal. [¶¶13-20 ¶49]
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khullar.
For claim 11, Khullar teaches The method of claim 1 wherein:
the heart-motion-induced signal is generated by a detection means of a device. [IMUs 102-112 and/or wearable 114 in ¶15 ¶41]
Khullar fails to teach the ABP signal displayed on a display means. However, Examiner takes official notice that such a step would be well-known in the pertinent art.
Claim(s) 3, 4, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khullar in view of Salo (US 20210145298 A1).
For claim(s) 3, 4, and 19, Khullar fails to teach the detection means in a bed and the signal being a PCG and/or a BCG signal.
Salo teaches a cardiac signal analysis system and method [abstract] comprising a mattress [Fig(s). 6] embedded with PCG and/or BCG sensor(s). [¶55 ¶91]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the system of Khullar to incorporate the PCG and/or BCG sensor embedded mattress of Salo in order to increase the comfort and efficacy of measurement. As motivated by Salo ¶¶5-7 ¶33.
Claim(s) 12-14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Khullar in view of De Groot (US 20190298195 A1).
For claim(s) 12-14, Khullar fails to teach determining an operability / quality / sensor arrangement deviation determination step.
De Groot teaches a BP determination method [abstract] comprising a step determining a sensor functional determination which equally / additionally determines signal quality against a threshold value and sensor positioning arrangement against a threshold value and only proceeds with signal analysis if the functional test succeeds via a signal quality being above a threshold and a movement of the sensor being below another threshold. [throughout ¶¶43-55]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of Khullar to incorporate the signal quality step(s) of De Groot in order to aid in improving signal analysis quality via selective removal of noisy signal data. As motivated by De Groot ¶¶43-55.
For claim(s) 16-17, Khullar fails to teach the BP signal being a continuous BP signal.
De Groot teaches determining and outputting a continuous BP signal defining BP for each timepoint in a period (24 hours). [¶17]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the method of Khullar to incorporate the continuous output of De Groot in order to improve BP signal use, accuracy, and efficacy. As motivated by De Groot ¶17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571) 272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791