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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a manual input collecting module”, “a physiological measurement input collecting module”, “an input weighing module” and “an input converting module” in claim 8. These modules areinterpreted as software modules that are performed by the processing circuitry.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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. Claims 1, 8 and 15 recite a method, a system and a computer-readable storage medium storing computer-readable instructions for performing operations comprising:
collecting manual input from an input interface of a pain assessment regularizing system;
collecting physiological measurement input from a physiological sensor of the pain assessment regularizing system affixed to an operative position on a patient's body;
weighing at least one input among the manual input and the physiological measurement input; and
converting each input among the manual input and the physiological measurement input into a respective regularized pain assessment factor.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a method, claim 8 is directed to a system and claim 15 is directed to a computer-readable storage medium storing computer-readable instructions for performing operations and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 8 and 15 recite a method, a system and a computer-readable storage medium storing computer-readable instructions for performing operations comprising:
collecting manual input from an input interface of a pain assessment regularizing system;
collecting physiological measurement input from a physiological sensor of the pain assessment regularizing system affixed to an operative position on a patient's body;
weighing at least one input among the manual input and the physiological measurement input; and
converting each input among the manual input and the physiological measurement input into a respective regularized pain assessment factor.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 8, and 15 recite an abstract idea of a mental process.
Steps 1 and 2 are directed to a pre-solution activity of collecting data and steps 3 and 4 are limitations as drafted in the claims, under the broadest reasonable interpretation, covers performance of the claimed steps (steps 3 and 4) in the mind, but for the recitation of a generic processor. Other than reciting a generic physiological sensor worn on the patient’s body, an input interface, a generic processor, memory and a generic patient-controlled analgesia device, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example, a clinician can obtain the data and weigh at least one input among the manual input and the physiological measurement input; and convert each input among the manual input and the physiological measurement input into a respective regularized pain assessment factor manually or via pen and paper.
Further, dependent Claims 2-7, 9-14, 16-20 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 8 and 15 recite the additional elements of a generic physiological sensor worn on the patient’s body, an input interface, a generic processor, memory. while claims 7 and 14 recite a generic patient-controlled analgesia device. However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, a generic physiological sensor worn on the patient’s body, an input interface, a generic processor, memory and a generic patient-controlled analgesia device as recited to perform the steps of : collecting manual input from an input interface of a pain assessment regularizing system; collecting physiological measurement input from a physiological sensor of the pain assessment regularizing system affixed to an operative position on a patient's body; weighing at least one input among the manual input and the physiological measurement input; and converting each input among the manual input and the physiological measurement input into a respective regularized pain assessment factor and further claims 7 and 14 that recite collecting patient-controlled analgesia (PCA) input; weighing the PCA input; and converting the PCA input into a respective regularized pain assessment factor amount to no more than mere instructions to apply the exception using generic computer components.
Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Annoni et al (U.S. Patent Application Publication Number: US 2020/0359960A1, hereinafter “Annoni” - APPLICANT CITED), Zuckerman-Stark et al (U.S. Patent Application Publication Number: US 2020/0359914A1, hereinafter “Stark” - APPLICANT CITED), Thakur et al (U.S. Patent Application Publication Number: US 2020/0188673 A1, hereinafter “Thakur”- APPLICANT CITED) teach physiological sensor worn on the patient’s body, an input interface, a generic processor, memory and a generic patient-controlled analgesia device) and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Claims 15-20 are rejected under 35 U.S.C. 101 because Claims 15-20 recite a 'computer-readable storage medium'. None of the claims, specification or record disclose that the claimed 'computer-readable storage medium' is a non-transitory medium. The Examiner asserts that the claimed 'computer-readable medium' can be a transitory signal, which is non-statutory. The Examiner suggests that Applicant replace 'computer readable storage medium' with 'non-transitory computer readable medium'.
Claim Rejections - 35 USC § 102
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.
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.
Claims 1-6, 8-13 and 15-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Annoni et al (U.S. Patent Application Publication Number: US 2020/0359960A1, hereinafter “Annoni”).
Regarding claims 1, 8 and 15, Annoni teaches a system, a method and a computer-readable storage medium storing computer-readable instructions executable by one or more processors, that when executed by the one or more processors, cause the one or more processors to perform operations comprising:
collecting manual input from an input interface (e.g. 224,226 Fig.2, [0052], [0056]: patient information input device for input from the patient such as perceived pain levels, mood, and stress levels) of a pain assessment regularizing system;
collecting physiological measurement input from a physiological sensor (e.g. 212,214 Fig.2, Table 1, [0052]-[0054], [0058]: non-invasive sensors for measuring heart rate, blood pressure, EEG, EMG, chemical analyte parameters) of the pain assessment regularizing system affixed to an operative position on a patient's body (e.g. Fig.3);
weighing at least one input among the manual input and the physiological measurement input (e.g. Fig.4, [0049],[0050], [0063]-[0065]: weighting factors are generated, and the signal metric is produced using the one or more physiological parameters, the one or more functional parameters, and the one or more patient parameters with the weighting factors each applied to one of these parameters.); and
converting each input among the manual input and the physiological measurement input into a respective regularized pain assessment factor (e.g. Figs. 4, 6).
Regarding claims 2, 3, 9, 10, 16 and 17, Annoni further teaches collecting image capture input (e.g. Fig. 2, Table 1: Functional measure including facial features and expressions associated with pain are obtaining using imaging modalities) or video capture input from an image capture device of the pain assessment regularizing system directed upon an expressive location on a patient's body, wherein the expressive location and the operative position do not correspond to a location where the patient is experiencing or reporting pain;
weighing the image capture input or video capture input (e.g. Fig.4, [0049],[0050], [0063]-[0065]: weighting factors are generated, and the signal metric is produced using the one or more physiological parameters, the one or more functional parameters, and the one or more patient parameters with the weighting factors each applied to one of these parameters.); and
converting the image capture input or video capture input into a respective regularized pain assessment factor (e.g. Figs. 4, 6, [0049], [0050]: signal metric).
Regarding claims 4, 11 and 18, Annoni teaches the physiological measurement input comprises at least one of: blood pressure; pulse rate or pulse waveform; respiratory rate; galvanic skin response; cortical activity; muscle contraction; and blood carbon dioxide level (e.g. 212,214 Fig.2, Table 1, [0052]-[0054], [0058]: non-invasive sensors for measuring heart rate, blood pressure, EEG, EMG, chemical analyte parameters).
Regarding claims 5, 12 and 19, Annoni further teaches deriving a combined regularized pain assessment factor collectively from each regularized pain assessment factor (e.g. [0046], [0048]-[0051]: composite pain score).
Regarding claims 6,13 and 20, Annoni further teaches recording each combined regularized pain assessment factor in a time series; and forecasting a trend of the time series of combined regularized pain assessment factors (e.g. [0064]: sensing is based on circadian rhythms and signal metric is determined and monitored and the signal metric is trended and composite pain score is computed based on the trend).
Claim Rejections - 35 USC § 103
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.
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.
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Annoni et al (U.S. Patent Application Publication Number: US 2020/0359960 A1, hereinafter “Annoni”- APPLICANT CITED) in view of Annoni et al (U.S. Patent Application Publication Number: US 2018/0193644 A1, hereinafter “Annoni’644”).
Regarding claims 7 and 14, Annoni teaches the claimed invention as discussed above and further teaches the system is configured with a drug delivery pump for drug therapy to deliver one or more pain suppression agents (e.g. [0075]) and that the therapy is adjusted based on the pain score (e.g. [0071],[0072]). They do not specifically teach collecting patient-controlled analgesia (PCA) input from a PCA device intravenously connected to a patient; weighing the PCA input; and converting the PCA input into a respective regularized pain assessment factor.
In a similar field of endeavor, Annoni ‘644 teaches a drug delivery system that includes a computerized patient-controlled analgesia pump that delivers the prescribed pain medication to the patient such as via an intravenous line (e.g. [0066]) and further teaches that the pain-relief effect of the delivered pain therapy is assessed based on the signal metrics such as the cardiovascular parameters, and the therapy is adjusted in a commanded mode upon receiving from a system user a command or confirmation of parameter adjustment to achieve desirable pain relief and the therapy adjustment. they teach that the responses of the signal metrics to pain therapy delivered at may be used to gauge composite pain score computation such as by adjusting the weight factor (e.g. [0097]) and therefore they teach collecting patient-controlled analgesia (PCA) input from a PCA device intravenously connected to a patient; weighing the PCA input; and converting the PCA input into a respective regularized pain assessment factor as claimed. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the teachings of Annoni to include a computerized patient-controlled analgesia pump that delivers the prescribed pain medication to the patient such as via an intravenous line and collecting patient-controlled analgesia (PCA) input; weighing the PCA input; and converting the PCA input into a respective regularized pain assessment factor as taught by Annoni’644 in order to provide the predictable results of providing a more effective and safe closed loop therapy to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792