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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Applicant's arguments, filed 05/04/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 05/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 7, 29, and 31.
Applicants have left claims 2-5, 9-12, 16, 18-20, and 23-26 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 6, 8, 13-15, 17, 21-22, 27-28, 30, and 32.
Claims 1-5, 7, 9-12, 16, 18-20, 23-26, 29, and 31 are the current claims hereby under examination.
Claim Objections - Newly Applied Necessitated by Applicant’s Amendments
Claims 1, 29, and 31 are objected to because of the following informalities:
Regarding claim 1, line 35 recites “a result”, however it appears it should read --the result-- (emphasis added).
Regarding claim 29, line 5 recites “perception data”, however it appears it should read --the perception data-- (emphasis added).
Regarding claim 29, line 5 recites “one or more”, however it appears it should read --the one or more-- (emphasis added).
Regarding claim 29, line 6 recites “one or more limbs”, however it appears it should read --the one or more limbs-- (emphasis added).
Regarding claim 29, line 6 recites “a test subject”, however it appears it should read --the test subject-- (emphasis added).
Regarding claim 29, line 11 recites “a prediction model”, however it appears it should read --the at least one prediction model-- (emphasis added).
Regarding claim 29, line 12 receives “at least one risk variable”, however it appears it should read --the at least one risk variable-- (emphasis added).
Regarding claim 29, line 12 recites “a risk”, however it appears it should read --the risk-- (emphasis added).
Regarding claim 29, line 13 recites “a result”, however it appears it should read --the result-- (emphasis added).
Regarding claim 29, line 14 recites “prediction data”, however it appears it should read --the prediction data-- (emphasis added).
Regarding claim 31, line 11 recites “prediction data”, however it appears it should read --the prediction data-- (emphasis added).
Regarding claim 31, line 12 recites “a result”, however it appears it should read --the result-- (emphasis added).
Claim Interpretation - 35 USC § 112(f) - Newly Applied Necessitated by Applicant’s Amendments
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.
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:
Claim 1: The claim limitation “feedback device configured to allow a test subject to signal upon sensing a vibration of the probe” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “configured to allow a test subject to signal upon sensing a vibration of the probe” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“The feedback device 5 may include any combination of a button, keyboard, keypad, touch screen, microphone, gesture recognition system, etc. …”, or equivalents thereof, as described on page 7, lines 34-36 of the disclosure filed on 08/17/2023.
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 § 112 - Withdrawn
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Response to Arguments
Applicant’s arguments, see 9 of Remarks, filed 05/04/2026, with respect to claim 7 have been fully considered and are persuasive. Applicants have amended claim 7 to depend from 5, rendering the rejection moot. The 112(d) rejection of claim 7 has been withdrawn.
Claim Rejections - 35 USC § 101 - Maintained/Newly Applied Necessitated by Applicant’s Amendments
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 1-5, 7, 9-12, 16, 18-20, 23-26, 29, and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1, 29, and 31:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a device, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 29 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Claim 31 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 29, and 31 recite an abstract idea. In particular, the claims recite the following:
Operate at least one prediction model on the perception data to determine at least one risk variable, which is indicative of a risk that the test subject will develop peripheral neuropathy as a result of chemotherapy; and
Generate prediction data based on the at least one risk variable representing the risk that the test subject will develop peripheral neuropathy as a result of chemotherapy.
These elements recited in claims 1, 29, and 31 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Operating at least one prediction model to determine a risk variable is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably use received perception data printed on a piece of paper to determine a subject has a certain risk of developing peripheral neuropathy as a result of chemotherapy if the perception data is within a certain range. There is nothing to suggest an undue level of complexity in operating at least one prediction model, as currently claimed.
Generate prediction data based on the at least one risk variable representing the risk that the test subject will develop peripheral neuropathy as a result of chemotherapy is drawn to a mental process that can be practically performed in the human mind, with the aid of pen and paper. For example, a person with ordinary skill in the art can reasonably generate prediction data based on the determined at least one risk variable. There is nothing to suggest an undue level of complexity in generating prediction data, as currently claimed.
Additionally, the claims recite a law of nature and/or natural phenomena. Specifically, the claims recite determining a risk/correlation between a patients perception data, chemotherapy, and developing peripheral neuropathy. See MPEP 2106.04(b), I, and at least Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012).
Prong Two: Claims 1, 29, and 31 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea or law of nature. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “control unit … an analysis device comprising: circuitry configured to predict a risk of chemotherapy …” (claim 1, claim 29, claim 31), “computer-implemented …” (claim 29)), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “vibrometer … electro-dynamic device … probe … feedback device … control unit … receive input data …”).
As a whole, the additional elements merely serve to gather information to be used by the exceptions, while generically implementing it on a computer. There is no practical application because the exceptions are not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a vibrometer … an electro-dynamic device … a probe … a feedback device … a control unit configured to operate the vibrometer …”, as disclosed by the instant specification (pg. 7) and by David Poisner (US 20090082694 A1) - (Fig. 1, para. [0010-0011], para. [0013], para. [0016-0018]).
Further, “a control unit”, “an analysis device”, “circuitry” and “computer-implemented” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 29, and 31 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution steps of necessary data gathering, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-5, 7, 9-12, 16, 18-20, and 23-26 depend from the independent claim. The dependent claims merely further define the exceptions and are, therefore, directed to the exceptions for similar reasons: they merely
Further describe the abstract idea (“determine the at least one risk variable by operating the at least one prediction model on the perception data and on the set of parameter values” (claim 10), “generate a plurality of variables based on the input data, wherein the at least one prediction model is configured to determine the at least one risk variable by combining the plurality of variables by use of a plurality of predetermined weight factors” (claim 16), “wherein the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy that persists at least six months after completion of the chemotherapy” (claim 18), “wherein the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy during the chemotherapy” (claim 19), “wherein the prediction data is indicative of one of at least three predefined risk classes comprising: a first risk class associated with a low risk, a second risk class associated with a high risk, and a third risk class intermediate the first and second risk classes” (claim 20), “wherein the at least one risk variable comprises a first risk variable and a second risk variable, and wherein the circuitry is further configured to: determine a first category based on the first risk variable, determine a second category based on the second risk variable, and generate the prediction data as a logic combination of the first category and the second category” (claim 23), “wherein the circuitry is further configured to: operate a first prediction model on the input data to determine the first risk variable, and operate a second prediction model on the input data to determine the second risk variable” (claim 24), “wherein the first risk variable is indicative of a low risk of developing CIPN, and the second risk variable is indicative of a high risk of developing CIPN” (claim 25), “wherein said circuitry is further configured to: evaluate the input data in relation to a set of content requirements to determine an adequacy score, and selectively, based on the adequacy score, output a request for further input data” (claim 26)),
Further describe the pre-solution activity (or the structure used for such activity) (“wherein the one or more predefined frequencies comprises at least two different frequencies below 64 Hz” (claim 2), “wherein said at least one of the one or more predefined frequencies is at or below 60 Hz, 50 Hz, 40 Hz, 35 Hz, 30 Hz, 25 Hz, 20 Hz, 15 Hz, or 10 Hz” (claim 3), “wherein the perception data comprises a plurality of perception values that differ by at least one of: predefined frequency, predetermined location, or limb of the test subject” (claim 4), “wherein the chemotherapy comprises a time sequence of sessions with administration of at least one chemotherapeutic agent, and wherein the perception data represents the measured perception of the vibrations by the test subject prior to at least one session in the time sequence of sessions” (claim 5), “wherein the perception data represents the measured perception of the vibrations by the test subject prior to at least an initial session in the time sequence of sessions” (claim 7), “wherein the chemotherapy comprises administration of at least one chemotherapeutic agent in the group consisting of: platinum-containing chemotherapeutic agents, taxanes, immunomodulatory agents, vinca alkaloids, epothilones, and protease inhibitors” (claim 9), “wherein the input data further comprises a set of parameter values representing the test subject and/or the chemotherapy” (claim 10), “wherein the set of parameter values is indicative of one or more of: an age of the test subject, a gender of the test subject, one or more physical characteristics of the test subject, a current temperature of the test subject, a health status of the test subject, a medication status of the test subject, and a medical history of the test subject” (claim 11), “wherein the set of parameter values is indicative of one or more of: a chemotherapy treatment history of the test subject, a chemotherapeutic agent administered in the chemotherapy, an accumulated dose of the chemotherapeutic agent administered during the chemotherapy, a method of administrating the chemotherapeutic agent, and a schedule of the chemotherapy” (claim 12)),
Further describe the computer implementation (“circuitry” (multiple claims)).
Further, “circuitry” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the exception is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-5, 7, 9-12, 16, 18-20, 23-26, 29, and 31 are rejected.
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 9-10 of Remarks, filed 05/04/2026, that “the claimed predictive device is therefore more than an abstract idea and requires certain physical device and their interconnections … the analysis device which takes the feedback signal through a prediction model to determine the risk … That is not a calculation that can be performed within a human brain …”.
The Examiner respectfully disagrees. In regards to the physical and their interconnections, as recited above in the rejection, the vibrometer is directed towards well-known, routine, and conventional methods of gathering perception data, as recited within the instant specification and within the prior art. Further, the perception data gathered by the vibrometer is drawn towards necessary pre-solution data gathering steps to be used by the abstract idea. In regards to the prediction model being performed within a human brain, as currently claimed and reiterated above, there is nothing to suggest an undue level of complexity in the determining the risk variable.
Additionally, as recited above, the claims recite a law of nature and/or natural phenomena.
Claim Rejections - 35 USC § 103 - Maintained/Newly Applied Necessitated by Applicant’s Amendments
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7, 9-12, 16, 18-20, 23-26, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over David Poisner (US 20090082694 A1) (previously cited), hereinafter referred to as Poisner, in view of Rubenstein et al. (US 20190371468 A1) (previously cited), hereinafter referred to as Rubenstein.
The claims are generally directed towards a prediction device, comprising: a vibrometer comprising a measurement device, wherein the measurement device comprises: an electro-dynamic device that vibrates at one or more predefined frequencies when supplied with a current or voltage, wherein at least one of the one or more predefined frequences is below 64 Hz, a probe coupled to the electro-dynamic device, and a feedback device configured to allow a test subject to signal upon sensing a vibration of the probe; a control unit configured to operate the vibrometer, wherein the control unit is connected to the vibrometer by wire or wirelessly to provide a control signal to the measurement device and to receive a feedback signal from the feedback device, wherein the feedback signal represents perception data of vibrations at one or more predetermined locations on one or more limbs of the test subject, wherein the perception data represents, for vibrations at each of one or more predefined frequencies, a vibration energy that causes the test subject to switch between perception and non-perception of the vibrations; and an analysis device comprising: circuitry configured to predict a risk of chemotherapy-induced peripheral neuropathy (CIPN), in the test subject, said circuitry being configured to: receive input data comprising the feedback signal representing the perception data, operate at least one prediction model on the perception data to determine at least one risk variable, which is indicative of a risk that the test subject will develop peripheral neuropathy as a result of chemotherapy, and generate prediction data based on the at least one risk variable representing the risk that the test subject will develop peripheral neuropathy as a result of chemotherapy.
Regarding claim 1, Poisner discloses a prediction device (Abstract, Fig. 1), comprising:
a vibrometer comprising a measurement device (Fig. 1, element 110, element 116, para. [0010]), wherein the measurement device comprises:
an electro-dynamic device that vibrates at one or more predefined frequencies when supplied with a current or voltage, wherein at least one of the one or more predefined frequences is below 64 Hz (Fig. 1, element 116, para. [0010], “vibrating element may be utilized to generate vibrations in neuropathy monitor that are capable of being modulated in frequency and/or amplitude …”, para. [0013], para. [0017], “frequency of vibrations may run from as low as about 60 Hertz … frequency may range from tens of Hertz to hundreds of Hertz … gradually increased from a lower amplitude to a higher amplitude, or from a higher amplitude to a lower amplitude …”,
a probe coupled to the electro-dynamic device (Fig. 1, element 116, para. [0010], “coupling vibrations generated by vibrating element to a human extremity … weight scale … separate box … built into a glove, wristband, boot, sock …”), and
a feedback device configured to allow a test subject to signal upon sensing a vibration of the probe (Fig. 1, element 124, 126, para. [0011], “methods or mechanisms for the user to indicate … no longer feel one or more generated vibrations … button or key … a remote control … pressure sensor … microphone …”, para. [0016-0018]);
a control unit configured to operate the vibrometer (Fig. 1, element 110, para. [0013]), wherein the control unit is connected to the vibrometer by wire or wirelessly to provide a control signal to the measurement device and to receive a feedback signal from the feedback device (para. [0013], “processor to conduct one or more neuropathy tests and to control … vibrating element … receive and process data obtained from the user including one or more results of the test … wired or wireless connection …”), wherein the feedback signal represents perception data of vibrations at one or more predetermined locations on one or more limbs of the test subject, wherein the perception data represents, for vibrations at each of one or more predefined frequencies, a vibration energy that causes the test subject to switch between perception and non-perception of the vibrations (para. [0010], “human extremity of the user …”, para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …”); and
an analysis device (Fig. 1, element 110, para. [0013]) comprising:
circuitry configured to predict a risk of chemotherapy-induced peripheral neuropathy (CIPN), in the test subject (Abstract, “peripheral neuropathy monitor … monitoring a trend towards peripheral neuropathy …”, Fig. 1, para. [0001]), said circuitry being configured to:
receive input data comprising the feedback signal representing the perception data (para. [0010], “human extremity of the user …”, para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …”),
operate at least one prediction model on the perception data to determine at least one risk variable, which is indicative of a risk that the test subject will develop peripheral neuropathy (para. [0014-0015], “running a diagnosis program, for example using artificial intelligence or the like, to infer and/or diagnose a condition of the user based at least in park on one or more test results …”, para. [0017], “detect progression of the user towards peripheral neuropathy … indicated a trends towards peripheral neuropathy …”), and
generate prediction data based on the at least one risk variable (para. [0018], “may be trending towards or suffering from peripheral neuropathy … result may be flagged … display a visual flag …”).
However, Poisner does not explicitly disclose the development of peripheral neuropathy is the result of chemotherapy, and the prediction data is based on the at least one risk variable representing the risk that the test subject will develop peripheral neuropathy as a result of chemotherapy.
Rubenstein teaches an analogous prediction device (Abstract, Fig. 2, para. [0030], para. [0041]). Rubenstein teaches receiving input data comprising perception data (Fig. 2, element 202, element 218, para. [0041], “neuropathy related data”). Rubenstein further teaches operating a prediction model to determine at least one risk variable, where the risk is based on a treatment-regiment-related outcome as a result of chemotherapy (para. [0041], para. [0055], para. [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction model to additionally include chemotherapy data to determine a risk of developing peripheral neuropathy as a result of chemotherapy, and have the prediction data be based on the risk that the test subject will develop neuropathy as a result of chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches chemotherapy can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 2, modified Poisner discloses the prediction device of claim 1, wherein the one or more predefined frequencies comprises at least two different frequencies below 64 Hz (para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …”).
Regarding claim 3, modified Poisner discloses the prediction device of claim 1, wherein said at least one of the one or more predefined frequencies is at or below 60 Hz, 50 Hz, 40 Hz, 35 Hz, 30 Hz, 25 Hz, 20 Hz, 15 Hz, or 10 Hz (para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …”).
Regarding claim 4, modified Poisner discloses the prediction device of claim 1, wherein the perception data comprises a plurality of perception values that differ by at least one of: predefined frequency, predetermined location, or limb of the test subject (para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …”).
Regarding claim 5, modified Poisner discloses the prediction of claim 1, wherein the perception data represents the measured perception of the vibrations by the test subject prior to at least one session in a time sequence of sessions (para. [0015], “previously run tests …”).
However, modified Poisner does not explicitly disclose wherein the chemotherapy comprises a time sequence of sessions administration of at least one chemotherapeutic agent.
Rubenstein further teaches the chemotherapy comprises a time sequence of sessions administration of at least one chemotherapeutic agent (para. [0024], para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction device taught by modified Posner to explicitly have the chemotherapy comprises a time sequence of sessions administration of at least one chemotherapeutic agent, as taught by Rubenstein. This is because Rubenstein teaches chemotherapy, including a chemotherapy regimen, can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 7, modified Poisner discloses the prediction device of claim 5, wherein the perception data represents the measured perception of the vibrations by the test subject prior to at least an initial session in the time sequence of sessions (para. [0015], “previously run tests …”).
Regarding claim 9, modified Poisner discloses the prediction device of claim 1.
However, modified Poisner does not explicitly disclose wherein the chemotherapy comprises administration of at least one chemotherapeutic agent in the group consisting of: platinum-containing chemotherapeutic agents, taxanes, immunomodulatory agents, vinca alkaloids, epothilones, and protease inhibitors.
Rubenstein further teaches the chemotherapy comprises administration of at least one chemotherapeutic agent in the group consisting of: platinum-containing chemotherapeutic agents, taxanes, immunomodulatory agents, vinca alkaloids, epothilones, and protease inhibitors (para. [0029], para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction device to additionally determine the risk as a result of chemotherapy comprising the administration of at least one chemotherapeutic agent in the group consisting of: platinum-containing chemotherapeutic agents, taxanes, immunomodulatory agents, vinca alkaloids, epothilones, and protease inhibitors, as taught by Rubenstein. This is because Rubenstein teaches chemotherapeutic agents can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 10, modified Poisner discloses the prediction device of claim 1, wherein the input data further comprises a set of parameter values representing the test subject and/or the chemotherapy, and wherein said circuitry is configured to determine the at least one risk variable by operating the at least one prediction model on the perception data and on the set of parameter values (para. [0015], “advance processing and adaptive learning based at least in part on one or more test results from previously run tests …”, para. [0018], “temperature test … one or more vibration tests … tests results may be analyzed …”).
Regarding claim 11, modified Poisner discloses the prediction device of claim 10, wherein the set of parameter values is indicative of one or more of: an age of the test subject, a gender of the test subject, one or more physical characteristics of the test subject, a current temperature of the test subject, a health status of the test subject, a medication status of the test subject, and a medical history of the test subject (para. [0015], “advance processing and adaptive learning based at least in part on one or more test results from previously run tests …”, para. [0018], “temperature test … one or more vibration tests … tests results may be analyzed …”).
Regarding claim 12, modified Poisner discloses the prediction device of claim 11.
However, modified Poisner does not explicitly disclose wherein the set of parameter values is indicative of one or more of: a chemotherapy treatment history of the test subject, a chemotherapeutic agent administered in the chemotherapy, an accumulated dose of the chemotherapeutic agent administered during the chemotherapy, a method of administrating the chemotherapeutic agent, and a schedule of the chemotherapy.
Rubenstein further teaches the set of parameter values is indicative of one or more of: a chemotherapy treatment history of the test subject, a chemotherapeutic agent administered in the chemotherapy, an accumulated dose of the chemotherapeutic agent administered during the chemotherapy, a method of administrating the chemotherapeutic agent, and a schedule of the chemotherapy (para. [0041]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction device taught by modified Poisner to additionally include a set of parameter values is indicative of one or more of: a chemotherapy treatment history of the test subject, a chemotherapeutic agent administered in the chemotherapy, an accumulated dose of the chemotherapeutic agent administered during the chemotherapy, a method of administrating the chemotherapeutic agent, and a schedule of the chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches different cancer regimen data, including chemotherapeutic agents, can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 16, modified Poisner discloses the prediction device of claim 1, wherein the circuitry is further configured to: generate a plurality of variables based on the input data, wherein the at least one prediction model is configured to determine the at least one risk variable by combining the plurality of variables by use of a plurality of predetermined weight factors (para. [0018], “temperature test … one or more vibration tests … test results may be analyzed … determine any trend or pattern …”).
Regarding claim 18, modified Poisner discloses the prediction device of claim 1.
However, modified Poisner does not explicitly disclose wherein the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy that persists at least six months after completion of the chemotherapy.
Rubenstein further teaches the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy that persists at least six months after completion of the chemotherapy (para. [0030-0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction device taught by modified Poisner to explicitly have the risk variable be indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy that persists at least six months after completion of the chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches different cancer regimen data, including chemotherapeutic agents, can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 19, modified Poisner discloses the prediction device of claim 1.
However, modified Poisner does not explicitly disclose wherein the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy during the chemotherapy.
Rubenstein further teaches the at least one risk variable comprises a risk variable which is indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy during the chemotherapy (para. [0030-0031]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction device taught by modified Poisner to explicitly have the risk variable be indicative of the risk that the test subject will develop chemotherapy-induced peripheral neuropathy during the chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches different cancer regimen data, including chemotherapeutic agents, can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 20, modified Poisner discloses the prediction device of claim 1.
However, modified Poisner does not explicitly disclose wherein the prediction data is indicative of one of at least three predefined risk classes comprising: a first risk class associated with a low risk, a second risk class associated with a high risk, and a third risk class intermediate the first and second risk classes.
Rubenstein further teaches the prediction data is indicative of one of at least three predefined risk classes comprising: a first risk class associated with a low risk, a second risk class associated with a high risk, and a third risk class intermediate the first and second risk classes (para. [0054-0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify prediction data disclosed by modified Poisner to additionally include at least three predefined risk classes comprising: a first risk class associated with a low risk, a second risk class associated with a high risk, and a third risk class intermediate the first and second risk classes, as taught by Rubenstein. This is because Rubenstein teaches providing multiple levels of risk levels allows for the patient to be better informed about the risks of the treatment regimens and the risk of developing peripheral neuropathy (para. [0055-0056]).
Regarding claim 23, modified Poisner discloses the prediction device of claim 1.
However, modified Poisner does not explicitly disclose wherein the at least one risk variable comprises a first risk variable and a second risk variable, and wherein the circuitry is further configured to: determine a first category based on the first risk variable, determine a second category based on the second risk variable, and generate the prediction data as a logic combination of the first category and the second category.
Rubenstein further teaches the at least one risk variable comprises a first risk variable and a second risk variable, and wherein the circuitry is further configured to: determine a first category based on the first risk variable, determine a second category based on the second risk variable, and generate the prediction data as a logic combination of the first category and the second category (para. [0071-0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the at least one risk variables taught by modified Poisner to additionally include a first risk variable and a second risk variable, and wherein the circuitry is further configured to: determine a first category based on the first risk variable, determine a second category based on the second risk variable, and generate the prediction data as a logic combination of the first category and the second category, as taught by Rubenstein. This is because Rubenstein teaches combining a plurality of risk variables to determine prediction data allows for the model to use multiple data variables to determine the most favorable treatment result (para. [0070-0071]).
Regarding claim 24, modified Poisner discloses the prediction device of claim 23.
However, modified Poisner does not explicitly disclose wherein the circuitry is further configured to: operate a first prediction model on the input data to determine the first risk variable, and operate a second prediction model on the input data to determine the second risk variable.
Rubenstein further teaches the circuitry is further configured to: operate a first prediction model on the input data to determine the first risk variable, and operate a second prediction model on the input data to determine the second risk variable (para. [0071-0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the circuitry taught by modified Poisner to additionally be configured to operate a first prediction model on the input data to determine the first risk variable, and operate a second prediction model on the input data to determine the second risk variable, as taught by Rubenstein. This is because Rubenstein teaches operating multiple prediction models allows for the models to use multiple data variables to determine the most favorable treatment result (para. [0070-0071]).
Regarding claim 25, modified Poisner discloses the prediction device of claim 23.
However, modified Poisner does not explicitly disclose wherein the first risk variable is indicative of a low risk of developing CIPN, and the second risk variable is indicative of a high risk of developing CIPN.
Rubenstein further teaches the first risk variable is indicative of a low risk of developing CIPN, and the second risk variable is indicative of a high risk of developing CIPN (para. [0054-0056], para. [0071-0086]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the risk variables taught by modified Poisner to explicitly have the first risk variable is indicative of a low risk of developing CIPN, and the second risk variable is indicative of a high risk of developing CIPN, as taught by Rubenstein. This is because Rubenstein teaches providing multiple levels of risk levels allows for the patient to be better informed about the risks of the treatment regimens and the risk of developing peripheral neuropathy (para. [0055-0056]).
Regarding claim 26, modified Poisner discloses the prediction device of claim 1, wherein said circuitry is further configured to: evaluate the input data in relation to a set of content requirements to determine an adequacy score, and selectively, based on the adequacy score, output a request for further input data (para. [0014]).
Regarding claim 29, Poisner discloses a computer-implemented prediction method for predicting a risk that a test subject will develop peripheral neuropathy as a result of chemotherapy using the prediction device of claim 1 (Abstract, “peripheral neuropathy monitor … monitoring a trend towards peripheral neuropathy …”, Fig. 1, para. [0001], para. [0010] - further see the rejection of claim 1), comprising:
receiving, in the analysis device, input data from the vibrometer comprising perception data that designates measured perception of vibrations at one or more predetermined locations on one or more limbs of a test subject (para. [0010], “human extremity of the user …”, para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …” - further see the rejection of claim 1);
operating a prediction model in the analysis device on the perception data to determine at least one risk variable, which is indicative of a risk that the test subject will develop peripheral neuropathy (para. [0014-0015], “running a diagnosis program, for example using artificial intelligence or the like, to infer and/or diagnose a condition of the user based at least in park on one or more test results …”, para. [0017], “detect progression of the user towards peripheral neuropathy … indicated a trends towards peripheral neuropathy …” - further see the rejection of claim 1); and
generating prediction data based on the at least one risk variable (para. [0018], “may be trending towards or suffering from peripheral neuropathy … result may be flagged … display a visual flag …” - further see the rejection of claim 1).
However, Poisner does not explicitly disclose the development of peripheral neuropathy is the result of chemotherapy.
Rubenstein teaches an analogous prediction method (Abstract, Fig. 2, para. [0030], para. [0041]). Rubenstein teaches receiving input data comprising perception data (Fig. 2, element 202, element 218, para. [0041], “neuropathy related data”). Rubenstein further teaches operating a prediction model to determine at least one risk variable, where the risk is based on a treatment-regiment-related outcome as a result of chemotherapy (para. [0041], para. [0055], para. [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction model to additionally include chemotherapy data to determine a risk of developing peripheral neuropathy as a result of chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches chemotherapy can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Regarding claim 31, Poisner discloses a prediction method for predicting a risk that a test subject will develop peripheral neuropathy as a result of chemotherapy using the prediction device of claim 1 (Abstract, “peripheral neuropathy monitor … monitoring a trend towards peripheral neuropathy …”, Fig. 1, Fig. 3, para. [0001] - further see the rejection of claim 1), comprising:
determining the perception data that designates measured perception of vibrations at one or more predetermined locations on one or more limbs of the test subject (para. [0010], “human extremity of the user …”, para. [0011], “no longer feel one or more generated vibrations …”, para. [0017], “vibration sensitivity tests to measure changes in sensation by the user to vibrations … frequency of vibrations may run from as low as about 60 Hertz … frequency range may range from the tens of Hertz … frequency may be gradually increased …” - further see the rejection of claim 1); and
operating the analysis device on the perception data to generate prediction data indicative of the risk that the test subject will develop peripheral neuropathy (para. [0014-0015], “running a diagnosis program, for example using artificial intelligence or the like, to infer and/or diagnose a condition of the user based at least in park on one or more test results …”, para. [0017], “detect progression of the user towards peripheral neuropathy … indicated a trends towards peripheral neuropathy …” - further see the rejection of claim 1).
However, Poisner does not explicitly disclose the development of peripheral neuropathy is the result of chemotherapy.
Rubenstein teaches an analogous prediction method (Abstract, Fig. 2, para. [0030], para. [0041]). Rubenstein teaches receiving input data comprising perception data (Fig. 2, element 202, element 218, para. [0041], “neuropathy related data”). Rubenstein further teaches operating a prediction model to determine at least one risk variable, where the risk is based on a treatment-regiment-related outcome as a result of chemotherapy (para. [0041], para. [0055], para. [0072]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prediction model to additionally include chemotherapy data to determine a risk of developing peripheral neuropathy as a result of chemotherapy, as taught by Rubenstein. This is because Rubenstein teaches chemotherapy can cause side effects, such as chemotherapy-induced peripheral neuropathy, and determining the risk allows for the patient to select the best outcome (para. [0030-0031]).
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 10-12 of Remarks, filed 05/04/2026, that “there is nothing within Poisner to suggest an ability to predict the risk of a patient developing neuropathy … there is nothing within Rubinstein to suggest that measurement of vibration perception by a patient would have any predictive value with respect to whether that patient would at some point in the future during chemotherapy develop peripheral neuropathy …”.
The Examiner respectfully disagrees. As reiterated above, Poisner explicitly disclose generating a prediction risk that a test subject will develop peripheral neuropathy (para. [0017-0018], “test results may be analyzed … determined that the user may be trending towards … peripheral neuropathy …”). Further, as reiterated above, Rubinstein explicitly discloses utilizing neuropathy related data in combination other clinical data, including diagnosis data, cancer-stage data, regimen related data, etc. to generate a prediction that a patient will develop chemotherapy related outcomes (para. [0041], para. [0055], para. [0072]). Further, Applicant’s arguments regarding generating a predictive value that the patient would develop peripheral neuropathy at some point in the future during chemotherapy is not commensurate in scope with the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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