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 Objections
Claims 1, 8-9, 12, and 15-16 are objected to because of the following informalities:
in claim 1, line 6: “motion” should be inserted before “data”;
in claim 8, line 2: “time and wherein” should be “time, and wherein”;
in claim 9, line 2: “a hand or” should be “a hand, or”;
in claim 12, line 7: “motion” should be inserted before “data”;
in claim 15, line 3: “repletion” should be “repetition”; and
in claim 16, line 2: “time and to perform” should be “time, and to perform”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “An apparatus according to claim 12” in line 1. This appears to indicate that the claim is a device claim directed towards the device of claim 12. However, the subsequent recitations in claim 18 do not further limit the subject matter to which the claim is directed; rather, the further limitations are directed towards a clinical trial system. This causes the metes and bounds of the claim to be unclear. It is suggested that Applicant amend the claim to recite " A clinical trial system comprising the apparatus according to claim 12, the clinical trial system further comprising a central computer…” in order to overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 18 “An apparatus according to claim 12” in line 1; but it is not clear if this recitation is the same as, related to, or different from the recitation “An apparatus” in claim 12, line 1. The similar phraseology suggests that they are the same, but the indefinite article “An” suggests that they are different. If the recitations are the same, the present recitation should be “The apparatus according to claim 12”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same.
Claim 18 recites “a plurality of user devices” in line 2; however, the relationship between the apparatus of claim 12 and the plurality of user devices is not clear. Is the apparatus part of the user devices, or separate from the user devices? There is further confusion on the relationship between the functions of the user devices with recitations as recited in claim 12. In claim 18, such confusion lies with the recitation “collect motion data relating to repeated rotational motion of a body part of a user associated with the user device” in lines 3-4, and the recitation “a medical biomarker indicative of a neurodegenerative disease or other disease impacting musculature control for determining a medical biomarker” in lines 6-8. Furthermore, “determining a medical biomarker” in line 8 appears to be repeated and should be deleted. Appropriate clarification is required.
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 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. A claim that covers both statutory and non-statutory embodiments (under the broadest reasonable interpretation of the claim when read in light of the specification and in view of one skilled in the art) embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. "A tangible computer readable medium comprising computer implementable instructions" can encompass non-statutory forms of signal transmission, such as, a propagating electrical or electromagnetic signal per se. See In re Nuijten, 500 F.3d 1346, 84 USPQ2d 1495 (Fed. Cir. 2007). When the broadest reasonable interpretation of machine readable media encompasses transitory forms of signal transmission, the claim is directed to non-statutory subject matter. It is suggested that Applicant amend the claim to recite " A tangible non-transitory computer readable medium comprising computer implementable instructions” in order to recite statutory subject matter.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed towards abstract ideas without significantly more.
Claim 1 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “processing the data to identify orientation in the frame of reference associated with the sensor of primary, secondary, and tertiary axes of rotation for the motion of the body part of the user” is being interpreted as mathematical calculations/evaluations and/or judgements/observations (see specification pg. 16 ¶2 – pg. 18 ¶1). The recitation “extracting the medical biomarker by analysing the rotational motion of the body part of the user about at least one of the primary, secondary, and tertiary axes” is being interpreted as mathematical calculations/evaluations (see specification pg. 10 ¶6 – pg. 14 ¶1 and pg. 18 ¶2 – pg. 23 ¶2). The recitations are computer-implemented, as indicated in the specification (see specification pg. 4 ¶7 and pg. 6 ¶1-11).
Claim 12 interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claim are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art. See MPEP 2111. Based on the specification, the recitation “process the data to identify orientation in the frame of reference associated with the sensor of primary, secondary, and tertiary axes of rotation for the motion of the body part of the user” is being interpreted as mathematical calculations/evaluations and/or judgements/observations (see specification pg. 16 ¶2 – pg. 18 ¶1). The recitation “extract the medical biomarker by analysing the rotational motion of the body part of the user about at least one of the primary, secondary, and tertiary axes” is being interpreted as mathematical calculations/evaluations (see specification pg. 10 ¶6 – pg. 14 ¶1 and pg. 18 ¶2 – pg. 23 ¶2). The recitations are computer-implemented, as indicated in the specification (see specification pg. 4 ¶7 and pg. 6 ¶1-11), and in the claim lines 2-3.
Step 1: This part of eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Claim 1 recites a method, which is directed towards a process (a statutory category of invention). Claim 12 recites an apparatus, which is directed towards a machine and/or a manufacture (a statutory category of invention). Step 1: YES.
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(a)(2)(I). The courts consider mathematical calculations, when the claim is given its BRI in light of the specification, as falling within the “mathematical concept” grouping of abstract ideas. A claim does not have to recite “calculating” in order to be considered a mathematical calculation. For example, a step of “determining” a variable or number using a mathematical method, or “performing” a mathematical operation, may also be considered a mathematical calculation when the BRI of the claim in light of the specification encompasses a mathematical calculation. As discussed in the claim interpretation section, the limitations include, under the BRI, mathematical calculations/evaluations for identification of the orientation and extraction of the medical biomarker. Accordingly, the limitations as seen in claims 1 and 12 recite judicial exceptions (abstract ideas that fall within the mathematical calculations grouping of mathematical concepts).
Alternatively or additionally, these steps describe the concept of using implicit mathematical formulas (i.e., calculations to determine a likelihood score) to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts (Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
Furthermore, as explained in MPEP 2106.04(a)(2)(III). The courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). The “mental processes” abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgements, and opinions. As discussed in the claim interpretation section, the limitations include, under the BRI, judgements/observations (to identify the orientation) and/or mathematical calculations/evaluations for identification of the orientation and extraction of the medical biomarker. Accordingly, the limitations as seen in claims 1 and 12 recite judicial exceptions (abstract ideas that fall within the mental process grouping). No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
In particular, claim 1 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
a method of determining a medical biomarker indicative of a neurodegenerative disease or other disease impacting musculature control, the method comprising:
receiving motion data from a sensor held or mounted for rotation with a body part of a user during a repeated rotational motion of the body part,
the motion data being provided relative to a frame of reference associated with the sensor;
processing the data to identify orientation in the frame of reference associated with the sensor of primary, secondary, and tertiary axes of rotation for the motion of the body part of the user,
wherein each of the primary, secondary, and tertiary axes are mutually perpendicular to one another;
extracting the medical biomarker by analysing the rotational motion of the body part of the user about at least one of the primary, secondary, and tertiary axes.
Furthermore, claim 12 recites the following elements, which are part of the abstract idea (i.e., the algorithm):
determining a medical biomarker indicative of a neurodegenerative disease or other disease impacting musculature control, configured to:
receive motion data from a sensor held or mounted for rotation with a body part of a user during a repeated rotational motion of the body part,
the motion data being provided relative to a frame of reference associated with the sensor;
process the data to identify orientation in the frame of reference associated with the sensor of primary, secondary, and tertiary axes of rotation for the motion of the body part of the user,
wherein each of the primary, secondary, and tertiary axes are mutually perpendicular to one another;
extract the medical biomarker by analysing the rotational motion of the body part of the user about at least one of the primary, secondary, and tertiary axes.
Step 2A Prong One: YES.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the judicial exceptions into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exceptions, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exceptions into a practical application. Claim 1 recites no additional element such that claim 1 recites no elements that integrate the abstract ideas into a practical application. Claim 12 recites the additional element of an apparatus including one or more processors and memory, which is directed towards a generic computer. The apparatus is merely instructions to implement an abstract idea on a generic computer or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Note that the sensor is not a positively recited element in either of claims 1 or 12, as both claims merely receive sensor data from the sensor. The sensor is not part of the claimed method or apparatus itself. Furthermore, the sensor is generic. In addition, such receiving of data can be seen as merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g) using generic components (i.e., the sensors are generic).
Step 2A Prong Two: NO.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with Step 2A Prong Two, the claims recite additional elements which are directed towards the usage of a generic computer, and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. These elements/steps can be seen as well-understood, routine, and conventional individually and in combination. Claim 1 recites no additional element such that claim 1 recites no elements that amount to significantly more than the recited exceptions. Claim 12 recites the additional element of an apparatus including one or more processors and memory, which is directed towards a generic computer. Thus, the apparatus/method do not qualify as significantly more because these limitations are 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)).
Note that the sensor is not a positively recited element in either of claims 1 or 12, as both claims merely receive sensor data from the sensor. The sensor is not part of the claimed method or apparatus itself. Furthermore, the sensor is generic Therefore, the sensors cannot be seen as significantly more than the recited exceptions.
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. Step 2B: NO.
Claims 1 and 12 are not eligible.
Claims 2-11 and 19-20; and 14-18 depend from claims 1 and 12, respectively, and merely further define the abstract ideas of claims 1 and 12 with no further element that integrates the abstract ideas into a practical application or that qualifies as being significantly more. The claims contain elements which are directed towards a generic computer. Therefore, the apparatus/method are merely instructions to implement an abstract idea on a generic computer (i.e., the generic smartphone) or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Further that, the claims recite additional elements which are directed towards the usage of a generic computer (i.e., the generic smartphone), and are at best the equivalent of merely adding the words “apply it” to the judicial exceptions. Mere instructions to apply an exception cannot provide an inventive concept. These elements/steps can be seen as well-understood, routine, and conventional individually and in combination. Thus, the apparatus/method do not qualify as significantly more because these limitations are 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)).
Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, 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.
Claim 13 depends from claim 12 and further includes an accelerometer and/or a gyroscope for supplying the motion data, which is a positive recitation of the sensor. However, such a sensor is not integration into a practical application because it is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). In addition, such sensors cannot be seen as significantly more than the recited exceptions as those sensors are well-understood, routine, and conventional. For example, Sillay et al. (US Patent Application Publication 2014/0257047) teaches about an objective measurement medical data collection device for population health measurements within the restorative neurosciences such as Parkinson disease individuals diagnosed with disease, in which the data collection device may comprise one or more of a gyroscope, an accelerometer, a locator, a camera and a magnetometer for collecting, for example, data related to tremors experienced by the individuals diagnosed with disease and receive instruction data responsive to evaluation of the collected data in relation to the cohort database (see abstract and Fig. 8), in which accelerometers and gyroscopes are known components on commercial products, such as an Apple® wireless telecommunication device (see ¶[0004] and ¶[0165]), an Android® device, or an APDM wearable inertial monitoring device (see ¶[0165]). Therefore, the sensors would not integrate the abstract ideas into a practical application or amount to significantly more.
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 1-3, 5-18, and 20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Sillay et al. (US Patent Application Publication 2014/0257047), hereinafter Sillay.
Regarding Claims 1 and 12, Sillay teaches about an objective measurement medical data collection device for population health measurements within the restorative neurosciences such as Parkinson disease individuals diagnosed with disease, in which the data collection device may comprise one or more of a gyroscope, an accelerometer, a locator, a camera and a magnetometer for collecting, for example, data related to tremors experienced by the individuals diagnosed with disease and receive instruction data responsive to evaluation of the collected data in relation to the cohort database (see abstract and Fig. 8). Sillay teaches a method/apparatus of/for determining a medical biomarker indicative of a neurodegenerative disease or other disease impacting musculature control (see abstract, ¶[0165], and ¶[0174] the device/method may be utilized for health measurements, such as determining metrics for Parkinson disease individuals),
the apparatus comprising one or more processors and memory (¶[0151]-[0152] and ¶[0158] a server including processors executing stored programs, which would be stored on memory, may be utilized to implement the functions of the disclosure)
the one or more processors and memory configured to/the method comprising:
receiving motion data from a sensor held or mounted for rotation with a body part of a user during a repeated rotational motion of the body part (¶[0164]-[0177] various sensors may be utilized for motion data capture on the body/limbs of the user, such as accelerometers and/or gyroscopes, such as a repetitions of rotations of the arms, see ¶[0177]; Figs. 8 and 11),
the motion data being provided relative to a frame of reference associated with the sensor; processing the data to identify orientation in the frame of reference associated with the sensor of primary, secondary, and tertiary axes of rotation for the motion of the body part of the user (¶[0177]-[0178] the data acquisition for data in measuring forearm bradykinesia, in which user and the sensors thereon are positioned sitting in an armless chair against an appropriate background, ¶[0181]-[0189] the alignment of the mobile device, including the sensors within, consistent between tests, and processing that minimizes or removes the effects of misalignment, the coordinate system may be re-determined on a regular, periodic, or occasional bases, or to utilize a mounting or position system that contains additional sensors to provide information that can be utilized to re-determine or update or estimate the chosen coordinate system, the singular value decomposition (SVD) analysis on the matrix to determine the direction of maximum variation for alignment; Figs. 8 and 11),
wherein each of the primary, secondary, and tertiary axes are mutually perpendicular to one another (¶[0183] the axes may represent X, Y, and Z in 3-dimensional space; Fig. 8);
extracting the medical biomarker by analysing the rotational motion of the body part of the user about at least one of the primary, secondary, and tertiary axes (see generally ¶[0177]-[0189] the various biomarkers that are extracted from the rotational motion data, such as determining the maximum rate of angular acceleration, degrees traveled per oscillation, peak angular velocity, hesitations, fatiguing, and amplitude of angular velocity used in the rating score, see ¶[0178] and Fig. 11).
Regarding Claim 2, Sillay teaches the method of claim 1 as stated above. Sillay further teaches analysing the rotational motion of the body part of the user is performed in a continuous manner throughout the repeated motion (¶[0177]-[0178] and ¶[0184]-[0185] the user is monitored continuously through the repeated motion, and such data is analyzed, the matrix of measurements including the time of measurement, which may be in ascending or descending order; Fig. 11).
Regarding Claim 3, Sillay teaches the method of claim 1 as stated above. Sillay further teaches analysing the rotational motion includes extracting the rotational motion along the first, second and/or third axes as a function of time (¶[0184]-[0185] the matrix of measurements including the time of measurement, which may be in ascending or descending order).
Regarding Claims 5 and 14, Sillay teaches the method/apparatus of claims 1 and 12, respectively, as stated above. Sillay further teaches the medical biomarker is indicative of a discrepancy between the motion of the body part and a model motion which the user is instructed to make (¶[0160], ¶[0194], and ¶[0242]-[0243] the comparisons of the user data to broader population data, such as the comparison of objective measurements of performance of a simple motor test).
Regarding Claims 6 and 15, Sillay teaches the method/apparatus of claims 1 and 12, respectively, as stated above. Sillay further teaches extracting the medical biomarker includes extracting one or more of: frequency of repetition of the rotational motion; time for a single rotational motion; average time for a single rotational motion; an angular amplitude of the rotational motion (¶[0178] metrics may include determining the maximum rate of angular acceleration, degrees traveled per oscillation, peak angular velocity, hesitations, fatiguing, and amplitude of angular velocity used in the rating score; Fig. 11); asymmetry of an angular amplitude of the rotational motion relative to a neutral point; asymmetry of angular velocity or acceleration of the rotational movement; and/or a ratio of an angular amplitude of the rotational motion along one of the first, second and third axes to an angular amplitude of the rotational motion along a different one of the first, second and third axes.
Regarding Claim 7, Sillay teaches the method of claim 1 as stated above. Sillay further teaches extracting the medical biomarker includes detecting a change in one or more of: frequency of repetition of the rotational motion; time for a single rotational motion; the orientation of one or more of the first, second and third axes in the frame of reference associated with the sensor; an angular amplitude of the rotational motion (¶[0178] metrics may include determining the maximum rate of angular acceleration, degrees traveled per oscillation, peak angular velocity, hesitations, fatiguing, and amplitude of angular velocity used in the rating score; Fig. 11); asymmetry of an angular amplitude of the rotational motion relative to a neutral point; asymmetry of angular velocity or acceleration of the rotational movement; and/or a ratio of an angular amplitude of the rotational motion along one of the first, second and third axes to an angular amplitude of the rotational motion along a different one of the first, second and third axes.
Regarding Claims 8 and 16, Sillay teaches the method/apparatus of claims 1 and 12, respectively, as stated above. Sillay further teaches the one or more processors and memory is further configured to divide a time period for which the repeated rotational motion occurs into two or more distinct sub-periods of time and to perform the analysing individually on motion data received during one of the sub-periods of time (¶[0177]-[0178] the different time periods of movement data that is recorded and then analyzed, ¶[0184] the acquisition of data at a sequence of times within a desired time interval over which data are to be acquired).
Regarding Claim 9, Sillay teaches the method of claim 1 as stated above. Sillay further teaches the repeated rotational motion is a pronation and supination of a hand or bending and straightening of a knee or elbow (¶[0170] the gait analysis, which would include the knee, ¶[0171] the sensors positioned on the hand/wrist, such as for use of the hand, ¶[0177] the sensors positioned on the arm for measuring forearm bradykinesia).
Regarding Claims 10 and 17, Sillay teaches the method/apparatus of claims 1 and 12, respectively, as stated above. Sillay further teaches calculating, based on the orientation of the primary, secondary, and tertiary axes, a transform to align the received motion data with the primary, secondary, and tertiary axes (¶[0181]-[0189] the alignment of the mobile device, including the sensors within, consistent between tests, and processing that minimizes or removes the effects of misalignment, the coordinate system may be re-determined on a regular, periodic, or occasional bases, or to utilize a mounting or position system that contains additional sensors to provide information that can be utilized to re-determine or update or estimate the chosen coordinate system, the singular value decomposition (SVD) analysis on the matrix to determine the direction of maximum variation for alignment; Figs. 8 and 11).
Regarding Claim 11, Sillay teaches the method of claim 1 as stated above. Sillay further teaches a tangible computer readable medium comprising computer implementable instructions for causing a programmable computer device to carry out the steps of claim 1 (¶[0151]-[0152] and ¶[0158] a server including processors executing stored programs, which would be stored on memory, may be utilized to implement the functions of the disclosure).
Regarding Claim 13, Sillay teaches the apparatus of claim 12 as stated above. Sillay further teaches further including an accelerometer and/or a gyroscope for supplying the motion data (¶[0164]-[0177] various sensors may be utilized for motion data capture on the body/limbs of the user, such as accelerometers and/or gyroscopes, such as a repetitions of rotations of the arms, see ¶[0177]; Figs. 8 and 11).
Regarding Claim 18, Sillay teaches the apparatus of claim 12 as stated above. Sillay further teaches an apparatus according to claim 12 (see above claim 12 mapping),
forming part of a clinical trial system comprising a central computer that communicates with a plurality of user devices (¶[0151]-[0152] the invention utilizes personal devices such as smart phones (FIG. 8) or other wearable computers (FIG. 105), which may contain data acquisition components such as gyroscopes, accelerometers… once the data are acquired, or intermittently as the data are acquired, the data can be transferred to a server computer),
each user device being arranged to collect motion data relating to repeated rotational motion of a body part of a user associated with the user device (¶[0164]-[0177] various sensors may be utilized for motion data capture on the body/limbs of the user, such as accelerometers and/or gyroscopes, such as a repetitions of rotations of the arms, see ¶[0177]; Figs. 8 and 11); and
wherein the central computer or at least one user device comprises a tangible computer readable medium comprising computer implementable instructions for causing a programmable computer device (¶[0151]-[0152] and ¶[0158] a server including processors executing stored programs, which would be stored on memory, may be utilized to implement the functions of the disclosure)
to carry out a method of determining a medical biomarker indicative of a neurodegenerative disease or other disease impacting musculature control for determining a medical biomarker (see generally ¶[0177]-[0189] the various biomarkers that are extracted from the rotational motion data, such as determining the maximum rate of angular acceleration, degrees traveled per oscillation, peak angular velocity, hesitations, fatiguing, and amplitude of angular velocity used in the rating score, see ¶[0178] and Fig. 11).
Regarding Claim 20, Sillay teaches the method of claim 1 as stated above. Sillay further teaches extracting the biomarker further includes comparing the biomarker to thresholds derived from statistical analyses of the biomarker across a population (¶[0160]-[0163] and ¶[0177]-[0178] the processing of the data into aggregate data with which recorded data may be compared to).
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.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sillay as applied to claim 3 above, and in view of Mhajna (US Patent Application Publication 2021/0236046), hereinafter Mhajna.
Regarding Claim 4, Sillay teaches the method of claim 3 as stated above. Sillay further teaches extracting local maxima and minima by identifying times at which peaks and troughs have a magnitude greater than a predetermined threshold (¶[0184]-[0189] the maximum and minimum variation, such as via the maximum and minimum angular or translational acceleration or velocity of an individual with disease's joint, limb, hand, foot, or head).
Sillay does not specifically that a prominence is analyzed.
Mhajna teaches systems and methods for maternal uterine activity detection via received acoustic inputs (see abstract and Figs. 1A-3) and motion data (see ¶[0155]-[00167), in which the received data may be sharped by determining the prominence of each peak, and removing the peaks with prominence less than a threshold (see ¶[0008], ¶[0019], and ¶[0220]-[0235]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the signal sharpening via prominence thresholding of Mhajna with the maximum and minimum determination of Sillay because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results; and/or (2) sharpening the signal would enable the maximum to be easier picked out from the data; and/or (3) it would be within the skill of one of ordinary skill in the art before the effective filing date to apply a commensurate sharpening for the minimum determination and extraction.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sillay as applied to claim 1 above, and in view of Guzman et al. (US Patent 11,080,789), hereinafter Guzman.
Regarding Claim 19, Sillay teaches the method of claim 1 as stated above. Sillay further teaches that eigenvalue/eigenvector analysis deconstructions/decompositions may be utilized (see ¶[0184] and ¶[0188]), but not specifically that the biomarker includes an axial variability parameter, Vax.
Guzman teaches systems and methods for creating indicators to quantify and index correlation risk (see abstract), in which obtained data may be analyzed (see generally col. 8 ln. 54 – col. 9 ln. 65), in which principal component analysis (PCA) may be utilized as an eigenvalue decomposition, which includes the calculation of the highest eigenvalue, which tells the dimension (axis) that generates the maximum amount of individual variability (see col. 12 ln. 21 – col. 13 ln. 4, see also generally col. 13 ln. 5 – col. 15 ln. 34).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the PCA decomposition of Guzman as the deconstruction/decomposition in Sillay because (1) it is the application of a known technique to a known method ready for improvement to yield predictable results and/or (2) Sillay requires a deconstruction/decomposition and contemplates eigenvalue/eigenvector analysis deconstructions/decompositions, and Guzman teaches one such deconstruction.
Conclusion
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/J.D.M./ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791
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