DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
“electronic control unit” in claim 1;
“communication unit” in claim 1;
“processing module” in claim 1;
The claim limitation “electronic control unit” is a generic placeholder for performing claimed functions (i.e. “for obtaining, from said measurement signals, a time succession of values of a physiological parameter (PF) representative of the skin conductance of the skin of the patient;” see also – functions of the processing module). The “electronic control unit” is modified by functional language, i.e., “for.” The “electronic control unit” is not modified by sufficient structure, material, or acts for performing the claimed function; Examiner notes that being operatively connected to other structures does not delineate the structure of the “electronic control unit” which allows it to perform the claimed function(s). The corresponding structure for “electronic control unit” is “Advantageously, the electronic control unit 3 of the device 1 comprises an electronic processor (preferably a microprocessor), which is suitably programmed for carrying out the above-described functions” (Specification, page 13).
The claim limitation “communication unit” is a generic placeholder for performing the claimed function (“for controlling said communication unit"). The claim limitation “communication unit” is a generic placeholder for performing the claimed function (“emit at least one off-notification signal”). The term “communication unit” is implicitly modified by functional language since it must be configured to emit at least one off-notification signal. The term “communication unit” is not modified by sufficient structure, material, or acts for performing the claimed function (see analysis of “electronic control unit” above regarding operative connection to other elements). The corresponding structure for a “communication unit” is “Advantageously, the communication unit 4 of the device 1 comprises a wireless communication module (such as a radio transmitter)…” (Specification, page 13).
The claim limitation “processing module” is a generic placeholder for performing multiple claimed functions (i.e., “for defining… updating… calculating… comparing… sending…”). The claim limitation “processing module” is a generic placeholder for performing the claimed functions identified above. The “electronic control unit” is modified by functional language, i.e., “for.” The term “processing module” is not modified by sufficient structure, material, or acts for performing the claimed function (see analysis of “electronic control unit” above regarding operative connection to other elements). The corresponding structure for a “processing module” appears to be identical to that of the electronic control unit, and is interpretable as a generic computer processor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claims 1-13 are 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.
Re. Claims 1 and dependent claims thereof: Claim 1 recites “for predicting the wearing-off conditions in a patient affected by Parkinson's disease.” There is insufficient antecedent basis for the term “the wearing-off conditions.”
Claim 1 further appears either redundant or unclear when specifying “a physiological parameter (PF) representative of the skin conductance of the skin.” Pages 4, 5, and 7 of Applicant’s specification appears to equate a “physiological parameter” with “skin conductance,” which makes the claim redundant in requiring a physiological parameter. However, if the term “physiological parameter” differs from or is derived from skin conductance, the specification is silent regarding what or how such a physiological parameter is determined, rendering the claim physiological parameter indefinite.
Claim 1 further recites “by means of the processing of the values.” There is insufficient antecedent basis for the term “the processing of the values.” The same limitation above also poses an additional issue of indefiniteness. The recitation of “by means of the processing of the values” indicates that prior processing is performed; however, no steps are defined which could define “the processing.” Thus, the limitation of “the processing of the values” is indefinite since no limitations define what processing occurred prior.
Claim 1 further recites “calculating, within said movable time window (FT), an overall time variation.” It is unclear what the term “overall” is modifying since determination of a value within a movable time window at a particular step indicates a local calculation which is not considered “overall” to the full spectrum of values the moving time window would through. Examiner requests clarification if Applicant intends to define “overall” as calculating a time variation per movement step of the time window or if “overall” is defined as the time variation after the time window has passed through all data points which are intended to be analyzed.
Claims 2-13 are rejected due to their dependency upon claim 1.
Re. Claim 3: Claim 3 recites two limitations which are not provided with sufficient antecedent basis: “the average value” and “the time derivative.”
Re. Claim 5: The term “substantially” in claim 5 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Examiner notes that since the term “substantially” is not provided with a standard for ascertaining the requisite degree, any time window larger than three minutes can be interpreted as encompassing the claim requirement of a time window “substantially comprised between one minute and three minutes.”
Re. Claim 13: Claim 13 recites two limitations which are not provided with sufficient antecedent basis: “the slope” and “the progression.”
Additionally, the term “mainly” in claim 13 is a relative term which renders the claim indefinite. The term “mainly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus “the progression of said physiological parameter (PF) takes on mainly within the entire said movable time window” may be interpreted as a progression which the PF takes on at any duration within said time window and also encompassing durations outside of said time window.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7-9, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by :
Ouwerkerk et al. (US 20170000398 A1) (hereinafter – Ouwerkerk).
Re. Claim 1: Ouwerkerk teaches A device (Fig. 3: device 18)
for predicting the wearing-off conditions in a patient affected by Parkinson's disease (Examiner notes that this is a recitation of intended use – each limitation of the claims is fulfilled by citations of the prior art which follow),
said device comprising:
- an electrodermal activity sensor (2) intended to be placed at the skin of a patient and arranged for detecting at least one electrical magnitude associated with the skin conductance of the patient and to generate corresponding measurement signals (Fig. 3: sensor unit 20; Paragraph 0047: “The sensor unit 20 is preferably configured as a galvanic conductivity sensor which is able to measure the conductivity of the skin of the living being”);
- an electronic control unit (3), which is operatively connected to said electrodermal activity sensor (2) in order to receive said measurement signals, and is arranged for obtaining, from said measurement signals, a time succession of values of a physiological parameter (PF) representative of the skin conductance of the skin of the patient (Fig. 3: processor 10 in communication with sensor unit 20; Figs. 5A, 7A: successive values of skin conductance data obtained over time);
- a communication unit (4) operatively connected to said electronic control unit (3) which is arranged for controlling said communication unit (4) to emit at least one off-notification signal (Fig. 3: output unit 17; Paragraph 0043: “Preferably, the processor 10 further comprises an output unit 17 for outputting at least one signal indicating a certain stage of a predetermined stress state;” Paragraphs 0016-0018: output of various stages);
wherein said electronic control unit (3) comprises at least one processing module (7) (Fig. 3: calculating unit 14 and/or analyzing unit 16),
which is arranged for
- defining, in said time succession of values of said physiological parameter (PF), a movable time window (FT) of duration greater than or equal to thirty seconds (Paragraph 0042: “… the summation can also comprise determination of a number of the data peaks per time unit. The time unit is variable, i.e. a skin conductance peak data signal can be computed every minute, every five minutes or every hour, etc.;” Paragraph 0054: “Here, the time unit is chosen to be a day;”), and
- updating said movable time window (FT) by making it advance along said time succession of values (Paragraph 0013: cumulative sum per time unit requires moving along windows of time units to calculate a cumulative sum therefrom; Paragraph 0069: time segments comprised of plurality of time units);
wherein, for each update of said movable time window (FT), said processing module (7) is arranged for:
- calculating, within said movable time window (FT), an overall time variation of said physiological parameter (PF) indicative of an increase of the skin conductance within said movable time window (FT), by means of the processing of the values of said time succession contained in said movable time window (FT) (an “overall time variation” within a time window can be encompassed by any of the following: Fig. 5B: cumulative sum of rising edges of skin conductance data peaks; Fig. 6: the graph of absolute value of the cumulative sum; Fig. 7: number of data peaks over time; Fig. 8: median value of data peak density distribution);
- comparing said overall time variation with a specific threshold value (VS) (Figs. 6, 8; Paragraph 0008: “… wherein said analyzing unit is configured to compare the average and/or absolute value of said skin conductance peak data signal against two different thresholds…;” similarly recited in Paragraphs 0043, 0044, 0054-0061);
- with said overall time variation greater than said threshold value (VS), sending to said communication unit (4) at least one control signal (SC), which is adapted to enable said communication unit (4) to emit said off-notification signal (Paragraphs 0008, 0016, 0017, 0043, 0055-0057, 0071-0072: output unit outputting stage dependent on comparison of peak data signal against thresholds).
Re. Claim 2: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein said processing module (7) is arranged for determining said overall time variation as a function of the time derivative of said physiological parameter (PF) in said movable time window (FT) (Paragraph 0052: particularly, “Each data peak of the skin conductance data shown in FIG. 5A comprises at least one rising edge, which is an indication of changes in the slope of the skin conductance”).
Re. Claim 3: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein said processing module (7) is arranged for determining said overall time variation as a function of the average value of the time derivative of said physiological parameter (PF) calculated within said movable time window (FT) (Fig. 8 as described in Paragraph 0069: overall a time segment may be the average value of peak data (i.e., comprised of rising edges indicative of changes in slope)).
Re. Claim 4: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein said movable time window (FT) is less than or equal to about five minutes (Paragraph 0042: “The time unit is variable, i.e. a skin conductance peak data signal can be computed every minute, every five minutes…”).
Re. Claim 5: Ouwerkerk teaches the invention according to claim 4. Ouwerkerk further teaches the invention wherein said movable time window (FT) is substantially comprised between one minute and three minutes (Paragraph 0042: “The time unit is variable, i.e. a skin conductance peak data signal can be computed every minute… ).
Re. Claim 7: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein said threshold value (VS) is determined as a function of peak values of said time succession of values of said physiological parameter (PF) (Paragraphs 0055: “The upper threshold 22 is chosen such that when the absolute value of the skin conductance peak data signal exceeds the upper threshold 22, the individual is in an early stage of a stress state;” Paragraphs 0056-0061: thresholds 0022, 0024, 0026 correspond to different stressor states and are defined by activity of the individual over time, i.e., dependent on the different data peaks of an individual; Paragraph 0070: similar process carried out for thresholds shown in Fig. 8).
Re. Claim 8: Ouwerkerk teaches the invention according to claim 7. Ouwerkerk further teaches the invention wherein said electronic control unit (3) is arranged for being set in a calibration condition, wherein, in a specific calibration time interval (IT), said processing module (7) is arranged for detecting said peak values of said time succession of values, and for calculating said threshold value (VS) as a function of said peak values (Paragraph 0060: thresholds 22, 24, 26 change for individuals over time depending on different data peaks; since the invention of Ouwerkerk contemplates periods of time which intakes individual stress response data to change thresholds 22, 24, 26 as the individual’s stress response changes over time, at least one period of time within such periods can be identified as a “calibration time interval”).
Re. Claim 9: Ouwerkerk teaches the invention according to claim 8. Ouwerkerk further teaches the invention wherein said threshold value (VS) is a function of at least one average value of said peak values detected in said calibration time interval (IT) (Fig.8: thresholds defined by where median (average) value of the skin conductance peak marks a healthy state of an individual).
Re. Claim 12: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein said overall time variation of said physiological parameter (PF) is obtained as a ratio between an increase of the values of said physiological parameter (PF) detected in said movable time window (FT) and the duration of said movable time window (FT) (Fig. 5B: identification of rising edges necessitates determination of an increase of skin conductance per time unit in an expanding cumulative window).
Re. Claim 13: Ouwerkerk teaches the invention according to claim 1. Ouwerkerk further teaches the invention wherein the overall time variation of said physiological parameter (PF) is indicative of the slope that the progression of said physiological parameter (PF) takes on mainly within the entire said movable time window (FT). (FT) (Fig. 5B: cumulative skin conductance peak graph (i.e., overall time progression as the window expands to encompass a full time interval) comprises rising edges which are indicative of changes in the slope of the skin conductance).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over:
Ouwerkerk et al. (US 20170000398 A1) (hereinafter – Ouwerkerk) in view of
Tanishima et al. (US 20210259617 A1) (hereinafter –Tanishima).
Re. Claim 6: Ouwerkerk teaches the invention according to claim 1, but does not teach the invention wherein said processing module (7) is arranged for determining said time variation as a function of the difference between at least a maximum value and a minimum value of said physiological parameter (PF) in said movable time window (FT).
Tanishima teaches analogous art in the technology of quantifying autonomic nerve dysfunctions (Abstract) using electrical signals of a user (Fig. 1: electrocardiogram sensor). Tanishima further teaches the invention wherein said processing module (7) is arranged for determining said time variation as a function of the difference between at least a maximum value and a minimum value of said physiological parameter (PF) in said movable time window (FT) (Paragraphs 0059-0060: calculation of variation width of a parameter using the difference between a maximum value and a minimum value of the parameter).
It would have been obvious to one having skill in the art before the effective filing date to have modified Ouwerkerk to have also considered determining a difference between a maximum and minimum of a signal as a measure of its variation as taught by Tanishima, the motivation being that doing so assesses a trend which a third party (e.g., a medical worker) may not readily grasp in the data (Paragraph 0004) which may be useful in assessing the extent of how a particular signal changes over time.
Allowable Subject Matter
Claims 10 and 11 would be allowable if independent claim 1 is rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 10 recites:
wherein, in said calibration condition, said processing module (7) is arranged for determining
at least one rest reference value (VRR) as a function of the values of said time succession outside said peak periods (PP), and
at least one peak reference value (VRP) as a function of said peak values, and
for calculating said threshold value (VS) as a function of the difference between said peak reference value (VRP) and said rest reference value (VRR)
The closest prior art of record regarding the above identified limitation is as follows:
Loddenkemper et al. (US 20200383627 A1) (hereinafter – Loddenkemper);
Kazlausky et al. (US 20010029319 A1) (hereinafter – Kazlausky).
Loddenkemper teaches analogous art in the technology of analysis of electrical physiological data (Abstract). Loddenkemper further teaches identification of a baseline amplitude (Paragraph 0040) during periods in which spikes (i.e., significant peaks) do not occur, which are periods akin to the flat signal in the first portion of the skin conductance peak data of Ouwerkerk (Fig. 5B). Thus, Loddenkemper’s identification of a baseline amplitude reads upon the claim requirements of identification of at least one rest reference value (VRR). However, Loddenkemper does not teach calculation of a peak reference value as a function of said peak values since threshold determination in Loddenkemper is based on a multiple of a baseline value (Paragraph 0040).
Kazlausky teaches analysis of physiological signals (Abstract), and determines a baseline mean value of a signal (Paragraphs 0044, 0088); however, similarly to Loddenkemper, Kazlausky does not does calculation of a peak reference value as a function of said peak values since threshold determination in Kazlausky is based on a number of deviations from a baseline value.
Conclusion
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/JUSTIN XU/ Primary Examiner, Art Unit 3791