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
Claim 1 is objected to because of the following informalities: the terms “Obtaining…Computing…Computing…Detecting…Detecting…Detecting…Generating” should all be lowercase. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the phrase “the patient and health care provider”, the term “health care provider” lacks an article and should recite “the patient and a health care provider”. Appropriate correction is required.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Claim 5 was skipped and not numbered. The following claims will be renumbered as such:
Claim 6 is now claim 5.
Claim 7 is now claim 6.
Claim 8 is now claim 7.
Claim 6 is objected to because of the following informalities: the terms “abonormal” should be amended to recite “abnormal”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the terms “5bpm” is missing a spacing and should recite “5 bpm”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the terms “challenge,and” is missing a spacing and should recite “challenge, and”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “comprising” is improper as new steps are being introduced, and should recite “further comprising”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “falling risk” is grammatically incorrect, and should recite “fall risk”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the phrase “if the patient indicates sympathetic excess…if the patient indicated beta-sympathetic excess… if the patient indicates sympathetic excess” is improper as patient’s do not indicate these problems, rather they are “exhibited” by the patient. The claim should recite “if the patient exhibits sympathetic excess…if the patient exhibits beta-sympathetic excess… if the patient exhibits sympathetic excess”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the phrase “comprising” is improper as new steps are being introduced, and should recite “further comprising”. Appropriate correction is required.
Claims 1-7 are now pending and under examination.
Claim Rejections - 35 USC § 112
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claim 1 fail to sufficiently describe 1) how the pulse data and respiratory data is found in the plurality of stages, 2) the use of “signal analysis” and pulse data and respiratory data to compute for sympathetic and parasympathetic activity for each stage, 3) and how to compute for sympathovagal balance for each stage from sympathetic and parasympathetic activity to have sufficient written description of the claimed invention. Regarding 1), the mere disclosure of Fig. 4’s stages fail to disclose how pulse data and respiratory data are used to jump to get the stages. It is unknown what within or how to manipulate the pulse data and respiratory data, which can be used to determine the graphs for the stages of resting, deep breathing, Valsalva maneuver, and standing. There is insufficient disclosure on how the pulse data and respiratory data is used, how the resting, deep breathing, Valsalva maneuver, and standing charts are produced, and what calculations/steps/processes are used to achieve each “stage”. Regarding 2), the instant specification discloses the steps of calculating sympathetic to parasympathetic activity, specifically by using “signal processing techniques” by combining center frequency to isolate sympathetic to parasympathetic activity ([0031] (note all citations are from PG Pub US 20250107743)). There is insufficient disclosure as to what the “signal processing techniques” are used for obtaining the frequency of pulse and respiratory data as well as the signal processing required to isolate the center frequency. The instant specification provides no insight as to how the sympathetic to parasympathetic activity is computed over time, other than the mere recitation in [0031]. The trend plots of sympathetic activity (LFa) and parasympathetic activity (RFa) is unknown the calculations required to achieve such plots, found in Fig. 3 and 4. Further, there is insufficient disclosure the techniques used to distinguish between sympathetic to parasympathetic activity. Although the instant specification distinguishes the sympathetic to parasympathetic activity nominally via LFa and RFa, respectively, the techniques fail to distinguish the methods of determining LFa and RFa. Regarding 3), the mere statement and recitation in [0035] of the instant specification discloses that sympathovagal balance (SB) is calculated based on a ratio of sympathetic to parasympathetic activity fails to establish how the sympathetic and parasympathetic activity is calculated and the equations required for both activities. Further, the instant specification discloses the incorporation of reference of wavelet transformation of pulse and respiratory data representing sympathovagal balance ([0008]). This disclosure fails to disclose how the sympathetic to parasympathetic activities are used, and how these results may differ from the use of sympathetic to parasympathetic activities. Therefore, claims 1-7 do not provide sufficient detail to have sufficient written description of the claimed invention.
Claim 6 fail to sufficiently describe how to calculate the fall risk to have sufficient written description of the claimed invention. The instant specification discloses the conditions for computing the fall risk ([0055]), but fails to disclose the techniques/steps/calculations/equations necessary to calculate a risk for a fall. The specification provides insufficient guidance to the input data required for determining the fall risk and what the output (fall risk numerical value) would represent. Therefore, claim 6 do not provide sufficient detail to have sufficient written description of the claimed invention.
Claim 7 fail to sufficiently describe how to calculate the SFD risk to have sufficient written description of the claimed invention. The instant specification provides the condition in which SFD can be determined ([0054]), but fails to disclose the techniques/steps/calculations/equations necessary to calculate SFD. The specification provides insufficient guidance to the input data required for determining the SFD risk and what the output (SFD risk numerical value) would represent. Therefore, claim 6 do not provide sufficient detail to have sufficient written description of the claimed invention.
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 1-7 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.
Regarding claim 1, it is unclear what category of/recognized disease does “sympathetic and parasympathetic disorder risk levels” fall under. Is the disorder referring to sympathetic and parasympathetic autonomic dysfunction, sympathetic excess, parasympathetic excess, or something else?
Regarding claim 1, it is unclear if the “combination” of line 14 and 17 is the same or different than the “combination” of line 11.
Regarding claim 1, the phrase “each stage corresponding to a level of exertion by the patient” is confusing as to what type of exertion is being done because claim 2 recites that “the stages [are] resting, deep breathing, Valsalva maneuver, and standing”, which are not conventional levels of exertion. Resting and standing require how much “exertion”. Does “deep breathing” require exertion at all?
Regarding claim 1, it is unclear if the “threshold” of line 13 and 16 is the same or different than the “combination” of line 10. Further, it is unclear if the threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination, for each detection are the same or different than one another.
Claim 1 recites the limitation "the presence" in line 21. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the following" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, it is unclear if the “parasympathetic excess” of line 1 is the same or different than the “parasympathetic excess” of line 15 of claim 1.
Regarding claim 3, it is unclear if the “sympathovagal balance” of line 3 is the same or different than the “sympathovagal balance” of line 9 of claim 1.
Regarding claim 3, it is unclear if the “parasympathetic activity” of line 4, 6, and 8 is the same or different than the “parasympathetic activity” of line 7 of claim 1.
Regarding claim 3, it is unclear if the “resting” of line 5, 7, and 8 is the same or different than the “resting” of line 2 of claim 2.
Regarding claim 3, it is unclear if the “standing” of line 8 is the same or different than the “standing” of line 2 of claim 2.
Claim 4 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the following" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 4, it is unclear if the “sympathetic excess” of line 1 is the same or different than the “beta-sympathetic excess” of line 11-12 of claim 1.
Regarding claim 4, it is unclear if the “sympathovagal balance” of line 3 is the same or different than the “sympathovagal balance” of line 9 of claim 1.
Regarding claim 4, it is unclear if the “sympathetic activity” of line 4, and 6 is the same or different than the “sympathetic activity” of line 7 of claim 1.
Regarding claim 4, it is unclear if the “resting” of line 5 and 6 is the same or different than the “resting” of line 2 of claim 2.
Regarding claim 4, it is unclear if the “standing” of line 6 is the same or different than the “standing” of line 2 of claim 2.
Claim 5 recites the limitation "the step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the condition" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 5, it is unclear if the “alpha-sympathetic withdrawal” of line 1 is the same or different than the “alpha-sympathetic withdrawal” of line 17-18 of claim 1.
Regarding claim 5, it is unclear if the “sympathetic activity” of line 2 is the same or different than the “sympathetic activity” of line 7 of claim 1.
Regarding claim 5, it is unclear if the “resting” of line 3 is the same or different than the “resting” of line 2 of claim 2.
Regarding claim 5, it is unclear if the “standing” of line 2 is the same or different than the “standing” of line 2 of claim 2.
Claim 6 recites the limitation "the additional step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the following" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the standing challenge" in line 5 and 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the other stages" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, it is unclear if the “sympathetic excess” of line 3 and 9 is the same or different than the “beta-sympathetic excess” of line 11-12 of claim 1.
Regarding claim 6, in the phrase “if the patient indicates beta-sympathetic excess during the standing challenge, and also alpha-sympathetic withdrawal”, the term “also” renders the limitation indefinite because it fails to establish a functional relationship between the beta-sympathetic excess and alpha-sympathetic withdrawal during the standing challenge. Specifically, it is unclear if the alpha-sympathetic withdrawal is an alternative to the beta-sympathetic excess, a required addition where both are needed, or completely independent.
Regarding claim 6, it is unclear if the “beta-sympathetic excess” of line 5 is the same or different than the “beta-sympathetic excess” of line 11-12 of claim 1.
Regarding claim 6, it is unclear if the “alpha-sympathetic withdrawal” of line 6 is the same or different than the “alpha-sympathetic withdrawal” of line 17-18 of claim 1.
Regarding claim 6, it is unclear if the “parasympathetic excess” of line 8 is the same or different than the “parasympathetic excess” of line 15 of claim 1.
Regarding claim 6, it is unclear if the “resting” of line 7 is the same or different than the “resting” of line 4 of claim 6.
Regarding claim 6, it is unclear if the “standing” of line 8 is the same or different than the “standing” of line 4 of claim 6.
Regarding claim 6, it is unclear if the “pulse” of line 6 is the same or different than the “pulse” of line 3 of claim 6.
Regarding claim 7, the phrase “small fiber disease (SFD)” is not a known term in the art. A simple Google search generates the disease “small fiber neuropathy”. It is unclear if the SFD of the instant specification is the same or different than small fiber neuropathy.
Claim 7 recites the limitation "the following" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the additional step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the deep breathing" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 7 is not dependent on claim 2 which recites the deep breathing.
Claim 7 recites the limitation "the Valsalva maneuver" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 7 is not dependent on claim 2 which recites the Valsalva maneuver.
Regarding claim 7, it is unclear if the “parasympathetic activity” of line 3 is the same or different than the “parasympathetic activity” of line 7 of claim 1.
Regarding claim 7, it is unclear if the “sympathetic activity” of line 5 is the same or different than the “sympathetic activity” of line 7 of claim 1.
Regarding claim 7, it is unclear if the “resting” of line 6 is the same or different than the “resting” of line 4 of claim 7.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1, the following step is an abstract idea:
“Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits beta-sympathetic excess;
Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits parasympathetic excess;
Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits alpha-sympathetic withdrawal”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could observe and evaluate if a threshold is surpassed for beta-sympathetic excess, parasympathetic excess, and alpha-sympathetic withdrawal.
Examiner notes that although some limitations (i.e. “computing, using signal analysis” and “computing…a sympathovagal balance”) may be based on mathematical concepts, the mathematical concepts are not recited in the claim.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “monitoring device”, and “display” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the signal analysis is by definition automating the human thinking process with a computer.
- “sympathetic and parasympathetic disorder risk levels”, “plurality of stages”, “pulse data and respiratory data”, “level of exertion”, “period of time”, “sympathetic activity”, “parasympathetic activity”, “sympathovagal balance”, “threshold”, “beta-sympathetic excess”, “parasympathetic excess”, “alpha-sympathetic withdrawal”, “chart/ first and second axis”, and “presence indicated” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “signal analysis” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “monitoring device”, and “display” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
It is noted that the signal analysis is by definition automating the human thinking process with a computer.
- “sympathetic and parasympathetic disorder risk levels”, “plurality of stages”, “pulse data and respiratory data”, “level of exertion”, “period of time”, “sympathetic activity”, “parasympathetic activity”, “sympathovagal balance”, “threshold”, “beta-sympathetic excess”, “parasympathetic excess”, “alpha-sympathetic withdrawal”, “chart/ first and second axis”, and “presence indicated” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “signal analysis” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f).
The additional elements of claim 1, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the monitoring device, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor, EKG sensor, pulse oximeter sensor, and blood pressure sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]), Boppart (US 20090306489) teaches the use of a pulse oximetry sensor to measure oxygen saturation ([0011]), Shin et al (US 20060253041) teaches a blood pressure sensor for measuring blood pressure ([0011]-[0012]).
Dependent claims 2-7 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to insignificant extra-solution activity (claims 2-7) and to mental process (claims 6-7), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-7 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Colombo et al. (“Parasympathetic and Sympathetic Monitoring Identifies Earliest Signs of Autonomic Neuropathy”, NeuroSci 2022, 3(3), 408-418; https://doi.org/10.3390/neurosci3030030, Published: 13 July 2022)(Hereinafter Colombo).
Regarding claim 1, Colombo teaches A method of differentiating sympathetic and parasympathetic disorder risk levels in a monitoring device (Title “Parasympathetic and Sympathetic Monitoring Identifies Earliest Signs of Autonomic Neuropathy” P&S Monitor 4.0 of page 412 line 16.), comprising:
Obtaining, in a plurality of stages, pulse data and respiratory data from a monitoring device connected to a patient, each stage corresponding to a level of exertion by the patient, over a period of time (Page 412-413 line 23-24 and 1-2 “P&S Monitoring collects EKG, respiratory activity from chest electrodes and BP during four challenges [stages]: (1) rest (baseline, 5-min), (2) deep breathing (0.1 Hz, a parasympathetic challenge, 1-min), (3) short Valsalva maneuvers (<15 s, as a sympathetic challenge, 1:35-min), and (4) head-up postural change (stand, which is equivalent to tilt, 5-min [34]).”);
Computing, using signal analysis and the pulse data and respiratory data of the patient, sympathetic activity and parasympathetic activity for each stage (Page 413 lines 3-4 “With spectral analyses these data are analyzed, and independent and simultaneous P&S activity is measured throughout the clinical study” );
Computing, based on the sympathetic activity and parasympathetic activity, a sympathovagal balance for each stage (Fig. 3 “Risk is stratified by sympathovagal balance. the space between the two outer diagonal lines defines normal sympathovagal balance (“LFa/RFa”). Regardless of resting autonomic state, normal sympathovagal balance normalizes morbidity and mortality risks.”);
Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits beta-sympathetic excess (Fig. 3 “Risk is stratified by sympathovagal balance. the space between the two outer diagonal lines defines normal sympathovagal balance (“LFa/RFa”). Regardless of resting autonomic state, normal sympathovagal balance normalizes morbidity and mortality risks…Below and to the right of the lower diagonal line indicates high sympathovagal balance which is a resting sympathetic excess.” Fig. 3 where the LFa/RFa value is above 3.0 is beta-sympathetic excess.);
Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits parasympathetic excess (Fig. 3 Page 416 lines 8-12 “P&S monitoring permits follow-up testing and includes indications for PAN (including small C-fiber disorder) as well as P&S dysfunctions (including autonomic neuropathies) not detected by typical autonomic monitors. Such P&S dysfunctions include: (1) sympathetic withdrawal (an alpha-adrenergic insufficiency upon assuming a head-up posture, associated with orthostatic dysfunction; see Figure 4) [39] and (2) parasympathetic excess (an excessive cholinergic response to a stress, as modeled by Valsalva challenge or upon assuming a head-up posture, associated with parasympathetic or vagal over-reactions)” Fig. 3 “Risk is stratified by sympathovagal balance. the space between the two outer diagonal lines defines normal sympathovagal balance (“LFa/RFa”). Regardless of resting autonomic state, normal sympathovagal balance normalizes morbidity and mortality risks. Above and to the left of the upper diagonal line indicates low sympathovagal balance which is a resting parasympathetic excess.” See Fig. 3 where the LFa/RFa value is below 0.4 which is parasympathetic excess.);
Detecting, based on a threshold of the sympathetic activity, parasympathetic activity, sympathovagal balance, or a combination thereof, whether the patient exhibits alpha-sympathetic withdrawal (Page 416 lines 8-12 “P&S monitoring permits follow-up testing and includes indications for PAN (including small C-fiber disorder) as well as P&S dysfunctions (including autonomic neuropathies) not detected by typical autonomic monitors. Such P&S dysfunctions include: (1) sympathetic withdrawal (an alpha-adrenergic insufficiency upon assuming a head-up posture, associated with orthostatic dysfunction; see Figure 4) [39] and (2) parasympathetic excess (an excessive cholinergic response to a stress, as modeled by Valsalva challenge or upon assuming a head-up posture, associated with parasympathetic or vagal over-reactions)” ); and
Generating, on a display, a chart for the patient and health care provider, wherein the sympathetic activity is displayed on a first axis, the parasympathetic activity displayed on a second axis, and wherein the presence of alpha-sympathetic withdrawal, beta-sympathetic excess, or parasympathetic excess is indicated if detected (Fig. 4 “The figure displays a stand response plot demonstrating a normal Parasympathetic (a decreased response from rest, ‘A’, to stand, ‘F’) with a normal Sympathetic response (an increased response from rest, ‘A’, to stand, ‘F’).” See Figs. 3-4.).
Regarding claim 2, Colombo teaches wherein the step of obtaining the pulse data and respiratory data comprises the stages of resting, deep breathing, Valsalva maneuver, and standing (Page 412-413 line 23-24 and 1-2 “P&S Monitoring collects EKG, respiratory activity from chest electrodes and BP during four challenges [stages]: (1) rest (baseline, 5-min), (2) deep breathing (0.1 Hz, a parasympathetic challenge, 1-min), (3) short Valsalva maneuvers (<15 s, as a sympathetic challenge, 1:35-min), and (4) head-up postural change (stand, which is equivalent to tilt, 5-min [34]).” Figs. 1-4.).
Regarding claim 3, Colombo teaches wherein the step of detecting parasympathetic excess comprises one or more of the following conditions:
a sympathovagal balance under 0.9, or 0.4 for geriatric and chronically ill patients (See Fig. 3 where the LFa/RFa value is below 0.4 which is parasympathetic excess.);
an age-adjusted excessive increase in parasympathetic activity during the deep breathing, compared to resting (Fig. 1);
an age adjusted increase in parasympathetic activity of over 600% during the Valsalva maneuver, compared to resting (Fig. 2); and
any increase in parasympathetic activity during standing, compared to resting (Fig. 4).
Regarding claim 4, Colombo teaches wherein the step of detecting sympathetic excess comprises one or more of the following conditions:
a sympathovagal balance over 3.0, or 1.1 for geriatric and chronically ill patients (Fig. 3 where the LFa/RFa value is above 3.0 is beta-sympathetic excess.);
an age-adjusted excessive increase in sympathetic activity during the Valsalva maneuver, compared to resting (Fig. 2); and
an increase in sympathetic activity during standing of over 500%, compared to resting (Fig. 4).
Regarding claim 5, Colombo teaches wherein the step of detecting alpha-sympathetic withdrawal comprises the condition wherein there is a decrease in sympathetic activity during standing, compared to resting (Page 416 lines 8-12 “P&S monitoring permits follow-up testing and includes indications for PAN (including small C-fiber disorder) as well as P&S dysfunctions (including autonomic neuropathies) not detected by typical autonomic monitors. Such P&S dysfunctions include: (1) sympathetic withdrawal (an alpha-adrenergic insufficiency upon assuming a head-up posture, associated with orthostatic dysfunction; see Figure 4) [39] and (2) parasympathetic excess (an excessive cholinergic response to a stress, as modeled by Valsalva challenge or upon assuming a head-up posture, associated with parasympathetic or vagal over-reactions)” It is noted that the decrease in sympathetic activity during standing occurs because of alpha-adrenergic insufficiency upon assuming a head-up posture.).
Regarding claim 7, Colombo teaches comprising the additional step of calculating a small fiber disease risk (Abstract “either testing modality may be used to risk stratify patients with suspected autonomic dysfunction, including the earliest stages of PAN and SFD.”), comprising one or more of the following conditions:
an age-adjusted abnormally low increase in parasympathetic activity during the deep breathing, compared to resting (Fig. 1 “Borderline low to low deep breathing responses are some of the earliest signs of PAN and risk of sudomotor abnormality or SFD.”); and
an age-adjusted abnormally low increase in sympathetic activity during the Valsalva maneuver, compared to resting (Fig. 2 “Borderline low to low Valsalva responses are some of the earliest signs of PAN and risk of sudomotor or SFD.”).
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(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colombo et al. (“Parasympathetic and Sympathetic Monitoring Identifies Earliest Signs of Autonomic Neuropathy”, NeuroSci 2022, 3(3), 408-418; https://doi.org/10.3390/neurosci3030030, Published: 13 July 2022)(Hereinafter Colombo) in view of Yang (US 20210219923)(Hereinafter Yang).
Regarding claim 6, Colombo teaches the invention of claim 1. Although Colombo teaches that the Stand or Head-Up Postural Change of Fig. 4 teaches orthostatic dysfunction, Colombo does not teach the calculating of a fall risk. Yang, in the same field of endeavor, teaches obtaining blood pressure, and heart rate, along with measuring the sit to stand (Abstract and [0084]), and further teaches comprising the additional step of calculating a falling risk ([0084]), comprising one or more of the following conditions:
if the patient indicates sympathetic excess, an increase in pulse of less than 5bpm during standing, compared to resting (Conditional language, as noted below. Examiner interprets that the patient has normal conditions.);
if the patient indicates beta-sympathetic excess during the standing challenge, and also alpha-sympathetic withdrawal, an abonormal increase in pulse or decrease in blood pressure during the standing challenge, compared to resting (Conditional language, as noted below. Examiner interprets that the patient has normal conditions.); and
if the patient indicates sympathetic excess during standing, and any parasympathetic excess during the other stages (Conditional language, as noted below. Examiner interprets that the patient has normal conditions.) to accurately classify a patient’s condition ([0084]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the method of Colombo, with the calculating of a fall risk of Yang, because such a modification would allow to accurately classify a patient’s condition.
“The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” “The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur.” Note the phrase, “if the patient indicates sympathetic excess, an increase in pulse of less than 5bpm during standing, compared to resting;
if the patient indicates beta-sympathetic excess during the standing challenge,and also alpha-sympathetic withdrawal, an abonormal increase in pulse or decrease in blood pressure during the standing challenge, compared to resting; and
if the patient indicates sympathetic excess during standing, and any parasympathetic excess during the other stages” in claim 6 is conditional language, that is, if a condition precedent in a method claim is not met, the conditional steps recited in the claim are not required to be performed. The conditions of if the patient indicates sympathetic excess, beta-sympathetic excess during the standing challenge,and also alpha-sympathetic withdrawal, an abonormal increase in pulse or decrease in blood pressure during the standing challenge, compared to resting, and sympathetic excess during standing, and any parasympathetic excess during the other stages. As such, the broadest reasonable interpretation of such a method claim does not include the conditional step along with the steps proceeding the conditional step. See MPEP 2111.04(II).
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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