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 Rejections - 35 USC § 112
Claims 5,13-17 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.
In claim 5, the ’stimulation unit microprocessor’ lacks clear antecedent basis.
In claim 13, line 9, ’the wearable device’ lacks clear antecedent basis.
Claim Rejections - 35 USC § 101
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-12 are directed to a device, and claims 13-17 are directed to a system, and claim 18 is directed to a method. Thus, the claims are for statutory subject matter.
Step 2A, prong 1
Claim 1 includes a microprocessor that computes power spectral density data. At least ¶52 of applicant’s specification as filed states that such computation includes Fast Fourier transform, auto regression analysis or other equivalent mathematical transformation. Thus, computing the power spectral density is considered to be an abstract idea in the form of mathematical calculations. Claim 13 includes a processor which analyzes PSD data for indicators of ANS imbalance, compares indicators to stored information, and determines recommended therapeutic action. Such steps are considered to be an abstract idea in the form of mental processes. That is, the steps can all be performed in the user’s head or with pencil and paper. Claim 18 includes the steps of analyzing PSD data to identify imbalance indicators, comparing ANS imbalance indicators, and determining recommended corrective therapy. Such steps are considered to be an abstract idea in the form of mental processes in that they can be performed in the head of the user, or with paper and pencil. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) See MPEP 2106.04(a).
Step 2A, prong 2
Claim 1 includes, other than the abstract idea, a substrate, bladder pressure sensor, microprocessor with communication means, power source, securing member. These elements are considered to be elements used to accumulate data for use in the abstract idea, or to correcting an autonomic imbalance. Thus, they do not integrate the abstract idea into a practical application. Further, communication means which transmits PSD data merely applies the abstract idea, and does not integrate it into a practical application. Claims 2-4 include various external devices which merely apply the abstract idea, and thus do not serve to integrate it into a practical application. Claims 5-7 include a microprocessor and communication means. Such elements are used by the abstract idea but do not integrate it into a practical application. Claims 8-12 include elements that are used to gather data for the abstract idea, or elements that apply the abstract idea. However, there is no element that integrates the abstract idea into a practical application. Claim 13 includes a processor which is used to gather and transmit signals and apply the abstract idea, and other elements such as a wearable detector, stimulator that apply or use the abstract idea. There are no elements in the claim which integrate the abstract idea into a practical application. Claim 14 includes recommended therapies, but does not include application of the therapies that would integrate the abstract idea into a practical application. Claim 15 includes processors that transmit instructions to apply therapy but does not include application of the therapies that would integrate the abstract idea into a practical application. Claim 16 includes transmitting respiration data, which is considered to facilitate the abstract idea, but not integrate it into a practical application. Claim 17 merely recites various health conditions that can be treated.
Claim 18 includes the steps of determining recommended therapy including paced breathing, vibrational stimulation and neuromodulation, and then applying the recommended therapy. Thus, the claim includes a step that integrates the abstract idea into a practical application and the claim is therefor eligible under 35 USC 101.
Step 2B
As mentioned above, claims 1-17 include, other than the abstract idea, bladder, sensor, microprocessor, power source, communication means, securing member, stimulator. These elements are either used to gather data for use with the abstract idea or are used to apply the abstract idea. They are also considered to be well understood, routine and conventional when considered by themselves or when considered as a whole with the abstract idea.
Claim Rejections - 35 USC § 103
Claim(s) 1,2,3,5,6,7,18 is/are rejected under 35 U.S.C. 103 as being unpatentable over English (2024/0023820) and Lu et al (2005/0143668).
1. A device for diagnosing and correcting autonomic nervous system imbalance in vertebrates
comprising a wearable detector having a body substantially comprised of at least one
flexible substrate (at least ¶142 and figure 1 of English teaches a wearable support 32 which is considered to be the substrate) and containing:
a. a bladder; (see at least ¶168 and figure 13 of English which shows bladder 84)
b. a pressure sensor; (see at least figure 11 of English which shows pressure sensors 58, and ¶164 of English)
C. a detector microprocessor with communication means; (at least figure 11 of English teaches a controller which is considered to be an obvious analog of a processor. It would have been obvious to use a processor in place of the controller since processors can perform the same functions as a controller in a more general manner, and processors are well known in the art to efficiently control digital systems in a predicable manner. Further, at least ¶180 of English teaches a communication link to transmit data to an external device and therefore teaches communication means)
d. a power source member; (see at least ¶144 of English which teaches batteries)
e. an exterior side; (see figure 1 of English which shows an exterior side of the substrate 32)
f. a user contact side; (see figure 1 of English which shows a user contact side of the substrate 32)
g. at least one securing member (see at least figure 4 and ¶152 of English which teaches hook and loop fasteners)
wherein said at least one securing member is configured to envelop at least one of the
following: a thumb, a finger, a wrist, an ankle, and scalp; (see at least ¶142 and figure 15D of English)
wherein the bladder is placed adjacent an artery and secured by the at least one
securing member measure pulsatile waveform and detect inter-beat intervals (IBI) to be read by the pressure sensor; (figure 15D of English shows placement adjacent artery. At least ¶141,149 of English teaches sensing HRV. HRV, as is known, uses the interbeat interval to determine how it changes from beat to beat)
wherein the detector microprocessor uses IBI data to compute power spectral density
(PSD) data comprising an evolving autonomic nervous system spectra for evaluating
parasympathetic tone; (English is silent as to PSD. However, Lu teaches determining HRV, see at least ¶35, and peak to peak interval, see at least ¶42, which is the same as interbeat interval. Further, it uses this data to determine the power spectrum to determine the amount of power in each frequency to indicate parasympathetic nervous system function, see at least ¶58. As the patient’s ANS changes over time, the spectra of the ANS will evolve and change. It would have been obvious to determine PSD, as shown by Lu, with the device of English, since it would reveal important information re the patient’s condition in a predictable manner)
wherein said PSD data is transmitted to at least one communicatively coupled external
device. (at least ¶37 of Lu teaches output of a test report to a remote terminal, such as a doctor’s computer, and ¶63 teaches that the report can be used to evaluate ANS function, and as mentioned, ¶58 teaches determining PSD, which gives an indication of ANS function. It would have been obvious to transmit PSD, as shown by Lu, with the device of English, since it can be used to evaluate the patient’s condition via remote physician, thus improving patient care.)
2. The device of claim 1 wherein said at least one external device is selected from the group of
a user device, a stimulation unit, and a respiration monitor. (Lu, at ¶37, teaches that the remote external device can be a computer terminal, which is considered to be a user device. It would have been obvious to use such computer terminal as the external device used with English since it would allow for a remote physician to see the patient’s ANS condition. Further, English teaches an external device 129 in the form of a stimulation unit, see at least figure 57 and ¶243.
3. The device of claim 2 wherein said at least two of said at least one external device are
communicatively coupled to each other. (as mentioned, Lu teaches an external computer terminal, see at least ¶37. At least figure 57 of English teaches an external housing 129 including neuromodulating electrodes 47 which is in communication with the device 34. It would have been obvious have been obvious to make the device 129 of English in communication with the computer terminal of Lu since it would yield predictable results such as the ability to control therapy if the physician deems it to be necessary)
5. The device of claim 2 wherein the stimulation unit microprocessor controls application of
stimulation based on received data, said data including instructions for when to engage
stimulation, duration of stimulation, intensity of stimulation, and frequency of stimulation. (at least ¶243 of English teaches a stimulation unit with controller, see also figure 57. As mentioned supra, a microprocessor is considered to be an obvious variant of a controller. The controller shown in figure 57 of English (inside housing 129) can adjust frequency, amplitude, duration of the stimulation)
6. The device of claim 5 wherein said instructions are transmitted from said user device to said
stimulation unit. (as mentioned supra, Lu teaches a user device, see at least ¶37. It would have been obvious to make the user device of Lu in communication with the external stimulator 129 of English so that the external stimulator could be controlled to stimulate the patient in a manner deemed appropriate for the patient)
7. The device of claim 1 wherein the communication means is at least one from the group of
wired, Bluetooth, WiFi, NFC, RFID, or other wireless communication. (at least ¶180 of English teaches WiFi, Bluetooth, etc.)
18. A method of correcting ANS imbalance comprising:
i) Computing PSD data based on IBIs detected by a wearable detector; (At least ¶141,149 of English teaches sensing HRV. HRV, as is known, uses the interbeat interval to determine how it changes from beat to beat. English is silent as to PSD. However, Lu teaches determining HRV, see at least ¶35, and peak to peak interval, see at least ¶42, which is the same as interbeat interval. Further, it uses this data to determine the power spectrum to determine the amount of power in each frequency to indicate parasympathetic nervous system function, see at least ¶58. It would have been obvious to determine PSD, as shown by Lu, with the device of English, since it would reveal important information re the patient’s condition in a predictable manner)
ii) Transmitting said PSD data to an external device; at least ¶37 of Lu teaches output of a test report to a remote terminal, such as a doctor’s computer, and ¶63 teaches that the report can be used to evaluate ANS function, and as mentioned, ¶58 teaches determining PSD, which gives an indication of ANS function. It would have been obvious to transmit PSD, as shown by Lu, with the device of English, since it can be used to evaluate the patient’s condition via remote physician, thus improving patient care.)
iii) Analyzing PSD data to identify ANS imbalance indicators based on PSD data; (the remote physician at the remote terminal will review the results, as is customary in order to determine appropriate therapy for the patient, ¶37 of Lu)
iv) Comparing ANS imbalance indicators to like information in database; (at least ¶36 of Lu teaches comparison to values in a database)
v) Determining recommended corrective therapy using one or more techniques chosen
from paced breathing, vibrational stimulation, neuromodulation; (at least ¶141,243 of English teaches neuromodulation therapy and vibration therapy applied to patient.)
vi) Providing recommended therapy to user via electronic display; (as mentioned supra, English teaches a stimulator device 124 that causes neuromodulation or vibration therapy for the patient, where the device can communicate with another device 34 to receive instructions and control, see at least ¶243 and figure 57. Lu, as mentioned, teaches a remote physician computer where the physician reviews the ANS status (PSD) of the patient. It would have been obvious to provide recommended therapy to the stimulator device of English, from the computer terminal of Lu, since it would allow for therapy to be provided to the patient if the patient’s ANS (PSD) condition was deemed not proper and therapy was warranted. The device 129 of figure 57 of English shows a display UI (user interface with screen), see ¶235 of English, that can indicate to the patient the recommended therapy)
vii) Applying recommended therapy; (the therapy would be applied by the device 129 shown in figure 57 of English)
viii) Continuously updating PSD data during therapy; (as mentioned, Lu teaches determining PSD, see at least ¶58. It would have been obvious to continuously update PSD during therapy so that changes to PSD can be accounted for, thus giving a more accurate diagnoses and therapy for the patient)
ix) Recording results of therapy application to store on database. (as mentioned, at least ¶37 of Lu teaches a physician computer. It would have been obvious to record results of the therapy since it would provide the predictable results of providing data that will inform the physician’s decisions at a later time re the results of therapy, and any changes that need to be made)
Allowable Subject Matter
Re claim 4, the prior art does not fairly teach where the stimulation unit has HRV monitor. Re claim 8, the prior art does not fairly teach a translucent substrate, the welded bladder as well as the thumb pump in combination with the other elements of the claim. Re claim 9, the prior art does not fairly teach the translucent substrate, bladder welded to substrate, and pressure sensor printed on bladder in combination with the other elements of the claim. Re claim 10, the prior art does not fairly teach the translucent substrate, bladder welded to substrate, as well as an LED connected to pressure sensor in combination with the other elements of the claim. Re claim 11, the prior art does not fairly teach the translucent substrate, bladder welded to substrate with an air channel therethrough, and a third of the substrate having a U shaped configuration. Re claim 12, the prior art does not fairly teach the translucent substrate, bladder welded to substrate with an air channel therethrough as well as an LED connected to a pressure sensor. Re claim 13, the prior art does not fairly teach the claimed observation period as well as the sampling frequency of at least 300 Hz.
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/Scott M. Getzow/Primary Examiner, Art Unit 3792