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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the buzzer unit of claims 1 and 3 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because of the following informalities:
Shading does not aid in understanding the invention but rather makes drawings difficult to decipher and reduces legibility -- 37 CFR 1.84 (m)
Lines, numbers, and letters are not sufficiently clean, dense and dark, or uniformly thick and well-defined, resulting in illegibility and unclear identification of features -- 37 CFR 1.84 (l)
Numbers and letters are too small and interfere with comprehension – 37 CFR 1.84 (p)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
Claim 1 is objected to because of the following informalities: use of parentheses should be avoided unless to enclose reference characters.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b
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 1-3 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, the terms in parentheses "and other limbs" and “tremor” render the claim(s) indefinite because it is unclear whether the limitation(s) within the parentheses are part of the claimed invention and the claim(s) include(s) elements not actually disclosed (those encompassed by "other limbs"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
In claim 1, the recitation of “a power button,” “a button to navigate,” and “a button to acknowledge” are unclear as to how many distinct buttons are present, as a single button may be used for multiple purposes.
Claims 2 and 3 are narrative in form and replete with indefinite language. Claims 2 and 3 only contain preambles, with no transitional phrase or body to the claim, which makes the meets and bounds are of claimed invention unclear. The structure which goes to make up the device must be clearly and positively specified.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rosenbluth (US 20150321000 A1).
Regarding claim 2, Rosenbluth teaches a TENS unit ([0135] In some embodiments, the effector may be an electrical stimulator. Electrical effectors can include an electrode, an electrode pair, an array of electrodes or any device capable of delivering an electrical stimulation to a desired location. Electrical stimulation may be transcutaneous or subcutaneous. For example, transcutaneous electrical stimulation may be achieved with electrodes placed on the surface of the skin) that is used as an intervention to dampen tremor activity and can automatically be controlled in response to the onset of tremors ([intended use and capability statements hold no patentable weight, however they are still anticipated by Rosenbluth] [0139] Electrical stimulation may be designed to suppress tremors by interfering with proprioceptive input, inducing compensatory muscle contractions, or by a combination of both methods; [0136] The stimulation parameters may be adjusted automatically, or controlled by the user; [0143] The stimulation at site 2 is delayed after site 1 by time T/2, where T is the period of the native tremor. For example, if the tremor is at 8 Hz the period is 125 ms and the stimulation of site 2 would be delayed by 62.5 ms. The stimulation is designed to reset the phase of the neuron, which may be implemented using high frequency stimulation [above 100 Hz] or a DC pulse.).
Regarding claim 3, Rosenbluth teaches a buzzer unit that is used as an intervention to dampen tremor activity ([0128] The device may further contain a display or indicators 790 to communicate with the user and report on the status of the device. Indicators are preferably a light-emitting diode [LED] or some visual indicator but can alternatively be an audio indicator. The information may include the battery power or the stimulation status. [intended use statement holds no patentable weight, but is still anticipated by Rosenbluth]).
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 20150321000 A1). For compact prosecution, claim 1 is/are further rejected under 35 U.S.C. 103 as being unpatentable over Rosenbluth (US 20150321000 A1) in view of Powers (US 20190365286 A1) and Fafiani (US 20210022659 A1).
Regarding claim 1, Rosenbluth teaches a wearable device that can be worn on the wrists (and other limbs) of individuals that exhibit tremors or involuntary movement (Fig. 7A, tremor altering system 700, housing 1450), comprising:
a wristband ([0166] the housing 1450 may have the configuration of a wristwatch as shown in FIG. 14H-L worn on the wrist or arm of the user);
a processing unit that includes various circuitry and a gyroscope to measure accelerations in three dimensions ([0212] The processor 797, as illustrated in FIGS. 7A-7D for example, may function to operate on data, perform computations, and control other components of the tremor reduction device. It may preferably be a microprocessor with peripherals or a microcontroller; [0132] The sensor 780 could include motion sensors including accelerometers, gyroscopes and magnetometers; [0183] Sensor fusion techniques can also be used to analyze different aspects of the tremor. For example, a multi-axis accelerometer and gyroscope attached to the backside of the hand could be combined to reduce noise and drift and determine an accurate orientation of the hand in space. If a second pair of multi-axis accelerometer and gyroscope were also used on the wrist, the joint angle and position of the wrist could be determined during the tremor);
a power button to turn on/off the sensor unit; a button to navigate the display of the sensor unit; a button to acknowledge ([0127] The device could include a controls module 740 that communicates with the processor 797 and could be used by the user to control stimulation parameters. The controls allow the user to adjust the operation of the device. For example, the controls can be configured to turn the device on, turn the device off, adjust a parameter of the effector, such as the intensity.);
a micro-SD card as a non-volatile memory card ([0214] The data storage unit 770 may function to store operational statistics about the device and usage statistics about the device, … in the form of a micro-SD card.);
a mathematical algorithm that analyzes gyroscope three-dimensional acceleration measurements into a single net acceleration ([0180] Algorithms will be used to extract information about tremors from the stream of data provided by the sensors; [0181] Motion data can be taken as each raw sensor channel or by fusing the raw signals of multiple sensors. As one example, multi-axis accelerometer data can be combined into a single numerical value for analysis.);
a signal processing pipeline that filters the acceleration measurements into separate involuntary movement signals [tremors] and voluntary movement signals ([0178] These sensors may also be used to determine activities, such as to distinguish involuntary movements [e.g. tremor] from voluntary movements [e.g. drinking, writing] or the presence and absence of the tremor relative to the time of day or other detected activities such as sleep/wake cycles; [0181] Alternatively, if a patient is known to have a tremor that flexes and extends the wrist by a maximum of 5-degrees then an analysis algorithm would determine that a measured motion of 45-degree wrist flexion is likely due to intentional gross movement rather than tremor.);
a software program that analyzes tremors and provides a profile of the tremor to identify dominant frequencies that are present [and tremor characteristics based on time-domain signal, frequency-domain signal, amplitude] ([0178] The data from these tremor sensors is used measure the patient's current and historical tremor characteristics such as the amplitude, frequency and phase; [0180] The tremor may be identified based off its time-domain signal, frequency-domain signal, amplitude, or firing pattern (e.g. bursts, spikes). For example, in FIG. 18A-18B, the frequency analysis of the spectral power of gyroscopic motion data indicates that the tremor is centered at approximately 6.5 Hz [see the maximum power in the lower plot]; [0181] As each patient has a dominant tremor frequency, this range may be narrowed based on specific knowledge of the patient's tremor or tremor history. For example, for a patient with a 6 Hz tremor an analysis algorithm may extract only motion data in the 5 to 7 Hz range… Alternatively, the algorithm will sample the motion data by identifying time periods likely to correspond to postural holds or kinetic fine motor tasks.);
a switch that interfaces the processing unit with non-intrusive tremor relieving interventions ([0127] The device could include a controls module 740 that communicates with the processor 797 and could be used by the user to control stimulation parameters. The controls allow the user to adjust the operation of the device. For example, the controls can be configured to turn the device on, turn the device off, adjust a parameter of the effector, such as the intensity.);
a TENS unit (TENS Device 100; interface 1452, electrodes 1454; [0135] In some embodiments, the effector may be an electrical stimulator. Electrical effectors can include an electrode, an electrode pair, an array of electrodes or any device capable of delivering an electrical stimulation to a desired location. Electrical stimulation may be transcutaneous or subcutaneous. For example, transcutaneous electrical stimulation may be achieved with electrodes placed on the surface of the skin);
a buzzer unit ([0128] The device may further contain a display or indicators 790 to communicate with the user and report on the status of the device. Indicators are preferably a light-emitting diode [LED] or some visual indicator but can alternatively be an audio indicator. The information may include the battery power or the stimulation status.).
While Rosenbluth teaches tremor characteristics based on its time-domain signal, frequency-domain signal, amplitude, or firing pattern, Rosenbluth doesn’t explicitly mention presence of harmonics, percent time with tremors, median tremor duration [including range of tremor duration], and median time between tremors [including range of time between tremors]. However, it would be an obvious matter of design choice for one of ordinary skill in the art because deriving the presence of harmonics, percent time with tremors, and median values of tremor duration and relaxation facilitates known mathematical means using the time-domain signal, frequency-domain signal, amplitude, or firing patterns recited in Rosenbluth.
Still, for compact prosecution, Powers teaches passive tracking of dyskinesia and tremor symptoms using a wearable computer and discloses presence of harmonics ([0039] Harmonics are detected and folded into their “base” frequency [e.g., Acc_Max_Frequency] before calculating spectral entropy, as described in reference to FIGS. 8 and 9. One or more of harmonics detection, jerk detection, power calculations and entropy calculations can also occur at multiple sensor sites). Furthermore, Fafiani teaches a wearable device for recording motion data and discloses percent time with tremors median tremor duration [including range of tremor duration], and median time between tremors [including range of time between tremors] ([0069] reporting on objective measures such as e.g. Median Dyskinesia Score [DKS], percentage of time spent in Dyskinesia [PTD], Median Bradykinesia Score [BKS], percentage of time spent in tremor [PTT], percentage of time spent immobile [PTI]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Rosenbluth to include harmonics as disclosed in Powers to assist in the detection of dyskinesia/chorea (Powers [0039]) and percent time with tremors as disclosed in Fafiani to present objective characteristics of the movement disorder symptoms evident in motion data recorded for the specific subject (Fafiani [0069]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791