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 .
Election/Restrictions
Applicant’s election without traverse of invention III, claims 11-20 in the reply filed on January 7, is acknowledged. Applicant argues that claims 1 to 9 (i.e., invention I) have been amended to align with invention III, claims 11-20 but the Examiner respectfully disagrees because claims 1 to 9 have a materially different function than claims 11 to 20 as claims 1 to 9 pertain to generating a first haptic output signal and a second haptic output signal, whereas claims 11 to 20 pertain to generating a first selection of haptic signals and a second selection of haptic signals. Claim 1 being amended to recite “a hand-held device” does not align the materially different function of claims 1 to 9 with the function of claims 11 to 20 (i.e., generating a first and second haptic output signal is different than generating a first and second selection of haptic signals). Therefore, as applicant has elected invention III, claims 11-20 without traverse, only claims 11-20 will be given search and consideration. See MPEP section 818.01.
This Office Action is responsive to the Reply to Office Action filed on January 7, 2026. The Examiner acknowledges the amendments to claim 1, and the cancellation of claim 10. Claims 11-20 are currently pending, with claims 1-9 being withdrawn as being drawn to a nonelected invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites “wherein generating the first selection comprises generating a first haptic signal comprising a first vibration signal within a first frequency range, and generating the second selection comprises generating a second haptic signal comprising a second vibration signal within a second frequency range different than the first frequency range”. It is unclear whether there is only one signal in each of the first selection and the second selection, as claim 11, which claim 13 depends upon, recites a first selection of haptic signals and a second selection of haptic signals. The examiner respectfully requests clarification of this claim. For examination purposes, it will be interpreted that the first and second selections each comprise a plurality of haptic signals.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20210283399 --as cited by applicant--, hereinafter referenced as "Willand" in view of US Patent Application Publication 20160361543, hereinafter referenced as "Kaula".
With respect to claim 11, Willand teaches a method of operating a hand-held device 100 configured to apply electrical stimulation to tissue (see Willand, par 0080, 0171-0174, 0184, 0187-0189, 0192, fig. 2A), the method comprising:
generating with the hand-held device 100, haptic signals associated with a condition pertaining to the device or to the stimulation, in response to detecting the condition (i.e., a non-visual indicator, such as a haptic feedback indicator, is activated when at least one validation condition that indicates an electrode assembly of the device is working to deliver electrical stimulation energy is detected) (see Willand, par 0043, 0053, 0315-0316, fig. 2A).
Willand fails to teach generating with the hand-held device, a first selection of haptic signals associated with a first condition pertaining to the device or to the stimulation, in response to detecting the first condition, and generating with the hand-held device, a second selection of haptic signals associated with a second condition pertaining to the device or to the stimulation, in response to detecting the second condition, wherein the first condition is different than the second condition, and the first selection of haptic signals is different than the second selection of haptic signals.
Kaula teaches a system, method, and device for providing feedback to a patient during electrical stimulation, wherein a haptic feedback signal is generated by a tactile feedback mechanism (see Kaula, fig. 10B, par 0102). The tactile feedback mechanism generates vibrations using tiny electric motors or a piezoelectric device that varies as a stimulation current amplitude of the electrical stimulation device is ramped up or ramped down, wherein as the stimulation current amplitude is increased, the frequency of the vibration provided by the tactile feedback mechanism is increased accordingly, and as the stimulation current amplitude is decreased, the frequency of the vibration provided by the tactile feedback mechanism is decreased accordingly (i.e., there are multiple and different sets of haptic signals generated that are associated with different conditions in response to the respective conditions being detected, and the first condition (i.e., an increase in stimulation current amplitude) is different than the second condition (i.e., a decrease in stimulation current amplitude), and further the first set of haptic signals (i.e., an increase in frequency of vibration) is different than the second set of haptic signals (i.e., a decrease in frequency of vibration)) (see Kaula, par 0102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Willand such that it comprises generating with the hand-held device, a first selection of haptic signals associated with a first condition pertaining to the device or to the stimulation, in response to detecting the first condition, and generating with the hand-held device, a second selection of haptic signals associated with a second condition pertaining to the device or to the stimulation, in response to detecting the second condition, wherein the first condition is different than the second condition, and the first selection of haptic signals is different than the second selection of haptic signals because this would improve the method of Willand by providing a feedback mechanism that sufficiently communicates to a user how the electrical stimulation parameters of the method/device are being varied as stimulation occurs (see Kaula, par 0004).
With respect to claim 12, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches a first haptic signal of the first selection differs from a second haptic signal of the second selection in at least one of: a number of perceived vibrations, a vibration sharpness, a vibration duration, a vibration intensity, and a vibration frequency (i.e., the first haptic signal is an increase in frequency of vibration and the second haptic signal is a decrease in frequency of vibration) (see Kaula, par 0102).
With respect to claim 13, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches generating the first selection comprises generating a first haptic signal comprising a first vibration signal within a first frequency range, and generating the second selection comprises generating a second haptic signal comprising a second vibration signal within a second frequency range different than the first frequency range (i.e., the first haptic signal is an increase in frequency of vibration and the second haptic signal is a decrease in frequency of vibration, therefore the haptic signals have different frequency ranges) (see Kaula, par 0102).
With respect to claim 14, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches generating the first and second selections comprises generating a first haptic signal of the first selection using a first haptic signal generator, and generating a second haptic signal of the second selection using a second haptic signal generator different than the first haptic signal generator (i.e., vibrations are generated by a plurality of tiny electric motors, therefore the haptic signals are generated by the different tiny electric motors) (see Kaula, par 0102).
With respect to claim 15, Willand as modified by Kaula teaches the method of claim 14, and Willand as modified by Kaula further teaches each of the first haptic signal generator and the second haptic signal generator comprises a different selection from the group consisting of: a linear resonant actuator, a piezo vibration actuator, a linear magnetic ram, and an eccentric rotating mass (i.e., vibrations are generated by tiny electric motors or a piezoelectric device within the tactile feedback mechanism) (see Kaula, par 0102).
With respect to claim 16, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches detecting the first condition, wherein the first condition is a device status condition (i.e., an increase in stimulation current amplitude of the electrical stimulation device) (see Kaula, par 0102).
With respect to claim 17, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches detecting the second condition, wherein the second condition is an alarm condition (i.e., stimulus output can be alerted to a user using haptic output, and as a result of a decrease in stimulation current amplitude, a decrease in frequency of vibration is output by the tactile feedback mechanism to alert the user of the decrease in stimulation current amplitude) (see Willand, par 0228-0229, 0341, Kaula, par 0102).
With respect to claim 18, Willand as modified by Kaula teaches the method of claim 11, and Willand as modified by Kaula further teaches generating at least one of the first and second selections comprises generating a sequence of haptic signals at different locations in the device (i.e., haptic signals are generated by a plurality of tiny electric motors, therefore the haptic signals are generated at different locations in the device as they are generated by the plurality of different tiny electric motors) (see Kaula, par 0102).
With respect to claim 19, Willand as modified by Kaula teaches the method of claim 11, and Willand further teaches adjusting a current density of the electrical stimulation, in response to a user input (i.e., the electrode lead of the device is shapeable by the user which permits adjusting the current density, such as reducing the current density needed to provide treatments in desired sites/regions) (see Willand, par 0405).
With respect to claim 20, Willand as modified by Kaula teaches the method of claim 11, and Willand further teaches adjusting at least one of an amplitude, a pulse width, a duration, an output energy, a frequency, and a burst frequency, of the electrical stimulation, in response to user input (i.e., parameters of the stimulus being delivered by the hand-held device can be adjusted by the user, such as the stimulus amplitude or pulse width, to determine the threshold of nerve activation desired) (see Willand, par 0200).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791