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 .
Response to Amendment
No claims are amended.
Claims 1-12 are pending. Claims 5-12 are withdrawn from further consideration due to being drawn to unelected inventions.
Examiner has withdrawn the objection to claim 2.
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 and 4 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by:
Gefen (US 9173568 B2) (hereinafter – Gefen).
Re. Claim 1: Gefen teaches an apparatus for measuring peripheral nerve impairment (Abstract; see discussion of peripheral nerve disorders in Background), the apparatus comprising:
a housing that includes a mechanically compliant surface (Fig. 1: platform 1 comprising a surface 21 made from a hard rubber or plastic);
an actuator accessible from an outer surface of the housing and in contact with the mechanically compliant surface of the housing, the actuator being configured to transfer, via the mechanically compliant surface, a stimulation signal to a skin surface that is in contact with the housing (Col. 6, lines 43-46: “The platform 1 has a surface 21 made from a thermally insulating material, such as hard rubber or plastic, in which a plurality of stimulators 2, also described below, are embedded;” Fig. 5: stimulator 2b comprising heating element 83 and vibrator 84); and
processing circuitry configured to:
control the actuator to generate the stimulation signal (Fig. 1: CPU 3; Col. 6, lines 45-50: “The activity of each stimulator is under the control of a computer processing unit (CPU) 3 which communicates with the stimulators 2 via a communication line 7 which may be a wired link or a wireless link”);
receive, from a subject, a response to the stimulation signal (Col. 4, line 34 – Col. 5, line 12: reception of subject input of heating and/or vibratory sensation); and
based on the received response, form a diagnosis with respect to a neurological disability (Abstract: detection, i.e., diagnosis, of neuropathy).
Re. Claim 4: Gefen teaches the invention according to claim 1. Gefen further teaches the invention wherein the stimulation signal is a vibrotactile signal (Abstract: “The stimulators may deliver thermal and/or vibrational energy to the skin region”), and
wherein the processing circuitry is further configured to receive stimulation information that is based on at least one of an amplitude or a phase of the vibrotactile signal (Col. 4, line 43 – Col. 5, line 12; Examiner notes that in order to provide gradually increasing vibratory stimulation signals, the processor of Gefen must necessarily receive commands detailing stimulation information regarding the amplitude of sequential vibratory 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.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over:
Gefen (US 9173568 B2) (hereinafter – Gefen) in view of
LaCourse et al. (US 5002065 A) (hereinafter – LaCourse) (disclosed by Applicant).
Re. Claim 2: Gefen teaches the invention according to claim 1, but does not teach the invention further comprising an accelerometer, wherein to receive the response to the stimulation signal, the processing circuitry is configured to receive a vibration measurement from the accelerometer. Gefen teaches that the magnitude of vibration at the time of the subject’s response to vibrational stimulation is recorded (Col. 4, lines 63-65), but is silent regarding what component performs such measurement.
LaCourse teaches analogous art in the technology of diagnostic apparatuses which apply a vibratory stimuli to a user to assess a physical condition of a body part and, particularly, neuropathy (Abstract; Background). LaCourse further teaches the invention further comprising an accelerometer, wherein to receive the response to the stimulation signal, the processing circuitry is configured to receive a vibration measurement from the accelerometer (Col. 3, line 52 – Col. 4, line 10: vibrations provided as stimuli, with vibration amplitude recorded via accelerometer; Examiner notes that the accelerometer only detects vibration in response to the probe 3 causing vibratory stimulus; therefore, the accelerometer detects a response to the stimulation signal; Figs. 3, 4).
It would have been obvious to one having skill in the art before the effective filing date to have modified Gefen to include an accelerometer to record vibration signals in response to the applied stimulation, the motivation being that Gefen states that a subject’s response to vibrational stimulation is recorded (Col. 4, lines 63-65: “In the case of vibrational stimulation, the magnitude of the vibration of the stimulator at the time of the patient's response is recorded”), and LaCourse teaches that an acceptable sensor to record such vibration is an accelerometer.
Re. Claim 3: Gefen as modified by LaCourse teaches the invention according to claim 2. Gefen further teaches the invention further comprising a memory (Fig. 1: memory 11).
LaCourse, in modifying Gefen to include the use of an accelerometer as described in claim 2, further teaches the invention wherein the processing circuitry is further configured to record, in the memory, the vibration measurement received from the accelerometer (see citations of LaCourse in rejection of claim 2; additionally, see also Gefen, Col. 4, lines 63-65: “In the case of vibrational stimulation, the magnitude of the vibration of the stimulator at the time of the patient's response is recorded”),
and one or more of date information, time information, stimulation information, protocol information, or subject identification information, or subject response information associated with the received response (see citations of LaCourse in rejection of claim 2: recording vibration signals encompasses “stimulation information” and “protocol information;” see also, citation of Gefen above).
Response to Arguments
Applicant's arguments filed January 14, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
In contrast to the "mechanically compliant surface" of claim 1, the Gefen disclosure Gefen repeatedly and explicitly states that its platform is rigid, not compliant. For instance, at col. 6, 11. 3 & 4, Gefen states that its system comprises a rigid platform. At col. 5, 11. 6-15, Gefen states that the rigid platform is required so that neuropathy can be assessed "under physiological loading." Nothing in Gefen discloses or suggests any mechanically compliant surface, and indeed, only contemplates advantages of the rigid structure that is fundamental to the Gefen design and function.
While Gefen does describe the platform as a whole as “rigid,” this does not necessarily mean that the materials Gefen uses are precluded from some degree of mechanical compliance. Rigidity is the ability to resist deformation under load. Mechanical compliance is the ability of a material to deform elastically under load. Having rigidity does not preclude having mechanical stiffness except in the case of theoretical materials having perfect rigidity. Gefen discloses that the platform 1 of their device comprises a surface 21 made from “a thermally insulating material, such as hard rubber or plastic” (Col. 6, line 45). Hard rubber as known in the art refers to a type of rubber which has been vulcanized to enhance its hardness and durability; while the hardness of the rubber material is increased, vulcanization does not cause the material to be precluded from having some degree of mechanical compliance - the degree of rigidity or compliance of vulcanized rubbers depends on varying factors in the treatment process. Similarly, the use of plastic as stated by Gefen also encompasses materials having some degree of mechanical compliance (i.e., thermoplastics, TPU, etc.) while also having some degree of rigidity. The two terms “rigid” and “mechanically compliant” are not mutually exclusive unless the ranges for what is considered “rigid” and the ranges for what is considered “mechanically compliant” are specified as non-overlapping. Thus, Applicant’s argument appears to utilize a narrower scope of range than what is encompassed in the broadest reasonable interpretation of the scope of the claim.
Regarding Applicant’s argument:
Gefen also fails to disclose the functionality to "form a diagnosis" as set forth in claim 1. The Gefen system records temperatures or vibration thresholds, maps detected sensation values, and optionally compares them against normative databases. However, the Gefen system only provides the measurement data for interpretation by a clinician for any diagnosis formation.
Gefen teaches a device for detecting quantitative measures of neuropathy (Abstract). Applicant’s identification of Gefen’s measurement data and processes associated therewith (i.e., temperature, vibration threshold, mapping of detected sensation values, and comparison to normative databases), appears to neglect that such a process and metrics provide a “quantitative measure of neuropathy condition” (Col. 9, lines 23-33), which Examiner considers a formation of a diagnosis with respect to a neurological disability, particularly since such metrics may be indicative of the degree to which neuropathy (i.e., damage to, dysfunction, or disease of nerves) is considered to cause substantially limit an individual’s ability to perform major life activities (i.e., a disability). Applicant’s
Applicant’s argument appears to stem from a narrower interpretation of the limitation “form a diagnosis with respect to a neurological disability,” such as outputting an indication that a user has a specific disability (e.g., Parkinson’s identified via detected tremors falling within particular frequency ranges and activity patterns as described in Applicant’s Paragraph 0051). Should the term “neurological disability” be interpreted as narrowly as Applicant contends, Examiner notes that the broad genus of forming a diagnosis of any neurological disability is not provided in Applicant’s disclosure with a sufficient number of representative species to adequately support the claimed genus. At best, Applicant’s Specification discloses a process similar to that of Gefen, such as:
identifying tremors, i.e., a quantitative measure and not in and of itself a particular neurological disability (Paragraph 0050);
providing such a quantitative measure to a clinician (Paragraph 0051); and
performing statistical analysis of tremor frequency and patterns without explicitly forming a diagnosis (Paragraph 0051 only specifies that certain parameters of tremor may be indicative of Parkinson’s may be analyzed; however, the conclusion that the subject has Parkinson’s is not explicitly described as formed by the processor, whereby Paragraph 0051 merely states that such quantitative data is indicative of different types of tremor, i.e., a judgement formed post-processing).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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