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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-8, in the reply filed on 01 June 2026 is acknowledged. The traversal is on the ground(s) that the applicant has amended the claims to include matter that was not present in the prior art of record McFarlin et. al.’120. This is not found persuasive because although the amendments do overcome McFarlin et. al.’120, the examiner has cited an additional application within this office action that contains each of the shared technical features of Groups I, II, and III based on the applicant’s amendments to the claims. Therefore, the examiner’s position is that the shared technical features of Groups I, II, and III are not special technical features given that they do not make a contribution over the prior art Chabal et. al.'432 (U.S. Patent Publication 20230218432). Claims 9-18 are withdrawn from consideration and the examiner has examined the elected Group I, Claims 1-8, accordingly.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities: Paragraphs [0103-104] of the instant application discloses the "RF generator" as both elements "3" and "7". Figures 1 and 2 label the "RF generator" as element 7. Therefore, it is unclear if element “3” or element “7” should be used to represent the “RF generator”.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 1 includes an "RF stimulator" as element “3” which is not disclosed within the instant application's specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation "them" recited in the eleventh line of the claim could be misconstrued to represent other elements or features that are different from the desired element. It is suggested that the limitation be recited similar to "converting the stimulus features" to avoid possible confusion or misinterpretation. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “monitoring module” in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The applicant fails to provide any description as to what structural components, algorithms, or storage mediums are used to comprise a “monitoring module” in a manner that one of ordinary skill in the art at the time the invention was effectively filed could accurately replicate this element of the invention.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The element “monitoring module” has not been provided with any structural details within the instant application’s specification that would make it understood by one of ordinary skill in the art as to what comprises this “module”. Is this “module” a type of system, storage medium, controller, computer or none of the above? Without proper clarification, it is unclear what entails a “monitoring module” that would enable one of ordinary skill in the art at the time this invention was effectively filed to recreate this element.
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 1-8 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 limitation "a user of the device" recited in the twelfth line of the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a user of the system". Additionally, the term “small-area” is a relative term which renders the claim indefinite. The term “small-area” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The exact dimensions or size of what constitutes a “small-area” probe is up to interpretation and relative to the examiner’s understanding.
Regarding Claim 3, the limitation "the group" recited in the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a group".
Regarding Claim 7, the limitation "the group" recited in the claim lacks proper antecedent basis. This limitation is being interpreted to mean "a group".
Claims not explicitly rejected above are rejected due to their dependence on the above claims.
Claim limitation “monitoring module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The claim limitation uses a generic placeholder coupled with functional language, and the disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Chabal et. al.'432 (U.S. Patent Publication 20230218432) in view of Kang et. al.'538 (U.S. Patent Publication 20210267538).
Regarding Claim 1, Chabal et. al.'432 discloses a system for the assessment of small nerve fiber function (Paragraph [0151] - FIG. 18 illustrates a system 1800 for delivering a stimulus and monitoring physiological parameters of a subject configured in accordance with embodiments of the present technology. The system 1800 can include a control unit 1801, one or more stimulus devices 1802, one or more monitoring devices 1803, feedback data 1804, facility 1805, and a program 1806), comprising:
a radiofrequency (RF) generator configured to generate electromagnetic currents in the RF range (Paragraph [0154] - The control unit 1801 can communicate with the stimulus device 1802 and/or monitoring device 1803 through any accepted wireless or wired protocol, including radio frequency (RF));
small-area probes to apply the electromagnetic currents to a subject's skin, thus generating non-invasive thermal stimuli selective to small nerve fibers at the subject's skin (Paragraph [0058] - the stimulus pod 110 can include sensors; Paragraph [0131] - For example, conductive heat and/or radiant heat (e.g., infrared heat) may be applied to skin; Paragraph [0151] - applying a thermal stimulus to a surface area of the skin; Paragraph [0154] - the signals can be sent and received through the subject's skin; Paragraph [0155] -In some embodiments, the stimulus device 1802 can be generally similar to or the same as stimulus pod 110; Paragraph [0086] - The present technology includes methods of applying stimuli to reduce pain. For example, certain methods described herein activate the skin's thermoreceptors (e.g., the thermoTRPs) to block and/or otherwise mask the sensation of pain. In some embodiments, the present technology is configured to desensitize specific thermoreceptors such as TRPV1, TRPV2, TRPV3, TRPV4, TRPA1, and/or TRPM8 to reduce the sensation of pain);
a monitoring module for recording body responses to the non-invasive thermal stimuli delivered by the small-area probes (Paragraph [0154] - The monitoring device 1803 can monitor physiological parameters including, but not limited to, heart rate, respiratory rate, blood pressure, muscle tension, electrical activity of the brain, blood flow, oxygenation, body temperature, skin temperature, perspiration, limbic movement, and/or hormone level);
a microprocessor (Paragraph [0154] - The control unit 1801 can be a desktop or laptop computer, a smartphone, a tablet, or other device) configured to:
send stimulus features to the RF generator for converting them to non-invasive thermal stimuli according to stimulation parameters selected by a user of the system (Paragraph [0151] - The facility 1805 can provide systems and methods for controlling the control unit 1801, stimulus devices 1802, monitoring devices 1803, feedback data 1804, and program 1806. The program 1806 can include component 1808 configured to receive user preferences, component 1810 configured to store user preferences, component 1812 configured to receive feedback data from monitoring devices 1803, component 1814 configured to display feedback data, component 1816 configured to calculate settings for stimulus devices 1802 based on the user preferences, component 1818 configured to generate a plan based on the calculated settings, and component 1820 configured to implement the generated plan); and
analyze the body responses to the non-invasive thermal stimuli recorded by the monitoring module to provide an assessment of the small nerve fiber function (Paragraph [0129] - The present technology and methods may be advantageous over existing thermal therapies because the present technology may target thermoreceptors and nerve fibers that promote and activate the hedonic response; Paragraph [0151] - FIG. 18 illustrates a system 1800 for delivering a stimulus and monitoring physiological parameters of a subject configured in accordance with embodiments of the present technology; Paragraph [0167] - For example, the treatment protocol can synchronize the pulsed or continuous heating to produce measured physiological parameters corresponding to nerve fiber stimulation, thermoreceptor stimulation, reduction of muscle activity and tension, and/or other desired outcomes or metrics).
Chabal et. al.'432 fails to disclose small-area RF probes to apply the electromagnetic currents to a subject’s skin, thus generating non-invasive thermal stimuli. Kang et. al.’538 teaches RF probes configured to apply various stimuli to a subject’s skin (Paragraph [0055] - Furthermore, the stimulus providing units 12 may be provided with one or more electrodes that provide a radio frequency (RF) current, on a 2-dimensional plane. Then, the stimulus providing units output RF currents to electrodes with an RF module… the patient may feel electric stimuli, and the skin of the patient is heated by an RF current of a specific intensity or more so that the patient may feel temperature stimuli together). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Chabal et. al.’432 to include small-area RF probes in order to control the intensity of the stimuli applied to the subject’s skin as seen in Kang et. al.’538.
Regarding Claims 3-4, Chabal et. al.'432 in view of Kang et. al.’538 discloses the system of Claim 1. Chabal et. al.'432 further discloses wherein the electromagnetic currents generated by the RF generator have a waveform consisting of square-wave (Paragraph [0110] - FIG. 11 is a graph of energy applied versus time illustrating a sine wave pattern 1101 of energy applied and the resultant skin temperature 1102 of a patient in accordance with an embodiment of the present technology. In other embodiments, the pattern of applied energy can be a square, crescendo, de-crescendo, intermittent, or any other conceivable pattern. Thus, there are at least five variables that can be adjusted to ensure optimal analgesia; duration of ramp-up time, duration of heating “heat time,” “recovery times” between heat times, intensity of heating, and pattern of heating (sine wave, square wave, saw tooth, etc.)) (emphasis added).
Regarding Claim 5, Chabal et. al.'432 in view of Kang et. al.’538 discloses the system of Claim 1. Chabal et. al.'432 further discloses wherein the small-area RF probes are selected from contact probes and contactless probes (Paragraph [0059] - the stimulus pod 110 includes a stimulus surface 150 that contacts the patient's skin to deliver heat, mild electrical stimuli, vibration, and/or other stimuli to the patient's body in a measured, deliberate pattern to relieve pain and discomfort in the patient's body).
Regarding Claim 6, Claim 6 depends from Claim 5, which recites "the small-area RF probes are selected from contact probes and contactless probes". Read in combination with Claim 5, Claim 6 requires "the small-area RF probes are selected from contact probes and contactless probes that comprise a distance-adjusting mechanism". Dependent claim 6 fails to positively recite that the small area probes are contactless probes (emphasis added). Instead, as with Claim 5, it provides an option between a contact probe and a contactless probe. As Chabal et. al.'432 discloses a contact probe, it reads on Claim 6.
Regarding Claims 7 and 8, Chabal et. al.'432 in view of Kang et. al.’538 discloses the system of Claim 1. Chabal et. al.'432 further discloses wherein the body response recorded by the monitoring module consists of radiofrequency evoked potentials from an electroencephalogram (Paragraph [0151] - a system 1800 for delivering a stimulus and monitoring physiological parameters of a subject; Paragraph [0159] - In one embodiment, applying stimuli to a subject can be synchronized with the subject's brain waves. One or more monitoring devices 1803 can monitor and measure the electrical activity of the brain. For example, the monitoring device 1803 can be an EEG device for recording brain activity and a quantitative EEG (qEEG) device for analyzing the recordings. The analyzed output of brain activity can be brain waves (neural oscillations). The brain waves can be used as feedback data for calculating settings for the stimulus device 1802…The parameters can be selected to synchronize with the frequency of the brain waves. In some embodiments, the parameters for pulsing and cycling heat can be synchronized with alpha waves (neural oscillations in the frequency range of 8-12 Hz) to promote the hedonic response. Alpha waves are associated with feelings invoked by the hedonic response, including relaxed, calm, and lucid).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Chabal et. al.'432 (U.S. Patent Publication 20230218432) in view of Kang et. al.'538 (U.S. Patent Publication 20210267538), as applied to Claim 1 above, and further in view of Simon et. al.'118 (U.S. Patent Publication 20140324118).
Regarding Claim 2, Chabal et. al.'432 in view of Kang et. al.’538 discloses the system of Claim 1. Chabal et. al.'432 further discloses wherein the RF generator is configured to generate electromagnetic currents of various durations (Paragraph [0101] - In operation, the heating device (e.g., one or more of the stimulus pods 110) may deliver heat intermittently. The heat may be applied for a period long enough to heat the skin to a desired level; upon reaching the desired skin temperature the device turns off and the skin is allowed to cool; after a preprogrammed interval the device may reactivate the heat unit and the cycle repeats. Alternatively, multiple cycles may be delivered sequentially for a predetermined duration; Paragraph [0150] - The user preferences can include adjustments to…duration of applying stimuli (e.g., 10 seconds, 10 minutes, and 1 hour)), but fails to explicitly disclose wherein the RF generator is configured to generate electromagnetic currents of a duration ranging from 5 to 500 ms. Simon et. al.'118 teaches generating electrical stimuli for a duration of 100 to 1000 ms (Paragraph [0066] - The somatosensory electrical stimulus used in FIG. 1A to stimulate nerves is ordinarily a monophasic square wave pulse having a duration of 100 microsecond to 1 second). With the teaching by Simon et. al.'118 that durations consisting of 100-1000 ms are "ordinary" when stimulating nerves, it would have been obvious, through routine experimentation, for one of ordinary skill in the art at the time the invention was effectively filed to have determined the optimal durations of applied currents, particularly within the range of 100-1000 ms, which would include the claimed limitations of 5-500 ms in order to modify Chabal et. al.'432 in view of Kang et. al.’538. This is further defended by 2144.05 MPEP Section II.A. that recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Prouza et. al.'119 (U.S. Patent Publication 20210146119) discloses a device comprising contactless application of electromagnetic waves in order to avoid creating “hot spots” on a user’s skin. Vallejo et. al.’548 (U.S. Patent 11607548) discloses a device capable of applying a thermal stimuli to a user and observing signals related to pain relief. George’550 (U.S. Patent Publication 20230201550) discloses a probe device used to treat pain via applied stimuli such as heat.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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