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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Korea on 11/28/2023. It is noted, however, that applicant has not filed a certified copy of the Korean application as required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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: generating unit in claim 1 and 11, and dependents; control unit in claim 1 and 11 and dependents.
With respect to the generating unit, there appears to be no additional disclosure of any corresponding structure for performing the claimed function.
With respect to the control unit, the corresponding structure appears to be found in Specification dated 6/18/2024 ¶[00104] as filed: “In the case of hardware implementation, the methods according to the embodiments of the present invention may be implemented using one or more ASICs (Application Specific Integrated Circuits), DSPs (Digital Signal Processors), DSPDs (Digital Signal Processing Devices), PLDs (Programmable Logic Devices), FPGAs (Field Programmable Gate Arrays), processors, controllers, microcontrollers, microprocessors, etc.”.
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.
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 1-15 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 11, claim limitation “generating unit” 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. 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.
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 1-15 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 claims 1 and 11, claim limitation “generating unit” 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. 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.
Regarding claim 10, the limitation “wherein the pain occurring in the first region comprises knee joint pain, frozen shoulder pain, shoulder impingement syndrome pain, carpal tunnel syndrome pain, plantar fasciitis pain, rheumatoid arthritis pain, postherpetic neuralgia pain, back pain, lumbar stenosis pain, and neck pain.” renders the claims indefinite because these types of pain occur in different regions of the body. Applicant’s disclosure clearly shows that the electrodes are placed at the location of pain, therefore, the disclosure does not clearly support that all of the claimed regions are treated simultaneously by one device as claimed and does not resolve the indefiniteness or lack of clarity. For the purposes of examination, these locations will be interpreted as a list recited in the alternative: “wherein the pain occurring in the first region comprises knee joint pain, frozen shoulder pain, shoulder impingement syndrome pain, carpal tunnel syndrome pain, plantar fasciitis pain, rheumatoid arthritis pain, postherpetic neuralgia pain, back pain, lumbar stenosis pain, and/or neck pain.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 and all its dependent claims recite the limitation of “an electrode attached to at least one part of the body to deliver the generated electrical signal”, which encompasses a human subject. Applicant is recommended to amend this limitation to --an electrode configured to be attached to at least one part of the body to deliver the generated electrical signal-- in order to overcome this rejection.
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) 1-7, and 9-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Page et al. (U.S. Patent Application Publication No. 2020/0269046) hereinafter referred to as Page.
Regarding claim 1, Page teaches a pain relief device (Abstract, treatment of head and face pain) comprising:
a generating unit that generates an electrical signal recognized as non-painful by the brain (¶[0046]);
an electrode attached to at least one part of the body (¶¶[0055-0059], e.g., Fig. 7, throughout) to deliver the generated electrical signal (¶[0046]); and
a control unit that controls the operation of the generating unit and the electrode (¶[0046]);
wherein, during the process in which a pain signal generated in a first region of the body is transmitted to the brain (this is interpreted as the user experiencing pain), the electrical signal delivered by the electrode is transmitted to the brain along with the pain signal through surface stimulus receptor of the first region, thereby alleviating the pain perceived by the brain in the first region (¶[0018-0019], ¶¶[0150-0151]),
wherein the electrical signal is an alternating current stimulation (ACS) signal (¶[0034]), and
wherein the alternating current stimulation signal repeatedly switches on and off according to a predetermined first frequency (Fig. 10A, duty cycle at one periodicity, ¶[0034], ¶[0036]), and is a first combined stimulation that applies the signal switched on according to the first frequency as stimulus according to a predetermined second frequency (Fig. 10A, duty cycle at one periodicity, and stimulation inside comprising a waveform frequency, ¶[0037] burst stimulation frequency, e.g.).
Regarding claim 2, Page teaches the pain relief device of claim 1.
Page further teaches wherein the signal switched on according to the first frequency is a burst signal that a positive signal having a value exceeding a predetermined standard and a negative signal having a value below the predetermined standard repeat, and each of the positive signal and the negative signal comprises at least one spike signal (Fig. 10A-P contemplated signal shapes including both positive and negative and spike signals, ¶[0035] biphasic and charge balanced, ¶[0209]).
Regarding claim 3, Page teaches the pain relief device of claim 2.
Page further teaches wherein the positive signal and negative signal consist of multiple positive spike signals and multiple negative spike signals (Fig. 10A-P contemplated signal shapes including both positive and negative and spike signals, ¶[0035] biphasic and charge balanced, ¶[0209]).
Regarding claim 4, Page teaches the pain relief device of claim 2.
Page further teaches wherein the burst signal is a signal comprising multiple rectangular signals having a positive value and a negative current value, a first rectangular signal among the multiple rectangular signals comprises at least one positive spike signal, and a second rectangular signal following the first rectangular signal comprises at least one negative spike signal(Fig. 10A-P contemplated signal shapes including both positive and negative and spike signals, ¶[0035] biphasic and charge balanced, ¶[0209], see particularly Fig. 10D).
Regarding claim 5, Page teaches the pain relief device of claim 4.
Page further teaches wherein the control unit, when the degree of pain relief according to the first combined stimulation is below a predetermined range, controls the generating unit to generate a second combined stimulation signal that at least one of the first frequency, the second frequency, and the output, the waveform and the period of the stimulation according to the second frequency is modified, and controls the second combined stimulation signal to be delivered to the surface stimulus receptor through the electrode (¶¶[0256-0258] stimulation parameters are altered to ensure adequate pain inhibition, ¶[0298]).
Regarding claim 6, Page teaches the pain relief device of claim 2.
Page further teaches wherein the electrical signal is a similar electrical signal within a certain error range of a biological signal in the body, thus being recognized as non-painful by the brain (¶[0190] modulation of pain signals while maintaining non-painful sensory function, ¶[0191], ¶[0203] avoiding damage).
Regarding claim 7, Page teaches the pain relief device of claim 6.
Page further teaches wherein the electrode is arranged in multiple numbers near the first region (¶[0177] electrodes A-H, 8 electrodes).
Regarding claim 9, Page teaches the pain relief device of claim 8.
Page further teaches wherein the electrical signal has an intensity of 100 µA to 1000 µA (¶[0219] 1mA is equivalent to 1000 µA) and is applied for 10 to 60 minutes (¶[0221] 10-15, 15-20, 20-25, or 25-30 minutes).
Regarding claim 10, Page teaches the pain relief device of claim 1.
Page further teaches wherein the pain occurring in the first region comprises knee joint pain, frozen shoulder pain, shoulder impingement syndrome pain, carpal tunnel syndrome pain, plantar fasciitis pain, rheumatoid arthritis pain, postherpetic neuralgia pain, back pain, lumbar stenosis pain, and neck pain (¶[0178] shoulder, neck, head, ¶[0014]).
Regarding claim 11-14, the claims are directed to substantially the same subject matter as claim 1-2, and 4-5 and is rejected under substantially the same sections of Page.
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.
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) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Page as applied to claims 1 and 11 above, and further in view of Vallejo et al. (U.S. Patent Application Publication No. 2018/0028812) hereinafter referred to as Vallejo.
Regarding claim 8, Page teaches the pain relief device of claim 7.
Page does not teach wherein the multiple electrodes deliver an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region.
Attention is drawn to the Vallejo reference, which teaches an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region (¶[0061] electrical field stimulates glial cells to provide a priming response moving synapses to normal state including signaling release of transmitters such as ATP).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Page to include optimization for subthreshold stimulation to modulate the behavior of glial cells and the way they interact with neurons at a synaptic level to control the balance of transmitters for improved pain relief and minimal power usage (Vallejo ¶[0007] and ¶¶[0061-0062]).
Regarding claim 15, Page teaches the control method of the pain relief device of claim 12.
Page further teaches wherein the electrical signal is a similar electrical signal within a certain error range of a biological signal in the body, thus being recognized as non-painful by the brain (¶[0190] modulation of pain signals while maintaining non-painful sensory function, ¶[0191], ¶[0203] avoiding damage; and ¶[0219] 1mA), and the electrode is arranged in multiple numbers near the first region (¶[0221] 10-15, 15-20, 20-25, or 25-30 minutes).
Page does not teach wherein the multiple electrodes deliver an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region.
Attention is drawn to the Vallejo reference, which teaches an electrical signal to promote ATP (adenosine triphosphate) generation in the first region, and the promoted ATP generation improves blood flow, thereby improving inflammation related to the first region (¶[0061] electrical field stimulates glial cells to provide a priming response moving synapses to normal state including signaling release of transmitters such as ATP).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the stimulation of Page to include optimization for subthreshold stimulation to modulate the behavior of glial cells and the way they interact with neurons at a synaptic level to control the balance of transmitters for improved pain relief and minimal power usage (Vallejo ¶[0007] and ¶¶[0061-0062]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2020/0155847 to Perez teaches low amplitude electrical stimulation for relieving pain.
U.S. Patent Application Publication No. 2023/0148168 to Boggs et al. teaches relieving pain with periodic waveforms by blocking neural transmission, particularly without paresthesia perception.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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