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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 Aug 2025 has been entered.
This Office Action is responsive to the amendment filed on 20 Aug 2025. As directed by the amendment: claims 1-2, 19-20, and 27-28 have been amended, claims 3, 7-18, 21, 24, and 35 have been canceled, claims 19-20, 22-25, 27-30, and 32-34 have been withdrawn, and no claims have been added. Thus, claims 1-2 and 4-6 are presently pending examination.
Response to Arguments
Objection to the Claims
Applicant’s arguments, see Remarks, filed 20 Aug 2025, with respect to the objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
However, new claim objections are made below.
Rejections to the Claims under 35 U.S.C. 102 and 103
Applicant’s arguments, see Remarks, filed 20 Aug 2025, with respect to the rejection of claim 1 under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kong et al. (US 20200179694 A1), hereinafter Kong, as explained in further detail below.
Applicant argues that “the current amplitude value is distinct from the charge value - as is clear from the definitions in paragraph [0099] of the present application as published. In fact, the charge is defined as the current intensity multiplied by time, and is measured in coulombs” (Remarks, page 12). Examiner respectfully disagrees. Although the claims are read in light of the specification, the subject matter from the specification is not imported into the claims, per MPEP 2111. The definition of “an electrical charge” is not present in the claims, so the broadest interpretation of “an electrical charge value” includes any parameter related to electrical charge, including current (charge/time) and charge density.
Applicant further argues that the specific values of the multiplication constants A and B are required to be above the user-specific sensory threshold (Remarks, page 13). Examiner agrees with this statement and that the previously cited Pal reference does not disclose this feature. As explained below, Kong discloses that A and B are above the user-specific sensory threshold, but does not explicitly disclose the claimed ranges of these values. However, it is not clear from the specification why the specific ranges are necessary, and therefore it would have been obvious to determine an optimum range of multiplication constants, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1:
“electrode-array” in lines 4 and 12 should read “electrode array”
“sensory-threshold” in line 10 should read “sensory threshold”
Claim 2: ”an inverse of electrical pulse frequency” in lines 4-5 should read “an inverse of an electrical pulse frequency”
Appropriate correction is required.
Claim Interpretation
For clarity, the following limitations of claim 1 will be interpreted as follows:
Limitation
Lines
Interpretation
at least one parameter value of said first treatment parameter values
6-7
at least one first treatment parameter value of said first set of treatment parameter values
at least one parameter value of a set of user-specific sensory threshold parameter values
7-8
at least one sensory threshold parameter value of a set of user-specific sensory threshold parameter values
an electrical charge parameter value of said first set of treatment parameter values
9
a first electrical charge parameter value of said first set of treatment parameter values
an electrical charge parameter value of said set of user-specific sensory threshold parameter values
10-11
a sensory threshold electrical charge parameter value of said set of sensory threshold parameter values
at least one parameter value of said second set of treatment parameter values
14-15
at least one second treatment parameter value of said first set of treatment parameter values
said at least one parameter value of said first set of treatment parameter values
15-16
said at least one first treatment parameter value of said first set of treatment parameter values
an electrical charge parameter value of said second set of treatment parameter values
17-18
a second electrical charge parameter value of said second set of treatment parameter values
an electrical charge parameter value of said first set of treatment parameter values
18-19
the first electrical charge parameter value of said first set of treatment parameter values
(see 112(b) rejection below)
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.
Claims 1-2 and 4-6 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.
Claim 1 recites “at least one parameter value of said first set of treatment parameter values” (lines 6-7) and “an electrical charge parameter value of said first set of treatment parameter values” (line 9). It is not explicitly clear whether the electrical charge parameter value is one of the at least one parameter values of said first set of treatment parameter values. For the purposes of examination, the electrical charge parameter value of said first set of treatment parameter values will be interpreted as one of the at least one parameter values of said first set of treatment parameter values. Similar reasoning applies to the limitations “at least one parameter value of said second set of treatment parameter values” (lines 14-15) and “an electrical charge parameter value of said second set of treatment parameter values” (lines 17-18), and the limitations “at least one parameter value of a set of user-specific sensory threshold parameter values” (lines 7-8) and “an electrical charge parameter value of said set of user-specific sensory threshold parameter values” (lines 10-11).
Claim 1 recites “an electrical charge parameter value of said first set of treatment parameter values” in lines 9-10 and 18-19. It is unclear as to whether the second recitation of this limitation is referring to the first recitation. For the purposes of examination, the recitations of this limitation will be interpreted per the table above.
Claims 2 and 4-6 are also rejected because they are dependent on claim 1.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Shakour et al. (WO 2017141257 A1, previously cited), hereinafter Shakour, in view of Kong et al. (US 20200179694 A1), hereinafter Kong.
Regarding claim 1, Shakour discloses a method (Abstract) of determining user-specific treatment parameter values (page 13, lines 25-27; page 20, line 1) for a multi-channel transdermal neurostimulation treatment applied at multiple locations on a user's scalp (Fig. 1b, page 14, lines 21-24, electrode array 102), the method comprising:
(a) setting a first set of treatment parameter values for a first electrode array (page 15, lines 18-21, first cathode-anode pair) in engagement with a first portion of the user's scalp for administering electrical pulses thereto (page 3, lines 10-11; page 14, lines 21-23), according to a first correlation that includes a first direct relationship between at least one parameter value of said first set of treatment parameter values and a corresponding at least one parameter value of a set of user-specific sensory-threshold parameter values (page 34, lines 16-30); and
(b) setting a second set of treatment parameter values for a second electrode array (page 15, lines 21-23, second cathode-anode pair) in engagement with a second portion of the user's scalp for administering electrical pulses thereto (page 3, lines 10-11; page 14, lines 21-23), according to a second correlation that includes a second direct relationship between at least one parameter value of said second set of treatment parameter values and said at least one parameter value of said first set of treatment parameter values (page 35, lines 10-12),
wherein (ii) said first portion of the scalp is a posterior portion (Fig. 1b, page 15, lines 9-10, electrodes 104e, 104f, and 104g) and said second portion of the scalp is an anterior portion (Fig. 1b, page 15, lines 10-11, electrodes 104a and 104b).
Shakur further discloses that the electrical charge parameter value is up to 14.3 mA/cm2 (page 24, line 19). Shakour does not disclose that an electrical charge parameter value of said first set of treatment parameter values is equal to an electrical charge parameter value of said set of user-specific sensory-threshold parameter values multiplied by A, where A is not less than 1.3 and not greater than 1.9, not that an electrical charge parameter value of said second set of treatment parameter values is equal to an electrical charge parameter value of said first set of treatment parameter values multiplied by B, where B is not less than 1.1 and not greater than 3.8.
However, Kong teaches an apparatus for assessing the accuracy of a target stimulation intensity level used in transcutaneous electrical nerve stimulation (Abstract), wherein an electrical charge parameter value is equal to an user-specific sensory-threshold parameter value multiplied by a value between 1.1 and 3.8 (paragraph [0101], "the sensation threshold intensity (the first intensity to evoke electrotactile sensation) and the therapeutic intensity (the strong yet not painful stimulation) can be predicted based on user profile ... In subsequent presentation of test current, the intensity IL(k+1) shall be two times of the previously presented test current intensity IL(k) ... In another embodiment of IL(k+1) modification, the test current intensity is reduced to 110% of the predicted therapeutic intensity: IL(k+1)=1.1*PTI.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shakour with the teachings of Kong so that the multipliers A and B are between 1.3 and 1.9, and between 1.1 and 3.8, respectively, because doing so ensures that the stimulation is effective yet within safety bounds (Kong, paragraph [0101]).
Although Kong does not explicitly disclose that that A is between 1.3 and 1.9, nor that B is between 1.1 and 3.8, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to do so, for the purpose of limiting the amount of electrical charge applied to a safe and/or comfortable range, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, the method of claim 1 is obvious over Shakour and Kong, as explained above. Shakour further discloses that each respective set of treatment parameter values includes values for:
an electrical charge parameter having values of total electric charge for a given time period (page 33, line 24), and at least one of:
(i) a value for a current-intensity parameter (page 34, lines 12-16, current density), and
(ii) separate values for each of the pulse duration parameter (page 7, lines 14 and 24; page 14, line 1) and the frequency parameter (page 7, lines 14 and 23; page 14, line 1).
Shakour does not explicitly disclose that the given time period is an integer multiple of an inverse of electrical pulse frequency. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use an integer multiple of an inverse of electrical pulse frequency, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 4, the method of claim 1 is obvious over Shakour and Kong, as explained above. Shakour further discloses that second direct relationship is based in part on a relationship between respective electrode surface-areas of said first and second electrode arrays (page 30, lines 3-8).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Shakour et al. (WO 2017141257 A1, previously cited), hereinafter Shakour, in view of Kong et al. (US 20200179694 A1), hereinafter Kong, and further in view of Wongsarnipoon et al. (US Publication No. 20130204315 A1, previously cited), hereinafter Wongsarnipoon.
Regarding claim 5, the method of claim 1 is obvious over Shakour and Kong, as explained above. Shakour does not explicitly disclose that values of the set of user-specific sensory-threshold parameter values are based on a first user input received during application of a series of electrical pulses to a single one of the first and second portions of the user's scalp. However, Wongsarnipoon teaches a method of brain stimulation (Abstract) wherein values of the set of user-specific sensory-threshold parameter values are based on a first user input received during application of a series of electrical pulses to a single one of the first and second portions of the user's scalp (paragraphs [0054], [0077]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shakour and Kong with the teachings of Wongsarnipoon to use a first user input received during application of a series of electrical pulses to a single one of the first and second portions of the user's scalp to determine values of the set of user-specific sensory-threshold parameter values because doing so makes electrode placement before each treatment session fast, comfortable and accurate (paragraphs [0037], [0044]).
Regarding claim 6, the method of claim 1 is obvious over Shakour and Kong, as explained above. Shakour does not explicitly disclose that said first and second correlations are linear relationships based on respective empirical correlations. However, Wongsarnipoon teaches a method of brain stimulation (Abstract) wherein the correlation between the stimulation intensity and the threshold for discomfort is linear and based on empirical data (paragraphs [0054], [0077]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Shakour and Kong with the teachings of Wongsarnipoon to use empirical correlations for said first and second correlations because doing so makes electrode placement before each treatment session fast, comfortable and accurate (paragraphs [0037], [0044]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796