DETAILED ACTION
This action is a response to the filing on 12/10/2025. Examiner acknowledges the amendments to claims 1, 8, 10, 12, 14, 17, 21-24, 28, and 35; cancellation of claims 20, 27, 31, and 33; and the addition of claims 38-40.
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 .
Drawings
The drawings were received on 12/10/2025. These drawings are accepted.
It is noted that the submitted drawings are clear but the scan is blurred. The submitted drawing file should be the one used for publication.
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:
Cranial nerve stimulation component in claims 1, 17 and 23;
Physiological parameter monitoring component in claims 1, 23, and 28;
User activity output monitoring component in claims 12, 15, 17, 28, and 38;
Device that monitors user activity not pertaining to physiological parameters in claim 12;
Augmented reality component in claim 17; and
Timer component in claim 23.
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.
Based on Applicant’s specification the limitation are interpreted as follows:
Cranial nerve stimulation component in claims 1, 17 and 23 – program that controls stimulation (figure 9; page 13, line 21-page 15, line 10);
Physiological parameter monitoring component in claims 1, 23, and 28 – any sensor or device capable of detecting and/or monitoring a physiological parameter (page 5, lines 3-9);
User activity output monitoring component in claims 12, 15, 17, 28, and 38 – any device or sensor capable of detecting user output (page 5, lines 16-19);
Device that monitors user activity not pertaining to physiological parameters in claim 12 – camera, spatiotemporal sensors, accelerometers, gyroscope (page 5, lines 16-19;
Augmented reality (AR) component in claim 17 – any device capable of providing AR to the user (page 4, lines 8-12); and
Timer component in claim 23 – appears to be part of a controller computing device that controls timing of stimulations (paragraph 26, 40-44, and 50).
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 15, 16, 22, and 28 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 15 recites the limitation "the user activity output component" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation should be –the user activity output monitoring component—and the claim be dependent on claim 38 due to the amendment to claim 1.
Claim 16 inherits the deficiencies of claim 15 and is likewise rejected.
Claim 22 is dependent on a cancelled claim which makes the claim unclear. The claim should probably be amended to be dependent on claim 17.
Claim 28 recites the limitation "the user activity output component" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claim should be dependent on claim 38 due to the amendment made to claim 1.
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 and 17 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 recites the limitation “wherein the controller directs the CNFS component to administer CNFS to the user” in lines 15-16, which is a positive recitation to a human organism. This should be -- wherein the controller is configured to direct the CNFS component to administer CNFS to the user --.
Claim 17 recites the limitation “wherein the controller directs the CNFS component to administer CNFS to the user” in line 7, which is a positive recitation to a human organism. This should be -- wherein the controller is configured to direct the CNFS component to administer CNFS to the user --.
Claims 4, 8, 10, 12, 14, 15, 16, 21, 22, 28, 30, 38, and 39 inherit the deficiencies of claims 1 and 17 and are likewise rejected.
Allowable Subject Matter
Claims 23, 24, 35, and 40 are allowed.
Claims 1, 4, 8, 10, 12, 14, 15, 16, 17, 21, 22, 28, 30, 38, and 39 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and/or 35 U.S.C. 101 set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claims 1 and 17, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein the controller is configured to direct the CNFS component to administer the CNFS to the user at or before a predetermined time in an AR scenario provided to the user by the AR component, the predetermined time being a time at which an aroused state of the user was recorded during a prior iteration of the AR scenario provided to the user.
Claims 4, 8, 10, 38, 12, 14, 15, 16, 28, 30, 39, 21, and 22 are dependent on allowable matter from claims 1 or 17 and would be allowable once the 112 and/or 101 rejections are overcome.
In regards to claim 23, the prior art of record does not teach or suggest a system, as claimed by Applicant, wherein
(a) the system administers CNFS at or before a predetermined time of user activity output as detected by the user activity output monitoring component: or
(b) the system administers CNFS at or before a predetermined time of an aroused state as previously determined by the physiological parameter component.
Claims 24, 35, and 40 are dependent on allowed matter from claim 23 and are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791