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
The amendment filed on July 25, 2025 was considered by the examiner. Claims 1-2, 7, and 9-13 are pending in the application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters are not mentioned in the description: in Fig. 1A: 100, 200, 300, and 400; and in Fig. 4: 500 and 600. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters 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:
in claim 1, line 11: “electrode ” should be deleted.
Appropriate correction is required.
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.
Claim 7 is 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.
Claim 7 recites “the data analyzer is remote and is configured to determine the effectiveness of the stimulus presented to the infant or the young child by measuring attention, emotion, and memory retention” in lines 1-3. This is clearly a computer implemented recitation. Under the current guidelines of 35 USC 112, the specification fails to support a claim that defines the invention in functional language specifying a desired result when the specification does not sufficiently identify how the invention achieves the claimed function. For there to be sufficient disclosure for a computer-implemented claim limitation, it is not enough that one skilled in the art could write a program to achieve the claimed function. Rather, the specification must disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill can reasonably conclude that the inventor invented the claimed subject matter. See Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, Fed. Reg. Vol. 76, No. 27, February 9, 2011, p. 7162-7175 (“the Supplementary Examination Guidelines”). With respect to claim 7, this claim is rejected under §112, first paragraph, based on lack of written description because the specification fails to provide the algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function. In particular, no specificity is provided with respect to the effectiveness determination process. The disclosure provides no algorithm, flow chart, or other detailed description of the effectiveness determination process itself, but only refers to the effectiveness determination process in a “black box” description, meaning that the effectiveness determination process is referred to in a general sense but the specifics of the effectiveness determination process itself is not elaborated upon such that one of ordinary skill in the art would not have understood that the invention was in possession of the claimed invention, especially since it appears that the effectiveness determination process is one of central features of the claimed invention. See specification pg. 25, ¶2; pg. 27, ¶1-3; and Figs. 1 and 4. Appropriate correction is required.
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.
Claim 1-2, 7, and 9-13 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 the limitation "the aggregated data" in line 5. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claims 2, 7, and 9-13 are rejected by virtue of their dependence from claim 1.
Claim 7 recites the limitation "the effectiveness" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 7 recites the limitation "the stimulus" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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, 9, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ofek (US Patent 8,805,489 – cited in prior action), hereinafter Ofek, in view of in view of Bibian et al. (US Patent 11,109,789 – cited in prior action), hereinafter Bibian, and in view of Denison et al. (US Patent Application 2014/0316230).
Regarding Claim 1, Ofek teaches processing EEG signals after a stimulus is applied (see abstract), in which electrodes are positioned on the head (see Fig. 1), including emotional response to stimuli (see col. 11 ln. 40 – col. 12 ln. 25), user’s attention (see col. 10 ln. 50-52), and memory of the user (see col. 20 ln. 20-24); and can be utilized with children (see col. 13 ln. 39 – col. 14 ln. 10). Ofek teaches an apparatus (see abstract), comprising:
a plurality of reference electrodes (see col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes includes additional electrodes, such as placement in anterior, central, and occipital areas, col. 10 ln. 10-19, the usage of a reference electrode or reference electrodes), and
a data analyzer (col. 9 ln. 59-67, the computer, see claim 1, the processor to process the recorded EEG signal; col. 11 ln. 40 – col. 12 ln. 25, the emotional response to stimuli, col. 10 ln. 50-52, the user’s attention response to stimuli; col. 13 ln. 39 – col. 14 ln. 10, the system may work with children, which would include a young child),
electroencephalography (EEG) electrodes configured to make optimum point contacts with a scalp of an infant or a young child (see col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes on the head of the user; col. 13 ln. 39 – col. 14 ln. 10, the system may be utilized with children),
wherein one or more of the EEG electrodes are positioned either (1) in an arrangement of 13 electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, O1 and O2, or (2) in an arrangement of 17 electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, PO3, PO4, O1 and O2 (see col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes on the head of the user, including at positions AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, O1, and O2 and/or at AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, PO3, PO4, O1, and O2). The electrodes in Ofek include the positions as required by the claims and/or are capable of being positioned at such locations. Furthermore, it is noted that the data analyzer is not interpreted as part of the claimed apparatus pe se. However, the emotional response to the stimuli in the computer of Ofek still meets the data analysis of the present application since the specification relates the effectiveness of stimulus to attention and/or emotion (see specification pg. 24 ln. 24 – pg. 25 ln. 8).
Ofek is silent regarding a transmitter configured to transmit the aggregated data wirelessly to a data analyzer.
Bibian teaches an EEG system to monitor brain function for traumatic brain injury, TBI (see abstract). Bibian teaches EEG electrodes (see col. 4 ln. 41 – col. 5 ln. 32, col. 17 ln. 18 – col. 18 ln. 6; the system gathers EEG signals utilizing the electrode array; Figs. 1a-3b) that may be placed on frontal, temporal, parietal, anterior, central, and occipital areas (see col. 17 ln. 44-53). Bibian teaches amplifiers associated with the electrodes (see col. 11 ln. 1-15, col 52 ln. 43 – col. 53 ln. 12, the amplifiers are present on the device; Fig. 12). Bibian teaches that EEG data from two or more channels may be combined (aggregated), to improve the determination (analysis) (see col. 12 ln. 30-60 and col. 17 ln. 44 – col. 18 ln. 6, the EEG electrodes used in array, the plurality of electrodes are present, col. 21 ln. 57-61; EEG data from two or more channels may be combined). Bibian teaches the wireless uploading of data to the cloud, which includes data analysis, thus the cloud is a remote data analyzer (see col. 8 ln. 32-37, the wireless uploading of data to the cloud, which can include analysis, as the cloud may analyze and store the data, the cloud would be a remote data analyzer).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the remote data analysis of Bibian with the EEG system of Ofek because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) using a cloud for data analysis means less computing power is required on-site, and thus less cost to each individual apparatus.
The modified Ofek does not specifically teach about the usage of two reference electrodes, including at positions A1 and A2.
Denison teaches about portable, consumer, EEG devices (see abstract), and about prior art, in which reference electrodes are generally positioned at one or both ears, i.e., A1 and/or A2 (see ¶[0126] and Fig. 7).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the two reference electrodes of Denison with the modified Ofek because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the usage of the reference electrodes would help to remove noise (see Denison ¶[0067]); and/or (3) Ofek teaches the usage of reference electrodes and Denison teaches one such modality of implementing the reference electrodes.
Regarding Claim 2, Ofek in view of Bibian and Denison teaches the device of claim 1 as stated above. The modified Ofek is silent regarding a flexible support structure attached to the EEG electrodes.
Bibian further teaches the electrode array is integrated with flexible substrate (see col. 19 ln. 29-32, col. 45 ln. 41 – col. 46 ln. 12; Figs. 1a-3b).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the flexible support structure of Bibian with the modified Ofek because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the flexible substrate would provide an easy to apply and adjustable electrode array to the user; and/or (3) the modified Ofek teaches to apply electrodes to regions on the head of the user, but not the specific deployment mechanism, and Bibian teaches one such deployment mechanism.
Regarding Claim 9, Ofek in view of Bibian and Denison teaches the device of claim 1 as stated above. The modified Ofek further teaches contacting the apparatus to the scalp (see Ofek col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes on the head of the user; see Bibian col. 17 ln. 44-53, the electrodes placed on frontal, temporal, parietal, anterior, central, and occipital areas) of the infant or the young child (see Ofek col. 13 ln. 39 – col. 14 ln. 10, the system may be used with children, which would include a young child) to assess a characteristic of the infant or the young child (see Ofek col. 11 ln. 40 – col. 12 ln. 25, the emotional response to stimuli, col. 10 ln. 50-52, the user’s attention response to stimuli). The emotional response to the stimuli of Ofek still meets the data analysis since the specification relates the effectiveness of stimulus to attention and/or emotion (see specification pg. 24 ln. 24 – pg. 25 ln. 8).
Regarding Claim 12, Ofek in view of Bibian and Denison teaches the device of claim 1 as stated above. Ofek further teaches the electrodes are positioned at the positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, O1 and O2 (see col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes includes positions at AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, O1, and O2).
Regarding Claim 13, Ofek in view of Bibian and Denison teaches the device of claim 1 as stated above. Ofek further teaches the electrodes are positioned at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, PO3, PO4, O1 and O2 (see col. 16 ln. 53-55 and Fig. 1, the placement of the EEG electrodes includes positions at AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, PO3, PO4, O1, and O2).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ofek in view of Bibian and Denison as applied to claim 1 above, and in view of Johnson, JR. (US Patent Application Publication 2002/0062089 – cited in prior action), hereinafter Johnson, JR.
Regarding Claim 7, Ofek in view of Bibian and Denison teaches the device of claim 1 as stated above. The modified Ofek further teaches the data analyzer (see Ofek col. 9 ln. 59-67, the computer, see claim 1, the processor to process the recorded EEG signal; see Bibian col. 8 ln. 32-37, the wireless uploading of data to the cloud, the cloud is the remote data analyzer) is configured to determine the effectiveness of the stimulus presented to the infant or the young child by measuring attention (Ofek col. 11 ln. 40 – col. 12 ln. 25) and emotion (see Ofek col. 10 ln. 50-52).
The modified Ofek is silent regarding the determining the effectiveness of the stimulus presented to the infant or the young child by measuring memory retention.
Johnson, JR. teaches receiving EEG responses to stimuli (see abstract, ¶[0091]) in which electrodes are placed on the head (see ¶[0014]; Fig. 1), and emotional response is measured (see ¶[0064]) and memory retention tested (see ¶[0024]-[0025], ¶[0067]-[0072], ¶[0105], ¶[0119]-[0120]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the memory retention testing of Johnson, JR. with the modified Ofek because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) the additional metric will provide a better picture of the subject’s overall condition.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ofek in view of Bibian and Denison as applied to claim 9 above, and in view of Williams et al. (US Patent Application Publication 2004/0030258 – cited in prior action), hereinafter Williams.
Regarding Claim 10, Ofek in view of Bibian and Denison teaches the device/use of claim 9 as stated above. The modified Ofek is silent regarding the infant is greater than 0 months and less than or equal to 12 months in age.
Williams teaches long-term recording of EEG signals of an infant (see abstract), as infants may be at risk to brain injury (see ¶[0002]-[0007]), in which the sensor arrangement is designed to be placed on the infant’s head, and the infant may be monitored from birth until about one year after full term (see ¶[0012]; Fig. 8).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode apparatus of the modified Ofek (claim 1) for stimulus effectiveness determination of Ofek and/or EEG monitoring of Williams, with infants because it can help medical professionals monitor infants with stimulus response and/or potential brain injury.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ofek in view of Bibian and Denison as applied to claim 9 above, and in view of Szabo (US Patent Application Publication 2011/0053889 – cited in prior action), hereinafter Szabo.
Regarding Claim 11, Ofek in view of Bibian and Denison teaches the device/use of claim 9 as stated above. Ofek teaches monitoring children (see Ofek col. 13 ln. 39 – col. 14 ln. 10, the system may be used with children, which would include a young child); however, the modified Ofek does not specifically teach the age of the children.
Szabo teaches monitoring the effects of critical glyconutrient dietary supplements on infants and through their growth (see abstract), in which brain function may be monitored in the infants/children through 3 years of age utilizing EEG recordings in response to various stimuli (see ¶[0078]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the electrode apparatus of the modified Ofek (claim 1) for stimulus response determination of Ofek and/or Szabo because it can help medical professionals monitor infants/children with potential brain function problems.
Response to Arguments
Applicant’s arguments, objections to the drawings
Applicant’s arguments, see pg. 6-7, filed July 25, 2025, with respect to the objections to the drawings have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s drawings filed on July 25, 2025.
Applicant’s arguments, objection to the specification
Applicant’s arguments, see pg. 7, filed July 25, 2025, with respect to the objection of specification have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 7, filed July 25, 2025, with respect to the objections of to the claims have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s amendment filed on July 25, 2025.
Applicant’s arguments 35 U.S.C. § 112(a)
Applicant’s arguments, see pg. 7-9, filed July 25, 2025, with respect to the rejections of claims 1-2, 4, 7, and 9-13 under 35 U.S.C. § 112(a) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made to claim 7 under 35 U.S.C. § 112(a) that was necessitated by Applicant’s amendment filed on July 25, 2025.
Applicant’s arguments 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 9-10, filed July 25, 2025, with respect to the rejections of claims 1-2, 4, 7, and 9-13 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made to the claims under 35 U.S.C. § 112(b) that were necessitated by Applicant’s amendment filed on July 25, 2025.
Applicant’s arguments 35 U.S.C. § 103
Applicant’s arguments, see pg. 7-9, filed July 25, 2025, with respect to the rejections of claims 1-2, 4, 7, and 9-13 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made in view of Denison et al. (US Patent Application 2014/0316230).
The Applicant also made arguments related to the Ofek not meeting the recitations for the two arrangement of EEG electrodes. The examiner respectfully disagrees. In this case, the claim is directed towards an apparatus with electrodes capable of being placed on a patient. The positions of using the electrodes are not part of the claimed apparatus. If the positions were to be included, this would cause additional problems relating to 35 U.S.C. § 101 as encompassing a human organism, as the position are positions on a human head. As Ofek teaches that the electrodes utilized may be placed in such positions, Ofek teaches the claimed elements. Furthermore, the use of “consisting” under arrangement merely requires an arrangement consisting of 13 or 17 EEG electrodes. There is no requirement in the claim that there cannot be additional electrodes to the particular arrangements. As Ofek teaches all such electrode placements, Ofek teaches the claimed elements for this reason as well. Therefore, Applicant’s arguments pertaining the EEG electrode arrangement are not persuasive.
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 JONATHAN D. MORONESO whose telephone number is (571)272-8055. The examiner can normally be reached M-F: 8:30AM - 6:00 PM, MST.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791