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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 30, 2026 has been entered. Claims 1-2, 7, and 9-13 are pending in the application.
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 1-2, 7, and 9-13 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 “wherein the EEG electrodes and the reference electrodes are positioned…” in line 6. This recitation appears to claim the positions of the electrodes. As the positions are locations on a human head, this claim is rejected to as improperly encompassing a human organism.
Claims 2, 7, and 9-13 are rejected by virtue of their dependence from claim 1.
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 1-2, 7, and 9-13 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.
Claim 1 recites “(1) in an arrangement consisting of 13 EEG electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, 01 and 02 and consisting of 2 reference electrodes at positions consisting of Al and A2, wherein the apparatus includes no other EEG electrodes or reference electrodes” in lines 6-10; and “(2) in an arrangement consisting of 17 EEG electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, P03, P04, 01 and 02 and consisting of 2 reference electrodes at positions consisting of Al and A2, wherein the apparatus includes no other EEG electrodes or reference electrodes” in lines 10-13. From MPEP § 2173.05(i), “[a]ny negative limitation or exclusionary proviso must have basis in the original disclosure” and that “as with positive limitations, the disclosure must only 'reasonably convey[] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date”. In this case, the specification only indicates that “The data collection mechanism includes multiple electrodes including. It should be noted that although specific electrode arrangement may vary from implementation to implementation, preferred electrode arrangement is provided herein” (see specification pg. 26, ¶5); and that “Figure 2A shows the electrode (13) arrangement for the effective assessment of infants’ positive and negative affect…” and “Figure 2B shows the electrode (17) arrangement for the effective assessment of infants’ positive and negative affect…” (see amended specification pg. 26 as filed on 07/25/2025). There is nothing in the disclosure that indicates only the highlighted electrode placements of Figs. 2A-2B are utilized; rather, the disclosure merely highlights those specific electrode placement and further indicates that “It should be noted that although specific electrode arrangement may vary from implementation to implementation” (see specification pg. 26, ¶5). Therefore, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
Claims 2, 7, and 9-13 are rejected by virtue of their dependence from claim 1.
Claim 7 recites “wherein the data analyzer is remote” in lines 1-2. The specification indicates that the data analyzer may receive data over “network interfaces” (see specification pg. 25, ¶3), including a wide area network (see pg. 26, ¶7 and pg. 27, ¶2). However, such transmission over a network does not necessitate or require that the data analyzer be remote. Therefore, one of ordinary skill in the art would not have recognized Applicant was in possession of the claimed invention at the time the application was effectively filed.
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, 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 “(1) in an arrangement consisting of 13 EEG electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CPz, 01 and 02 and consisting of 2 reference electrodes at positions consisting of Al and A2, wherein the apparatus includes no other EEG electrodes or reference electrodes” in lines 6-10. The claim is not clear as the first portion of the arrangement appears to indicate a closed group of electrodes; however, the claim then further recites an additional group of two additional electrodes. This inconsistency renders claim 1 indefinite. For the purposes of examination, the first arrangement is interpreted to consist of the 13 EEG electrodes and 2 reference electrodes. Appropriate clarification is required.
Claim 1 recites “(2) in an arrangement consisting of 17 EEG electrodes at positions consisting of AF3, AF4, F5, F6, FC1, FC2, T7, T8, P7, P8, CP3, CP4, CPz, P03, P04, 01 and 02 and consisting of 2 reference electrodes at positions consisting of Al and A2, wherein the apparatus includes no other EEG electrodes or reference electrodes” in lines 10-13. The claim is not clear as the first portion of the arrangement appears to indicate a closed group of electrodes; however, the claim then further recites an additional group of two additional electrodes. This inconsistency renders claim 1 indefinite. For the purposes of examination, the second arrangement is interpreted to consist of the 17 EEG electrodes and 2 reference electrodes. Appropriate clarification is required.
Claims 2, 7, and 9-13 are rejected by virtue of their dependence from 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, 7, 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. 24 ln. 1-30, different electrode groups may be utilized of the full set, at least one electrode is utilized; 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 consisting 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, col. 24 ln. 1-30, different electrode groups may be utilized of the full set, at least one electrode is utilized, 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. In addition, as Ofek teaches that different groups and the usage of at least one electrode (see col. 24 ln. 1-30, different electrode groups may be utilized of the full set, at least one electrode is utilized), the 13 or 17 arrangements without additional electrodes may be utilized. 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 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 is remote (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).
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, col. 24 ln. 1-30, 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 (col. 16 ln. 53-55, col. 24 ln. 1-30, 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 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. 5, filed March 30, 2026, with respect to the objections to the drawing as failing to comply with 37 CFR 1.84(p)(5) have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 5, filed March 30, 2026, with respect to the objection of claim 1 have been fully considered and are persuasive. Therefore, the objection has been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112(a)
Applicant’s arguments, see pg. 5, filed March 30, 2026, with respect to the rejection of claim 7 under 35 U.S.C. § 112(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection are made that were necessitated by Applicant’s amendment filed on March 30, 2026.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 5-6, filed March 30, 2026, with respect to the rejections of claims 1-2, 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 that were necessitated by Applicant’s amendment filed on March 30, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 6-7, filed March 30, 2026, with respect to the rejections of claims 1-2, 7, and 9-13 under 35 U.S.C. § 112(b) have been fully considered and are NOT persuasive. Applicant argues that there is no teaching or suggestion in the cited art to include only the specified EEG electrodes (i.e., the 13 or 17 electrode arrangements) and two reference 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 (see above 35 U.S.C. § 101 rejection) 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, and that different groups of electrodes, and using at least one electrode, Ofek teaches the claimed elements. Therefore, Applicant’s arguments are not persuasive.
Conclusion
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
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