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 .
Election/Restrictions
Applicant’s election without traverse of group II, claims 14, 15, 17-21, 23 and 25, in the reply filed on 3/9/2026 is acknowledged. The examiner notes that the response did not also provide an election of species in response to the restriction requirement mailed on 12/5/2025 which included a restriction between species A and species B. As noted in the attached interview summary, the examiner called applicant’s representative Mark Cohen to obtain an election of species. The applicant elected species A, claims 17-19, without traverse during the telephone call on 3/20/2026. Accordingly, claims 14, 15, 17-19, 21, 23 and 25 are currently elected for examination as being drawn to Invention II, species A.
Claims 1-4, 10, 13, 20, 28-29 and 35-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions I, III, IV and V, and species B there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/9/2025 and during the phone call on 3/20/2026 (see attached interview summary).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/17/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The examiner notes that the instant application is a 371 of PCT/IL2021/050270 which was filed on 3/11/2021. The applicant has further submitted a Certified Copy of Foreign Priority Application on 10/30/2023 that includes US provisional application 62/988984, which was filed on 3/13/2020. However, it is noted that the ADS submitted 2/29/2024 has removed priority to the provisional application. Accordingly, the examiner is affording the current application a priority date of the 3/11/2021 for the filing date of PCT/IL2021/050270. Examiner notes that the art provided in the rejections below still qualifies as prior art for the filing date of the provisional application on 3/13/2020.
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.
Currently, no limitations of the instant claims are being interpreted as invoking a 35 USC 112(f) interpretation.
Claim Rejections - 35 USC § 102
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 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.
Claims 14 and 17-19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Deutsch et al (US 2022/0313135 A1).
Regarding claims 14 and 17-19; Deutsch discloses a system for collecting EEG signals (figures 9A-C, 16A-D), comprising:
a cap (element 180) shaped and sized for fitting onto the head of the patient (wherein inner shell element 180 is adjustable to fit onto the scalp; [paragraph [0139]; figures 9A-C and 16A-D); the cap comprising:
a plurality of dry EEG electrodes (elements 170) including at least a first set of electrodes and a second set of electrodes (wherein the system and processor can group electrodes into different groups that cover different parts of the head and measure signals from the cortex; paragraphs [0029]-[0030],[0093],[0150]-[0154]);
an actuator (elements 70) configured to press said first set of electrodes against the patient's scalp to record EEG signals from a first set of spatial scalp locations, and then to press said second set of electrodes against the patient's scalp to record EEG signals from a second set of spatial scalp locations at least partially different than the first set of spatial scalp locations (wherein each actuator is individually controllable and the controller communicates to groupings of electrodes to advance for measurement of EEG over a particular morphology; paragraphs [0029]-[0031],[0039],[0046]-[0048],[0131]- [0154], specifically [0143] and [0150]-[0154]; figures 8A-10B, 16A-D, specifically 9B); and
a processor (elements 18 and 72) programmed to interpolate data recorded by said first set of electrodes and said second set of electrodes to determine EEG events (records EEG signals from groups of electrodes and processes for analysis; paragraphs [0093]-[0100], [0153]).
Further regarding claim 17 and 18; Deutsch discloses said electrodes (elements 170) are mounted onto inflatable tubes (combined tube elements 162 and balloon elements 70) defined within said cap and wherein said actuator is configured to inflate said tubes to move said electrodes into contact with the scalp (wherein pneumatic tube elements 162 are inflated with air when air is passed through them to inflate balloon elements 71 which act as part of the pneumatic tubes to move said selected groups of electrodes into contact with the scalp; paragraph [0139]; figures 9a).
Further regarding claim 18; Deutsch discloses each electrode (element 170) is operably attached to a spring (element 73), wherein deflation of a tube releases tension on said spring, causing said spring to bounce distally, thereby retracting the electrode away from the scalp (whereby tension applied to spring element 73 as depicted in figure 8F is released when balloon element 71 is deflated spring extends distally away from scalp and electrode disengages from scalp as depicted in figures H; paragraphs [0137]-[0138]; figures 8F-H).
Further regarding claim 19; Deutsch discloses said first set of electrodes is mounted onto a first tube or set of tubes (combined tube elements 162 and balloon elements 71), and wherein said second set of electrodes is mounted onto a second tube or set of tubes (combined tube elements 162 and balloon elements 71), said first and second tube or sets of tubes independently inflatable (wherein each balloon element 71 is individually and independently inflatable via the controller element 72 in order to control advancement and retraction of a specific electrode or group of electrodes; paragraphs [0029]-[0031],[0039],[0046]-[0048],[0131]- [0154], specifically [0143] and [0150]-[0154]; figures 8A-10B, 16A-D, specifically 9B).
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.
Claims 15, 21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch as applied to claim 14 above, and further in view of Soutar (US 2019/0269365 A1).
Regarding claims 15, 21 and 25; Deutsch is described in the rejection of claim 14 above. Deutsch further discloses the controller (element 72) works with a switch (paragraphs [0151]-[0154]) configured to activate the actuators to apply force to individual electrodes or group of electrodes (abstract; paragraph [0093]).
However, Deutsch does not explicitly disclose the switch or timer is configured to alternate between the first and second electrode sets throughout a total duration of between 1-5 days.
Soutar teaches a similar dynamic EEG recording system wherein the dynamic EEG collection system is configured to selectively utilize particular sensor(s) (i.e. group or set of sensors) of a plurality of sensors for a predetermined period of time and/or in accordance with a predetermined time interval sequence programmed into a controlling computer to selectively activate or deactivate the respective sensors to collect data corresponding to activity at particular regions and/or networks of the brain of the subject (paragraph [0024],[0029],[0077]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Deutsch’s controller to activate the switch or timer to activate the actuator to alternate the electrodes according to a predetermined programmed sequence of groups for the duration of the program as taught by Soutar in order to collect data from the different EEG electrode groups from various locations over a period of time for quantitative analysis. Furthermore, the examiner notes that the applicant’s specification does not provide any criticality to the specific sequence of activating the sets of electrodes, or the duration of the sequence (wherein the specification simply states that the EEG system can be used to monitor short term or long term, see paragraphs [0039],[0094]-[0095],[0100],[0128]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to further modify the Deutsch/Soutar combination to use known sequences over a desired time period as a matter of routine engineering design choice depending on the data the user desired to collect.
In the alternative, the examiner notes that the claim limitation of “switch or timer configured to alternate between the first and second electrode sets throughout a total duration of between 1-5 days” is functional language associated with a switch or timer, but not a controller/processor, and as such if the structure is capable of providing the claimed function, it meets the claim limitations (see MPEP 2114). Accordingly, the Deutsch/Soutar combination as described discloses a switch which is capable of providing the claimed function and thus meets the BRI of the claim.
Further regarding 21; the Deutsch/Soutar combination as described in the rejection of claim 15 above.
However; the Deutsch/Soutar combination does not explicitly disclose the cap comprises fixtures configured for attachment onto designated anatomical landmarks comprising two or more of: the nasion, the inion and the preauricular point.
Deutsch discloses a cap with a plurality of electrodes for collecting data on the scalp, the electrodes having fixtures (elements 40) configured for attachment onto the scalp for recording. Soutar further teaches that the EEG collection system is adapted for desired placement electrodes to collect brain activity at particular locations, specifically the 10-20 international standard electrode locations (paragraph [0061]). The examiner notes that the 10-20 international standard electrode locations include the nasion, the inion and the left and right preauricular point.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Deutsch/Soutar combination such that the cap and fixtures are configured to attachment to the head to place the electrodes in the 10-20 EEG international standard electrode locations as taught by Soutar which includes the nasion, the inion and the preauricular points in order to collect EEG data recognized by the international standard for easy comparison to EEG data collected from other systems.
Further regarding claim 25; Deutsch discloses said processor (elements 18 and 72) is in communication with a remote server (paragraph [0150]) for transferring the recorded data and/or for comparing the recorded data onto data stored on the remote server (wherein controller and processor include communications to an external system such as a CPU, cloud computing facility or cloud storage facility which inherently have remote servers; paragraph [0150]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing for the Deutsch/Soutar combination to provide the same function.
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Deutsch in view of Soutar as applied to claim 15 above, and further in view of Gunasekar et al (US 2020/0237249 A1).
Regarding claim 23; The Deutsch/Soutar combination is described in the rejection of claim 15 above; however, it does not explicitly disclose the size of the cap is adjustable via one or more pullable straps for obtaining a personal fit to the patient’s scalp.
Deutsch does disclose the cap is adjustable to fit onto the scalp but is silent to the mechanism for adjustment (paragraph [0139]). Gunasekar teaches a similar system for places EEG electrodes on the head, wherein the headset/cap includes one or more pullable straps (element 121) for obtaining a personal fit to the patient scalp (wherein adjustment mechanism element 131 pulls the band to adjust the headset to the user’s scalp/head; paragraph [0116]-[0121]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the Deutsch/Soutar combination to modify the cap’s adjustment such that the cap is adjustable via one or more pullable straps for obtaining a personal fit to the patient’s head as taught by Genasekar in order to ensure a proper fit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0233124 A1 to Connor; discloses a dry EEG electrode for use on a hair-covered portion of a person’s head that discusses actuatable EEG electrodes.
US 2019/0000338 A1 to Van den Ende et al; discloses a method and system for obtaining signals from dry EEG electrodes that allows for adjustment of electrode placement.
US 2018/0317848 A1 to Gunasekar et al; discloses a system and method for testing contact quality of EEG electrodes.
US 2005/0107716 A1 to Eaton et al; discloses a system for positioning and receiving signals from a plurality of sensors on the head.
US 2014/0051961 A1 to Badower et al; discloses a system and method to gather and analyze EEG data.
WO 2019/053168 A1 to Francois et al; discloses a tool for measuring at least one property of a body surface of the head wherein the sensors are independently advanceable and retractable from contact with the subject.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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