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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
Response to Arguments
Applicant’s amendment filed 10/10/2025, with respect to the 35 USC 112b rejection as set forth in the Final Rejection dated 4/11/2025 have been fully considered and are persuasive. The 35 USC 112b rejection as set forth in the Final Rejection dated 4/11/2025 has been withdrawn.
Applicant's arguments filed 10/10/2025 with respect to the 35 USC 101, 102 and 103 rejections have been fully considered but they are not persuasive.
Regarding the 35 USC 101 rejection, Applicant argues the amendments “do not simply set up the environment, but rather help a user to more quickly assess the connection state of each electrode and adjust a placement of the wearable sensor to improve electrode contact, if needed”. This is not found persuasive in that the structure recited (EEG electrodes) and placing these electrodes on the user still amount to genetically linking the abstract idea to another technological environment or field of use and amount to the insignificant, extra-solution activity of data gathering.
Regarding the 35 USC 102/103 rejection with respect Ambrose, Applicant argues Ambrose does not disclose the test signal having a frequency different from an EEG frequency band. The Examiner respectfully disagrees. Ambrose discloses applying a test signal having a frequency in the range of 10-50 Hz which is outside an EEG Delta (0.5-4 Hz) and Theta (4-7 Hz) frequency band, either of which qualifies as “an EEG frequency band”. EEG’s have multiple, distinct frequency bands and the claim does not require the frequency to be outside of every EEG frequency band. However, in the event that Applicant intends the frequency to be outside of every EEG frequency band, the Examiner notes Bibian et al. (10,130,766) which discloses using test signals outside of the EEG frequency bands for the purpose of avoiding corruption of the EEG signals (col. 30, lines 35-47). An alternative rejection is made in the event Applicant intends the test frequency to be outside of every EEG frequency band
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6-17 and 20-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10980480 in view of Montgomery et al. (2005/0165323). The Patent discloses the same limitations of steps a)-f) in Claim 1 and the same limitation of step g) in Claim 4. The claims differ in that step g) of the current claim requires assessing connection quality during EEG monitoring. Montgomery discloses that connection quality assessments using impedance values are typically done in conventional EEG systems (par. [0012]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to doe electrode quality assessments during EEG monitoring in order to ensure accurate measurements
Claims 1, 6-17 and 20-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10285646 in view of Montgomery et al. (2005/0165323). The Patent discloses the same limitations of steps a)-d). Step i) and ii) of the patent cover repeating steps d) and e) of the current application for two electrodes. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to do the impedance check on any number of electrodes in the device, 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. The Patent also discloses step g) of the claim in step f) of the Patent. he claims differ in that step g) of the current claim requires assessing connection quality during EEG monitoring. Montgomery discloses that connection quality assessments using impedance values are typically done in conventional EEG systems (par. [0012]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to doe electrode quality assessments during EEG monitoring in order to ensure accurate measurements
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, 6-17 and 20-22 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 "displaying the connection quality" in step (g). There is insufficient antecedent basis for this limitation in the claim.
Additionally, the preamble states “assessing quality of a connection” but the body of the claim has been amended to remove any actual generation of a connection quality metric using the impedance. Impedance is determined but is not used in the claim for any particular purpose. As currently written, there is not a clear connection between impedance and connection quality color-coding
Claims 6-17 and 20-22 are rejected as being dependent on indefinite 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.
Claims 1, 6-17 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The Claims recite a process (method)
Step 2A, Prong 1
Claim 1 recites the abstract ideas of “d) determining…a voltage difference”; “e) determining…an impedance” and “f) repeating steps (d) and (e)…”. Steps d) and e) are so broadly recited that they can be performed mentally since a user could read voltage values from a printout or display; take a difference; and determine impedance using Ohm’s Law. Additionally, the taking of a voltage differential and the calculation of impedance from the differential amounts to a mathematical concept (calculating differences and using Ohm’s law to derive impedances).
Step 2A, Prong 2
Claim 1 recites the additional elements of “(a) placing the wearable sensor…comprising a plurality of electroencephalography (EEG) electrodes”; “(b) contacting the plurality of electrodes to the tissue of a subject”; “(c) providing a test signal…”; “a processor” and “(g) notifying, with an output device…”. The placing of the electrodes amounts to generically linking the abstract idea to another technological environment of field of use. The electrical sensor with EEG electrodes for obtaining sensed data amounts to the insignificant, extra-solution activity of data gathering. The providing a test signal amounts to insignificant extra-solution activity in that it is not a particular prophylaxis and simply sets up the environment in which the data is gathered (see MPEP §2106.04(d)(2), example c.)The processor is recited at such a high level of generality to only amount to generic computer implementation of the abstract idea; and the notifying with an output device amounts to the insignificant, post-solution activity of data display on a generic computer structure (i.e. a display). These additional elements therefore do not integrate the abstract idea into a practical application.
Step 2B
Claim 1 recites the additional elements of “(a) placing the wearable sensor…comprising a plurality of electroencephalography (EEG) electrodes”; “(b) contacting the plurality of electrodes to the tissue of a subject”; “(c) providing a test signal…”; “a processor” and “(g) notifying, with an output device…”. The placing of the electrodes amounts to generically linking the abstract idea to another technological environment of field of use. The electrical sensor with EEG electrodes for obtaining sensed data amounts to the insignificant, extra-solution activity of data gathering. The providing a test signal amounts to insignificant extra-solution activity in that it is not a particular prophylaxis and simply sets up the environment in which the data is gathered (see MPEP §2106.04(d)(2), example c.)The processor is recited at such a high level of generality to only amount to generic computer implementation of the abstract idea; and the notifying with an output device amounts to the insignificant, post-solution activity of data display on a generic computer structure (i.e. a display). These additional elements, alone or in combination, therefore do not amount to significantly more than the abstract idea itself.
Claim 6 amounts to merely linking the abstract idea to another technological environment or field of use.
Claims 7-13 and 20-22 amount to generic structure for data gathering and/or merely linking the abstract idea to another technological environment or field of use.
Claims 14-16 only further define the extra-solution activity of providing the test signal.
Claim 17 only further define the insignificant, extra-solution activity of data reporting.
The claims are not patent eligible.
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.
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, 6-17 and 20-22 are rejected under 35 U.S.C. 103 as obvious over Ambrose (2018/0345006) in view of Sunderland (2014/0088394).
Regarding Claims 1 and 20-22, Ambrose discloses an electrode apparatus for EEG detection and transcranial electrical stimulation (TES) (par. [0009, 0240, 0270]) having a plurality of electrodes. Ambrose further discloses applying the electrodes to tissue of a subject and then injecting a test signal to a first electrode of an electrode pair (step 94; Fig. 9, par. [0686-0687]) and detecting the test signal with a second electrode of the electrode pair to determine an impedance value (step 96, Fig. 9; par. [0688]). The value is recorded and then a new pair of electrodes is tested and the process is repeated for any desired number of isolated sub-regions of a scalp of the user across multiple modules (par. [0690-0691]). Ambrose discloses applying a test signal having a frequency in the range of 10-50 Hz which is outside an EEG Delta (0.5-4 Hz) and Theta (4-7 Hz) frequency band, either of which qualifies as “an EEG frequency band”. Lastly, Ambrose discloses an alert or notification is issued if the impedance is above a predetermined threshold, i.e. falls outside of a working range (see steps 144, 146, Fig. 9; par. [0704]). Ambrose discloses this test with respect to a TES system but notes in par. [0009, 0013] that determining and providing good electrical connection quality in an EEG system would improve signal to noise ration and therefore improve accuracy of EEG signal analysis. Ambrose does not disclose that the visual alert is a color coded display.
However, Sunderland, in the same field of endeavor of EEG electrode quality assessment and concerned with the same problem of identifying electrode connection quality to a user, discloses providing a visual alert with electrodes color coded with respect to their connection quality (Claim 20; Fig. 15)for the purpose of providing a more intuitive visual indication of the various connection qualities throughout the electrode array (par. [0141]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ambrose reference to include color coding a visual presentation according to connection quality, as taught and suggested by Sunderland, for the purpose of providing a more intuitive visual indication of the various connection qualities throughout the electrode array.
Alternately, Ambrose does not specifically state the assessment is done during EEG mode. However, Ambrose indicates good connection quality would improve EEG signal-to-noise ratio and that the determination of connection quality using impedance would provide the ability to better target the application of electrolytes to the electrode regions to promote patient safety and comfort and improve signal to noise ratio of signals (par. [0009, 0013]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ambrose reference to include assessing connection quality in EEG mode, as taught and suggested by Ambrose, for the purpose of identifying regions that can have better application of electrolytes that would in turn provide better signal quality.
In regards to Claim 17, Ambrose discloses outputting an audible, visual or tactile alarm in response to the detected impedance (par. [0049]).
In regards to Claims 6-13, Ambrose discloses utilizing an electrode cap with a plurality of adjacent electrodes, wherein the cap covers both hemispheres of the head (see Fig. 3).
Regarding Claim 14, Ambrose discloses testing impedance using test signals of different, predetermined frequencies (par. [0049]).
In regards to Claim 15, Ambrose discloses using a frequency of 10-50 Hz, which lies within the claimed range of 1-150 H (par. [0686]).
With regards to Claim 16, Ambrose discloses utilizing a constant current source for impedance measurement (par. [0056]).
The following is an alternative rejection in the event Applicant intends for the test signal frequency band to be outside of every EEG frequency band.
Claims 1, 6-17 and 20-22 are rejected under 35 U.S.C. 103 as obvious over Ambrose (2018/0345006) in view of Bibian et al. (10,130,766), further in view of Sunderland (2014/0088394).
Regarding Claims 1 and 20-22, Ambrose discloses an electrode apparatus for EEG detection and transcranial electrical stimulation (TES) (par. [0009, 0240, 0270]) having a plurality of electrodes. Ambrose further discloses applying the electrodes to tissue of a subject and then injecting a test signal to a first electrode of an electrode pair (step 94; Fig. 9, par. [0686-0687]) and detecting the test signal with a second electrode of the electrode pair to determine an impedance value (step 96, Fig. 9; par. [0688]). The value is recorded and then a new pair of electrodes is tested and the process is repeated for any desired number of isolated sub-regions of a scalp of the user across multiple modules (par. [0690-0691]). Ambrose discloses applying a test signal having a frequency in the range of 10-50 Hz which is outside an EEG Delta (0.5-4 Hz) and Theta (4-7 Hz) frequency band but ode snot disclose using a signal having a frequency outside of other frequency bands such as Alpha (8-12 Hz), Beta (13-30 Hz) or Gamma bands (greater than 30 Hz. Lastly, Ambrose discloses an alert or notification is issued if the impedance is above a predetermined threshold, i.e. falls outside of a working range (see steps 144, 146, Fig. 9; par. [0704]). Ambrose discloses this test with respect to a TES system but notes in par. [0009, 0013] that determining and providing good electrical connection quality in an EEG system would improve signal to noise ration and therefore improve accuracy of EEG signal analysis. Ambrose does not disclose that the visual alert is a color coded display.
With respect to the impedance test signal frequency, Bibian discloses using test signals outside of the EEG frequency bands for the purpose of avoiding corruption of the EEG signals (col. 30, lines 35-47). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ambrose reference to include using test signals outside of the EEG frequency bands, as taught and suggested by Bibian, for the purpose of p avoiding corruption of the EEG signals.
Additionally , Sunderland, in the same field of endeavor of EEG electrode quality assessment and concerned with the same problem of identifying electrode connection quality to a user, discloses providing a visual alert with electrodes color coded with respect to their connection quality (Claim 20; Fig. 15)for the purpose of providing a more intuitive visual indication of the various connection qualities throughout the electrode array (par. [0141]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ambrose and Bibian combination to include color coding a visual presentation according to connection quality, as taught and suggested by Sunderland, for the purpose of providing a more intuitive visual indication of the various connection qualities throughout the electrode array.
Alternately, Ambrose does not specifically state the assessment is done during EEG mode. However, Ambrose indicates good connection quality would improve EEG signal-to-noise ratio and that the determination of connection quality using impedance would provide the ability to better target the application of electrolytes to the electrode regions to promote patient safety and comfort and improve signal to noise ratio of signals (par. [0009, 0013]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Ambrose reference to include assessing connection quality in EEG mode, as taught and suggested by Ambrose, for the purpose of identifying regions that can have better application of electrolytes that would in turn provide better signal quality.
In regards to Claim 17, Ambrose discloses outputting an audible, visual or tactile alarm in response to the detected impedance (par. [0049]).
In regards to Claims 6-13, Ambrose discloses utilizing an electrode cap with a plurality of adjacent electrodes, wherein the cap covers both hemispheres of the head (see Fig. 3).
Regarding Claim 14, Ambrose discloses testing impedance using test signals of different, predetermined frequencies (par. [0049]).
In regards to Claim 15, Ambrose discloses using a frequency of 10-50 Hz, which lies within the claimed range of 1-150 H (par. [0686]).
With regards to Claim 16, Ambrose discloses utilizing a constant current source for impedance measurement (par. [0056]).
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796