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 Arguments
Applicant’s amendment filed 6/8/2026 has overcome the previously applied 35 USC 112(b) rejection of the claims.
Applicant’s arguments regarding the 35 USC 101 rejection have been considered and are not persuasive. Applicant argues on pg. 6 of the response “The claimed method improves the functionality of wearable EEG sensor devices by helping a user to quickly assess the connection state of each electrode of the wearable sensor devices and adjust the placement of the wearable sensor so that appropriate contact is made by each of the electrodes, in a manner not taught or suggested by the prior art.” However, the Examiner notes that the assessment of connection quality by a user is the abstract idea itself and cannot be considered an additional element that integrates the abstract idea into a practical application or amount to significantly more than the abstract idea itself. Furthermore, the argued adjustment of electrode placement is not presently claimed and therefore the arguments are not commensurate in scope with he claimed invention. The claim instead ends with reporting a result of a connection quality assessment with no further action taken.
Regarding the prior art rejections, the Examiner notes the rejection with respect to Ambrose (2018/0345006) has been updated to reflect the claim language. Applicant’s addition of “a patch electrode” is simply adding another form/shape the electrode can take. Applicant only mentions “patch electrode” twice in the entire specification (par. [0011, 0024]) and does not provide any assertion of criticality or unexpected results with the use of this structure. Ambrose provides embodiments in which various electrode shape/types can be used (Fig. 2A-C; 3). Chen et al. (2013/0231580) further discloses that patch electrodes are well-known electrode types for EEG recordings. The type/shape of electrode used for EEG recordings and the impedance testing is an obvious matter of design choice in choosing known structures for the suitable purpose of EEG detection.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the single embodiment in which electrodes dispose don a headband along with a patch electrode coupled to the plurality of electrodes, as currently claimed, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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, 9, 13-17, 20, 21 and 23 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 has been amended to require “a plurality of electroencephalography (EEG) electrodes disposed on a headband and a patch electrode coupled to the plurality of electrodes”. Paragraph [0024] of the specification states “The apparatus may further comprise one or more of a wearable headset coupled to the plurality of electrodes, an electrode patch coupled to one or more electrodes of the plurality of electrodes, or an electrode lead coupled to one or more electrodes of the plurality of electrodes and advanceable through the tissue, a body cavity, or a body lumen.”. This does not state that a patch electrode is connected to the plurality of electrodes on the headband, as each option states “a wearable headset coupled to the plurality of electrodes, an electrode patch coupled to one or more electrodes of the plurality of electrodes…”. The plurality of electrode are described as something outside the headband structure and the patch structure and therefore, the specification at best, discloses a plurality of electrodes, some connected to a headband and/or at least one connected to a patch. Nothing in this disclosure links the electrodes of the headband to the at least one patch electrode as claimed. This is new matter.
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, 9, 13-17, 20, 21 and 23 are 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
1, 9, 13-17, 20, 21 and 23 are 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, 9, 13-17, 20, 21 and 23 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 "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
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, 9, 13-17, 20, 21 and 23 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…an impedance between the first EEG electrode on the first side of the headband and each other EEG electrode of the plurality of electrodes on the first side”; and “e) comparing the impedances determined in step (d) to a predetermined impedance threshold to assess a connection quality of the first electrode” are so broadly recited that they can be performed mentally since a user could read impedance values from a printout or display and determine which values correspond to quality connections and which ones do not.
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 “(f) generating a notification…”. 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 notification amounts to the insignificant, post-solution activity of data display or reporting. 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 “(f) generating a notification…”. 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 notification amounts to the insignificant, post-solution activity of data display or reporting. These additional elements, alone or in combination, therefore do not amount to significantly more than the abstract idea itself.
Claims 9, 13, 20 and 21 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.
Claims 17 and 23 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, 9, 13-17, 20 and 21 are rejected under 35 U.S.C. 103 as obvious over Ambrose (2018/0345006) in view of Chen et al. (2013/0231580).
Regarding Claims 1, 20 and 21, Ambrose discloses an electrode apparatus for EEG detection and transcranial electrical stimulation (TES) (par. [0009, 0240, 0270]) having a plurality of electrodes 22 on a headband 28 (Fig. 3; par. [0008]). 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 discloses various examples of electrodes that can be used in Fig. 2A-C, but does not label any of them a “patch electrode”. However, the Examiner notes EEG electrodes come in various shapes, sizes and forms (as the brief examples of Ambrose illustrate) and notes the claimed “patch electrode” are known electrode forms for EEG systems, as evidenced by Chen (see par. [0004]). 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 at least one patch electrode or to form all of the electrodes out of patch electrodes, as taught and suggested by Chen, since doing so would be simple substitution of one known element for another to obtain the predictable result of accurate EEG detection.
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 9 and 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) and thus some of the electrode impedance measurements would traverse the head from one hemisphere to another after all pairs are tested.
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, 9, 13-17, 20 and 21 are rejected under 35 U.S.C. 103 as obvious over Ambrose (2018/0345006) in view if Chen et al. (2013/0231580), further in view of Bibian et al. (10,130,766).
Regarding Claims 1, 20 and 21, Ambrose discloses an electrode apparatus for EEG detection and transcranial electrical stimulation (TES) (par. [0009, 0240, 0270]) having a plurality of electrodes 22 on a headband 28 (Fig. 3; par. [0008]). 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 discloses various examples of electrodes that can be used in Fig. 2A-C, but does not label any of them a “patch electrode”. However, the Examiner notes EEG electrodes come in various shapes, sizes and forms (as the brief examples of Ambrose illustrate) and notes the claimed “patch electrode” are known electrode forms for EEG systems, as evidenced by Chen (see par. [0004]). 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 at least one patch electrode or to form all of the electrodes out of patch electrodes, as taught and suggested by Chen, since doing so would be simple substitution of one known element for another to obtain the predictable result of accurate EEG detection.
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 and hen combination to include using test signals outside of the EEG frequency bands, as taught and suggested by Bibian, for the purpose of avoiding corruption of the EEG signals.
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 9 and 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) and thus some of the electrode impedance measurements would traverse the head from one hemisphere to another after all pairs are tested.
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]).
Claim 23 is rejected under 35 U.S.C. 103 as obvious over Ambrose (2018/0345006) in view if Chen et al. (2013/0231580), further in view of Sunderland (2014/0088394). Ambrose and Chen disclose all of the claimed invention except for displaying the connection quality using color-coded status indicators. 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 and Chen 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.
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.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796