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 .
The amendment filed on July 9, 2026 has been received and considered. By this amendment, no claims are amended, cancelled, or added, and claims 1, 3-11, 13-17, and 21-23 are now pending in the application.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 101
Claims 1,3-11,13-17,21-23 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 are for a method. Thus, the claims are directed to statutory subject matter.
Step 2a, prong 1
Claim 1 includes the step of assessing a condition of the patient. This step is considered to be an abstract idea in the form of a mental step. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) See MPEP 2106.04(a).
Step 2a, prong 2
Claim 1 also includes the steps of positioning an electrode array and obtaining electrophysiological measurements. These steps are considered to be used to gather data for use in the abstract idea. Thus, they do not integrate the abstract idea into a practical application. Claims 3-11 include further details about the data gathering steps. However, they do not include limitations that improve a technical field or treat a particular medical condition or use a particular machine. Thus, they do not include limitations that integrate the abstract idea into a practical application. Claim 13-17,21-23 also include further details regarding the data gathering steps, and thus also do not integrate the abstract idea into a practical application.
Step 2b
The claims include electrodes, and an imaging modality such as MRI, CT. These elements are considered to be well understood, routine and conventional in the art in order to gather data for use with the abstract idea, whether considered by themselves or as a whole with the abstract idea. For example, Spector (2020/0138319), submitted by applicant, teaches use of electrode arrays, ¶14, and CT, ¶94. Also, Dubois et al (2018/0325400), submitted by applicant, teaches MRI and CT, ¶139, and electrode arrays, ¶78.
Claim Rejections - 35 USC § 103
Claim(s) 1,3-11,13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al (2020/0289002) and Spector (2014/0200575).
1, (Previously Presented) A method for assessing a condition of a patient, the method comprising: positioning a two-dimensional electrode array at a non-cardiac target site on or in a patient, the two-dimensional electrode array comprising a plurality of orthogonal, close, unipolar (OCU) electrode[[s]] pairs configured to be deployed over a surface of the non-cardiac target site, wherein the OCU electrode pairs each comprise an index electrode in contact with the surface of the non-cardiac target site and an indifferent electrode separated from the index electrode; (Chae teaches a two dimensional array of electrodes placed on the surface of the brain, see at least figure 1 and ¶12. Chae is silent as to OCU electrodes.
Spector teaches using OCU electrodes, see at least ¶281-308 and figures 38b,39,40,49. Further, figure 38b shows index electrode 382 and indifferent electrode 383. At least at ¶295-298 of Spector there is set forth advantages of using such OCU arrays. It would have been obvious to use OCU arrangement including an index electrode and indifferent electrode, as shown by Spector for the sensing of brain signals of Chae since it would yield the predictable result of a clearer and more noise free signal, as set forth in Spector.)
obtaining, by at least one of the OCU electrode pairs, electrophysiological measurements of bioelectrical activity at non-cardiac target site; (see at least ¶12,13 of Chae which teaches sensing ECoG)
assessing a condition of the patient based, at least in part, on the
electrophysiological measurements. (at least ¶30 of Chae teaches that the recorded signals are sent to a practitioner and can also be stored for later analysis. It is considered to have been obvious that the practitioner reviews the signals to determine if therapy is needed.)
3. (Previously Presented) The method of claim 1, wherein an axis between the index
electrode and the indifferent electrode is orthogonal to the surface of the non-cardiac target
site during the obtaining step. (see at least ¶281-308 and figures 38b,39,40,49 of Spector)
4. (Previously Presented) The method of claim 1, wherein the electrophysiological
measurements include an OCU electrogram signal calculated by subtractive analysis, (see at
least ¶307,354 of Spector)
5. (Previously Presented) The method of claim 4, wherein the subtractive analysis comprises
subtracting signal recorded by the indifferent electrode from signal recorded by the index
electrode. (see at least ¶307,354 of Spector)
6. (Previously Presented) The method of claim 1, wherein the plurality of orthogonal, close,
unipolar (OCU) electrode pairs are arranged in a nonlinear configuration and distributed
across the two-dimensional electrode array at predetermined locations and wherein the index
electrode is separated from the indifferent electrode by a predetermined distance. (see at least
¶281-308 and figures 38b,39,40,49 of Spector)
7. (Previously Presented) The method of claim 1, wherein the
electrophysiological measurements comprise one bioelectrical-signals-are selected from the
group consisting of electrocardiogram({KGG) clectroencephalogram (KEG), electrocorticogram
(ECoG or i1REG), electromyogram (EMG), clectroontlogram (EOG), eleciroretinogram
(ERG), electronystagmogram (ENG), dectroollactogram {EOG), electroantennogram
(EAG), electrocochlecogram (ECOG or ECochG), electrogastrogram (EGG),
electrogastroenterogram (EGEG), electroglotlogram (EGG), clectropalatogram (EPG),
electroarteriogram (ZAG), electroblepharogram (EBG), electrodermogram (RDG),
clectrohysterogram (EHG), electroneuronogram (ENeG or ENoG), electropneumogram (EPG),
electrospinogram (ESG), electrovomerogram {EVG), galvanic skin response (GSR), and
electrodermal activity (EDA). (at least ¶30 of Chae teaches sensing ECoG)
8. (Previously Presented) The method of claim 1, wherein the target site comprises a tissue
associated with an organ. (see at least ¶30 of Chae)
9. (Previously Presented) The method of claim 8, wherein the organ is selected from the group
consisting of a, brain, spinal cord, skeletal muscle, smooth muscle, eye, cochlea, stomach,
bladder, bowel, and lungs. (see at least ¶30 of Chae)
10. (Previously Presented) The method of claim 9, wherein the tissue comprises at least one
of skin, non-cardiac muscle tissue, and nervous tissue. (see at least ¶30 of Chae. The brain
is an organ of nervous tissue; see
https://www.ncbi.nim.nih.gov/bools/NBK542179#text=The620brain620s620an9620orga
n,%2C%20thought%20processing%2C9%20and%20memory.)
11. (Previously Presented) The method of claim 10, wherein the tissue is associated with
one of a central nervous system (CNS) and a peripheral nervous system (PNS). (see at least
¶30 of Chae. The brain is part of the central nervous system)
13. (Previously Presented) The method of claim 1, further comprising tracking at least an
indicator of the condition. (at least ¶4 of Chae teaches that certain EEG patterns are sensed and tracked; such are considered an indication)
14, (Previously Presented) The method of claim 13, wherein the indicator comprises at least
one of physiological function, psychological function, and cognitive function. (at least ¶4 of Chae teaches treating epilepsy, which is indicative of a physiological function)
15. (Previously Presented) The method of claim 14, wherein the step of assessing the condition
is further based on the indicator. (as mentioned in at least ¶30, the sensed signals are review by the practitioner, and the indicator is the EEG signal that is indicative of epilepsy)
16, (Previously Presented) The method of claim 1, wherein the condition comprises at least one of a physiological disorder, psychological disorder, and cognitive disorder. (at least ¶4 of Chae teaches epilepsy, which is a physiological condition)
17. (Previously Presented) The method of claim 1, further comprising administering electrical
stimulation therapy to the non-cardiac target site of the patient to treat the condition. (see at least ¶14 of Chae)
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al (2020/0289002) and Spector (2014/0200575), and further in view of Sanchez et al (2018/0207450).
21. (Previously Presented) The method of claim 1, further comprising collecting measurements indicative of the non-cardiac target site's total boundary length, total surface area, and/or boundary-length-to- surface-area ratio. (Chae is silent as to boundary length or surface area. Sanchez teaches determining target tissue characteristics and location, using MRI or Ct or ultrasound, see at least ¶32. It would have been obvious to use such imaging to determine boundary length or surface area of the target tissue since it would enable the practitioner to determine the extent of the area to stimulate so that all necessary regions are stimulated appropriately)
22. (Previously Presented) The method of claim 21, wherein the measurements are made using an imaging modality. (see at least ¶32 of Sanchez)
23. (Previously Presented) The method of claim 22, wherein the imaging modality is selected from the group consisting of: MRI, CT, rotational angiography, three-dimensional ultrasound, and three- dimensional electro-anatomic mapping. (see at least ¶32 of Sanchez)
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 USC 101 as being directed to an abstract idea, the Applicant argues that the process is performed by a particular novel, non-obvious apparatus and, thus, claim 1 cannot reasonably be said to be “directed to an abstract idea”. This “particular novel, non-obvious apparatus” described by Applicant is the claimed two-dimensional array of OCU electrode pairs. However, as discussed in the rejection above, the two-dimensional array of electrode pairs is well understood, routine and conventional in the art in order to gather data for use with the abstract idea, as shown by Spector (2020/0138319), submitted by applicant, which teaches use of electrode arrays, ¶14, and CT, ¶94 and Dubois et al (2018/0325400), submitted by applicant, which teaches MRI and CT, ¶139, and electrode arrays, ¶78. As such, the process is not performed by a particular novel, non-obvious apparatus. As such, the rejection stands.
Regarding the rejection of the claims as being unpatentable over Chae in view of Spector, Applicant argues that the references fail to disclose obtaining electrophysiological measurements using an OCU electrode array on non-cardiac tissue for assessing a condition of the patient based on the electrophysiological measurements. As discussed in the rejection, Chae teaches the measurement of electrophysiological measurements and assessment of a condition of the patient using a two dimensional electrode array, but fails to disclose the electrode array comprises a plurality of orthogonal, close, unipolar electrode pairs. Spector is relied upon for this teaching of an OCU electrode array for measurement of electrophysiological measurements. Although Spector is disclosed as measuring cardiac signals, it would be obvious to modify Chae to substitute the OCU electrode array of Spector for the two dimensional electrode array of Chae since it would yield the predictable result of a clearer and more noise free signal. Applicant further argues that the cited references teach away from the combination because modifying Chae’s thin elastomer layer to include OCU electrodes “would undermine the flexibility Chae requires for curving against the surface of a brain”. However, it is respectfully submitted that the electrode arrangement of Spector does not teach away from a flexible electrode arrangement, but rather is explicitly disclosed as “a soft flexible planar material” in paragraph [0312]. As such, the teachings of Spector do not teach away from the combination with Chae and, therefore, the combination would be obvious. For at least the reasons given above, the rejection stands.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cohen discloses an array of electrodes 20 configured to be placed at a non-cardiac target site (see Figure 4 where the surface of the chest of a patient is considered to satisfy the BRI of “non-cardiac target site” since the skin surface is not the cardiac surface) to sense an electrophysiological signal (“an array of unipolar recordings”, column 8, lines 36-37) and which comprises orthogonal, close, unipolar electrode pairs (the arrangement of the electrodes in rows and columns, as shown in Figure 4, has electrodes which are oriented at right angles to each other and, therefore, orthogonal, and “close” because they are located on the same electrode assembly, and as described at column 7, lines 9-13, as unipolar).
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
