DETAILED ACTION
This action is pursuant to the claims filed on January 15, 2026. Claims 18-34 are pending. Claims 1-17 is/are canceled. A final action on the merits of claims 18-34 is as follows.
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 . 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 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.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 18-28, 30-31 & 34 are rejected under 35 U.S.C. 103 as being unpatentable over Flyod (U.S. PGPub. No. 2018/0271444), further in view of Henson et al. (hereinafter ‘Henson’, U.S. PGPub. No. 2015/0011857), and further in view of Callahan et al. (hereinafter ‘Callahan’, U.S. PGPub. No. 2008/0177168).
In regards to independent claims 18 and 34 and claims 21-28, Floyd discloses an electrode set (electrode template 50 in Fig. 2), the electrode set comprising:
a plurality of nodes comprising at least one first node and one second node (electrode locations 90 each comprising a pad/electrodes (not shown) positioned along electrode locations 90, [0037]), the first node comprising a first pad for receiving electromagnetic energy from a first portion of a part being studied (central electrode location 90 along row 54 and intersecting central column 62 in Fig. ), the second node comprising a second pad for receiving electromagnetic energy from a second portion of the part being studied or for sending a signal into the first portion of the part being studied (any of the electrode locations 90 along row 54);
at least one connector connecting the first node to the second node (expandable portion 192 in exemplary Fig. 5; 194 in Fig. 6; 196 in Fig. 7 along the cross row 54 and the central column 62), the connector formed from a shape that provides for a consistent deformation from a first distance between the first node and the second node to one or more second distances between the first node and the second node as a pull force is applied to the first node or the second node ([0008], [0003], 192 in Fig. 5/194 in Fig. 6/196 in Fig. 7 along the central rows 62 and the columns allows for the adjacent electrode locations 90 to space apart along the pull force being applied along the central row), wherein in an undeformed state the first node and the second node are planar (see template 50 in Fig. 2) and in a deformed state the first node are non-planar (see the non-planar, three-dimensional fitting of the template 50 in Fig. 3), wherein a length of the connector remains constant from the undeformed state to the deformed state (due to the generally resilient material of the template 50, the overall length of the template 50 remains constant during fitting depending upon the size of the patient’s head);
at least one alignment marker affixed to either the first node or the second node ([0038]: first 94 and second 98 ends each having a marking “I’ indicating the inion and ‘N’ to indicate nasion; each of the markings are affixed to the electrode locations 90 along the central row 54 that is closer to the alignment markers 94 & 98), the at least one alignment marker to be removably affixed to a landmark on the subject of the part being studied (the first end 94 and second end 98 are adapted to be removably attached to the inion and nasion of the wearer), wherein the at least one alignment marker is configured to transfer the pull force to either the first node or the second node as the alignment marker is being affixed to the landmark ([0007]: pulling on the ends 94 and 98 during fitting transfers the pulling force along the central row 54).
However, Floyd is silent as to a wire within the connector, in electrical communication with the pad and extending to a measurement lead, wherein the measurement lead terminates at a measurement connector to be inserted into a monitoring/input device, wherein the monitoring/input device is configured to receive data of electrophysiological signals received from the first pad or the second pad and a monitoring service in communication with the monitoring/input device for receiving the data of the electrophysiological signals or transmitting instructions to the monitoring/input device.
Henson teaches an EEG wearable device (EEG sensor strip 600 in Fig. 6A) similar to Flyod having a flexible substrate formed from a plastic material ([0082]: the dielectric material 605 forms the flexible substrate and is formed from polyester or polyimide, thus meeting claim 22) with printed wires and measurement leads (conductive traces 610 and its cable attachment portion 615) and a plurality of EEG electrodes (electrodes 614). Henson further teaches a general stiffener (the sensory assembly 800 includes a memory shape film or foil) to provide stiffness during fitting to a patient’s head ([0081]: since claim 62 does not specifically recite how the pad stiffener secures an electrical connection between the pad and the wire, the examiner is in the position that any element that provides some structural sturdiness/rigidity assist in mechanical and electrical securing of elements fixed to the assembly), thus meeting claim 21. Henson further discloses that the electrode is conductive and is formed from various materials including silver-chloride material ([0082]), thus meeting claims 23-27. In addition, Henson further discloses providing a foam reservoir (970 in Fig. 17) configured to be attached to the electrode layer (908) comprising a foam (912) configured to inject conductive gel through the foam which reads on a plurality of openings configured to inject electroconductive material enhancing electrical contact with skin, thus meeting claim 28. Henson further teaches connecting the measurement lead to a monitoring/input device ([0041]: a shielded ribbon cable configured to link the assembly 600 with the EEG recorder); and a monitoring service in communication with the monitoring/input device for receiving the electrophysiological signals ([0076]: the EEG recorder is connected to the cable and during use, is initiated to provide the incoming EEG signals to the clinicians for further evaluation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Floyd which does not provide details as to the electrode, the wiring along the electrode and incorporate the structural details of embedding wire, providing electrodes and connecting to the monitoring/input device and a monitoring service as taught by Henson, thereby arriving at the claimed invention. Incorporating the specific electrodes and wirings of Henson along the wearable EEG electrodes of Floyd to meet the first and second wires involve routine skilled in the art and enhance comfortability as the wires are embedded onto the headset/substrate ([0091]-[0094]). Furthermore, providing a monitoring/input device and a cable to connect the EEG wearable device to display and store EEG signals is also routine in the art and a predictable result would ensue.
However, Flyod/Henson combination does not disclose wherein at least one connector comprises a sinusoidal shape, a spiral, a double spiral, a horseshoe, or an angular shape.
Callahan teaches a plurality of electrode connectors, each connected to an electrode having a serpentine pattern comprising two loops extending in opposite directions with an electrical trace printed onto the substrate to allow the connectors to extend or stretch a sufficient length along the longitudinal axis of each connector to place the electrodes at a desired position ([0064], Fig. 4B, 460a-d; 760a-d). Callahan further discloses that the serpentine or sinusoidal pattern provides a first distance at an undeformed state being less than the length of said connector in the deformed state ([0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify each of the connectors of Floyd/Henson so that the connectors have serpentine, angular, double spiral or sinusoidal pattern, thereby arriving at the claimed invention and as taught by Callahan as doing so is known in the art to provide sufficient adjustable length between the electrodes to be able to fit on different sized patients.
With respect to the functional limitation, “once affixed to the landmark of the subject, exert the pull force on the node closest to the alignment marker through each connector in order to transfer the pull force in directions of two or more force vectors to either the first node or the second node and shift the electrode set from a planar undeformed state into a non-planar deployed state”, the examiner notes that the claim is silent as to the structure associated with how the longitudinal and transverse alignment markers are being removably affixed to the landmark of the subject. Therefore, applying a force (e.g. via holding the ‘nasion’ marker in place) is capable of exerting a pull force on the adjacent nodes along the headset (template 50). In addition, given that the electrode headset is formed from a single flexible substrate (Floyd, [0045]-[0047]), pulling of the alignment marker inherently will transfer the pulling force in two or more force vectors to move the nodes of the electrode set. The examiner further notes that the assembled electrode set (template 50 as shown in Fig. 3 of Floyd) assumes a planar arrangement because it collapses to an undeformed state (this is broadly claimed and is an undeformed state is interpreted as no external force or pull force being applied to the template 50) and once applied onto the user’s head tightly, it engages with the head of the subject to assume a non-planar deployed state.
With respect to the functional limitation, “wherein once the alignment marker is affixed to the landmark of the subject, the predetermined elastic force and the sinusoidal shape causes each connector of the electrode set to deform in a predetermine manner leading the nodes to space apart at distances in the direction of the force vectors that allow for a proper placement of the nodes on the portions of the part being studied, the distances being directly related to the exerted pulling force on the connectors”, the examiner notes that this is intended use and the deformation of the nodes occurs as appropriate force is applied during the placement of the electrode set.
With respect to the functional limitation, “wherein the shape of each connector of the electrode set is designed to allow for the planar undeformed state when the alignment marker is not affixed to the landmark of the subject while allowing for the non-planar deployed state once the alignment marker is affixed to the landmark of the subject”, the examiner notes that sinusoidal shaped connectors of the Floyd/Henson/Callahan combination is capable of being stretched from its original or planar undeformed state (e.g. when no pulling force is applied) to a non-planar deformed state (e.g. when external force is applied) so as to fit against the head of the user.
In regards to claims 19 & 20, Floyd/Henson/Callahan combination discloses the invention substantially as claimed in claim 18 and discussed above. Floyd/Henson combination further discloses a plurality of third nodes (electrode locations 90 along the columns 77, 78, 62, 82, 86 in Fig. 2), at least a portion of the plurality of third nodes comprising a third pad for receiving electromagnetic energy from a plurality of third portions of the part being studied (a plurality of electrodes disposed on the electrode locations 90 positioned along the columns 77, 62, 82, 86 in Fig. 2 configured for EEG sensing, [0037]); and a plurality of second connectors connecting at least one of the plurality of third nodes to either the first node or the second node (specifically, the column portion between the electrode location 90 is in connection with the adjacent electrodes 90 along column 62 in Fig. 2), the plurality of second connectors formed from the shape that provides for consistent deformation from a first distance between at least a portion of the plurality of third nodes to one or more second distances between at least a portion of the plurality of third nodes as a pull force is applied to the at least one alignment maker ([0008], [0003], 192 in Fig. 5/194 in Fig. 6/196 in Fig. 7 along the central rows 62 and the columns 77, 78, 62, 82, 86; these shapes allow the template 50 to transition from planar to a 3D shape during fitting; note that pulling of the template along one direction via the markings, I or N, during fitting further provides deformation to the other columns), wherein in an undeformed state the first node and the second node are planar (see template 50 in Fig. 2) and in a deformed state the first node are non-planar (see the non-planar, three-dimensional fitting of the template 50 in Fig. 3).
In regards to claim 30, Floyd/Henson/Callahan combination further discloses a fourth node, wherein the fourth node comprises a fourth pad to receive electromagnetic energy resulting from the electromagnetic transmission from the third pad (electrode locations 90 along the columns 77,78,62, 82, 86 in Fig. 2, [0037]).
In regards to claim 31, Floyd/Henson/Callahan combination discloses at least one third node is configured for receiving a sensor (electrode locations 90 along the columns 77,78,62, 82, 86 in Fig. 2, [0037]).
In regards to independent claim 32, Floyd/Henson/Callahan combination discloses an electrode set according to claim 18. Floyd further discloses a method of measuring electrophysiological signals of a part of a subject (EEG recording from a user’s head as shown in Figs. 2-3), the method comprising:
placing an electrode set according to claim 18, proximate to the part to be measured ([0036]: position template 50 on the patient), affixing the alignment markers to the landmarks on the subject of the part being studied ([0038]: marked letters are affixed to corresponding locations and used to position template 50 on the patient).
Henson further teaches connecting the measurement lead to a monitoring/input device ([0041]: a shielded ribbon cable configured to link the assembly 600 with the EEG recorder); and instantiating a monitoring application in the monitoring/input device to commence measuring the electrophysiological signals of the part of the subject ([0076]: the EEG recorder is connected to the cable and during use, is initiated to provide the incoming EEG signals to the clinicians for further evaluation). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further incorporate the monitoring/input device and the monitoring service of Henson so that the system of Flyod/Henson combination is used to transmit the EEG sensed data from the electrode for further analysis ([0076]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Floyd, Henson and Callahan as applied to claim 18 above, and further in view of Machon & Rothman (hereinafter ‘Machon’, U.S. PGPub. No. 2014/0257073).
In regards to claim 20, Floyd/Henson/Callahan combination discloses the invention substantially as claimed in claim 18 and discussed above.
However, Floyd/Henson/Callahan combination does not disclose a plurality of second alignment markers affixed to one or more of the plurality of third nodes as claimed in claim 20.
Machon teaches an EEG headset (multi-axis adjustability array 400 in Fig. 3) configured to be attached to a wearer’s head (electrode array 400 in Fig. 3) comprising a plurality of electrodes (electrodes 402, 404, 406, 418, 430, 412, 414 in Fig. 3) and a plurality of alignment markers (labels disclosing including arrows 602 and/or pictorial illustrations 606) along tabs (422 in Figs. 3 and 5) along each of the electrodes indicating where these electrodes of the EEG headset should be positioned along the wearer ([0071]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Flyod/Henson/Callahan combination and further incorporate additional tabs/alignment markers with pictorial illustrations along the tabs corresponding to each of the electrode location of Floyd/Henson combination as taught by Machon, thereby arrive at the claimed invention. Doing so allows the technician pictorial illustration of the placement and or the direction of pulling of the electrode set during fitting ([0071]).
Claim 29 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Floyd, Henson and Callahan as applied to claim 18 and 32 above, and further in view of Cahan et al. (hereinafter ‘Cahan’, U.S. PGPub. No. 2017/0164861).
In regards to claims 29 and 33, Floyd/Henson/Callahan combination discloses the invention substantially as claimed in claim 18 and 32, respectively and discussed above.
However, Floyd/Henson/Callahan combination fails to disclose wherein the pad is configured to receive near infrared light, infrared light or visible light.
Cahan teaches a system and apparatus for electroencephalography (EEG) for obtaining electrical activity within a brain via electrodes and wires similar to Floyd/Henson combination. Alternatively, Cahan discloses transmitting or obtaining electromagnetic waves using fiber-optic cable and appropriate sensor for the same purpose. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing to select biopotential or optical sensors and to sense electromagnetic waves or electrical signals would be within the level of ordinary skill in the art.
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.
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Claims 18-19 and 21-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 44, 62-70, 72-73, and 99 of copending Application No 16/880,104.
Although the claims at issue are not identical, they are not patentably distinct from each other because every limitation in the instant application is recited in the conflicting copending application, and the differences between the claims are highlighted below.
In regards to claims 18 and 19, the copending application include all the limitations of claim 18 except for a second wire within the connector. However, it would have been obvious to one having ordinary skill in the art to provide additional wires to connect each of the nodes of the plurality of nodes to the monitoring/input device, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 44 of the copending application differs from claim 18-19 of the instant application in that it recites “a plurality of nodes” and “a plurality of third nodes” and “a plurality of connectors” and “a plurality of second connectors”. However, the reference patent recites “a plurality of nodes comprising longitudinal series of nodes and transverse series of nodes” and “a plurality of connectors… connecting nodes of the longitudinal series of nodes and transverse series of nodes” fall within the “a plurality of nodes”, “a plurality of third nodes”, “a plurality of connectors” and “a plurality of second connectors”.
In regards to claim 21, Claim 62 anticipates claim 21.
In regards to claim 22, Claim 63 anticipates claim 22.
In regards to claim 23-24, Claim 64-65 anticipates claim 23-34.
In regards to claims 25-28, Claims 66-69 anticipates claim 25-28.
In regards to claim 29, Claim 70 anticipates claim 29.
In regards to claim 32-33, Claims 72-73 anticipates claims 32-33.
In regards to claim 34, claim 99 anticipates claim 32.
Claim 20 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over copending Application No 16/880,104, and further in view of Machon.
In regards to claim 20, Application ‘104 recites all the limitations under examination of instant application except for a plurality of second alignment markers.
Machon teaches an EEG headset (multi-axis adjustability array 400 in Fig. 3) configured to be attached to a wearer’s head (electrode array 400 in Fig. 3) comprising a plurality of electrodes (electrodes 402, 404, 406, 418, 430, 412, 414 in Fig. 3) and a plurality of alignment markers (labels disclosing including arrows 602 and/or pictorial illustrations 606) along tabs (422 in Figs. 3 and 5) along each of the electrodes indicating where these electrodes of the EEG headset should be positioned along the wearer ([0071]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the claimed invention of copending application and incorporate additional tabs/alignment markers with pictorial illustrations along the tabs corresponding to each of the electrode location as taught by Machon, thereby arrive at the claimed invention. Doing so allows the technician pictorial illustration of the placement and or the direction of pulling of the electrode set during fitting ([0071]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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 EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 3/20/2026