DETAILED ACTION
This action is pursuant to the claims filed on December 22, 2025. Claims 44, 46, and 48-57, and 60-102 are pending. Claims 1-43, 45, 47, and 58-59 are canceled. A final action on the merits of claims 44, 46, and 48-57, and 60-102 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 44-63, 64-69, 71-97 and 99-102 are rejected under 35 U.S.C. 103 as being unpatentable over Floyd (U.S. PGPub. No. 2018/0271444) in view of Hensen 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 claim 44, 74 & 102 and claims 62-63, 64-69 & 89-97, Floyd discloses an electrode set/a headset for acquiring an electroencephalogram signal of a brain of a subject (electrode template 50 in Fig. 2), the electrode set comprising:
a plurality of nodes (electrode locations 90) each comprising a pad (electrodes (not shown) are positioned along electrode locations 90, [0037]) for receiving electromagnetic energy from a portion of a part being studied ([0037]: electrodes are attached at the nineteen electrode locations 90 configured for neurological monitoring), wherein the nodes arranged in at least one longitudinal line (a plurality of electrodes disposed on electrode locations 90 positioned along the cross row 54, [0037]), and at least one transverse series of nodes of nodes aligned along at least one transverse line extending transversally to the longitudinal line (a plurality of electrodes disposed on electrode locations 90 are positioned along the central column 62 and the first 74, second, 78, third 82, fourth 86 columns, where each of these columns are transverse to the cross row 54, [0037]), the longitudinal series of nodes including opposite end nodes spaced apart in a longitudinal direction (two most anterior and posterior electrodes 90 along the cross row 54) and the transverse series of nodes including opposite end nodes spaced apart in a transverse direction transversal to the longitudinal direction (far right and left electrodes 90 along each of the central and first, second, third and fourth columns 74, 78, 82, 86);
a plurality of connectors each connecting two adjacent nodes (expandable portion 192 in Fig. 5, 194 in Fig. 6 or 196 in Fig. 7 connecting two electrode locations 90, [0048]-[0049]), the connectors connecting nodes of the longitudinal series of nodes being aligned along the longitudinal line and the connectors connecting nodes of the transverse series of nodes being aligned along the transverse line (the expandable portion 192 in Fig. 5, 194 in Fig. 6 or 196 in Fig. 7 are along the cross row 54 and the central 62 and the first-fourth columns 74, 78, 82 & 86) and the shape of the connectors being changed during fitting (see the expandable portion 196 in Fig. 7 comprising folds to accommodate expansion of the template 50);
wherein the electrode set further comprises at least two longitudinal alignment markers each affixed to one of the end nodes of the longitudinal series ([0038]: first 94 and second 98 ends each have a marking ‘I’ indicating the Inion and ‘N’ to indicate Nasion), and at least two transverse alignment markers each affixed to one of the end nodes of the transverse series ([0039]: first end 102 and second end 126 along the central column 62), and
However, Floyd is silent as to a wire within each connector, in electrical communication with the pad and extending to measurement lead, wherein the measurement lead terminates at a measurement connector to be inserted into a monitoring/input device ([0076]).
Hansen teaches an EEG wearable device (EEG sensor strip 600 in Fig. 6A) similar to Floyd having a flexible substrate formed from a plastic substrate ([0082]: the dielectric material 605 forms the flexible substrate and is formed from polyester or polyimide) with printed wires and measurement leads (conductive traces 610 and its cable attachment portion 615) and a plurality of EEG electrodes (electrodes 614). Hansen further teaches a general stiffener (the sensory assembly 800 includes a memory shape film or foil) to provide stiffness and bias the assembly into a concave shape to conform to the shape of 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 stiffener which provides some structural sturdiness assists in mechanical and electrical securing of any elements fixed to the assembly). Hansen further discloses that the electrode is conductive and is formed from various materials including silver-chloride material ([0082]), thus meeting claims 66-68. In addition, Hansen 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 read on a plurality of openings configured to inject electroconductive materials to enhance electrical contact between the electrode and the skin ([0091]-[0094]), thus meeting claim 69.
However, Flyod/Hensen combination does not disclose wherein each connector of the longitudinal series of nodes and the transverse series of nodes present at least one loop ends of the connector comprising a sinusoidal shape and a predetermined elastic force connecting two adjacent nodes as claimed.
Callahan teaches a plurality of electrode connectors, each connected to an electrode having a serpentine pattern comprising two loops extending in opposite directions which is a sinusoidal shape 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 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/Hensen so that the connectors have sinusoidal pattern which comprises at least two loop of that when stretched along its respective longitudinal axis from a first distance in the undeformed state that is less than half a second distance in the deformed state or when pulling force is applied, thereby arriving at the claimed invention and as taught by Callahan as doing so is known in the art to provide sufficient length, double the length of the first distance of the connector in the undeformed state for placing the electrodes on different sized patients.
With respect to the functional limitation, “the longitudinal and transverse alignment markers being configured to be removably affixed to a landmark on the subject of the part being studied and to, once affixed to the landmark of the subject, exert a pull force on the node closest to the alignment marker through marker connectors in order to transfer the pull force in directions of two or more force vectors to the node of the electrode set , 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 Flyod) 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 markers are affixed to the landmarks of the subject, the predetermined elastic force and the sinusoidal shape cause the connectors 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 markers are not affixed to the landmarks of the subject while allowing for the non-planar deployed state once the alignment markers are affixed to the landmarks 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 undeformed state (e.g. when no pulling force is applied) to a deformed state (e.g. when external force is applied) so as to fit against the head of the user.
With respect to the functional limitation, “wherein a distance between the nodes is thus configured to be changed from the first distance to one or more second distances depending on how much the connectors are pulled, a ratio of the first distance between two nodes linked by a connector in the non-planar deployed state and a second distance between the same two nodes linked by the same connector in the planar undeployed state is greater than 1.05”, the examiner notes that depending upon the pulling force, each of the sinusoidal connectors of the electrode set of the Floyd/Henson/Callahan combination is more than capable of meeting this claim limitation.
In regards to claim 46, 50, 51, 76, 77, & 78, Floyd/Hensen/Callahan combination further discloses wherein the nodes are arranged in a plurality of adjacent longitudinal series of nodes, the longitudinal directions of said plurality of adjacent longitudinal series of nodes being parallel to each other and extending along its respective longitudinal line in the undeformed state ([0043]: a plurality of rows and columns can be provided on the template as needed for custom pattern for electrodes or a standard 10-20 pattern). Note that providing at least two rows, each parallel to the center row (54) meets the limitations as set forth in claims 50 & 51.
In regards to claim 48 & 82, Floyd/Hensen/Callahan combination further discloses wherein said plurality of connectors comprises peripheral connectors each connecting adjacent end nodes ([0040]-[0041]: each of the column rows comprises ends having adhesives or keys for connecting to the other end of the columns, specifically 120 as shown in Fig. 2).
In regards to claims 49, 55, 83 & 84, Floyd/Hensen/Callahan combination further discloses wherein the connectors of the longitudinal series and the transverse series of nodes are identical (each of the expandable portion between two adjacent electrodes has the same configuration selected from 192 in Fig. 5, 194 in Fig. 6 or 196 in Fig. 7).
In regards to claim 52 & 79, Floyd/Hensen/Callahan combination further discloses wherein the nodes are arranged in a plurality of adjacent transverse series of nodes (columns 62, 74, 78, 82, 86 as shown in Figs. 2-3), the transverse directions of said plurality of adjacent transverse series of nodes being parallel to each other (Fig. 2 illustrates the parallel nature of the columns).
In regards to claim 53 & 80, Floyd/Hensen/Callahan combination further discloses wherein the plurality of adjacent transverse series of nodes include a central transverse series of nodes (central column 62 in Fig. 2) between two lateral transverse series of nodes (columns 78 and 82 in Fig. 2) extending along a straight transverse line and the transverse series of nodes extending along curved transverse lines in the undeformed state (see each of the columns having a curved nature in Fig. 3), the curved transverse lines presenting respective concavities oriented opposite the central transverse series of nodes (the columns 78 and 82 each are curved and are positioned on opposite directions (anterior or posterior to) from the central column 62 as shown in Fig. 3).
In regards to claim 54 & 81, Floyd/Hensen/Callahan combination further discloses wherein the connectors of the transverse series of nodes further includes two end transverse series of nodes arranged each adjacent one of the lateral transverse series opposite the central transverse series, the end transverse series of nodes extending along a straight transverse line (columns 74 and 86 are positioned opposite to the central column 62 as shown in Fig. 2).
In regards to claim 56 & 85, Floyd/Hensen/Callahan combination further discloses wherein the transverse direction is perpendicular to the longitudinal direction (the electrodes along the columns are perpendicular to the electrodes along the row 54 and its adjacent ones (not shown in Fig. 2 but is a contemplated modification) in Fig. 2, [0043]).
In regards to claim 57 & 86, Floyd/Hensen/Callahan combination further discloses wherein the longitudinal series of nodes includes at least one internal node between the end nodes (electrodes 90 disposed along row 54) and the transverse series of nodes includes at least one internal node between the end nodes (electrodes 90 disposed along column 62), and wherein, in the undeformed state, each of the end nodes is directly connected to two adjacent end nodes (node 90 disposed along columns 54/78 and node 90 disposed along 54/82) and one adjacent internal node and each of the internal nodes are connected to four adjacent nodes (the node 90 disposed along columns 52/62 surrounded by four electrode nodes 90, two along the clumn 52 and two along column 62).
In regard to claims 60-61 & 87-88, Floyd/Hensen/Callahan combination further meets all the limitations as set forth in claims 60-61 since each connector extend along either the longitudinal line or the transverse line (the expandable portion 192, 194 and 196 as shown in Figs. 5, 6, 7, respectively are positioned between the electrode location 90 of the central row 54 or the column rows 74, 78, 82, 86 and 62 in Fig. 2).
In regards to independent claims 71 & 99, as explained in claim 44 and 75, Floyd/Hensen/Callahan combination discloses an electrode set according to claim 44 and 75, respectively.
Although Floyd does not explicit disclose a monitoring/input device one of ordinary skilled in the art would understand that such device is essential for acquiring EEG signal. Furthermore, Hensen discloses that an EEG wearable system comprises a monitoring/input device configured to be connected to the measurement lead of the electrode set and to receive data of electrophysiological signals received from the pad ([0041]: a shielded ribbon cable configured to link the assembly 600 with the EEG recorder); and 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 ([0076]: the EEG recorder is connected to the cable is used to provide to the clinician the incoming EEG signal for further evaluations). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the monitoring/input device and the monitoring service of Hensen so that the system of Floyd/Hensen/Callahan combination operates as intended, to transmit the EEG sensed data from the electrode for further analysis ([0076]).
In regards to independent claims 72 & 100, as explained in claim 44 and 75, Floyd/Hensen/Callahan combination discloses an electrode set according to claim 44 and 75, respectively. Floyd further discloses a method of measuring 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 44 proximate to the part to be measured ([0036]: position template 50 on the patient) and 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).
Hensen 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 Hensen so that the system of Flyod/Hensen combination is used to transmit the EEG sensed data from the electrode for further analysis ([0076]).
In regards to claims 73 & 101, in view of the combination as set forth in claim 44, Hansen 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 high permeability nature of the foam which is read as a plurality of openings, to enhance electrical contact between the electrode and the skin ([0091]-[0094]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the foam reservoir as taught by Hansen as doing so provides enhanced electrical contact between the electrode and the skin ([0091]-[0094]).
Claim 70 & 98 are rejected under 35 U.S.C. 103 as being unpatentable over Floyd, Hensen and Callahan as applied to claim 44 or 75 above, and further in view of Cahan et al. (hereinafter ‘Cahan’, U.S. PGPub. No. 2017/0164861).
In regards to claims 70 & 98, Floyd/Hensen/Callahan combination discloses the invention substantially as claimed in claim 44 and 75, respectively and discussed above.
However, Floyd/Hensen/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/Hensen/Callahan 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.
Response to Arguments
Applicant’s Remarks filed on May 28, 2025 is fully acknowledged.
With respect to independent claim 44, Applicant argues that Floyd (U.S. PGPub. No. 2018/0271444), Henson (U.S. PGPub. No. 2015/0011857) and Callahan et al. (U.S. PGPub. No. 2008/0177168) fail to disclose the newly added limitations including:
(1) the electrode set presents a plurality of connectors presenting a sinusoidal shape and a
predetermined elastic force,
(2) the electrode set presents longitudinal and transverse alignment markers being
configured to be removably affixed to a landmark on the subject of the part being studied,
(3) once the alignment markers are affixed to the landmark of the subject, they exert a pull
force on the node closest to the alignment marker through marker connectors in order to transfer
the pull force in directions of two or more force vectors to the nodes of the electrode set,
(4) the affixing of the alignment markers generates a shift of the electrode set from a planar
undeformed state into a non-planar deployed state,
(5) once the alignment markers are affixed to the landmarks of the subject, the
predetermined elastic force and the sinusoidal shape cause the connectors of the electrode set to
deform in a predetermined 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,
(6) each connector of the longitudinal series of nodes presenting at least one loop between
the ends of said connector, wherein, in the planar undeformed state, said loop extends transversely to the longitudinal line in a plane including the nodes connected by said connector so as to stretch along the longitudinal line from a first distance to a second distance when the pull force is applied,
(7) each connector of the transverse series of nodes presenting at least one loop between
the ends of said connector, wherein, in the planar undeformed state, said loop extends transversely to the transverse line in a plane including the nodes connected by said connector so as to stretch along the transverse line from the first distance to a second distance when the pull force is applied,
(8) a distance between the nodes is thus configured to be changed from the first distance to
one or more second distances depending on how much the connectors are pulled, a ratio of the first distance between two nodes linked by a connector in the non-planar deployed state and a second distance between the same two nodes linked by the same connector in the planar undeployed state is greater than 1.05.
With respect to (1), (6) and (7), 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). The concept of providing a sinusoidal shaped connectors to allow to extend or stretch to a desired position is well-known in the art and is an obvious matter of design choice to one having ordinary skill in the art at the time the invention. Furthermore, the Floyd/Henson/Callahan combination provides the sinusoidal shaped electrode connectors between the plurality of nodes and meets the limitations of (6) and (7) since the sinusoidal pattern oscillates about or extends transversely to an axis defined by the series of nodes.
With respect to (2), (3) and (4), the examiner notes that there is no particular structure associated with how the longitudinal and transverse alignment markers and removably affixed to a landmark on the subject. Furthermore, these recitations are merely intended use recitation in that when a user or physician exerts a pulling force on the ‘N’ marker, the markers are capable of transferring the pull force onto the adjacent nodes. Furthermore, the examiner notes that because the electrode set is generally formed from a flexible material, even in the assembled form as shown in Floyd of Fig. 3, the electrode set collapses into a planar form and when positioned against the user’s head, is capable of shifting to a non-planar deployed state.
With respect to (5) & (8), the examiner notes that this is intended use. The placement of the electrode set of Floyd/Henson/Callahan combination causes alignment markers to be positioned on the landmarks of the subject. Note that a predetermined elastic force is inherent to the material of the headset and that any stretching of the material is in essence overcoming an inherent predetermined elastic force to deform the electrode set and its connects to contour and affix onto the user’s head.Therefore, these arguments are unpersuasive and the rejection is maintained by the examiner.
Furthermore, Applicant’s remarks on page(s) 4-5 are solely directed towards the secondary references failure to cure the above-noted deficiency of independent claim 44. Therefore, the arguments are unpersuasive and the rejection under 35 U.S.C. 103 is maintained.
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