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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/250,584, filed on 04/26/2023.
Response to Amendment
The Amendments under 37 CFR 1.132 filed 05/20/2026 is insufficient to overcome the rejection of claim 1 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (WO 2010054352 A1), further in view of Tilt (US 20130281814 A1) as set forth in the last Office action because:
Tilt teaches each conductive path travelling from the electrode to be connected to the at least one connector ([0039] Electrical traces electrically couple each of the electrodes 16 to terminal ends 42 of a connector 40, as shown in FIG. 1), to said at least one connector, through a plurality of substrate nodes and straight portions ([0039] Electrical traces electrically couple each of the electrodes 16 to terminal ends 42 of a connector 40, as shown in FIG. 1. For instance, each of the electrodes 16 in the section 30 are electrically connected with corresponding pins or terminals located at the connector 40. That is, electrical traces travel from the each of the electrodes 16 along the loops 22, to corresponding base strips 44 and 46 and then electrically connect with the terminal ends in the connector 40), wherein some of the straight portions connecting two substrate nodes have an embedded conductive path travelling from one substrate node to the other substrate node ([0039] That is, electrical traces travel from the each of the electrodes 16 along the loops 22, to corresponding base strips 44 and 46 and then electrically connect with the terminal ends in the connector 40).
Response to Arguments
Applicant's arguments filed 05/28/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims presented herein include limitations which are neither taught nor suggested by the proposed combination of Ramanathan and Tilt. However, Examiner respectfully disagrees.
Ramanathan teaches the same advantages of Applicant's claimed invention by providing an enhanced capacity of repositioning of nodes and corresponding electrodes without the loss of electrical connectivity if some nodes need to be cut ([0043] As a further example, selected sensors 20 and portions of the strips 22 may be removed (e.g., by cutting) from a given section such as to accommodate smaller sized patients) ([0043] Typically such removal is performed by cutting a length of a given strip 22 including extra sensors from a distal end of the strip that is opposite the end where connectors 24 are located. Such repositioning and/or removal of sensors 20 and strips enables the same set of strips to be utilized for a variety of different body types, body sizes and under different conditions).
Tilt teaches a multi electrodes sensor apparatus that is able to be configured differently to accommodate the user and for specific purposes ([0039] different numbers of electrodes and different configurations of sections can be utilized according to application requirements for a given type of electrophysiology or other purpose). Further, Tilt teaches that electrodes may be repositioned and that one or more frangible sections could be added for access to the chest without damaging the electrodes ([0030]). Furthermore, some electrodes have a connecting strip with no traces ([0065] In the example of FIG. 8, adjacent pair electrodes 122 of each of the loop, such as at the distal-most end, can be connected to each other by a corresponding curved portion 132 with no electrically conductive trace on such curved portion 132).
Therefore, it would have been obvious to implement the supporting strip with no traces taught by Tilt into the sensor array taught by Ramanathan for ease of repositioning of the electrodes in a desired location without interrupting the electrical path of connecting nodes.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding claim 5, Wang teaches electrodes configured in a zig-zag configuration (Fig 1). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein neighbor substrate nodes and respective electrodes belonging to different columns are disposed in zig-zag, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 6, Wang teaches a hexagonal lattice of electrodes (Fig 1). It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein for all inner substrate nodes, each substrate node is surrounded by six neighboring substrate nodes, each neighboring substrate node being disposed in a corner of an imaginary hexagon centered around the substrate node, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
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.
The factual inquiries 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.
6. Claim(s) 1-4, 7, 8, 10-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (WO 2010054352 A1), further in view of Tilt (US 20130281814 A1).
Regarding claim 1, Ramanathan teaches a device for measuring electrical potentials of a body part of a patient ([abstract] Systems and methods are disclosed for sensing electrical activity of a patient), the device comprising: a plurality of substrate nodes made of a flexible material (Fig 2; 20 and 25), the plurality of substrate nodes being configured to be disposed on the torso of the patient ([0033] FIG. 1, sections 12 and 16 are configured for placement along the lateral (or side) portions of a patient's torso), wherein some pairs of substrate nodes of the plurality of substrate nodes are interconnected by straight portions of flexible material (Fig 3; nodes 20 connected by elongated strips 22) ([0038] The connecting elements 36 can be distributed at spaced apart locations along the coextensive length of each strip pair 32 and 34), the plurality of substrate nodes and the straight portions of flexible material forming a flexible substrate (Fig 3; [0045] the sensor array section 14 is configured as a generally rectangular sheet of flexible material that includes a plurality of sensors 20) ([0035] Each of the sections 12, 14, 16 and 18 also includes one or more strips 22 of a flexible substrate material to which each of the sensors 20 is attached. The strips 22 can be substantially linear elongated sheets of the substrate material that extend between spaced apart ends thereof), wherein there is one straight portion per pair of substrate nodes to be interconnected (Fig 3; nodes 20 connected by elongated strips 22) ([0038] The connecting elements 36 can be distributed at spaced apart locations along the coextensive length of each strip pair 32 and 34), a plurality of electrodes (FIG. 3; each of the sensors 20 is numbered (e.g. , labeled ' 1 ' to '64')), wherein each electrode of the plurality of electrodes is disposed on a respective substrate node of the plurality of substrate nodes ([0035] Each of the conductive elements 23 provides an electrically conductive path that extends from an electrically conductive sensor body portion 25 each of the sensors 20 to the strip and travels along the strip where it terminates at a respective connector 24), and at least one connector (Fig 3; 24), wherein each electrode of the plurality of electrodes is connected to the at least one connector through a respective conductive path ([0035] Each of the conductive elements 23 provides an electrically conductive path that extends from an electrically conductive sensor body portion 25 each of the sensors 20 to the strip and travels along the strip where it terminates at a respective connector 24), wherein each conductive path is embedded in the flexible substrate formed by substrate nodes and straight portions (Fig 2 and 3), each conductive path travelling from the electrode to be connected to the at least one connector (Fig 2; path 23, connector 24), wherein only some of the straight portions connecting two substrate nodes have an embedded conductive path (Fig 2 and 3; straight portions 32 and 34 include conductive elements 23 whereas straight portions 38 and 39 do not), some of the straight portions connecting two substrate nodes do not have an embedded conductive path travelling from one substrate node to the other substrate node (Fig 2 and 3; straight portions 38 and 39), the device being configured to remove one or more substrate nodes and corresponding electrodes by cutting the portions which connect the one or more substrate nodes and corresponding electrodes with the remaining substrate nodes in the device ([0043] As a further example, selected sensors 20 and portions of the strips 22 may be removed (e.g., by cutting) from a given section such as to accommodate smaller sized patients), without interrupting the conductive paths of the remaining electrodes in the device ([0043] Typically such removal is performed by cutting a length of a given strip 22 including extra sensors from a distal end of the strip that is opposite the end where connectors 24 are located. Such repositioning and/or removal of sensors 20 and strips enables the same set of strips to be utilized for a variety of different body types, body sizes and under different conditions).
Ramanathan fails to teach each conductive path travelling from the electrode to be connected to the at least one connector, to said at least one connector, through a plurality of substrate nodes and straight portions, wherein some of the straight portions connecting two substrate nodes have an embedded conductive path travelling from one substrate node to the other substrate node.
However, Tilt teaches each conductive path travelling from the electrode to be connected to the at least one connector ([0039] Electrical traces electrically couple each of the electrodes 16 to terminal ends 42 of a connector 40, as shown in FIG. 1), to said at least one connector, through a plurality of substrate nodes and straight portions ([0039] Electrical traces electrically couple each of the electrodes 16 to terminal ends 42 of a connector 40, as shown in FIG. 1. For instance, each of the electrodes 16 in the section 30 are electrically connected with corresponding pins or terminals located at the connector 40. That is, electrical traces travel from the each of the electrodes 16 along the loops 22, to corresponding base strips 44 and 46 and then electrically connect with the terminal ends in the connector 40), wherein some of the straight portions connecting two substrate nodes have an embedded conductive path travelling from one substrate node to the other substrate node ([0039] That is, electrical traces travel from the each of the electrodes 16 along the loops 22, to corresponding base strips 44 and 46 and then electrically connect with the terminal ends in the connector 40).
It would have been an obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Ramanathan to include each conductive path travelling from the electrode to be connected to the at least one connector, to said at least one connector, through a plurality of substrate nodes and straight portions, wherein some of the straight portions connecting two substrate nodes have an embedded conductive path travelling from one substrate node to the other substrate node. Doing so would allow for increased flexibility in placement of the electrodes and would allow for the connections to be held while repositioning the electrodes.
Regarding claim 2, Ramanathan teaches the device of claim 1, wherein the substrate nodes have circular shape (Fig 3; 20 and 25).
Regarding claim 3, Ramanathan teaches the device of claim 1, wherein each substrate node is connected to between two and six adjacent nodes by a respective number of straight portions (Fig 6; 97 connected to 88 by connecting element 36. 97 is also connected to 106 by connecting element 38).
Regarding claim 4, Ramanathan teaches the device of claim 1, wherein groups of substrate nodes and respective electrodes are aligned forming columns (Fig 3 and 6).
Regarding claim 7, Ramanathan teaches the device of claim 1, configured for placement on the anterior portion of a user's torso (Fig 4 and 5; front and back of torso), the device comprising five columns of substrate nodes and corresponding electrodes, wherein a first column has five substrate nodes, a second column has five substrate nodes, a third column has nine substrate nodes, a fourth column has eight substrate nodes, and a fifth column has eight substrate nodes (Fig 3 and 7).
Regarding claim 8, Ramanathan teaches the device of claim 1, configured for placement on the posterior portion of a user's torso (Fig 4 and 5; front and back of torso), the device comprising four columns of substrate nodes and corresponding electrodes, wherein a first column has five substrate nodes, a second column has eight substrate nodes, a third column has eight substrate nodes, and a fourth column has eight substrate nodes (Fig 3 and 7).
Regarding claim 10, Ramanathan teaches the device of claim 1, wherein the at least one connector is connected to an acquisition system for further processing of the sensed electrical potentials ([0036] Each of the connectors 24 can be electrically connected to a connector box (not shown), which can be used to communicate the electrical signal information to a data acquisition system for further processing).
Regarding claim 11, Ramanathan teaches the device of claim 1, further comprising a substrate portion disposed between the at least one connector and one of the substrate nodes, said substrate portion carrying a portion of all the conductive paths connecting the electrodes with the at least one connector (Fig 2; [0035] Each of the sections 12, 14, 16 and 18 also includes one or more strips 22 of a flexible substrate material to which each of the sensors 20 is attached. The strips 22 can be substantially linear elongated sheets of the substrate material that extend between spaced apart ends thereof).
Regarding claim 12, Ramanathan teaches the device of claim 1, further comprising a unique identifier associated with at least some of the electrodes, the unique identifier enabling automatic identification of the location of electrode with which it is associated ([0045] Each of the sensors 20 in the other sections 12, 16 and 18 similarly could be numbered or otherwise uniquely identified to facilitate identification of sensors via a user interface of a data acquisition system) [0046] The connectors 24 can also be identified by a combination of a letter and a number that uniquely identifies each connector).
Regarding claim 13, Ramanathan teaches the device of claim 12, wherein the unique identifier is a visual code ([0045] Each of the sensors 20 in the other sections 12, 16 and 18 similarly could be numbered or otherwise uniquely identified to facilitate identification of sensors via a user interface of a data acquisition system) [0046] The connectors 24 can also be identified by a combination of a letter and a number that uniquely identifies each connector).
Regarding claim 15, Ramanathan teaches a system comprising at least two devices according to claim 1 (Fig 1; four separate sensor array sections 12, 14, 16 and 18).
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (WO 2010054352 A1) further in view of Tilt (US 20130281814 A1), in view of Wang (US 20120200302 A1).
Regarding claim 5, Ramanathan teaches device of claim 4, but fails to fully teach wherein neighbor substrate nodes and respective electrodes belonging to different columns are disposed in zig-zag. However, Wang teaches wherein neighbor substrate nodes and respective electrodes belonging to different columns are disposed in zig-zag (Fig 1; “zig-zag” like configuration electrodes 1-85). It would have been an obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Ramanathan to include wherein neighbor substrate nodes and respective electrodes belonging to different columns are disposed in zig-zag. Doing so allows for collection and analysis of electrical impedance data by eliminating or reducing redundant data (Wang [0040]).
Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein neighbor substrate nodes and respective electrodes belonging to different columns are disposed in zig-zag, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 6, Ramanathan teaches device of claim 1, but fails to fully teach wherein for all inner substrate nodes, each substrate node is surrounded by six neighboring substrate nodes, each neighboring substrate node being disposed in a corner of an imaginary hexagon centered around the substrate node. However, Wang teaches wherein for all inner substrate nodes, each substrate node is surrounded by six neighboring substrate nodes, each neighboring substrate node being disposed in a corner of an imaginary hexagon centered around the substrate node (Fig 1; hexagonal lattice). It would have been an obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Ramanathan to include wherein for all inner substrate nodes, each substrate node is surrounded by six neighboring substrate nodes, each neighboring substrate node being disposed in a corner of an imaginary hexagon centered around the substrate node. Doing so allows for collection and analysis of electrical impedance data by eliminating or reducing redundant data (Wang [0040]).
Further, It would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein for all inner substrate nodes, each substrate node is surrounded by six neighboring substrate nodes, each neighboring substrate node being disposed in a corner of an imaginary hexagon centered around the substrate node, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (WO 2010054352 A1) further in view of Tilt (US 20130281814 A1).
Regarding claim 9, Ramanathan teaches device of claim 1, but fails to fully teach wherein the width of each portion connecting two substrate nodes depends on the number of conductive paths it carries. It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was made to include wherein the width of each portion connecting two substrate nodes depends on the number of conductive paths it carries, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramanathan (WO 2010054352 A1) further in view of Tilt (US 20130281814 A1), in view of Tarler (US 7206630 B1).
Regarding claim 14, Ramanathan teaches device of claim 1, further comprising at least one additional substrate node and corresponding electrode serving as electrical reference ([0085] Data acquisition system 200 can support a sensor ground which will be used as a dynamic amplification baseline potential for all sensors) ([0086] Data acquisition system 200 can support a sensor reference, which may be used as a measurement reference). Ramanathan fails to fully teach at least one additional substrate node. However, Tarler teaches further comprising at least one additional substrate node and corresponding electrode serving as electrical reference ([41] The electrode patch 10 in FIG. 1 consists of four electrodes 14--with one of those electrodes being used as a reference electrode 15). It would have been an obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Ramanathan to include at least one additional substrate node and corresponding electrode serving as electrical reference. Doing so allows for the other electrodes to be compared to a refence electrode for reliable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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