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 June 4, 2026 has been received and considered. By this amendment, claims 1, 6, and 10 are amended and claims 1-20 are now pending in the application, with claims 14-19 withdrawn from further consideration as being drawn to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to describe the newly-added limitation of “wherein each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer”. The disclosure does describe a serpentine shape and shows a serpentine shape at least in Figures 2, 3, 4A, and 7A, however the serpentine shape is part of the claimed “plurality of bridges” rather than being a shape for the electrodes or how the electrodes are formed. It appears that Applicant’s disclosure has support for the plurality of bridges being formed with at least one microchannel having a serpentine shape, but fails to provide adequate written description for the claim limitation of “each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer”. As such, the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5, 6, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 109645987 A, previously cited). Regarding claim 1, Sun discloses an electrocardiographic (ECG) device for sensing cardiac activities in a test subject (“The purpose of the invention is to overcome the disadvantages of the existing electrocardiograph connecting wire”, translation page 2, lines 9-10), the electrocardiographic device comprising: a plurality of electrodes; and a plurality of bridges connecting adjacent electrodes of the plurality of electrodes; wherein each electrode of the plurality of electrodes has a structure comprising a first layer 2 and a third layer 2 disposed above the first layer (“the substrate 2 has upper and lower two layers and cemented together”, translation page 3, lines 20-21), a second layer 1 of liquid metal disposed between the first and third layers (“a conductive silver paste layer 1 sandwiched between the two layers of base material 2”, translation page 3, line 21), and a fourth layer 3 of conductive material disposed on the third layer (“the contact electrode 3 exposed on the upper substrate 2”, translation page 3, line 22), and wherein the second layer of liquid metal is electrically connected with the fourth layer of conductive material (“the conductive paste layer 1 a certain distance fixed with convex, which can acquire human electrocardiogram signal to the contact electrode 3”, translation page 3, lines 12-14, where the ability to acquire human electrocardiogram signal to the contact electrode is considered a disclosure of electrical connection) (see Annotated Figures below). Sun further discloses a serpentine shape for the interconnect or bridge between adjacent electrodes (see Figure 2). However, Sun fails to disclose a serpentine shape for the electrodes or wherein each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of Sun to have a serpentine shape like the interconnect of Sun as a matter of obvious design choice, since applicant has not disclosed that electrodes having a serpentine shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with electrodes as shaped in Sun.
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Regarding claim 5, Sun discloses that the first and third layers are formed with stretchable material such that the electrocardiographic (ECG) device is skin-adherent, stretchable, and conformal (“the substrate 2 of the invention is medical grade TPE film…transverse stretching force is 18 Newton”, translation page 3, lines 15-17).
Regarding claim 6, Sun discloses that each of the stretchable first and third layers is formed with an elastomeric polymer material (“the substrate 2 of the invention is medical grade TPE film…transverse stretching force is 18 Newton”, translation page 3, lines 15-17).
Regarding claim 12, Sun discloses that each of the third layers of the electrodes is formed with a recess for containing the fourth layer (see annotated Figure above).
Regarding claim 13, Sun discloses that the plurality of electrodes comprise ten electrodes (see annotated Figure 6 below with numbered electrodes).
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Claims 1, 2, 4-7, 9, 11, 12, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Felix (U.S. Patent No. 10,918,296). Regarding claim 1, Felix discloses an electrocardiographic (ECG) device for sensing cardiac activities in a test subject (“A system and method for providing a flexible electrocardiogram (ECG) pad structure have been disclosed.”, Abstract), the electrocardiographic device comprising: a plurality of electrodes 102/300/350 (“The wireless sensor device 100 (“wearable device”) includes a sensor 102”, col. 3, ln. 47-49, “the sensor 102 is…an embedded sensor with electrodes”, col. 4, ln. 5-7, and “In one embodiment, the HealthPatch® wearable device is a disposable adhesive patch biosensor worn on the chest that incorporates two surface electrodes with hydrogel on the bottom”, col. 4, ln. 25-28); and a plurality of bridges connecting adjacent electrodes of the plurality of electrodes (considered the area of wireless sensor device 100 that is between the electrodes); wherein each electrode of the plurality of electrodes has a structure comprising a first layer 314 and a third layer 310 disposed above the first layer, a second layer 308 of liquid metal disposed between the first and third layers (silver paste 308 is considered to satisfy the broadest reasonable interpretation for a “liquid metal”), and a fourth layer 312 of conductive material disposed on the third layer (see Figures 3A and 3B), and wherein the second layer of liquid metal is electrically connected with the fourth layer of conductive material (“In one embodiment, electrical contact to the body is made through the use of hydrogel”, col. 2, ln. 9-10, and “The combination of the silver paste trace layer connection portion and the pad portion that includes the Ag/AgCl and hydrogel layers complete the silver paste contact and trace construct.”, col. 3, ln. 38-41). However, Felix fails to disclose a serpentine shape for the electrodes or wherein each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of Felix to have a serpentine shape as a matter of obvious design choice, since applicant has not disclosed that electrodes having a serpentine shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with electrodes as shaped in Felix.
Regarding claim 2, Felix discloses that each electrode further comprising a metal film 302 (“copper layer 302”, col. 5, ln. 34).
Regarding claim 4, Felix discloses that the metal film is made of copper (“copper layer 302”, col. 5, ln. 34).
Regarding claim 5, Felix discloses that the first and third layers are formed with stretchable material such that the electrocardiographic (ECG) device is skin-adherent, stretchable, and conformal (“The flexible ECG pad structure utilizes a polyimide based flex technology”, col. 2, ln. 49-50, and “The polyimide provides a base that the flex circuit and associated flexible ECG pad structure are built on top of.”, col. 2, ln. 54-56).
Regarding claim 6, Felix discloses that each of the stretchable first and third layers is formed with an elastomeric polymer material (“The flexible ECG pad structure utilizes a polyimide based flex technology”, col. 2, ln. 49-50).
Regarding claim 7, Felix discloses that each of the first layers of the electrodes is formed with at least one microchannel on a top surface of the first layer for containing the liquid metal of the second layer (“The silver paste trace layer is provided by using a silk screen of a silver (Ag) paste trace that is applied to the vias at the contact area near the ENIG cover.”, col. 3, ln. 9-12, where the vias are considered the claimed microchannel).
Regarding claim 9, Felix discloses that the conductive material of the fourth layer is conductive hydrogel (“electrical contact to the body is made through the use of hydrogel”, col. 2, ln. 9-10).
Regarding claim 11, Felix discloses that the second layers of liquid metal of the electrodes are connected with external data acquisition devices for receiving and/or transmitting electric signals (“The information is transmitted to the transmitter 110 and in turn relayed to another user or device for further processing, analysis, and storage.”, col. 3, ln. 65-col. 4, ln. 1).
Regarding claim 12, Felix discloses that each of the third layers of the electrodes is formed with a recess for containing the fourth layer (“the hydrogel layer 312 can be housed within a certain section of the Ag/AgCl layer 310”, col. 5, ln. 44-46).
Regarding claim 20, Felix discloses an electrocardiographic system comprising: an electrocardiographic (ECG) device of claim 1 configured to sense cardiac activities in a test subject; one or more electronic components configure to receive ECG signals from the electrodes of the electrocardiographic (ECG) device; and a processing component 104 configured to receive electric signals transmitted from the one or more electronic components and to process the received electric signals (see Figure 1 and “The sensor 102 obtains the physiological signal data from the user, which is transmitted to the memory 106 and in turn to the application 108 via the processor 104. The processor 104 executes the application 108 to process and analyze the data to obtain health-related information.”, col. 3, ln. 60-65).
Claims 1-3, 5, 6, 8, 10, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McClung (U.S. Patent No. 11,864,858, previously cited) in view of Felix (U.S. Patent No. 10,918,296, cited above). Regarding claim 1, McClung discloses an electrocardiographic (ECG) device 20 for sensing cardiac activities in a test subject (“The emergency cardiac and electrocardiogram (ECG) electrode device places multiple wireless electrodes in the appropriate anatomic locations on the patient to quickly obtain an ECG in a pre-hospital setting.”, Abstract), the electrocardiographic device comprising: a plurality of electrodes 50 (see Figures 3, 5, and 19-21); and a plurality of bridges connecting adjacent electrodes of the plurality of electrodes (considered the area between electrodes as shown in the aforementioned figures and annotated in the figure below); wherein each electrode of the plurality of electrodes has a structure comprising a first layer 30 and a third layer 31 disposed above the first layer, a second layer 61 disposed between the first and third layers, and a fourth layer 52 of conductive material disposed on the third layer (see Figure 30A), and wherein the second layer is electrically connected with the fourth layer of conductive material (“Each of the electrodes 50 preferably comprises a connection stud 51 and a contact pad 52. Each contact pad 52 is preferably has a diameter ranging from to 40 mm, and most preferably 35 mm, to allow for retention of a gel protector. Each contact pad 52 is preferably composed of a material from 3M.”, col. 11, ln. 58-62). However, McClung fails to disclose a serpentine shape for the electrodes or wherein each of the first layers of the electrodes is formed with at least one microchannel having a serpentine shape on a top surface of the first layer configured to contain the liquid metal of the second layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of McClung to have a serpentine shape as a matter of obvious design choice, since applicant has not disclosed that electrodes having a serpentine shape solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with electrodes as shaped in McClung.
Further, McClung fails to disclose that the second layer 61 is a liquid metal. Felix teaches an electrocardiographic (ECG) device for sensing cardiac activities in a test subject (“A system and method for providing a flexible electrocardiogram (ECG) pad structure have been disclosed.”, Abstract), the electrocardiographic device comprising: a plurality of electrodes 102/300/350 (“The wireless sensor device 100 (“wearable device”) includes a sensor 102”, col. 3, ln. 47-49, “the sensor 102 is…an embedded sensor with electrodes”, col. 4, ln. 5-7, and “In one embodiment, the HealthPatch® wearable device is a disposable adhesive patch biosensor worn on the chest that incorporates two surface electrodes with hydrogel on the bottom”, col. 4, ln. 25-28); and a plurality of bridges connecting adjacent electrodes of the plurality of electrodes (considered the area of wireless sensor device 100 that is between the electrodes); wherein each electrode of the plurality of electrodes has a structure comprising a first layer 314 and a third layer 310 disposed above the first layer, a second layer 308 of liquid metal disposed between the first and third layers (silver paste 308 is considered to satisfy the broadest reasonable interpretation for a “liquid metal”), and a fourth layer 312 of conductive material disposed on the third layer (see Figures 3A and 3B), and wherein the second layer of liquid metal is electrically connected with the fourth layer of conductive material (“In one embodiment, electrical contact to the body is made through the use of hydrogel”, col. 2, ln. 9-10, and “The combination of the silver paste trace layer connection portion and the pad portion that includes the Ag/AgCl and hydrogel layers complete the silver paste contact and trace construct.”, col. 3, ln. 38-41). It would have been obvious to one having ordinary ski9ll in the art before the effective filing date of the claimed invention to modify the second layer 61 of McClung to be a liquid metal, as taught by Felix, as it has been held that simple substitution of one known element, the material of Felix, for another, the material of McClung, to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
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Regarding claim 2, McClung discloses that each electrode further comprising a metal film 51 (Figure 30A and “Each of the electrodes 50 preferably comprises a connection stud 51 and a contact pad 52.”, col. 11, ln. 58-59).
Regarding claim 3, McClung discloses that the metal film connects the second layer with the fourth layer of conductive material (Figure 30A and “Each of the electrodes 50 preferably comprises a connection stud 51 and a contact pad 52.”, col. 11, ln. 58-59).
Regarding claim 5, McClung discloses that the first and third layers are formed with stretchable material such that the electrocardiographic (ECG) device is skin-adherent, stretchable, and conformal (“Each extension member of the body 21 preferably comprises a top layer 30 composed of a flexible material and an adhesive layer 31 composed of a flexible material”, col. 11, ln. 46-49).
Regarding claim 6, McClung discloses that each of the stretchable first and third layers is formed with an elastomeric polymer material (“One preferred material for the flexible material is KT TAPE from Spidertech.”, col. 6, ln. 67-col. 7, ln. 2).
Regarding claim 8, McClung discloses the invention substantially as claimed, including that each of the plurality of bridges has a structure comprising a stretchable first layer 30, a stretchable third layer 31 disposed above the first layer, and a second layer 60 disposed between the first and third layers, wherein the stretchable first layer has at least one microchannel formed on a top surface of the stretchable first layer and the second layer of the bridge is disposed in the at least one microchannel (see Figure 30A, which shows integrated printed wire or elastic electrical conducting material 60 disposed between first layer 30 and third layer 31). However, McClung fails to disclose that the second layer 60 is a liquid metal. Felix teaches an electrocardiographic (ECG) device for sensing cardiac activities in a test subject (“A system and method for providing a flexible electrocardiogram (ECG) pad structure have been disclosed.”, Abstract), the electrocardiographic device comprising: a plurality of electrodes 102/300/350 (“The wireless sensor device 100 (“wearable device”) includes a sensor 102”, col. 3, ln. 47-49, “the sensor 102 is…an embedded sensor with electrodes”, col. 4, ln. 5-7, and “In one embodiment, the HealthPatch® wearable device is a disposable adhesive patch biosensor worn on the chest that incorporates two surface electrodes with hydrogel on the bottom”, col. 4, ln. 25-28); and a plurality of bridges connecting adjacent electrodes of the plurality of electrodes (considered the area of wireless sensor device 100 that is between the electrodes); wherein each electrode of the plurality of electrodes has a structure comprising a first layer 314 and a third layer 310 disposed above the first layer, a second layer 308 of liquid metal disposed between the first and third layers (silver paste 308 is considered to satisfy the broadest reasonable interpretation for a “liquid metal”), and a fourth layer 312 of conductive material disposed on the third layer (see Figures 3A and 3B), and wherein the second layer of liquid metal is electrically connected with the fourth layer of conductive material (“In one embodiment, electrical contact to the body is made through the use of hydrogel”, col. 2, ln. 9-10, and “The combination of the silver paste trace layer connection portion and the pad portion that includes the Ag/AgCl and hydrogel layers complete the silver paste contact and trace construct.”, col. 3, ln. 38-41). It would have been obvious to one having ordinary ski9ll in the art before the effective filing date of the claimed invention to modify the second layer 60 of McClung to be a liquid metal, as taught by Felix, as it has been held that simple substitution of one known element, the material of Felix, for another, the material of McClung, to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 10, McClung discloses that the stretchable first layer, the second layer of liquid metal, and the stretchable third layer of each bridge of the plurality of bridges is connected with the first layer, the second layer of liquid metal, and the third layer of the electrodes that the bridge connects respectively (see annotated Figure above).
Regarding claim 11, McClung discloses that the second layers of liquid metal of the electrodes are connected with external data acquisition devices for receiving and/or transmitting electric signals (“In one embodiment, a data cable brings individual electrodes into one cable that encompasses a minimum of ten wires/leads of the typical ECG analysis which is then compatible with various ECG devices and wireless transfer system.”, col. 9, ln. 6-10).
Regarding claim 20, McClung discloses an electrocardiographic system comprising: an electrocardiographic (ECG) device of claim 1 configured to sense cardiac activities in a test subject; one or more electronic components 16 configure to receive ECG signals from the electrodes of the electrocardiographic (ECG) device; and a processing component 104 configured to receive electric signals transmitted from the one or more electronic components and to process the received electric signals (it is inherent that ECG machine 16, which generates an ECG 17 has a processing component in order to take in the electrical information from the electrodes and output the ECG 17).
Response to Arguments
Applicant's arguments filed June 4, 2026 have been fully considered but they are not persuasive. Regarding the rejection of the claims as being anticipated by Sun, Applicant argues that Sun relates to flexible electronic devices, whereas the invention is directed to highly stretchable, electrode-position-adjustable ECG devices and “flexibility and stretchability are fundamentally different mechanical requirements”. Applicant argues that “the subject invention requires large elastic deformation and recovery while maintaining conductivity”. However, it is noted that the claims as currently presented do not reflect this. Applicant argues that Sun discloses conductive silver past and not the liquid metal conductive structures as claimed because Sun’s silver paste is cured into a solid conductive trace. However, Applicant’s claims do not require that the liquid metal remain a liquid at room temperature. Applicant is advised to add such limitations to the claims. Applicant further argues that Sun’s microchannel is formed to have a circular portion connected to a linear portion, not a serpentine shape, pointing to Figure 2. However, it can clearly be seen in Figure 2 of Sun that there is a serpentine shape interconnecting the electrodes. Furthermore, as discussed above, the claims are requiring the electrodes have a serpentine shape, which is unsupported by Applicant’s specification. Applicant’s arguments with respect to the manufacturing methods of Sun are considered moot, as the method of manufacturing claims have been restricted out. For at least the reasons given above, the rejection stands.
Applicant fails to present any additional arguments against the other rejections in the application and, as such, these rejections are considered to stand, at least as presented above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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