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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13 and 20, in the reply filed on November 26, 2025 is acknowledged.
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 26, 2025.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Specification
The use of the term Ecoflex, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 10 is objected to because of the following informalities: the first line of claim 10 refers to the “electrocardiographic (ECG) device of claim 7”, however, lines 1-3 refer to “the stretchable first layer, the second layer of liquid metal, and the stretchable third layer of each bridge of the plurality of bridges”, language which is found in claim 8. It is believed that claim 10 should instead refer to “electrocardiographic (ECG) device of claim 8” in order to have proper antecedent basis. For the purposes of this communication, claim 10 will be treated as if it appropriately refers to and is dependent on claim 8. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 contains the trademark/trade name Ecoflex. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the material of the first and third layers and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al. (CN 109645987 A, cited by Applicant), herein Sun. 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).
PNG
media_image1.png
276
294
media_image1.png
Greyscale
PNG
media_image2.png
279
493
media_image2.png
Greyscale
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 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).
PNG
media_image3.png
466
536
media_image3.png
Greyscale
Claims 1, 2, 4, 5, 7, 9, 11, 12, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Felix et al. (U.S. Patent No. 10,918,296), herein Felix. 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).
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 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).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 6, 8, 10, 11, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McClung et al. (U.S. Patent No. 11,864,858) 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 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).
PNG
media_image4.png
560
660
media_image4.png
Greyscale
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 the invention substantially as claimed, but fails to disclose that each of the stretchable first and third layers is formed with Ecoflex material. 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 invention of McClung such that each of the stretchable first and third layers is formed with Ecoflex material, as it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07
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).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796