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 .
Response to Arguments
Applicant's arguments filed 2/3/26 have been fully considered but they are not persuasive and the previous Response to Arguments are repeated from the office action of 11/6/25 as they address the applicant’s current arguments. It is noted that a shift in the claims/invention will be allowed by the examiner upon filing of an RCE—It is suggested to cancel claims 1-22 and add new claims starting at claim 23, however this is not necessary.
The arguments are not persuasive regarding the application’s support for the encapsulation of each electrode for the following reasons below.
Encapsulation is used in the disclosure in several paragraphs (e.g. paras. 50, 125, 142, 207, 250, 283, 325 of the current specification) to provide a flexible cover for sealing the skin device, 20, and isolate the “inner components” of the skin device “from the environment of the living thing”. It is clear that the encapsulation provides a biocompatible, flexible cover for the skin device, 20, to seal it and its inner components from fluids.
--The electrodes are not inner components (e.g. see figures 14 and 15, etc.).
--When specifically discussing the use of the skin device with the ECG electrodes for heart/ECG monitoring, the specification unambiguously says in paragraph 325 that encapsulation is used to cover and seal the skin device, 20, and isolate the “inner components” of the skin device “from the environment of the living thing” and again does not discuss the external ECG electrodes being encapsulated.
--Most importantly, the ECG electrodes discussed throughout the disclosure are set forth as a separate element and are called out separately from the circuitry (e.g. paras. 168, 184, etc.). Nowhere is disclosed that the electrodes are encapsulated/covered. Every time the circuitry is discussed, it is described as a separate element. Nowhere is disclosed that the electrodes are part of the circuitry and the disclosure provides exactly the opposite. The electrodes are set forth as a separate element from the circuitry, such as being separate from the communication circuit, as discussed in paragraphs 168 and 184 describing the “electrodes being…in communication with processor, memory, and a communication circuit”.
--Paragraph 50 states that there is encapsulation of the skin device discussed “in figure 2” and associated circuitry and is the only place that discusses the circuitry being encapsulated. It is clear from this paragraph that figure 2 is being discussed. Figure 2 shows what it considers the circuitry and corresponds to what is shown in associated figure 12A (e.g. paras. 42, 94-116). Figures 2 and 12A nowhere disclose ECG electrodes, or ECG electrodes being part of the circuitry, but describe associated circuitry that is inside the skin device (e.g. figures 2, 12A, paras. 94-119).
--No amount of direction is provided by the disclosure as to how the ECG electrodes are encapsulated (partial or full) and what material is used to encapsulate the ECG electrodes.
It is clear, the electrodes are not circuitry, are separately described elements, and no amount of direction or guidance has been set forth regarding how the electrodes are encapsulated.
The applicant’s argument that “the encapsulation layer does not prevent pick up of the electrical signals but does prevent touching” is not persuasive. The applicant has not provided any showing where this is located in the disclosure. No direction is provided as to how the electrodes are encapsulated, what material is used for the encapsulation, and/or how much of the electrodes are encapsulated.
The argument that the present application incorporates by reference provisional application 62/659586 and therefore there is support for the ECG electrodes being encapsulated is not persuasive. The incorporation by reference is only appending 62/659586 to the current application. The current application does not reference any element or teaching of the 62/659586 provisional application, and the current application does not state that the current application and teachings used therein are using anything from 62/659586. In addition, the applicant has not pointed out any area in 62/659586 where it states that an ECG electrode is encapsulated. The applicant does highlight the provisional’s use of “glass” to seal implants, but it is unclear how glass can be used over ECG electrodes to sense electrical signals as glass is not an electrical conductor but is an electrical insulator.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/387394, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior filed application fails to provide adequate support for having implantable encapsulation material encapsulating each electrode, and/or the material preventing direct touching of the ECG electrode by a user when implanted inside of a living body, and/or to isolate the associated ECG electrode from matter inside of the living body when implanted, in combination with the other elements or steps in the claim(s).
The original disclosure only discussed encapsulating the skin device and its internal components/circuitry (e.g. paras. 50, 125, of the submitted specification, etc.) and did not mention encapsulating each individual ECG electrode, and/or to prevent direct touching of the ECG electrode, and/or to isolate the ECG electrode from matter inside the body. It is unclear where these claim limitations are located in the disclosure. In addition, it is unclear what material is used to encapsulate the ECG electrodes and how much of the ECG electrodes are encapsulated.
This application repeats a substantial portion of prior Application No. 16/387394, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it does constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: The original disclosure only discussed encapsulating the skin device and its internal components/circuitry (e.g. paras. 50, 125, of the submitted specification, etc.) and did not mention encapsulating each individual ECG electrode, and/or to prevent direct touching of the ECG electrode, and/or to isolate the ECG electrode from matter inside the body. It is unclear where these claim limitations are located in the disclosure. In addition, it is unclear what material is used to encapsulate the ECG electrodes and how much of the ECG electrodes are encapsulated.
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 encapsulation of each electrode 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not mention the encapsulation material encapsulating each ECG electrode, and/or to prevent direct touching of the ECG electrode, and/or to isolate the ECG electrode from matter inside of the living body.
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 1-11, 13-19, and 21-22 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 subject matter not described in the disclosure is having implantable encapsulation material encapsulating each ECG electrode, in combination with the other elements or steps in the claim(s).
The original disclosure only discussed encapsulating the skin device and its internal components/circuitry (e.g. paras. 50, 125, of the submitted specification, etc.) and did not mention encapsulating each individual ECG electrode. It is unclear where this claim limitations is located in the disclosure.
While the applicants/inventors may have had a general idea of encapsulating each ECG electrode (by filing the original claims without disclosure support), they did not possess the specific details of how each ECG electrode is encapsulated when they filed the application. It is unknown what material is used for the encapsulation and/or how much of the electrode is encapsulated (i.e. a portion or all of the electrode).
This rejection is related to written description.
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 1-2, 15-17, and 19 are rejected under 35 U.S.C. 102a1 as being anticipated by Scheuermann (8224461). Scheuermann discloses spatially distributed ECG/cardiac sensing electrodes 40, 48, and 50 (e.g. figure 1, col. 4, lines 43-68, etc.) where each electrode is coated and encapsulated to prevent tissue ingrowth (e.g. col. 5, line 55 to col. 6, line 11, etc.) and contains electrical wires (e.g. col. 5, lines 39-54, etc., the claimed transmitter) to transmit the cardiac electric signals to the implantable electronic pacing/sensing device and to control the ECG electrodes with a control signal, such as a pacing/therapy signal (e.g. figure 1, element 12, col. 5, lines 13-22, etc.).
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.
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 1-11, 13-19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Juhasz et al (2019/0320925) in view of Scheuermann (8224461). The current application contains the exact same disclosure, structure, and methods as in Juhasz ‘925 except for the newly submitted original claims in this application of having the structure or steps of having the ECG electrodes encapsulated (as discussed above). Therefore, the current application does not have an effective filing date back to the Juhasz ‘925 application but an effective filing date of 11/16/23 when the original claims in this application where filed. As a result, the ‘925 publication can be used as prior art.
Juhasz ‘925 discloses all the elements and steps as set forth in the current claims since Juhasz ‘925 has the exact same disclosure of this application, except Juhasz ‘925 does not disclose the newly claimed device or steps of having the ECG electrodes being encapsulated. Scheuermann teaches it is known to encapsulate the cardiac sensing electrodes (i.e. ECG electrodes) to prevent direct touching of the electrodes from matter inside the body so that there is not tissue ingrowth and tissue does not grow around the electrodes (e.g. col. 5, lines 55-67, etc.). It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Juhasz ‘925, with the encapsulation of the ECG electrodes to prevent direct touching of the electrodes from matter inside the body, as taught by Scheuermann, since it would provide the predictable results of preventing tissue ingrowth in the tissues and so tissue does not grow around the electrodes.
Claims 9-10, 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Scheuermann (8224461). Scheuermann discloses the claimed system and method having an implanted pacemaker or defibrillator to receive the ECG data, but does not state the system and method further has a smartphone computer with processor, display, and memory for storing instructions to generate ECG data and render the data on the display. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Scheuermann, with the implantable device system and method further having a smartphone computer with processor, display, and memory for storing instructions to generate ECG data and render the data on the display, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing the implantable device to transmit the data to an external device for display and review by a physician using the physician’s smartphone to provide the physician with data to determine the patient’s condition and program the implantable device or schedule delivery from the implantable device.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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, Benjamin Klein can be reached on 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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/George R Evanisko/Primary Examiner, Art Unit 3792 2/14/26