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 .
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.
Claims 8 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 8 and 18, the set of electrodes integrated with the inlay is vague as claims 1 and 11 have a first electrode mounted on the underside of the lower layer and it is unclear how the electrodes are then integrated with the inlay.
In claim 21, the computing device generating the three leads is vague as claim 11 has the processing device generating the multiple leads. It is unclear if the three leads are the same element or not as the multiple leads. In addition, it is unclear if the computing device is generating the three leads or the processing device is generating the leads, or if the processing device generates a multiple lead ECG and then the computing device generates an additional three leads. In addition, the last two lines of the claim are vague and seem to conflict. The “data” is introduced in claim 11 as being the multi-lead ECG from the processing device. This data in claim 11 is then used by the computing device to synthesize the augmented leads. However in claim 21, the data (which is sent by the processing device from claim 11) comprises the three leads and the one or more augmented leads. It is unclear how the data can be the augmented leads as the augmented leads are not sent or generated by the processing device, but by the computing device. It is unclear what the claim is reciting and the prior art could not be applied due to its unclear construction.
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 1-2, 8, 11-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al (2020/0315480) in view of Albert (WO2020/060780) , or Hwang et al in view of Drake (9730598).
Hwang discloses a credit card form factor housing (e.g. figure 1, para. 83, etc.) having 3 or 4 electrodes, with two on the top and 1 or 2 on the bottom (e.g. figures 1, 22, paras. 24, 37, 139-140, etc.; Note, top/upper and bottom/lower are relative, and the system of Hwang can be used in any orientation relative to the center of the Earth and thus flipping top vs bottom) where the system includes a microcontroller (i.e. the claimed processing device, paras. 25, 32-35, 110-118, etc.) to perform a multi-lead ECG having 2 or 3 leads (e.g. paras. 24, 139-140, etc.) and to transmit the data corresponding to the multi-lead ECG (e.g. figure 11, abstract, para. 38, etc.) to a computing device (e.g. figure 13, element 210, etc.) to synthesize additional leads and display the ECG data (e.g. paras. 38, 114, 119, etc.). The system does necessarily include a memory coupled to the processing device as the digital microcontroller 1180 must somewhere store instructions/software for the microcontroller to operate (e.g. para. 25, etc.). In addition, the computing device 210 does include memory to store data and is operatively coupled to microcontroller 1180 (e.g. computer, paras. 1, 119, etc.). For claim 2, note that the processing device is considered the microcontroller in operative communication with the computing device 210 operating together as one processing device to synthesize the leads.
Hwang therefore discloses a multilayer structure as it contains a top layer with electrodes and a bottom layer with electrodes. In addition, Hwang discloses the processing device and memory are part of a circuit embedded in the device (i.e. another layer, or an inlay—in the alternative for claims 8 and 18, see the 103 rejection below in view of Albert 10,342,444) and necessarily has them mounted to the lower layer as: they are connected to the housing/apparatus (e.g. embedded in the device, figure 11, para. 113, etc.); those parts cannot be floating in thin air; and/or the claims do not state how they are mounted or that they are “directly” mounted to the lower layer. Note that the upper layer can be considered the lower layer as the orientation is relative to how it is oriented.
Hwang does not disclose the first electrode mounted on an underside of the lower layer protrudes beyond an edge of the underside of the lower layer. Albert WO ‘780 discloses the use of electrodes (top/lower, figures 3, 6; paras. 13, 16, etc.) protruding beyond an edge of the housing/lower layer (note that the upper layer can be considered the lower layer as the orientation is relative to how it is oriented) so that the patient can find the location of the electrode to easily place the electrode at the proper location on the body. Similarly, Drake discloses protruding electrodes on the lower layer (e.g. figure 2, col. 10, lines 1-25, 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 Hwang, with the first electrode mounted on an underside of the lower layer protrudes beyond an edge of the underside of the lower layer, as taught by Albert WO ‘780 or Drake, since it would provide the predictable results of allowing the patient to easily find the location of the electrode so the patient can properly place the electrode at the correct location on the body to allow sensing of the patient’s electrical signals and/or allow the electrode to ensure good contact with the skin.
Claims 9-10 and 19-20, and in the alternative claims 8 and 18, are rejected under 35 U.S.C. 103 as being unpatentable over Hwang (2020/0315480) in view of Albert WO ‘780 or Drake (i.e. “modified Hwang”), and further in view of Albert et al (10342444).
Modified Hwang discloses the claimed invention having a circuit embedded in the credit card form factor housing and therefore modified Hwang discloses a multilayer structure as it contains a top layer with electrodes and a bottom layer with electrodes and circuit mounted/embedded in between. Modified Hwang does not disclose the housing being plastic or a polymer (claims 9-10 and 19-20) and in the alternative, an inlay sandwiched between the layers having electrode, memory and processing device integrated with the inlay (claims 8 and 18). Albert teaches a credit card form factor processing the ECG signals in a multi-layer system where the electrodes, memory and processing device are used on a printed circuit board, connected/mounted inside the housing, and therefore to the upper and lower layers (note that upper and lower are relative orientations and either upper or lower can be the other), and the housing being plastic or a polymer (e.g. figure 9C, col. 7, line 35 to col. 8, line 42, etc.) to allow for processing of the ECG signals in the credit card housing as a compact, flexible housing and ECG system that the patient can carry unobtrusively. 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 modified Hwang, with the housing being plastic or a polymer (claims 9-10 and 19-20) or, in the alternative, an inlay sandwiched between the layers having electrode, memory and processing device integrated with the inlay, as taught by Albert, since it would provide the predictable results of allowing for processing of the ECG signals in the credit card housing, and as a compact, flexible housing and ECG system that the patient can carry unobtrusively.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over modified Hwang. Modified Hwang discloses the claimed invention except for the bar code on the outer surface of the housing to provide access to the data. 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 (and is admitted prior art as the applicant has not specifically pointed out the errors in the examiner’s findings and/or provided evidence of non-obviousness) to have modified the system and method as taught by modified Hwang, with a bar code such as on the outer surface of the housing to provide access to the data, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of allowing the user or a physician to readily access instructions or data about the system or patient by scanning the bar code on the device being used.
Response to Arguments
Applicant's arguments filed 2/23/26 have been fully considered but they are not persuasive in view of the new grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record is considered pertinent to applicant's disclosure and shows some of the well-known in the art elements and other credit card ECG monitors.
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 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.
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.
/George R Evanisko/Primary Examiner, Art Unit 3792 5/11/26
Prosecution Insights