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 .
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 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.
Election/Restrictions
Applicant’s election without traverse of Group III (previously presented claims 14-20) in the reply filed on 23 July 2024 is acknowledged. Applicant’s amendments to claim 1 and cancellation of claims 12 and 13 have rendered moot the Restriction/Election Requirement dated 23 May 2024. The restriction is withdrawn, and claims 1-11 and 14-22 are currently under consideration for patentability.
Status of Claims
Claims 1-11 and 14-22 are pending and under consideration for patentability; claims 1, 9, 11, and 14 have been amended; claims 12 and 13 have been cancelled; claims 21 and 22 have been added as new claims.
Information Disclosure Statement
The Information Disclosure Statements submitted on 29 June 2022 and 29 January 2026 have been acknowledged and considered by the Examiner.
Claim Objections
Claims 18-20 are objected to because of the following informalities.
Claims 18 and 19 contain minor typographical and/or grammatical errors.
Claim 18, line 4: Applicant is advised to change “a UI” to “the UI”
Claim 19, line 2: Applicant is advised to change “the UI component” to “the UI”
Appropriate correction is required.
Applicant is advised that should claim 16 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 8, 9, 14, 17, and 21 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Volosin et al. (US 2019/0160278 A1).
Regarding claims 1 and 14, Volosin describes a method and system comprising
providing, via an external pacing device ([0047]) at a first time, a first electrical stimulation at a first current level to an external surface of a patient ([0057])
receiving, by a sensor analysis component of the external pacing device, from a first biological sensor at a second time after the first time ([0090]), first data associated with a first biological parameter of the patient ([0076], [0084])
receiving, by the sensor analysis component, from a second biological sensor at the second time, second data associated with a second biological parameter of the patient ([0076], [0084]), the second biological parameter different from the first biological parameter ([0018] - [0019])
determining, based on the first data and the second data received at the second time, a likelihood that the first electrical stimulation has caused capture of a heart of the patient ([0038])
comparing the likelihood to a threshold likelihood ([0038])
responsive to determining that the likelihood is less than the threshold likelihood, providing a second electrical stimulation at a second current level via the external pacing device, the second current level being different than the first current level ([0038], a preferred amount of electric current is set, which is incrementally increased until capture is detected)
Regarding claims 2 and 21, Volosin describes wherein the first data associated with the first biological parameter comprises a T-wave or QRS complex identified in an electrocardiogram ([0038]).
Regarding claim 3, Volosin describes wherein the second data associated with the second biological parameter comprises a different T-wave or QRS complex or oxygen saturation signal ([0038], [0050] - [0051]).
Regarding claim 8, Volosin describes wherein the capture corresponds to electrical capture of the heart of the patient ([0038]).
Regarding claim 9, Volosin describes
receiving, at a third time prior to the first time at which the patient was provided the first electrical stimulation, third data associated with the first biological parameter ([0038], acquiring and monitoring ECG signals for capture events inherently requires receiving baseline or reference signals in order to compare the post-stimulation signals)
determining a difference between the third data associated with the first biological parameter and the first data associated with the first biological parameter received at the second time ([0038], measuring a widening of the QRS complex or T-wave morphology compared to a baseline or reference signal)
wherein determining the likelihood is further based on the difference ([0038])
Regarding claim 17, Volosin describes wherein
the biological sensor is a first biological sensor ([0090])
the biological parameter is a first biological parameter ([0090])
the data is first data ([0076], [0084])
the sensor analysis component is further configured to receive, from a second biological sensor at the second time, second data associated with a second biological parameter of the patient ([0076], [0084]), the second biological parameter different from the first biological parameter ([0018] - [0019])
the capture component is configured to determine the likelihood based on the first data and the second data ([0038])
Claim Rejections - 35 USC § 103
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 4, 18, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Volosin in view of Rueter et al. (US 2003/0083712 A1).
Regarding claims 4 and 22, Volosin describes the method of claim 1 and the system of claim 14, including displaying user data via a user interface ([0070]), but Volosin does not explicitly disclose
displaying a first representation of the first biological parameter in a user interface
displaying a second representation of the second biological parameter on the user interface with the first representation of the first biological parameter
displaying an indicator overlaying the first representation and the second representation at the first time at which the first electrical stimulation was provided
However, Rueter also describes a method for determining cardiac capture ([0013]) including
displaying a first representation of the first biological parameter in a user interface ([0056] - [0058], figure 5a, ECG traces, for example)
displaying a second representation of the second biological parameter on the user interface with the first representation of the first biological parameter ([0056] - [0058], figure 5a, EGM trace, for example)
displaying an indicator overlaying the first representation and the second representation at the first time at which the first electrical stimulation was provided ([0056] - [0058], figure 5a, third panel showing pacing pulse 48)
As Rueter is also directed towards determining cardiac capture and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to display the biological data and stimulation data on a user interface, similar to that described by Rueter, when using the method described by Volosin, as doing so advantageously allows the user to visually correlate the electrical stimulation and potential capture events more easily.
Regarding claim 18, Volosin describes the system of claim 14, including a user interface component implemented at least partially in hardware of the external pacing device and configured to display user data ([0070]). Volosin does not explicitly disclose wherein, responsive to the capture component determining that the likelihood is less than the threshold likelihood, a suggestion in the user interface to provide the second electrical stimulation at the second current level via the external pacing device. However, Rueter also describes a method for determining cardiac capture ([0013]) including wherein, responsive to a capture component determining that a likelihood of capture is less than a threshold likelihood, a suggestion in the user interface to provide a second electrical stimulation at a second current level via the pacing device ([0059]). As Rueter is also directed towards determining cardiac capture and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use the user interface to suggest an increase in the current level, similar to that described by Rueter, when using the system described by Volosin, as doing so advantageously allows the user to adjust the electrical stimulation in order to increase the likelihood of cardiac capture.
Claims 6, 7, 10, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Volosin in view of Whiting et al. (US 2019/0262608 A1).
Regarding claims 6, 16, and 20, Volosin describes the method of claim 1 and the system of claim 14 but does not explicitly disclose wherein determining the likelihood comprises inputting the first data associated with the first biological parameter and the second data associated with the second biological parameter into a machine-learned model trained to identify heart capture and receiving, from the machine-learned model, the likelihood that the first electrical stimulation has caused the capture of the heart of the patient. However, Whiting also describes a method for determining cardiac capture ([0012]), including wherein determining the likelihood of capture comprises inputting data associated with first and second biological parameters into a machine-learned model trained to identify heart capture and receiving, from the machine-learned model, the likelihood that electrical stimulation has caused the capture of the heart of the patient ([0184]). As Whiting is also directed towards determining cardiac capture and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a machine learning model similar to that described by Whiting when using the method described by Volosin, as doing so advantageously allows the resulting method to automatically determine capture and adjust stimulation parameters more efficiently.
Regarding clam 7, Whiting describes wherein the machine-learned model comprises a logistic regression model ([0184], [0203]).
Regarding claim 10, Volosin describes the method of claim 9, and Whiting describes inputting data associated with a biological parameter and the difference into a machine-learned model trained to identify heart capture and receiving, from the machine-learned model, a likelihood that an electrical stimulation has caused the capture of the heart of the patient ([0184]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Volosin in view of Bohn et al. (US 2013/0245709 A1).
Regarding claim 15, Volosin describes the system of claim 14 but does not explicitly disclose wherein the first electrical stimulation is provided at a first timing interval, and wherein the capture component is further configured to, responsive to determining that the likelihood is less than the threshold likelihood, cause the pacing component to provide the second electrical stimulation at a second timing interval, the second timing interval being different than the first timing interval. However, Bohn also describes a system for determining cardiac capture ([0012]), including wherein a first electrical stimulation is provided at a first timing interval, and wherein a capture component is further configured to, responsive to determining that a likelihood of capture is less than a threshold likelihood, cause a pacing component to provide second electrical stimulation at a second timing interval, the second timing interval being different than the first timing interval (claims 1 and 8). As Bohn is also directed towards determining cardiac capture and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the timing interval, similar to that described by Bohn, when using the system described by Volosin, as doing so advantageously allows the resulting method to modify a parameter that is known to effect cardiac capture.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Volosin in view of Rueter, further in view of Bohn.
Regarding claim 19, Volosin in view of Rueter suggests the system of claim 18, including wherein the user interface provides suggestion to the user (Rueter: [0056] - [0058]) and the first electrical stimulation is provided at a first timing interval (Volosin: [0057]). Neither Volosin nor Rueter explicitly disclose wherein the UI component is further configured to display a second suggestion in the UI to provide the second electrical stimulation at a second timing interval, the second timing interval being different than the first timing interval. However, Bohn also describes a system for determining cardiac capture ([0012]), including and wherein a capture component is configured to provide a suggestion in to provide a second electrical stimulation at a second timing interval, the second timing interval being different than a first timing interval (claims 1 and 8). As Bohn is also directed towards determining cardiac capture and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the timing interval, similar to that described by Bohn, when using the system described by Volosin and Rueter, as doing so advantageously allows the resulting method to modify a parameter that is known to effect cardiac capture.
Allowable Subject Matter
Claims 5 and 11 are objected to as being dependent upon rejected base claims, but the claims would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
Regarding claim 5, the prior art of record does not disclose or suggest the limitations of determining a first delay associated with receiving the first data from the first biological sensor, determining a second delay associated with receiving the second data from the second biological sensor, and wherein a location of the indicator relative to the first representation and the second representation is based on the first delay and the second delay. Guidance regarding this limitation is provided in paragraph [0038] of Applicant’s Specification, the relevant section of which is copied below with Examiner’s emphasis.
[0038] … In some examples, the UI component 110 displays the representation 204, the representation 206, the representation 208 (collectively, “representations 204, 206, and 208”), and the indicators 210 by accounting for delays in receiving the respective signals from the biological sensors providing the ECG sensor data, the SpO2 sensor data, and the CO2 sensor data. In an illustrative example, the UI component 110 may determine that the ECG sensor data is received at a 50 millisecond delay, and the SpO2 sensor data is received at a 200 millisecond delay, such as based on responses detected by the sensor analysis component 102 to administration of the electrical stimulation pulses during pacing. Accordingly, the UI component 110 displays the indicators 210 at locations relative to the representations 204, 206, and 208 such that the indicators 210 appear at a same time in each of the representations 204, 206, and 208. This may include the UI component delaying display of a representation of biological parameter(s), such as by delaying output of the ECG sensor data by 150 milliseconds to account for the delay in the illustrative example above.
The Examiner respectfully submits that the prior art does not describe such a feature of adjusting the location of the indicator in order to align the indicator based on the respective delays between receiving each of the first and second biological signals.
Regarding claim 11, Volosin describes the method of claim 1, including wherein the first data associated with the first biological parameter comprises an indication of the first electrical stimulation ([0076], [0084]). Volosin also describes determining a magnitude of a response of the patient to the first electrical stimulation from the first data ([0038], [0084]). However, Volosin and the other prior art of record do not disclose or suggest the limitations of removing the magnitude of the response from the first data and wherein determining the likelihood of capture is further based on removing the magnitude of the response from the first data.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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 by telephone 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796
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