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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14, specifically independent claims 1, 6 & 11 are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a method, which is a statutory category of invention.
Claim 6 is directed to a system, i.e. a product, a statutory category of invention.
Claim 11 is directed to a non-transitory computer readable medium embodying instructions executable by a hardware processor, which is a product, i.e. a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the method steps of:
“…issuing a first initial interrogation signal from a patient monitor…”
“…selectively issuing a second initial interrogation signal from the patient monitor…”
“…and timing issuance of at least one subsequent interrogation signal to the primary ECG lead set…”
“…minimizing an interference signal by controlling a time…”
Claim 6 recites the method steps of (via the patient monitor having a processor):
“…issue an initial interrogation signal…”
“…times issuance of at least one subsequent interrogation signal to the ECG lead…”
“…minimizing an interference signal by controlling a time…”
Claim 11 recites the method steps of (hardware processor to):
“…issue an initial interrogation signal from a patient monitor…”
“…selectively issue an initial interrogation signal from the patient monitor…”
“…minimize an interference signal by controlling a time…”
These limitations, under the broadest interpretation, fall within the mental processes (i.e. issuing, selectively issuing, etc.) grouping of an abstract idea. It would be practical, but for the recitation “patient monitor/processor to) to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 17 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
Claim 1
“…an external patient monitor to identify a primary ECG lead set type…” which is directed to data gathering, see MPEP 2106.05(g).
“…the primary ECG lead set type to identify an auxiliary ECG lead set…” which is directed to data gathering, see MPEP 2106.05(g).
Claim 6
“…an external patient monitor…” which is directed to data gathering, see MPEP 2106.05(g).
“…a processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…a user interface…” which is directed to data output, see MPEP 2106.05(g).
“…a primary ECG lead set…” which is directed to data gathering, see MPEP 2106.05(g)
Claim 11
“…a processor…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…an external patient monitor…” which is directed to data gathering, see MPEP 2106.05(g).
“…a primary ECG lead set…” which is directed to data gathering, see MPEP 2106.05(g)
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1, 6 and 11 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claims are silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 9-28 are rejected under 35 U.S.C 101.
The limitations of the dependent claims 2-5, 7-10 & 12-14 further defines steps of utilizing a non-critical ECG interval and initial interrogation signal which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 2-5, 7-10 & 12-14 are also directed to patient-ineligible subject matter.
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)(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.
Claim(s) 1-2, 4-7, 9-12 & 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Webb et al. (US 2008/0270036).
Webb et al. discloses:
1.
A method of operating (e.g., method for facilitating analysis of data collection, [0001]) an external patient monitoring system (e.g., external device 110 programmed for automated analysis of data sets and a data handling system 120, Fig. 1), comprising: issuing a first initial interrogation signal from an external patient monitor {e.g., via the disclosed link established from the external device 110 and the data handling system 120, where data sets are transferred thereto and handled from a plurality of medical devices [0013]-[0014] & (Fig 1)} to identify a primary electrocardiogram (‘ECG’) lead set type coupled to the external patient monitor {e.g., via the collected and received data including data describing episodes classified by analysis performed by a device 10, said data sets comprising ‘Lead Analysis Results’ corresponding to information on one or both of the leads 15 [0013], [0020] & (Fig 2B)}
Note that the examiner is interpreting the collection of data sets that are ‘linked’ to the external device 110 to the stored/accessible in the data handling system 120 as being the claimed first interrogation signal from an external device (e.g. [0013]-[0014]).
selectively issuing a second initial interrogation signal from the external patient monitor (e.g., via the remote data handling system 120 transferring data sets to a server 130, i.e. an analysis service 132, via a link, i.e. the internet, [0014]-[0015]), depending upon the identified type of the primary ECG lead set to identify an auxiliary ECG lead set (e.g., via the disclosed data exchange invoking a service/message to notify the user of analysis results, i.e. faulty connection of leads [0015] & [0020]).
and minimizing an interference signal by controlling a time issuance of at least one subsequent interrogation signal to the primary ECG lead set to correspond to a non-critical ECG interval.
E.G. via the disclosed ‘Episode and Oversensing Analysis ‘portion 290 that provides indications of a number of cardiac episodes, i.e. detecting oversensing, undersensing versus a classified cardiac event {[0020] & (Fig 2B)}, further based on a graphical display that shows event/episode ‘marker’ data corresponding to EGM data {[0025] & (Fig 4A)}.
2.
The method of claim 1, wherein the non-critical ECG interval comprises an interval following occurrence of a T-wave in a detected ECG signal and prior to occurrence of a subsequent P-wave in the detected ECG signal.
E.G. via the disclosed descriptions 390 that provide more detailed information associated with each episodes and is visually displayed via the page 40 that depicts the cardiac descriptions 390 in signal form {[0023]-[0026] & (Figs 3-4AB)}.
4.
The method of claim 1, wherein the non-critical ECG interval comprises an interval in which the external patient monitor is adjusting ECG signal processing parameters.
E.G. via the disclosed user being able to facilitate automated monitoring of a specific parameter, such as device impedance, over time in order to provide further auxiliary analysis [0027].
5.
The method of claim 1, wherein the initial interrogation signal and at least one subsequent interrogation signal are communicated to circuitry included in the primary ECG lead set.
E.G. via the disclosed wireless communication, i.e. telemetry, between the leads 15,17 and device 110, used in order to transmit and/or receive data from the external device 110 {[0013] & (Fig 1)}.
6.
A patient monitoring system {E.G. via the disclosed system and methods for facilitating auxiliary analysis of data collected by a device 10 [0001], [0013] & (Fig 1)}.
comprising: an external patient monitor (e.g., 110) having a processor (e.g., via programmable means in which the algorithm are ‘included,’ [0013] and a user interface (e.g., 141) for displaying an electrocardiogram (“ECG”) signal {e.g., having a display with EGM data {[0025] & (Fig 4A)}.
Note that it is inherently understood that the disclosed external device 110, which includes programmable data, i.e. the disclosed algorithms, operates via a processor, microprocessor and/or controller means.
and a primary ECG lead set, coupled to the patient monitor, for providing ECG signals to the patient monitor {E.G. via the disclosed leads 15, 17 [0013] & (Fig 1)}.
wherein: the external patient monitor (e.g., 110) issues an initial interrogation signal {e.g., via the disclosed link established from the external device 110 and the data handling system 120, where data sets are transferred thereto and handled from a plurality of medical devices [0013]-[0014] & (Fig 1)} to identify the type of the primary ECG lead set {e.g., via the collected and received data including data describing episodes classified by analysis performed by a device 10, said data sets comprising ‘Lead Analysis Results’ corresponding to information on one or both of the leads 15 [0013], [0020] & (Fig 2B)};
the external patient monitor minimizes an interference signal by controlling a time issuance of at least one subsequent interrogation signal to the ECG lead set to correspond to a non-critical ECG interval {E.G. via the disclosed ‘Episode and Oversensing Analysis ‘portion 290 that provides indications of a number of cardiac episodes, i.e. detecting oversensing, undersensing versus a classified cardiac event {[0020] & (Fig 2B)}.
7.
The patient monitoring system of claim 6, wherein the non-critical ECG interval comprises an interval following occurrence of a T-wave in a detected ECG signal and prior to occurrence of a subsequent P-wave in the detected ECG signal.
E.G. via the disclosed descriptions 390 that provide more detailed information associated with each episodes and is visually displayed via the page 40 that depicts the cardiac descriptions 390 in signal form {[0023]-[0026] & (Figs 3-4AB)}.
9.
The patient monitoring system of claim 6, wherein the non-critical ECG interval comprises an interval in which the external patient monitor is adjusting ECG signal processing parameters.
E.G. via the disclosed user being able to facilitate automated monitoring of a specific parameter, such as device impedance, over time in order to provide further auxiliary analysis [0027].
10.
The patient monitoring system of claim 6, wherein the initial interrogation signal and at least one subsequent interrogation signal are communicated to circuitry included in the primary ECG lead set.
E.G. via the disclosed wireless communication, i.e. telemetry, between the leads 15,17 and device 110, used in order to transmit and/or receive data from the external device 110 {[0013] & (Fig 1)}.
11.
A non-transitory computer-readable medium, tangibly embodying instructions executable by a hardware processor {E.G. via the disclosed software application 134 that is linked to a personal or lap computer 140 that supports the operation of the system [0015] & (Fig 1)}.
to: issue an initial interrogation signal from an external patient monitor {e.g., via the disclosed link established from the external device 110 and the data handling system 120, where data sets are transferred thereto and handled from a plurality of medical devices [0013]-[0014] & (Fig 1)} to identify a primary electrocardiogram (“ECG”) lead set type coupled to the patient monitor {e.g., via the collected and received data including data describing episodes classified by analysis performed by a device 10, said data sets comprising ‘Lead Analysis Results’ corresponding to information on one or both of the leads 15 [0013], [0020] & (Fig 2B)};
selectively issue an initial interrogation signal from the external patient monitor, depending upon the identified type of the primary ECG lead set, to identify an auxiliary ECG lead set {E.G. via the disclosed data sets that are projected via a user interface 141 which displays a report 29 further comprising a ‘Lead Analysis Results’ portion 295 corresponding to information on one or both of the leads 15, 17 [0020] & (Fig 2B), wherein said data sets may be based on ‘evidence descriptions’ based on ‘lead types’ [0023]}.
and minimize an interference signal by controlling a time issuance of at least one subsequent interrogation signal to the primary ECG lead set to correspond to a non-critical ECG interval {E.G. via the disclosed ‘Episode and Oversensing Analysis ‘portion 290 that provides indications of a number of cardiac episodes, i.e. detecting oversensing, undersensing versus a classified cardiac event {[0020] & (Fig 2B)}, further based on a graphical display that shows event/episode ‘marker’ data corresponding to EGM data {[0025] & (Fig 4A)}.
12.
The non-transitory computer-readable medium of claim 11, wherein the non-critical ECG interval comprises an interval following occurrence of a T-wave in a detected ECG signal and prior to occurrence of a subsequent P-wave in the detected ECG signal {E.G. via the disclosed descriptions 390 that provide more detailed information associated with each episodes and is visually displayed via the page 40 that depicts the cardiac descriptions 390 in signal form [0023]-[0026] & (Figs 3-4AB)}.
14.
The non-transitory computer-readable medium of claim 11, wherein the non-critical ECG interval comprises an interval in which the external patient monitor is adjusting ECG signal processing parameters (E.G. via the disclosed user being able to facilitate automated monitoring of a specific parameter, such as device impedance, over time in order to provide further auxiliary analysis [0027]).
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.
Claim(s) 3, 8 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (US 2008/0270036) in view of one having ordinary skill in the art.
Webb et al. discloses a method, a system and a non-transitory computer readable medium executing a processor to issue an interrogation signal from a patient monitor to identify a primary ECG lead set type corresponding to a non-critical ECG interval, via a user interface 141 display a report 29 further comprising a ‘Lead Analysis Results’ portion 295 corresponding to information on one or both of the leads 15, 17, except wherein said interval explicitly is an interval in which the patient monitor is limiting a voltage on an ECG lead of the lead set.
However, Webb et al. teaches that it is known to use an application that notifies the user of analysis results via said report 29 that further provides summary evidence of oversensing, undersensing, abnormal impedance and/or other data indicative of device integrity in the form of a lead issue based on specific selected analyzed episodic data, i.e. displayed interval data 45 {[0020]-[0023], [0025] & (Figs 2B-4A)}. The examiner notes that the data associated with oversensing, undersensing, abnormal impedance are parameters directly associated with a sensed voltage.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the disclosed ‘Lead Analysis Results,’ as providing interval data sets directly associated with limiting a voltage on an ECG lead since such a modification would provide the predictable results pertaining to outputting and displaying data indicative of device integrity in the form of a lead issues based on selected analyzed episodic data, i.e. displayed interval data 45 associated with a specific cardiac event {[0020]-[0023], [0025] & (Figs 2B-4A)}.
Response to Arguments
Applicant's arguments filed January 15, 2026 have been fully considered but they are not persuasive. The applicant argues the following arguments in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The applicant argues that the pending claims are directed towards patent eligible subject matter since the claims are not directed to an abstract idea by way of a ‘mental process’ that does not integrate the abstract idea into a practical application based on: 1). Step 2A prong 1, i.e. the office action fails to consider the claims a whole and consider the key elements of the claims.
2.) That the claims present an improvement to an existing technology and offer significantly more to any alleged abstract idea, i.e. the interrogation signals are not merely a signal but can contain multiple sets of data that can be critical to the determination of a lead type needed and/or adjusted.
3.) The claim amendment “minimizing an interference signal by controlling a time issuance…” cannot be performed in the human mind nor can the “timing” of the issuance, as stated by said claim amendment.
4. Per Step 2A, prong 2, the applicant argues that the claims are directed towards improvements in the patient monitoring system/process by utilizing interrogation signals and a time issuance of such to minimize interference with ECG signals, and are therefore patent eligible
The applicant’s arguments filed January 15, 2026 have been considered but are not persuasive. The rejection under 35 U.S.C. §101 is maintained for the reasons set forth below.
The applicant’s arguments that the office action fails to consider the claims “as a whole” is not persuasive. The analysis under Step 2A, prong 1 evaluates whether the claim recites a judicial exception, which may be identified even when considering the claim as whole (see MPEP 2106.04).
The claim recites steps of receiving, analyzing and determining information (e.g., interrogation signals and associated data), which fall within the category of mental processes, as these steps can be practically performed in the human mind or with pen and paper.
The mere recitation of these steps in the context of a system does not remove them from the mental processes grouping where the underlying operations remain evaluative and data-processing in nature.
The applicant’s assertion that the claims provide an improvement to existing technology is not persuasive. While the applicant contends that interrogation signals may contain multiple sets of data, the claims do not recite any specific improvement to the functioning of a device or system, no do they describe a particular technological mechanism by which such data improves system performance. Instead, the claims merely recite the use of data for analysis and determination purposes, which amounts to the application of an abstract idea using generic components. The additional data within the signal does not, by itself, constitute a technological improvement absent a claimed change in how the technology operates (see MPEP 2106.05(a)).
The applicant’s argument that the claim amendment limitation of “minimizing an interference signal by controlling a time issuance” cannot be performed in the human mind is not persuasive. Even if this limitation is not practically performed mentally, the claim as a whole is still directed to a judicial exception where the additional elements, including timing control, merely represents the application of the abstract idea using conventional techniques.
The recitation of controlling timing does not impose a meaningful limit on the judicial exception, as it does not reflect an improvement in the functioning of a computer or other technology, but rather represents a generic implementation of signal coordination.
With respect to Step 2A, Prong 2, applicant’s argument that the claims are integrated into a practical application is not persuasive. The claims do not recite any specific improvement to the functioning of a patient monitoring system, but instead use the alleged abstract idea in conjunction with generic components to perform data collection and analysis.
The claimed interrogation and analysis of signals, even when applied in a medical context, merely link the abstract idea to a particular field of use and do not integrate the exception into a practical application (see MPEP 2106.05(h)). No element or combination of elements reflects transformation, a particular machine integral to the claim or any other meaningful limitation sufficient to impose a practical application
Accordingly, the pending claims are directed to a judicial exception and do not integrate the exception into a practical application. Therefore, the rejection under 35 U.S.C. §101 is maintained.
The applicant argues that the primary reference, Webb et al., fails to teach each and every element as set forth in the claim, since Webb is generally directed to systems and method for data analysis from information collected by an implantable medical device, i.e. Webb describes analysis of stored information from an implantable medical device which ‘already’ knows what type of leads are present and Webb does not identify lead types. The applicant also argues that the Office Action mischaracterizes the ‘interrogation signal,’ in which the communication between the implanted device and the external device does not include interrogation signals, which are signals that are transmitted/received that contain data.
Based on the broadest reasonable interpretation of the claims the examiner disagrees and further points out that Webb et al. discloses an external device 110 programmed for automated analysis of data sets and a data handling system 120, which communicates via a disclosed link established between said external device and data handling system, each of which are externally-disposed. Webb et al. further discloses that data sets are transferred thereto and handled from a plurality of medical devices via said external device and data handling, which is in contrast to the argument that data analysis is from data collected by the implantable medical device {[0013]-[0014] & (Fig 1)}.
The examiner also notes that the data shared between said external device and the data handling system includes data sets describing episodes classified by ‘Lead Analysis Results’ corresponding to information on one or both of the leads 15/17 {[0013], [0020] & (Fig 2B)}, therefore providing the claim limitation of identifying a primary electrocardiogram (‘ECG’) lead set type coupled to the external patient monitor.
Note that the examiner is interpreting the collection of data sets that are ‘linked’ to the external device 110 to be stored/accessible in the data handling system 120 as being the claimed first interrogation signal from an external device (e.g. [0013]-[0014]). As stated by the applicant’s own omission, an interrogation signal contain data. Therefore, Webb et al. provides each and every claim element and is still maintained as the primary prior art.
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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