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 1-12 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 re claim 1, the limitation, “the result of the comparisons” lacks antecedent basis.
In re claim 3, the limitation, “the third time interval” lacks antecedent basis.
In re claim 6, the limitations
“the…third…thresholds”
“the values of the acquired intervals“
lack antecedent basis.
In re claim 8, regarding the limitation, “the third threshold” see in re claim 6 above.
In re claim 10, the limitation, “the electrogram image” lacks antecedent basis.
In re claim 10, the limitation, “the signals” is unclear regarding whether this is a new limitation that lacks antecedent basis, or if this is directed to a combination of the earlier recited first, second, third, and fourth detection signals (recited in claim 4).
For examination purposes, the limitation, “the signals” is interpreted as being directed to a combination of the earlier recited first, second, third, and fourth detection signals.
In re claim 11, regarding the limitation, “the result of the comparisons” see in re claim 1 above.
In re claim 11, the limitations,
“on the one hand”
“on the other hand”
lack antecedent basis.
In re claim 12, regarding the limitation, “the result of the comparisons” see in re claim 1 above.
Appropriate correction is required.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1, 11, and 12 are directed a computer implemented method, a system, and a non-transitory storage medium comprising instructions for assigning an item of identification information to a detection signal, respectively. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1, 11, and 12 recite the following claim limitations which are directed to abstract ideas, specifically mental processes and mathematical concepts (see MPEP § 2106.04(a)(2)):
In re claim 1:
“assigning an item of identification information to the first detection signal” (mental process – person can assign an item of identification information to a signal)
said item of identification information being determined as a function of the result of the comparisons performed by the first comparison algorithm (mathematical function and relationships – Applicant’s specification [0233-0234]: ….calculator K is configured to implement an algorithm…the calculator K is configured to implement one or more functions... In an example, the assignment function implemented by the calculator K comprises the assignment of the item of identification information…).
In re claim 11, see above.
In re claim 12, see above.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, as well as concepts that involve mathematical functions and relationships.
Therefore, the claim limitations fall within the 'mental processes' and ‘mathematical concepts’ groupings of abstract ideas.
Step 2A, Prong 2:
Claims 1, 11 and 12 recite the following additional elements:
In re claim 1,
acquiring, by a probe, a first detection signal in response to receiving a cardiac electrical current,
said first detection signal comprising a signal portion corresponding to an electrical pattern over a first time interval,
said first time interval being defined between two events defined from at least one electrical pattern;
applying a first comparison algorithm comprising:
comparing the first time interval with a first threshold;
comparing a second time interval associated with a portion of a second detection signal prior to the first detection signal with a second threshold;
said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware.
In re claim 11, see above and the following limitations:
an electrical device comprising at least one probe
a calculator
a display for generating a graphical marker overlaid on an electrogram comprising the first detection signal in order to temporally locate the item of identification information of the first detection signal
a memory for recording data;
a communication interface for exchanging data with equipment in a remote data network.
In re claim 12, see above and the following limitations:
a non-transitory storage medium comprising instructions…
…a computer
The following limitations:
acquiring, by a probe, a first detection signal in response to receiving a cardiac electrical current,
said first detection signal comprising a signal portion corresponding to an electrical pattern over a first time interval,
said first time interval being defined between two events defined from at least one electrical pattern;
applying a first comparison algorithm comprising:
comparing the first time interval with a first threshold;
comparing a second time interval associated with a portion of a second detection signal prior to the first detection signal with a second threshold;
said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware,
an electrical device comprising at least one probe,
are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information used to discriminate a detection signal having a physiological cause from a detection signal having a malfunction of electronic hardware.
Additionally, regarding the limitations:
said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware,
a display for generating a graphical marker overlaid on an electrogram comprising the first detection signal in order to temporally locate the item of identification information of the first detection signal, and
a communication interface for exchanging data with equipment in a remote data network
Examiner asserts that these limitations are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited “display” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited “display” is such that it substantially encompasses all applications of the recited exception (such as moving information).
There is nothing in the claims which show how displaying the above recited limitations integrates the judicial exception into a practical application.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Regarding the limitations, “applying a first comparison algorithm comprising:
comparing the first time interval with a first threshold;
comparing a second time interval associated with a portion of a second detection signal prior to the first detection signal with a second threshold”,
Examiner asserts that the above recited limitations amount to nothing more than mere instructions to apply the abstract idea using a generic computer (MPEP 2106.05(f), Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983).
Additionally, the above recited claims’ recitation of a calculator, a memory, a communication interface, a non-transitory storage medium comprising instructions, and a computer are merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-12 amount to significantly more than the abstract idea itself. Accordingly, claims 1-12 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
(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 1-7, 9, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunderson (US 2011/0098766).
In re claim 1, Gunderson discloses a computer implemented method [0012, 0042-0043] for assigning an item of identification information to a detection signal ([0008]): detecting lead related condition associated with a non-sustained tachyarrhythmia (NST)) comprising:
acquiring, by a probe (fig. 2: any one of electrodes: 40, 42, 44, 46, 48, 50, 62, 64, and 66; [0033-0034]), a first detection signal ([0030]: cardiac electrical signal associated with an NST) in response to receiving a cardiac electrical current [0030],
said first detection signal comprising a signal portion corresponding to an electrical pattern over a first time interval ([0061]: a second NST detected from a later cardiac electrical signal than an NST detected from an earlier cardiac electrical signal is interpreted as a first time interval),
said first time interval being defined between two events defined from at least one electrical pattern ([0008]: each NST comprises intervals i.e. events during the NST; [0070]: NST R-R intervals would be between two events);
applying a first comparison algorithm (fig. 8: flow diagram; [0076-0079]: comparison is made based on detected metrics to detect lead related condition; [0080]: cardiac electrical signals are examined for a plurality of NSTs for a period of time to detect lead related condition) comprising:
comparing the first time interval with a first threshold ([0065]: each NST is compared with a metric threshold);
comparing *a second time interval associated with a portion of a second detection signal prior to the first detection signal ([0061]: an NST detected from an earlier cardiac electrical signal than the cardiac electrical signal from the first detection signal is interpreted a second detection signal, which would have a second time interval) with a second threshold
([0065]: each NST is compared with a metric threshold and can include multiple metrics which would have multiple thresholds [0070]; [0079]: comparison can be made when multiple metrics are met; [0086]: combination between various examples may be made);
assigning an item of identification information to the first detection signal ([0079-0080]: each NST is analyzed against a metric or a set of metrics to detect a lead related condition),
said item of identification information being determined as a function of the result of the comparisons performed by the first comparison algorithm [0079-0080] and
said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware ([0008]: NST is differentiated between an NST or a lead related condition; [0006]: lead related conditions may be structural issues related with electrodes, leads, or conductors).
Regarding the limitations “a second time interval associated with a portion of a second detection signal prior to the first detection signal”, Examiner asserts that under broadest reasonable interpretation, a second time interval can be interpreted as a cardiac electrical signal associated with a portion of a second detection signal that occurs prior to another later cardiac electrical signal that is part of a first time interval associated with a portion of a first detection signal.
In re claim 2, Gunderson discloses
wherein the first comparison algorithm comprises: comparing a third time interval associated with a portion of a third detection signal ([0061]: third NST is interpreted as being detected before the NST of the second detection signal) with a third threshold ([0079-0080]: each NST is compared with a metric threshold),
said third detection signal being prior to the second detection signal (see in re claim 1 above, where similarly, under broadest reasonable interpretation, the third detection signal can be interpreted as an earlier cardiac electrical signal than the cardiac signal associated with the second detection signal; [0061, 0079-0080]).
In re claim 3, Gunderson discloses comprising: implementing a second comparison algorithm ([0079-0080]: comparison may be made between various metrics) comprising:
comparing the first time interval with a fourth threshold ([0079-0080]: any NFT may be compared with various metrics; [0070]: metric includes seven parameters which each include its own respective threshold);
comparing the second time interval with a fifth threshold [0079-0080, 0070];
comparing the third time interval with a sixth threshold [0079-0080, 0070].
In re claim 4, Gunderson discloses comprising implementing, by the first comparison algorithm or the second comparison algorithm, the comparison of a seventh threshold (see in re claim 3, where there are second metrics and therefore second threshold) with a fourth time interval associated with a portion of a fourth detection signal prior to the third detection signal
(see in re claim 1 above, where similarly, under broadest reasonable interpretation, the fourth detection signal can be interpreted as an earlier cardiac electrical signal than the cardiac signal associated with the third detection signal; [0079-0080]: each NST is compared with metric(s); [0061]).
In re claim 5, Gunderson discloses wherein the item of identification information is assigned to the first detection signal according to the result of the comparisons of
at least one of the first and second comparison algorithms (see in re claim 1 above, where the identification information is assigned based on the result of the comparisons of the first comparison algorithm) or
a combination of the first and second comparison algorithms.
In re claim 6, Gunderson discloses wherein one or more thresholds among the first, second, third, fourth, fifth, sixth and seventh threshold [0070] are defined by:
-a predefined threshold value [0070] or;
- a median value or an average of several values together or;
- a mathematical function defined relative to one or more time intervals; or
- a mathematical function independent of the values of the acquired intervals or;
- a combination of several mathematical functions.
In re claim 7, Gunderson discloses wherein the item of identification information assigned to the first detection signal comprises either:
an item of physiological information characterizing an item of heart rate data;
an item of anomaly information characterizing an item of non-physiological signal data ([0006]: lead related conditions may be structural issues and therefore are associated with non-physiological signal data).
In re claim 9, Gunderson discloses comprising:
generating a notification or alert (256; [0077]) when the item of identification information assigned to the first detection signal comprises the item of anomaly information (254; [0077]);
saving said alert/notification in a memory space ([0060]: memory 82 may store and retrieve stored data associated with the cardiac electrical signal; [0065]: memory 82 stores data associated with NSTs; [0088]: instructions stored to perform functions such as sending alerts),
emitting said alert/notification generated to equipment of a remote data network ([0077]: results may be sent to telemetry module 88 which may send an alert action to programmer 24; [0081]: telemetry module 88 of IMD 16 communicates with programmer 24 wirelessly; fig. 1: 24).
In re claim 12, Gunderson discloses a non-transitory storage medium [0088, 0042] comprising instructions [0088].
Regarding the limitation, “which, when the instructions are run by a computer, cause the latter to implement the following steps:
a first comparison algorithm comprising:
comparing a first time interval, over which an electrical pattern of a portion of a first detection signal acquired by means of a probe extends, with a first threshold ;
comparing a second time interval associated with a portion of a second detection signal prior to the first detection signal with a second threshold;
assigning an item of identification information to the first detection signal said item of identification information being determined as a function of the result of the comparisons performed by the comparison algorithm and said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware”.
Claim Rejections - 35 USC § 102 / 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 8 is rejected under 35 U.S.C. 102(a)(1) / 103 as being unpatentable over Gunderson (US 2011/0098766).
In re claim 8, Gunderson discloses the item of identification information assigned to the first detection signal comprises an item of anomaly information characteristic of a probe breakage ([0006]: short/open circuits and other structural modifications that worsen sensing integrity are interpreted as probe breakage): either
when
the first time interval is less than the first threshold (fig. 8: block 244 when average value is less than a predetermined threshold; [0077]),
the second time interval is greater than the second threshold (fig. 8: block 252 when range value is greater than a predetermined threshold; [0077]) and
**the third time interval is greater than the third threshold ([0077-0079]: other metrics may additionally or alternatively be used, such as one that would require the third interval to be greater than the third threshold to detect the lead related condition; [0080]: plurality of NSTs i.e. time intervals may need to be met for a lead related condition to be detected) or
when
the first time interval is below the first threshold and
the second time interval is above the second threshold,
the third time interval is above the third threshold and
the fourth time interval is above the seventh threshold.
**Regarding the limitation, “the third time interval is greater than the third threshold”, Gunderson discloses a flowchart (fig. 8) comprising three values being compared with respective thresholds (fig. 8: 244, 248, and 252). Gunderson further teaches that a plurality of NSTs (i.e. time intervals) may be analyzed for the determination of a lead related condition [0079-0080], and that seven metrics may be selected from for the comparison [0070]. Additionally, Gunderson teaches that although fig. 8 shows three criteria related to three metrics, other examples may consist of a different number of metrics and criteria [0078].
A third threshold could have been selected to be compared with the third time interval that would satisfy the above recited limitation. However, in the instance that this is not explicitly disclosed by Gunderson, claim 8 is alternatively rejected under 35 U.S.C 103 as follows:
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the computer implemented method taught by Gunderson, to provide wherein anomaly information characteristic of a probe breakage includes the third time interval being greater than the third threshold, as taught by Gunderson, because multiple criteria and metrics may have been selected, for instance, another metric that satisfy the third time interval being greater than the third threshold for the detection of probe breakage.
Claim Rejections - 35 USC § 103
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson (US 2011/0098766) in view of Spors et al. (US 2016/0292373).
In re claim 10, Gunderson fails to disclose comprising:
generating an electrogram comprising a graphical representation of at least one detection signal among the signals and of at least one time interval;
acquiring, recording and transmitting the electrogram image acquired to at least one piece of equipment in a data network.
Spors teaches displaying information related to a health event [0002] and teaches
generating an electrogram (fig. 6C: 674; [0063]) comprising a graphical representation of at least one detection signal (fig. 6C: 674) among the signals ([0050]: graph may show different time periods rather than just one shown, therefore, multiple signals must exist) and of at least one time interval [0050];
acquiring, recording and transmitting the electrogram image acquired ([0063]: mobile device receives heart activity from connected sensor device; [0063]: provider receives the ECG graph via care provider environment or event manager; fig. 1: care provider 105 receives data from mobile device 135 via network 145; [0026]) to at least one piece of equipment (fig. 1: 105) in a data network ([0026]: mobile device includes monitoring application that permits communication with a care provider environment via network 145; [0029, 0063]); and
a display (fig. 6C: 660; [0050, 0061]) for generating a graphical marker ([0050]: selector bar) overlaid on an electrogram ([0050]: graph may include the selector bar so a user can scroll the graph to see different time periods) comprising the detection signal (fig. 6C: 674) in order to temporally locate the item of identification information of the first detection signal (fig. 6C: 674 may be viewed to detect when the electrode has been detached and the selector bar can be sed to switch between different time periods [0050]).
Spors further teaches that the ECG graph can be used to determine a mobile device stops receiving heart activity from a sensor [0063], such as when normal heart activity turns is followed by a flat line [0063], which indicates a failure in the sensor device [0063], rather than a cardiac event such as a heart attack [0063].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the computer implemented method taught by Gunderson, to provide generating an electrogram comprising a graphical representation of at least one detection signal among the signals and of at least one time interval and acquiring, recording and transmitting the electrogram image acquired to at least one piece of equipment in a data network, as taught by Spors, because the display of the ECG graph can be used to differentiate between a failure in the sensor device and a cardiac event such as a heart attack.
In re claim 11, a system [0010-0011] for generating an item of identification information of a cardiac detection signal [0008, 0010-0011] comprising:
an electrical device (fig. 1: 16) comprising at least one probe (fig. 2: any one of electrodes: 40, 42, 44, 46, 48, 50, 62, 64, and 66; [0033-0034]) for acquiring a first detection signal in response to receiving a cardiac electrical current (see in re claim 1 above), said detection signal comprising a signal portion corresponding to an electrical pattern over a first time interval (see in re claim 1 above);
a calculator ([0070]: calculation module calculates one or more metrics and makes a comparison with a threshold to determine presence of a lead related condition; [0067]: calculation module 128 is part of processor 80; [0042])….;
…a memory (fig. 4: 82; [0042]) for recording data [0068];
a communication interface (88; [0081]) for exchanging data with equipment (fig. 1: 24) in a remote data network [0077, 0081]).
Regarding the limitations,
“a calculator configured to implement:
on the one hand, a comparison algorithm comprising:
i. comparing the first time interval with a first threshold;
ii. comparing a second time interval associated with a portion of a second detection signal prior to the first detection signal with a second threshold;
on the other hand,
a function for assigning an item of identification information to the first detection signal said item of identification information being determined according to the result of the comparisons performed by the comparison algorithm,
said item of identification information making it possible to discriminate a detection signal having a physiological cause from a detection signal having for cause a malfunction of electronic hardware”,
see in re claim 1 above.
Regarding the limitations, “a display for generating a graphical marker overlaid on an electrogram comprising the first detection signal in order to temporally locate the item of identification information of the first detection signal”, see the proposed combination yielded in re claim 10 above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Kracker (US 2009/0326600) discloses performing lead integrity test (abstract) by comparing impedances (abstract) of a lead at a plurality of times (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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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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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796