DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pages 11-16, filed 6/18/2026, with respect to 35 U.S.C. 102 rejection
have been fully considered and are persuasive. The 35 U.S.C. 102 rejection of claims 1-29 has been withdrawn.
35 U.S.C. 102:
Regarding claim 1, the applicant argues that Fishler does not teach “determine whether or not a
variation associated with the AA interval is within a specified tolerance, and based thereon, determine whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event.” After further consideration, the examiner agrees and argues that Fishler does not explicitly teach transmitting and atrial event to the vLP. Fisher specifically discloses transmitting ventricle events to the vLP. Therefore, the 35 U.S.C. 102 rejection is withdrawn.
Applicant's arguments, see pages 16-21, filed 6/18/2026, have been fully considered but they
are not persuasive.
35 U.S.C. 101:
Regarding independent claims 1, 14, and 27, applicant argues that the claimed invention recites
an improvement to technology or computer functionality that is not abstract. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016)"). The specific improvement is towards reducing power consumption in leadless pacemakers, thereby minimizing the need for surgical replacements of the leadless pacemakers. Support for this improvement is explained in paragraph [0052] of the applicant’s specification.
The examiner respectfully disagrees and argues that the technological improvement is directed towards the abstract idea of “determine whether or not a variation associated with the AA interval is within a specified tolerance, and based thereon, determine whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event.” Furthermore, the independent claims recite using the specified determination steps to decide whether to abstain or transmit atrial event messages to the vLP. The steps, comparing signals to a predetermined threshold and deciding whether to give a diagnosis based on that comparison, recite an improvement in the abstract idea and not the computer system or technology itself. Reducing power consumption in the leadless pacemaker is a result from the specified determination steps.
Applicant is reminded that abstract ideas cannot provide a practical application or significantly more (e.g., an improvement). Both Step 2A Prong 2 and Step 2B require an additional element, not an abstract idea, to provide a practical application or significantly more (e.g., an improvement). See Genetic Technologies Limited v. Merial LLC (Fed Cir 2016). Here, the additional elements of claims 1-29 are merely generically recited computer elements used as tools for executing the abstract ideas or insignificant extra-solution activity.
Furthermore, the applicant argues that the independent claims recite additional elements and
transmitting steps that cannot be performed in the mind, specifically, “transmit the atrial message to the vLP.” SRI Int', Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1304 (Fed. Cir. 2019). SiRF Tech., Inc. v. Int'/ Trade Comm'n, 601 F.3d 1319, 94 USPQ2d 1607 (Fed. Cir. 2010). The examiner respectfully argues that the abstract idea is not towards the transmission of atrial messages to the vLP. The abstract idea is recited in the determination steps when comparing signals to a predetermined threshold and deciding whether to give a diagnosis based on that comparison.
Regarding SRI Int', the examiner argues that the additional elements used to obtain signals is
recited as extra-solution activity to the step of data gathering. Comparing the received signals to a specified tolerance is an abstract idea. Furthermore, the additional elements used to transmit the atrial message to the vLP recite post solution activity.
Lastly, applicant argues that the claims are directed to significantly more than the judicial
exception under Step 2B. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). The examiner respectfully disagrees and argues that the additional elements do not provide significantly more other than extra-solution activity to perform the steps of data gathering and giving a diagnosis. The improvement to reducing power consumption is a result from reducing how often atrial messages are transmitted. Reducing the transmission of atrial messages is an improvement towards the abstract idea of simplifying a diagnostic step. Therefore, the 35 U.S.C. 101 rejection is maintained.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an
abstract idea without significantly more. Claims 1, 14 and 27 recite an apparatus and two methods with instructions for performing operations of the device comprising:
the aLP determining an atrial-to-atrial interval (AA interval) for an atrial event and determining whether or not a variation associated with the AA interval is within a specified tolerance, wherein the AA interval comprises a duration between the atrial event and an immediately preceding atrial event;
the aLP determining, based on results of the determining whether or not the variation associated with the AA interval is within the specified tolerance, whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event;
the aLP, in response to determining that the atrial event message should not be transmitted to the vLP, abstaining from transmitting the atrial event message to the vLP and thereby abstaining from informing the vLP of the atrial event;
the aLP determining a further AA interval when a further atrial event occurs and determining whether or not a variation associated with the further AA interval is within the specified tolerance, wherein the further AA interval corresponds to a duration between the further atrial event and an atrial event immediately preceding the further atrial event;
and the aLP, in response to determining that the variation associated with the further AA interval is not within the specified tolerance, transmitting an atrial event message to the vLP and thereby informing the vLP of the further atrial event.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is
evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to an apparatus, and claims 14 and 27 recite two methods with
instructions to perform steps and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural
phenomenon?
Claims 1, 14 and 27 recite an apparatus and two methods with instructions for performing
operations of the device comprising:
the aLP determining an atrial-to-atrial interval (AA interval) for an atrial event and determining whether or not a variation associated with the AA interval is within a specified tolerance, wherein the AA interval comprises a duration between the atrial event and an immediately preceding atrial event;
the aLP determining, based on results of the determining whether or not the variation associated with the AA interval is within the specified tolerance, whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event;
the aLP, in response to determining that the atrial event message should not be transmitted to the vLP, abstaining from transmitting the atrial event message to the vLP and thereby abstaining from informing the vLP of the atrial event;
the aLP determining a further AA interval when a further atrial event occurs and determining whether or not a variation associated with the further AA interval is within the specified tolerance, wherein the further AA interval corresponds to a duration between the further atrial event and an atrial event immediately preceding the further atrial event;
and the aLP, in response to determining that the variation associated with the further AA interval is not within the specified tolerance, transmitting an atrial event message to the vLP and thereby informing the vLP of the further atrial event.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the
limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Therefore, claims 1, 9, and 17 recite an abstract idea of a mental process.
Claims 1, 14 and 27recite the abstract idea of a mental process. The limitations as drafted in the
claims, under its broadest reasonable interpretation, covers performance of the claimed steps in the mind, but for the recitation of a generic processor. Other than reciting a generic processing system and memory, nothing in the elements of the claims precludes the step from practically being performed in the mind or manually by a clinician. For example:
“The aLP determining an atrial-to-atrial interval (AA interval) for an atrial event and determining whether or not a variation associated with the AA interval is within a specified tolerance, wherein the AA interval comprises a duration between the atrial event and an immediately preceding atrial event;” A physician may determine whether a variation associated with the AA interval is within a specified tolerance though observation and simple comparison.
“The aLP determining, based on results of the determining whether or not the variation associated with the AA interval is within the specified tolerance, whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event;” A physician may make the determination to alert a patient of an atrial event based on the variation associated with the AA interval being within or outside a specified tolerance.
“The aLP, in response to determining that the atrial event message should not be transmitted to the vLP, abstaining from transmitting the atrial event message to the vLP and thereby abstaining from informing the vLP of the atrial event;” A physician may make the determination to not alert a patient of an atrial event based on the variation associated with the AA interval being within or outside a specified tolerance.
“The aLP determining a further AA interval when a further atrial event occurs and determining whether or not a variation associated with the further AA interval is within the specified tolerance, wherein the further AA interval corresponds to a duration between the further atrial event and an atrial event immediately preceding the further atrial event;” A physician may determine whether a variation associated with the AA interval is within a specified tolerance though observation and simple comparison. A physician may also determine an AA interval based on duration between two atrial events.
“And the aLP, in response to determining that the variation associated with the further AA interval is not within the specified tolerance, transmitting an atrial event message to the vLP and thereby informing the vLP of the further atrial event.” A physician may make the determination to alert or not alert a patient of an atrial event based on the variation associated with the AA interval being within or outside a specified tolerance.
Furthermore claims 2-7, 9, 11-13, 15-18, 20-21, 23-26, and 28-29 recite additional steps that can be manually performed by the clinician.
Regarding claims 2-5, 7, 9, 11-13, 15-16, 23-26, and 28-29. A physician may make the determination to alert or not alert a patient of an atrial event based on the variation associated with the AA interval being within or outside a specified tolerance.
Regarding claims 18 and 20. A physician may alert the patient and adjust the ventricular target interval based on the comparison between the interval and the specified tolerance.
Regarding claims 6, 17, and 20-21. A physician may utilize a timer to determine whether or not a ventricular or atrioventricular target interval has elapsed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial
exception into a practical application?
Claims 1, 14, and 27 recite the additional elements of a “an atrial leadless pacemaker” and
“a ventricular leadless pacemaker”, which are being interpreted as a data gathering device.
an atrial and ventricular leadless pacemakers are recited to perform pre-solution activity to the step of data gathering.
However, these elements are recited at a high level of generality performing the function of generic data processing such that they amount to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Accordingly, the additional elements do not integrate the abstract idea into a practical
application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the
judicial exception?
The additional elements when considered individually and in combination are not enough to
qualify as significantly more than the abstract idea.
an atrial and ventricular leadless pacemakers are recited to perform pre-solution activity to the step of data gathering.
As discussed above with respect to integration of the abstract idea into a practical application, “an atrial leadless pacemaker” and “a ventricular leadless pacemaker”, which are being interpreted as a processor of a data gathering device as recited to perform the steps of:
the aLP determining an atrial-to-atrial interval (AA interval) for an atrial event and determining whether or not a variation associated with the AA interval is within a specified tolerance, wherein the AA interval comprises a duration between the atrial event and an immediately preceding atrial event;
the aLP determining, based on results of the determining whether or not the variation associated with the AA interval is within the specified tolerance, whether or not an atrial event message should be transmitted to the vLP to inform the vLP of the atrial event;
the aLP, in response to determining that the atrial event message should not be transmitted to the vLP, abstaining from transmitting the atrial event message to the vLP and thereby abstaining from informing the vLP of the atrial event;
the aLP determining a further AA interval when a further atrial event occurs and determining whether or not a variation associated with the further AA interval is within the specified tolerance, wherein the further AA interval corresponds to a duration between the further atrial event and an atrial event immediately preceding the further atrial event;
and the aLP, in response to determining that the variation associated with the further AA interval is not within the specified tolerance, transmitting an atrial event message to the vLP and thereby informing the vLP of the further atrial event.
amount to no more than mere instructions to apply the exception using generic computer
components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Fishler et al. US Pub.: US 20160121128 A1, hereinafter Fishler) teaches a data gathering device with a processor and memory, and conventional limitations that amount to mere instructions or elements to implement the abstract idea. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. Therefore, the claims are not patent eligible.
Although no prior art rejection is disclosed. The claims are not allowable due to the 35 U.S.C. 101 rejection as disclosed above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20160121128 A1: discloses the transmission of ventricle messages to the aLP.
US 20150224315 A1: device determines that the atrial contraction rate is above the threshold, the first device may switch into a different mode.
US 20200215340 A1: determination of the VP interval is stable (e.g., within a specified tolerance) for a specific number of (e.g., 10) consecutive cardiac cycles.
US 20220062646 A1: Cardiac event detector 224 may include a sense amplifier or other detection circuitry that compares the incoming rectified, cardiac electrical signal to a cardiac event sensing threshold, which may be an auto-adjusting threshold.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.J.T./Examiner, Art Unit 3792
/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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