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 .
Information Disclosure Statement
The information disclosure statement(s) filed 05/02/2024 and 01/29/2026 has/have been considered by the Examiner.
Election/Restrictions
Applicant’s arguments filed 05/15/2026, with respect to restriction of Groups I (claims 1-9) and II (claims 10-18) have been fully considered and are persuasive. The restriction requirement of Groups I and II has been withdrawn.
Applicant’s election of Groups I and II in the reply filed on 05/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, specifically regarding Group III (claims 19-20) in the response filed on 05/15/2026, the election of Groups I and II has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/16/2026.
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.
Claim(s) 10-18 is/are rejected under 35 U.S.C. §101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim(s) 10-18 is/are interpreted to read on a human organism because claim 10 recites, “An ambulatory medical device, the device comprising: a therapy circuit configured to deliver cardiac pacing stimulation energy when connected to electrodes that include at least one conduction system pacing (CSP) electrode positioned in an interventricular septum of a subject…”, thereby improperly defining the structure (electrode) in positive relation/connection with a living being (interventricular septum). The claims should define the elements as being “configured to” to avoid the positive recitation. Dependent claims 11-18 are further rejected for their dependencies.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 1-9 recite a method of operating a cardiac rhythm management (CRM) system, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 10-18 recite an ambulatory medical device, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A method of operating a cardiac rhythm management (CRM) system, the method comprising:
measuring a baseline P-wave to intrinsic R-wave interval (baseline PR interval) of a cardiac depolarization of a subject;
measuring one or both of a heart sound and a width of the QRS complex (QRS width) of the cardiac depolarization for the baseline PR interval;
delivering pacing stimulation to a ventricle after a sensed atrial event to set an atrial sense to ventricular pace interval (AsVp interval) and measuring the one or both of the heart sound and the QRS width for the AsVp interval, wherein the pacing stimulation is delivered using a conduction system pacing (CSP) vector that includes an electrode positioned in an interventricular septum;
delivering pacing stimulation to an atrium to set an atrial pace to ventricular pace interval (ApVp interval) and measuring the one or both of the heart sound and the QRS width for the ApVp interval;
and generating a recommended atrial to ventricular delay (AV delay) setting for CSP according to the measured one or both of the heart sounds and the QRS widths.
Independent claim 10 recites:
10. An ambulatory medical device, the device comprising:
a therapy circuit configured to deliver cardiac pacing stimulation energy when connected to electrodes that include at least one conduction system pacing (CSP) electrode positioned in an interventricular septum of a subject;
a cardiac signal sensing circuit configured to sense cardiac signals representative of cardiac activity when connected to the electrodes;
a heart sound sensing circuit to produce a heart sound signal;
and a control circuit operatively coupled to the therapy circuit, the cardiac signal sensing circuit, and the heart sound circuit; wherein the control circuit is configured to:
measure a baseline P-wave to intrinsic R-wave interval (baseline PR interval) of a sensed cardiac signal; measure one or both of a heart sound and a width of the QRS complex (QRS width) of a cardiac depolarization for the baseline PR interval;
deliver pacing stimulation to a ventricle using the at least one CSP electrode to set an atrial sense to ventricular pace event interval (AsVp interval) and measure the one or both of the heart sound and the QRS width for the AsVp interval;
deliver pacing stimulation to an atrial electrode to set an atrial pace to ventricular pace interval (ApVp interval) and measure the one or both of the heart sound and the QRS width for the ApVp interval;
and generate a recommended atrial to ventricular delay (AV delay) setting for CSP according to one or both of the measured heart sounds and the measured QRS widths.
Independent claims 1 and 18 is/are all ultimately directed to a MENTAL PROCESS of generating a recommended atrial to ventricular delay (AV delay) setting, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally generate recommended AV delay settings by observing and analyzing measured heart sound and QRS width data, and in turn mentally formulating settings or timings between an atrial event and a ventricular pacing, or mentally formulating AV delay values based on measured data.
Dependent claims 2-9 and 11-18 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Specifically, dependent claims 2-9 and 11-18 only further define the abstract ideas (mental process), and do not amount to significantly more than the abstract idea itself. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 1-18 do not disclose using the result of the mental process steps (i.e. generating AV delay settings), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, radiation therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process step of generating recommended AV delay settings. In other words, there is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to a mental process of generating recommended AV delay settings, which as stated above can be done mentally or with pen and paper. Accordingly, claims 1-18 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-18 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of a therapy circuit, electrodes, a cardiac signal sensing circuit, heart sound sensing circuit, and control circuit, but these elements have not been described with sufficient detail to constitute an improvement in the tech field, as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). Furthermore, by failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis and data transfer). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements further include steps of “delivering pacing stimulation” to a ventricle and atrium, all of which can be considered insignificant extra-solution activities. Specifically, these additional steps can be considered pre-solution activities as data-gathering steps by delivering stimulation to gather AsVp and ApVP data to later analyze, and therefore does not add any meaningful limitations to the claim. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2-9 and 11-18 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited a therapy circuit, electrodes, a cardiac signal sensing circuit, heart sound sensing circuit, and control circuit is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry, as shown in the reference as taught by Siejko (US 20040106961 A1) which teaches a pacemaker system/device (abstract – “A cardiac rhythm management system provides a phonocardiogrphic image indicative of a heart's mechanical events related to hemodynamic performance”), and further teaches heart sound sensing circuit (paragraph 0031), electrodes (paragraph 0036), controller (paragraph 0037), and ECG circuit (paragraph 0044).
Additionally, Owen (US 20040116969 A1) similarly teaches a cardiac pacing system (paragraph 0020 – “Yet another embodiment of the present invention provides an apparatus and method for delivering electrotherapy to a patient in which the electrotherapy is comprised of pacing stimuli and seeks capture of a cardiac pulse in the patient”) which senses heart sounds (paragraph 0068), cardiac signals (paragraph 0076), and further includes stimulation electrodes (paragraph 0067) and controller (paragraphs 0191, 0217).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 1-18 are not patent eligible under 35 USC § 101.
Allowable Subject Matter
Claims 1-18 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: the prior art searched does not, alone or in combination, anticipate and/or render obvious to the method of operating a cardiac rhythm management (CRM) system of claims 1 and 18 in their entireties, including at least to the method/devices comprising steps of delivering pacing stimulation to a ventricle after a sensed atrial event to set an atrial sense to ventricular pace interval (AsVp interval) and measuring the one or both of the heart sound and the QRS width for the AsVp interval, wherein the pacing stimulation is delivered using a conduction system pacing (CSP) vector that includes an electrode positioned in an interventricular septum; delivering pacing stimulation to an atrium to set an atrial pace to ventricular pace interval (ApVp interval) and measuring the one or both of the heart sound and the QRS width for the ApVp interval; and generating a recommended atrial to ventricular delay (AV delay) setting for CSP according to the measured one or both of the heart sounds and the QRS widths, in combination with the other limitations of the claims. Dependent claims 2-9 and 11-18 are further allowed due to their dependencies.
Closest prior art is considered to be Good (US 20090088814 A1) which teaches a pacemaker device/system (abstract – “Heart stimulating system for stimulating at least a ventricle of a heart including: stimulation pulse generator adapted to generate stimulation pulses and connected to a ventricular stimulation electrode for delivering stimulation pulses…”), comprising stimulation electrodes (paragraph 0072) and programming ApVp delays (paragraph 0054), but does not include measuring heart sound and/or the QRS width for an AsVp interval, and generating a recommended atrial to ventricular delay (AV delay) setting for CSP according to the measured one or both of the heart sounds and the QRS widths as claimed.
Claims 1-18 remain rejected under 35 USC 101 as stated above.
Conclusion
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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