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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-15, in the reply filed on December 22, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invetnion, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 22, 2025.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/6/2023 and 2/5/2024 has/have been acknowledged and is/are being considered by the Examiner.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7, 9-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hastings et al. (U.S. 2009/0018599), herein Hastings. Regarding claim 1, Hastings discloses an implantable cardiac monitor comprising: a main body 26 having a motherboard 216 including a processor and a memory, the memory including a tangible, non-transitory computer readable medium with processor-executable instructions stored thereon (“a seed circuit 216 within the seed 207, which may include capability for charge storage, electrical stimulation (pace) delivery, electrical sense, and information transmit, receive and storage. Seed 207 may correspond to any of the seeds shown in FIGS. 1-4 and described above”, paragraph [0053], where it is understood that seed circuit 216 is likewise included in seed 26, and seed circuit 216 inherently includes a processor and memory in order to have the functions of electrical stimulation delivery, electrical sense, and information transmit, receive, and storage); and a tail member 38a-c connected to the main body and having one or more electrodes 36a-c being adapted to receive electrical signals relative to a first position (“one or more additional electrode assemblies 36 may be positioned at appropriate pacing sites, and may be electrically connected to the seed electrode assembly 26 via micro lead wires 38.”, paragraph [0038], see Figure 1 showing tail members attached to seed 26).
Regarding claim 2, Hastings discloses that the motherboard includes a monitoring module configured to generate monitoring data based on received cardiac electrical signals from a patient, and the memory is configured to store the monitoring data (“At step 765, sense circuitry monitors for detection of a native cardiac electrical signal within a specified time period from the receipt of the transmitted signal. In an implementation, the wireless electrode assembly includes sense circuitry to sense the native cardiac electrical signal and timing circuitry to implement a monitoring period.”, paragraph [0084]).
Regarding claim 3, Hastings discloses that the monitoring data includes at least one of a heartrate, a P-wave, a PR interval, a PR segment, a QRS complex, a ST segment, a T wave, or a combination thereof (“normal sinus rhythm” as disclosed at paragraph [0085] includes a P-wave, a PR interval, a PR segment, a QRS complex, a ST segment, and a T wave).
Regarding claim 7, Hastings discloses that the main body further comprises an internal battery in electrical communication with the motherboard (“the wireless electrode assembly 26 includes a battery to store received electrical charge”, paragraph [0033]).
Regarding claim 9, Hastings discloses that the main body further comprises an internal coil 212 in electrical communication with the internal battery and configured to be inductively coupled to an external coil (“The seed coil 212 may be inductively coupled to the lead coil 203 to permit transmissions from the leaded transmitter to the leadless receiver”, paragraph [0054]).
Regarding claim 10, Hastings discloses that the main body further comprises an internal antenna 212 (“Each of coils 203 and 212 may be considered an antenna”, paragraph [0056]) in electrical communication with the motherboard and configured to be in wireless communication with an external monitoring device (“The seed coil 212 may be inductively coupled to the lead coil 203 to permit transmissions from the leaded transmitter to the leadless receiver”, paragraph [0054]).
Regarding claim 11, Hastings discloses a second tail member having one or more electrodes being adapted to receive electrical signals relative to a second position (see Figure 1, which shows three lead wires 38a-c and three electrodes 36a-c).
Regarding claim 12, Hastings discloses a third tail member having one or more electrodes being adapted to receive electrical signals relative to a third position (see Figure 1, which shows three lead wires 38a-c and three electrodes 36a-c).
Regarding claim 15, Hastings discloses that the main body includes one or more electrodes being adapted to receive electrical signals relative to a second position (“FIG. 4 is a diagram of various exemplary implementations of leadless electrode assemblies 26 that may be used in the systems of FIGS. 1-3….A first leadless (or wireless) electrode assembly 26a includes a proximal electrode 121 at or near a proximal end of the assembly 26a and a distal electrode 129 at or near a distal end of the assembly 26a, according to an implementation.”, paragraph [0043]).
Claims 1-7, 9-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higgins et al. (U.S. 2020/0196899), herein Higgins. Regarding claim 1, Higgins discloses an implantable cardiac monitor 10 comprising: a main body 15 having a motherboard including a processor 224 and a memory 226, the memory including a tangible, non-transitory computer readable medium with processor-executable instructions stored thereon (see Figures 1A and 2 and “ ICD 10 may receive programmable operating parameters and algorithms via telemetry circuit 330 for storage in memory 226 or other memory. For example, memory 226 may be any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.”); and a tail member 6/11/16 connected to the main body and having one or more electrodes 28/30/24/26/17/21/8 (“RV lead 16 is equipped with pacing and sensing electrodes shown as a ring electrode 30 and a tip electrode 28. In some examples, tip electrode 28 is an extendable helix electrode mounted retractably within an electrode head 29. RV lead 16 is further shown to carry defibrillation electrodes 24 and 26”, paragraph [0028], “Lead 11 is equipped with pacing and sensing electrodes 17 and 21”, paragraph [0030], and “CS lead 6 is shown in the embodiment of FIG. 1A as having one or more electrodes 8”, paragraph [0031]) being adapted to receive electrical signals relative to a first position (see Figure 1A).
Regarding claim 2, Higgins discloses that the motherboard includes a monitoring module configured to generate monitoring data based on received cardiac electrical signals from a patient, and the memory is configured to store the monitoring data (“Processor 224 may employ digital signal analysis techniques to characterize the digitized signals stored in memory 226 to recognize and classify the patient's heart rhythm employing any of numerous signal processing methodologies for analyzing cardiac signals and cardiac event waveforms”, paragraph [0050]).
Regarding claim 3, Higgins discloses that the monitoring data includes at least one of a heartrate, a P-wave, a PR interval, a PR segment, a QRS complex, a ST segment, a T wave, or a combination thereof (“Processor 224 may employ digital signal analysis techniques to characterize the digitized signals stored in memory 226 to recognize and classify the patient's heart rhythm employing any of numerous signal processing methodologies for analyzing cardiac signals and cardiac event waveforms, e.g., P-waves and R-waves.”, paragraph [0050]).
Regarding claim 4, Higgins discloses that the monitoring module is configured to predict a cardiac event based on the monitoring data (“a series of measured intervals for analysis by the processor 224 for predicting or diagnosing an arrhythmia”, paragraph [0060]).
Regarding claim 5, Higgins discloses that the cardiac event includes at least one of atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular tachycardia, pause, atrial brady, atrial tachycardia, atrial bigeminy, atrial trigeminy, ventricular bigeminy, ventricular trigeminy, acute coronary syndrome, or a combination thereof (“The differences between successive RR intervals (RRIs) are analyzed for determining evidence of atrial tachyarrhythmia, e.g., atrial fibrillation.”, paragraph [0025], and “FIG. 9 is a schematic diagram of a method for detecting atrial fibrillation that may be performed by ICD 10”, paragraph [0127]).
Regarding claim 6, Higgins discloses that the monitoring module includes an algorithm configured to predict the cardiac event (“Techniques disclosed herein may be utilized as part of an overall tachyarrhythmia detection and discrimination algorithm implemented in ICD 10”, paragraph [0085]).
Regarding claim 7, Higgins discloses that the main body further comprises an internal battery in electrical communication with the motherboard (“As described above in conjunction with FIG. 2, housing 115 may house… one or more batteries”, paragraph [0066]).
Regarding claim 9, Higgins discloses that the main body further comprises an internal coil 332 in electrical communication with the internal battery and configured to be inductively coupled to an external coil (“antenna 332”, paragraph [0054], and Figure 2).
Regarding claim 10, Higgins discloses that the main body further comprises an internal antenna 332 in electrical communication with the motherboard and configured to be in wireless communication with an external monitoring device (“antenna 332”, paragraph [0054], and Figure 2).
Regarding claim 11, Higgins discloses a second tail member having one or more electrodes being adapted to receive electrical signals relative to a second position (see Figure 1A, which shows three lead wires 6/11/16 and electrodes 28/30/24/26/17/21/8).
Regarding claim 12, Higgins discloses a third tail member having one or more electrodes being adapted to receive electrical signals relative to a third position (see Figure 1A, which shows three lead wires 6/11/16 and electrodes 28/30/24/26/17/21/8).
Regarding claim 15, Higgins discloses that the main body includes one or more electrodes being adapted to receive electrical signals relative to a second position (“The housing 115 may function as a housing electrode (sometimes referred to as a can electrode)”, paragraph [0065]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 8, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hastings (U.S. 2009/0018599, cited above). Regarding claim 8, Hastings discloses the invention substantially as claimed, but fails to disclose that the internal battery has a rectangular shape with rounded corners. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Hastings such that the internal battery has a rectangular shape with rounded corners, because Applicant has not disclosed that the internal battery has a rectangular shape with rounded corners provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the battery shape of Hastings, because it provides adequate power to the device and since it appears to be an arbitrary design consideration which fails to patentable distinguish over Hastings. Therefore, it would have been an obvious matter of design choice to modify Hastings to obtain the invention as specified in the claim.
Regarding claim 13, Hastings discloses the invention substantially as claimed, but fails to disclose a fourth tail member having one or more electrodes being adapted to receive electrical signals relative to a fourth position. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Hastings to include a fourth tail member having one or more electrodes being adapted to receive electrical signals relative to a fourth position, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04
Regarding claim 14, Hastings discloses that the main body includes one or more electrodes being adapted to receive electrical signals relative to a fifth position (“FIG. 4 is a diagram of various exemplary implementations of leadless electrode assemblies 26 that may be used in the systems of FIGS. 1-3….A first leadless (or wireless) electrode assembly 26a includes a proximal electrode 121 at or near a proximal end of the assembly 26a and a distal electrode 129 at or near a distal end of the assembly 26a, according to an implementation.”, paragraph [0043]).
Claims 8, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Higgins (U.S. 2020/0196899, cited above). Regarding claim 8, Higgins discloses the invention substantially as claimed, but fails to disclose that the internal battery has a rectangular shape with rounded corners. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the device of Higgins such that the internal battery has a rectangular shape with rounded corners, because Applicant has not disclosed that the internal battery has a rectangular shape with rounded corners provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the battery shape of Higgins, because it provides adequate power to the device and since it appears to be an arbitrary design consideration which fails to patentable distinguish over Higgins. Therefore, it would have been an obvious matter of design choice to modify Higgins to obtain the invention as specified in the claim.
Regarding claim 13, Higgins discloses the invention substantially as claimed, but fails to disclose a fourth tail member having one or more electrodes being adapted to receive electrical signals relative to a fourth position. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Higgins to include a fourth tail member having one or more electrodes being adapted to receive electrical signals relative to a fourth position, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04
Regarding claim 14, Higgins discloses that the main body includes one or more electrodes being adapted to receive electrical signals relative to a fifth position (“The housing 115 may function as a housing electrode (sometimes referred to as a can electrode)”, paragraph [0065]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796