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 without traverse of Species B (claim 17) in the reply filed on 01/22/2026 is acknowledged. Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/22/2026.
Remarks
This action is in response to the remarks filed 01/22/2026.
Claims 1, 13-15, and 17-36 are examined in the office action below.
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, 13-15, and 17-36 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.
Claim 1 recites the limitations "the position" in line 4, “the electrical activity” in line 6, and “the tissue” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, it is unclear what is meant by “stent-like structure”. It is unclear what shape the anchoring element comprises. For examination purposes, “stent-like structure” will be understood to mean a hollow structure.
Claims 33 and 34 end with the phrase “and, optionally” and does not include a period.
Claims 13-15, 17-19, 21-32, 35, and 36 are rejected based on their dependency on claim 1.
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.
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.
Claims 1, 13-15, 17-22, 24-33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2014/0046389), hereinafter Anderson, further in view of Sun et al. (US Patent Application Publication 2019/0224476), hereinafter Sun.
Regarding claim 1, Anderson discloses a system for providing therapy to a heart of a patient (e.g. Abstract), the system comprising:
an implantable device configured to be implanted proximate the heart of the patient (e.g. Par. [0028]), the implantable device comprising:
an anchoring element configured to maintain the position of the implantable device after implantation in the patient (e.g. Par. [0048]: fixation member);
at least one sensing electrode configured to sense the electrical activity of the heart (e.g. Par. [0036]);
at least three pacing electrodes configured to deliver electrical energy to the tissue of the heart (e.g. Par. [0053]); and
a controller including an algorithm, wherein the algorithm is configured to determine when the patient requires therapy (e.g. Par. [0052]: processor 70; Par. [0032]: algorithm can be used); and
an external device comprising a transceiver configured to communicate with the implantable device (e.g. Par. [0033]), wherein the implantable device does not comprise a battery (e.g. Fig. 6: IMD 12 does not have a battery).
However, Anderson fails to specifically disclose a transceiver configured to transmit energy to the implantable device. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses transmitting energy to the implantable device (e.g. Pars. [0040]-[0041]: charging the device by harvesting electrical energy from the communication device).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson to include the energy transmission as taught by Sun because doing so would charge the device.
Regarding claim 13, Anderson further discloses wherein the implantable device comprises at least a portion that is configured to be implanted in a blood vessel of the patient and wherein the at least a portion comprises at least one electrode of the at least three pacing electrodes (e.g. Par. [0030]).
Regarding claim 14, Anderson further discloses wherein the at least a portion is configured to be implanted in a vein of the patient (e.g. Par. [0030]).
Regarding claim 15, Anderson fails to specifically disclose wherein the vein comprises the Vein of Marshall. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses the device being implanted in the Vein of Marshall (e.g. Par. [0070]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the vein being the Vein of Marshall as taught by Sun to enable pacing and defibrillation (e.g. Sun, par. [0070]).
Regarding claim 17, Anderson further discloses wherein the at least a portion comprises a geometry that allows flow of blood through the at least a portion (e.g. Fig. 6: lead 16 does not block the portion so it would allow flow of blood).
Regarding claim 18, Anderson further discloses wherein the implantable device comprises at least a first portion that is configured to be implanted in a blood vessel of the patient, wherein the first portion comprises at least one electrode of the at least three pacing electrodes (e.g. Par. [0036]; Par. [0053]; Par. [0030]). However, Anderson fails to disclose at least a second portion that is configured to be implanted on the epicardial surface of the patient's heart, wherein the second portion comprises at least one electrode of the at least three pacing electrodes.
Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses a second portion that is configured to be implanted on the epicardial surface of the patient's heart, wherein the second portion comprises at least one electrode of the at least three pacing electrodes (e.g. Par. [0068]: epicardial placement).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include a portion implanted on the epicardial surface as taught by Sun because this placement would allow pacing and defibrillation for treatment of arrhythmia.
Regarding claim 19, Anderson further discloses wherein the implantable device comprises at least a first portion that is configured to be implanted in a blood vessel of the patient, wherein the first portion comprises at least one electrode of the at least three pacing electrodes (e.g. Par. [0036]; Par. [0053]; Par. [0030]). However, Anderson fails to disclose at least a second portion that is configured to be implanted at a second anatomical location, wherein the second portion comprises the controller.
Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses a second portion that is configured to be implanted at a second anatomical location, wherein the second portion comprises a controller (e.g. Par. [0068]: epicardial placement).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include a second portion implanted on the epicardial surface as taught by Sun because this placement would allow pacing and defibrillation for treatment of arrhythmia.
Regarding claim 20 (as best understood, see rejection of claim 20 under 35 U.S.C. 112(b) above), Anderson further discloses wherein the anchoring element comprises a stent- like structure (e.g. Fig. 5: anchor 32 is hollow to allow lead body to pass through).
Regarding claim 21, Anderson further discloses wherein the anchoring element comprises a diameter that tapers between a first portion of the anchoring element and a second portion of the anchoring element (e.g. Fig. 5).
Regarding claim 22, Anderson further discloses wherein the anchoring element comprises a first anchor positioned at a first end of the implantable device and a second anchor positioned at a second end of the implantable device (e.g. Fig. 5: anchor element 44 anchored at both ends).
Regarding claim 24, Anderson fails to disclose wherein the external device transceiver is configured to transmit electromagnetic energy to the implantable device. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses transmitting energy to the implantable device (e.g. Pars. [0040]-[0041]: charging the device by harvesting electrical energy from the communication device).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the energy transmission as taught by Sun because doing so would charge the device.
Regarding claim 25, Anderson further discloses wherein the implantable device is configured to treat atrial fibrillation (e.g. Par. [0060]).
Regarding claim 26, Anderson further discloses wherein the implantable device is configured to monitor the electrical activity of the heart for atrial fibrillation (e.g. Par. [0060]).
Regarding claim 27, Anderson further discloses wherein the implantable device is configured to pace the heart muscle to restore sinus rhythm when atrial fibrillation is detected (e.g. Par. [0029]; Par. [0060]).
Regarding claim 28, Anderson further discloses wherein at least two of the at least three pacing electrodes are positioned at different locations (e.g. Fig. 7: electrodes 24, 26, and 28 at different locations).
Regarding claim 29, Anderson further discloses wherein the at least two of the at least three pacing electrodes are positioned at different locations proximate the left atrium (e.g. Par. [0037]).
Regarding claim 30, Anderson fails to disclose wherein the implantable device comprises a first geometry and a second geometry, wherein the first geometry comprises an undeployed geometry and the second geometry comprises a deployed geometry. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses wherein the implantable device comprises a first geometry and a second geometry, wherein the first geometry comprises an undeployed geometry and the second geometry comprises a deployed geometry (e.g. Par. [0095]; Fig. 6: device shown in undeployed and deployed geometry).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the undeployed and deployed geometry as taught by Sun because this configuration would allow the device to be implanted into a patient.
Regarding claim 31, Anderson fails to disclose wherein the implantable device is configured to transition from the first geometry to the second geometry. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses wherein the implantable device is configured to transition from the first geometry to the second geometry (e.g. Par. [0095]; Fig. 6: device shown in undeployed and deployed geometry).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include transitioning from the undeployed to the deployed geometry as taught by Sun because this configuration would allow the device to be implanted into a patient.
Regarding claim 32, Anderson fails to disclose wherein the second geometry comprises a helical geometry. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses wherein the second geometry comprises a helical geometry (e.g. Par. [0095]; Fig. 6: device shown in undeployed and deployed geometry with a helical portion).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the deployed helical geometry as taught by Sun because this configuration would allow the device to be implanted into a patient.
Regarding claim 33, Anderson further discloses wherein the implantable device further comprises a functional element that comprises an element selected from the group consisting of: a sensor; a transducer; a pumping mechanism; and combinations thereof (e.g. Par. [0034]: electrode can be used as a sensor).
Regarding claim 36, Anderson fails to disclose an implantation device configured to deliver the implantable device into the patient and/or to treat the patient. Sun, in a similar field of endeavor, is directed towards wireless treatment of arrhythmias. Sun discloses an implantation device configured to deliver the implantable device into the patient and/or to treat the patient (e.g. Par. [0095]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the implantation device as taught by Sun because this configuration would allow the device to be implanted into a patient.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2014/0046389), hereinafter Anderson, further in view of Sun et al. (US Patent Application Publication 2019/0224476), hereinafter Sun, as applied to claim 1 above, and further in view of Rottenberg (US Patent Application Publication 2018/0177431).
Regarding claim 23, Anderson fails to disclose wherein the algorithm comprises an artificial intelligence algorithm. Rottenberg, in a similar field of endeavor, is directed towards an implantable monitoring device. Rottenberg discloses using an artificial intelligence algorithm to monitor the patient (e.g. Par. [0093]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the artificial intelligence algorithm as taught by Rottenberg to provide improved monitoring of biological conditions.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2014/0046389), hereinafter Anderson, further in view of Sun et al. (US Patent Application Publication 2019/0224476), hereinafter Sun, as applied to claim 33 above, and further in view of Savoie et al. (US Patent Application Publication 2011/0022025), hereinafter Savoie.
Regarding claim 34, Anderson fails to disclose wherein the functional element comprises a pumping mechanism configured to deliver a flowable material selected from the group consisting of: a pharmaceutical drug; a cooling fluid; a warming fluid; an insufflation fluid; and combinations thereof. Savoie is directed towards a medical device. Savoie discloses a functional element with a pumping element that delivers a pharmaceutical drug (e.g. Par. [0012]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the pumping element as taught by Savoie because doing so would provide the user with a pharmaceutical drug to treat the patient.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US Patent Application Publication 2014/0046389), hereinafter Anderson, further in view of Sun et al. (US Patent Application Publication 2019/0224476), hereinafter Sun, as applied to claim 1 above, and further in view of Koop et al. (US Patent Application Publication 2018/0264270), hereinafter Koop.
Regarding claim 35, Anderson fails to disclose wherein the functional element comprises a sensor selected from the group consisting of: accelerometer; position sensor; gravimetric sensor; pressure sensor; strain gauge; and combinations thereof. Koop, in a similar field of endeavor, is directed towards an implantable medical device. Koop discloses using an accelerometer and pressure sensor (e.g. Par. [0165]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson in view of Sun to include the accelerometer and pressure sensor as taught by Koop because doing so would allow identification of patient posture and/or activity level and changes in blood pressure (e.g. Koop, par. [0165]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bulkes et al. (US 2008/0039904) is directed towards an intravascular implant system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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