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 (IDS) submitted on 05/01/2024 is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Element 14 is not shown in Figure 2A but is mentioned in the specification on page 8, para. 56.
Element 160 is not shown in Figure 15 but is mentioned in the specification on page 13, para. 73.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 8 has element 122, but contains no written description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Device for Left Atrial Appendage to Reduce Blood Stagnation.
Claim Objections
Claims 1-2, 7, 11, and 19-20 are objected to because of the following informalities:
Claim 1 line 3 reads "an actuatable device" should read "the actuatable device".
Claim 2 line 1 reads “claim 16” should read “claim 1”.
Claim 7 line 1 reads “comprises” should read “further comprises”.
Claim 11 line 3 reads “an actuatable device” should read “the actuatable device”.
Claim 19 line 1 reads “claim 17” should read “claim 16”.
Claim 20 lines 1 reads “claim 17” should read “claim 16”.
Appropriate correction is required.
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 10 and 14 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.
The term “threshold” in claim 10 is a relative term which renders the claim indefinite. The term “threshold” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not disclose what value the threshold is.
Claim 10 recites the limitation "power generation element" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "structure" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 fails to further limit claim 11. Claim 13 appears to further limit the detection of atrial fibrillation, but introduces new subject matter ("generated power") that is not positively recited in claim 11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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, 2, 4, and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rabito et al. (US 11369780 B2), hereinafter, Rabito.
Regarding claim 1, Rabito teaches a method for reducing blood stagnation within a left atrial appendage (LAA) using an actuatable device (abstract (methods and devices)), the method comprising:
disposing an actuatable device within the LAA (Fig. 18A, element 142, col. 8, line 66-67 (device is implanted between the PA and LAA)) that is adapted to create blood flow within the LAA (abstract (increasing the flow through the LAA));
actuating the actuatable device in order to reduce blood stagnation within the LAA (col. 9, line 4 (preventing stasis)).
Regarding claim 2, Rabito teaches actuating the method of claim 1, wherein actuating the actuatable device comprises subjecting the actuatable device to blood flow within the LAA ((abstract (increasing the flow through the LAA), col. 9, line 4 (preventing stasis));
Regarding claim 4, Rabito teaches the method of claim 1, wherein the actuatable device comprises a propeller (Fig. 18A, element 144, col. 8, line 67 (first impeller), Fig. 18A, element 146, col. 9, line 2 (second impeller)).
Regarding claim 6, Rabito teaches the method of claim 4, wherein the propeller is adapted to be actuatable via motion within the LAA (col. 8, line 67 - col. 9 lines 1-4 (first impeller is rotated by the blood flow through the PA and transfers its rotational energy to the second impeller, which agitates the blood in the LAA, preventing stasis)).
Claims 11 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Goldberger et al. (US 20040015104 A1), hereinafter Goldberger.
Regarding claim 11, Goldberger teaches a method for reducing blood stagnation within a left atrial appendage (LAA) using an actuatable device (abstract (devices and methods for reducing the risk of thrombus formation)), the method comprising:
disposing an actuatable device (Fig. 1, element 100, para. 0021 (device implanted in the heart to increase blood flow)) within the LAA that is adapted to create blood flow within the LAA (abstract (provide energy to blood flowing within a chamber or vessel to prevent blood stasis));
monitoring for indications of atrial fibrillation (para. 0020 (monitoring devices to measure the heart rhythm and/or blood flow), 0039 (monitor the heart rhythm for detection of atrial fibrillation episodes));
and in response to detecting atrial fibrillation, actuating the actuatable device in order to reduce blood stagnation within the LAA (para. 0020 (device activated when atrial fibrillation or stasis in blood flow is detected or observed)).
Regarding claim 12, Goldberger teaches the method of claim 11, further comprising ceasing operation of the actuatable device when a normal heart rhythm is once again detected (para. 0056 (normal electrical rhythm of the atria of the heart is sinus rhythm), 0039 (when sinus rhythm returns, the device would cease operation)).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rabito and in view of Strauss et al. (US 20160192942 A1), hereinafter Strauss.
Regarding claim 3, Rabito teaches the method of claim 1.
Rabito does not teach wherein the actuatable device comprises an oscillating piston pump.
Strauss teaches wherein the actuatable device comprises an oscillating piston pump (para. 0084 (piston is being ejected or expelled from the distal end of the catheter tube… piston can grasp a portion of the implant)).
Rabito and Strauss are considered to be analogous to the claimed invention because they are in the same field of preventing thrombus formation within the body. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rabito to incorporate the teachings of Strauss and provide an oscillating piston pump. Although Rabito does teach the “device includes implants that are external to the LAA but use the walls of the LAA to act as a pump” which allows blood flow into and out of the LAA, Rabito does not explicitly disclose a piston pump (col. 8, lines 31-35). Therefore, incorporating Strauss teachings of the piston pump would have predictably provided a controlled and consistent blood flow within the device, as opposed to relying on the motion of the LAA, which enhances thrombus prevention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Rabito and in view of Tamburino et al. (WO 2015075576 A1), hereinafter Tamburino.
Regarding claim 5, Rabito teaches the method of claim 4.
Rabito does not teach wherein the actuatable device further comprises a motor adapted to rotate the propeller.
Tamburino teaches wherein the actuatable device (para. 0017 (endoluminal device)) comprises a motor (para. 0051 (electric motor for operating the control element)) adapted to rotate the propeller (para. 0041 (control element comprises three rotating vanes)).
Rabito and Tamburino are considered to be analogous to the claimed invention because they are in the same field of creating blood flow within the heart to prevent heart failure. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rabito to incorporate the teachings of Tamburino and provide a motor adapted to rotate the propeller. Doing so would have predictably enabled efficient and controlled blood flow to the LAA, where natural blood flow from the propeller only, may be insufficient.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rabito and in view of Dang et al. (US 20210401418 A1), hereinafter, Dang.
Regarding claim 7, Rabito teaches the method of claim 4.
Rabito does not teach wherein the actuatable device comprises a piezoelectric material and a battery.
Dang teaches wherein the device comprises a piezoelectric material and a battery (para. 0045 (devices can include piezoelectric material and an energy storage device (batteries) for energy harvesting)).
Rabito and Dang are considered to be analogous to the claimed invention because they are in the same field of preventing thrombus formation within the body. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rabito to incorporate the teachings of Dang and provide a piezoelectric motor and a battery. Doing so would provide a self-powered device, reducing the assistance of external users to operate the device.
Regarding claim 8, Rabito teaches the method of claim 7.
Rabito does not teach wherein normal motion during times without atrial fibrillation is used to charge the battery, and wherein energy is released via the piezoelectric material during times of atrial fibrillation.
Dang teaches wherein normal motion during times without atrial fibrillation is used to charge the battery (para. 0045 (energy storage device (batteries) for energy harvesting), 0053 (energy harvesting from blood flow-induced vibrations)), and wherein energy is released via the piezoelectric material (para. 0049 (piezoelectric sensor to generate an electrical signal in response to fluid pressure or other external stimulus)) during times of atrial fibrillation (para. 0047 (physiological parameters that can be tracked by sensor-enabled occluders can include arrhythmia), 0048 (electrical activity sensors can provide information used to detect arrhythmia)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rabito to incorporate the teachings of Dang and provide an energy harvested battery being charged during normal motion without atrial fibrillation, as well as releasing energy during atrial fibrillation. Dang teaches energy harvesting from the piezoelectric material, and detection of arrhythmia conditions. This ensures that power is available during atrial fibrillation due to a self-powered device, which reduces the assistance of external users to operate the device.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rabito and in view of Leonhardt et al. (US 20210077687 A1), hereinafter, Leonhardt.
Regarding claim 9, Rabito teaches the method of claim 1, wherein the actuatable device comprises:
a housing adapted to be secured within the LAA (Fig. 6, element 60, col. 6, line 55-56 (flow diverter is anchored to the LLF of the LA));
a housing inlet that is adapted to allow blood to flow into the actuatable device (col. 7, line 1 (flow diverter redirects blood flow));
a housing outlet that is adapted to allow blood to flow out of the actuatable device (col. 7, line 1 (flow diverter redirects blood flow));
a power generation element adapted to harness the blood flow to generate power (col. 8, line 67 - col. 9 lines 1-4 (first impeller is rotated by the blood flow through the PA and transfers its rotational energy to the second impeller, which agitates the blood in the LAA, preventing stasis)).
Rabito does not teach the actuatable device comprising a battery that is charged by the power generated by the power generation element.
Leonhardt teaches wherein an actuatable device comprising a battery that is charged by the power generated by the power generation element (para. 0016 (rotating impeller), 0085 (battery backup power source can be charged by impeller blade turns)).
Rabito and Leonhardt are considered to be analogous to the claimed invention because they are in the same field of providing circulatory support within the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rabito to incorporate the teachings of Leonhardt and provide a battery within the device, that is charged with the power generated by the power generation element. Doing so would allow the battery to be charged within the implantable device as opposed to being charged by external sources.
Claims 14-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tamburino and in view of Rabito.
Regarding claim 14, Tamburino teaches an actuatable device for reducing blood stagnation within a left atrial appendage (LAA) (para. 0017 (endoluminal device), para. 0002 (creation of a two-way controlled of interatrial blood)), the actuatable device comprising:
structure adapted to anchor the actuatable device within the LAA (Fig. 1, element 10, para. 0018 (anchor));
a moveable element that is constrained by the structure but is movable relative to the structure in response to an applied stimuli (para. 0041 (control element comprises three rotating vanes));
wherein movement of the moveable element in response to the applied stimuli causes blood flow within the LAA, thereby reducing blood stagnation (para. 0043 (the interatrial blood flow is achieved through a single control element), 0048 (system for the treatment of heart failure, and in particular for the control of interatrial blood for the creation of a controlled two way flow)).
Tamburino does not explicitly disclose the device being within a left atrial appendage.
Rabito teaches an actuatable device for reducing blood stagnation (col. 9, line 4 (preventing stasis)) within a left atrial appendage (LAA) (Fig. 18A, element 142, col. 8, line 66-67 (device is implanted between the PA and LAA)), the actuatable device comprising:
a moveable element that is constrained by the structure but is movable relative to the structure in response to an applied stimuli (Fig. 18A, element 144, col. 8, line 67 (first impeller), Fig. 18A, element 146, col. 9, line 2 (second impeller));
wherein movement of the moveable element in response to the applied stimuli causes blood flow within the LAA, thereby reducing blood stagnation (col. 8, line 67 - col. 9 lines 1-4 (first impeller is rotated by the blood flow through the PA and transfers its rotational energy to the second impeller, which agitates the blood in the LAA, preventing stasis)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tamburino to incorporate the teachings of Rabito and have the actuatable device be within the left atrial appendage. Doing so would target specifically the left atrial appendage, to reduce thrombi formation, and promote blood flow.
Regarding claim 15, Tamburino (in view of Rabito) teaches the actuatable device of claim 14, wherein the applied stimuli comprises movement of cardiac tissue during a cardiac cycle (abstract (rotation of the control element in relation to the central body)).
Regarding claim 16, Tamburino (in view of Rabito) teaches the actuatable device of claim 14, wherein the applied stimuli comprises an applied current (para. 0043 (the interatrial blood flow is achieved through a single control element)).
Regarding claim 17, Tamburino (in view of Rabito) teaches the actuatable device of claim 14, wherein the moveable element comprises a propeller (para. 0041 (control element comprises three rotating vanes)).
Regarding claim 18, Tamburino (in view of Rabito) teaches the actuatable device of claim 17, further comprising a motor adapted to rotate the propeller (para. 0051 (electric motor for operating the control element)).
Regarding claim 20, Tamburino (in view of Rabito) teaches the actuatable device of claim 17, wherein the applied current is internally generated (abstract (rotation of the control element in relation to the central body)).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tamburino and in view of Rabito and in further view of Wemeth et al. (WO 2019136218 A1), hereinafter, Wemeth.
Regarding claim 19, Tamburino (in view of Rabito) teaches the actuatable device of claim 17.
Tamburino (in view of Rabito) does not teach wherein the applied current is externally provided.
Wemeth teaches an actuatable device (para. 003 (implant position in the left atrial appendage)) wherein the applied current is externally provided (para. 099 (communication device is maintained outside of the patient’s body, configured to transfer energy to implant), 115 (implant can comprise electronics module to receive energy from communication device)).
Tamburino, Rabito and Wemeth are all considered to be analogous to the claimed invention because they are in the same field of preventing thrombus formation within the heart. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tamburino (in view of Rabito) to incorporate the teachings of Wemeth and provide an applied current that is externally provided. Doing so would allow the device to deliver stimulation energy to pace the heart when an abnormal cardiac rhythm is detected, for patient safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 7:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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