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 10/9/23 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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.
Claim 13 is 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. It is unclear from the claim which element further comprises the hydrophilic coating-could be on catheter or balloon. Examiner interprets as on catheter.
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 1-12,17,19-25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Johnson et al. (US 2020/0046364) (“Johnson”).
A catheter device and method comprising: a catheter 200 including a longitudinal lumen and having a proximal end and a distal end, wherein the distal end is capable of insertion into at least the internal carotid artery [0049]; an occlusion balloon 204 connected to the distal end and operable to occlude blood flow in a blood vessel by inflation and deflation using a pressurization fluid [0057]; a pressure sensor 300 associated with the distal end and operable to measure blood pressure data from at least one of a downstream and upstream location of the occlusion balloon and transmit the blood pressure data to a controller; and the controller 400 operable to: receive the blood pressure data from the pressure sensor; generate inflation control information based on the blood pressure data; and transmit the inflation control information to the occlusion balloon, wherein the occlusion balloon is operable to inflate or deflate 408 based on the inflation control information by changing a selected volume of the pressurization fluid within the occlusion balloon. See abstract, Fig.1
the occlusion balloon is operable to inflate via injection of the selected volume of pressurization fluid into the occlusion balloon or deflate via removal of at least a portion of the selected volume from the occlusion balloon. [0019,0056-0058]
the inflation control information includes a value for the selected volume. [0056-0058] Figs. 8a-c, 9a-b
the pressurization fluid is saline and free of contrast agent. [0057]
the occlusion balloon is configured to dynamically adjust balloon inflation or deflation to maintain occlusion during movement of the catheter in the blood vessel based on feedback from the pressure sensor. [0108]
the occlusion balloon is operable to maintain sufficient occlusion without using a contrast agent to visualize occlusion. (occlusion is monitored via upstream and downstream sensors, not visualized [0018,0040,0043])
the catheter has a variable stiffness along a portion of a length of the catheter, wherein the variable stiffness comprises a catheter tip stiffness that is less than a catheter shaft stiffness. ([0044] catheter may be any catheter well-known in the art, having a length sufficiently long such that the catheter may be inserted into a patient via the femoral artery or radial artery, and extend through the patient’s vasculature into the aorta, [0048,0049])
the distal end (of catheter) is capable of insertion into at least one of the anterior cerebral arteries, anterior communicating arteries, and the middle cerebral arteries. ([0044] catheter may be any catheter well-known in the art, having a length sufficiently long such that the catheter may be inserted into a patient via the femoral artery or radial artery, and extend through the patient’s vasculature into the aorta, [0048,0049])
the catheter is adapted for radial access and further comprises a radial pressure sensor oriented along a radial portion of the longitudinal lumen, wherein the radial portion is in the radial artery. ([0044] catheter may be any catheter well-known in the art, having a length sufficiently long such that the catheter may be inserted into a patient via the femoral artery or radial artery, and extend through the patient’s vasculature into the aorta, [0048,0049])
the pressure sensor is operable to measure blood pressure data within a margin of error of less than 1 mmHg. [0059-0060]
the pressure sensor is operable to measure blood pressure waveform pulsatility and blood flow information. [0054,0077]
the inflation control information is generated from the blood pressure data and pressure-tracing algorithms. [0053-0058]
a graphical user interface electrically connected to the controller and operable to display blood pressure data and blood flow information. [0053-0055]
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Garrison (US 10,799,855).
Johnson discloses the invention as substantially claimed but does not directly disclose the obvious element of a hydrophilic coating including polyethylene terephthalate (PET), polytetrafluorethylene (PTFE), polyethylene (PE), or a combination thereof. Garrison, in the analogous art, teaches a hydrophilic coating on the working portion of the device. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added a hydrophilic coating on the catheter and/or balloon of Johnson as taught by Garrison to improve the ease of advancement of the device through the vasculature (Garrison C9L66-C10L2).
Claims 14-16,18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Barbut (US 6,312,444).
Johnson discloses the invention as substantially claimed but does not directly disclose the obvious elements of a balloon occlusion device such as proximal and distal occlusion balloons, a stent retriever to capture and remove a blood clot, a suction source to remove debris from a blood clot via aspiration and embolization delivery. Barbut, in the analogous art, teaches these obvious features. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have proximal and distal balloons, a stent retriever, suction source aspiration and embolization delivery to the device of Johnson as taught by Barbut as obvious design considerations for the safety of the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783