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 Group I in the reply filed on 12/05/2025 is acknowledged.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/05/2025.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 2, “first” should be inserted before “blood vessel”.
Appropriate correction is required.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0164867 (Kassab).
1. A system, comprising:
an intravascular catheter or guidewire (device 100) sized and shaped for positioning within a first blood vessel of a patient (FIG. 1; P0081); and
a processor circuit (processing circuit 104) configured for communication with the intravascular catheter or guidewire (FIG. 1; P0081)(P0010, P0090, P0092-P0093, P0102-P0106), wherein the processor circuit is configured to:
determine, using the intravascular catheter or guidewire, a first metric corresponding to a first state of a sympathetic nervous system of the patient (P0010 and P0092-P0093);
control the intravascular catheter or guidewire to alter a blood flow within the first blood vessel (FIG. 6; P0040, P0095);
determine, using the intravascular catheter or guidewire, a second metric corresponding to a second state of the sympathetic nervous system of the patient, the second state of the sympathetic nervous system resulting from the altered blood flow within the first blood vessel P0105-P0106); and
provide, to a display in communication with the processor circuit, an output based on the first metric and the second metric (P0102-P0105).
2. The intravascular catheter or guidewire comprises a blood flow sensor (sensor 130), and
wherein the processor circuit is configured to receive, from the blood flow sensor, blood flow data representative of the blood flow within the first blood vessel (P0082).
3. The processor circuit is configured to control the intravascular catheter or guidewire to alter the blood flow based on the blood flow data (FIG. 6; P0040, P0095).
4. The intravascular catheter or guidewire comprises a balloon (balloon 602), and
wherein, to control the intravascular catheter or guidewire to alter the blood flow, the processor circuit is configured to control expansion of the balloon within the first blood vessel to restrict the blood flow (FIG. 6; P0040, P0095).
5. The intravascular catheter or guidewire comprises a pump (P0095), and
wherein to control the intravascular catheter or guidewire to alter the blood flow, the processor circuit is configured to control the pump to: move blood from the first blood vessel to a second blood vessel; or move blood from the second blood vessel to the first blood vessel (FIG. 6; P0040, P0095).
6. The intravascular catheter or guidewire comprises a pressure sensor (pressure sensor 130), and wherein the first metric comprises a first blood pressure metric and the second metric comprises a second blood pressure metric (FIG. 7; P0094, P0096, and P0109-P0110).
7. The intravascular catheter or guidewire comprises at least one pressure sensor (pressure sensor 130) and at least one flow sensor (blood flow sensor 130), and wherein the first metric comprises a first fluid resistance metric and the second metric comprises a second fluid resistance metric (FIG. 7; P0082, P0094, P0096, and P0109-P0110).
8. The intravascular catheter or guidewire comprises an electrode (electrode 122, 124, 126, 128), and wherein the first metric corresponds to a first voltage metric and the second metric corresponds to a second voltage metric (P0010, P0090, P0092-P0093, P0095, P0102).
9. The intravascular catheter or guidewire comprises a strain sensor (strain gauge 130), and wherein the first metric corresponds to a first resistance metric and the second metric corresponds to a second resistance metric (P0110).
10. The processor circuit is configured to perform a comparison based on the first metric and the second metric (P0105-P0106).
11. The comparison comprises a determination of whether a difference between the first metric and the second metric exceeds a threshold difference (P0092-P0093).
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.
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.
Claim(s) 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0164867 (Kassab), as applied to claim 10 above, and further in view of US 2019/0090856 (Van Der Horst).
Kassab discloses the invention substantially as claimed as discussed above and further discloses the blood vessel being an artery (P0148) but does not disclose a renal artery. Van Der Horst teaches a system in the same field of endeavor where a similar intravascular device is used to recommend renal denervation or confirm success (FIG. 1a-1b; P0045-P0046) for the purpose of making an informed medical decision (FIG. 1a-1b; P0045-P0046). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system to include wherein the processor circuit is configured to recommend renal denervation or confirm success as taught by Van Der Horst in order to make an informed medical decision.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
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