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 .
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 8, 16 and 17 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 8 recites “the amplifier” and “the rectifier”. There is insufficient antecedent basis for this limitation. Examiner assumes claim 8 is dependent on claim 7.
Claim 16 and 17 recite “the comparison”. There is insufficient antecedent basis for this limitation.
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 11 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 11 limits the blood vessel, and fails to further limit the system.
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)(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) 1-10, 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab et al. (US 20170164867 – cited by Applicant), hereinafter Kassab.
Regarding Claim 1, Kassab teaches: A system, comprising:
an endovascular catheter or guidewire configured to be positioned within a blood vessel of a patient (figure 1), wherein the endovascular catheter of guidewire comprises:
a first set of electrodes comprising a first electrode and a second electrode (electrodes 126 and 128); and
a second set of electrodes comprising a third electrode and a fourth electrode (electrodes 122 and 124); and
a processor circuit configured for communication with the endovascular catheter or guidewire (processing circuit 104), wherein the processor circuit is configured to:
control the first set of electrodes such that an electrical current is transmitted between the first electrode and the second electrode (paragraph 0010);
control the second set of electrodes to obtain a first measurement of a voltage difference between the third electrode and the fourth electrode (paragraph 0010; paragraph 0090 – voltage across detection electrodes);
determine, based on the first measurement of the voltage difference, a first flow metric for blood flow within the blood vessel (paragraph 0092-0093); and
output the first flow metric to a display in communication with the processor circuit (paragraph 0105-0106).
Regarding Claim 2, Kassab teaches: The system of claim 1, further comprising a power source configured for electrical communication with the processor circuit and the first set of electrodes (paragraph 0089).
Regarding Claim 3, Kassab teaches: The system of claim 2, wherein, to control the first set of electrodes, the processor circuit is configured to control the power source to provide the electrical current to only the first electrode (paragraph 0088).
Regarding Claim 4, Kassab teaches: The system of claim 3, wherein the first electrode is configured to transmit the electrical current to the second electrode using a first electrical circuit formed between the first electrode and the second electrode by the blood flow (paragraph 0102, 0095).
Regarding Claim 5, Kassab teaches: The system of claim 4, wherein the second set of electrodes is configured to obtain the first measurement of the voltage difference using a second electrical circuit formed between the third electrode and the fourth electrode by the blood flow (paragraph 0092-0093).
Regarding Claim 6, Kassab teaches: The system of claim 4, wherein the electrical current comprises a constant electrical current (paragraph 0098-0100).
Regarding Claim 7, Kassab teaches: The system of claim 1, further comprising at least one of an amplifier or a rectifier configured for electrical communication with the second set of electrodes (paragraph 0109).
Regarding Claim 8, Kassab teaches: The system of claim 5, wherein the processor circuit is configured to control at least one of the amplifier or the rectifier to determine the first measurement of the voltage difference based on the electrical communication with the third electrode and the fourth electrode (paragraph 0109).
Regarding Claim 9, Kassab teaches: The system of claim 1, wherein the third electrode and the fourth electrode are positioned between the first electrode and the second electrode (figure 1).
Regarding Claim 10, Kassab teaches: The system of claim 1,
wherein the first electrode and the second electrode comprise a first spacing, and
wherein the first electrode and the third electrode comprise a second spacing less than the first spacing (figure 1).
Regarding Claim 12, Kassab teaches: The system of claim 1, further configured to:
control the second set of electrodes to obtain a second measurement of the voltage difference between the third electrode and the fourth electrode; and
determine, based on the first measurement of the voltage difference, a second flow metric for the blood flow (paragraph 0089-0092).
Regarding Claim 13, Kassab teaches: The system of claim 12, wherein the processor circuit is configured to output the second flow metric to the display (paragraph 0105-0106).
Regarding Claim 14, Kassab teaches: The system of claim 12, wherein the processor circuit is configured to compare the first flow metric and the second flow metric (paragraph 0105-0106).
Regarding Claim 15, Kassab teaches: The system of claim 14,Kassab teaches: wherein the processor circuit is configured to provide an output based on the comparison to the display (paragraph 0105-0106).
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(s) 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of Kassab et al. (US 20140276121 – cited by Applicant), hereinafter Kassab2014.
Regarding Claim 11, Kassab teaches: The system of claim 1, but does not mention wherein the blood vessel comprises a renal artery.
Kassab2014 teaches the use of a similar device within mammalian vasculature, including the renal artery (paragraph 0161). 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 blood vessel comprises a renal artery in order to determine renal health of a subject.
Regarding Claim 18, Kassab teaches: A system, comprising:
an endovascular catheter or guidewire (figure 1), wherein the endovascular catheter of guidewire comprises:
an outer set of electrodes comprising a first electrode and a second electrode (figure 1; electrodes 126 and 128); and
an inner set of electrodes comprising a third electrode and a fourth electrode (electrodes 122 124); and
a processor circuit configured for communication with a power source and the endovascular catheter or guidewire, wherein the processor circuit is configured to (paragraph 0024):
control the power source to provide constant electrical current to the first electrode such that the constant electrical current is transmitted from the first electrode to the second electrode with a first electrical circuit formed between the first electrode and the second electrode by blood flow within the renal artery (paragraph 0010, 0090, 0095, 0102);
control the third electrode and the fourth electrode to obtain a measurement of a voltage difference with a second electrical circuit formed between the third electrode and the fourth electrode with the blood flow, wherein the voltage difference is generated based on a change in the blood flow (paragraph 0010, 0090);
determine, based on the measurement of the voltage difference, a flow metric representative of the change in the blood flow (paragraph 0092-0093); and
provide an output based on the flow metric to a display in communication with the processor circuit (paragraph 0102-0105).
Kassab does not mention wherein the blood vessel comprises a renal artery.
Kassab2014 teaches the use of a similar device within mammalian vasculature, including the renal artery (paragraph 0161). 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 blood vessel comprises a renal artery in order to determine renal health of a subject.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of Kassab2014 further in view of Van Der Horst et al. (US 20190090856), hereinafter Van Der Horst.
Regarding Claim 16, Kassab in view of Kassab2014 teach: The system of claim 14,
wherein the blood vessel is a renal artery (Kassab 2014 - paragraph 0161),
wherein the first measurement is obtained before a stimulation of a sympathetic nervous system of the patient and the second measurement is obtained after the stimulation (Examiner notes that this method step is merely a functional limitation and lack patentable weight), but does not mention
wherein the processor circuit is configured to:
determine whether renal denervation is recommended for the patient based on the comparison; and
provide an output based on the determination to the display renal denervation.
Van Der Horst teaches using a similar intravascular device to recommend renal denervation (figure 1a 1b; paragraph 000045-0046). 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:
determine whether renal denervation is recommended for the patient based on the comparison; and
provide an output based on the determination to the display renal denervation in order to give additional information to a care taker for the purposes of making an informed medical decision.
Regarding Claim 17, Kassab in view of Kassab2014 teach: The system of claim 14,
wherein the blood vessel is a renal artery (Kassab 2014 - paragraph 0161),
wherein the first measurement is obtained before a renal denervation procedure and the second measurement is obtained after the renal denervation procedure (Examiner notes that this method step is merely a functional limitation and lack patentable weight), but does not mention
wherein the processor circuit is configured to:
determine if the renal denervation procedure was successful based on the comparison, and
provide an output based on the determination to the display.
Van Der Horst teaches using a similar intravascular device to recommend renal denervation and determine success (figure 1a 1b; paragraph 000045-0046). 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:
determine if the renal denervation procedure was successful based on the comparison; and
provide an output based on the determination to the display renal denervation in order to give additional information to a care taker for the purposes of making an informed medical decision.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791