The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 is objected to because “wherein the electrode configured to emit” in line 3 should read “wherein the electrode is configured to emit”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
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 1-7 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 is rejected because the preamble recites “a method for improving kidney function”, however, the actual method steps state “improving a flow of blood through vasculature of the patient”. It is unclear how, or if, improved flow of blood through any portion of vasculature of a patient would inherently improve kidney function.
Claim 1 is rejected because it is unclear what the scope of “improving a flow of blood through vasculature” truly entails. In other words, the word “improving” is a subjective term and it is not clear what constitutes an improvement for the claimed subject matter.
Claims 2-7 are rejected for their dependency on claim 1, thereby containing the same issues.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more, as exemplified by the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claims are to a process.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?
Yes, claim 1 recites “activating a baroreceptor”, which is a natural phenomenon. As evidenced by the Cleveland Clinic article about the Baroreceptor Reflex (see https://my.clevelandclinic.org/health/body/24556-baroreceptor-reflex), “Your baroreceptor reflex is a series of quick actions your body takes to keep your blood pressure in a normal range in response to an abrupt change in position (particularly, a seated/lying down position to a standing position)” (see “What is the baroreceptor reflex?”). Also, the following is stated:
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Therefore, the “activating a baroreceptor” is a natural phenomenon undertaken by the human body in multiple, common situations, some of which are mentioned above. Additionally, “improving a flow of blood through vasculature of the patient” is a direct result of the baroreceptor reflex, as it states that this is “to keep your blood pressure in a normal range”. Therefore, this is also part of the natural phenomenon of the baroreceptor reflex.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, there are no additional elements. The remainder of the body of claim 1 states “improving a flow of blood through vasculature of the patient”, which appears to be the response to the activation of a baroreceptor, which is arguably part of the natural phenomenon of the baroreceptor reflex. Additionally, the preamble states “a method for improving kidney function of a patient”, which merely provides the intended result of the method described in the body of the claim. As such, there are no additional elements.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, there are no additional elements, as described above in Step 2A, Prong 2.
Based on the above analysis, claim 1 attempts to claim the natural phenomenon of activating a baroreceptor, which the human body does naturally. Therefore, the claim is not patent eligible.
Claims 2-7 recite additional steps of positioning stents and/or leads at or near a baroreceptor. However, these claims merely recite positioning these devices in locations related to a baroreceptor, but never positively recite a step of activating the baroreceptor with these devices. For example, claim 2 states “wherein activating the baroreceptor includes positioning a stent at or near a baroreceptor, the stent configured to stretch the vasculature”. However, this does not state that the activation is in any way related to the stent. Similarly, claim 4 recites positioning a lead at or near a baroreceptor, and “wherein the electrode configured to emit one or more electrical signals”. However, it is not claimed that the baroreceptor is activated by this, or any other, electrical signal. As such, there is no connection in any of these claims between these devices, or how they function and the method step of claim 1 of “activating a baroreceptor”. Therefore, these claims do not add significantly more based on their current wording.
Claim Rejections - 35 USC § 102
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kieval et al. (US Patent No. 8,583,236).
Regarding claim 1, Kieval discloses a method for improving kidney function of a patient (see Abstract; treatment of renal disorders, column 1, line 19-25), comprising; activating a baroreceptor (see column 4, line 20-24, baroreceptor activation device used to active a baroreceptor); and improving a flow of blood through vasculature of the patient (see column 3, line 42-56, device affects heart rate and blood pressure).
Regarding Claim 2, Kieval discloses the method of claim 1, wherein activating the baroreceptor includes positioning a stent at or near a baroreceptor (see column 20, line 13-27, activation device 620 includes stent 640 disposed in an artery that contains baroreceptors; see also Fig. 20), the stent configured to stretch the vasculature (see column 16, line 51-53, stent is self-expanding)
Regarding Claim 3, Kieval discloses the method of claim 2, wherein the stent is positioned at or near a superior vena cava of the patient (see stent 640 in carotid artery 14, Fig. 20; carotid artery near and above superior vena cava).
Regarding claim 4, Kieval discloses the method of claim 1, further comprising positioning a lead at or near a baroreceptor (see column 20, line 13-27 and Fig. 20, lead 639, activation device 620 includes stent 640 disposed in an artery that contains baroreceptors), the lead comprising a proximal end (proximal end of lead 639 not pictured, Fig. 20) and a distal end (distal end of lead 639 attaches to electrode pad 634, Fig. 20) and an electrode connected to the distal end of the lead (see Fig. 20, electrode pad 634), wherein the electrode configured to emit one or more electrical signals (see column 4, Line 44-50, electrode produces electrical current).
Regarding claim 5, Kieval discloses the method of claim 4, wherein the electrode is configured to emit an intermittent electrical stimulus (see column 12, Line 44-53, electrical activation can be modulated pulses).
Regarding claim 6, Kieval discloses the method of claim 1, wherein activating the baroreceptor including positioning a lead at or near a baroreceptor (see column 17, lines 26-50, with discussion of transmitted signals delivered to inside surface of the vascular wall adjacent baroreceptors via the electrode pads 634, and discussion of “simply the electrode pads 634 without the coil 632 as when the device 620 is hard wired to the control system 60”, would inherently be hardwired via leads), the lead comprising a proximal end (this is inherent as one end of the hardwired connection would be at the control system – i.e., the proximal end) and a distal end (the distal end of the hardwired lead would be at the electrode pad) and an electrode connected to the distal end of the lead (“The assembly 630 may include… simply the electrode pads 634 without the coil 632 as when the device 620 is hard wired to the control system 60”), wherein the electrode configured to emit one or more electrical signals.
Regarding claim 7, Kieval discloses the method of claim 6, wherein the electrode is configured to emit an intermittent electrical stimulus (see column 12, Line 42-44, electrical activation can be constant current or constant voltage).
Regarding claim 8, Kieval discloses a system (see Abstract; activation device 620, Fig. 20) comprising: a stent (see stent 640, Fig. 20) comprising a tubular body made of a flexible material (see column 16, line 51-53, stent is self-expanding) and configured to be positioned within a patient's vasculature at or near a baroreceptor (see column 20, line 13-27 and Fig. 20, activation device 620 includes stent 640 disposed in an artery that contains baroreceptors); and a lead (see lead 639, Fig. 20) having a proximal end (proximal end of lead 39 not pictured, Fig. 20) and a distal end (see distal end of lead 639 attaches to electrode pad 634, Fig. 20), an electrode connected to the distal end of the lead (see electrode pad 634, Fig. 20), the electrode configured to emit one or more electrical signals (see column 4, line 44-50, electrode produces electrical current) to vasculature surrounding the electrode (see column 4, line 44-50, activates vascular receptors); wherein the stent is configured to stretch the vasculature (see column 16, line 51-53, stent is self-expanding) and the lead is configured to electrically stimulate the baroreceptor (see Fig. 20, lead 639 configured to deliver energy to electrode pad 634; see also column 4, line 20-24, baroreceptor activation device used to active a baroreceptor).
Regarding Claim 9, Kieval discloses the system of claim 8, wherein the stent is positioned at or near a superior vena cava (see stent 640 in carotid artery 14, Fig. 20; carotid artery near and above superior vena cava).
Regarding Claim 10, Kieval discloses the system of claim 8 or 9, wherein the lead is positioned at or near a superior vena cava (see lead 639 attached to stent 640 in carotid artery 14, Fig. 20; carotid artery near and above superior vena cava).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/ Primary Examiner, Art Unit 3792