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 . 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.
Specification
The disclosure is objected to because the first paragraph does not provide the most current status for the related applications. That is, at least one of the parent applications is referenced as a U.S. application even though it has issued as a patent. The paragraph should be amended to include the appropriate patent number(s).
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 36 is objected to because of the following informalities: In line 2, -at- should be inserted before “a distal”. 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 34 and 36-40 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 34 recites the limitation "nerves" in line 3. The antecedent basis for this limitation is confusing since it’s unclear how/whether they’re related to the previously-recited “one or more nerves”.
Claim 36 recites the limitation "the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
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.
Claim(s) 21-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hastings, U.S. 2011/0257523 (hereinafter Hastings).
Regarding claim 21, Hastings discloses (note fig. 8) a neuromodulation system comprising: a catheter (67) including a balloon (64) and a therapeutic element (50) at a distal portion of the catheter, wherein the therapeutic element is capable of delivering energy to one or more nerves proximate a hepatic blood vessel, the hepatic blood vessel having a blood vessel wall; and a fluid delivery device configured to: deliver a fluid to the balloon to expand the balloon within the hepatic blood vessel (note paragraph 104), circulate, when the balloon is expanded within the hepatic blood vessel, the fluid through the balloon to maintain a continuous contact pressure of the balloon against the blood vessel wall (note paragraph 107) and to cool the blood vessel wall while the therapeutic element delivers energy to the one or more nerves proximate the hepatic blood vessel (note paragraphs 106-108). It should be noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 22, Hastings discloses (see above) a neuromodulation system wherein to circulate the fluid through the balloon, the fluid delivery device is configured to continuously circulate the fluid through the balloon during delivery of the energy by the therapeutic element (note paragraph 107).
Regarding claim 23, Hastings discloses (see above) a neuromodulation system wherein the fluid delivery device is capable of circulating the fluid through the balloon for a period of time prior to delivery of energy by the therapeutic element.
Regarding claim 24, Hastings discloses (see above) a neuromodulation system wherein the fluid delivery device is necessarily configured to cool a surface of the therapeutic element by circulating the fluid through the balloon.
Regarding claim 25, Hastings discloses (see above) a neuromodulation system wherein to deliver the fluid, the fluid delivery device is configured to pump the fluid into the balloon via an inlet into the balloon, and wherein the fluid exits the balloon via an outlet tube (note paragraph 108).
Regarding claim 26, Hastings discloses (see above) a neuromodulation system wherein a time duration of the delivery of the energy by the therapeutic element is capable of being 1 second to 120 seconds.
Regarding claim 27, Hastings discloses (see above) a neuromodulation system wherein the hepatic blood vessel is capable of including a hepatic artery.
Regarding claim 28, Hastings discloses (see above) a neuromodulation system wherein the fluid is saline or water (note paragraph 106).
Regarding claim 29, Hastings discloses (see above) a neuromodulation system wherein the fluid is nonconductive (see ‘D5W’ in paragraph 106).
Regarding claim 30, Hastings discloses (see above) a neuromodulation system wherein the continuous contact pressure is capable of being 1 g/mm2 to about 50 g/mm2.
Regarding claim 31, Hastings discloses (see above) a neuromodulation system wherein the continuous contact pressure is sufficient to fully occlude a portion of the hepatic blood vessel (note paragraphs 104 and 106).
Regarding claim 32, Hastings discloses (see above) a neuromodulation system wherein a flow rate of the fluid is capable of being less than 500 mL/minute.
Regarding claim 33, Hastings discloses (see above) a neuromodulation system wherein a range of drive pressures within the balloon to provide the flow rate is capable of being 25 psi to 150 psi.
Regarding claim 34, Hastings discloses (see above) a neuromodulation system wherein the therapeutic element comprises an ultrasound transducer (52), and wherein the energy comprises ultrasound energy capable of ablating nerves surrounding the hepatic blood vessel.
Regarding claim 35, Hastings discloses (see above) a neuromodulation system wherein the ultrasound transducer is cylindrical (note fig. 8).
Claim(s) 36-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sogard, U.S. 9,668,811 (hereinafter Sogard) which incorporates Hastings by reference (note col. 15, line 34).
Regarding claim 36, Sogard discloses a method comprising: delivering, by a therapeutic element at a distal portion of the catheter, energy to one or more nerves proximate a hepatic blood vessel (note col. 11, line 43; col. 16, line 1), the hepatic blood vessel having a blood vessel wall; delivering, by a fluid delivery device (note col. 15, line 34), a fluid to a balloon at the distal portion of the catheter to expand the balloon within the hepatic blood vessel (note paragraphs 104 and 108 of Hastings); and circulating, by the fluid delivery device and when the balloon is expanded within the hepatic blood vessel, the fluid through the balloon to maintain a continuous contact pressure of the balloon against the blood vessel wall (note paragraphs 104, 106, and 107 of Hastings) and to cool the blood vessel wall while the therapeutic element delivers energy to the one or more nerves proximate the hepatic blood vessel (note paragraphs 104 and 108 of Hastings).
Regarding claim 37, Sogard discloses (see above) a method wherein circulating, by the fluid delivery device, the fluid through the balloon includes continuously circulating the fluid through the balloon during delivery of the energy by the therapeutic element (note paragraph 107 of Hastings).
Regarding claim 38, Sogard discloses (see above) a method further comprising necessarily cooling a surface of the therapeutic element by circulating the fluid through the balloon (note fig. 8 of Hastings).
Regarding claim 39, Sogard discloses (see above) a method wherein the fluid is saline or water (note paragraph 106 of Hastings).
Regarding claim 40, Sogard discloses (see above) a method wherein the continuous contact pressure is sufficient to fully occlude a portion of the hepatic blood vessel (note paragraphs 104 and 106 of Hastings).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794