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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosures of the prior-filed provisional applications, U.S. Provisional Application Nos. 61/831,507 and 61/906,830, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. More specifically, these applications fail to disclose ‘determining lesion severity’.
The Examiner notes that support for the instant claims has been found in International Application No. PCT/US2014/040949. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 6/4/2014, this being the filing date of International Application No. PCT/US2014/040949.
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 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, 22, and 27-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van der Weide, U.S. 2013/0116679 (hereinafter Van der Weide).
Regarding claims 21 and 31, Van der Weide discloses a neuromodulation system comprising: a catheter including an ultrasound transducer at a distal portion of the catheter (note paragraphs 9, 90, and 94); and a controller configured to: control the ultrasound transducer to deliver ultrasound energy to a target site to create a lesion (note paragraph 87); determine, based on one or more signals that are received by the ultrasound transducer, one or more of a size of the lesion and a severity of the lesion (note paragraph 173); and adjust, based on the determined size or severity of the lesion, the ultrasound energy delivered by the ultrasound transducer (note paragraph 173). 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, Van der Weide discloses (see above) a neuromodulation system wherein to adjust the ultrasound energy delivered by the ultrasound transducer, the controller is configured to stop delivery of the ultrasound energy by the ultrasound transducer in response to determining that the size of the lesion has reached a therapeutically sufficient size or in response to determining that the severity of the lesion has reached a threshold level (note paragraph 172).
Regarding claim 27, Van der Weide discloses (see above) a neuromodulation system wherein the one or more signals for determining the one or more of the size of the lesion and the severity of the lesion necessarily comprises an ultrasound signal.
Regarding claim 28, Van der Weide discloses (see above) a neuromodulation system wherein the controller is configured to generate a map of tissue changes during delivery of the ultrasound energy (note paragraphs 171-172).
Regarding claim 29, Van der Weide discloses (see above) a neuromodulation system wherein the controller is necessarily configured to receive the signals from the ultrasound transducer.
Regarding claim 30, Van der Weide discloses (see above) a neuromodulation system wherein the controller is configured to control the ultrasound transducer to deliver the ultrasound energy that heats target tissue to 40 degrees Celsius to 60 degrees Celsius (note paragraph 171).
Claim Rejections - 35 USC § 103
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.
Claim(s) 32, 33, and 38-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rittman, U.S. 6,506,189 (hereinafter Rittman) in view of Fung, U.S. 2011/0282250 (hereinafter Fung).
Regarding claims 32, 38, and 40, Rittman discloses a method comprising: controlling, by a controller, an ultrasound transducer of a catheter to deliver ultrasound energy to one or more nerves proximate a hepatic blood vessel to create a lesion (note col. 12, line 14; col. 18, line 46); determining, by the controller and based on one or more signals that are received, one or more of a size of the lesion and a severity of the lesion (note col. 11, line 58); and adjusting, by the controller and based on the size of the lesion or the severity of the lesion, the ultrasound energy delivered by the ultrasound transducer (note col. 11, line 58; col. 16, line 22). However, Rittman fails to explicitly disclose determining lesion size/severity based on one or more signals that are received by the ultrasound transducer. Fung teaches a similar procedure that comprises determining lesion size in any of a variety of ways, including via ultrasound (note paragraph 79). It is well known in the art that these different configurations for assessing lesions are widely considered to be interchangeable (as can be seen in Fung). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the procedure of Rittman to comprise determining lesion size in any of a variety of ways, including via one or more signals that are received by the ultrasound transducer. This is because this modification would have merely comprised a simple substitution of interchangeable lesion-assessing configurations in order to produce a predictable result (see MPEP 2143).
Regarding claim 33, Rittman discloses (see above) a method wherein adjusting, by the controller and based on the one or more of the size of the lesion and the severity of the lesion, the ultrasound energy by the ultrasound transducer includes stopping delivery of the ultrasound energy by the ultrasound transducer in response to determining that the size of the lesion has reached a therapeutically sufficient size or in response to determining that the severity of the lesion has reached a threshold level (note col. 16, line 22).
Regarding claim 39, Rittman discloses (see above) a method further comprising controlling, by the controller, the ultrasound transducer to deliver the ultrasound energy that heats tissue surrounding the hepatic blood vessel to 40 degrees Celsius to 60 degrees Celsius (note col. 6, line 33).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide in view of Roundhill, U.S. 5,908,389 (hereinafter Roundhill).
Regarding claim 23, Van der Weide discloses (see above) a neuromodulation system comprising a controller configured to determine the size of the lesion based on signals received by the ultrasound transducer. However, Van der Weide fails to explicitly disclose that the controller is configured to perform echo decorrelation in order to monitor the lesion in this manner. Roundhill teaches a similar system that performs echo decorrelation in order to better process ultrasonic data (note col. 10, line 9). It is well known in the art that these different signal/data processing configurations are widely considered to be interchangeable, and that the configuration of Roundhill would result in improved signal/data quality (as can be seen in Roundhill) thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Van der Weide to comprise a controller configured to perform echo decorrelation in order to monitor the lesion size. This is because this modification would have merely comprised a simple substitution of interchangeable signal/data processing configurations in order to increase safety and efficiency (see MPEP 2143).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rittman in view of Fung as applied to claims 32, 33, and 38-40 above, and further in view of Roundhill.
Regarding claim 34, Rittman in view of Fung teaches (see above) a method comprising a controller configured to determine the size of the lesion based on signals received by the ultrasound transducer. However, this modified reference fails to expressly teach that the controller is configured to perform echo decorrelation in order to monitor the lesion in this manner. Roundhill teaches a similar system that performs echo decorrelation in order to better process ultrasonic data (note col. 10, line 9). It is well known in the art that these different signal/data processing configurations are widely considered to be interchangeable, and that the configuration of Roundhill would result in improved signal/data quality (as can be seen in Roundhill) thereby resulting in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the method of Rittman to comprise a controller configured to perform echo decorrelation in order to monitor the lesion size. This is because this modification would have merely comprised a simple substitution of interchangeable signal/data processing configurations in order to increase safety and efficiency (see MPEP 2143).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide in view of Berger, U.S. 2004/0015079 (hereinafter Berger).
Regarding claim 24, Van der Weide discloses (see above) a neuromodulation system comprising a controller configured to determine the size of the lesion based on signals received by the ultrasound transducer. However, Van der Weide fails to explicitly disclose that the controller is configured to perform ultrasound elastography in order to monitor the lesion in this manner. Berger teaches a similar system that performs ultrasound elastography in order to produce higher-quality ultrasonic data (note paragraphs 328 and 330), which results in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the system of Van der Weide to comprise a controller configured to perform ultrasound elastography to monitor the lesion size, in order to produce higher-quality ultrasonic data and increase safety and efficiency (see MPEP 2143).
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rittman in view of Fung as applied to claims 32, 33, and 38-40 above, and further in view of Berger.
Regarding claim 35, Rittman in view of Fung teaches (see above) a method comprising a controller configured to determine the size of the lesion based on signals received by the ultrasound transducer. However, this modified reference fails to expressly teach that the controller is configured to perform ultrasound elastography in order to monitor the lesion in this manner. Berger teaches a similar system that performs ultrasound elastography in order to produce higher-quality ultrasonic data (note paragraphs 328 and 330), which results in increased safety and efficiency. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the method of Rittman to comprise a controller configured to perform ultrasound elastography to monitor the lesion size, in order to produce higher-quality ultrasonic data and increase safety and efficiency (see MPEP 2143).
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van der Weide in view of Gertner, U.S. 2012/0065493 (hereinafter Gertner).
Regarding claims 25-26, Van der Weide discloses (see above) a neuromodulation system comprising a controller configured to: control the ultrasound transducer to deliver ultrasound energy to a target site to create a lesion; and ultrasonically determine one or more of a size of the lesion and a severity of the lesion. However, Van der Weide fails to explicitly disclose that the controller is configured to control the ultrasound transducer to deliver ultrasound energy at a first frequency for assessing the lesion, and to deliver ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue. Gertner teaches a similar system that delivers ultrasound energy at a first frequency for assessing a lesion (note paragraph 467), and delivers ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue (note paragraph 361). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have modified the system of Van der Weide to comprise a controller configured to control the ultrasound transducer to: deliver ultrasound energy at a first frequency for assessing the lesion, and deliver ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result.
Claim(s) 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rittman in view of Fung as applied to claims 32, 33, and 38-40 above, and further in view of Gertner.
Regarding claims 36-37, Rittman in view of Fung teaches (see above) a method comprising a controller configured to: control the ultrasound transducer to deliver ultrasound energy to a target site to create a lesion; and ultrasonically determine one or more of a size of the lesion and a severity of the lesion. However, this modified reference fails to expressly teach that the controller is configured to control the ultrasound transducer to deliver ultrasound energy at a first frequency for assessing the lesion, and to deliver ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue. Gertner teaches a similar system that delivers ultrasound energy at a first frequency for assessing a lesion (note paragraph 467), and delivers ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue (note paragraph 361). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed, to have further modified the method of Rittman to comprise a controller configured to control the ultrasound transducer to: deliver ultrasound energy at a first frequency for assessing the lesion, and deliver ultrasound energy at a second specific frequency of between 1 MHz and 10 MHz for ablating tissue. This is because this modification would have merely comprised a simple substitution with known parameter values in order to produce a predictable (and desirable) result.
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