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 .
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.
Claim(s) 1-7, 13-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The judicial exception being an abstract idea. The claim(s) recite(s) collecting data, analyzing data, and providing a classification indication similar to Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) which was directed to process of organizing information through mathematical correlations’ and found to be an abstract idea and patent ineligible. This judicial exception is not integrated into a practical application because when the claims are considered as a whole, there is no element or combination of elements in the claims that are sufficient to ensure that the claims amount to significantly more that the abstract idea itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims fail to recite any improvements to another technology or technical field, improvements to the functioning of the processor itself, and/or meaningful limitation beyond generally link the use of an abstract idea to a particular environment. The use of a computing device is merely generic. Therefore, because there is no meaningful limitations in the claim to transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim is rejected under 35 USC 101 as being directed to non-statutory subject matter.
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 12 is 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 12 is unclear who is discriminating (the system, computer or clinician) and where the image comes from.
Claim 12 recites the limitation "the image" and “discriminating” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rotman et al. (US 20160000341).
Regarding claim 1, Rotman discloses a computing device configured to:
obtain, for each location of a plurality of locations of a vessel of a patient, a corresponding indication of stiffness associated with the location of the vessel (section 0091);
determine whether the corresponding indications of stiffness satisfy a homogeneity condition (sections 0091, 0133); and
responsive to the computing device determining that the corresponding indications of stiffness satisfy the homogeneity condition (section 0069-0070), output an indication that the patient is a candidate for a denervation therapy (Section 0143-0144).
Regarding claim 2, Rotman discloses,
wherein the corresponding indications of stiffness is a first plurality of corresponding indications of stiffness (sections 0091, 0133), and
wherein the computing device (section 0069-0070) is further configured to:
obtain, for the plurality of locations of the vessel, a second plurality of corresponding indications of stiffness in response to a perturbation of blood flow through the vessel (Section 0144); and
determine a difference between the first plurality of corresponding indications of stiffness and the second plurality of corresponding indications of stiffness (section 0144),
wherein the computing device is configured to output the indication that the patient is the candidate for the denervation therapy (Section 0143-0144) in response to the computing device:
determining that the first plurality of corresponding indications of stiffness satisfy the homogeneity condition (sections 0091, 0133); and
determining that the difference satisfies a difference condition (Section 0144).
Regarding claim 4, Rotman discloses
wherein the vessel is an artery, wherein the artery is an aorta (section 0095), a renal artery (Fig. 7, section 0079, 0140, 0144), a splanchnic artery, a hepatic artery, or a mesenteric artery.
Regarding claim 5, Rotman discloses
wherein the computing device is configured to obtain, for each location of the plurality of locations, at least one of:
a corresponding localized pulse wave velocity measured using pulse wave imaging; or
a corresponding shear wave speed measured using ultrasound shear wave elastography (section 0133, 0168).
Regarding claim 6, Rotman discloses
the computing device is further configured to receive data representative of an image of the vessel, wherein the image is obtained using a contrast enhanced ultrasound, and wherein the image provides an indication of whether at least one of plaque (section 0117), extravascular calcification, aneurysm, or vessel dissection within the vessel is present.
Regarding claim 7, Rotman discloses
wherein the vessel comprises a renal vessel, and wherein the denervation therapy comprises renal denervation therapy (section 0144).
Regarding claim 8, a system (Figs. 4, 7, section 0144) comprising:
a generator configured to deliver denervation therapy to a patient (Section 0144);
a denervation device coupled to the generator (Section 0144;
a data collection device configured to collect data indicative of vessel stiffness (Section 0133, 0144); and
a computing device communicatively coupled to the data collection device (section 0069-0070), wherein the computing device is configured to:
obtain, for a location of a vessel of the patient and at a first time, a first corresponding indication of stiffness (Section 0144);
obtain, for the location and at a second time, a second corresponding indication of stiffness, wherein the second time is subsequent to the first time (section 0144);
determine a difference between the first corresponding indication of stiffness and the second corresponding indication of stiffness (Section 0144); and
output an indication to end the delivery of denervation therapy in response to the difference satisfying a delivery condition (section 0144).
Regarding claim 9, Rotman discloses
the first time is prior to the generator initiating the delivery of denervation therapy, and wherein the second time is subsequent to the generator initiating the delivery of denervation therapy (section 0144)
Regarding claim 12, Rotman discloses
wherein the image is obtained using a contrast enhanced ultrasound, wherein discriminating between reversible vessel stiffness and irreversible vessel stiffness is based on identifying at least one of plaque, extravascular calcification, aneurysm, or vessel dissection within the vessel based on the image of the vessel (Section 0117)
Regarding claim 13, Rotman discloses a method comprising:
obtaining, by a computing device (Section 0069-0070), for each location of a plurality of locations of a vessel of a patient, a corresponding indication of a stiffness of the associated with the location of the vessel (Section 0091);
determining, by the computing device (section 0069-0070), whether the corresponding indications of stiffness satisfy a homogeneity condition (sections 0091, 0133); and
in response to determining that the corresponding indications of stiffness satisfy the homogeneity condition, outputting, by the computing device (section 0069-0070), an indication that the patient is a candidate for a denervation therapy (Section 0143-0144).
Regarding claim 14, Rotman discloses corresponding indications of stiffness is a first plurality of corresponding indications of stiffness, and wherein the method further comprises:
obtaining, by the computing device, for the plurality of locations of the vessel, a second plurality corresponding indications of stiffness in response to a perturbation of blood flow through the vessel (section 0091, 0144); and
determining, by the computing device, a difference between the first plurality of corresponding indications of stiffness and the second plurality of corresponding indications of stiffness (section 0144); and
wherein outputting the indication that the patient is a candidate for the denervation therapy comprises outputting the indication that the patient is a candidate for the denervation therapy in response to determining that the first plurality of corresponding indications of stiffness satisfy the homogeneity condition and determining that the difference satisfies a difference condition (section 0143-0144).
Regarding claim 16, Rotman discloses wherein
outputting the indication that the patient is a candidate for the denervation therapy comprises outputting the indication that the patient is the candidate for the denervation therapy in response to determining that the corresponding indications of stiffness satisfy the homogeneity condition (Section 0091, 0133),
determining that the difference satisfies the difference condition (section 0143-0144), and
determining that the second plurality of corresponding indications of stiffness satisfies a maximum condition (section 0144).
Regarding claim 17, Rotman discloses wherein
the vessel is an artery, wherein the artery is an aorta (section 0095), a renal artery (Fig. 7, section 0079, 0140, 0144), a splanchnic artery, a hepatic artery, or a mesenteric artery.
Regarding claim 19, Rotman discloses further comprising:
receiving, by the computing device, data representative of an image of the vessel; and discriminating, by the computing device, based on the image of the vessel, between reversible vessel stiffness and irreversible vessel stiffness, wherein discriminating between reversible vessel stiffness and irreversible vessel stiffness is based on identifying at least one of plaque (section 0117), extravascular calcification, aneurysm, or vessel dissection within the vessel based on the image of the vessel.
Regarding claim 20, Rotman discloses wherein
the computing device is configured to output the indication that the patient is the candidate for the denervation therapy in response to the computing device determining that the first and second pluralities of corresponding indications of stiffness satisfy the homogeneity condition (Section 0091, 0133),
determining that the difference between the first and second pluralities of corresponding indications of stiffness satisfies the difference condition (Section 0143-0144), and
determining that the second plurality of corresponding indications of stiffness satisfies a maximum condition (Section 0144).
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.
Claim(s) 10, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotman et al. (US 20160000341) in view of Van Der Horst (EP 3613339).
Regarding claims 10 and 18, Rotman discloses the invention substantially as claimed however does not show wherein the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity.
Van Der Horst discloses wherein the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity (Sections 0025, 0030, 0043-0044). This allows for proper stiffness parameter to be used for specific locations. Therefore it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a localized pulse wave velocity, and wherein the computing device is configured to obtain, from the data collection device and for the location, a first corresponding localized pulse wave velocity and a second corresponding localized pulse wave velocity as taught by Van Der Horst in order to facilitate proper stiffness parameter to be used for specific locations.
Claim(s) 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rotman et al. (US 20160000341) in view of Cao et al. (CN 109567872 A)
Regarding claims 11 and 18, Rotman discloses the invention substantially as claimed however does not show wherein the data collection device is configured to measure, for the location, a shear wave speed, and wherein the computing device is configured to obtain, from the data collection device, a first corresponding shear wave speed and a second corresponding shear wave speed.
Cao discloses the data collection device is configured to measure, for the location, a shear wave speed, and wherein the computing device is configured to obtain, from the data collection device, a first corresponding shear wave speed and a second corresponding shear wave speed (Fig. 3, Page 2, paragraph 5, Page 7, paragraph 6, a shear wave propagating in the thin wall structure with strong frequency dispersion behavior and harmonic frequency of the sheet size and shear wave speed and wave the relation. The frequency of the extraction film layer dispersion curve as providing machine learning to analyze original data, but in other parts of the human body, ultrasonic elastography is given of shear wave speed, shear wave amplitude attenuation degree of the wave meets the interface of transmission/reflectance). This allows proper imaging data to be analyzed. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Rotman by adding the data collection device is configured to measure, for the location, a shear wave speed, and wherein the computing device is configured to obtain, from the data collection device, a first corresponding shear wave speed and a second corresponding shear wave speed as taught by Cao in order to facilitate proper imaging data to be analyzed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
Prosecution Insights