DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-15 are pending.
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 Claim(s) 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 Claim(s) particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 14 is/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 pre-AIA the applicant regards as the invention.
Claim 14 recites limitation “the processor being configured to: ...; and an imaging modality that is configured to generate the sequence of images”. The meaning of this limitation is unclear due to a grammatical error, rendering the claim indefinite.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pfister (US20120082363A1) in view of Burnett et al (US20140276038A1).
Regarding claims 1 and 13-15, Pfister teaches a method for assessing the effect of a medical instrument during a vascular intervention, the method comprising:
(Pfister, "To treat an abdominal aortic aneurysm, a stent is to be inserted into the aorta. In preparation for the insertion of the stent, a catheter is inserted into the aorta. The insertion of the stent is to be assisted by imaging.", [0029]; Pfister teaches a method for assisting a vascular intervention (stent/catheter insertion) by predicting instrument effects through imaging)
obtaining a sequence of images, wherein the sequence of images map a vessel section and at least some images of the sequence of images map a first medical instrument arranged in the vessel section;
(Pfister, "During the interventional procedure additional fluoroscopic images are acquired at low X-ray dose.", [0029]; "The catheter 14 can be seen in fluoroscopic images taken during the intervention.", [0035]; acquiring a sequence of fluoroscopic images showing a medical instrument (catheter) inside a vessel (aorta))
ascertaining a deformation of the vessel section based on the sequence of images;
(Pfister, "However, as the insertion of the catheter causes deformation of the vessel walls of the aorta, the fluoroscopic image and the reference image per se would no longer match up directly.", [0029]; "The vectors v1, v2, v3, etc. indicate the extent to which the aorta 10 has obviously deformed.", [0035]; determining vessel deformation based on the images by using vectors derived from the fluoroscopic image)
obtaining first mechanical instrument properties of the first medical instrument;
(Pfister, "Finally, the parameters X3(l) with l=1, . . . M specify properties of the inserted instrument, e.g. its size and rigidity.", [0033]; obtaining mechanical properties of the inserted instrument, specifically its rigidity)
determining mechanical vessel properties of the vessel section based on the first mechanical instrument properties and the deformation of the vessel section;
(Pfister, "The deformation is then measured and corresponding deformation parameters are assigned to the other parameters.", [0030]; "It shall now be assumed that there is a function F which can calculate the deformation vector ΔP from the input vectors X1 , X2 , X3 only using calculation parameters W(p)...", [0038]; Burnett, "...measuring the vessel displacement with and without catheter insertions of different stiffness...", [0009]; Pfister describes a model correlating vessel parameters (X2) and instrument parameters (X3) with measured deformation (ΔP). Burnett explicitly teaches measuring displacement with catheters of different stiffness to generate material parameters)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to incorporate the teachings of Burnett into the system or method of Pfister in order to determine specific mechanical vessel properties for a patient by observing the deformation caused by a first instrument with known stiffness. The combination of Pfister and Burnett also teaches other enhanced capabilities.
The combination of Pfister and Burnett further teaches:
obtaining second mechanical instrument properties of a second medical instrument; and
(Pfister, "...the particular object inserted is also characterized likewise in step e) by assigning values to the second predefined parameters.", [0015]; "...specify properties of the inserted instrument, e.g. its size and rigidity.", [0033]; characterizing the specific object to be inserted (a second/particular instrument) by its mechanical parameters)
assessing an expected deformation of the vessel section during a vascular intervention on the vessel section using the second medical instrument based on the second mechanical instrument properties and the mechanical vessel properties.
(Pfister, "In step g), on the basis of the first and second parameter values... deformation parameter values are then inferred which describe the deformation of the particular vessel by the particular object.", [0015]; "On the basis of the empirical values, it can therefore be regularly deduced in the case of new patients how a particular vessel will deform the aorta 10.", [0044]; using the learned model (which incorporates vessel and instrument properties) to infer/predict the expected deformation for a particular object (second instrument))
Regarding claim 2, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, further comprising:
assessing a further expected deformation of the vessel section during a vascular intervention on the vessel section using the first medical instrument, using a predefined simulation model as a function of the first mechanical instrument properties and as a function of predefined initial vessel properties of the vessel section; and
selecting the first medical instrument from a predefined plurality of medical instruments as a function of the further expected deformation.
(Pfister, "To treat an abdominal aortic aneurysm, a stent is to be inserted into the aorta. In preparation for the insertion of the stent, a catheter is inserted into the aorta. The insertion of the stent is to be assisted by imaging. For this purpose, prior to the interventional procedure a reference image of the patient is taken ... if the behavior of the catheter in the aorta is known, the deformation can be predicted.", [0029]; predicting deformation (assessing expected deformation) prior to the interventional procedure using a model based on vessel (X2) and instrument (X3) parameters. Selecting a medical instrument based on its predicted behavior (rigidity/size) is a known and predictable use of such a simulation to assist a physician)
Regarding claim 3, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 2, wherein:
the simulation model is updated as a function of the deformation and the further expected deformation;
the simulation model is updated as a function of the mechanical vessel properties and the initial vessel properties; or
a combination thereof.
(Pfister, "The function F can likewise also be gradually learnt by a neural network which can also be provided by an algorithm as an artificial neural network.", [0040]; "The calculation parameters are determined by the neural network as part of a learning process. Neural networks can “learn” particular values based on experience.", [0043]; updating the simulation model (learning the function F) based on experience, which involves correlating measured deformation results with initial parameters)
Regarding claim 4, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 3, wherein the expected deformation of the vessel section is assessed using the updated simulation model as a function of the second mechanical instrument properties and the mechanical vessel properties.
(Pfister, "On the basis of the empirical values, it can therefore be regularly deduced in the case of new patients how a particular vessel will deform the aorta 10.", [0044]; "The calculation parameters are determined by the neural network as part of a learning process.", [0043]; the learned/updated model parameters are used to deduce (assess) expected deformation for new cases/instruments)
Regarding claim 5, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, wherein the expected deformation of the vessel section during a vascular intervention on the vessel section using the second medical instrument is assessed using a predefined simulation model as a function of the second mechanical instrument properties and the mechanical vessel properties.
(Pfister, "On the basis of the measured values which are obtained using a plurality of patients and interventional instruments, the function can be gradually determined and the defoiniation parameters can then be calculated subsequently for subjects on which the deformation measurement is not performed.", [0039]; using a predefined simulation model (function F) to calculate/assess deformation for an interventional instrument)
Regarding claim 6, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, further comprising outputting an item of user information that proposes the second medical instrument for use during a vascular intervention on the vessel section as a function of the expected deformation.
(Pfister, "To facilitate same for the treating physician, fluoroscopic images (X-ray pictures) of the patient can be taken continuously during stent positioning.", [0004]; Pfister describes the system providing information to "facilitate" the physician's work during an intervention based on the predicted deformation. It would be obvious to a person having ordinary skill in the art to provide a specific proposal/recommendation of a suitable instrument (the second instrument) as a routine application of the prediction output to improve surgical planning)
Regarding claim 7, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, wherein the first medical instrument is a first stent, the second medical instrument is a second stent, or the first medical instrument is the first stent and the second medical instrument is the second stent.
(Pfister, "To repair it, a so-called stent is inserted, i.e. an angioplasty.", [0004]; "To introduce a stent, guide wires and catheters are inserted into the aorta. Inserting such objects into the aorta may cause deformation of the vessel walls...", [0006]; the intervention involves inserting a stent and that stents/catheters cause the claimed deformation)
Regarding claim 8, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 7, wherein
the first mechanical instrument properties include a geometric shape, a diameter, a length, a rigidity, an elasticity, a surface lubricity, or any combination thereof of the first stent;
the second mechanical instrument properties include a geometric shape, a diameter, a length, a rigidity, an elasticity, a surface lubricity, or any combination thereof of the second stent; or
a combination thereof.
(Pfister, "Finally, the parameters X3(l) with l=1, . . . M specify properties of the inserted instrument, e.g. its size and rigidity.", [0033]; mechanical properties of the instrument include its size (diameter/length) and rigidity)
Regarding claim 9, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, wherein the first medical instrument is a first vessel catheter, the second medical instrument is a second vessel catheter, or the first medical instrument is the first vessel catheter and the second medical instrument is the second vessel catheter.
(Pfister, "To introduce a stent, guide wires and catheters are inserted into the aorta.", [0006]; this identifies catheters as the medical instruments inserted into the vessel section)
Regarding claim 10, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 9, wherein:
the first mechanical instrument properties include a diameter, a geometric shape, a length, a rigidity, a surface lubricity of a tip or a shaft or part of the tip or the shaft, or any combination thereof of the first vessel catheter;
the second mechanical instrument properties include a diameter, a geometric shape, a length, a rigidity, a surface lubricity of a tip or a shaft or part of the tip or of the shaft, or any combination thereof of the second vessel catheter; or
a combination thereof.
(Pfister, "Finally, the parameters X3(l) with l=1, . . . M specify properties of the inserted instrument, e.g. its size and rigidity.", [0033]; mechanical properties of the instrument (catheter) include its size and rigidity)
Regarding claim 11, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, wherein:
the sequence of images represents a movement of the first medical instrument;
the expected deformation is a deformation that is to be expected due to an intentional movement of the second medical instrument in the vessel section; or
a combination thereof.
(Pfister, "fluoroscopic images (X-ray pictures) of the patient can be taken continuously during stent positioning.", [0004]; "catheter 14 is to be inserted into the aorta.", [0035]; images are taken during the "positioning" or "insertion" of the instrument, which inherently represents movement. Predicting deformation from insertion (intentional movement) is the core purpose of Pfister’s simulation)
Regarding claim 12, the combination of Pfister and Burnett teaches its/their respective base claim(s).
The combination further teaches the method of claim 1, wherein the sequence of images is a sequence of X-ray images.
(Pfister, "fluoroscopic images (X-ray pictures) of the patient can be taken continuously during stent positioning.", [0004]; indicating the images as X-ray pictures)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANXUN YANG whose telephone number is (571)272-9874. The examiner can normally be reached on MON-FRI: 8AM-5PM Pacific Time.
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/JIANXUN YANG/
Primary Examiner, Art Unit 2662 8/8/2026
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