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 § 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 1-11 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 recites “assessing a risk of rupture of the hollow organ” in line 13 page 1, and it is indefinite, since “assessing a risk of rupture of a hollow organ” was previously recited in line 1 page 1, and is not definite whether it is a new and distinct risk assessment or meant to recite same “risk.”
Claim 8 recites “a first nominal balloon size of the balloon catheter is determined based on the first fluid quantity, wherein a first further size difference between the first nominal balloon size and the balloon size in the first expansion state is determined.” It is not definite if there exists a difference between a first nominal balloon size and the balloon size in the first expansion state, since claim 7 recites “a first quantity of fluid present inside the balloon catheter in the first expansion state, thus, seems to imply that first nominal balloon size is the balloon size in the first expansion sate.
Claim 10 recites the limitation " the corresponding volume " in lines 5-6 page 4. There is insufficient antecedent basis for this limitation in the claim, since “corresponding volume of the balloon catheter” was not previously recited in claims 1 and 10.
Claims 2-11 are rejected as they inherit rejection of claim 1 set forth above.
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.
Claims 1-2, 5, 9, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over “Wesselmann et al.,” US 2022/0288359 (hereinafter Wesselmann) and “Cole et al.,” US 2018/0360545 (hereinafter Cole).
Regarding to claim 1, Wesselmann teaches a method for assessing a risk of rupture of a hollow organ during balloon dilation, the method comprising:
obtaining at least one first image that maps a first expansion state of a balloon catheter disposed in the hollow organ (imaging to determine diameter [0023]; imaging of expanding balloon [0049]);
determining a balloon size of the balloon catheter in the first expansion state based on the at least one first image (imaging method to determine reference diameter corresponding to a nominal vessel diameter of the vessel [0023], [0032]);
determining an internal balloon pressure of the balloon catheter in the first expansion state (a pressure inside the balloon when zeroing [0040]);
determining the internal balloon pressure in the second expansion state (over expansion [0025]; a maximum pressure in the balloon interior [0040], [0071]); and
generating information for assessing a risk of rupture of the hollow organ based on the internal balloon pressure in the first expansion state, the internal balloon pressure in the second expansion state, the balloon size in the first expansion state, and the balloon size in the second expansion state (pressure and diameter expansion in % [0043]-[0044]; increased risk of rupture is communicated to the user when exceeds recommended expansion range [0071]);
Wesselmann does not explicitly disclose following limitations:
obtaining at least one second image that maps a second expansion state of the balloon catheter disposed in the hollow organ;
determining the balloon size in the second expansion state based on the at least one second image;
However, in the analogous field of endeavor in assessing inflation of balloon catheter within the blood vessel, Cole teaches that sensors sensing the shape change of the balloon with imaging the inflating balloon (real time images of inflatable medical instrument acquired and generate overlay which is proportional to the balloon diameter [0048]-[0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Cole, since real-time images of inflating balloon was well known in the art as taught by Cole. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, acquiring real-time images of inflatable balloon catheter to determine parameters, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide improved tracking of shape changes ([0032]) , and there was reasonable expectation of success.
Regarding to claims 2, 5, and 9, Wesselmann and Cole together teach all limitations of claim 1 as discussed above.
With respect to calm 2, Cole further teaches wherein a visual representation is generated and displayed on a display device, and wherein, in the visual representation, the internal balloon pressure in the first expansion state is associated with the balloon size in the first expansion state and the internal balloon pressure in the second expansion state is associated with the balloon size in the second expansion state (Figures 5-6 displaying overlay indicating balloon diameter, color coded overlays indicating pressure conditions, [0048]-[0051]).
With respect to claim 5, Wesselmann teaches wherein a sensor signal is received from a pressure sensor disposed inside the balloon catheter, and wherein the internal balloon pressure in the first expansion state and/or the internal balloon pressure in the second expansion state are determined based on the sensor signal (sensor measuring the pressure in the balloon interior [0027] and [0084]).
With respect to claim 9, Wesselmann teaches wherein the balloon size in the first expansion state and the balloon size in the second expansion state are each determined as a corresponding lateral expansion perpendicular to a longitudinal axis of the balloon catheter (Radial direction, diameter measurement qualifies for lateral expansion perpendicular to a longitudinal axis of the ballon catheter [0034]).
Regarding to claim 12, Wesselmann teaches a data processing apparatus (processing unit [0045]) comprising: at least one computing unit (processing device, computer unit [0045]) configured to:
obtain at least one first image that maps a first expansion state of a balloon catheter disposed in the hollow organ (imaging to determine diameter [0023]; imaging of expanding balloon [0049]);
determine a balloon size of the balloon catheter in the first expansion state based on the at least one first image (imaging method to determine reference diameter corresponding to a nominal vessel diameter of the vessel [0023], [0032]);
determine an internal balloon pressure of the balloon catheter in the first expansion state (a pressure inside the balloon when zeroing [0040]);
determine the internal balloon pressure in the second expansion state (over expansion [0025]; a maximum pressure in the balloon interior [0040], [0071]); and
generate information for assessing a risk of rupture of the hollow organ based on the internal balloon pressure in the first expansion state, the internal balloon pressure in the second expansion state, the balloon size in the first expansion state, and the balloon size in the second expansion state (pressure and diameter expansion in % [0043]-[0044]; increased risk of rupture is communicated to the user when exceeds recommended expansion range [0071]);
Wesselmann does not explicitly disclose following limitations:
obtain at least one second image that maps a second expansion state of the balloon catheter disposed in the hollow organ;
determine the balloon size in the second expansion state based on the at least one second image;
However, in the analogous field of endeavor in assessing inflation of balloon catheter within the blood vessel, Cole teaches that sensors sensing the shape change of the balloon with imaging the inflating balloon (real time images of inflatable medical instrument acquired and generate overlay which is proportional to the balloon diameter [0048]-[0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Cole, since real-time images of inflating balloon was well known in the art as taught by Cole. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, acquiring real-time images of inflatable balloon catheter to determine parameters, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide improved tracking of shape changes ([0032]) , and there was reasonable expectation of success.
Regarding to claim 13, Wesselmann teaches an imaging system for monitoring balloon dilation of a hollow organ, the imaging system comprising:
An imaging modality configured to generate at least one first image and to generate at least one second image (imaging unit such as X-ray image [0032] and [0060])
data processing apparatus (processing unit [0045]) having an at least one computing unit (processing device, computer unit [0045]) configured to:
obtain at least one first image that maps a first expansion state of a balloon catheter disposed in the hollow organ (imaging to determine diameter [0023]; imaging of expanding balloon [0049]);
determine a balloon size of the balloon catheter in the first expansion state based on the at least one first image (imaging method to determine reference diameter corresponding to a nominal vessel diameter of the vessel [0023], [0032]);
determine an internal balloon pressure of the balloon catheter in the first expansion state (a pressure inside the balloon when zeroing [0040]);
determine the internal balloon pressure in the second expansion state (over expansion [0025]; a maximum pressure in the balloon interior [0040], [0071]); and
generate information for assessing a risk of rupture of the hollow organ based on the internal balloon pressure in the first expansion state, the internal balloon pressure in the second expansion state, the balloon size in the first expansion state, and the balloon size in the second expansion state (pressure and diameter expansion in % [0043]-[0044]; increased risk of rupture is communicated to the user when exceeds recommended expansion range [0071]);
Wesselmann does not explicitly disclose following limitations:
obtain at least one second image that maps a second expansion state of the balloon catheter disposed in the hollow organ;
determine the balloon size in the second expansion state based on the at least one second image;
However, in the analogous field of endeavor in assessing inflation of balloon catheter within the blood vessel, Cole teaches that sensors sensing the shape change of the balloon with imaging the inflating balloon (real time images of inflatable medical instrument acquired and generate overlay which is proportional to the balloon diameter [0048]-[0050]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Cole, since real-time images of inflating balloon was well known in the art as taught by Cole. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, acquiring real-time images of inflatable balloon catheter to determine parameters, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide improved tracking of shape changes ([0032]) , and there was reasonable expectation of success.
Regarding to claim 14, Wesselmann and Cole together teach all limitations of claim 13 as discussed above.
Wesselmann further teaches wherein the imaging modality is an X-ray based angiography system, a computed tomography system, a magnetic resonance based angiography system, or an ultrasound based imaging system (X-ray imaging [0060]).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wesselmann and Cole as applied to claim 1 above, and further in view of “Fetherston et al.,” US 2024/0058129 (hereinafter Fetherston), and further in view of “Oh et al.,” WO 2023/195724 ( hereinafter Oh).
Regarding to claims 3-4, Wesselmann and Cole together teach all limitations of claim 1 as discussed above.
Wesselmann does teach diameter increase and pressure increase to assess risk for rupture ([0043]-[0044]; [0071]) and displaying a warning signal when the diameter exceeds the maximum threshold value ([0036]), reads on claimed outputting a warning message depending on a result of the comparison.
The examiner notes that Wesselmann’s disclosure of pressure and diameter increase ([0043]-[0044]) indicate “calculating a pressure difference and a size difference in the first and second expansion state” as claimed.
Wesselmann does not further disclose calculating a risk value based on a ratio of the pressure difference to the size difference.
However, in the analogous field of endeavor in assessing a rupture using balloon catheter, Fetherston teaches comparing changes in the diameter of the inflatable medical balloon to changes in the pressure of the balloon ([0192]), and when pressure rises without a similar increase in diameter (Thus, results in increased ratio as claimed), a risk value would be high while the diameter increases without an increase in pressure (which would result in lower ratio), risk is low ([0192]-[0193]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Fetherston, since assessing ratio of pressure increase to size increase was well known in the art as taught by Fetherston. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, using its calculated pressure changes and diameter changes and calculating a ratio of the changes, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide indication of safe expansion of the ballon catheter without causing a rupture ([0192]-[0193]), and there was reasonable expectation of success.
Fetherston does not explicitly disclose a risk value and comparing the risk value with a predetermined limit value.
However, in the analogous field of endeavor in assessing blood vessel rupture risk, Oh discloses using the blood vessel image and other parameters, outputting a rupture risk and if the rupture risk is greater than a predetermined rupture threshold value, predicting that rupture is possible or not possible (see abstract of WO 2023/195724).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Oh, since calculating a rupture risk by comparing to a risk threshold was well known in the art as taught by Oh. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, using its risk for rupture to compare it to the rupture threshold, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide accurate prediction of risk for rupture (abstract), and there was reasonable expectation of success.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wesselmann and Cole as applied to claim 1 above, and further in view of “Saul et al.,” US 2019/0083057 (hereinafter Saul).
Regarding to claim 6, Wesselmann and Cole together teach all limitations of claim 1 as discussed above.
Wesselmann further discloses estimating current diameter from the current pressure using a measurement curve or calibration showing the diameter as a function of the pressure of interior of the balloon ([0027]).
Wesselmann does not explicitly teach pressure is determined based on the balloon size as claimed.
However, in the analogous field of endeavor in inflatable catheter, Saul teaches inflatable balloon with association curve between pressure and diameter, using the curve, pressure can be determined ([0086] Figure 17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Saul, since determining pressure based on the relationship of pressure and diameter of inflatable member was well known in the art as taught by Saul. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, by using association between pressure and diameter to estimate pressure, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to identify appropriate inflation pressure by monitoring relative change in modulus ([0086]), and there was reasonable expectation of success.
Claims 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wesselmann, Cole, and Saul as applied to claims 1 and 6 above, and further in view of “ Isla Garcia et al.,” US 2024/0181227 (hereinafter Isla Garcia, corresponding to WO 2023/018564).
Regarding to claim 7, Wesselmann, Cole, and Saul together disclose all limitations of claim 6 as discussed above.
Wesselmann further teaches wherein a first and/or a second quantity of fluid present inside the balloon catheter in the first and/or second expansion state is determined (inflated liquid volume [0081]), but does not explicitly disclose the internal balloon pressure in the first expansion state is associated with the first quantity of fluid and the balloon size in the first expansion state in accordance with the association rule, and/or wherein the internal balloon pressure in the second expansion state is associated with the second quantity of fluid and the balloon size in the second expansion state in accordance with the association rule.
However, in the analogous field of endeavor in inflating balloon catheter, Isla Garcia teaches pressure is associated with the quantity of fluid (volume) and the balloon diameter in accordance with the association rule (Figures 3-6, [0093] corresponding to 2nd paragraph page 19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Isla Garcia, since association of pressure with quantity of liquid and balloon diameter was well known in the art as taught by Isla Garcia. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, by implementing association between pressure, volume of liquid, and diameter, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to regulate pressure of inflatable balloon catheter while preventing hyperinflation ([0052]-[0054]), and there was reasonable expectation of success.
Regarding to claim 8, Wesselmann, Cole, Saul, and Isla Garcia together disclose all limitations of claim 6 as discussed above.
Wesselmann further teaches wherein a first nominal balloon size of the balloon catheter is determined based on the first fluid quantity (balloon interior is filled with a fluid medium, reference diameter [0017]) and wherein a first further size difference between the first nominal balloon size and the balloon size in the first expansion state is determined (reference diameter corresponds to a nominal vessel diameter [0023]; over-expansion of the nominal vessel diameter by 5, 10, and 20% [0024]-[0025]).
As set forth for claim 5, Saul teaches inflatable balloon with association curve between pressure and diameter, using the curve, pressure can be determined ([0086] Figure 17).
Regarding to claim 10, Wesselmann and Cole together teach all limitations of claim 1 as discussed above.
Wesselmann further discloses estimating current diameter from the current pressure using a measurement curve or calibration showing the diameter as a function of the pressure of interior of the balloon ([0027]), and pressure is based on the fluid volume ([0081]), but does not indicate the balloon size at corresponding volume of the balloon catheter.
However, in the analogous field of endeavor in inflating balloon catheter, Isla Garcia teaches pressure is associated with the quantity of fluid (volume) and the balloon diameter in accordance with the association rule (Figures 3-6, [0093] corresponding to 2nd paragraph page 19).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Isla Garcia, since association of pressure with quantity of liquid and balloon diameter was well known in the art as taught by Isla Garcia. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, by implementing association between pressure, volume of liquid, and diameter, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to regulate pressure of inflatable balloon catheter while preventing hyperinflation ([0052]-[0054]), and there was reasonable expectation of success.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wesselmann and Cole as applied to claim 1 above, and further in view of “Fetherston et al.,” US 2024/0058129 (hereinafter Fetherston).
Regarding to claim 11, Wesselmann and Cole teach all limitations of claim 1 as discussed above.
Wesselmann and Cole do not disclose wherein the at least one first image comprises two or more first images, wherein respective viewing directions of the two or more first images differ from each other, and/or wherein the at least one second image comprises two or more second images, wherein respective viewing directions of the two or more second images differ from each other.
However, in the analogous field of endeavor in medical balloon sensing method, Fetherston teaches acquiring multiple images to determine a surface topography of the plurality of predetermined locations, and generate 3D/4D map of plurality of predetermined locations using two or more image sensors ([0100] and [0339]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify balloon size monitoring as taught by Wesselmann to incorporate teaching of Fetherston, since using plurality of image sensors was well known in the art as taught by Fetherston. One of ordinary skill in the art could have combined the elements as claimed by Wesselmann with no change in their respective functions, using multiple image sensor to generate 3D/4D maps, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention. The motivation would have been to provide 3D map of medical inflatable balloon ([0339]), and there was reasonable expectation of success.
Conclusion
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798