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.
Response to Amendment
The amendment filed 03/09/2026 has been entered. Claims 1-2, 4, 6, 12-15, and 18 remain pending in the application. Claims 3, 5, 7-10, 16-17 have been cancelled. Claims 19-21 have been added and are pending in the application.
Response to Arguments
Applicant's arguments filed 03/09/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the functional limitations recited in the previous Office Action are structural and not functional, the Examiner respectfully disagrees. Applicant’s claim 1 does not define any of the architecture or structure of the underlying code or algorithm, but simply defines the intended function of said code or algorithm. There is no reasonable certainty of what the algorithm’s architecture or internal function of the algorithm, only the external functional output that the program intends to accomplish. To simplify, imagine the algorithm is within a blackbox, in which said blackbox takes in inputs, and spits out outputs. What is the internal structure or architecture within the blackbox? The internal structure/innerworkings within the blackbox would be the structure of the algorithm. Applicant’s claims only recite the inputs and outputs of the algorithm, and mention that there is an algorithm present. Applicant’s mention of the sentence “unlike in the mechanical arts, the specific structure of software code and applications is partly defined by its function,” is not relevant, as the sentence clearly states the function only partly defines the structure. Without any description of the internal architecture of the code or algorithm, the intended functional output is insufficient to define the underlying structure and is therefore still considered functional language. As the prior art has a processing unit that has code programmed within it that can take in commands and data as well as store data that connects to sensors that can measure the diameter of the vessel wall, this claim does not introduce anything novel that the prior art would not be capable of. Database units, processing units with code programmed on them capable of receiving outputs of sensor signals as inputs and producing outputs, and sensors and their relationship to one another are all present in the prior art. Furthermore, applicant’s mention of the sentence “we have explained that claim limitations like the recited 'computer program code,' when combined with a description of what the code is intended to accomplish, convey definite structure to the ordinarily skilled artisan” from a federal circuit case is also not supportive of their claim. This sentence further supports the fact that the internal structure and interworking’s of the algorithm would be needed to convey definite structure to the ordinarily skilled artisan. The Instant Applicant’s claims only have one portion of the sentence, being “a description of what the code is intended to accomplish,” and is not combined with any further internal structure of the algorithm. The previous rejection of claim 1 is therefore sustained.
Given that O’Beirne discloses that “it has been found that the optimal size of a dilatation balloon is about 0.9 to about 1.3 the size of the vessel being treated” (see paragraph [0004]), and the threshold value is in an overlapping range of 5% to 20% of the “predefined reference value,” the reference value being the size of the vessel being treated, it would have been obvious for the threshold value to be within a range of an optimal size of a dilatation balloon. The rejection is sustained.
Regarding Applicant’s argument that O’Beirne’s disclosure does not disclose a plurality of sensors at one or both of the distal end portion of the balloon and the proximal end portion of the balloon, the Examiner respectfully disagrees. The reference discloses that there can be multiple optical strain sensors (FBG sensors) coupled with multiple optical parallel optical fibers wrapped around the outer surface of balloon for measuring strain in more than one location of the balloon (see paragraph [0034]).
Regarding Applicant’s argument that no artisan would replace O’Beirne’s optical sensor, the Examiner would like to point out that claim 4 states that the plurality of sensors comprise contact sensors, leaving room for the device to also comprise of different types of sensors. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to include contact sensors disposed at the proximal and/or distal balloon end to provide the sensor signals to determine the reference value through contact with the healthy portion of the vessel wall, as contact sensors are well known in the art to assist the clinician in placing, sizing, and securing devices correctly as taught by Hunter (see paragraph [0093]). By this logic, as the contact sensors are known within the art to assist in sizing components, the contact sensors would assist with determining the correct value for the reference value in accordance with the patient’s anatomy.
Regarding Applicant’s argument that Hunter does not teach determining reference values for balloon inflation or the position of said sensors on the balloon, the reference is brought in to teach the concept of contact sensors and why they would be beneficial to include into the prior art, not to determine reference values or to show that a specific location on the balloon would be beneficial. These concepts are already taught by O’Beirne as modified before Hunter is introduced. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding the argument that Hoem is insufficient for the limitations that the prior art lacks being “to have a pump for filling the balloon interior with the fluid medium” and “to have a processing unit able to control the pump,” additional evidence from the prior art is added in the rejection to strengthen the position. Hoem teaches the pump (211) in communication with pressure sensors, a control circuit, and a stop valve to control it (see paragraphs [0086] and [0087]), so it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne to have a pump for filling the balloon interior with the fluid medium, as the substitution of one known element (inflation mechanism of O’Beirne) for another (pump of Hoem) would have been obvious to someone of ordinary skill, since the substitution of the inflation mechanism shown in O’Beirne would have yielded predictable results, namely, a balloon that is inflated by a pump as taught by Hoem (see paragraph [0086]-[0089]). It would have been further obvious to modify the balloon catheter system of O’Beirne such that the processing unit is configured with an algorithm that causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium. Hoem teaches that the control system for inflation of the balloon allows dosing a defined fluid amount into the pressure tank as a function of the pressure measurement values, which then would allow the processing unit to initiate the inflation to be terminated if the pressure measured in the pressure tank reaches the pressure target value (see paragraphs [0086] and [0088]).
It is additionally noted that Hoem is not relied upon for teaching the sensors, but only the control of the pump for protecting the vessel [0006]. Additionally, Hoem teaches the importance of not overstressing the vessel wall, achieving safer occlusion, and having a well-controlled environment for the inflation of balloon, which makes the device and its purpose directly applicable to O-Beirne (see Abstract of Hoem, see also paragraph [0006]). Finally, even though the prior art has a different reason for modifying/combining, it still teaches all the claimed elements as shown in the additional evidence presented in the rejection of claim 1. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Regarding the argument that Hoem teaches away from using the claim 1 features of using the algorithm, processing unit, and sensor information to control the pump to terminate filling of the balloon interior, the Examiner disagrees. Applicants have not identified where the cited reference actually criticizes or discourages using the system to terminate filling of the balloon. See DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) ("A reference does not teach away, however, if it merely expresses a general preference for an alternative invention but does not 'criticize, discredit, or otherwise discourage' investigation into the invention claimed." (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 12, 15, 18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 20120271339 A1 (hereafter --O'Beirne--), in view of US 20150366485 A1 (hereafter --Kassab--), in further view of US 20160287260 A1 (hereafter --Hoem--).
Regarding Claim 1, O'Beirne discloses a balloon catheter system comprising: a balloon extending in an axial direction (see annotated balloon 122 in Figures 1 and 2 below) that may form the basis of a stent delivery system (see paragraph [0024]); and a catheter connected to the balloon (see annotated catheter 102 in Figures 1 and 2 below), including a lumen (110) in fluid communication with a balloon interior of the balloon (see paragraph [0024], see also annotated lumen in Figures 1A and 2 below); a plurality of sensors disposed at a plurality of different axial positions on an outer surface of the balloon (see paragraph [0034] denoting that there can be multiple optical strain sensors (FBG sensors) coupled with multiple optical parallel optical fibers wrapped around the outer surface of balloon for measuring strain in more than one location of the balloon) configured to measure expansion of the balloon in a radial direction (see paragraph [0028] denoting an optical sensor 138 that measures the material strain, see also annotated sensor 138 in Figures 1 and 2 below), wherein the plurality of sensors comprise sensors at one or both of a distal end portion of the balloon and a proximal end portion of the balloon, wherein the sensors at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon are distributed on a cylindrical part of the balloon over a circumference of the balloon at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon (see paragraph [0034] denoting that there can be multiple optical strain sensors (FBG sensors) coupled with multiple optical parallel optical fibers wrapped around the outer surface of balloon for measuring strain in more than one location of the balloon, in which they may be positioned along the working portion of the balloon in order to monitor balloon diameter variation between the proximal end of the balloon and the distal end of the balloon and ensure symmetrical expansion of the balloon); a processing unit connected to receive a signal from the plurality of sensors (see paragraph [0028] denoting a wavelength detector 105 that correlates the strain into a diameter value, thereby is considered a “processing unit” as claimed, see also paragraph [0029], see also annotated processing unit 105 in Figures 1 and 2 below), the signal being indicative of a current diameter of the balloon in the radial direction (see paragraph [0028] describing that the signal from the sensor determines the diameter output from the processing unit 105), the reference value corresponding to a balloon diameter upon contact of one or both of the proximal and distal balloon end portions of the balloon with a vessel wall (see paragraphs [0034] and [0038]), as sensed by the plurality of sensors at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon (see paragraph [0034] and [0038]).
The limitations “with a healthy portion of the vessel wall” and “wherein the algorithm implemented on the processing unit determines the reference value during a zeroing procedure based upon sensor signals from the plurality of sensors indicating the diameter of the healthy portion of the vessel wall as sensed by the sensors at the one or both of the distal end portion of the balloon and the proximal end portion the balloon” are treated as functional language, that are given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the reference disclosing that the processing unit 105 is able to calculate the strain of the balloon, in which the balloon would experience more strain upon contacting the vessel surface (see paragraphs [0028] and [0030]), as well as disclosed that the device blows up until the device reaches and expands the vessel wall (see paragraph [0006] and [0038]), the processor could use the sensor signals of the optical sensor 138 to determine the value in which the balloon touches the vessel, and store said value as the reference value if commanded to do so (see paragraph [0029] denoting that the processor 105 can process and store values, commands, and information), and therefore could have the reference value correspond to a balloon diameter upon contact of a proximal and/or distal balloon end with a healthy vessel wall. Additionally, the health of the vessel is not given patentable weight as the vessel is not a part of the claimed apparatus.
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O'Beirne fails to disclose a stent crimped onto an outer surface of the balloon, a pump configured to fill the balloon interior with a fluid medium, and the processing unit being configured with an algorithm implemented on the processing unit, wherein the algorithm causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium (M) if the signal reaches a threshold value of 5% to 20% above a predefined reference value. However, O'Beirne discloses that the balloon catheter system may form the basis of a stent delivery system (see paragraph [0024]), as well as discloses prompting a display device to output a display (see paragraph [0028] denoting the display 107 outputting the diameter value) if the signal reaches a threshold value above a predefined reference value (see paragraph [0032], see also paragraph [0038]).
Kassab discloses a balloon catheter system comprising: a balloon extending in an axial direction, including a lumen in fluid communication with a balloon interior of the balloon (see annotated balloon, catheter, and lumen in Figure 7A below), at least one sensor associated with the balloon to measure expansion of the balloon in a radial direction (see paragraph [0030] denoting that there is a pressure sensor on the balloon, see also paragraph [0036] denoting that there is a conductance sensor as well in the system), a processing unit receiving a signal from the at least one sensor (see paragraph [0036]), and a display for showing the signal data (see paragraph [0117]), wherein the system constitutes the filling of the balloon interior with a fluid medium (see paragraph [0031]). Kassab teaches a stent crimped onto an outer surface of the balloon (see annotated stent in Figure 7A below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention for the balloon catheter system of O'Beirne to include a stent crimped around the balloon, as by doing so would allow the system to be used as a stent delivery system treat stenosis (see paragraph [0084]) as is desired by O’Beirne.
O’Beirne as modified fails to disclose a pump configured to fill the balloon interior with a fluid medium, the processing unit being configured with an algorithm implemented on the processing unit, wherein the algorithm causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium (M) if the signal reaches a threshold value of 5% to 20% above a predefined reference value.
Hoem discloses a balloon catheter system comprising: a balloon extending in an axial direction (see annotated balloon and balloon catheter system in Figure 1 below), and a catheter connected to the balloon, including a lumen in fluid communication with a balloon interior of the balloon (see annotated catheter and balloon in Figure 1 above). Hoem teaches a pump (211) for filling the balloon interior with the fluid medium (see paragraphs [0039], [0040], [0086]). Hoem teaches the system includes control of the filing of the balloon so that the vessel wall with not be overstressed and to achieves safe occlusion (abstract; [0006]). Since O’Bierne is directed towards filling of a balloon, on of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the balloon catheter system of O’Beirne as modified above, to have a pump for filling the balloon interior with the fluid medium as the utilization of a pump to fill up a balloon with fluid, as by doing so would enable the system to equalize pressure in the balloon (see paragraph [0040]). Additionally, the substitution of one known element (inflation mechanism of O’Beirne) for another (pump of Hoem) would have been obvious to one of ordinary skill in the art at the time of the invention, since the substitution of the inflation mechanism shown in O’Beirne would have yielded predictable results, namely, a balloon that is inflated by a pump as taught by Hoem (see paragraph [0086]-[0089]).
O’Beirne as modified further fails to disclose wherein the processing unit is configured with an algorithm implemented on the processing unit, wherein the algorithm causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium (M) if the signal reaches a threshold value of 5% to 20% above a predefined reference value.
Hoem teaches wherein the processing unit is configured with an algorithm implemented on the processing unit (see paragraphs [0025] and [0086]-[0089]), wherein the algorithm causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium (see paragraph [0088]). Hoem teaches that the control system aids in preventing irreversible damage tissue while achieving safe occlusion (abstract; [0006]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to have wherein the processing unit is configured with an algorithm implemented on the processing unit, wherein the algorithm causes the processing unit to automatically control the pump to terminate filling of the balloon interior with a fluid medium, as Hoem teaches this prevents the balloon from exceeding a predetermined pressure limit [00061] and helps to prevent damage to surrounding tissue (see paragraphs [0006], [0086] and [0088]).
O’Beirne as modified further fails to disclose wherein the threshold value exceeds the predefined reference value by 5% to 20%.
O’Beirne teaches that it is well known in the art that the optimal size of the diameter of a balloon in a balloon catheter system ranges from -10% (negative 10 percent) - 30% (positive 30 percent) of the vessel that is being treated (corresponding to the “threshold value” (see paragraph [0004]) of the size of the diameter of the artery itself (corresponding to the “reference value,” as the reference value is claimed as being when the balloon touches the walls of the artery).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the balloon of the balloon catheter system of O’Beirne as modified have a threshold value to expand the diameter to that is from -10% to 30% of the size of the reference value (size of the artery/vessel being treated). Doing so would ensure that the balloon would be an optimal size for the vessel being treated, as it would reduce the likelihood of coronary dissection or significant residual stenosis as taught by O’Beirne (see paragraph [0004]). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the threshold value from the range of exceeding the reference value by -10% to 30% of the reference value to by about 5% to 20% of the reference value as claimed, since in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 2, O'Beirne as modified discloses the balloon catheter system according to claim 1, wherein the plurality of sensors comprise a strain sensor and the algorithm causes the processing unit to calculates the current diameter from strain sensed by the strain sensor (see paragraph [0028] denoting an optical sensor 138 that measures the material strain, and a processing unit 105 that turns the strain into a diameter value).
Regarding Claim 12, O’Beirne as modified discloses balloon catheter system according to claim 1, wherein the algorithm uses the sensor signals and one or more of case data, acute result data, and clinical result data, and wherein the algorithm causes the processing to transmit data based upon the sensor signals to a database unit (see paragraphs [0029] and [0031] denoting that the processing unit 105 can be associated with a memory device that stores data).
The limitation “wherein the database unit comprises processing to automatically determine the threshold value from stored and received sensor data, stored and received sensor case data, stored and received acute result data, and/or stored and received clinical result data, and provides the threshold value to the algorithm” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the database unit being able to store logical instructions, commands, and/or code (algorithm) executed by the programming unit, the database unit would be able to determine a threshold value when given data.
Regarding Claim 15, O’Beirne as modified discloses the balloon catheter system according to claim 1, wherein the processing unit is configured to receive, recommended and/or updated values for the threshold value (see paragraph [0030]).
O’Beirne as modified fails to disclose wherein the algorithm causes the processing unit to receive, via an Internet connection, recommended and/or updated values for the threshold value.
The Instant Application does not disclose receiving the values via an Internet connection solves any problem or is for any particular purpose, nor does it place criticality on the limitation (see page 14, lines 1-2 stating only that it is “preferable”). It appears that the processing unit of O’Beirne would perform equally well and function as intended with the recommended and/or updated values received through user input through a corresponding algorithm that is downloaded onto the processing unit, as taught by O’Beirne, because the method of delivering/receiving the values onto the device is not relevant to the manner in which the values/instructions are processed once received into the device. The input of the values through either method yields the same result of the instructions being available within the processing unit. Therefore, it would have been obvious to one having ordinary skill in the art to have the processing unit configured to receive, via an Internet connection, recommended and/or updated values for the threshold value as an obvious matter of design choice within the skill of the art.
Regarding Claim 18, O'Beirne as modified discloses the balloon catheter system according to claim 1, wherein the plurality of sensors comprise a strain sensor (see paragraph [0028] denoting an optical sensor 138 that measures the material strain).
Regarding Claim 20, O’Beirne as modified discloses the balloon catheter system according to claim 1, wherein the plurality of sensors comprise sensors at both of the distal end portion of the balloon and the proximal end portion of the balloon (see paragraph [0034] denoting that there can be multiple optical strain sensors (FBG sensors) coupled with multiple optical parallel optical fibers wrapped around the outer surface of balloon for measuring strain in more than one location of the balloon, in which they may be positioned along the working portion of the balloon in order to monitor balloon diameter variation between the proximal end of the balloon and the distal end of the balloon and ensure symmetrical expansion of the balloon). The term “portion” is very broad and can refer to any area of the stent. For example, the “proximal portion” can be any arbitrary area of the stent that is not the absolute distal most part or distal terminal end, as portion can be given its broadest reasonable interpretation to mean “an often limited part of a whole” (see Merriam Webster Online definition 3). The Examiner recommends narrowing the limitations “distal portion” and “proximal portion”.
Regarding Claim 21, O’Beirne as modified discloses the balloon catheter system according to claim 1, wherein the signal from the plurality of sensors comprises data from each of the plurality of sensors and the algorithm implemented on the processing unit continuously calculates and monitors the diameter of the balloon (see paragraph [0028]).
The limitation “the algorithm calculating over-expansion of the balloon beyond the reference value from the data” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the reference disclosing that the processing unit 105 is able to continuously (see paragraph [0028]) calculate the strain of the balloon, in which the balloon would experience more strain upon contacting the vessel surface (see paragraphs [0028] and [0030]), as well as disclosed that the device blows up until the device reaches and expands the vessel wall (see paragraph [0006] and [0038]), the processor could use the sensor signals of the optical sensor 138 to determine the value in which the balloon touches the vessel, store said value as the reference value if commanded to do so (see paragraph [0029] denoting that the processor 105 can process and store values, commands, and information), and thus flag when the balloon is over-expanded over said stored reference value, and therefore it would be capable of continuously calculating over-expansion of the balloon beyond the reference value from the data.
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over US 20120271339 A1 (hereafter --O'Beirne--), in view of US 20150366485 A1 (hereafter --Kassab--), in even further view of US 20160287260 A1 (hereafter --Hoem--), as applied to claim 1 above, in further view of US 20170196509 A1 (hereafter --Hunter--).
Regarding Claim 4, O’Beirne as modified discloses the balloon catheter system according to claim 1.
O’Beirne as modified fails to disclose wherein the plurality of sensors at one or both of the distal end portion of the balloon and the proximal end portion of the balloon comprise contact sensors.
Hunter discloses a balloon catheter delivery device, in which a balloon and catheter, forming the delivery device, is disposed under the stent for the delivery of the stent (see annotated stent, balloon, and catheter in Figure 12C below), as well as the delivery device having sensors and a processing and database unit (see paragraphs [0124] and [0125]). Hunter teaches that it is well known in the art to use contact sensors on delivery devices (see paragraph [0093], see also paragraphs [0086] and [0087]), which would include on the balloon that is delivering the stent, in which said plurality of sensors can send signals to a processing unit upon contact of a surface (see paragraphs [0124] and [0125]).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to include contact sensors disposed at the proximal and/or distal balloon end to provide the sensor signals to determine the reference value through contact with the healthy portion of the vessel wall, as contact sensors are well known in the art to assist the clinician in placing, sizing, and securing devices correctly as taught by Hunter (see paragraph [0093]). By this logic, as the contact sensors are known within the art to assist in sizing components, the contact sensors would assist with determining the correct value for the reference value in accordance with the patient’s anatomy.
Regarding Claim 6, O’Beirne as modified discloses the balloon catheter system according to claim 4, wherein the plurality of sensors at the one or both of a distal end portion of the balloon and the proximal end portion of the balloon signaled contact with the healthy portion of vessel wall (see claims 1 and 4 rejections above).
O’Beirne as modified fails to disclose wherein the processing unit is configured to control the pump to expand the balloon.
Hoem teaches the processing unit being able to “activate or deactivate” meaning inflate or deflate, the “occlusion component” (see paragraph [0016] of Hoem saying the control system 140 includes a processing unit that executes computer-readable instructions to activate/deactivate the component) meaning the inflatable balloon (see paragraph [0016] denoting that the occlusion component is the inflatable balloon, see also paragraph [0020]), and repeating inflating/deflating the balloon until the pressure in the balloon reach a “predetermined target value,” and storing the last provided fluid amount as a “reference value” (see paragraph [0057], [0058], and [0060]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to have a processing unit able to control the pump as by doing so allows a gradual approach to the introduction of fluid into the balloon to prevent the pressure in the balloon to exceed a predetermined target value as taught by Hoem (see paragraph 0061]). O’Beirne as modified further fails to disclose wherein the balloon comprises contact sensors, wherein the processing unit is configured to prompt the pump to expand the balloon until all of the contact sensors have signaled contact with the vessel wall, the processing unit being configured to respond to signaled contact by setting the diameter of the balloon as the reference value.
The limitation “wherein the algorithm causes the processing unit to determine the reference value by controlling the pump to expand the balloon until the plurality of sensors at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon signal contact with the healthy portion of the vessel wall, the algorithm causing the processing unit to set the diameter of the balloon as the reference value” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Due to the processing unit of O’Beirne as modified being able to execute stored instructions, commands, or code (algorithm) and therefore control the pump (see rejection above), as well as the processing unit as modified able to receive signals from contact sensors upon contact of tissue, as well as the balloon catheter system having the sensor that can send a signal to the processing unit to calculate the current strain and diameter of the balloon (see paragraph [0028] of O’Beirne), the processing unit would be able to prompt the pump to expand the balloon until all of the contact sensors have signaled contact with the vessel wall, the processing unit being configured to respond to signaled contact by setting the diameter of the balloon as the reference value.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 20120271339 A1 (hereafter --O'Beirne--), in view of US 20150366485 A1 (hereafter --Kassab--), in further view of US 20160287260 A1 (hereafter --Hoem--), as applied to claim 1 above, in even further view of US 6179858 B1 (hereafter --Squire--).
Regarding Claim 13, O’Beirne as modified disclose the balloon catheter system according to claim 1.
O’Beirne fails to disclose where the plurality of sensors measure change in the pressure of the fluid medium (M) and the algorithm causes the processing unit to calculate the current diameter (D) from pressure.
Squire discloses balloon catheter system comprising: a balloon extending in an axial direction; a stent crimped onto an outer surface of the balloon; a catheter connected to the balloon including a lumen in fluid communication with a balloon interior of the balloon (see Abstract); and a plurality of sensors a plurality of sensors disposed at a plurality of different axial positions on an outer surface of the balloon configured to measure expansion of the balloon in a radial direction (R), wherein the plurality of sensors comprise sensors at one or both of a distal end portion of the balloon and a proximal end portion of the balloon, wherein the sensors at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon are distributed on a cylindrical part of the balloon over a circumference of the balloon at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon (see annotated pressure sensors in Figure 6A below, in which there are two on each side of the balloon (proximal and distal), see also column 5, lines 26-49), a processing unit connected to receive a signal from the plurality of sensors, the signal being indicative of a current diameter of the balloon in the radial direction (see Abstract, see also column 2, lines 27-63). Squire teaches wherein the plurality of sensors measure change in the pressure of the fluid medium (M) and therefore see readings that are directly proportional to the current diameter (D) of the balloon from pressure (see also column 5, lines 26-49, see Abstract, see also column 2, lines 27-63).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to have pressure sensors measure the pressure of the balloon to illustrate changes in diameter, in which the sensor signals could be picked up by the processing unit of O’Beirne to calculate the diameter of the balloon, as by doing so would merely involve the substitution of two elements known in the art, as the substitution of one known element (strain sensor on outside of balloon as taught by O’Beirne) for another (pressure sensor on outside of balloon as taught by Squire) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the type of sensors would have yielded predictable results, namely, pressure sensors located on the outside of the balloon (as taught by Squire) to measure the pressure and therefore diameter of the balloon.
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20120271339 A1 (hereafter --O'Beirne--), in view of US 20150366485 A1 (hereafter --Kassab--), in further view of US 20160287260 A1 (hereafter --Hoem--), in even further view of US 20100094209 A1 (hereafter Drasler).
Regarding Claim 14, O’Beirne as modified disclose the balloon catheter system according to claim 1.
O’Beirne fails to disclose wherein the plurality of sensors comprise an ultrasonic sensor and the algorithm causes the processing unit to calculate the current diameter (D) from ultrasonic measurement.
Drasler discloses balloon catheter system comprising: a balloon extending in an axial direction; a stent crimped onto an outer surface of the balloon; a catheter connected to the balloon including a lumen in fluid communication with a balloon interior of the balloon (see Abstract, see also annotated Figure 6 below); and a plurality of sensors a plurality of sensors disposed at a plurality of different axial positions on an outer surface of the balloon configured to measure expansion of the balloon in a radial direction (R), wherein the plurality of sensors comprise sensors at one or both of a distal end portion of the balloon and a proximal end portion of the balloon, wherein the sensors at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon are distributed on a cylindrical part of the balloon over a circumference of the balloon at the one or both of the distal end portion of the balloon and the proximal end portion of the balloon (see paragraphs [0078], see also paragraph [0159] denoting that the sensors can be on the external spaces around the balloon, see also annotated ultrasound sensor 142 and other sensor 144 in Figure 6 below). Drasler teaches an ultrasonic sensor (142) that produces signals that enable calculation of the balloon’s current diameter (D) from ultrasonic measurement (see paragraphs [0078], see also paragraph [0159] denoting that the sensors can be on the external spaces around the balloon, see also annotated ultrasound sensor 142 in Figure 6 below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to include an ultrasound sensor to measure the diameter of the balloon (see paragraph [0078]), in which the sensor signals could be picked up by the processing unit of O’Beirne to calculate the exact diameter of the balloon, as by doing so would merely involve the substitution of two elements known in the art, as the substitution of one known element (strain sensor on outside of balloon as taught by O’Beirne) for another (ultrasound sensor on outside of balloon as taught by Drasler) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the type of sensors would have yielded predictable results, namely, an ultrasound sensor located on the outside of the balloon (as taught by Drasler) to measure the diameter of the balloon.
Regarding Claim 19, O’Beirne discloses balloon catheter system according to claim 1.
O’Beirne fails to disclose wherein the plurality of sensors comprise a capacitive sensor or ultrasonic sensor.
Drasler teaches an ultrasonic sensor (142) that produces signals that enable calculation of the balloon’s current diameter (D) from ultrasonic measurement (see paragraphs [0078], see also paragraph [0159] denoting that the sensors can be on the external spaces around the balloon, see also annotated ultrasound sensor 142 in Figure 6 above).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon catheter system of O’Beirne as modified to include an ultrasound sensor to measure the diameter of the balloon (see paragraph [0078]), in which the sensor signals could be picked up by the processing unit of O’Beirne to calculate the exact diameter of the balloon, as by doing so would merely involve the substitution of two elements known in the art, as the substitution of one known element (strain sensor on outside of balloon as taught by O’Beirne) for another (ultrasound sensor on outside of balloon as taught by Drasler) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the type of sensors would have yielded predictable results, namely, an ultrasound sensor located on the outside of the balloon (as taught by Drasler) to measure the diameter of the balloon.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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