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 .
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Regarding the amendments to the independent claims, newly-found reference of Carlson has been introduced. Carlson teaches an elongate device with multiple echogenic regions with differing sizes and shapes.
Regarding new claim 32, previously-found reference of Fearnot has been applied.
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 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.
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 1-3, 5-6, 8-13 & 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm (US 2013/0053770) in view of Carlson (US 2008/0097213), Ebert (WO 2010/059408), and Webler (US 2009/0131910).
Regarding claims 1 & 5-6, Aggerholm teaches a medical device, comprising:
a first layer (first balloon layer 30, [0045]/first balloon layer 46, [0057]) defining an elongated body extending along a longitudinal axis from a proximal end to a distal end ([0042] & Figure 1) and defining a lumen extending longitudinally within the elongate body ([0043]), the first layer comprising a first polymer ([0045]); and
a second layer (second balloon layer 32, [0045]/second balloon layer 48, [0057]) disposed on and radially adjacent to the first layer ([0045]), the second layer comprising a second polymer ([0046]);
Paragraph [0048] teaches that the polymers used in the first and second balloon layers may be different. However, even if the layers are made of the same polymer, as is also taught in [0048], the claims do not specify that the first polymer and second polymer must be different.
wherein a density of the first polymer is within a range from about 0.7 g/cm3 to about 5.5 g/cm3 ([0044]); and
Paragraph [0044] teaches that the material used for the balloon may be nylon 12, polyether block amide, PET, or polyethylene. Nylon 12 has a density of 1.01 g/cm3, polyether block amide has a density of 1.00-1.03 g/cm3, PET has a density of 1.38 g/cm3, and polyethylene has a density of 0.88-0.96 g/cm3.
wherein a density of the second polymer is within a range from about 0.7 g/cm3 to about 5.5 g/cm3 ([0044]).
Per above, several polymers with densities within the claimed range are proposed. Therefore, two different polymers can be selected for each of the first and second layer with each falling within the claimed density range.
However, Aggerholm fails to disclose that at least a portion of the second layer defines a first echogenic region and a second echogenic region located on the distal portion and spaced apart from each other, wherein the first echogenic region and the second echogenic region are dissimilar in one or both of size or shape to be echogenically indicative of an orientation and a trajectory of the distal portion, and wherein each of the first echogenic region and the second echogenic region is configured to diffusely scatter an ultrasonic soundwave.
Carlson teaches that at least a portion of the second layer (catheter 80, [0032]) defines a first echogenic region (band 81 of echogenic marks, [0032], Figure 8) and a second echogenic region (band 82 of echogenic marks, [0032], Figure 8) located on the distal portion and spaced apart from each other ([0032] & Figure 8), wherein the first echogenic region and the second echogenic region are dissimilar in one or both of size or shape to be echogenically indicative of an orientation and a trajectory of the distal portion ([0026]-[0027] & [0031]-[0032], Figures 5-9), and wherein each of the first echogenic region and the second echogenic region is configured to diffusely scatter an ultrasonic soundwave.
By definition, an echogenic region scatters sound waves. Because the echogenic particles are dispersed in the catheter, the tubular shape ensures that the particles are dispersed concentrically around the catheter. This would result in the soundwave being scattered in all directions.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Aggerholm such that at least a portion of the second layer defines a first echogenic region and a second echogenic region located on the distal portion and spaced apart from each other, wherein the first echogenic region and the second echogenic region are dissimilar in one or both of size or shape to be echogenically indicative of an orientation and a trajectory of the distal portion, and wherein each of the first echogenic region and the second echogenic region is configured to diffusely scatter an ultrasonic soundwave, as taught by Carlson. Providing two distinguishable echogenic regions on the device allows the exact position and orientation of the device in the body to be determined, resulting in a more effective navigation.
However, Aggerholm in view of Carlson fail to disclose that the echogenic region comprises an echogenic ceramic material dispersed in the second layer, wherein the echogenic ceramic material is dispersed in the second polymer.
Ebert teaches that the echogenic region ([0011]) comprises an echogenic ceramic material ([0011] & [0026]) dispersed in the catheter (catheter 10, [0015]), wherein the echogenic ceramic material is dispersed in the second polymer (base polymeric material, [0011]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm and Carlson such that at least a portion of the catheter defines an echogenic region comprising an echogenic ceramic material dispersed in the catheter, wherein the echogenic ceramic material is dispersed in the polymer, as taught by Ebert. An echogenic region in the catheter ensures that the location of the catheter can be tracked via ultrasound imaging during the procedure.
However, Aggerholm in view of Carlson and Ebert fail to disclose that the elongated body comprises a distal portion defining an articulating segment configured to controllably bend in a geometric plane, and a difference between a density of the echogenic region and a density of the first polymer is within a range from about 0 g/cm3 to about 4.5 g/cm3.
Webler teaches that the elongated body (elongated shaft 11, [0026]) comprises a distal portion defining an articulating segment (deflectable distal shaft section 12, [0026], Figure 7) configured to controllably bend in a geometric plane ([0026] & Figure 7), and a difference between a density of the echogenic region (particles and inner layer 22, [0036] & [0062]) and a density of the first polymer (outer layer 21, [0036]) is within a range from about 0 g/cm3 to about 4.5 g/cm3 ([0036]).
Paragraph [0036] teaches that the particles may comprise 0% to 90% of the weight of the particle/polymer blend. At 0% weight, two polymers of the same material would have a density difference of 0 g/cm3. Using the same polymer for each layer is supported in [0067] of Webler, as well as [0048] of Aggerholm. Also at 0% weight, any combination of polymers taught in [0044] of Aggerholm would fulfill the claimed density difference range. Using different polymers for each layer is supported in Claim 17 of Webler, as well as [0048] and Aggerholm. The maximum weight percent for a particular particle material to fall within the claimed range depends on the density of the material, the total amount of the particle in the polymer, and the densities of the two polymers. However, for any particle of any density, a weight percent exists between 0% and 90% in which the difference in densities falls within the claimed range. Paragraph [0062] teaches that the particles may be ceramic echogenic particles, and [0036] teaches that the particles may be placed in either layer.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm, Carlson, and Ebert such that the elongated body comprises a distal portion defining an articulating segment configured to controllably bend in a geometric plane, and a difference between a density of the echogenic region and a density of the first polymer is within a range from about 0 g/cm3 to about 4.5 g/cm3, as taught by Webler. A steerable catheter gives greater control in navigating to a target region. A sufficient difference in density between the echogenic region and the polymer ensures that the echogenic region is visible, both visually and acoustically.
Regarding claim 2, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the medical device comprises at least one of a medical balloon (balloon 10, [0042]) or a catheter (balloon catheter 22 [0042]).
Regarding claim 3, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
Ebert further teaches that the echogenic ceramic material comprises tungsten carbide ([0011]), aluminum oxide, titanium dioxide, or titanium nitride ([0025]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm such that the echogenic ceramic material comprises tungsten carbide, aluminum oxide, titanium dioxide, or titanium nitride, as taught by Ebert. These materials provide the proper echogenic properties to allow the device to be tracked via ultrasound imaging during the procedure.
Regarding claim 8, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches a third layer (third balloon layer 50, [0058]) radially adjacent to the second layer ([0058]), wherein the third layer comprises a third polymer ([0058]).
Paragraph [0058] teaches that the polymers used in the first and third balloon layers may be different. However, even if the layers are made of the same polymer, as is also taught in [0058], the claims do not specify that the first polymer and third polymer must be different.
Regarding claim 9, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
Ebert further teaches that the echogenic ceramic material has a density within a range from about 1 g/cm3 to about 20 g/cm3 ([0026]).
Tungsten carbide has a density of 15.6 g/cm3.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm such that the echogenic material has a density within a range from about 1 g/cm3 to about 20 g/cm3, as taught by Ebert. Using a ceramic material with a sufficiently high density allows it to easily be visualized in an ultrasound image.
Regarding claim 10, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
Ebert further teaches that the echogenic ceramic material has a specific acoustic impedance within a range from about 10 MRayl to about 110 MRayl ([0026]).
Of the materials listed for the echogenic material in the rejection of claim 3, tungsten carbide, aluminum oxide, and titanium dioxide provide the claimed acoustic impedance. Per ualberta.ca (see PTO-892 dated 04/28/2023), tungsten carbide has an acoustic impedance of 58.48 MRayl, aluminum oxide has an acoustic impedance of 26.28 MRayl, and titanium dioxide has an acoustic impedance of 22.08 MRayl.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm such that the echogenic ceramic material has a specific acoustic impedance within a range from about 10 MRayl to about 110 MRayl, as taught by Ebert. Using a ceramic material with a sufficiently high acoustic impedance allows it to easily be visualized in an ultrasound image.
Regarding claim 11, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that a radial thickness of the first layer is within a range from about 0.001 mm to about 2 mm ([0052]).
Regarding claim 12, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that a radial thickness of the second layer is within a range from about 0.001 mm to about 2 mm ([0052]).
Regarding claim 13, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
Ebert further teaches that the echogenic material comprises a plurality of particles, wherein an average diameter of the plurality of particle is within range from about 0.1 µm to about 50 µm ([0029]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device taught by Aggerholm such that the echogenic material comprises a plurality of particles, wherein an average diameter of the plurality of particle is within range from about 0.1 µm to about 50 µm, as taught by Ebert. Particles of this size are small enough such that soundwaves can be diffusely scattered.
Regarding claim 15, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the first layer defines an outermost surface of the medical device ([0045]).
Regarding claim 16, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the second layer defines an innermost surface the medical device ([0045]).
Regarding claim 17, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the second layer is disposed on an inner surface of the first layer ([0045]).
Regarding claim 18, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the echogenic region is expandable together with an adjacent portion of the first layer ([0043] & [0045]).
Regarding claim 31, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1, and Aggerholm further teaches that the second polymer is different from the first polymer ([0044]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm in view of Carlson, Ebert, and Webler, as applied to claim 1, above, in further view of Quearry (US 2014/0276073).
Regarding claim 14, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
However, Aggerholm in view of Carlson, Ebert, and Webler fail to disclose that the soundwave that the echogenic region is configured to diffusely scatter comprises an ultrasonic soundwave having a frequency within a range from about 1 MHz to about 20 MHz.
Quearry teaches that the soundwave that the echogenic region is configured to diffusely scatter ([0031]) comprises an ultrasonic soundwave having a frequency within a range from about 1 MHz to about 20 MHz ([0065]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the medical device taught by Aggerholm such that the soundwave that the echogenic region is configured to diffusely scatter comprises an ultrasonic soundwave having a frequency within a range from about 1 MHz to about 20 MHz, as taught by Quearry. Selecting an echogenic material capable of scattering frequencies common to ultrasound imaging systems ensures that the echogenic region can be detected in an image.
Claims 19-22 & 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm in view of Carlson, Ebert, and Webler in further view of Abraham (US 2019/0022399).
Claims 19 & 22 are rejected for similar reasons to claim 1.
Ebert teaches that the echogenic region has a density within a range from about 1.5 g/cm3 to about 3.0 g/cm3.
The following equation is used:
1.5
≤
100
-
w
100
ρ
2
+
w
100
(
ρ
p
a
r
t
i
c
l
e
s
)
≤
3.0
wherein ρ is the density of the second polymer, w is the percent weight of the radiopaque particles, and ρparticles is the density of the particles. Take, for instance, that the second polymer is nylon 12, as is taught in Aggerholm, and the particles are tungsten carbide, as is taught in Ebert. Nylon 12 has a density of 1.01 g/cm3 and tungsten carbide has a density of 15.63 g/cm3. Thus, it can be calculated that the claimed density range is achieved with a weight loading of tungsten carbide between 3.35-13.61%.
However, Aggerholm in view of Carlson, Ebert, and Webler fail to disclose a second medical device sized for delivery out of the distal end of the elongate body and configured for at least one of therapy delivery or sensing, wherein the second medical device comprises at least one of a medical electrical lead or an implantable medical device.
Abraham teaches a second medical device (implantable cardioverter defibrillator, Abstract) sized for delivery out of the distal end of the elongate body (ultrasound image guided catheter, Abstract) (Figure 2C) and configured for at least one of therapy delivery or sensing (Abstract), wherein the second medical device comprises at least one of a medical electrical lead or an implantable medical device (Abstract).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the medical device taught by Aggerholm to include a second medical device sized for delivery out of the distal end of the elongate body and configured for at least one of therapy delivery or sensing, wherein the second medical device comprises at least one of a medical electrical lead or an implantable medical device, as taught by Abraham. Delivering the second medical device via the echogenic delivery catheter ensures that the position of the delivery catheter can be easily recognized and ultrasound images, allowing for a more accurate placement of the second medical device.
Regarding claim 20, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the first medical device comprises at least one of a medical balloon (balloon 10, [0042]) or a catheter (balloon catheter 22 [0042]).
Regarding claim 21, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the echogenic region is configured to be expanded with a fluid ([0043] & [0045]).
Regarding claim 24, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the first medical device further comprises a handle assembly (associated couplings, [0062]) configured to controllably expand the first medical device from a collapsed configuration to an expanded configuration ([0062]).
Regarding claim 25, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the first layer defines an outermost surface of the medical device ([0045]).
Regarding claim 26, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the second layer defines an innermost surface the medical device ([0045]).
Regarding claim 27, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the second layer is disposed on an inner surface of the first layer ([0045]).
Regarding claim 28, Aggerholm in view of Carlson, Ebert, Webler, and Abraham teach the kit of claim 19, and Aggerholm further teaches that the echogenic region is expandable together with an adjacent portion of the first layer ([0043] & [0045]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm in view of Carlson and Ebert, as applied to claim 19 above, in further view of Desjardins (US 2021/0052173) and Webler.
Claim 30 is rejected for similar reasons to claims 1 & 2.
However, Aggerholm in view of Carlson and Ebert fail to disclose that forming the second layer comprises applying an echogenic coating to one of the first layer or the second layer to form the echogenic region.
Desjardins teaches that forming the second layer (polymer, [0049]) comprises applying an echogenic coating (aluminum oxide, [0049]) to one of the first layer or the second layer to form the echogenic region ([0049]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method taught by Aggerholm, Carlson, and Ebert such that forming the second layer comprises applying an echogenic coating to one of the first layer or the second layer to form the echogenic region, as taught by Desjardins. Applying the echogenic material as a coating to the layer ensures that it is evenly distributed around the layer, increasing its ability to diffusely scatter the soundwave.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm in view of Carlson, Ebert, and Webler, as applied to claim 1 above, in further view of Fearnot (US 2013/0267848).
Regarding claim 32, Aggerholm in view of Carlson, Ebert, and Webler teach the medical device of claim 1.
However, Aggerholm in view of Carlson, Ebert, and Webler fail to disclose that the first echogenic region is spaced apart from the second echogenic region by a distance along the articulating segment within a range from about 5 mm to about 25 mm.
Fearnot teaches that the first echogenic region (marker 26, [0025], Figure 1) is spaced apart from the second echogenic region (marker 27, [0025], Figure 1) by a distance along the articulating segment within a range from about 5 mm to about 25 mm ([0025] & Figure 1).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Aggerholm, Carlson, Ebert, and Webler such that the first echogenic region is spaced apart from the second echogenic region by a distance along the articulating segment within a range from about 5 mm to about 25 mm, as taught by Fearnot. This provides a substantial separation in order to differentiate the two echogenic regions, as well as provide a known distance in images.
Conclusion
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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