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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 14, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 7,959,667 (Ta et al.).
Ta discloses a balloon catheter for treating a diseased bifurcating blood vessel (see Figure 23), the balloon catheter comprising:
a proximal hub (103);
a shaft (107);
a distal hub (119);
and a bifurcated balloon assembly comprising a first balloon (117) having a proximal segment and a distal segment, and a second balloon (129) having a proximal segment and a distal segment, wherein the first balloon (117) and the second balloon (129) are arranged substantially in parallel (see Fig 1), and wherein the proximal segment of the first balloon is connected to the shaft (107), the distal segment of the first balloon is connected to the distal hub (119) (via member 111A), and the distal segment of the second balloon (129) is connected to the distal hub (119) (via 125).
Regarding claim 2, Ta includes a first guidewire lumen (112) (within shaft 111) and a second guidewire lumen (within shaft 128).
In regards to claim 14, the device can be described as having the balloons positioned between a proximal shaft (107) and a distal shaft (111A) (See Fig. 23).
Regarding claim 18: the first balloon (117) is connected to the distal hub (119) via a first flexible conduit (111A), and the distal segment of the second balloon (129) connected to the distal hub (119) via flexible conduit (125).
In regards to claim 19, a first guidewire (116) extends through the first guidewire lumen (111) (from the port 115) and exits a distal end of the balloon catheter (see guidewire 116 extending distally from the distal hub (119) in Figures 23 and 27).
Claim(s) 1, 2, 14, 16, 18, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 2015/0126986 (Kelly et al.).
Kelly discloses a balloon catheter for treating a diseased bifurcating blood vessel (see Figure 3), the balloon catheter comprising:
a proximal hub (308);
a shaft (316);
a distal hub (338);
and a bifurcated balloon assembly comprising a first balloon (334) having a proximal segment and a distal segment, and a second balloon (336) having a proximal segment and a distal segment, wherein the first balloon and the second balloon are arranged substantially in parallel (see Fig 3), and wherein the proximal segment of the first balloon is connected to the shaft (316), the distal segment of the first balloon (334) is connected to the distal hub (338) (via member 319), and the distal segment of the second balloon (336) is connected to the distal hub (338) (via member 321).
Regarding claim 2, Ta includes a first guidewire lumen (112) (within shaft 111) and a second guidewire lumen (within shaft 128).
In regards to claim 14, the device can be described as having the balloons positioned between a proximal shaft (316) and a distal shaft (319/320/321).
In regards to claim 16, Kelly discloses a tether (628 or 650) that extends through an opening the shaft (316) that is proximal to the bifurcated balloon assembly (the lumen of shaft 316 meeting the broad requirement of “opening”) and couples to a proximal end of the second balloon (extends within balloon 336) (see Fig. 6).
Regarding claim 18: the first balloon (334) is connected to the distal hub (320) via a first flexible conduit (319), and the distal segment of the second balloon (336) connected to the distal hub (320) via flexible conduit (321).
In regards to claim 19, a first guidewire (342) extends through the first guidewire lumen (322) (from the port 308) and exits a distal end of the balloon catheter (see guidewire 342 extending distally from the catheter in Figure 3).
Claim(s) 1, 2, 14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2008/0051869 (Yribarren).
Yribarren discloses a balloon catheter for treating a diseased bifurcating blood vessel (see Figures 2, 8), the balloon catheter comprising:
a proximal hub (30);
a shaft (12);
a distal hub (80);
and a bifurcated balloon assembly comprising a first balloon (20) having a proximal segment and a distal segment, and a second balloon (18) having a proximal segment and a distal segment, wherein the first balloon and the second balloon are arranged substantially in parallel (see Fig 2 and 8), and wherein the proximal segment of the first balloon (20) is connected to the shaft (12), the distal segment of the first balloon (20) is connected to the distal hub (80 in Fig.8), and the distal segment of the second balloon (18) is connected to the distal hub (80) (via member 70).
Regarding claim 2, Yribarren includes a first guidewire lumen (within shaft 12) and a second guidewire lumen (within shaft 16) (see guidewires 100 and 102 in Figures 7C-D; [0065]).
In regards to claim 14, the device can be described as having the balloons positioned between a proximal shaft (12) and a distal shaft (80) (Fig. 8).
Regarding claim 18: the first balloon (20) is connected to the distal hub (enlarged portion of 80) via a first flexible conduit (proximal portion of 80), and the distal segment of the second balloon (18) is connected to the distal hub (80) via flexible conduit (70).
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.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ta in view of WO 01/43665 (Wilson).
Although Ta fails to disclose a constraining sleeve, Wilson teaches that a delivery device having two parallel balloons can be constrained by a restraining sleeve (28) to provide a low profile during delivery of a Y-shaped stent (see Figure 14; page 14, lines 8-10). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the restraining sleeve taught by Wilson with the Ta assembly, in order to aid in maintaining a low profile delivery for the balloons and stents to the treatment site.
In regards to claim 5, Wilson teaches materials for the sheath can be polyethylene, polyurethane, nylons, PEEK, PTFE, or PET, which encompasses both compliant and non-compliant materials (page 11, lines 10-15). Ta discloses PEBAX PEEK, urethanes, PET or nylon for balloon materials (wherein at least nylon is non-compliant). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to form the balloons of modified Ta of non-compliant material and the sheath from a compliant material, as Wilson teaches both types of materials are known in construction of a balloon catheter. Additionally, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yribarren in view of US Patent No. 6,099,497 (Adams et al.).
Yribarren fails to disclose the balloons have a shape that defines a waist, with a proximal portion of the balloon having a substantially constant diameter and the distal segment varying in diameter. Adams discloses another delivery device for a bifurcated stent having two parallel balloons (24 and 26) and teaches that the balloon may be shaped to define a waist (36 and 46) between proximal and distal ends, such that a proximal segment (38 and 48) of the balloon has a constant diameter and the distal segment (combination of 50 and 44 for balloon 26; combination of 40 and 34 for balloon 24) has a varied diameter (Figure 2A). Adams teaches that this shape of the balloons aid in accommodating the diameters of the main and branch vessels (column 3, lines 38-42) and the waist portions (36 and 46) are pre-bent to more easily orient the balloons towards separate branch vessels (column 3, lines 45-64). Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the balloons of the Yribarren to have a waist portion, a constant diameter proximal portion and a varied diameter distal portion, as taught by Adams, in order to provide balloons having a shape optimized for treating bifurcated vessels.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 6,099,497 (Adams et al.). in view of US Patent No. 6,086,611 (Duffy et al.).
Adams discloses a method of deploying a bifurcated stent comprising a main body stent (64) and two branch stents (74, 82) comprising a step of expanding the two branch stents (74, 82) and the main body stent (64) with two parallel balloons (24, 26) (See Fig. 9; column 5, line 36 to column 6, line 6).
Adams fails to disclose a second step of further expanding the main body stent with a single balloon. Duffy discloses another assembly having a bifurcated stent mounted on two parallel balloons (see ballons 4 in Figure 4). Similar to Adams, Duffy discloses deploying both the main body and branch stents with the two balloons (Figures 6A-C; column 6, lines 37-54). Duffy teaches an alternative method in which a single balloon is used to further inflate the main body after the branches are expanded with branch balloons (see Figures 7A-E; column 6, line 55 through column 7, line 12). Therefore, one of ordinary skill in the art would have found it obvious to perform a second step of further inflating the main body of the stent during the Adams method, as taught by Duffy, as the modification merely involves a combination of known methods of expanding a bifurcated stent that obtains a predictable result of using a single balloon to expand a main body of a stent to a desired degree.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 6,099,497 (Adams et al.). in view of US Patent No. 6,086,611 (Duffy et al.), and further in view of USPAP 2008/0125847 (Krever et al.).
Regarding claim 9, Although Adams and Duffy fail to disclose the main body stent is expanded to an oval cross-section, Krever discloses that it is known in the art for a main body of a stent (100) to have an oval cross-section while the branch stents (220a and 220b) to have an oval cross-section (see Figure 5B and 6, . Therefore, it would have been obvious to one of ordinary skill in the art to configure the main body of the stent of modified Adams to obtain an oval cross-section at some point during its expansion, as taught by Krever, as the modification merely involves a change in cross-sectional shape of an expandable balloon.
Regarding claim 10, it is generally understood that a balloon of a balloon catheter has a circular cross-section (see for instance Figure 15B of Adams). Therefore, it would have been obvious to one of ordinary skill in the art to decrease ovality of the distal end of the main body of the stent by performing the second step of inflating the single balloon within the main body during the modified Adams method, in order to optimize the size and shape of the prosthesis for a particular patient’s anatomy.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2022/0387200 (Kamat) in view of US 10,219,926 (Bourang et al.).
Kamat discloses a balloon catheter with two parallel balloons(1820, 1822), a main body stent (1802) and two branch stents (1806, 1808) (See Figure 18A). Figure 18B shows the cross sections of the components in a compressed profile. The main body (phantom line 1802) defines a circular profile while the two branch stents (1806, 1808) have an oval cross-section.
Kamat fails to disclose the steps achieved to obtain the compressed profile. Bourang teaches that it is known in the art to use an iris crimper to compress different parts of a stent having different diameters in separate steps. A distal portion (3524) of the stent in Figure 35b has a smaller diameter than the proximal portion (3526) and corresponds with a branch of the Kamat device. Bourang discloses a step of compressing a smaller diameter segment (3524) inwardly towards its centerline (Figures 35g-35j) (columns 49-51). Bourang then teaches a step of compressing another portion of the stent (3526) (see Figure 35b; larger diameter portion 3526 corresponds with the main body of the bifurcated stent of Kamat) inwardly towards its centerline (Figures 35K-N) (columns 51-52). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to apply the Bourang method of crimping different parts of the stent in different steps to the Kamat device, as the modification merely involves the application of a known method of crimping to a known stent assembly that obtains a predictable result of compressing each segment of the Kamat device inwardly towards the respective centerlines. It would have been further obvious to perform a step of compressing the main body and two branch stents towards a common centerline with the crimping tool taught by Bourang, in order to obtain a desired diameter for a particular procedure.
Regarding claim 12, Kamat discloses an oval cross-section of the branch stents, and Bourang teaches that a final step of compressing components the assembly together may result in components have an oval cross-section (Fig. 35p).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kamat in view of Bourang et al., as applied to claim 11 above, and further in view of USPAP 2009/0299453 (Arcand et al.).
Although Kamat and Bourang fail to disclose a crimping tool with a bifurcating channel. Arcand discloses another method and tool for crimping a bifurcated stent (450) onto two parallel balloons (448) [0118-0119]. Arcand teaches that a crimping tool may be configured to have a bifurcating channel, where a first section of the channel has a larger diameter than a second section (474) of the channel (see Figure 22; [0120]). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to use a crimping tool with a bifurcating channel taught by Arcand in the modified method of crimping the Kamat assembly, as the modification merely involves a combination of a known crimping tool with a crimping method to achieve a predictable result of crimping a stent having sections of varying diameter.
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ta in view of WO 01/43665 (Wilson), as applied to claim 4 above, and further in view of USPAP 2004/0148007 (Jackson et al.).
Although Ta and Wilson fail to disclose the restraining sleeve has a larger diameter at the distal end, Jackson teaches that it is known in the art to configure a sleeve of a stent delivery catheter to have a larger portion (56) at the distal end to house the stent ([0044]; see especially Figure 2, wherein the distal portion of the sleeve 14 covering the stent has a larger diameter than a proximal portion of the sleeve). One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to configure the sleeve of modified Ta to have a larger distal portion, as taught by Jackson, in order to accommodate the stent and balloons of the modified Ta catheter.
Allowable Subject Matter
Claim 3, 15, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claims 3 and 15, the closest reference Kelly discloses an embodiment in Figure 8 with two guidewire lumens, wherein each lumen extends through one balloon. Kelly fails to configure the second guidewire lumen to extend from the proximal hub through the shaft, the first balloon, the distal hub and the second balloon.
Further in regards to claim 15, the prior art fails to disclose or render obvious a second guidewire lumen that terminates at an opening at a proximal end of the second balloon.
In regards to claim 20, the prior art fails to disclose or render obvious a second guidewire that extends through the second guidewire lumen through the shaft, the first balloon, and the distal hub and then exits a first opening of the distal hub to form a loop distal to the distal hub and the second guidewire enters a second opening of the distal hub and extends through the second guidewire lumen to the second balloon and exits a proximal end of the second balloon.
Conclusion
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774