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 .
Election/Restrictions
Applicant’s election without traverse of Group I and Species A in the reply filed on 08/31/2026 is acknowledged.
Claims 8, 10-12, and 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and Species B-G, there being no allowable generic or linking claim.
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.
Claim(s) 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US 2014/0142688).
Regarding claim 1, Duffy discloses a prosthetic valve delivery assembly (FIGs 2-9, wherein device 10 can be a prosthetic valve, [0020]) comprising: a dilator (18 and 29, [0028]) extending along a dilator axis (Along axial direction 64, FIG 5) between a proximal end (End of 29 which attaches to handle 17) and a distal end (Distal end of 18 shown in FIG 5), the dilator comprising: a first tapered region (28, FIG 5 and 8, [0043] discloses the taper) extending along the dilator axis between the distal end and a first central end (See annotated FIG 8 below), the first tapered region comprising a tapered shape with a first diameter at the distal end and a second diameter at the first central end (Respective diameters at the annotated positions below), the second diameter greater than the first diameter (FIG 8 shows the diameter at the first central end is greater than the diameter at the distal end, due to the direction of the taper); a central region (See annotated FIG 8 below) coaxial with the first tapered region (FIGs 5-9 show the central region is coaxial with 28) and attached to the first central end (FIG 8), the central region comprising the second diameter that is substantially constant along a central length of the central region (The diameter is interpreted as being substantially constant along the length of the central region, FIG 8); a second tapered region (Tapered end of 30, [0043]) extending along the dilator axis (FIG 5-9) between a second central end and a third central end (See annotated FIG 8 below), the second central end attached to the central region (FIG 8), the second tapered region comprising a tapered shape ([0043]) with the second diameter at the second central end and a third diameter at the third central end, the third diameter less than the second diameter (FIG 8 shows the diameter at the third central end is less than the diameter at the second central end); and a proximal shaft region (29, FIG 5, [0028] discloses 29 being connected to 18) extending from and in contact with the third central end (FIG 5 shows the contact between the third central end and the distal end of 29), the proximal shaft region comprising the third diameter (FIG 5).
Duffy further suggests that the second diameter can be “for example 19 Fr or another suitable diameter” ([0048]) and the third diameter is shown to be smaller than the second diameter, due to the inward taper of the second tapered region, but is silent regarding the third diameter and therefore fails to teach a difference between the second diameter and the third diameter being within a French gauge range from about 3Fr to about 5Fr.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Duffy to have a third diameter that is 3-5 Fr smaller than the second diamteter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Duffy would not operate differently with the claimed diameter and since the difference in the diamteter of the second and third diameters should be sufficiently large to provide a space for housing the prosthetic valve, the device would function appropriately having the claimed change in diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter difference “may” be within the claimed ranges (specification pp. [0081]).
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Regarding claim 4, Duffy discloses the invention substantially as claimed, as set forth above for claim 1. Duffy further discloses the second diameter is less than about 1.5 times a vessel diameter of the vessel (The vessel/vessel diameter is not a positively recited limitations of the claim and will vary depending on a particular use and application of the device. The device of Duffy is at least capable of being used in such a manner that the second diameter would be less than 1.5 times a vessel diameter if placed in an according sized vessel).
Regarding claim 5, Duffy discloses the invention substantially as claimed, as set forth above for claim 1. Duffy further discloses a handle (17, FIG 2) attached adjacent to the proximal end of the dilator ([0028] discloses the proximal end of 29 is attached to the handle 17), the handle axially fixed relative to the dilator and comprising a non-constant cross-sectional size along a length of the handle (FIG 2 shows the handle is axially fixed and aligned with the dilator, and also that there is a variation in the cross sectional size of the handle).
Regarding claim 6, Duffy discloses the invention substantially as claimed, as set forth above for claim 1. Duffy further discloses the dilator comprises at least one lumen extending axially through the dilator (24 and 43, [0035], FIG 5).
Regarding claim 7, Duffy discloses the invention substantially as claimed, as set forth above for claim 6. Duffy further discloses the at least one lumen comprises a first lumen (Lumen of section 30, FIG 5), a second lumen (Lumen of section 28, FIG 5), and a third lumen (lumen 43 of 29), the first lumen laterally offset from, and between, the second lumen and the third lumen (As shown in the positioning of FIG 5).
Claim(s) 2, 3, 9, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US 2014/0142688) in further view of Luo et al. (CN 102671287).
Regarding claims 2-3, Duffy discloses the invention substantially as claimed, as set forth above for claim 1.
Duffy is silent regarding the central region comprises a central length that is within a range from about 1 mm to about 150 mm and the tapered shape of the second tapered region comprises a taper angle that is within a range from about 1 degree to about 30 degrees.
However, Luo et al. teaches in the same field of endeavor of vascular dilators (abstract, [0005-0006]) having tapered regions (12, 14, 16, FIG 4) and central regions of constant diameter (11, 13, 15, FIG 4), wherein the central region comprises a central length that is within a range from about 1 mm to about 150 mm ([0048] provides an exemplary length of 40 mm) and the tapered shape of the second tapered region comprises a taper angle that is within a range from about 1 degree to about 30 degrees ([0048] provides an exemplary taper angle of 10 degrees).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a central length of 40 mm and a taper angle of 10 degrees, as taught by Lou, for the purpose of using dilator dimensions commonly known in the art for appropriately expanding an opening diameter without causing unnecessary trauma to the tissue, and since it has been held that "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 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, Duffy discloses a prosthetic valve delivery assembly (FIGs 2-9, wherein device 10 can be a prosthetic valve, [0020]) comprising: a sheath (27/19, FIG 2-5) comprising a wall surrounding an elongate chamber (lumen, [0029], FIG 5), the sheath configured to be received within a vessel (Such as lumen 31, FIG 6); and dilator (18 and 29, [0028]) configured to be received within the chamber (FIG 5, [0028-0030])and extending along a dilator axis (Along axial direction 64, FIG 5) between a proximal end (End of 29 which attaches to handle 17) and a distal end (Distal end of 18 shown in FIG 5), the dilator comprising: a first tapered region (28, FIG 5 and 8, [0043] discloses the taper) extending along the dilator axis between the distal end and a first central end (See annotated FIG 8 above), the first tapered region comprising a tapered shape with a first diameter at the distal end and a second diameter at the first central end (Respective diameters at the annotated positions above), the second diameter greater than the first diameter (FIG 8 shows the diameter at the first central end is greater than the diameter at the distal end, due to the direction of the taper); a central region (See annotated FIG 8 above) coaxial with the first tapered region (FIGs 5-9 show the central region is coaxial with 28) and attached to the first central end (FIG 8), the central region comprising the second diameter that is less than about 1.5 times a vessel diameter of the vessel (The vessel/vessel diameter is not a positively recited limitations of the claim and will vary depending on a particular use and application of the device. The device of Duffy is at least capable of being used in such a manner that the second diameter would be less than 1.5 times a vessel diameter if placed in an according sized vessel); a second tapered region (Tapered end of 30, [0043]) extending along the dilator axis (FIG 5-9) between a second central end and a third central end (See annotated FIG 8 above), the second central end attached to the central region (FIG 8), the second tapered region comprising a tapered shape ([0043]) with the second diameter at the second central end and a third diameter at the third central end, the third diameter less than the second diameter (FIG 8 shows the diameter at the third central end is less than the diameter at the second central end); and a proximal shaft region (29, FIG 5, [0028] discloses 29 being connected to 18) extending from and in contact with the third central end (FIG 5 shows the contact between the third central end and the distal end of 29), the proximal shaft region comprising the third diameter (FIG 5).
Duffy further suggests that the second diameter can be “for example 19 Fr or another suitable diameter” ([0048]) and the third diameter is shown to be smaller than the second diameter, due to the inward taper of the second tapered region, but is silent regarding the third diameter and therefore fails to teach the third diameter within a range from about 60% to about 90% of the second diameter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Duffy to have a third diameter that is about 60% to about 90% of the second diameter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Duffy would not operate differently with the claimed diameter and since the difference in the diameter of the second and third diameters should be sufficiently large to provide a space for housing the prosthetic valve, the device would function appropriately having the claimed change in diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter difference “may” be within the claimed ranges (specification pp. [0081]).
Duffy is further silent regarding the central region comprising a central length that is within a range from about 1 mm to about 150 mm and the tapered shape of the second tapered region comprises a taper angle that is within a range from about 1 degree to about 30 degrees.
However, Luo et al. teaches in the same field of endeavor of vascular dilators (abstract, [0005-0006]) having tapered regions (12, 14, 16, FIG 4) and central regions of constant diameter (11, 13, 15, FIG 4), wherein the central region comprises a central length that is within a range from about 1 mm to about 150 mm ([0048] provides an exemplary length of 40 mm) and the tapered shape of the second tapered region comprises a taper angle that is within a range from about 1 degree to about 30 degrees ([0048] provides an exemplary taper angle of 10 degrees).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a central length of 40 mm and a taper angle of 10 degrees, as taught by Lou, for the purpose of using dilator dimensions commonly known in the art for appropriately expanding an opening diameter without causing unnecessary trauma to the tissue, and since it has been held that "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 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 13, Duffy/Luo discloses the invention substantially as claimed, as set forth above for claim 9. Duffy further discloses the second diameter is constant along the central length of the central region (The diameter is constant along at least some length of the central region, FIG 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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