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 Amendment
The Amendment filed 5/18/2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 2/17/2026.
Specification
The disclosure is objected to because of the following informalities:
The reference character “106” has been used to refer to “first longitudinal sheath section” in paragraph 0031, line 8 and “second longitudinal sheath section” in paragraph 0031, line 9.
Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/4/2026 was filed after the mailing date of the Non-Final Office Action on 2/17/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities:
Regarding claim 7, line 2, the recitation “a distal sheath tip” appears to be amended to recite “the distal sheath tip” in order to refer to “a distal sheath tip” recited in claim 1.
Regarding claim 7, line 2, the recitation “a distal end” appears to be amended to recite “the distal end” in order to refer to “a distal end” recited in claim 1.
Claim 17 recites the limitation “the distal sheath tip” in line 13. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, lines 21-22, the recitation “a distal sheath tip” appears to be amended to recite “the distal sheath tip” in order to refer to “distal sheath tip” recited previously in line 13.
Appropriate correction is required.
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, 7-9, 11, 12, 14, 16, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) and further in view of Razi (US 5,542,936).
Regarding claims 1 and 7, Kume discloses a medical device (figure 2), comprising:
an introducer sheath 220, the introducer sheath 220 comprising a tubular structure (structure of element 220) comprising a wall (wall of element 220) defining a sheath lumen (hollow portion inside element 220) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (axis extending along a length of element 220) therethrough, the tubular structure further comprising:
a first longitudinal sheath section 231 having a first sheath stiffness (stiffness of element 231); and
a second longitudinal sheath section 223 distal to the first longitudinal sheath section 231, the second longitudinal sheath section 223 having a single second sheath stiffness (stiffness of element 223) that is less than the first sheath stiffness throughout the second longitudinal sheath section (paragraph 0055), the second longitudinal sheath section comprising a distal sheath tip (tip where element 230 is present) at a distal end (end where element 230 is present) of the second longitudinal sheath section 223; and
a sheath transition 225 from the first longitudinal sheath section 231 to the second longitudinal sheath section 223, the sheath transition 231 being proximal to the distal sheath tip (tip where element 230 is present); and
a dilator 260 configured to occupy the sheath lumen, the dilator comprising:
a shaft (shaft of element 260) comprising a wall (wall of element 260) defining a dilator lumen (paragraph 0089, lines 12-21, in order for the dilator to pass over the guide wire dilator needs to be hollow thereby having a dilator lumen) extending longitudinally throughout the shaft, the shaft defining a second longitudinal axis (longitudinal axis of element 260) that is coaxial with the longitudinal axis when the dilator 260 occupies the sheath lumen (hollow portion inside element 220), the shaft further comprising:
a first longitudinal dilator section (portion of element 260 closer to element 264) having a first dilator stiffness (stiffness of portion of element 260 closer to element 264); and
a second longitudinal dilator section (portion of element 260 closest to and comprising element 268) distal to the first longitudinal dilator section; and
a dilator transition (portion of element 260 connecting portion of element 260 closer to element 264 and portion of element 260 closer to element 268) from the first longitudinal dilator section to the second longitudinal dilator section; and
wherein the sheath transition 225 is offset (element 225 will be longitudinally offset with respect to the portion of element 260 between the portion of element 260 closest to element 264 and the portion of element 260 closest to element 268) longitudinally from the dilator transition when the dilator 260 occupies the sheath lumen,
wherein the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section (due to proximal stiffness being higher than distal stiffness in sheath and dilator, the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section). Kume is silent regarding the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness.
However, Garrison teaches a design of a medical device (figure 1) comprising the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness (paragraph 0093, lines 1-7) for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second dilator stiffnesses of Kume to incorporate the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness as taught by Garrison for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Kume is further silent regarding the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip.
However, Razi teaches a design of a sheath assembly comprising a dilator (figure 4) wherein the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip (column 4, lines 40-43) and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip (column 4, lines 40-43) for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the dilator to incorporate the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip as taught by Razi for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Regarding claims 8 and 9, Kume is silent regarding wherein the shaft further comprises a third longitudinal dilator section distal to the second longitudinal dilator section, the third longitudinal dilator section having a third dilator stiffness different from the second dilator stiffness wherein the third dilator stiffness is less than the second dilator stiffness.
However, Garrison teaches wherein the shaft further comprises a third longitudinal dilator section distal to the second longitudinal dilator section, the third longitudinal dilator section having a third dilator stiffness different from the second dilator stiffness (paragraph 0093, lines 1-7, “increasingly stiffer material towards the more proximal sections” indicates that the materials become stiffer as moving towards the proximal sections thereby indicating that there exists more than two sections with third section being most flexible) wherein the third dilator stiffness is less than the second dilator stiffness (paragraph 0093, lines 1-7) for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shaft and dilator of Kume to incorporate wherein the shaft further comprises a third longitudinal dilator section distal to the second longitudinal dilator section, the third longitudinal dilator section having a third dilator stiffness different from the second dilator stiffness wherein the third dilator stiffness is less than the second dilator stiffness as taught by Garrison for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Regarding claim 11, Kume discloses wherein a longitudinal dilator length (length of element 260) is greater (see figure 2, paragraph 0072, lines 4-7, dilator distal tip is extending beyond the distal end of the sheath) than a longitudinal sheath length (length of element 220).
Regarding claim 12, Kume discloses an introducer sheath 220 comprising a tubular structure (structure of element 220) comprising a wall (wall of element 220) defining a sheath lumen (hollow portion inside element 220) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (axis extending along a length of element 220) therethrough, the tubular structure comprising:
a first longitudinal sheath section 231 having a first sheath stiffness (stiffness of element 231);
a second longitudinal sheath section 223 distal to the first longitudinal sheath section 231, the second longitudinal sheath section 223 having a single second sheath stiffness (stiffness of element 223) that is less than the first sheath stiffness throughout the second longitudinal sheath section (paragraph 0055), the second longitudinal sheath section comprising a distal sheath tip (tip where element 230 is present) at a distal end (end where element 230 is present) of the second longitudinal sheath section 223; and
a sheath transition 225 from the first longitudinal sheath section 231 to the second longitudinal sheath section 223, the sheath transition 231 being proximal to the distal sheath tip (tip where element 230 is present);
wherein a dilator 260 configured to be used with the introducer sheath 220 to occupy the sheath lumen such that the sheath transition 231 is offset (element 225 will be longitudinally offset with respect to the portion of element 260 between the portion of element 260 closest to element 264 and the portion of element 260 closest to element 268) longitudinally from a dilator transition from a first longitudinal dilator section (portion of element 260 closer to element 264) to second longitudinal dilator section (portion of element 260 closest to and comprising element 268), wherein the dilator comprises a shaft (shaft of element 260), the shaft comprising a wall (wall of element 260) defining a dilator lumen (paragraph 0089, lines 12-21, in order for the dilator to pass over the guide wire dilator needs to be hollow thereby having a dilator lumen) extending longitudinally throughout the shaft, the first longitudinal dilator section having a first dilator stiffness (stiffness of portion of element 260 closer to element 264); and the second longitudinal dilator section distal to the first longitudinal dilator section and having a second dilator stiffness (stiffness of element 260 closest to and comprising element 268);
wherein the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section (due to proximal stiffness being higher than distal stiffness in sheath and dilator, the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section). Kume is silent regarding the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness.
However, Garrison teaches a design of a medical device (figure 1) comprising the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness (paragraph 0093, lines 1-7) for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second dilator stiffnesses of Kume to incorporate the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness as taught by Garrison for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Kume is further silent regarding the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip.
However, Razi teaches a design of a sheath assembly comprising a dilator (figure 4) wherein the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip (column 4, lines 40-43) and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip (column 4, lines 40-43) for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the dilator to incorporate the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip as taught by Razi for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Regarding claim 14, Kume discloses wherein the sheath transition 225 is configured to be distal to the dilator transition (depending on positioning element 260 with respect to element 220, element 225 could be located distal to the dilator transition which is portion of element 260 connecting portion of element 260 closer to element 264 and portion of element 260 closer to element 268).
Regarding claim 16, Kume discloses wherein the dilator transition is configured to be distal to the sheath transition 225 (depending on positioning element 260 with respect to element 220, element 225 could be located proximal to the dilator transition which is portion of element 260 connecting portion of element 260 closer to element 264 and portion of element 260 closer to element 268).
Regarding claim 17, Kume discloses a dilator 260, a shaft (shaft of element 260), the shaft (shaft of element 260) comprising:
a wall (wall of element 260) defining a dilator lumen (paragraph 0089, lines 12-21, in order for the dilator to pass over the guide wire dilator needs to be hollow thereby having a dilator lumen) extending longitudinally throughout the shaft,
a first longitudinal dilator section (portion of element 260 closer to element 264) having a first dilator stiffness (stiffness of portion of element 260 closer to element 264); and
a second longitudinal dilator section (portion of element 260 closest to and comprising element 268) distal to the first longitudinal dilator section; and
a dilator transition (portion of element 260 connecting portion of element 260 closer to element 264 and portion of element 260 closer to element 268) from the first longitudinal dilator section to the second longitudinal dilator section;
wherein the dilator is configured to occupy a sheath lumen (hollow portion inside element 220) of an introducer sheath 220 such that a sheath transition 225 from a first longitudinal sheath section 231 to a second longitudinal sheath section 223 is offset (element 225 will be longitudinally offset with respect to the portion of element 260 between the portion of element 260 closest to element 264 and the portion of element 260 closest to element 268) longitudinally from the dilator transition, the sheath transition being proximal to the distal sheath tip (tip where element 230 is present), wherein the introducer sheath 220 comprising a tubular structure (structure of element 220) comprising a wall (wall of element 220) defining a sheath lumen (hollow portion inside element 220) extending longitudinally throughout the tubular structure, the tubular structure defining a longitudinal axis (axis extending along a length of element 220) therethrough, the tubular structure further comprising: the first longitudinal sheath section 231 having a first sheath stiffness (stiffness of element 231); and a second longitudinal sheath section 223 distal to the first longitudinal sheath section 231, the second longitudinal sheath section 223 having a single second sheath stiffness (stiffness of element 223) that is less than the first sheath stiffness throughout the second longitudinal sheath section (paragraph 0055), the second longitudinal sheath section comprising a distal sheath tip (tip where element 230 is present) at a distal end (end where element 230 is present) of the second longitudinal sheath section 223; and
wherein the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section (due to proximal stiffness being higher than distal stiffness in sheath and dilator, the first and second sheath stiffnesses and the first and second dilator stiffnesses provide a combined series of distally decreasing stiffness transitions along the longitudinal axis from the first longitudinal dilator section to the distal end of the second longitudinal sheath section). Kume is silent regarding the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness.
However, Garrison teaches a design of a medical device (figure 1) comprising the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness (paragraph 0093, lines 1-7) for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first and second dilator stiffnesses of Kume to incorporate the second longitudinal dilator section having a second dilator stiffness that is less than the first dilator stiffness as taught by Garrison for the purpose of navigating through different shapes and structures of the blood vessel to reach the target site (paragraph 0011).
Kume is further silent regarding the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip.
However, Razi teaches a design of a sheath assembly comprising a dilator (figure 4) wherein the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip (column 4, lines 40-43) and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip (column 4, lines 40-43) for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the dilator to incorporate the dilator distally extending about 0.5 centimeter (cm) to about 5.0 cm beyond the distal sheath tip and wherein when the dilator occupies the sheath lumen, the second longitudinal dilator section is configured to extend distally at least one centimeter through the distal sheath tip as taught by Razi for the purpose of providing a tapered shape that facilitate the entry of the sheath into the blood vessel (column 4, lines 40-43).
Regarding claim 19, Kume discloses wherein the sheath transition 225 is configured to be distal to the dilator transition (depending on positioning element 260 with respect to element 220, element 225 could be located distal to the dilator transition which is portion of element 260 connecting portion of element 260 closer to element 264 and portion of element 260 closer to element 268).
Claims 2, 8, 10, 13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) in view of Razi (US 5,542,936) and further in view of Gareth et al. (EP 3030306 B1).
Regarding claim 2, Kume/Garrison/Razi (hereinafter referred as “modified Kume”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kume is silent regarding wherein the first sheath stiffness is less than the first dilator stiffness.
However, Gareth teaches a design of a medical device wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa) for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness and the first dilator stiffness of modified Kume to incorporate wherein the first sheath stiffness is less than the first dilator stiffness as taught by Gareth for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Regarding claim 8, modified Kume discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kume is silent regarding wherein the shaft further comprises a third longitudinal dilator section distal to the second longitudinal dilator section, the third longitudinal dilator section having a third dilator stiffness different from the second dilator stiffness.
However, Gareth teaches wherein the shaft further comprises a third longitudinal dilator section 100a distal to the second longitudinal dilator section 100b, the third longitudinal dilator section 100a having a third dilator stiffness different from the second dilator stiffness 100b (page 6, lines 25-27) for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the shaft and dilator of modified Kume to incorporate wherein the shaft further comprises a third longitudinal dilator section distal to the second longitudinal dilator section, the third longitudinal dilator section having a third dilator stiffness different from the second dilator stiffness as taught by Gareth for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Regarding claim 10, modified Kume discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Kume is silent regarding wherein the third dilator stiffness is greater than the second dilator stiffness.
However, Gareth teaches wherein the third dilator stiffness is greater than the second dilator stiffness and/or equal to the first dilator stiffness (page 6, lines 25-27) for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the dilator of modified Kume to incorporate wherein the third dilator stiffness is greater than the second dilator stiffness as taught by Gareth for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021)
Regarding claim 13, modified Kume discloses the claimed invention substantially as claimed, as set forth above in claim 12. Modified Kume is silent regarding wherein the first sheath stiffness is less than the first dilator stiffness.
However, Gareth teaches a design of a medical device wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa) for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness and the first dilator stiffness of modified Kume to incorporate wherein the first sheath stiffness is less than the first dilator stiffness as taught by Gareth for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Regarding claim 18, modified Kume discloses the claimed invention substantially as claimed, as set forth above in claim 17. Modified Kume is silent regarding wherein the first sheath stiffness is less than the first dilator stiffness.
However, Gareth teaches a design of a medical device wherein the first sheath stiffness is less than the first dilator stiffness (page 8, lines 45-46, durometer of about 45D corresponds to EXP ((45+50)*0.0235-0.6403 = 4.91 MPa which is less than 0.8 GPa) for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the first sheath stiffness and the first dilator stiffness of modified Kume to incorporate wherein the first sheath stiffness is less than the first dilator stiffness as taught by Gareth for the purpose of steering the medical device to the target site by navigating through different shapes/structures of the blood vessels (paragraph 0021).
Allowable Subject Matter
Claims 3-6, 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.
The closest prior art of record, Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) in view of Razi (US 5,542,936) is silent regarding wherein the sheath transition is distal to the dilator transition especially with the requirement to have the dilator distally extending about 0.5 cm to about 5 cm beyond the distal sheath tip in combination with other claimed limitations of claim 3.
Claim 4 being dependent on claim 3 is also indicated allowable.
The closest prior art of record, Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) in view of Razi (US 5,542,936) is silent regarding wherein the dilator transition is distal to the sheath transition especially with the requirement to have the dilator distally extending about 0.5 cm to about 5 cm beyond the distal sheath tip in combination with other claimed limitations of claim 5.
Claim 6 being dependent on claim 5 is also indicated allowable.
The closest prior art of record, Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) in view of Razi (US 5,542,936), is silent regarding wherein the second dilator stiffness is less than the first sheath stiffness and greater than the second sheath stiffness in combination with other claimed limitations of claim 15.
The closest prior art of record, Kume et al. (US 2017/0296798 A1) in view of Garrison et al. (US 2018/0064453 A1) in view of Razi (US 5,542,936), is silent regarding wherein the second dilator stiffness is less than the first sheath stiffness and greater than the second sheath stiffness in combination with other claimed limitations of claim 20.
Response to Arguments
Applicant’s arguments with respect to claims 1, 12 and 17 have been considered but are moot because the arguments do not apply in view of the present rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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