DETAILED ACTION
This is in response to the Amendment filed 9/18/2026 wherein claims 10 and 17-19 are canceled and claims 1-9, 11-16, and 20-26 are presented for examination.
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 .
Drawings
The drawings were received on 9/18/2026. These drawings are acceptable.
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.
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 1-9, 11, 13, 16, 20, and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Rollins et al. (US 2010/0204613).
Regarding Independent Claim 1, Pigott teaches (Figures 1-31) a catheter system (10) comprising or consisting of:
an outer catheter (22) comprising an outer catheter shaft (at 22) defining an outer catheter lumen (within 22);
at least one inner member (11) being arranged within the lumen (within 22), the at least one inner member (11) being relatively movable with respect to the outer catheter (22) in an unrestricted moving state (see Paragraph 0073), and
an axial movement restriction device (21) comprising an actuation mechanism (at 31, 32) and a locking mechanism (at 33 or 32b), wherein the axial movement restriction device (21) is configured to restrict axial movement of the at least one inner member (11) in a restricted moving state (see Paragraph 0072 and Figures 4 and 7-8) and permit axial movement in the unrestricted moving state (see Paragraph 0073 and Figure 5).
Although Pigott teaches that his invention may be practiced with any other desired structure for preventing the inner member from slipping in relation to the sheath, Pigott does not teach that the actuation mechanism comprises a ball screw drive actuation mechanism which comprises an oscillating thread or groove.
Rollins teaches (Figures 1-11) the use of an actuation mechanism (700, 1116) used to lock a guidewire (102), wherein the actuation mechanism (700, 1116) comprises a ball screw drive actuation mechanism (see Paragraph 0048) which comprises a groove (a ball screw actuator will inherently include some type of groove for the ball bearings to travel).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott to have the actuation mechanism comprises a ball screw drive actuation mechanism which comprises an oscillating thread or groove, as taught by Rollins, in order to impart axial motion to the coupler and guidewire without any rotational motion (Paragraph 0047 of Rollins). It is additionally noted that a simple substitution of one known element (in this case, the clamp mechanism as taught by Pigott) for another (in this case, the clamp mechanism as taught by Rollins) to obtain predictable results (in this case, to lock an inner member of a catheter) was an obvious extension of prior art teachings, KSR, 550 U.S. at 415-421, 82 USPQ2d at 1396, MPEP 2141 III B.
Regarding Claim 2, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the actuation mechanism (at 31 or 32) and the locking mechanism at 33 or 32b) are connected or coupled to each other (see Paragraph 0070, Paragraph 0078, Figures 4-5, and Figures 7-8).
Regarding Claim 3, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the axial movement restriction device (21) comprises a connector (25) that connects the axial movement restriction device (21) with the outer catheter (22).
Regarding Claim 4, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the axial movement restriction device (21) comprises a receptor (the pocket defined by 32a) for the inner member (11).
Regarding Claim 5, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the outer catheter (22) is connected at its proximal end to a handle (see abstract and Figures 1, 3, and 26-30).
Regarding Claim 6, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the axial movement restriction device (21) is integrated in the handle (see abstract and Figures 1, 3, and 26-30).
Regarding Claim 7, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the outer catheter (22) is a support catheter (see Figures 2-5).
Regarding Claim 8, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the at least one inner member (11) is an inner tubular member (see Paragraph 0058 and Figures 2-5).
Regarding Claim 9, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the at least one inner member (11) is a dilator and/or a balloon catheter (see Paragraph 0058, Paragraph 0062, and Figures 2-5).
Regarding Claim 11, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the locking mechanism (at 33, 32b) comprises at least one clamp (see abstract, Figures 4-5, and Figures 8-9).
Regarding Claim 13, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the actuation mechanism (at 31, 32) is a manual actuation mechanism (see Paragraphs 0068 and 0073).
Regarding Independent Claim 16, Pigott teaches (Figures 1-31) an axial restriction device (21) for restricting an axial movement of at least one inner member (11) arranged in an outer catheter lumen (within 22) of an outer catheter (22), comprising:
a locking mechanism (at 33 or 32b) and an actuation mechanism (at 31, 32) connected or coupled with each other (see Paragraph 0070, Paragraph 0078, Figures 4-5, and Figures 7-8);
a connector (25) configured to connect the axial movement restriction device (21) with an outer catheter (22) having a tubular outer catheter lumen (within 22) capable of receiving an inner member (11), and
a tubular receptor (the opening within 30a for receiving 11; see Figures 4-5) for the inner member (11).
Although Pigott teaches that his invention may be practiced with any other desired structure for preventing the inner member from slipping in relation to the sheath, Pigott does not teach that the actuation mechanism comprises a ball screw drive actuation mechanism which comprises an oscillating thread or groove.
Rollins teaches (Figures 1-11) the use of an actuation mechanism (700, 1116) used to lock a guidewire (102), wherein the actuation mechanism (700, 1116) comprises a ball screw drive actuation mechanism (see Paragraph 0048) which comprises a groove (a ball screw actuator will inherently include some type of groove for the ball bearings to travel).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott to have the actuation mechanism comprises a ball screw drive actuation mechanism which comprises an oscillating thread or groove, as taught by Rollins, in order to impart axial motion to the coupler and guidewire without any rotational motion (Paragraph 0047 of Rollins). It is additionally noted that a simple substitution of one known element (in this case, the clamp mechanism as taught by Pigott) for another (in this case, the clamp mechanism as taught by Rollins) to obtain predictable results (in this case, to lock an inner member of a catheter) was an obvious extension of prior art teachings, KSR, 550 U.S. at 415-421, 82 USPQ2d at 1396, MPEP 2141 III B.
Regarding Claim 20, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the at least one inner member (11) being is relatively movable with respect to the outer catheter (22) via a translatory movement (Paragraph 0073).
Regarding Claim 24, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott further teaches (Figures 1-31) wherein the catheter (10) comprises a percutaneous transluminal angioplasty catheter (Paragraph 0004).
Regarding Independent Claim 25, Pigott teaches (Figures 1-31) a catheter system (10) comprising or consisting of:
an outer catheter (22) comprising an outer catheter shaft (at 22) defining an outer catheter lumen (within 22);
at least one inner member (11) being arranged within the lumen (within 22), the at least one inner member (11) being relatively movable with respect to the outer catheter (22) in an unrestricted moving state (see Paragraph 0073), and
an axial movement restriction device (21) comprising an actuation mechanism (at 31, 32) and a locking mechanism (at 33 or 32b), wherein the axial movement restriction device (21) is configured to restrict axial movement of the at least one inner member (11) in a restricted moving state (see Paragraph 0072 and Figures 4 and 7-8) and permit axial movement in the unrestricted moving state (see Paragraph 0073 and Figure 5).
Although Pigott teaches that his invention may be practiced with any other desired structure for preventing the inner member from slipping in relation to the sheath, Pigott does not teach that the actuation mechanism comprises a rotation-translation gear, a ball screw drive actuation mechanism, or a spindle driven actuation mechanism, and wherein the actuation mechanism is configured for regular or irregular oscillatory movement of the inner member.
Rollins teaches (Figures 1-11) the use of an actuation mechanism (326, 202) used to lock a guidewire (102), wherein the actuation mechanism (326, 202) comprises a rotation-translation gear (400, 402, 404), and wherein the actuation mechanism (326, 202) is configured for regular or irregular oscillatory movement (Paragraph 0025) of an inner member (300, 102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott to have actuation mechanism comprises a rotation-translation gear, wherein the actuation mechanism is configured for regular or irregular oscillatory movement of the inner member, as taught by Rollins, in order to create a jackhammer effect to cause a distal end of a guidewire to pass through an obstruction (Paragraph 0025 of Rollins). It is additionally noted that a simple substitution of one known element (in this case, the clamp mechanism as taught by Pigott) for another (in this case, the clamp mechanism as taught by Rollins) to obtain predictable results (in this case, to lock an inner member of a catheter) was an obvious extension of prior art teachings, KSR, 550 U.S. at 415-421, 82 USPQ2d at 1396, MPEP 2141 III B.
Regarding Independent Claim 26, Pigott teaches (Figures 1-31) an axial restriction device (21) for restricting an axial movement of at least one inner member (11) arranged in an outer catheter lumen (within 22) of an outer catheter (22), comprising:
a locking mechanism (at 33 or 32b) and an actuation mechanism (at 31, 32) connected or coupled with each other (see Paragraph 0070, Paragraph 0078, Figures 4-5, and Figures 7-8);
a connector (25) configured to connect the axial movement restriction device (21) with an outer catheter (22) having a tubular outer catheter lumen (within 22) capable of receiving an inner member (11), and
a tubular receptor (the opening within 30a for receiving 11; see Figures 4-5) for the inner member (11).
Although Pigott teaches that his invention may be practiced with any other desired structure for preventing the inner member from slipping in relation to the sheath including a screw mechanism, Pigott does not teach that the actuation mechanism comprises a rotation-translation gear, a ball screw drive actuation mechanism, or a spindle driven actuation mechanism, and wherein the actuation mechanism is configured for regular or irregular oscillatory movement of the at least one member.
Rollins teaches (Figures 1-11) the use of an actuation mechanism (326, 202) used to lock a guidewire (102), wherein the actuation mechanism (326, 202) comprises a rotation-translation gear (400, 402, 404), and wherein the actuation mechanism (326, 202) is configured for regular or irregular oscillatory movement (Paragraph 0025) of an inner member (300, 102).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott to have actuation mechanism comprises a rotation-translation gear, wherein the actuation mechanism is configured for regular or irregular oscillatory movement of the inner member, as taught by Rollins, in order to create a jackhammer effect to cause a distal end of a guidewire to pass through an obstruction (Paragraph 0025 of Rollins). It is additionally noted that a simple substitution of one known element (in this case, the clamp mechanism as taught by Pigott) for another (in this case, the clamp mechanism as taught by Rollins) to obtain predictable results (in this case, to lock an inner member of a catheter) was an obvious extension of prior art teachings, KSR, 550 U.S. at 415-421, 82 USPQ2d at 1396, MPEP 2141 III B.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Rollins et al. (US 2010/0204613) as applied to claim 11 above, and further in view of Lee et al. (US 2009/0281619).
Regarding Claim 12, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott in view of Rollins does not teach, as discussed so far, wherein the at least one clamp comprises two half shell clamps arranged together as one clamp.
Lee teaches (Figures 1-43C) at least one clamp (110) that comprises two half shell clamps (112, 114) arranged together as one clamp (see Figures 25-27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott in view of Rollins to have the at least one clamp comprises two half shell clamps arranged together as one clamp, as taught by Lee, in order to have the top and bottom members close onto and over a proximal end of a locking member to prevent the sheath from moving relative to the apparatus (see Paragraph 0151 of Lee).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Rollins et al. (US 2010/0204613) as applied to claim 1 above, and further in view of Nakano (US 2018/0116689).
Regarding Claim 14, Pigott in view of Rollins teaches the invention as claimed and as discussed above. Pigott in view of Rollins does not teach, as discussed so far, wherein the actuation mechanism is an electrically driven actuation mechanism comprising a drive unit.
Nakano teaches (Figures 1-48) an actuation mechanism (520) that is an electrically driven actuation mechanism (see Paragraph 0235) comprising a drive unit (60).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott in view of Rollins to have the actuation mechanism is an electrically driven actuation mechanism comprising a drive unit, as taught by Nakano, in order to provide rotational force to a drive shaft and control driving of the motor by a switch (Paragraph 0235 of Nakano).
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Rollins et al. (US 2010/0204613) and Nakano (US 2018/0116689) as applied to claim 14 above, and further in view of Mulvihill et al. (US 2014/0249472).
Regarding Claim 21, Pigott in view of Rollins and Nakano teaches the invention as claimed and as discussed above. Pigott in view of Rollins and Nakano does not teach, as discussed so far, wherein the drive unit is configured to oscillate the at least one inner tubular member with a frequency of 1 Hz to 100 kHz.
Mulvihill teaches (Figures 1-39) a drive unit (14) that is configured to oscillate an inner member (28) with a frequency of 1 Hz to 100 kHz (see Paragraph 0138).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott in view of Rollins and Nakano to have the drive unit is configured to oscillate the at least one inner tubular member with a frequency of 1 Hz to 100 kHz, as taught by Mulvihill, in order to operate the actuator to break up and clear clogs in tubes, while cleaning debris from tube walls (see Paragraph 0138 of Mulvihill).
Regarding Claim 22, Pigott in view of Rollins, Nakano, and Mulvihill teaches the invention as claimed and as discussed above. Pigott in view of Rollins, Nakano, and Mulvihill does not teach, as discussed so far, wherein the drive unit is configured to oscillate the at least one inner tubular with a frequency of 5 Hz to 15 kHz.
Mulvihill teaches (Figures 1-39) a drive unit (14) that is configured to oscillate an inner member (28) with a frequency of 5 Hz to 15 kHz (see Paragraph 0138).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott in view of Rollins, Nakano, and Mulvihill to have the drive unit is configured to oscillate the at least one inner tubular member with a frequency of 5 Hz to 15 kHz, as taught by Mulvihill, for the same reasons discussed above in claim 21.
Regarding Claim 23, Pigott in view of Rollins, Nakano, and Mulvihill teaches the invention as claimed and as discussed above. Pigott in view of Rollins, Nakano, and Mulvihill does not teach, as discussed so far, wherein the drive unit is configured to oscillate the at least one inner tubular with a frequency of 5 Hz to 500 Hz.
Mulvihill teaches (Figures 1-39) a drive unit (14) that is configured to oscillate an inner member (28) with a frequency of 5 Hz to 500 Hz (see Paragraph 0138).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Pigott in view of Rollins, Nakano, and Mulvihill to have the drive unit is configured to oscillate the at least one inner tubular member with a frequency of 5 Hz to 15 kHz, as taught by Mulvihill, for the same reasons discussed above in claim 21.
Allowable Subject Matter
Claim 15 is 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 following is a statement of reasons for the indication of allowable subject matter: Although the use of ball screws used in clamping assemblies are known (see Paragraph 0073 of Xie et al. US 2021/0268231), the prior art of record does not teach, in combination with the other limitations of the claim “wherein the actuation mechanism comprises a ball screw drive actuation mechanism, which comprises an oscillating thread”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11-14, 16, and 20-26 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS P BURKE whose telephone number is (571)270-5407. The examiner can normally be reached M-F 8:30-5:00 PM.
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
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