DETAILED ACTION
This is in response to the Patent Application filed 1/18/2024 wherein claims 10 and 17-19 are canceled and claims 1-9, 11-16, and 20-24 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 are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference characters “35” in Figure 3, “16” in Figure 6, “1333” in Figure 8, and “69” in Figures 13-15.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “10” has been used to designate two different elements in Figure 18.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 16 is objected to because of the following informalities:
“an outer catheter, catheter, comprising” (Claim 16, lines 3-4) is believed to be in error for - - an outer catheter, comprising - -;
“the at least one inner tubular member” (Claim 21, lines 2-3) is believed to be in error for - - the at least one inner member - -;
“the at least one inner tubular” (Claim 22, line 2) is believed to be in error for - - the at least one inner member - -; and
“the at least one inner tubular” (Claim 23, line 2) is believed to be in error for - - the at least one inner member - -.
Appropriate correction is required.
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.
Claims 1-9, 11-16, and 20-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the lumen" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-9, 11-15, and 20-24 are rejected for the same reason above based on their dependency to claim 1.
Claim 16 recites the limitation "an outer catheter" in line 9. It is unclear if the “outer catheter” recited in line 9 of claim 16 is referring to the same “outer catheter” recited in line 3 of claim 16, or if it is referring to a different outer catheter.
Claim 16 recites the limitation "an inner member" in line 10. It is unclear if the “inner member” recited in line 10 of claim 16 is referring to the “at least one inner member” recited in line 2 of claim 16, or if it is referring to a different inner member.
Claim 21 recites the limitation "the at least one inner tubular member" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the at least one inner tubular" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the at least one inner tubular" in line 2. There is insufficient antecedent basis for this limitation in the 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.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Foley et al. (US 2016/0136391).
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 balloon 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.
Foley teaches (Figures 1-59) the use of an actuation mechanism (56) used to lock a catheter (Paragraph 0087), wherein the actuation mechanism (56) comprises a spindle driven actuation mechanism (26).
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 comprise a spindle driven actuation mechanism, as taught by Foley, in order to retain or lock the catheter (Paragraph 0087). 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 spindle mechanism as taught by Foley) to obtain predictable results (in this case, to lock 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 Foley 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 balloon 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.
Foley teaches (Figures 1-59) the use of an actuation mechanism (56) used to lock a catheter (Paragraph 0087), wherein the actuation mechanism (56) comprises a spindle driven actuation mechanism (26).
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 comprise a spindle driven actuation mechanism, as taught by Foley, in order to retain or lock the catheter (Paragraph 0087). 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 spindle mechanism as taught by Foley) to obtain predictable results (in this case, to lock 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 Foley 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 Foley 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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Pigott et al. (US 2020/0001055) in view of Foley et al. (US 2016/0136391) as applied to claim 11 above, and further in view of Lee et al. (US 2009/0281619).
Regarding Claim 12, Pigott in view of Foley teaches the invention as claimed and as discussed above. Pigott in view of Foley 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 Foley 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 Foley et al. (US 2016/0136391) as applied to claim 1 above, and further in view of Nakano (US 2018/0116689).
Regarding Claim 14, Pigott in view of Foley teaches the invention as claimed and as discussed above. Pigott in view of Foley 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 Foley 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 Foley et al. (US 2016/0136391) 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 Foley and Nakano teaches the invention as claimed and as discussed above. Pigott in view of Foley 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 Foley 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 Foley, Nakano, and Mulvihill teaches the invention as claimed and as discussed above. Pigott in view of Foley, 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 Foley, 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 Foley, Nakano, and Mulvihill teaches the invention as claimed and as discussed above. Pigott in view of Foley, 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 Foley, 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 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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”.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached at (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS P BURKE/Primary Examiner, Art Unit 3741
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