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 Objections
Claim(s) 1 is/are objected to because of the following informalities:
Within claim 1, line 4: “string-like convert” should be replaced with –a string-like converter-- (for grammatical purposes).
Within claim 1, line 8: “operating unit” should be replaced with --an operating unit-- (for grammatical purposes).
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.
Claim(s) 1-6 is/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.
Within claim 1, lines 3: Applicant claims, “a sheath in which the tubular indwelling tool is accommodated”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the placement device ALONE; however, the aforementioned claim requirement is positively reciting the interaction with the tubular indwelling tool) which is a combination requirement (requiring BOTH the placement device AND the tubular indwelling tool). As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the placement device OR system of BOTH the placement device AND the tubular indwelling tool. For the purposes of examination, Examiner is assuming the aforementioned claim clause should be read as ---a sheath in which the tubular indwelling tool is configured to be accommodated --. Claim(s) 2-6, which depend from claim 1, inherit all the problems associated with claim 1.
Within claim 1, lines 4-5: Applicant claims, “[a] string-like converter that causes at least a portion of the tubular indwelling tool in an axial direction to be maintained in a contracted state”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the device alone; however, the aforementioned claim requirement is positively reciting the maintaining of the contracted state which is a method of use requirement. As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the device OR the method of using the device. For the purposes of examination, Examiner is assuming the claim clause should be read as --[a] string-like converter that is configured to cause at least a portion of the tubular indwelling tool in an axial direction to be maintained in a contracted state--.
Within claim 2, lines 4-5: Applicant claims, “an operating member that moves the fixing member in the axial direction in response to an operation by operator”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the device alone; however, the aforementioned claim requirement is positively reciting the movement of the fixing member which is a method of use requirement. As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the device OR the method of using the device. For the purposes of examination, Examiner is assuming the aforementioned claim clause should be read as --an operating member that is configured to move the fixing member in the axial direction in response to an operation by operator--. Claim(s) 3, 5-6, which depend from claim 2, inherit all the problems associated with claim 2.
Within claim 4, lines 3-4: Applicant claims, “the second operating portion further includes a power transmission portion that transmits rotation of the rotating member to the fixing member”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the device alone; however, the aforementioned claim requirement is positively reciting the rotation of the rotating member which is a method of use requirement. As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the device OR the method of using the device. For the purposes of examination, Examiner is assuming the aforementioned claim clause should be read as --the second operating portion further includes a power transmission portion that is configured to transmit rotation of the rotating member to the fixing member --.
Within claim 5, lines 2-3: Applicant claims, “the second operating portion further includes a stopper portion that restricts movement of the operating member in the axial direction”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the device alone; however, the aforementioned claim requirement is positively reciting the restriction of movement which is a method of use requirement. As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the device OR the method of using the device. For the purposes of examination, Examiner is assuming the aforementioned claim clause should be read as --the second operating portion further includes a stopper portion that is configured to restrict movement of the operating member in the axial direction--. Claim(s) 6, which depend from claim 5, inherit all the problems associated with claim 5.
Within claim 5, lines 4-5: Applicant claims, “the stopper portion is provided attachable to and detachable from the second operating portion, and is detached from the second operating portion to release restriction”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble, which is directed to the device alone; however, the aforementioned claim requirement is positively reciting detachment to release the restriction which is a method of use requirement. As such, it is unclear, and therefore indefinite, if Applicant is trying to claim the device OR the method of using the device. For the purposes of examination, Examiner is assuming the aforementioned claim clause should be read as --the stopper portion is provided attachable to and detachable from the second operating portion, and is configured to be detached from the second operating portion to release restriction--.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Chobotov et al. (US 2002/0151953 A1 – as cited by Applicant).
With respect to claim 1:
Chobotov et al. discloses a placement device (delivery system 10), as can be seen in fig. 1, for placing a tubular indwelling tool (graft 11) in a biological lumen (paragraph [0070]), the placement device (delivery system 10) comprising:
a sheath (distal section 276 of outer tubular member 53) in which the tubular indwelling tool (graft 11) is accommodated (paragraph [0130]);
string-like converter (belts 21, 22, 23) that causes at least a portion (self-expanding members 31, 32, 33) of the tubular indwelling tool (graft 11) in an axial direction to be maintained in a contracted state in a state in which the tubular indwelling tool (graft 11) is released from the sheath (distal section 276 of outer tubular member 53) and is able to convert the portion (self-expanding members 31, 32, 33) from the contracted state to an expanded state (paragraphs [0071-0072, 0131-0134]); and
operating unit configured to be operated to place the tubular indwelling tool (graft 11) in the biological lumen,
wherein the operating unit has a first operating portion (proximal end 261 of outer tubular member 53) for releasing the tubular indwelling tool (graft 11) from the sheath (distal section 276 of outer tubular member 53) (paragraph [0130]), and a second operating portion (proximal adaptor 42) for releasing restraint of the portion (self-expanding members 31, 32, 33) of the tubular indwelling tool (graft 11) by the converter (paragraph [0073]).
With respect to claim 2:
Wherein the second operating portion (proximal adaptor 42) has a fixing member (release wires 24, 25) to which the converter (belts 21, 22, 23) is connected (paragraphs [0084, 0133-0134]), and
an operating member (proximal ends of release wires 24, 25) that moves the fixing member (release wires 24, 25) in the axial direction in response to an operation by an operator (paragraph [0119]).
With respect to claim 5:
Wherein the second operating portion (proximal adaptor 42) further includes a stopper portion (proximal handles 93, 94) that restricts movement of the operating member (proximal ends of release wires 24, 25) in the axial direction (paragraph [0119]), and
the stopper portion (proximal handles 93, 94) is provided attachable to and detachable (via the threaded connection therebetween) from the second operating portion (proximal adaptor 42), and is detached from the second operating portion (proximal adaptor 42) to release restriction of the movement of the operating member (proximal ends of release wires 24, 25) (paragraph [0119]).
With respect to claim 6:
Wherein the stopper portion (proximal handles 93, 94) is rotatable in only one direction about the axial direction (when the proximal handles 93, 94 are fully tightened down onto the proximal ends 238 of the side arms 225, 226 the proximal handles 93, 94 will only be able to be loosened/ detached by rotating in one direction), and is configured to be detachable from the second operating portion (proximal adaptor 42) by rotating in the one direction (paragraph [0119]).
Claim(s) 1-2, 4 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by MARMUR et al. (US 2016/0302950 A1).
With respect to claim 1:
MARMUR et al. discloses a placement device (deployment system 10), as can be seen in fig. 1, for placing a tubular indwelling tool (stent graft 40) in a biological lumen (paragraph [0354]), the placement device (deployment system 10) comprising:
a sheath (outer sheath 34) in which the tubular indwelling tool (stent graft 40) is accommodated (paragraph [0354]);
a string-like converter (the portion 62 of the retraining wires 60) that causes at least a portion of the tubular indwelling tool (the first and second longitudinal portions 70, 170 of stent graft 40) in an axial direction to be maintained in a contracted state (partially radially expanded), as can be seen in fig. 6D, in a state in which the tubular indwelling tool (stent graft 40) is released from the sheath (outer sheath 34) and is able to convert the portion (the first and second longitudinal portions 70, 170) from the contracted state (partially radially expanded) to an expanded state (fully radially expanded), as can be seen in fig. 6F (paragraphs [0364, 0366, 0399, 0401]); and
operating unit (control handle 20) configured to be operated to place the tubular indwelling tool (stent graft 40) in the biological lumen (paragraph [0354]),
wherein the operating unit (control handle 20) has a first operating portion (portion of handle responsible for retracting outer sheath 34) for releasing the tubular indwelling tool (stent graft 40) from the sheath (outer sheath 34) (paragraphs [0396-0398]), and a second operating portion (withdrawal actuator 700) for releasing restraint of the portion (the first and second longitudinal portions 70, 170) of the tubular indwelling tool (stent graft 40) by the converter (the portion 62 of the retraining wires 60) (paragraphs [0399, 0454]).
With respect to claim 2:
Wherein the second operating portion (withdrawal actuator 700), as can be seen in figs. 14A-14E, has a fixing member (section of retaining wires 60 between the portions 62 and the spool 720) to which the converter (the portion 62 of the retraining wires 60) is connected (paragraphs [0454-0455]), and
an operating member (knob 722) that moves the fixing member (section of retaining wires 60 between the portions 62 and the spool 720) in the axial direction in response to an operation by an operator (paragraph [0455]).
With respect to claim 4:
wherein the second operating portion (withdrawal actuator 700) has a winding portion (spool 720) around which the converter (the portion 62 of the retraining wires 60) is wound (is capable of being wound if the wire 60 is sufficiently retracted) (paragraph [0455]), and
an operating member (knob 722) that rotates the winding portion (spool 720) in response to a rotating operation by an operator (paragraph [0455]).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over MARMUR et al. (US 2016/0302950 A1) in view of Poppe et al. (US 2019/0328523 A1).
With respect to claim 3:
MARMUR et al. discloses the invention substantially as claimed, as discussed above. Additionally, MARMUR et al. discloses the operating member (knob 722) is a rotating member, and the second operating portion (withdrawal actuator 700) further transmits rotation of the rotating member to the fixing member (section of retaining wires 60 between the portions 62 and the spool 720). However, MARMUR et al. does not disclose the second operating portion (withdrawal actuator 700) further includes a power transmission portion that transmits rotation of the rotating member.
Poppe et al. teaches a placement device (system 10) for a tubular indwelling tool (medical implant 16) including a rotating operating member (actuation members) (paragraph [0056]); the rotating operating member maybe manually rotationally activated or electrically powered by a motor (paragraph [0057]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the actuation of the rotating operating member (knob 722), as disclosed by MARMUR et al., motorized, as taught by Poppe et al., as Poppe et al. teaches the hand actuation and motorized actuation to be known alternatives within the catheter art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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REBECCA STRASZHEIM PRESTON
Primary Examiner
Art Unit 3774
/REBECCA S PRESTON/ Primary Examiner, Art Unit 3774
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