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 .
Cited Prior Art
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all relevant portions of the cited prior art if traversing a rejection based on the cited prior art.
Election/Restrictions
Claims 3, 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/23/2026. Applicant argues that all the claims can be examined at the same time without serious burden, adding that the search for the non-elected species would be substantially coextensive with the search for the elected species. To respectfully rebut, searching for the different configurations of the multiple different arrangements of the first support tube, the outer tube, the second support tube, and the inner tube has a cumulative effect of imposing an undue search burden for the application as a whole due to the number of permutations that exist and the potential additional divergent amendments that could be made for each of the species.
Claim Rejections - 35 USC § 112b
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 2, 16 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 2 recites “the second support tube overlapping the first support tube in the radial direction at the proximal-most position in which the inner tube is drawn out furthest from the outer tube”. This phrase is considered indefinite since it could be interpreted that “at the proximal-most position” applies to the overlapping, i.e. “the second support tube overlapping the first support tube in the radial direction at the proximal-most position”. Another interpretation is that “at the proximal-most position” applies to “in which the inner tube is drawn out furthest from the outer tube”, but this limitation is considered just repeating the earlier limitation: “wherein the inner tube is positionable at a proximal-most position in which the inner tube is drawn out furthest from the outer tube”, further leading to the indefinite interpretation. The claim language should be amended to clear up the indefiniteness.
Claim 16 appears to contain the same issue, along with nonelected claim 10.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 4-7, 17-20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Okubo JP2011072680.
Okubo discloses for claim 1, “An image diagnosis catheter comprising:
an outer tube (outer tube 54 and supporting structure holding portion 11; fig 3, 4; 0023) having a distal-most end;
a rotatable and axially movable drive shaft (drive shaft 20; fig 3, 4; 0021) disposed in the outer tube, the drive shaft having a distal end;
a signal transmitter and receiver (signal transmitting/receiving unit 30; fig 2; 0022) that transmits and receives a signal (0022), the signal transmitter and receiver being fixed to the drive shaft (0021), being located at the distal end of the drive shaft and being axially movable and rotatable together with the drive shaft, the signal transmitter and receiver being distal of the distal-most end of the outer tube (fig 2);
a first support tube (protective tube 15; fig 3, 4; 0040) positioned radially inwardly of the outer tube;
the drive shaft being positioned radially inwardly of the first support tube (fig 3, 4);
an inner tube (first inner tube 56a; fig 3, 4; 0049) positioned radially inwardly of the outer tube and radially outwardly of the first support tube; and
a second support tube (second inner tube 56b is inward of first inner tube 56a; fig 3, 4; 0049) positioned radially inwardly of the inner tube and radially outwardly of the drive shaft, the second support tube being axially movable together with the drive shaft and the inner tube (0049-0053 describes the movement of the tubes), the second support tube together with the drive shaft and the inner tube being axially movable relative to the outer tube and the first support tube (0053-0056 describes the movement of the shaft and tubes, relative to the outer tube and the first support tube)”.
Okubo discloses for claim 2, “The image diagnosis catheter according to Claim 1, wherein the inner tube is positionable at a proximal-most position in which the inner tube is drawn out furthest from the outer tube, the second support tube overlapping the first support tube in the radial direction at the proximal-most position in which the inner tube is drawn out furthest from the outer tube (fig 3, 4; 0053-0056 describes the movement of the shaft and tubes, relative to the outer tube and the first support tube)”.
Okubo discloses for claim 4, “The image diagnosis catheter according to Claim 1, wherein the inner tube is connected to a hub (e.g. first connector 50; fig 1; 0021-0022 describes the motion with respect to the inner tube) so that the inner tube and the hub move together”.
Okubo discloses for claim 5, “The image diagnosis catheter according to Claim 1, wherein the first support tube has a distal-most end, the distal-most end of the outer tube being distal of the distal-most end of the first support tube (the distal end of outer tube 54 and supporting structure holding portion 11 is distal to that of the first support tube/protective tube 15 as seen in fig 3)”.
Okubo discloses for claim 6, “The image diagnosis catheter according to Claim 1, wherein the inner tube is positionable at a distal-most position in which the inner tube is pushed furthest into the outer tube (fig 5A shows the first inner tube 56a positioned at a distal-most position where it is furthest into the outer tube 54), the second support tube having a distal-most end, the distal-most end of the outer tube being distal of the distal-most end of the second support tube in the distal-most position (the distal end of outer tube 54 and supporting structure holding portion 11 is distal to that of the second support tube/second inner tube 56b as shown in fig 5A)”.
Okubo discloses for claim 7, “The image diagnosis catheter according to Claim 6, wherein the first support tube has a proximal end portion and the second support tube has a distal end portion, the proximal end portion of the first support tube surrounding the distal end portion of the second support tube or the distal end portion of the second support tube surrounding the proximal end portion of the first support tube in the distal-most position (fig 3 shows the configuration where the second support tube/second inner tube 56b surrounds the proximal end of the first support tube/protective tube 15)”.
Okubo discloses for claim 17, “An image diagnosis catheter comprising:
a sheath (sheath 1; fig 1, 2; 0031) insertable into a cavity in a living body, the sheath having a proximal-most end;
an outer tube (outer tube 54 and supporting structure holding portion 11; fig 3, 4; 0023) fixed relative to the sheath and extending in a proximal direction away from the sheath;
a drive shaft (drive shaft 20; fig 3, 4; 0021) disposed in the sheath and in the outer tube, the drive shaft having a distal end;
a first support tube (protective tube 15; fig 3, 4; 0040) positioned radially inwardly of the outer tube;
the drive shaft being positioned radially inwardly of the first support tube (fig 3, 4);
an inner tube (first inner tube 56a; fig 3, 4; 0049) positioned radially inwardly of the outer tube and radially outwardly of the first support tube;
a second support tube (second inner tube 56b is inward of first inner tube 56a; fig 3, 4; 0049)positioned radially inwardly of the inner tube and radially outwardly of the drive shaft, the second support tube being axially movable together with the drive shaft and the inner tube (0049-0053 describes the movement of the tubes), the second support tube together with the drive shaft and the inner tube being axially movable relative to the outer tube and the first support tube (0053-0056 describes the movement of the shaft and tubes, relative to the outer tube and the first support tube); and
the second support tube having a distal-most end that is proximal of the proximal-most end of the sheath (fig 3)”.
Okubo discloses for claim 18, “The image diagnosis catheter according to Claim 17, wherein the first support tube has a distal-most end, the proximal-most end of the sheath being distal of the distal-most end of the first support tube (fig 3)”.
Okubo discloses for claim 19, “The image diagnosis catheter according to Claim 17, wherein the inner tube includes an enlarged locking portion (arrowhead-like stopper 58; fig 3; 0050) that is configured to contact a stopper surface to prevent further backward movement of the inner tube”.
Okubo discloses for claim 20, “The image diagnosis catheter according to Claim 17, wherein the drive shaft has a distal end, and further comprising a housing (housing 31; fig 2; 0037) fixed to the distal end of the drive shaft to house a signal transmitter and receiver that transmits and receives a signal”.
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) 8, 13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okubo and further in view of Gregorich US20070060880.
Okubo discloses for claim 8, “An image diagnosis catheter comprising:
an outer tube (outer tube 54 and supporting structure holding portion 11; fig 3, 4; 0023);
a first support tube (protective tube 15; fig 3, 4; 0040) disposed on a radially inner side of the outer tube;
a drive shaft (fig 3, 4) disposed on the radially inner side of the first support tube;
an inner tube (first inner tube 56a; fig 3, 4; 0049) disposed on the radially inner side of the outer tube and a radially outer side of the first support tube”.
Okubo does not disclose:
a second support tube disposed on the radially inner side of the inner tube and radially outer side of the drive shaft, the second support tube being axially movable together with the drive shaft and the inner tube, the second support tube together with the drive shaft and the inner tube being axially movable relative to the outer tube and the first support tube”.
Gregorich teaches in the same field of endeavor, providing an adjustable stiffness sheath (stiffness sheath 134; fig 15; 0083-0084) which are slidably disposed over a shaft. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the modification of Gregorich into the invention of Okubo in order to configure the catheter e.g. as claimed, specifically providing a stiffness sheath 134 as the claimed second support tube, immediately surrounding the drive shaft 20 of Okubo as seen in fig 15 of Gregorich because it provides the added advantage of adjustable and controllable stiffness for the catheter (0084).
Modified Okubo discloses for claim 13, “The image diagnosis catheter according to Claim 8, wherein the second support tube is disposed on the radially inner side of the first support tube (Gregorich: fig 15 shows the second support tube/stiffness sheath 134 directly surrounding the shaft 132, resulting in the second support tube/stiffness sheath 134 being disposed radially inside of the first support tube/protective tube 15, see Okubo fig 3)”.
Okubo discloses for claim 14, “The image diagnosis catheter according to Claim 13, wherein the image diagnosis catheter comprises a hub (e.g. first connector 50; fig 1; 0021-0022 describes the motion with respect to the inner tube) connected to a proximal end of the inner tube, and the second support tube is connected to the hub in an integrated manner”.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Okubo and Gregorich as applied to claim 8 above, and further in view of Ueda US20150087905 .
Okubo does not disclose for claim 15, “The image diagnosis catheter according to Claim 8, wherein the second support tube is coil-shaped”. Ueda teaches in the same field of endeavor, a coil shaped variable stiffness mechanism (coil spring 33; fig 4; 0061). Since Okubo fails to disclose the nature of the second support tube/variable stiffness mechanism, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any suitable shape known in the art, including the one taught by Gregorich to achieve the predictable result of implementing a variable stiffness mechanism.
Allowable Subject Matter
Claim 16 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE K WOO whose telephone number is (571)272-0837. The examiner can normally be reached M-F 8:30-2:30p, 6p-9p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jae Woo/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/15/26
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