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 2 is objected to because of the following informalities: in line 6, “thickness of the restriction part” should read “a thickness of the restriction part” and “than thickness of the shaft” should read “than a thickness of the shaft”. Appropriate correction is required.
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, 6, and 7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Adams et al. (US 2004/0254528). Adams discloses a balloon catheter (fig. 3, 7e) having a distal end and a proximal end in a longitudinal axis direction, comprising: a shaft (forming 121e,124e) having a lumen and extending in the longitudinal axis direction, the lumen of the shaft including a first lumen (lumen in 124e) through which a guidewire is to be inserted and a second lumen (lumen in 121e) extending in the longitudinal axis direction; a balloon (78; fig. 3) disposed at a distal part of the shaft; and a tube (123e; fig. 7e) disposed in the second lumen, wherein in a cross-section perpendicular to the longitudinal axis direction, the first lumen and the second lumen are in communication with each other (noting gap 127e;[0065]); the shaft has, in the lumen, a restriction part (indented part forming gap 127e) preventing the tube from moving from the second lumen to the first lumen; the balloon catheter has a gap (127e) between an outer wall of the tube (123e) and a wall of the second lumen, wherein the tube is disposed in the second lumen so that the outer wall of the tube does not contact with the wall of the second lumen to form the gap, and the gap is in communication with the first lumen (see below, noting that the tube 123e is free to move within toward gap 125e since Adams discloses that tube 123e can exit the lumen through 125e; [0065]); and a total length of the gap is equal to or shorter than a length defined by an outer edge of the tube on a straight line L2 in the cross-section perpendicular to the longitudinal axis direction, where L1 is a straight line connecting a figure center P1 of an outer edge of the shaft and a figure center P2 of the outer edge of the tube, and the straight line L2 is a straight line passing through the figure center P2 and being perpendicular to the straight line L1 (see annotated figure below). The examiner-annotated reproduction of fig. 7E below has been rotated 180 degrees from its natural orientation illustrated in Adams in order to facilitate comparison to the figure 2 of the instant application.
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Regarding claim 2, in the cross-section perpendicular to the longitudinal axis direction, the restriction part is disposed between a first position where the largest diameter of the first lumen is located and a second position where the largest diameter of the second lumen is located in a direction parallel to the straight line L2, and a thickness of the restriction part (consider thickness of restriction part along L3 in figure below) is thicker than a thickness of the shaft at the second position in the direction parallel to the straight line L2, so that the restriction part prevents the tube from moving from the second lumen to the first lumen. (Note: restriction part is thicker than the (wall) thickness of the shaft taken at the 2nd position since the restriction thickness isn’t taken along a radius of either lumen of the tube, but instead taken along L3, while the thickness at the second position is equal to the thickness of the tube in the radial direction of the second lumen.
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Regarding claim 6, in the cross-section perpendicular to the longitudinal axis direction, the shaft has the restriction part at a third position where the restriction part forms a minimum width of the lumen of the shaft in a direction parallel to the straight line L2, and the outer edge of the tube either contacts a line segment L3 or has a portion located on the opposite side of the figure center P2 with respect to the line segment L3, where the line segment L3 is a line segment connecting opposing inner walls of the lumen of the shaft at the third position and being parallel to the straight line L2. See the below annotated drawing, wherein the outer edge of the tube contacts line segment L3.
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Regarding claim 7 in the cross-section perpendicular to the longitudinal axis direction, the shaft has the restriction part at a third position where the restriction part forms a minimum width of the lumen of the shaft in a direction parallel to the straight line L2, and the outer edge of the tube does not have a portion located on the opposite side of the figure center P2 with respect to a line segment L3, where the line segment L3 is a line segment connecting opposing inner walls of the lumen of the shaft at the third position and being parallel to the straight line L2. See the above annotated figure 7E, wherein no portion of the tube is located on the opposite side of the figure center P2 with respect to line segment L3. In other words, the entire outer edge of the tube and figure center P2 are on the same side of line segment L3.
Claim(s) 1-3 and 7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Shimada et al. (US 2009/0270801). Shimada discloses a balloon catheter having a distal end and a proximal end in a longitudinal axis direction, comprising: a shaft (9; fig. 6) having a lumen and extending in the longitudinal axis direction, the lumen of the shaft including a first lumen (2a’; fig. 11) through which a guidewire is to be inserted (note: this is a functional recitation; since a guidewire can be inserted into this lumen via the proximal end of the lumen, it meets this functional recitation) and a second lumen (2a’’) extending in the longitudinal axis direction; a balloon disposed at a distal part of the shaft; and a tube (8) disposed in the second lumen, wherein in a cross-section perpendicular to the longitudinal axis direction, the first lumen and the second lumen are in communication with each other (see fig. 11 and annotated figure below); the shaft has, in the lumen, a restriction part (formed by 13) preventing the tube from moving from the second lumen (2a’’) to the first lumen (2a’); the balloon catheter has a gap (space) between an outer wall of the tube and a wall of the second lumen, wherein the tube is disposed in the second lumen so that the outer wall of the tube does not contact with the wall of the second lumen to form the gap (see fig. 11), and the gap is in communication with the first lumen; and a total length of the gap is equal to or shorter than a length defined by an outer edge of the tube on a straight line L2 in the cross-section perpendicular to the longitudinal axis direction, where L1 is a straight line connecting a figure center P1 of an outer edge of the shaft and a figure center P2 of the outer edge of the tube, and the straight line L2 is a straight line passing through the figure center P2 and being perpendicular to the straight line L1. See the examiner-annotated reproduction of fig. 11 below.
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Regarding claim 2, in the cross-section perpendicular to the longitudinal axis direction, the restriction part is disposed between a first position where the largest diameter of the first lumen (2a’) is located and a second position where the largest diameter of the second lumen (2a’’) is located in a direction parallel to the straight line L2, and a thickness of the restriction part is thicker than a thickness of the shaft at the second position in the direction parallel to the straight line L2, so that the restriction part prevents the tube from moving from the second lumen to the first lumen. See examiner-annotated figure below.
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Regarding claim 3, the shaft and the tube are formed from different materials (tube made high-density polyethylene or polyamide elastomer; proximal portion of shaft made of a stainless-steel alloy (SUS316 alloy; see [0124]-[0125], [0127]).
Regarding claim 7 in the cross-section perpendicular to the longitudinal axis direction, the shaft has the restriction part at a third position (see annotated figure above) where the restriction part forms a minimum width of the lumen of the shaft in a direction parallel to the straight line L2, and the outer edge of the tube does not have a portion located on the opposite side of the figure center P2 with respect to a line segment L3, where the line segment L3 is a line segment connecting opposing inner walls of the lumen of the shaft at the third position and being parallel to the straight line L2. In other words, the outer edge of the tube and P2 are on the same side of line segment L3 (line at 3rd position). See annotated figure above.
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 Adams in view of Solar (US 5,669,880). Adams discloses the invention substantially as stated above including that the components of the device may be made of various materials including polymeric and metal materials ([0031]) but does not expressly disclose that the shaft and tube are made from different materials.
Solar discloses another balloon catheter comprising a shaft (1/12/13; fig. 5) having first (3) and second (2) lumens and a tube (50) disposed within the second lumen. Solar further teaches that the shaft (12/13) is made from a polyolefin (col. 6, ll. 35-44) while the hypotube (50) is made from a metal (col. 6, ll. 50-65 and claim 3). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Adams to construct the shaft and tube of different materials such as polyolefin and metal as taught by Solar, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams. Adams discloses the invention substantially as stated above including that the shaft may be made of various know materials but does not expressly disclose that the stiffness of the tube is higher or lower than that of the shaft.
However, the stiffness of the tube of Adams must be either higher, lower, or equal to that of the shaft. Since there are only three possible options (i.e., a finite number of options), one skilled in the art would have considered modifying the materials of the tube and shaft of Adams to have any of these three comparative stiffnesses to be obvious and well within the purview of one of ordinary skill in the art since it has been held that a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product is not of innovation but of ordinary skill and common sense. (KSR, 550 U.S. at 421, 82 USPQ2d at 1397). Additionally, Adams discloses that the size, thickness, and composition of materials are selected on the basis of a desired characteristic which includes stiffness or flexibility, and “it is understood that these design elements are known to one of ordinary skill in the art” ([0031]). Thus, such a modification appears to be a mere design choice, as either configuration trades one advantage for another (high stiffness tube – better pushability and torque transmission; lower stiffness tube – improved flexibility and trackability), and the results of either configuration are predictable, with a reasonable expectation of success.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Michal et al. (US 2002/0002353). Adams discloses the invention substantially as stated above except for a hydrophilic or hydrophobic coating on an outer wall of the tube, an inner wall of the shaft, or an inner wall of the tube as claimed.
Michal discloses another balloon catheter and further teaches that various surfaces of the catheter including the outer surface of an inner tube (22) of a catheter and inner surfaces of the catheter (which would include inner surfaces of tube 22 and outer shaft 21) can have a hydrophilic coating in order to facilitate displacement of objects, such as a guidewire, within a lumen of the catheter ([0057]). Thus, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Adams to include a hydrophilic coating on the outer wall of the tube, the inner wall of the tube, and the inner wall of the shaft forming the first lumen in view of the teachings of Michal in order to facilitate displacement of objects, such as a guidewire, within the first and second lumens of Adams.
Conclusion
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KSH 3/20/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771