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 .
Response to Arguments
Applicant's arguments filed 10/31/25 regarding the rejection over Eberhards in view of Ohachi have been fully considered and found persuasive. Therefore, the rejection has been withdrawn. However, new grounds of rejection have been presented over Eberhardt in view if Bartholomew. Regarding the limitation “the distalmost portion of the accommodation unit is spaced and not welded to the shaft” col. 4, lines 21-55 of Bartholomew disclose a space between the shaft and the hub at the distalmost section.
The outer shaft comprised of a resin so that the outer surface of the proximal portion of the shaft that is accommodates in the accommodation unit is heated and melted when irradiated with electromagnetic waves, the shaft of Bartholomew is made of polyurethane and col. 4, lines 32-55, disclose that this material is found to adapt well to welding, and this material is one of the resins being disclosed in paragraph 28 of the current application as an example of a constituent material from which the outer layer may be fabricated, Bartholomew teaches the claimed subject matter.
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) 10-13, 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eberhardt et al. (US 2017/0340860) hereinafter Eberhardt in view of Bartholomew (US 4802947).
Regarding claim 10, Eberhardt teaches a catheter (Fig 2) comprising:
a shaft (360) possessing a distal end (381. Fig. 4) and a proximal end (371), the shaft being a tubular body that includes a lumen extending from the distal end of the shaft to the proximal end of the shaft (See Figure 4), the shaft including a shaft proximal end surface at the proximal end of the shaft (proximal end surface pointed by 371), the lumen opening to the shaft proximal end surface at the proximal end of the shaft, the shaft also possessing a radially outwardly facing shaft outer surface (outer surface of 360) that extends from the distal end of the shaft toward the proximal ed of the shaft and terminates at the shaft proximal end surface;
the shaft including a proximal portion (portion where 371 is pointing, See Figure 4), the proximal portion of the shaft including a radially outer portion and a radially inner portion that both extend along an axial extent of the proximal portion of the shaft (See Figure 4), the radially inner portion of the proximal portion of the shaft being radially inward of the radially outer portion of the proximal portion of the shaft (See Fig 4);
a hub (310) including an accommodation unit (321) in which is positioned the proximal portion of the shaft;
the accommodation unit including a hub melted surface (surface of 321 melts) that is directly welded to the shaft outer surface of the proximal portion of the shaft so that the accommodation unit and the shaft outer surface are welded to one another (Refer to paragraphs 34-35).
Eberhardt fails to explicitly teach the radially outer portion of the proximal portion of the shaft being comprised of a resin that absorbs electromagnetic waves or does not transmit electromagnetic waves, so that the outer surface of the proximal portion of the shaft that is accommodates in the accommodation unit is heated and melted when irradiated with electromagnetic waves,
and the accommodation unit (321) including a distal-most portion possessing an inner surface that faces the shaft outer surface and is spaced from and not welded to the shaft outer surface so that a gap exists between the inner surface of the accommodation unit and the shaft outer surface,
Bartholomew teaches a catheter shaft (11) the radially outer portion of the proximal portion of the shaft being comprised of a resin (Refer to col. 4, lines 21-55) that absorbs electromagnetic waves or does not transmit electromagnetic wave so that the outer surface of the proximal portion of the shaft that is accommodates in the accommodation unit is heated and melted when irradiated with electromagnetic waves (Refer to Col. 4, Lines 32-37, since the shaft of Bartholomew is made of polyurethane, the resin being disclosed in paragraph 28 of the current application as an example of a constituent material from which the outer layer may be fabricated),
the accommodation unit (17) including a distal-most portion (20a, Col. 3, lines 55-60) possessing an inner surface that faces the radially outwardly facing shaft outer surface (see Fig. 2) and is spaced from and not welded to the radially outwardly facing shaft outer surface so that a gap (See Fig. 2, gap between 20a and 11) exists between the inner surface of the accommodation unit and the shaft outer surface that face one another.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to shape the distal end of the accommodation unit to have an outwardly tapering distal portion and use a material of the catheter shaft that would such that would absorb electromagnetic waves or does not transmit electromagnetic waves as taught by Bartholomew as the material of the catheter shaft of Eberhardt, to provide an accommodation unit that can receive a catheter that can be fused with a hub.
Regarding claim 11, modified Eberhardt teaches the resin of the radially outer portion is a resin containing pigment (pigment of the polyurethane used to make the catheter) that absorbs or does not transmit the electromagnetic waves so that the radially outer portion of the shaft is heated and melts when the accommodation unit is irradiated with an infrared laser (refer to col. 5, lines 40-45).
Regarding claim 12, modified Eberhardt fails to explicitly teach an absolute value of a residual strain of the accommodation unit decreases in a radially outward direction from the welded surface.
However an ordinary skill in the art at the time the invention was filed would have known that the device of Eberhardt, teaches the “absolute value of a residual strain (internal stress) of the accommodation unit decreases outward in a radial direction from the welded surface” since a residual value would decrease in a direction were there is less/or no welding, and the welding of the hub of Eberhard to the outer shaft, would result in a decreased residual strain in the outward radial direction, there less welding/melting in that direction.
Regarding claim 13, modified Eberhardt fails to explicitly teach an absolute value of a residual strain of the accommodation unit gradually decreases, from a portion of the hub melted surface at which the absolute value is largest, toward both a distal direction and a proximal direction.
However an ordinary skill in the art at the time the invention was filed would have known that the device of Eberhardt, teaches the “absolute value of a residual strain (internal stress) of the accommodation unit decreases distally and proximally away from the area of melting” since a residual value would decrease in a direction were there is less/or no welding, and the welding of the hub of Eberhard to the outer shaft, would result in a decreased residual strain in the distal and proximal directions, since there less welding/melting in those directions.
Regarding claim 15, modified Eberhardt teaches the shaft proximal end surface (surface pointed by 371) at the proximal end of the shaft faces an adjacent surface of the accommodation unit of the hub, the hub (310) including a hub passage that extends from the adjacent surface to a proximal end of the hub, the hub passage communicating with the lumen in the shaft (See Figure 5).
Regarding claim 16, modified Eberhardt teaches at least an axially extending part of the hub passage possesses a tapered shape gradually increasing toward the proximal end of the hub (see Figure 3).
Regarding claim 17, modified Eberhardt teaches the gap between the inner surface of the accommodation unit and the shaft outer surface gradually widens toward a distal direction (see Walker Figure 2, element 20a, Col. 3 lines 55-60).
Regarding claim 18, modified Eberhardt teaches the shaft includes a reinforcement body embedded in the shaft (Refer to paragraph [0032]), the reinforcement body being comprised of wires that are braided or spirally wound (coil 364, paragraph 0032), with gaps between adjacent wire portions (spaces between the coils, Fig 4), the shaft being made of a material positioned in the gaps (the gaps are part of the shaft).
Reasons for Allowance
Claims 2 and 14 are 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.
Claims 1, 3-9 and 19-21 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the subject matter not found was the contour of the absolute value of the residual strain of the accommodation unit in a cross section passing through the longitudinal axis of the accommodation unit is arc-shaped protruding outward in the radial direction in combination with the other elements in the claims.
Regarding claim 19, The closest prior art of record Eberhard in view of Bartholomew teaches the that the outer portion comprises a resin that absorbs electromagnetic was or does not transmit electromagnetic waves, but does not explicitly disclose the step of irradiating electromagnetic waves having a wavelength that allows the electromagnetic waves to be transmitted through the accommodation unit of the hub in which the proximal portion of the shaft is positioned and that does not allow the electromagnetic waves to be transmitted through the shaft outer surface heating the shaft outer surface of the proximal portion of the shaft so that the shaft outer surface of the proximal portion of the shaft is heated and melted, in combination with the other elements in the claims.
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.
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772