DETAILED ACTION
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.
Claim(s) 1, 5-8, 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miki et al (US Pat: 6, 706, 010).
Regarding claims 1, 21-22, Miki et al disclose a catheter comprising:
an outer tube (4) having a distal end and a proximal end and having a lumen extending in a longitudinal direction [see abstract, figs 2-3, 11-12];
a bag-shaped body (balloon 3) provided to a distal portion of the outer tube (5), the bag-shaped body having an annular shape and having a portion that has a smaller outer diameter than the outer tube [see abstract, figs 2-3, 11-12];
a flow path (inflation lumen) configured to allow a fluid to be injected there through to the bag- shaped body [see figs 11-12, column 13 lines 1-13];
a flow path configured to allow a fluid to be injected therethrough to the bag-shaped body [see figs 11-12, column 13 lines 1-13];
wherein the bag-shaped body is configured so that a minimum inner diameter of the bag-shaped body in a pressurized state where the bag-shaped body is pressurized by injecting a fluid into the flow path is larger than a minimum inner diameter of the bag-shaped body in a non-pressurized state where the bag-shaped body is not pressurized by injecting a fluid into the flow path [see figs 11-12, abstract, column 13 lines 1-13, claim 1].
Regarding claim 5, Miki et al disclose wherein the bag-shaped body is disposed on a distal side relative to the distal end of the outer tube and has a tapered portion (taper portion 24) having an outer diameter that is reduced toward the distal side [see figs 11-12, column 13 lines 1-13, column 16 lines 1-5] by disclosing the outside diameter of the distal end portion of the outer tube 4 can be partially reduced without impeding the flow of the pressure fluid [see column 13 lines 1-13].
Regarding claim 6, Miki et al disclose wherein the catheter further comprises a radiopaque marker (X-ray impermeable marker) [see column 13 lines 45-47, fig 3];
wherein the radiopaque marker is provided to at least one of the bag-shaped body and a
region, of the outer tube, that extends 10 cm toward a proximal side from the distal end of the outer tube [see column 13 lines 45-47].
Regarding claim 7, Miki et al disclose wherein the outer tube has, at a proximal portion of the outer tube, a reduced diameter area having a diameter that is reduced toward a proximal side in a cross-sectional view perpendicular to the longitudinal direction [see figs 17-18].
Regarding claim 8, Miki et al disclose wherein the catheter further comprises a first tubular member (11) having a maximum outer diameter smaller than a maximum outer diameter of the outer tube (4) [see figs 2-3, 11-12];
the first tubular member (11) having a lumen extending in the longitudinal direction [see figs 2-3, 11-12];
the first tubular member (11) has a distal portion fixed to a proximal portion of the reduced diameter area of the outer tube [see abstract, figs -23, 11-12
the lumen of the first tubular member and the flow path are in communication with each other [see figs 2-3].
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) 9-10, 13, 15-16, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Miki et al (US Pat: 6, 706, 010) in view of Schneider et al (Pub. No.: US 2020/0155194).
Regarding claim 10, 13, 15-16, 20, Miki et al disclose wherein the catheter further comprises at least one bulging portion configured to bulge inward in a radial direction of the outer tube or outward in the radial direction of the outer tube;
the bulging portion and the flow path are configured to allow a fluid to be injected to the bulging portion though the flow path.
Nonetheless, Schneider et al disclose wherein the catheter further comprises at least one bulging portion (30) configured to bulge inward in a radial direction of the outer tube or outward in the radial direction of the outer tube [see 0146];
the bulging portion and the flow path are configured to allow a fluid to be injected to the bulging portion though the flow path [see 0146].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Miki et al and Schneider et al by using at least one bulging portion configured to bulge inward in a radial direction of the outer tube or outward in the radial direction of the outer tube and the bulging portion and the flow path are configured to allow a fluid to be injected to the bulging portion though the flow path; to impart radially inward forces on the balloon 22 to radially collapse the balloon [see 0146].
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: No prior arts of record alone or in combination discloses the following:
Claims 2-4,
“ the bag-shaped body has an inner surface portion facing an inner side and an outer surface portion facing an outer side, and when a state of the bag-shaped body is changed from the non-pressurized state to the pressurized state, an elongation rate of a length from a distal end to a proximal end of the inner surface portion is higher than an elongation rate of a length from a distal end to a proximal end of the outer surface portion”
Claims 11-12, 14, 17-19,
“wherein the at least one bulging portion is configured to bulge inward in the radial direction of the outer tube when the at least one bulging portion is pressurized at a first predetermined pressure or higher pressure by injecting a fluid into the flow path,
the bag-shaped body is configured so that a minimum inner diameter of the bag-shaped body in a state where the bag-shaped body is pressurized at a second predetermined pressure or higher pressure by injecting a fluid into the flow path is larger than the minimum inner diameter of the bag-shaped body in the non-pressurized state,
the second predetermined pressure is lower than the first predetermined pressure”
“ wherein the at least one bulging portion is configured to bulge outward in the radial direction of the outer tube when the at least one bulging portion enters a state of being pressurized at a first predetermined pressure or higher pressure by injecting a fluid into the flow path,
the bag-shaped body is configured so that a minimum inner diameter of the bag-shaped body in a state where the bag-shaped body is pressurized at a second predetermined pressure or higher pressure by injecting a fluid into the flow path is larger than the minimum inner diameter of the bag-shaped body in the non-pressurized state,
the second predetermined pressure is equal to or higher than the first predetermined pressure”
“ wherein the at least one bulging portion has a first inward bulging portion and a second inward bulging portion configured to bulge inward in the radial direction of the outer tube and arranged at positions that mutually differ in a circumferential direction, the first inward bulging portion and the second inward bulging portion are configured so that in the pressurized state, the first inward bulging portion comes into contact with the second inward bulging portion”
“wherein the at least one bulging portion has a first bulging portion and a second bulging portion arranged at positions that mutually differ in a circumferential direction, and a bulging height of the first bulging portion and a bulging height of the second bulging portion differ from each other”
“wherein the at least one bulging portion bulges inward in the radial direction of the outer tube, and a frictional force of a surface of the at least one bulging portion located on an inner side in the radial direction of the outer tube is higher than a frictional force of an inner surface, of the outer tube, that faces the lumen of the outer tube”
“wherein the at least one bulging portion bulges outward in the radial direction of the outer tube, a frictional force of an outer surface of the at least one bulging portion is higher than a frictional force of an outer surface of the outer tube”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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