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 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 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2020/030572 to Ghodsian (Ghodsian hereinafter).
Regarding claim 1, Ghodsian teaches a balloon catheter (600, see Fig. 6A) comprising a liquid supply tube (extending between 606 and 610, see paragraph 84: “a conduit fluidly communicating the first port 606… to an interior of the balloon 610), a mandrin guide tube (601) extending parallel to the liquid supply tube, a liquid supply connecting portion (606) configured to be connected with a liquid supply element (paragraph 84), and a balloon (610) with deflated and inflated modes.
Regarding claim 11, Ghodsian teaches a mandrin (650, 651) with a gripping portion (651) and a rod-shaped portion (650) inserted into the guide tube.
Claim(s) 1-4 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 112704552 to Zeng (Zeng hereinafter, copy and machine translation attached, citations refer to translation).
Regarding claim 1, Zeng teaches a balloon catheter (100), a liquid supply tube (11), a mandrin guide tube (15), a liquid supply connecting portion (10), and a balloon (13).
Regarding claim 2, Zeng teaches folding and insertion (page 7, ln. 10-27).
Regarding claim 3, Zeng teaches a separate, larger tube (15) within which the liquid supply tube extends.
Regarding claim 4, Zeng teaches a check valve (10, see page 7, ln. 3-9).
Regarding claim 10, Zeng teaches a fluid valve (10) configured to open on connection with the liquid supply tube.
Regarding claim 11, Zeng teaches a mandrin (15) with a proximal gripping portion (the examiner notes that this limitation is broad and reads on any section which may be grasped, including while not inserted).
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng.
Regarding claim 12, Zeng is silent to marking notches. The examiner takes Official Notice that this is a well-known feature, as evidenced by A61M2026/0008 in the CPC schedule. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a set of marking notches as is generally known in order to inform a user as to a degree of insertion.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng in view of U.S. Patent 5,908,407 to Frazee et al. (Frazee).
Regarding claim 5, Zeng is silent to a flexible element with a slit. Frazee teaches another catheter generally and particularly teaches that septum valves (127) are known to provide selective passage into a catheter (col. 6, ln. 31-50). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a slitted septum as taught by Frazee as the valve of Zeng in order to provide the one-way flow as desired by Zeng.
Regarding claim 6, Zeng teaches an outer valve sleeve (10) into which the septum valve of Frazee would be inserted. Whether the connection with the liquid supply tube is male or female is an obvious matter of design choice which does not substantively affect the operation of the catheter of Zeng.
Regarding claim 7, Zeng is silent to a penetratable flexible element with a slit. Frazee teaches another catheter generally and particularly teaches that septum valves (127) are known to provide selective passage into a catheter (col. 6, ln. 31-50). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a slitted septum as taught by Frazee as the valve of Zeng in order to provide the one-way flow as desired by Zeng.
Claim(s) 8-10 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng in view of U.S. Patent 10,327,880 to Connors et al. (Connors).
Regarding claims 8-9, Zeng is silent to a hand pump. Connors teaches that a balloon may be inflated with a squeezable hand pump (64). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a hand pump and tube connection as taught by Connors to the catheter of Zeng in order to inflate the balloon.
Regarding claim 10, Zeng is aware of fluid valves generally (see e.g. 10), and it would have been obvious to use such in the hand pump of Connors in order to prevent backflow or leakage as is generally known in the art.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeng in view of U.S. Patent 4,341,218 to U (U).
Regarding claim 13, Zeng is silent to an inner ball. U teaches a balloon catheter generally, and particularly teaches that the balloon may have a valve in order to prevent unwanted deflation, the valve including an inner ball (18). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a valve as taught by U in order to prevent unwanted deflation of the balloon thereof. Such a ball would be connected to the second end of the liquid supply tube in order to prevent backflow therethrough.
Regarding claim 14, U teaches a guiding tube (28, 38) extending into a supply tube (28) provided to convey fluid to the balloon. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a supply tube to convey fluid to the balloon of Zeng.
Regarding claim 15, Zeng teaches a balloon fold (e.g. with the tube).
Regarding claim 16, U teaches an inner fluid channel (32) extending through the guiding tube and the ball (at 20).
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 11 June 2026
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