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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/7/26 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 8/7/26. As directed by the amendment: claims 1, 2, 10, 21, and 22 have been amended, claims 11-20 have been cancelled, and no new claims have been added. Thus, claims 1-10, 21, and 22 are presently pending in this application.
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) 1-10, 21, and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takagi et al. (US 20130116622).
Regarding claim 1, Takagi et al. discloses a guidewire deflection system (fig. 1-5), comprising: a guidewire 3 having a distal guidewire section (comprising at least 12); an elongated catheter assembly 1 defining a catheter lumen 9 being configured to receive the distal guidewire section of the guidewire (see fig. 4A-5) and also defining an axial portal (distal facing opening of 9, see fig. 4A-5) and a radial portal 5; and a guidewire deflector (comprising 8 and 10) mounted to the elongated catheter assembly, the guidewire deflector configured to selectively deflect urged axial movement of the distal guidewire section of the guidewire away from the axial portal and radially toward the radial portal (see fig. 4A-4B), wherein the guidewire deflector includes: a balloon 8 configured to be selectively inflated and deflated (par. 0033; see fig. 4A-5); and an inflation lumen 10 in fluid communication with the balloon (see fig. 4A-5), wherein the balloon is configured to, when inflated, cause the distal guidewire section of the guidewire, when advanced distally along the catheter lumen, to directly contact the balloon and ramp against the balloon to deflect outward through the radial portal (see fig. 4B).
Regarding claim 2, Takagi et al. discloses a guidewire deflection system (fig. 1-5), comprising: a guidewire 3 having a distal guidewire section (comprising at least 12); an elongated catheter assembly 1 defining a catheter lumen 9 extending axially along the elongated catheter assembly (see fig. 4A-5); and the catheter lumen being configured to receive the distal guidewire section of the guidewire (see fig. 4A-5); and the elongated catheter assembly defining an axial portal extending axially from the catheter lumen (distal facing opening of 9, see fig. 4A-5); and the elongated catheter assembly also defining a radial portal 5 extending radially from the catheter lumen (see fig. 4A-5); and a guidewire deflector (comprising 8 and 10) mounted in the catheter lumen (see fig. 4A-5), wherein the guidewire deflector includes: a balloon 8 configured to be selectively inflated and deflated (par. 0033; see fig. 4A-5); an inflation lumen 10 in fluid communication with the balloon (see fig. 4A-5); the balloon configured to, when inflated, cause the distal guidewire section of the guidewire, when advanced distally along the catheter lumen, to directly contact the balloon and ramp against the balloon to deflect outward through the radial portal (see fig. 4B); and the balloon being configured to, when deflated, permit the distal guidewire section of the guidewire to travel axially along the catheter lumen through the axial portal (see fig. 4A and/or 5).
Regarding claim 3, Takagi et al. discloses the elongated catheter assembly has a sidewall (sidewall of 1 at a proximal end of the catheter); and the elongated catheter assembly also has a distal section extending from the sidewall (distal section visible in fig. 4A-5).
Regarding claim 4, Takagi et al. discloses the catheter lumen extends axially toward and through a distal section of the elongated catheter assembly to the axial portal (distal section illustrated in fig. 4A-5).
Regarding claim 5, Takagi et al. discloses a distal section of the elongated catheter assembly is configured to permit movement of the distal guidewire section of the guidewire travelling axially along the catheter lumen toward, and through, the axial portal (distal section as illustrated in fig. 4A-5); and the distal section defines the radial portal extending radially from the catheter lumen (see fig. 4A-5); and the radial portal extends radially through a sidewall of the elongated catheter assembly (see fig. 4A-5).
Regarding claim 6, Takagi et al. discloses the guidewire deflector is mounted in the catheter lumen at a distal section of the elongated catheter assembly (distal section as illustrated in fig. 4A-5); and the guidewire deflector is mounted proximate to the axial portal (see fig. 4A-5, they are mounted near each other as illustrated).
Regarding claim 7, Takagi et al. discloses a proximal section of the catheter lumen is configured to receive the distal guidewire section of the guidewire (proximal section of catheter 1 through which 3 is inserted); and a distal section of the catheter lumen defines the axial portal and the radial portal (distal section as illustrated in fig. 4A-5).
Regarding claim 8, Takagi et al. discloses the catheter lumen, the axial portal and the radial portal are in fluid communication with each other (see fig. 4A-5).
Regarding claim 9, Takagi et al. discloses the guidewire deflector is user controllable (via process of par. 0041).
Regarding claim 10, Takagi et al. discloses the inflation lumen is configured to be fluidly connected to an inflation source (via 7, see fig. 1 and par. 0031).
Regarding claim 21, Takagi et al. discloses a guidewire deflection system (fig. 1-5), comprising: a guidewire 3 having a distal guidewire section (comprising at least 12); an elongated catheter assembly 1 defining a catheter lumen 9 extending axially along the elongated catheter assembly (see fig. 4A-5); and the catheter lumen being configured to receive the distal guidewire section of the guidewire (see fig. 4A-5); and the elongated catheter assembly defining an axial portal extending axially from the catheter lumen (distal facing opening of 9, see fig. 4A-5); and the elongated catheter assembly also defining a radial portal 5 extending radially from the catheter lumen (see fig. 4A-5); and the catheter lumen, the axial portal and the radial portal are in fluid communication with each other (see fig. 4A-5); and a guidewire deflector (comprising 8 and 10) mounted in the catheter lumen, wherein the guidewire deflector includes: a balloon 8 configured to be selectively inflated and deflated to orient and direct movement of the distal guidewire section (par. 0033; see fig. 4A-5); and an inflation lumen 10 extending along a length of the elongated catheter assembly (see fig. 4A-5); and the inflation lumen being in fluid communication with the balloon (see fig. 4A-5); the balloon being configured to, when inflated, cause the distal guidewire section of the guidewire, when advanced distally along the catheter lumen, to directly contact the balloon and ramp against the balloon to deflect outward through the radial portal (see fig. 4B); and the balloon being configured to, when deflated, permit the distal guidewire section of the guidewire to travel axially along the catheter lumen through the axial portal (see fig. 4A and/or 5).
Regarding claim 22, Takagi et al. discloses the balloon extends distal of the radial portal (see fig. 4A-5, the balloon begins distal of the radial portal as occupied by 12).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10, 21, and 22, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Takagi et al. in view of Saeed et al. (US 7182756).
Regarding claims 1-10, 21, and 22, in addition to the analyses of those claims provided above under 35 U.S.C. 102(a)(1), Saeed et al. further teaches utilizing a balloon-based deflection tool to deflect various elongate medical devices 14 for various purposes, a catheter or a guidewire being specifically provided examples (col. 2, ln. 64-66; see fig. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Takagi et al. to deflect and position a guidewire of the type taught by Saeed et al., for the purpose of adapting the device for guidewire placement into branched body passageways as envisioned by Saeed et al.
Claim(s) 22, in the alternative, is/are rejected under 35 U.S.C. 103 as being unpatentable over Takagi et al. in view of Alvarez et al. (US 20130006167), or over Takagi et al. in view of Saeed et al., and further in view of Alvarez et al.
Regarding claim 22, in addition to the analysis of Takagi et al. as presented above, Alvarez et al. teaches configuring a similar balloon to extend distal of the radial portal (see fig. 6A-B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the balloon of Takagi et al. to extend as shown by Alvarez et al. since such a modification is the result of a simple substitution of one configuration for another to achieve the predictable result of balloon-based deflection through the portal.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gunday et a. (US 20140194776) discloses another balloon deflection mechanism.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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