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 .
Election/Restrictions
Applicant’s election without traverse of Species A: Exemplary medical device with handle 104, as illustrated in Figs. 1A-1D and described in paragraphs [0036-0037] of the specification, Subspecies 2: switch assembly 212, as illustrated in Figs. 2A-B and described in paragraphs [0038-0044] as applied to claims 1-9, 15-16, and 19-20 in the reply filed on 08/13/2026 is acknowledged.
Status of Claims
In the present application, claims 1-20 are currently pending. Claims 10-14 and 17-18 are withdrawn as being directed at a non-elected species. Claims 1-9, 15, 16, 19, and 20 are examined below.
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 5 should be amended as follows to maintain consistency throughout the claims “a switch assembly coupled to at least one of the first lumen or the second lumen…”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 15-16, and 19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Altshuler et al. (US2022/0142463) hereinafter Altshuler.
Regarding Claim 1, Altshuler discloses a medical device (Fig. 1 endoscopic system 40) comprising:
a handle (Figs. 1-2 steering handle 42) comprising a housing (housing of steering handle 42);
a first lumen (Fig. 2 first of lumens 140/144) extending distal to the housing (housing of steering handle 42);
a second lumen (Fig. 1-2 lumen of catheter 44) extending distal to the housing (housing of steering handle 42); and
a switch assembly (Fig. 1 manifold 48 to include isolations valves 96) coupled to at least one of the first lumen (Fig. 2 first of lumens 140/144) or second lumen;
wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) includes a first inlet (Fig. 2 inlet 92 in communication with irrigation system 52), a second inlet (Fig. 2 inlet 92 in communication with aspiration system 54), a first outlet (Fig. 1 near distal head portion 76) , and a second outlet (Fig. 2 output port 94), the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) being configured to receive a source of fluid (Fig. 2 irrigation system 52) and the second inlet (Fig. 2 inlet 92 in communication with aspiration system 54) being configured to receive a source of suction (Fig. 2 aspiration system 54); and
wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) is movable between a first configuration (fluid configuration from irrigation system 52) in which the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) is in communication with the first outlet (Fig. 1 near distal head portion 76) and the first lumen (Fig. 2 first of lumens 140/144) and a second configuration (aspiration configuration in communication with aspiration system 54) in which the second inlet (Fig. 2 inlet 92 in communication with aspiration system 54) is in communication with the first outlet (Fig. 1 near distal head portion 76) and the first lumen (Fig. 2 first of lumens 140/144).
Regarding Claim 2, Altshuler discloses the medical device of claim 1, wherein the medical device includes a shaft (Fig. 1-2 catheter 44) extending distally from the housing (housing of steering handle 42), the shaft (Fig. 1-2 catheter 44) defining the first lumen (Fig. 2 first of lumens 140/144) and the second lumen (Fig. 1-2 lumen of catheter 44), wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) is coupled to the housing (housing of steering handle 42) of the handle (Figs. 1-2 steering handle 42).
Regarding Claim 15, Altshuler discloses a medical device (Fig. 1 endoscopic system 40) comprising:
a handle (Figs. 1-2 steering handle 42) comprising a housing (housing of steering handle 42);
a shaft (Fig. 1-2 catheter 44) extending distally from the housing (housing of steering handle 42), the shaft (Fig. 1-2 catheter 44) defining a first lumen (Fig. 2 first of lumens 140/144) that terminates at a first opening (Fig. 1 near distal end portion 76 of lumens 140/144) and a second lumen (Fig. 1-2 lumen of catheter 44) that terminates at a second opening (Fig. 1-2 distal opening of lumen of catheter 44 near distal end portion 76); and
a switch assembly (Fig. 1 manifold 48 to include isolations valves 96) coupled to the housing (housing of steering handle 42) and including a first body (Fig. 1 manifold 48) movably coupled to a second body (Fig. 1 isolations valves 96) , wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) includes a first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) configured to receive a source of a fluid (Fig. 2 irrigation system 52), a second inlet (Fig. 2 inlet 92 in communication with aspiration system 54) configured to receive a source of suction (Fig. 2 aspiration system 54), a first outlet (Fig. 1 near distal head portion 76) in communication with the first lumen (Fig. 2 first of lumens 140/144), and a second outlet (Fig. 2 output port 94) in communication with the second lumen (Fig. 1-2 lumen of catheter 44), and wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) is movable between a first configuration (fluid configuration from irrigation system 52) in which the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) is in communication with the first outlet (Fig. 1 near distal head portion 76) and the first lumen (Fig. 2 first of lumens 140/144) and a second configuration (aspiration configuration in communication with aspiration system 54) in which the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) is in communication with the second outlet (Fig. 2 output port 94) and the second lumen (Fig. 1-2 lumen of catheter 44).
Regarding Claim 16, Altshuler discloses the medical device of claim 15, wherein the first opening (Fig. 1 near distal end portion 76 of lumens 140/144) is at a distalmost end of the shaft (Fig. 1-2 catheter 44) and the second opening (Fig. 1-2 distal opening of lumen of catheter 44 near distal end portion 76) is proximal to the first opening (Fig. 1 near distal end portion 76 of lumens 140/144).
Regarding Claim 19, Altshuler discloses a medical device (Fig. 1 endoscopic system 40) comprising:
a handle (Figs. 1-2 steering handle 42) comprising a housing (housing of steering handle 42);
a shaft (Fig. 1-2 catheter 44) extending distally from the housing (housing of steering handle 42), the shaft (Fig. 1-2 catheter 44) defining a first lumen (Fig. 2 first of lumens 140/144) that terminates at a first opening (Fig. 1 near distal end portion 76 of lumens 140/144) and a second lumen (Fig. 1-2 lumen of catheter 44) that terminates at a second opening (Fig. 1-2 distal opening of lumen of catheter 44 near distal end portion 76) proximal to the first opening (Fig. 1 near distal end portion 76 of lumens 140/144); and
a switch assembly (Fig. 1 manifold 48 to include isolations valves 96) coupled to the housing (housing of steering handle 42) and including a first body (Fig. 1 isolations valves 96) movably coupled to a second body (Fig. 1 manifold 48), wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) includes a first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) configured to receive a source of a fluid (Fig. 2 irrigation system 52), a second inlet (Fig. 2 inlet 92 in communication with aspiration system 54) configured to receive a source of suction (Fig. 2 aspiration system 54), a first outlet (Fig. 1 near distal head portion 76) in communication with the first lumen (Fig. 2 first of lumens 140/144), and a second outlet (Fig. 2 output port 94) in communication with the second lumen (Fig. 1-2 lumen of catheter 44), and
wherein the switch assembly (Fig. 1 manifold 48 to include isolations valves 96) is movable between a first configuration (fluid configuration from irrigation system 52) and a second configuration (aspiration configuration in communication with aspiration system 54) by rotating or axially moving the first body (Fig. 1 isolations valves 96) relative to the second body (Fig. 1 manifold 48), wherein in the first configuration (fluid configuration from irrigation system 52), the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) is in communication with the first outlet (Fig. 1 near distal head portion 76) and the first lumen (Fig. 2 first of lumens 140/144), and wherein in the second configuration (aspiration configuration in communication with aspiration system 54), the first inlet (Fig. 2 inlet 92 in communication with irrigation system 52) is in communication with the second outlet (Fig. 2 output port 94) and the second lumen (Fig. 1-2 lumen of catheter 44).
Allowable Subject Matter
Claims 3-9 and 20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Johnsen et al. (US2019/0254505);
Malcolm G. Munro (US5957849);
Stanton et al. (US2022/0049777); and
Comee et al. (US2021/0298567)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN E MONAHAN whose telephone number is (571)272-7330. The examiner can normally be reached Monday - Friday, 8am - 5pm.
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/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795
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