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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 26, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 4-5, 7, 9-11, 15-18, 20, 26-25, 28-29, 31-32 have been considered but are moot because the new ground of rejection does not rely on the grounds of rejection applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 4, 5, 16-18, 25 and 31-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lampropoulos et al. (US 20090259200 A1) hereinafter Lampropoulos.
Regarding claim 1, Lampropoulos teaches a hemostasis valve device comprising:
a valve body (10, Fig. 1) having an open first end (20, proximal end) and an open second end (distal end pointed by 14) with a main lumen (Lumen within 12) extending from the open first end to the open second end;
a valve member (32) disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position (Fig. 4) and a closed position (Fig. 3);
and an actuator (18, 24, 26, and 28) disposed between the valve member (32) and the open second end (distal end of 12 pointed by 14, Fig. 3), the actuator being configured to move the valve member between the open position and the closed position,
wherein the actuator (members 24, 26, and 28 translate along an axis parallel to the longitudinal axis of the main lumen) is configured to translate along an axis parallel to a longitudinal axis of the main lumen of the valve body
wherein the valve body further includes a hollow side port (22, Fig. 2) that extends radially outward from the valve body so as to define a Y-shaped structure (See Fig. 2), the hollow side port having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member (See Figures 2-3).
Regarding claim 4, Lampropoulos teaches a portion of the actuator that is accessible by a user is located between the hollow side port and the open second end of the valve body (See Figures 2-3).
Regarding claim 5, Lampropoulos teaches the actuator is located along a side of the valve body and is configured to translate a force applied to the actuator into opening of the valve member (Refer to paragraph [0042], See Figures 3-4), and wherein the force that is applied is perpendicular a longitudinal axis of the valve body (The force on the lever 18 is perpendicular (down) in relation to the longitudinal axis of the valve body).
Regarding claim 16, Lampropoulos teaches the actuator comprises a dual sided actuator that is accessible along opposite sides of the valve body (Actuator 18 has 2 sides (left and right) and the actuator is accessible along both sides of the valve body see figures 2-3).
Regarding claim 17, Lampropoulos teaches wherein the actuator comprises a first portion (18) that moves in a first direction and a second portion (portion 16) that moves in a second direction, the second direction being a direction that is different than the first direction and is along a longitudinal direction along the main lumen (See Figures 3-4).
Regarding claim 18, Lampropoulos teaches the first direction is perpendicular to the second direction (See Figures 3-4, actuator 18 moves perpendicular with respect to the movement of portion 16).
Regarding claim 25, Lampropoulos teaches the valve body includes a first finger support (curved Finger support between 12 and 22, See Fig. 2) along a side of the valve body and a second finger (curved section in the actuator 18) support along an opposite side of the valve body, wherein the actuator is disposed between: (1) the first finger support and second finger support and (2) the open second end of the valve body, and wherein the valve body further includes a hollow side port (22) that extends radially outward from the valve body, the hollow side port (22) having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member, wherein the first finger support (Curved Finger support between 12 and 22, See Fig. 2) is integrally formed as part of the hollow side port (See Figure 3).
Regarding claim 31, Lampropoulos teaches hemostasis valve device comprising:
a valve body (100, Figure 7A-7B) having an open first (end opposite to 20A) end and an open second end (20A) with a main lumen extending from the open first end to the open second end;
a valve member (84) disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position and a closed position (see Figures 7A-7B)
an actuator (82, 76, 78) disposed between the valve member and the open second end (end pointed by 20A), the actuator being movable between a first position in which the valve member is in the closed position (Figure 7A) and a second position (Figure 7B) in which the valve member is in the open position, the actuator being configured to translate an applied force that is
wherein the actuator (members 82, 76, and 78, translate along an axis parallel to the longitudinal axis of the main lumen) is moveable between the first and second position by translating in a direction parallel to a longitudinal axis of the main lumen of the valve body.
Regarding claim 32, Lampropoulos teaches the actuator includes a first portion (18a) that is accessible along one or more sides of the valve body and a second portion (82, 78, 76) that is disposed completely within the main lumen, the first portion being configured to translate the applied force into axial translation of the second portion within the main lumen resulting in the valve member being breached and opened by the second portion (see Figure 7B).
Second embodiment of Lampropoulos Figs 7A-7B:
Regarding claim 1, Lampropoulos teaches a hemostasis valve device comprising:
a valve body (100, Fig. 7A) having an open first end (proximal end pointed by 20) and an open second end (distal end pointed by 14) with a main lumen (lumen within 12) extending from the open first end to the open second end;
a valve member (84) disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position (Fig. 7B) and a closed position (Fig.7A);
and an actuator (18A/82/76/78) disposed between the valve member (84) and the open second end (distal end), the actuator being configured to move the valve member between the open position and the closed position,
wherein the actuator (members 76, 78, 82 translate along an axis parallel to the longitudinal axis of the main lumen See Figures 7A-7B) is configured to translate along an axis parallel to a longitudinal axis of the main lumen of the valve body.
wherein the valve body further includes a hollow side port (22 in Fig. 2, not labeled in figure 7A) that extends radially outward from the valve body so as to define a Y-shaped structure (See Fig. 2/7A), the hollow side port having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member (See Figures 2-3 and 7A-7B).
Regarding claim 5, Lampropoulos teaches the actuator is located along a side of the valve body and is configured to translate a force applied to the actuator into opening of the valve member (See Figures 7A-7B), and wherein the force that is applied is perpendicular a longitudinal axis of the valve body (The force on the lever 18a is perpendicular (down) in relation to the longitudinal axis of the valve body).
Regarding claim 7, Lampropoulos teaches wherein the actuator includes a first portion (18A) that is exposed along the side of the valve body and a second portion (82, 76, 78) that contacts the valve member to open the valve member, and wherein the first portion of the actuator comprises a biased part that moves between an extended position and a collapsed position (see Figures 7a-7b) and the second portion comprises an elongated hollow driven pin (82) that upon actuation of the actuator is driven into contact with the valve member to cause an opening thereof (See Fig. 7B), thereby fluidly connecting the open first end and the open second end of the valve body and upon retraction of the elongated hollow driven pin, the valve member seals and returns to the closed position (see Fig. 7A).
Claim Rejections - 35 USC § 103
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 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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos in view of Goode et al. (US 5350363) hereinafter Goode.
Regarding claim 20, Lampropoulos teaches the valve member (82, Figs 7A-7B) comprises an elastomeric gasket and a side wall, and fails to explicitly teach wherein the elastomeric gasket has a membrane extending between the side wall, the membrane having a slit formed therein, wherein in the open position, the slit is open and in the closed position, the slit is closed, and wherein the side wall of the gasket is sealingly fixed to an inner surface of the valve body. Lamporpoulos teaches that a variety of valves including resilient valves (elastomeric valves), can be used without departing the scope of the invention (See paragraph [0066]).
Goode teaches an elastomeric slit valve elastomeric gasket (24, Figs. 3-5) has a side wall and a membrane extending between the side wall, the membrane having a slit (40) formed therein, wherein in the open position, the slit is open and in the closed position, the slit is closed, and wherein the side wall of the gasket is sealingly fixed to an inner surface of the valve body (Refer to col. 4, lines 9-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use an elastomeric slit valve as the valve on Lampropoulos as taught by Goode, as an alternative valve member to facilitate opening and closing of the valve.
Allowable Subject Matter
Claims 9-11, 15, 23, 24 and 28-29 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.
Regarding claim 9, the subject matter not found was “the first portion includes a first spring and a second spring, the first and second springs being radially positioned around and symmetric about the longitudinal axis of the valve body.” The closest art of record Lampropoulos teaches a hemostasis valve as claimed, however the first portion of the valve of Lampropoulos does not include a first and second spring as claimed, and a modification of the valve of Lampropoulos would require a non-obvious structural modification.
Regarding claim 11, the subject matter not found was “the one or more side openings being in fluid communication with the main lumen and therefore the actuator is fluidly sealed relative to the valve body and about the one or more side openings”, and “when the first biased element and the second biased element are relaxed to a relaxed position, the valve member is closed and when the first biased element and the second biased element are compressed to a compressed position and store energy, the valve member is in the open position. wherein the first biased element and the second biased element are coupled to an elongated hollow driven pin that is driven into contact with the valve member to cause an opening thereof when the first biased element and the second biased element move from the relaxed position to the compressed position and conversely, when the first biased element and the second biased element return to the relaxed position, the elongated hollow driven pin retracts relative to the valve member for closing thereof”.
The closest art of record Lampropoulos teaches a hemostasis valve as claimed, however the valve of Lampropoulos does not teach the side openings being in fluid communication with the main lumen and therefore the actuator is fluidly sealed relative to the valve body and about the one or more side openings” and “hen the first biased element and the second biased element are relaxed to a relaxed position, the valve member is closed and when the first biased element and the second biased element are compressed to a compressed position and store energy, the valve member is in the open position. wherein the first biased element and the second biased element are coupled to an elongated hollow driven pin that is driven into contact with the valve member to cause an opening thereof when the first biased element and the second biased element move from the relaxed position to the compressed position and conversely, when the first biased element and the second biased element return to the relaxed position, the elongated hollow driven pin retracts relative to the valve member for closing thereof”. A modification of the valve of Lampropoulos to include these features would require a non-obvious structural modification. Claims 15 is objected as dependent on claim 11.
Regarding claim 23, the subject matter not found was an elastomeric cover that surrounds the actuator and is fluidly sealed to the valve body. A modification of the valve of Lampropoulos to include these features would require a non-obvious structural modification.
Regarding claim 24, the subject matter not found was the actuator comprises a pair of two-bar linkages that are pivotally coupled to the valve body and move between a relaxed position in which the valve member is closed and a compressed position in which the valve member is open. A modification of the valve of Lampropoulos to include these features would require a non-obvious structural modification.
Regarding claim 28, the subject matter not found was a cover that surrounds the actuator and is fluidly sealed to the valve body. A modification of the valve of Lampropoulos to include these features would require a non-obvious structural modification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moran et al. (US 20027/0010796). Moran teaches a hemostasis valve device comprising: a valve body (Fig. 9A) having an open first end (proximal end pointed by 10) and an open second end (distal end pointed by 40) with a main lumen (lumen within 10 extending to 34 and 40) extending from the open first end to the open second end; a valve member (26) disposed within the main lumen of the valve body at or proximate to the open first end, the valve member having an open position (Fig. 9B-9C) and a closed position (Fig.9A); and an actuator (324/320/12/134) disposed between the valve member (26) and the open second end (40, distal end), the actuator being configured to move the valve member between the open position and the closed position, wherein the actuator (320) is configured to translate along an axis parallel to a longitudinal axis of the main lumen of the valve body, wherein the valve body further includes a hollow side port (30) that extends radially outward from the valve body so as to define a Y-shaped structure (See Fig. 9a), the hollow side port having a center axis that intersects a longitudinal axis of the main lumen of the valve body at a location between the actuator and the valve member (See Figures 9a-9b).
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
