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 .
Response to Arguments
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Regarding the argument that Lampropoulos fails to teach “the center axis of the side port intersects a longitudinal axis of the main lumen at a location between the actuator and valve member”, is found not persuasive. The definition of between is at, into, or across the space separating two objects, or “in intermediate relation”. The intersection of the axis as claimed is intermediate, or across a space that separates the actuator (18) and the valve (32), this can be seen in figure 3 of Lampropoulos, in the same manner that the current invention’s axis intersect (see Annotated Figure 6 of Current invention and Annotated Fig. 3 of Lampropoulos. The arm of the actuator of Lampropoulos is above of where the intersection occurs, and the valve is in front of where the intersection occurs, therefore it is in between the intersection, and between the actuator and the valve member. It is noted that it seems that the actuator in the current invention, and the main lumen of the valve body, share the same longitudinal axis, however this has not been claimed
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Current Invention:
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Claim Objections
Claim 4 objected to because of the following informalities:
Claim 4 depends on canceled claim 2, since claim 2 was canceled and has been incorporated in claim 1, for examination purposes claim 4 has been treated as dependent on claim 1.
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.
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) 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 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) 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 parallel to a longitudinal axis of the main lumen into a longitudinal force pushing outwardly towards the open first end that causes a portion of the actuator to pierce the valve member by passing through a sealable slit to cause the valve member to open (See Figures 7A-7B, paragraphs [0063-0065]).
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) 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) 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 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) 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, Albert teaches fails to explicitly teach 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 th first portion of the valve of Lampropoulos does not include a first and second spring as claimed, and a modification of the valve of Albert 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDELMIRA BOSQUES whose telephone number is (571)270-5614. The examiner can normally be reached 9:00am-5:00pm M-F.
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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