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 .
Status of Claims
Claims 1, 4-13, and 16-22 are pending and currently under consideration for patentability.
Claims 1 and 12 are newly amended.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
The applicant argues Blanchard fails to teach “wherein the center slit (245) extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle relative to a center slit (240) (figure 11 and 12)." However the examiner disagrees. The examiner interpreted the claim to mean the acute angle is considered to be relative to the entrance of the slit, not the path of the slit. This is shown through the annotated diagram below. The curvature of the valve creates the acute angle, shown in the annotate figure.
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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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 7-13, 16, 19-20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Winsor (US 20140228776 A1) in view of Solomon (US 20190351210 A1) in view of Weaver (US 20160008530 A1) in view of Blanchard (US 20070161940 A1).
Regarding Claim 1, Winsor teaches a valved connector (16 and 18)(figure 2), comprising:
a connector body (16) defining a lumen (lumen, 46) ; and
a valve (valve, 18) configured to control a fluid flow through the lumen (lumen, 46), the valve (18) including a proximal face and a distal face (figure 2), one of the proximal face or the distal face defining an oval shape, the valve (18) defining a curved lateral axis and a linear transverse axis (see annotated figure 8 below, lateral axis is curved at circular region),
the valve (valve, 18) including:
a center slit (slit, 126) extending from the proximal face to the distal face (figure 8)(paragraph 0044);
However, Winsor fails to teach a side slit extending through the valve from the proximal face to the distal face at an angle relative to a longitudinal axis of the valve, the longitudinal axis disposed perpendicular to the valve. In a similar field of endeavor, namely catheter valves, Solomon teaches a side slit (slit, 158) extending through the valve (valve, 150) from the proximal face to the distal face at an angle relative to a longitudinal axis of the valve (150), the longitudinal axis disposed perpendicular to the valve (150)(paragraph 0055)(figures 8A-8C). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the valved connector of Winsor to include a side slit similar to that disclosed by Solomon, this would serve to weaken the valve so that it tears when engaged with a luer, thus leaving short flaps that do not interfere with the primary valve (as motivated by Solomon, paragraph 0055). Furthermore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve of Winsor that is configured to control a fluid flow through the lumen, for the side slit valve of Solomon since these mechanisms perform the same function of controlling fluid flow through the lumen. Simply substituting one resilient return means for another would yield the predicable result of allowing an articulated device to return to its initial un-stressed orientation. See MPEP 2143.
Winsor and Solomon fail to teach wherein the slit is a center slit and a side slit each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit. Weaver teaches a valve for controlling material flow through a catheter, comprises a first flexible member including a first moveable element, wherein the slit is a center slit (212) and a side slit (114) each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit (figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify slits of Winsor so the center slit and the side slit each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit similar to that of Weaver so that the flow through the slits will not interfere. In this case it would be obvious to add such parallel slits to the surface of 18, in addition to the center slit. The slits can be any size that allow the dome to maintain its structural integrity.
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The combination fails to teach wherein Winsor so the center slit extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle relative to a center slit.
However Blanchard teaches wherein the center slit (245) extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle relative to a center slit (240) (figure 11 and 12). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the valved connector of Winsor so the center slit extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle (paragraph [0011]) relative to a center slit similar to Blanchard so that the side slits will function only depending on pressure of fluid (Blanchard, paragraph [0053]).
Regarding Claim 4, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor further teaches wherein a first side slit (88) is angled in a first direction relative to the longitudinal axis and a second side slit (88) is angled in a second direction opposite the first direction, relative to the longitudinal axis (figure 6).
Regarding Claim 7, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor further teaches wherein one of the proximal face or the distal face of the valve includes a recess (120a) encircling a portion of the center slit (126) (figure 8).
Regarding Claim 8, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor further teaches wherein the connector body (16) includes a proximal housing piece (16) defining a first lumen (48a)(figure 2) and a distal housing piece (14) defining a second lumen (48c)(figure 2 and 3), and wherein a portion of the valve (118) (figure 2) is retained between the proximal housing piece (16) and the distal housing piece (18) to control a fluid flow between the first lumen (48a) and the second lumen (48c) (paragraph 0036).
Regarding Claim 9, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 8. Winsor further teaches wherein a portion (118) of the first lumen (48a) defines a reduced (reduced compared to valve, figure 3) cross-sectional area to modify an aspiration crack pressure (paragraph 0042).
Regarding Claim 10, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 8. Winsor further teaches wherein a portion (118) of the first lumen (48a) defines one of an oval shape to direct a fluid flow towards the center slit (figure 2).
Regarding Claim 11, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor and Solomon fail to explicitly teach wherein a radius of curvature of the lateral axis is between d=0.5z and d=4z, where d is a midpoint distance from a linear axis and z is a longitudinal thickness of the valve. Winsor teaches this value to be optimizable based on whether the valve is in a natural or rest shape (paragraph 0038). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the radius of curvature of the valve to is between d=0.5z and d=4z, where d is a midpoint distance from a linear axis and z is a longitudinal thickness of the valve, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller,105 USPQ 233. In addition, modifying the radius of curvature allow for a larger or smaller valve, and in order to reduce contact stress of the valve. By selecting the range above, the applicant allows for determination that the valve will have reduced contact stress, thus resulting in less pressure and strain on the valve.
Regarding Claim 12, Winsor teaches a method of manufacturing (paragraph 0053) a valved connector (16 and 18)(figure 2), comprising: forming a proximal housing piece (16) including a first lumen (48a) and a distal engagement surface (62) (figure 2);
forming a distal housing piece (14) including a second lumen and a proximal engagement surface (120a)(figure 3); (paragraph 0049)
forming a valve (18) including a proximal face (120a) and a distal face (120b) and a center slit (126) extending therebetween, one of the proximal face (120a) or the distal face (120b) defining an oval shape (figure 2) (paragraph 0037)(figures 1-3),
a lateral axis of the oval shape being wider than a transverse axis of the oval shape (annotated figure 3: lateral diameter of 120 is wider than the height of the valve);
retaining the valve (18) between the proximal housing piece (16) and the distal housing (14) piece to control a fluid flow between the first lumen (48a) and the second lumen (48c) (figure 2) (paragraph 0037) (paragraph 0049);
constraining the lateral axis of the valve to a curved shape to provide a convex shape to the proximal face (120a) (figure 2 and 3) (paragraph 0049); and
attaching (paragraph 0008) the distal engagement surface with the proximal engagement surface (62 and 120a) (figure 3).
Winsor and Solomon fail to teach wherein the slit is a center slit and a side slit each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit. Weaver teaches a valve for controlling material flow through a catheter, comprises a first flexible member including a first moveable element, wherein the slit is a center slit (212) and a side slit (114) each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit (figure 4). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify slits of Winsor so the center slit and the side slit each extend parallel to the lateral axis, and the side slit disposed in an off-set relationship along the transverse axis from the center slit similar to that of Weaver so that the flow through the slits will not interfere.
The combination fails to teach wherein Winsor so the center slit extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle relative to a center slit.
However Blanchard teaches wherein the center slit (245) extends through the valve parallel to the longitudinal axis of the valve (figure 11 and 12 and the side slit extends through the valve at an acute angle (paragraph [0011]) relative to a center slit (240) (figure 11 and 12). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the valved connector of Winsor so the center slit extends through the valve parallel to the longitudinal axis of the valve and the side slit extends through the valve at an acute angle relative to a center slit similar to Blanchard so that the side slits will function only depending on pressure of fluid (Blanchard, paragraph [0053]).
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Annotated Figure 3
Regarding Claim 13, Winsor in view of Solomon, Weaver, and Blanchard teaches the method according to claim 12. Winsor and Solomon fail to explicitly teach wherein a radius of curvature of the lateral axis is between d=0.5z and d=4z, where d is a midpoint distance from a linear axis and z is a longitudinal thickness of the valve between the proximal face and the distal face. However due to the language of the claim, Windsor could easily modify the radius of curvature. Winsor teaches this value to be optimizable based on whether the valve is in a natural or rest shape (paragraph 0038). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention wherein a radius of curvature of the lateral axis is between d=0.5z and d=4z, where d is a midpoint distance from a linear axis and z is a longitudinal thickness of the valve, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller,105 USPQ 233. In addition, modifying the radius of curvature allow for a larger or smaller valve, and in order to reduce contact stress of the valve. By selecting the range above, the applicant allows for determination that the valve will have reduced contact stress, thus resulting in less pressure and strain on the valve.
Regarding Claim 16, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 12. Winsor further teaches wherein a first side slit (88) is angled in a first direction relative to the longitudinal axis and a second side slit (88) is angled in a second direction opposite the first direction, relative to the longitudinal axis (figure 6).
Regarding Claim 19, Winsor in view of Solomon, Weaver, and Blanchard teaches the method according to claim 12. Winsor further teaches wherein one of the proximal face or the distal face of the valve includes a recess (120a) encircling a portion of the center slit (126) (figure 8).
Regarding Claim 20, Winsor in view of Solomon and Weaver teaches the method according to claim 12. Winsor further teaches wherein a portion (figure 2) of the first lumen (48a) defines a reduced (reduced compared to valve, figure 3) cross-sectional area to modify an aspiration crack pressure (paragraph 0042).
Claim(s) 5, 6 , 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Winsor (US 20140228776 A1) in view of Solomon (US 20190351210 A1) in view of Weaver (US 20160008530 A1) in view of Blanchard (US 20070161940 A1) in view of Spohn (US 20190083699 A1).
Regarding Claim 5, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor further teaches wherein the center slit (126) opens during both infusion and aspiration (paragraph 0054) and that the fluid only travels through the channels during infusion (paragraph 0054) but Winsor and Solomon fail to teach the side slit opens only during infusion. In the same field of endeavor, namely catheter calves, Spohn teaches a method of maintaining an overall flow rate in blood vessels (abstract) wherein the high crack pressure check valves (40, 42) may be check valves that allow flow in one direction (paragraph 0098)(figure 9). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the side slit of Winsor in view of Solomon to include the side slit opens only during infusion similar to that disclosed by Spohn so that valve allows for better pressure flow and better control of infusion(as motivated by Spohn, paragraph 0098).
Regarding Claim 6, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor and Solomon fail to teach, wherein a crack pressure of the slit is greater than a maintenance pressure of the center slit. Spohn teaches a method of maintaining an overall flow rate in blood vessels (abstract) wherein a crack pressure of the slit (40 and 42) is greater than a maintenance pressure of the slit (paragraph 0098). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure slit of Winsor to include a crack pressure of the slit is greater than a maintenance pressure of the slit similar to that disclosed by Spohn so that valve only allows fluid flow when the system has reached the maximum system pressure (as motivated by Spohn, paragraph 0098).
Regarding Claim 17, Winsor in view of Solomon, Weaver, and Blanchard teaches the method according to claim 12. Winsor further teaches wherein the center slit (126) opens during both infusion and aspiration (paragraph 0054) and that the fluid only travels through the channels during infusion (paragraph 0054) but Winsor and Solomon fail to teach the side slit opens only during infusion. Spohn teaches a method of maintaining an overall flow rate in blood vessels (abstract) wherein the high crack pressure check valves (40, 42) may be check valves that allow flow in one direction (paragraph 0098)(figure 9). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the side slit of Winsor in view of Solomon to include the side slit opens only during infusion similar to that disclosed by Spohn so that valve allows for better pressure flow and better control of infusion (as motivated by Spohn, paragraph 0098).
Regarding Claim 18, Winsor in view of Solomon, Weaver, and Blanchard teach the method according to claim 12. Winsor and Solomon fail to teach, wherein a crack pressure of the center slit is greater than a maintenance pressure of the slit. Spohn teaches a method of maintaining an overall flow rate in blood vessels (abstract) wherein a crack pressure of the slit (40 and 42) is greater than a maintenance pressure of the slit (paragraph 0098). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the pressure slit of Winsor in view of Solomon to include a crack pressure of the slit is greater than a maintenance pressure of the slit similar to that disclosed by Spohn so that valve only allows fluid flow when the system has reached the maximum system pressure (as motivated by Spohn, paragraph 0098).
Regarding Claim 21, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. The combination further teaches wherein the angle is between 5 and 85 degrees ( Blanchard, figure 11).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over Winsor (US 20140228776 A1) in view of Solomon (US 20190351210 A1) in view of Weaver (US 20160008530 A1) in view of Blanchard (US 20070161940 A1 in view of Sansoucy (US 20140012209 A1).
Regarding Claim 22, Winsor in view of Solomon, Weaver, and Blanchard teaches the valved connector according to claim 1. Winsor and Solomon fail to explicitly teach wherein the side slit extends through the valve at a non-perpendicular angle with respect to the proximal face or the distal face. Sansoucy teaches a catheter with valved openings wherein the side slit (120) extends through the valve at a non-perpendicular angle with respect to the proximal face or the distal face (figure 1A and 1B). Therefore, it would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the valved connector of Winsor so the side slit extends through the valve at a non-perpendicular angle with respect to the proximal face or the distal face similar to Sansoucy so the valves are only one way.
Conclusion
THIS ACTION IS MADE FINAL. 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 KATE ELIZABETH STRACHAN whose telephone number is (571)272-7291. The examiner can normally be reached M-F: 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on (571)-270-5879. The fax phone number for the organization where this application or proceeding is assigned is (571)-270-5879.
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/KATE ELIZABETH STRACHAN/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781