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 .
Response to Amendment
The amendment filed November 12, 2025 has been entered. Claims 1, 8-9, 19, 21, 25-30, and 32-38 remain pending in the application. Claims 2-7, 10-18, 20, 22-24, 31, and 39-10 have been cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 fails to further limit the subject matter of claim 1 upon which it depends. All of the limitations of claim 9 are present in claim 1, lines 25-30. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 8-9, 19, 25-30, 32, and 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gursel et al. (WO 2019152630) in view of Goral et al. (USPN 8652104).
Regarding claim 1, Gursel discloses a catheter assembly (catheter assembly 104), comprising:
a catheter adapter (catheter hub 122), comprising a distal end (distal end 140), a proximal end (proximal end 142), and a lumen (interior cavity 146) extending through the distal end and the proximal end (Figure 4B);
a catheter (catheter tube 124) extending distally from the distal end of the catheter adapter (Figure 4B);
a septum (seal member 132) disposed within the lumen (Figure 4B; “The seal member 132, alternatively referred to as a blood control valve 132, can also be secured within the interior cavity 146 of the catheter hub 122” [Page 17, lines 1-3]), wherein the septum comprises a distal end (distal end 172), a proximal end (proximal end 174), and a barrier (membrane 180) disposed between the distal end of the septum and the proximal end of the septum (Figure 6A), wherein the barrier divides an interior of the septum (interior cavity 178) into a distal cavity (distal portion 182) and a proximal cavity (proximal portion 184), wherein the barrier comprises a slit (slit 186), wherein the septum is configured to move from a proximal position (Figure 8A) to a distal position (Figure 8C) in response to insertion of a medical device (luer taper 200) into the proximal end of the catheter adapter (“As depicted in FIGS. 8B-C, upon insertion of a luer taper 200, the seal member 132 can be shifted distally relative to the actuator 130, so as to cause the flange 168 to push against the membrane 180, thereby causing the slit 186 of the membrane 180 to at least partially open.” [Page 20, lines 16-19]);
a septum actuator (actuator 130) fixed within the lumen (Figure 4B; “the distal portion 164 of the actuator 130 can be frictionally fit within the proximal end 134 of the catheter tube 124, which can be frictionally fit within the interior cavity 146 of the catheter hub 122, such that, the catheter tube 124 extends distally from the distal end 140 of the catheter hub 122” [Col 17, lines 21-24]), wherein the septum actuator is configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position (“As the seal member 132 axially shifts within the catheter hub 122, the proximal portion 166 of the actuator 130 contacts the membrane 180 and starts penetrating through the slit 186,… so as to gradually open the slit 186. Continued distal insertion of the luer taper 200 causes the seal member 132 to shift axially until the luer taper 200 is fully extended into the interior cavity 146 of the catheter hub 122, with the distal end 172 of the seal member 132 moved forward, or against a distal portion 150 of the interior cavity 146, thereby defining the open position of the seal member 132 (as depicted in FIG. 8C).” [Page 20, lines 25-32]), wherein the septum actuator comprises a tubular body (cylindrical body 152) and an annular lip (flange 168) extending outwardly from an outer surface of the tubular body (wall 158; Figure 5), wherein the annular lip is disposed at a proximal end (proximal end 156) of the septum actuator (Figure 5); and
a spring, wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter (“the catheter assembly 104 can be provided with a mechanism, such as a spring, elastic, or bellows, to provide a driving force to axially shift the seal member 132 back in the proximal direction, so as to shift the seal member 132 to the closed position. In one embodiment, the mechanism configured to provide a driving force to axially shift the seal member 132 back in the proximal direction can be integral to the seal.” [Page 21, lines 18-23]),
wherein a portion of an inner surface of the septum (actuator cavity 196) forming the distal cavity is smooth (Figure 6A), wherein the portion is distal to the barrier (membrane 180; Figure 6A), wherein the portion is aligned with a distal end of the annular lip when the septum is disposed in the proximal position, wherein the portion is radially spaced apart from the distal end of the annular lip when the septum is disposed in the proximal position such that the distal end of the annular lip does not contact of the portion of the inner surface of the septum (Figure 7, showing distal end of flange 168 radially spaced from and does not contact the walls of actuator cavity 196 and the seal 132 in its proximal position distal of the membrane 180),
an inner surface of the septum forming the distal cavity comprises a protrusion (narrowed portion 198) forming a point (Figure 6A and 7), wherein the annular lip further comprises a proximal end opposite the distal end of the annular lip and forming a proximal-most surface of the septum actuator (at fold: “the flange 168 can be formed by bending or folding a portion of the wall 158 at more than a 90° angle, such that in some embodiments a portion of the wall 158 is folded back upon itself.” [Page 17, lines 18-20]), wherein the proximal-most surface is aligned with (Figures 7 and 8A, aligned along the longitudinal axis) and directly contacts the point of the protrusion when the septum is disposed in the proximal position (Figures 7 and 8A, wherein the folded proximal-most surface of the flange 168 is in contact with the point of the narrowed portion 198. Additionally, one having ordinary skill in the art would recognize that changing the position at which the annular lip contacts the protrusion would be yield the same predictable results of maintaining the septum in position (Gursel [Page 20, lines 3-15]); and the present application does not disclose any criticality for the location at which the protrusion contacts the annular lip), wherein the annular lip (flange 168) is configured to pass the protrusion (narrowed portion 198) in response to the septum being moved from the proximal position to the distal position (Figures 8A-8C).
Gursel fails to explicitly teach the spring disposed within the lumen distal to the septum.
Goral discloses a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200 between proximal end 77 and outlet bore 86) disposed within a lumen of the catheter adapter (Figure 14), wherein the septum is configured to move from a proximal position (Figure 14) to a distal position (Figure 15) in response to insertion of a medical device (luer taper 30) into the proximal end of the catheter adapter (“the seal member 200 may be configured such that it is axially shiftable so as to slide axially along the main shaft 46 of the actuator 16 to the opened position. That shifting is accomplished by insertion of male luer taper 30 into and through the proximal end 20 of the catheter hub 12 such that the free or distal end 120 thereof impacts surface proximal end 77 of the seal member 200 and pushes the seal member 200 distally with enough force to overcome the friction forces holding the seal member 200 in place.” [Col 18, lines 49-57]); a septum actuator (actuator 16) configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position (Figure 15; “As the seal member 200 axially shifts within the catheter hub 12, the proximal free end 51 of the actuator 16 contacts the lower surface 80 of the membrane 72 and starts penetrating through the slit 82 causing the flaps 84 formed by the slit 82 to hinge or distend upwardly and slide along the barb 50, such as along the frustoconical surface 57 thereof, so as to gradually open the slit 82” [Col 18, line 65 – Col 19, line 4]); and a spring (biasing member 204 of seal member 200) disposed within the lumen distal to the septum (Figures 13-17), wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter (“when the male luer taper 30 is removed from the catheter hub 12, the biasing force generated by the compression of the tubular extension member 206 causes the seal member 200 to axially shift in the proximal direction.” [Col 19, lines 39-42]; “Due to biasing member 204, the seal member 200 is configured to be repeatedly moved between its opened and closed positions therefore providing the multi-use aspect of this design.” [Col 20, lines 2-5]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter assembly of Gursel to include the spring disposed within the lumen distal to the septum and configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 8, modified Gursel teaches the catheter assembly of claim 1, wherein the annular lip (flange 168) comprises a generally truncated cone shape (Figure 5).
Regarding claim 9, modified Gursel teaches the catheter assembly of claim 1, wherein an inner surface of the septum forming the distal cavity comprises a protrusion (narrowed portion 198), wherein the annular lip (flange 168) is configured to pass the protrusion in response to the septum being moved from the proximal position to the distal position (Figures 8A-8C).
Regarding claim 19, Gursel discloses a catheter assembly (catheter assembly 104), comprising:
a catheter adapter (catheter hub 122), comprising a distal end (distal end 140), a proximal end (proximal end 142), and a lumen (interior cavity 146) extending through the distal end and the proximal end (Figure 4B);
a catheter (catheter tube 124) extending distally from the distal end of the catheter adapter (Figure 4B);
a septum (seal member 132) disposed within the lumen (Figure 4B; “The seal member 132, alternatively referred to as a blood control valve 132, can also be secured within the interior cavity 146 of the catheter hub 122” [Page 17, lines 1-3]), wherein the septum comprises a distal end (distal end 172), a proximal end (proximal end 174), and a barrier (membrane 180) disposed between the distal end of the septum and the proximal end of the septum (Figure 6A), wherein the barrier divides an interior of the septum (interior cavity 178) into a distal cavity (distal portion 182) and a proximal cavity (proximal portion 184), wherein the distal cavity comprises a first wall and a second wall (left and right walls forming actuator cavity 196) generally parallel to the first wall (Figure 6A), wherein the first wall and the second wall are smooth and generally parallel to a longitudinal axis of the catheter assembly (Figure 6A), wherein the barrier comprises a slit (slit 186), wherein the septum is configured to move from a proximal position (Figure 8A) to a distal position (Figure 8C) in response to insertion of a medical device (luer taper 200) into the proximal end of the catheter adapter (“As depicted in FIGS. 8B-C, upon insertion of a luer taper 200, the seal member 132 can be shifted distally relative to the actuator 130, so as to cause the flange 168 to push against the membrane 180, thereby causing the slit 186 of the membrane 180 to at least partially open.” [Page 20, lines 16-19]);
a septum actuator (actuator 130) fixed within the lumen (Figure 4B; “the distal portion 164 of the actuator 130 can be frictionally fit within the proximal end 134 of the catheter tube 124, which can be frictionally fit within the interior cavity 146 of the catheter hub 122, such that, the catheter tube 124 extends distally from the distal end 140 of the catheter hub 122” [Col 17, lines 21-24]), wherein the septum actuator comprises a cylindrical tubular body (cylindrical body 152) and an annular lip (flange 168), wherein the annular lip is disposed at a proximal end (proximal end 156) of the septum actuator (Figure 5), wherein the septum actuator is configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position (“As the seal member 132 axially shifts within the catheter hub 122, the proximal portion 166 of the actuator 130 contacts the membrane 180 and starts penetrating through the slit 186,… so as to gradually open the slit 186. Continued distal insertion of the luer taper 200 causes the seal member 132 to shift axially until the luer taper 200 is fully extended into the interior cavity 146 of the catheter hub 122, with the distal end 172 of the seal member 132 moved forward, or against a distal portion 150 of the interior cavity 146, thereby defining the open position of the seal member 132 (as depicted in FIG. 8C).” [Page 20, lines 25-32]); and
a spring (“the catheter assembly 104 can be provided with a mechanism, such as a spring, elastic, or bellows, to provide a driving force to axially shift the seal member 132 back in the proximal direction, so as to shift the seal member 132 to the closed position. In one embodiment, the mechanism configured to provide a driving force to axially shift the seal member 132 back in the proximal direction can be integral to the seal.” [Page 21, lines 18-23]), wherein when the medical device (luer taper 200) is maximally inserted into the proximal end of the catheter adapter (Figure 8C), the annular lip (flange 168) penetrates the slit (slit 186) but does not bypass the barrier (membrane 180), such that the annular lip remains in contact with the barrier when the septum is in the distal position (“Continued distal insertion of the luer taper 200 causes the seal member 132 to shift axially until the luer taper 200 is fully extended into the interior cavity 146 of the catheter hub 122, with the distal end 172 of the seal member 132 moved forward, or against a distal portion 150 of the interior cavity 146, thereby defining the open position of the seal member 132 (as depicted in FIG. 8C). When the seal member 132 is in the open position, an unobstructed fluid path is established between the catheter tube 124 and the luer taper 200 via the actuator 130” [Page 20, line 29 – Page 21, line 3]; Figure 8C showing the flange 168 in contact with membrane 180 in the distal position), wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter (“the catheter assembly 104 can be provided with a mechanism, such as a spring, elastic, or bellows, to provide a driving force to axially shift the seal member 132 back in the proximal direction, so as to shift the seal member 132 to the closed position.” [Page 21, lines 18-21]), wherein the first wall and the second wall are aligned with and radially spaced apart from a distal end of the annular lip when the septum is disposed in the proximal position such that the distal end of the annular lip does not contact of the portion of the inner surface of the septum (Figure 7, showing distal end of flange 168 radially spaced from and does not contact the walls of actuator cavity 196 and the seal 132 in its proximal position distal of the membrane 180),
an inner surface of the septum forming the distal cavity comprises a protrusion (narrowed portion 198) forming a point (Figure 6A and 7), wherein the annular lip further comprises a proximal end opposite the distal end of the annular lip and forming a proximal-most surface of the septum actuator (at fold: “the flange 168 can be formed by bending or folding a portion of the wall 158 at more than a 90° angle, such that in some embodiments a portion of the wall 158 is folded back upon itself.” [Page 17, lines 18-20]), wherein the proximal-most surface is aligned with (Figures 7 and 8A, aligned along the longitudinal axis) and directly contacts the point of the protrusion when the septum is disposed in the proximal position (Figures 7 and 8A, wherein the folded proximal-most surface of the flange 168 is in contact with the point of the narrowed portion 198. Additionally, one having ordinary skill in the art would recognize that changing the position at which the annular lip contacts the protrusion would be yield the same predictable results of maintaining the septum in position (Gursel [Page 20, lines 3-15]); and the present application does not disclose any criticality for the location at which the protrusion contacts the annular lip), wherein the annular lip (flange 168) is configured to pass the protrusion (narrowed portion 198) in response to the septum being moved from the proximal position to the distal position (Figures 8A-8C).
Gursel fails to explicitly teach the spring disposed within the lumen distal to the septum.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200) configured to move from a proximal position (Figure 14) to a distal position (Figure 15) in response to insertion of a medical device (luer taper 30) into the proximal end of the catheter adapter (“the seal member 200 may be configured such that it is axially shiftable so as to slide axially along the main shaft 46 of the actuator 16 to the opened position. That shifting is accomplished by insertion of male luer taper 30 into and through the proximal end 20 of the catheter hub 12 such that the free or distal end 120 thereof impacts surface proximal end 77 of the seal member 200 and pushes the seal member 200 distally with enough force to overcome the friction forces holding the seal member 200 in place.” [Col 18, lines 49-57]); a septum actuator (actuator 16) configured to penetrate the slit in response to movement of the septum from the proximal position to the distal position (Figures 14-15); and a spring (biasing member 204 of seal member 200) disposed within the lumen distal to the septum (Figures 13-17), wherein the spring is configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter (“when the male luer taper 30 is removed from the catheter hub 12, the biasing force generated by the compression of the tubular extension member 206 causes the seal member 200 to axially shift in the proximal direction.” [Col 19, lines 39-42]; “Due to biasing member 204, the seal member 200 is configured to be repeatedly moved between its opened and closed positions therefore providing the multi-use aspect of this design.” [Col 20, lines 2-5]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter assembly of Gursel to include the spring disposed within the lumen distal to the septum and configured to return the septum from the distal position to the proximal position in response to removal of the medical device from the proximal end of the catheter adapter based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 25, modified Gursel teaches the catheter assembly of claim 19.
Modified Gursel fails to explicitly teach the spring surrounds the septum actuator.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200) surrounding the septum actuator (Figures 14-15).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter assembly of Gursel to include the spring surrounds the septum actuator based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 26, modified Gursel teaches the catheter assembly of claim 19.
Modified Gursel fails to explicitly teach the spring and the septum are constructed of an elastomer.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are constructed of an elastomer (“the seal member 200 may be generally flexible and be formed from suitable materials including, for example, silicone or polyisoprene.” [Col 18, lines 37-39]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are constructed of an elastomer based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 27, modified Gursel teaches the catheter assembly of claim 19.
Modified Gursel fails to explicitly teach the spring and the septum are constructed of silicon.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are constructed of silicon (“the seal member 200 may be generally flexible and be formed from suitable materials including, for example, silicone” [Col 18, lines 37-39], wherein silicone is formed of silicon).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are constructed of silicon based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 28, modified Gursel teaches the catheter assembly of claim 19.
Modified Gursel fails to explicitly teach the spring and the septum are monolithically formed as a single unit.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are monolithically formed as a single unit (Figures 13-17; “the biasing member 204 may include a generally thin-walled, circumferentially continuous tubular extension member 206 defining an open passageway 208 and integrally formed with proximal portion 202 so that seal member 200 forms a unitary member.” [Col 18, lines 32-36]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are monolithically formed as a single unit based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 29, modified Gursel teaches the catheter assembly of claim 19, wherein an outer surface of the tubular body (wall 158) is smooth (Figure 5).
Regarding claim 30, modified Gursel teaches the catheter assembly of claim 19, wherein the annular lip (flange 168) comprises a generally truncated cone shape (Figure 5).
Regarding claim 32, modified Gursel teaches the catheter assembly of claim 19, wherein a portion of an inner surface of the septum forming the distal cavity (actuator cavity 196) is smooth (Figure 6A), wherein the portion is distal to the barrier (membrane 180; Figure 6A), wherein the portion is aligned with or proximal to the annular lip (flange 168) when the septum is disposed in the proximal position (Figure 7, showing distal end of flange 168 radially spaced from the walls of actuator cavity 196).
Regarding claim 35, modified Gursel teaches the catheter assembly of claim 1.
Modified Gursel fails to explicitly teach the spring surrounds the septum actuator.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200) surrounding the septum actuator (Figures 14-15).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the catheter assembly of Gursel to include the spring surrounds the septum actuator based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 36, modified Gursel teaches the catheter assembly of claim 1.
Modified Gursel fails to explicitly teach the spring and the septum are constructed of an elastomer.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are constructed of an elastomer (“the seal member 200 may be generally flexible and be formed from suitable materials including, for example, silicone or polyisoprene.” [Col 18, lines 37-39]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are constructed of an elastomer based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 37, modified Gursel teaches the catheter assembly of claim 1.
Modified Gursel fails to explicitly teach the spring and the septum are constructed of silicon.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are constructed of silicon (“the seal member 200 may be generally flexible and be formed from suitable materials including, for example, silicone” [Col 18, lines 37-39], wherein silicone is formed of silicon).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are constructed of silicon based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Regarding claim 38, modified Gursel teaches the catheter assembly of claim 1.
Modified Gursel fails to explicitly teach the spring and the septum are monolithically formed as a single unit.
Goral teaches a catheter assembly (catheter assembly 10; Figures 13-17), comprising: a catheter adapter (catheter hub 12); a catheter (catheter tube 14); a septum (proximal portion 202 of seal member 200); a septum actuator (actuator 16); and a spring (biasing member 204 of seal member 200); wherein the spring and the septum are monolithically formed as a single unit (Figures 13-17; “the biasing member 204 may include a generally thin-walled, circumferentially continuous tubular extension member 206 defining an open passageway 208 and integrally formed with proximal portion 202 so that seal member 200 forms a unitary member.” [Col 18, lines 32-36]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the catheter assembly of Gursel to include the spring and the septum are monolithically formed as a single unit based on the teachings of Goral to force the septum into the proximal position to seal the catheter assembly and allowing the septum to be repeatedly opened and closed to therefore allow the catheter assembly to be used repeatedly (Goral [Col 4, lines 18-31]).
Claims 21 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Gursel et al. (WO 2019152630) in view of Goral et al. (USPN 8652104) as applied to claims 1 and 19 above, and further in view of Doyle (USPN 7044441).
Regarding claim 21, modified Gursel teaches the catheter assembly of claim 1.
Modified Gursel fails to explicitly teach the spring comprises a metal coil, wherein the metal coil further comprises a proximal end coupled to the distal end of the septum.
Doyle teaches a fluid connector assembly (Figure 11) comprising: an adapter (Figure 11 having rear end 53); a catheter (tubular distal end of male luer 10; Figure 1 for example); a septum (bladder member 56) configured to move from a proximal position (Figure 11, and Figure 9, for example) to a distal position (Figure 10, for example); a septum actuator (inner support 54); and a spring (spring member 68) comprising a metal coil (“The spring member 68 can any type as for example, those made of metal” [Col 8, line 5]), wherein the metal coil further comprises a proximal end coupled to the distal end of the septum (Figure 11, showing proximal end of spring member 68 coupled to/in contact with the distal end of bladder member 56).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the spring of the catheter assembly of Gursel as modified by Goral to comprise a metal coil having a proximal end coupled to the distal end of the septum based on the teachings of Doyle to provide the necessary structure and force to bias the septum to the proximal position when a medical device is not attached to prevent fluid leakage (Doyle [Col 7, line 44 – Col 8, line 8]).
Regarding claims 33-34, modified Gursel teaches the catheter assembly of claim 19.
Modified Gursel fails to explicitly teach the spring comprises a coil, wherein the coil surrounds the septum actuator, wherein the coil comprises a helical shape or a plurality of waves, as required by claim 33; and wherein the coil is constructed of metal, as required by claim 34.
Doyle teaches a fluid connector assembly (Figure 11) comprising: an adapter (Figure 11 having rear end 53); a catheter (tubular distal end of male luer 10; Figure 1 for example); a septum (bladder member 56) configured to move from a proximal position (Figure 11, and Figure 9, for example) to a distal position (Figure 10, for example); a septum actuator (inner support 54); and a spring (spring member 68) comprising a coil (Figure 11; “The spring member 68 can any type as for example, those made of metal” [Col 8, line 5]), wherein the coil surrounds the septum actuator (Figure 11), wherein the coil comprises a helical shape (Figure 11) or a plurality of waves, wherein the coil is constructed of metal (“The spring member 68 can any type as for example, those made of metal” [Col 8, line 5]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the spring of the catheter assembly of Gursel as modified by Goral to comprise a metal coil surrounding the septum actuator and comprising a helical shape based on the teachings of Doyle to provide the necessary structure and force to bias the septum to the proximal position when a medical device is not attached to prevent fluid leakage (Doyle [Col 7, line 44 – Col 8, line 8]).
Response to Arguments
Applicant's arguments filed November 12, 2025 have been fully considered but they are not persuasive.
Regarding the argument that the prior art of record fails to teach or suggest the limitations of the amendments to independent claims 1 and 19 (Remarks, page 1-2), the examiner respectfully disagrees. As detailed above, Gursel et al. (WO 2019152630) discloses an inner surface of the septum (132) forming the distal cavity (182) comprises a protrusion (198) forming a point (Figure 6A and 7), wherein the annular lip (168) further comprises a proximal end opposite the distal end of the annular lip and forming a proximal-most surface of the septum actuator (at fold: “the flange 168 can be formed by bending or folding a portion of the wall 158 at more than a 90° angle, such that in some embodiments a portion of the wall 158 is folded back upon itself.” [Page 17, lines 18-20]), wherein the proximal-most surface is aligned with (Figures 7 and 8A, aligned along the longitudinal axis) and directly contacts the point of the protrusion when the septum is disposed in the proximal position (Figures 7 and 8A, wherein the folded proximal-most surface of the flange 168 is in contact with the point of the narrowed portion 198), wherein the annular lip (168) is configured to pass the protrusion (198) in response to the septum being moved from the proximal position to the distal position (Figures 8A-8C). Additionally, one having ordinary skill in the art would recognize that changing the position at which the annular lip contacts the protrusion would be yield the same predictable results of maintaining the septum in position (Gursel [Page 20, lines 3-15]); and the present application does not disclose any criticality for the location at which the protrusion contacts the annular lip.
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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783