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
This Office Action is in response to the Applicant’s amendment filed 26 February 2026 wherein Claims 1, 7, 9, 10, 15, 17, and 18 are amended, Claims 6 and 11 are cancelled,
Claim 21 is newly added, and Claims 17 – 20 are previously withdrawn. Therefore Claims 1 – 5, 7 – 10, and 12 – 21 are currently pending wherein Claims 17 – 20 are withdrawn therefrom.
The Applicant’s amendments to the Drawings dated 26 February 2026 has overcome each Drawing Objection set forth in the Non-Final Rejection dated 4 December 2025 (hereinafter referred to as the “Non-Final Rejection”). Therefore, each Drawing Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendment to the Specification dated 26 February 2026 has overcome each Specification Objection set forth in the Non-Final Rejection. Therefore, each Specification Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 26 February 2026 has overcome each Claim Objection set forth in the Non-Final Rejection. Therefore, each Claim Objection set forth in the Non-Final Rejection is withdrawn.
The Applicant’s amendments to the Claims dated 26 February 2026 has overcome each Claim Rejection set forth under 35 U.S.C. § 112(b) in the Non-Final Rejection. Therefore, each Claim Rejection set forth under 35 U.S.C. § 112(b) in the Non-Final Rejection is withdrawn.
Response to Arguments
Applicant’s arguments, see pages 12 – 15, filed 26 February 2026, with respect to the rejection(s) of independent Claim 1 and its dependent claims under 35 U.S.C. §§ 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bierman (US 5,800,402 A) and Balbierz (US 5,814,021 A).
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 1 recites “each of the top end and the bottom end of the anchor body having an outer surface forming a convex surface along the longitudinal axis...”. Claim 5 recites “The medical fluid extension set system of Claim 1,…an outer surface of the tubing anchor.” Claim 5 is objected to because it cannot be determined if the “an outer surface” is the same “outer surface” recited in Claim 1. The Examiner suggests amending Claim 5 to recite “The medical fluid extension set system of Claim 1,…[[an]] the outer surface of the tubing anchor” to provide the proper antecedent basis for the claim language of Claim 5.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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, 3 – 5, 7 – 10, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman (US 5,800,402 A) and Balbierz (US 5,814,021 A).
Bierman and Balbierz are cited in the Notice of References Cited form dated 4 December 2025.
With regards to claim 1, Bierman discloses (see Figs. 1 – 9) a medical fluid extension set system (10) (see Col. 4, lines 40 – 50) comprising:
a tubing (40) (see Col. 6, lines 11 – 25) having a first end (see the end of the tubing 40 connected with the connector 42 shown in Fig. 2) and a second end (see the end of the tubing 40 connected to the catheter adapter 32 shown in Fig. 2);
a fluid coupling device (42) (see Col. 6, lines 11 – 25) coupled to the first end of the tubing (see Fig. 2); and
a tubing anchor (34) (see Col. 5, lines 38 – 48 and Col. 9, lines 8 – 18) the tubing anchor coupled to the tubing (see Fig. 2), between the first and second ends of the tubing (see Fig. 2).
However Bierman is silent with regards to the tubing anchor comprising an anchor body having a first end, a second end, a first sidewall, a second sidewall, a top end, a bottom end, and a tubing passage extending through the first and second ends of the tubing anchor and defining a longitudinal axis of the anchor body, each of the top end and the bottom end of the anchor body having an outer surface forming a convex surface along the longitudinal axis and between the first sidewall and the second sidewall, the tubing anchor coupled to the tubing, between the first and second ends of the tubing, with the tubing extending through the tubing passage.
Nonetheless Balbierz, which is within the analogous art of adjustable securing wings for tubing (see abstract and title), teaches the tubing anchor (110) (see Col. 4, lines 17 – 40) comprising an anchor body (see at 110 in Fig. 2) having a first end, a second end, a first sidewall, a second sidewall, a top end, a bottom end, and a tubing passage extending through the first and second ends of the tubing anchor and defining a longitudinal axis of the anchor body (see Examiner annotated Fig. 2 below hereinafter referred to as “Fig. A” and see Examiner annotated Fig. 7 below hereinafter referred to as “Fig. B”), each of the top end and the bottom end of the anchor body having an outer surface forming a convex surface along the longitudinal axis and between the first sidewall and the second sidewall (see Fig. B below at 110 and 140 which shows the top end and bottom end of the anchor body having an outer surface forming a convex surface along the longitudinal axis and between the first and second sidewalls), the tubing anchor coupled to the tubing (see Figs. 3, 5, and 7), between the first and second ends of the tubing (see Fig. 2 where the first end is near 120 and the second end is near 100), with the tubing extending through the tubing passage (see Fig. B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to either replace the tubing anchor 34 or modify the shape of the tubing anchor 34 of the medical fluid extension set system of Bierman in view of a teaching of Balbierz such that the tubing anchor comprising an anchor body having a first end, a second end, a first sidewall, a second sidewall, a top end, a bottom end, and a tubing passage extending through the first and second ends of the tubing anchor and defining a longitudinal axis of the anchor body, each of the top end and the bottom end of the anchor body having an outer surface forming a convex surface along the longitudinal axis and between the first sidewall and the second sidewall, the tubing anchor coupled to the tubing, between the first and second ends of the tubing, with the tubing extending through the tubing passage.
One of ordinary skill in the art would have been motivated to make this modification or replacement because Balbierz teaches this anchor device is sized to retain tubing such that it maintains its position on the body (see Col. 1, lines 31 – 50, Col. 2, lines 44 – 55, and Col. 4, lines 17 – 41 of Balbierz). Further the tubing anchor of Balbierz is beneficial because it fully encompasses the tubing while the tubing clip/tubing anchor of Bierman does not. As the tubing anchor of Balbierz fully surrounds the tubing it prevents any inadvertent removal of the tubing from the anchor and therefore the body of the patient. Finally, the tubing anchor of Balbierz is more stable than the tubing clip/tubing anchor of Bierman because it comprises wings that prevent the rotation of the tubing anchor upon movement of the tubing.
The medical fluid extension set system of Bierman modified in view of a teaching of Balbierz will hereinafter be referred to as the medical fluid extension set system of Bierman and Balbierz.
With regards to claim 3, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, and Bierman further teaches the medical fluid extension set system further comprising a catheter (12) (see Col. 4, lines 40 – 50) coupled to the second end of the tubing (see Fig. 2 and Col. 6, lines 11 – 24).
With regards to claim 4, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, the medical fluid extension set system of Bierman and Balbierz further teaches wherein the tubing anchor is coupled to the tubing such that movement of the tubing anchor along a length of the tubing between the first and second ends of the tubing is resisted (see Col. 9, lines 6 – 44 and Fig. 2 of Bierman and Col. 2, lines 13 – 29, Col. 4, lines 17 – 41, and Col. 6, lines 9 – 14 of Balbierz which teaches the tubing anchor 110 securing the tubing 100 to the patient).
With regards to claim 5, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, and Bierman further teaches the medical fluid extension set system further comprising an adhesive layer (28) (see Col. 9, lines 19 – 31) that extends along an outer surface of the tubing anchor (34) (see Col. 9, lines 19 – 31) (here the tubing anchor of the medical fluid extension set system of Bierman and Balbierz would be coupled to the adhesive layer 28 along an outer surface of the tubing anchor).
With regards to claim 7, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, however, Bierman is silent with regards to wherein the tubing anchor comprises a width between the first and second sidewalls, and wherein the width of the tubing anchor decreases in a direction from the first end of the tubing anchor toward the second end of the tubing anchor.
Nonetheless Balbierz, which is within the analogous art of adjustable securing wings for tubing (see abstract and title), further teaches the tubing anchor (110) (see Col. 4, lines 17 – 40) comprises a width between the first and second sidewalls (see Fig. A above and the width between the annotated first and second sidewalls), and wherein the width of the tubing anchor decreases in a direction from the first end of the tubing anchor toward the second end of the tubing anchor (see Fig. A above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the tubing anchor of the medical fluid extension set system of Bierman and Balbierz in view of a further teaching of Balbierz such that the tubing anchor comprises a width between the first and second sidewalls, and wherein the width of the tubing anchor decreases in a direction from the first end of the tubing anchor toward the second end of the tubing anchor. One of ordinary skill in the art would have been motivated to make this modification because Balbierz teaches this anchor device is sized to retain tubing such that it maintains its position on the body (see Col. 1, lines 31 – 50, Col. 2, lines 44 – 55, and Col. 4, lines 17 – 41 of Balbierz). Further the tubing anchor of Balbierz is beneficial because it fully encompasses the tubing while the tubing clip/tubing anchor of Bierman is not. As the tubing anchor of Balbierz fully surrounds the tubing it prevents any inadvertent removal of the tubing from the anchor and therefore the body of the patient. Finally, the tubing anchor of Balbierz is more stable than the tubing clip/tubing anchor of Bierman because it comprises wings that prevent the rotation of the tubing anchor upon movement of the tubing.
With regards to claim 8, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 7, and, Bierman further teaches is wherein the tubing (40) extends through the tubing anchor (34) such that the second end of the tubing anchor is oriented toward the fluid coupling device (42) (see Fig. 2 where the fluid communication from the second end of the tubing to the first end of the tubing is oriented toward the fluid coupling device 42).
With regards to claim 9, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, however, Bierman is silent with regards to wherein the first sidewall comprises a front portion and a rear portion, and the front and rear portions of the first sidewall extend away from the longitudinal axis and intersect at an apex of the first sidewall, and wherein the second sidewall comprises a front portion and a rear portion, and the front and rear portions of the second sidewall extend away from the longitudinal axis and intersect at an apex of the second sidewall.
Nonetheless Balbierz, which is within the analogous art of adjustable securing wings (see abstract), further teaches (Figs. 1 – 7) the first sidewall comprises a front portion and a rear portion (see Fig. A above), and the front and rear portions of the first sidewall extend away from the longitudinal axis and intersect at an apex of the first sidewall (see Fig. A above where the apex of the first sidewall is at the annotated “First sidewall”), and wherein the second sidewall comprises a front portion and a rear portion (see Fig. A above), and the front and rear portions of the second sidewall extend away from the longitudinal axis and intersect at an apex of the second sidewall (see Fig. A above where the apex of the first sidewall is at the annotated “Second sidewall”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the tubing anchor of the medical fluid extension set system of Bierman and Balbierz in view of a further teaching of Balbierz such that the first sidewall comprises a front portion and a rear portion, and the front and rear portions of the first sidewall extend away from the longitudinal axis and intersect at an apex of the first sidewall, and wherein the second sidewall comprises a front portion and a rear portion, and the front and rear portions of the second sidewall extend away from the longitudinal axis and intersect at an apex of the second sidewall. One of ordinary skill in the art would have been motivated to make this modification because Balbierz teaches this anchor device is sized to retain tubing such that it maintains its position on the body (see Col. 1, lines 31 – 50, Col. 2, lines 44 – 55, and Col. 4, lines 17 – 41 of Balbierz). Further the tubing anchor of Balbierz is beneficial because it fully encompasses the tubing while the tubing clip/tubing anchor of Bierman is not. As the tubing anchor of Balbierz fully surrounds the tubing it prevents any inadvertent removal of the tubing from the anchor and therefore the body of the patient. Finally, the tubing anchor of Balbierz is more stable than the tubing clip/tubing anchor of Bierman because it comprises wings that prevent the rotation of the tubing anchor upon movement of the tubing.
With regards to claim 10, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 9, however, Bierman is silent with regards to wherein a width of the tubing anchor between the apices of the first and second sidewalls, is greater than a height of the tubing anchor between the top and bottom ends.
Nonetheless Balbierz, which is within the analogous art of adjustable securing wings (see abstract), further teaches (Figs. 1 – 7) wherein a width of the tubing anchor between the apices of the first and second sidewalls (see the width of the tubing anchor between the apices of the first and second sidewalls which are located at the annotated “First sidewall” and “Second sidewall” in Fig. A above), is greater than a height of the tubing anchor between the top and bottom ends (see Fig. B above which shows the width being less than a height of the tubing anchor between the top and bottom ends).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the width and height of the tubing anchor of the medical fluid extension set of Bierman and Balbierz in view of a further teaching of Balbierz such that a width of the tubing anchor between the apices of the first and second sidewalls, is greater than a height of the tubing anchor between the top and bottom ends. One of ordinary skill in the art would have been motivated to make this modification because Balbierz teaches this anchor device is sized to retain tubing such that it maintains its position on the body (see Col. 1, lines 31 – 50, Col. 2, lines 44 – 55, and Col. 4, lines 17 – 41 of Balbierz). Further the tubing anchor of Balbierz is beneficial because it fully encompasses the tubing while the tubing clip/tubing anchor of Bierman is not. As the tubing anchor of Balbierz fully surrounds the tubing it prevents any inadvertent removal of the tubing from the anchor and therefore the body of the patient. Finally, the tubing anchor of Balbierz is more stable than the tubing clip/tubing anchor of Bierman because it comprises wings that prevent the rotation of the tubing anchor upon movement of the tubing.
With regards to claim 21, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 9, however, Bierman is silent with regards to wherein a portion of the anchor body proximal to an apex of the first sidewall or the second sidewall comprises a height that is less than a height of the anchor body along the longitudinal axis.
Nonetheless Balbierz, which is within the analogous art of adjustable securing wings (see abstract), further teaches (Figs. 1 – 7) wherein a portion of the anchor body (110) proximal to an apex of the first sidewall (see the apex of the first sidewall at the annotated “First sidewall” in Fig. A above) or the second sidewall (see the apex of the second sidewall at the annotated “Second sidewall” in Fig. A above) comprises a height that is less than a height of the anchor body along the longitudinal axis (see Fig. B above which shows the height at the apex of either the first or second sidewall being less than a height of the anchor body along the longitudinal axis).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the height of the anchor body along the apex of the first or second sidewall of the tubing anchor of the medical fluid extension set of Bierman and Balbierz in view of a further teaching of Balbierz such that a portion of the anchor body proximal to an apex of the first sidewall or the second sidewall comprises a height that is less than a height of the anchor body along the longitudinal axis. One of ordinary skill in the art would have been motivated to make this modification because Balbierz teaches this anchor device is sized to retain tubing such that it maintains its position on the body (see Col. 1, lines 31 – 50, Col. 2, lines 44 – 55, and Col. 4, lines 17 – 41 of Balbierz). Further the tubing anchor of Balbierz is beneficial because it fully encompasses the tubing while the tubing clip/tubing anchor of Bierman is not. As the tubing anchor of Balbierz fully surrounds the tubing it prevents any inadvertent removal of the tubing from the anchor and therefore the body of the patient. Finally, the tubing anchor of Balbierz is more stable than the tubing clip/tubing anchor of Bierman because it comprises wings that prevent the rotation of the tubing anchor upon movement of the tubing.
Claim(s) 2, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman and Balbierz as applied to claim 1 above, and further in view of Kakinoki (US 2019/0184152 A1).
Kakinoki is cited in the Notice of References Cited form dated 4 December 2025.
With regards to claim 2, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, however, Bierman is silent with regards to wherein the fluid coupling device comprising a first valve assembly and a second valve assembly, and wherein the first and second valve assemblies are removably coupled together to form a fluid flow path through the tubing and the fluid coupling device.
Nonetheless Kakinoki, which is within the analogous art of male and female connectors for medical devices (see abstract), teaches (Figs. 1 – 8) the fluid coupling device (1a, 2a) (see [0037]) comprising a first valve assembly (1a) and a second valve assembly (2a), and wherein the first and second valve assemblies are removably coupled together to form a fluid flow path through the tubing and the fluid coupling device (see Figs. 4 – 5, [0024] – [0025], and [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to replace the fluid coupling device of the medical fluid extension set system of Bierman and Balbierz in view of a teaching of Kakinoki such that the fluid coupling device comprises a first valve assembly and a second valve assembly, and wherein the first and second valve assemblies are removably coupled together to form a fluid flow path through the tubing and the fluid coupling device. One of ordinary skill in the art would have been motivated to make this modification because Kakinoki teaches that this fluid coupling device allows for the attaching and detaching of the male connector or female connector to form a route (infusion line) while simultaneously protecting a medical operator from a powerful drug such as an anticancer agent from adhering to a finger and the like of the medical operator (see [0003] and [0004] of Kakinoki). In other words, the fluid connector of Kakinoki is beneficial because it protects a medical operator from spilling dangerous medicament when attaching or detaching an IV drip bag with the extension set.
With regards to claim 15, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, however, Bierman is silent with regards to wherein the fluid coupling device comprises:
a first valve assembly comprising:
a housing having a first end, a second end, wherein the second end of the housing is opposite to the first end of the housing, and an inner surface forming a cavity that extends through the second end of the housing toward the first end of the housing;
a post having a proximal end portion and a distal end portion, wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing;
a fluid passage that extends through the first end of the housing and the post; and
a compressible valve positioned in the cavity, the compressible valve having a proximal end portion and a distal end portion, wherein the proximal end portion comprises a resilient member having an inner surface forming a recess, and wherein the distal end portion comprises a head having a slit that extends through the head to the recess;
a second valve assembly comprising:
a body having a first end, a second end, wherein the second end of the body is opposite to the first end of the body, an inner surface forming a bore that extends through the second end of the body toward the first end of the body, and a fluid passage that extends through the first end of the body to the bore; and
a valve plug positioned in the bore, the valve plug having a first end, a second end, and a slit that extends through the first and second ends of the valve plug.
Nonetheless, Kakinoki which is within the analogous art of male and female connectors for medical devices (see abstract), teaches (Figs. 1 – 8) the fluid coupling device (1a, 2a) (see [0037]) comprises:
a first valve assembly (1a) comprising:
a housing (10a) (see [0042]) having a first end (see at 43 in Fig. 2), a second end (19a) (see [0044]), wherein the second end of the housing is opposite to the first end of the housing (see Fig. 2), and an inner surface forming a cavity (11) (see [0038]) that extends through the second end of the housing toward the first end of the housing (see Fig. 2);
a post (46) (see [0048]) having a proximal end portion (see near 41 in Fig. 2) and a distal end portion (44) (see [0048]), wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing (see Fig. 2);
a fluid passage (41) (see [0040]) that extends through the first end of the housing and the post (see Fig. 2); and
a compressible valve (50a) (see [0038] and [0050]) positioned in the cavity (see Fig. 2), the compressible valve having a proximal end portion (see at 56 in Fig. 2) and a distal end portion (see at 57 in Fig. 2), wherein the proximal end portion comprises a resilient member (56) (see [0050]) having an inner surface forming a recess (see at 56 in Fig. 2), and wherein the distal end portion comprises a head (57) (see [0050]) having a slit (51) (see [0050]) that extends through the head to the recess (see Fig. 2);
a second valve assembly (2a) comprising:
a body (60a) (see [0039]) having a first end (see the end near 66 in Fig. 2), a second end (see the end near 71 in Fig. 2), wherein the second end of the body is opposite to the first end of the body (see Fig. 2), an inner surface forming a bore (61) (see [0039]) that extends through the second end of the body toward the first end of the body, and a fluid passage (66) (see [0039]) that extends through the first end of the body to the bore (see Fig. 2); and
a valve plug (70) (see [0039]) positioned in the bore (see Fig. 2), the valve plug having a first end (see the end opposite 71 in Fig. 2), a second end (see at 71 in Fig. 2), and a slit (71) (see [0055]) that extends through the first and second ends of the valve plug (see Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to replace the fluid coupling device of the medical fluid extension set system of Bierman and Balbierz in view of a teaching of Kakinoki such that the fluid coupling device comprises: a first valve assembly comprising: a housing having a first end, a second end, wherein the second end of the housing is opposite to the first end of the housing, and an inner surface forming a cavity that extends through the second end of the housing toward the first end of the housing; a post having a proximal end portion and a distal end portion, wherein the distal end portion of the post extends within the cavity in a direction from the first end of the housing toward the second end of the housing; a fluid passage that extends through the first end of the housing and the post; and a compressible valve positioned in the cavity, the compressible valve having a proximal end portion and a distal end portion, wherein the proximal end portion comprises a resilient member having an inner surface forming a recess, and wherein the distal end portion comprises a head having a slit that extends through the head to the recess; a second valve assembly comprising: a body having a first end, a second end, wherein the second end of the body is opposite to the first end of the body, an inner surface forming a bore that extends through the second end of the body toward the first end of the body, and a fluid passage that extends through the first end of the body to the bore; and a valve plug positioned in the bore, the valve plug having a first end, a second end, and a slit that extends through the first and second ends of the valve plug.
One of ordinary skill in the art would have been motivated to make this modification because Kakinoki teaches that this fluid coupling device allows for the attaching and detaching of the male connector or female connector to form a route (infusion line) while simultaneously protecting a medical operator from a powerful drug such as an anticancer agent from adhering to a finger and the like of the medical operator (see [0003] and [0004] of Kakinoki). In other words, the fluid connector of Kakinoki is beneficial because it protects a medical operator from spilling dangerous medicament when attaching or detaching an IV drip bag with the extension set.
The medical fluid extension set system of Bierman and Baliberz modified in view of a teaching of Kakinoki will hereinafter be referred to as the medical fluid extension set system of Bierman, Balbierz, and Kakinoki.
With regards to claim 16, the medical fluid extension set system of Bierman, Balbierz, and Kakinoki teaches the claimed invention of claim 15 however Bierman is silent with regards to when the first and second valve assemblies are separated from each other, the compressible valve is in a first position with a distal end of the head aligned with the second end of the housing and the distal end portion of the post positioned within the recess, and when the first and second valve assemblies are coupled together, the second end of the body is positioned within the cavity of the housing such that the compressible valve is in a second position with the head biased toward the first end of the housing and the distal end portion of the post extending through the slit of the head of the compressible valve and through the slit of the valve plug, such that the fluid passage of the first valve assembly is fluidly coupled with the fluid passage of the second valve assembly.
Nonetheless, Kakinoki which is within the analogous art of male and female connectors for medical devices (see abstract), further teaches (Figs. 1 – 8) when the first and second valve assemblies (1a, 2a) are separated from each other (see Fig. 2), the compressible valve (50a) (see [0038] and [0050]) is in a first position with a distal end of the head (57) (see [0050]) aligned with the second end of the housing (19a) (see [0044]) and the distal end portion (44) (see [0048]) of the post (46) (see [0048]) positioned within the recess (see at 56 in Fig. 2), and when the first and second valve assemblies are coupled together (see Fig .4), the second end (see the end near 71 in Fig. 2) of the body (60a) (see [0039]) is positioned within the cavity (11) (see [0038]) of the housing such that the compressible valve is in a second position with the head biased toward the first end of the housing (see Fig. 5) and the distal end portion of the post extending through the slit of the head of the compressible valve and through the slit of the valve plug (see Fig. 5), such that the fluid passage of the first valve assembly is fluidly coupled with the fluid passage of the second valve assembly (see Fig. 5, [0025], [0059], and [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the fluid coupling device of the medical fluid extension set system of Bierman, Balbierz, and Kakinoki in view of a further teaching of Kakinoki such that when the first and second valve assemblies are separated from each other, the compressible valve is in a first position with a distal end of the head aligned with the second end of the housing and the distal end portion of the post positioned within the recess, and when the first and second valve assemblies are coupled together, the second end of the body is positioned within the cavity of the housing such that the compressible valve is in a second position with the head biased toward the first end of the housing and the distal end portion of the post extending through the slit of the head of the compressible valve and through the slit of the valve plug, such that the fluid passage of the first valve assembly is fluidly coupled with the fluid passage of the second valve assembly.
One of ordinary skill in the art would have been motivated to make this modification because Kakinoki teaches that this fluid coupling device allows for the attaching and detaching of the male connector or female connector to form a route (infusion line) while simultaneously protecting a medical operator from a powerful drug such as an anticancer agent from adhering to a finger and the like of the medical operator (see [0003] and [0004] of Kakinoki). In other words, the fluid connector of Kakinoki is beneficial because it protects a medical operator from spilling dangerous medicament when attaching or detaching an IV drip bag with the extension set.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman and Balbierz as applied to claim 1 above, and further in view of Burkholz et al. (US 2019/0321599 A1; hereinafter referred to as “Burkholz”).
Burkholz is cited in the Notice of References Cited form dated 4 December 2025.
With regards to claim 12, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, and Bierman further teaches wherein a fluid connector (44) (see Col. 6, lines 28 – 32) is coupled to the second end of the tubing (see the end of the tubing 40 connected to the catheter adapter 32 shown in Fig. 2).
However Bierman is silent with regards to a portion of the fluid connector is coupled to the tubing anchor.
Nonetheless Burkholz, which is within the analogous art of catheter systems (see abstract and title), teaches wherein a fluid connector (34) (see [0041]) is coupled to the second end (26) of the tubing (24) (see Fig. 1B and [0049]), and a portion of the fluid connector is coupled to the tubing anchor (54) (see Figs. 1D – 1H and [0055] “the stabilization feature 54 may be disposed on the connector 30 or the connector 34”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the location of the fluid connector and tubing anchor of the medical fluid extension set of Bierman and Balbierz in view of a teaching of Burkholz such that a portion of the fluid connector is coupled to the tubing anchor. One of ordinary skill in the art would have been motivated to make this modification because Burkholz teaches that this coupling stabilizes the fluid connector to the patient (see [0054] – [0055] of Burkholz).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman and Balbierz as applied to claim 1 above, and further in view of Fuchs (US 4,161,177 A).
Fuchs is cited in the Notice of References Cited form dated 4 December 2025.
With regards to claim 13, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, however Bierman is silent with regards to wherein the fluid coupling device is pivotably coupled to the tubing anchor.
Nonetheless Fuchs, which is within the analogous art of (see abstract and title), teaches (see Figs. 1 – 2) wherein the fluid coupling device (2) is pivotably coupled (3) (see Col. 3, lines 26 – 32) to the tubing anchor (7,7’).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the fluid coupling device of the medical fluid extension set system of Bierman and Balbierz in view of a teaching of Fuchs such that the fluid coupling device is pivotably coupled to the tubing anchor. One of ordinary skill in the art would have been motivated to make this modification because Fuchs teaches pivotably coupling the fluid coupling device and the tubing anchor together is beneficial because any forces applied to the fluid coupling device will not act immediately on the tubing or other components of the medical fluid extension set but only upon the fluid coupling device and the hinge (see Col. 2, lines 20 – 45 of Fuchs). Preventing the force from acting on the tubing or other components of the medical fluid extension set will reduce the likelihood of detachment of components.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman and Balbierz as applied to claim 1 above, and further in view of Eby (US 3,046,984 A).
Eby is cited in the Notice of References Cited form dated 4 December 2025.
With regards to claim 14, the medical fluid extension set system of Bierman and Balbierz teaches the claimed invention of claim 1, and Bierman further teaches (Figs. 1 – 9) the medical fluid extension set system further comprising another tubing (20) (see Col. 4, lines 51 – 65) having a first end coupled to the fluid coupling device (42) (see Col. 6, lines 11 – 24).
However Bierman is silent with regards to another tubing anchor coupled to the another tubing, wherein the fluid coupling device is fluidly coupled between the tubing anchor and the another tubing anchor.
Nonetheless Eby, which is within the analogous art of anchoring devices (see abstract), teaches another tubing anchor (4) coupled to the another tubing (see at 36, 38 in Fig. 1) (see Col. 2, lines 22 – 53), wherein the fluid coupling device (6) is fluidly coupled between the tubing anchor (2) and the another tubing anchor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the medical fluid extension set system of Bierman and Balbierz in view of a teaching of Eby such that the medical fluid extension set system further comprises another tubing anchor coupled to the another tubing, wherein the fluid coupling device is fluidly coupled between the tubing anchor and the another tubing anchor. One of ordinary skill in the art would have been motivated to make this modification because Eby teaches another tubing anchor that anchors the tubing from the fluid container to the fluid coupling device (see Col. 1, lines 6 – 35 and Col. 2, lines 22 – 53). Here, incorporating the additional tubing anchor as taught by Eby for the fluid supply tube 20 of the medical fluid extension set of Bierman is beneficial because it will secure the fluid supply tube to the patient such that movement by the patient does not caused the fluid supply tube 20 from being disconnected from the connector 42.
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.
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/ROBERT F ALLEN/Examiner, Art Unit 3783
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
05/12/2026
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