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 on 3/25/2026 has been entered. Claims 1-20 remain pending in the application. Claims 11-13 and 19 have been withdrawn from consideration as detailed in the Non-final Office Action mailed 4/17/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/9/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-18 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claim 16,
Line 12-14 recites “the tail portion comprising a sliding surface disposed between and directly coupled to the covering portion and the tail portion”. It is unclear how the sliding surface, which is claimed as a component of the tail portion, can be coupled or disposed between the tail portion. Since the sliding surface is a part of the tail portion as claimed, it appears the sliding surface is coupled and disposed between a portion of the tail portion which is not the sliding surface. For examination purposes Examiner construes “the tail portion comprising a sliding surface disposed between and directly coupled to the covering portion and the tail portion” to be “the tail portion comprising a sliding surface disposed between and directly coupled to the covering portion and a portion of the tail portion”. Examiner suggests further defining the tail portion as comprising a sliding surface and a second surface and claiming that the sliding surface is disposed between and directly coupled to the covering portion and the second surface of the tail portion. Alternatively, claim 16 could be amended to recite the sliding surface as a separate component from the tail portion.
Examiner notes claims 17-18 and 20 are similarly rejected by virtue of their dependency on claim 16.
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.
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.
Claims 1-2, 6-8, 10, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Korogi (U.S. PG publication 20100292673) further in view of Wong (U.S. PG publication 20070106229).
In regard to claim 1,
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Korogi discloses an anti-snagging assembly (see all of figure 40 above; paragraph [0144]) for use in an infusion set (Examiner notes “for use in an infusion set” is a functional limitation. The anti-snagging assembly is fully capable of use in an infusion set which comprises an appropriately sized tubing which would be connected to the outlet labeled above and a component connected to the needleless connector labeled above. The infusion set is not positively required in claim 1), the anti-snagging assembly comprising:
an integrally formed anti-snagging component (see figure 40 above; paragraph [0144]; Examiner notes as the components in figure 40 form a single component/structure/unit, the anti-snagging component is construed as being integrally formed. Examiner notes “integrally formed” is different from “monolithically formed”. Integrally formed also does not require the component to be continuous) comprising:
a covering portion (see figure 40 below) configured to be received by a first input end of an infusion set component (see figure 40 above wherein the infusion set component is the remaining portion shown in figure 40 that is not the anti-snagging component), the first input end comprising a needleless connector (see figure 40 above);
[AltContent: textbox (Sliding surface)][AltContent: ][AltContent: connector][AltContent: textbox (Covering portion)][AltContent: connector][AltContent: textbox (Tail portion)][AltContent: ][AltContent: connector][AltContent: ]
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a tail portion (see figure 40 above) slidingly connected to the infusion set component (see figure 40 above wherein the tail portion is slidingly connected to the infusion set component as it can be removed/attached to the infusion set component; see also paragraph [0089] which supports that attachment means are provided for attachment to the infusion set component); and
a sliding surface (see figure 40 above) directly coupling the covering portion to the tail portion (see figure 40), the sliding surface configured to slidingly guide the infusion set component past an obstruction without snagging when the infusion set is moved (Examiner notes “configured to slidingly guide the infusion set component past an obstruction without snagging when the infusion set is moved” is a functional limitation. When the anti-snagging component is attached to the infusion set component, the sliding surface is fully capable of slidingly guiding the infusion set component past an obstruction without snagging when the infusion set is moved due to its structure, since the sliding surface is a smooth surface. Examiner notes the size and shape of the obstruction is not further defined),
wherein the covering portion is configured to cover at least an access point (opening of the needleless connector; see item 208 in figure 14 which shows an example of the access point as the access point is covered in figure 40; Examiner notes figure 14 is referenced for exemplary purposes only) of the needleless connector when the anti-snagging component is in an engaged position (see engaged positioned shown in figure 40; Examiner notes “configured to cover at least an access point of the needleless connector when the anti-snagging component is in an engaged position” is a functional limitation. Due to the structure of the covering portion, the covering portion is fully capable of covering at least an access point of the needleless connector when the anti-snagging component is in an engaged position),
and wherein the covering portion is configured to uncover the access point of the needleless connector when the anti-snagging component is in a disengaged position (see disengaged position for example shown in figure 14 i.e. when the covering portion is moved to uncover the access point of the needleless connector. Examiner notes “configured to uncover the access point of the needleless connector when the anti-snagging component is in a disengaged position” is a functional limitation. The covering portion is fully capable due to its structure of uncovering the access point of the needleless connector when the anti-snagging component is in a disengaged position. Examiner notes figure 14 is referenced for exemplary purposes only).
Although Korogi supports the anti-snagging component can be attached to a y-site infusion set component (paragraph [0008]), Korogi fails to disclose an input tube and that the infusion set component is a Y-site infusion set component. As a result, Korgoi fails to disclose a covering portion configured to be received by a first input end of a Y-site infusion set component; a tail portion slidingly connected to the input tube, the input tube configured to be received by a second input end of the Y-site infusion set component; and the sliding surface configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the infusion set is moved.
Wong teaches an input tube (figure 4, item 6), and the input tube configured to be received by a second input end (figure 4, item 12) of the Y-site infusion set component (see figure 1, item 1).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the infusion set component of Korogi to include a second input end therefore resulting in a Y-site infusion set component and to also include an input tube configured to be received by the second input end of the Y-site infusion set component, as taught by Wong, for the purpose of enabling multiple fluids to be delivered (paragraph [0030] of Wong). Examiner notes modifying Korogi to include an input tube and modifying the infusion set component of Korogi to be a y-site infusion set component results in a covering portion configured to be received by a first input end of a Y-site infusion set component; a tail portion slidingly connected to the input tube, the input tube configured to be received by a second input end of the Y-site infusion set component; and the sliding surface configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the infusion set is moved. Examiner further notes since the tail portion is slidingly connected to the Y-site infusion set component and the input tube is connected to the Y-site infusion set, the tail portion would also be slidingly connected to the input tube when the input tube is received by a second input end of the Y-site infusion set component.
In regard to claim 2,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 1, wherein the tail portion is comprised of a flexible material (paragraph [0105] and [0143] of Korogi).
In regard to claim 6,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 1, wherein the covering portion is a cap (see figure 40 of Korogi) comprising:
[AltContent: textbox (Side wall)][AltContent: textbox (Top surface)][AltContent: arrow][AltContent: arrow]
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a top surface (see figure 40 above of Korogi) configured to cover the access point in the engaged position (see figure 40 above of Korogi) of the ani-snagging component; and
a side wall (see figure 40 above of Korogi) configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 40 above of Korogi) of the ani-snagging component.
In regard to claim 7,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 6, wherein the cap is configured to slip on to a portion of the needleless connector (see figure 40 of Korogi and paragraph [0143] and [0008] of Korogi; Examiner notes “configured to slip on to a portion of the needleless connector” is a functional limitation and due to the structure of the cap, the cap is fully capable of slipping on to a portion of the needleless connector).
In regard to claim 8,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 7.
A first embodiment of Korogi in view of Wong fails to disclose wherein the side wall comprises one or more slits configured to allow expansion of the side wall when the cap is fit over the portion of the needleless connector.
A second embodiment of Korogi teaches wherein the covering portion (figure 6, item 112) is a cap (see figure 6) comprising: a top surface configured to cover the access point in the engaged position (see figure 6); and a side wall configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 6), wherein the cap is configured to slip on to a portion of the needleless connector (paragraph [0128]), wherein the side wall comprises one or more slits (figure 6, item 115) configured to allow expansion of the side wall when the cap is fit over the portion of the needleless connector (paragraph [0128]; Examiner notes “configured to allow expansion of the side wall when the cap is fit over the portion of the needleless connector” is a functional limitation. The cap is fully capable of the recited function due to its structure).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the side wall of the first embodiment of Korogi in view of Wong to include wherein the side wall comprises one or more slits configured to allow expansion of the side wall when the cap is fit over the portion of the needleless connector, as taught by the second embodiment of Korogi, for the purpose of enabling the cover to be used with variable sized valves (paragraph [0086] of Korogi).
In regard to claim 10,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 7.
A first embodiment of Korogi in view of Wong fails to disclose wherein the side wall is configured to cover less than a full circumference of the needleless connector.
The second embodiment of Korogi teaches wherein the covering portion (figure 6, item 112) is a cap (see figure 6) comprising: a top surface configured to cover the access point in the engaged position (see figure 6); and a side wall configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 6), wherein the cap is configured to slip on to a portion of the needleless connector (paragraph [0128]), wherein the side wall is configured to cover less than a full circumference of the needleless connector (see figure 6 where slits 115 result in the side wall being configured to cover less than a full circumference of the needleless connector. The slits allow expansion of the side wall when it is fit over the portion of the needleless connector as supported by paragraph [0128]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the side wall of the first embodiment of Korogi in view of Wong to include wherein the side wall comprises one or more slits configured to allow expansion of the side wall when it is fit over the portion of the needleless connector therefore resulting in wherein the side wall is configured to cover less than a full circumference of the needleless connector, as taught by the second embodiment of Korogi, for the purpose of enabling the cover to be used with variable sized valves (paragraph [0086] of Korogi).
In regard to claim 14,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 1.
A first embodiment of Korogi in view of Wong is silent as to wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion.
A third embodiment of Korogi teaches wherein the covering portion (removable lidding described in paragraph [0151]) comprises an anti-microbial coating disposed on an inner surface of the covering portion (paragraph [0151]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner surface of the first embodiment of Korogi in view of Wong to include wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion as taught by the third embodiment of Korogi, for the purpose of providing an antimicrobial agent to reduce unwanted bacteria (paragraph [0151] of Korogi).
In regard to claim 15,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 14, wherein the anti-microbial coating is configured to contact the access point in the engaged position of the anti-snagging component (see figure 48 and paragraph [0151] of Korogi; since the anti-microbial coating is on the inner surface which can contact the access point in the engaged position, the anti-microbial coating is fully capable of contacting the access point in the engaged position of the anti-snagging component).
In regard to claim 16,
[AltContent: textbox (Portion of tail portion that is the sliding surface)][AltContent: ][AltContent: connector][AltContent: textbox (Covering portion)][AltContent: connector][AltContent: ][AltContent: textbox (Portion of tail portion that is not the sliding surface)][AltContent: ][AltContent: textbox (Outlet port)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Fluid connector component)][AltContent: textbox (Needless connector)][AltContent: arrow][AltContent: textbox (Anti-snagging component)][AltContent: connector][AltContent: ]
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Korogi discloses an intravenous (IV) infusion set (see figure 39), comprising:
a fluid connector component (see figure 39 above) comprising:
a first inlet port comprising a needless connector (see figure 39 above), and
an outlet port (see figure 39 above);
an integrally formed anti-snagging component (see figure 39 above; Examiner notes as the components in figure 39 form a single component/structure/unit, the anti-snagging component is construed as being integrally formed. Examiner notes “integrally formed” is different from “monolithically formed”. Integrally formed also does not require the component to be continuous) comprising:
a covering portion (see figure 39 above) configured to cover an access point of the needleless connector (see figure 39 above) in an engaged position (see position shown in figure 39) and to uncover the access point of the needleless connector in a disengaged position (paragraph [0143], position when the cover is removed from the fluid connector; Examiner notes “configured to cover an access point of the needleless connector in an engaged position and to uncover the access point of the needleless connector in a disengaged position” is a functional limitation. The covering portion is fully capable of the intended function due to its structure); and
a tail portion (see figure 39 above wherein the tail portion includes a sliding surface and a portion that is not the sliding surface) slidingly and rotationally coupled to the needleless connector (see figure 39 wherein as a result of the tail portion being slidingly and rotationally coupled to the fluid connector component, the tail portion is also slidingly and rotationally coupled to the needleless connector via the fluid connector component), the tail portion comprising a sliding surface (figure 39 above) disposed between and directly coupled to the covering portion and the tail portion (see figure 39; wherein the sliding surface is disposed between the covering portion and a portion of the tail portion), the sliding surface configured to slidingly guide the fluid connector component past an obstruction without snagging when the IV infusion set is moved (Examiner notes “configured to slidingly guide the IV infusion set past an obstruction without snagging when the IV infusion set is moved” is a functional limitation. The sliding surface is fully capable of slidingly guiding the fluid connector component past an obstruction without snagging when the IV infusion set is moved due to its structure, since the sliding surface is a smooth surface. Examiner notes the size or shape of the obstruction is not further claimed).
Although Korogi supports the anti-snagging component can be used with a y-site infusion set component (paragraph [0008]), the embodiment of figure 39 of Korogi is silent as to a Y-site infusion set component comprising: a first inlet port comprising a needleless connector; a second inlet port; and an outlet port; an inlet IV tube coupled to the second inlet port; an outlet IV tube coupled to the outlet port. As a result, Korogi fails to disclose a tail portion slidingly and rotationally coupled to the inlet IV tube and the sliding surface configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the IV infusion set is moved.
Wong teaches a Y-site infusion set component (figure 2, item 1, 2 and 3) comprising: a first inlet port (port which item 4 connects to) comprising a needleless connector (figure 2, item 3; paragraph [0030]); a second inlet port (port of item 12 which item 6 is received in; paragraph [0030]); and an outlet port (port which item 7 is directly connected to and which receives fluid as detailed in paragraph [0030]); an inlet IV tube (figure 4, item 6) coupled to the second inlet port (see figure 4); an outlet IV tube (figure 4, item 7) coupled to the outlet port (see figure 4; paragraph [0030].
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid connector component of Korogi to include branch port 12 and tubing 6 and 7 of Wong, as taught by Wong, therefore resulting in a Y-site infusion set component comprising: a first inlet port comprising a needleless connector; a second inlet port; and an outlet port; an inlet IV tube coupled to the second inlet port; an outlet IV tube coupled to the outlet port, for the purpose of enabling multiple fluids to be delivered (paragraph [0030] of Wong). As a result of the fluid connector component being modified to be a Y-site infusion set component which has an inlet IV tube coupled to the second inlet port, the tail portion of Korogi would be slidingly and rotationally coupled to the inlet IV tube since the tail portion is slidingly and rotationally coupled to the Y-site infusion set component, and the inlet IV tube is coupled to the Y-site infusion set component. The claim does not require the tail portion to be directly coupled to the inlet IV tube. Additionally, the sliding surface is configured to slidingly guide the Y-site infusion set component past an obstruction without snagging when the IV infusion set is moved as a result of the fluid connector component being modified to be a Y-site infusion set component.
In regard to claim 17,
Korogi in view of Wong teaches the IV infusion set of Claim 16.
A first embodiment of Korogi in view of Wong is silent as to wherein the tail portion comprises a tube connection point that encircles the inlet IV tube, the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube.
A fourth embodiment of Korogi teaches wherein the tail portion (portion which connects the cover to a housing; paragraph [0103]) comprises a tube connection point that encircles the inlet IV tube (paragraph [0103] wherein the cover may be connected to a connector housing via a strap around the extension set tubing/inlet IV tube), the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube (Paragraph [0103] supports the tail portion is capable of encircling an inlet IV tube. “Configured to slide along the inlet IV tube and to rotate around the inlet IV tube” is a functional limitation. The tube connection point is fully capable of the intended function due to its structure. Since the tube connection point is capable of being slid onto and rotated on an appropriately sized inlet IV tube to connect the tube connection point with the inlet IV tube, the tube connection point is configured to slide along the inlet IV tube and to rotate around the inlet IV tube).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Korogi in view of Wong to substitute item 307-3 of the tail portion of the first embodiment which is a connection point, for a tube connection point that encircles the inlet IV tube, the tube connection point configured to slide along the inlet IV tube and to rotate around the inlet IV tube of the fourth embodiment, as taught by the fourth embodiment of Korogi, because the substitution is a simple substitution that would yield the same predictable result of connecting a cover (paragraph [0103]). Furthermore, Korogi discloses modifications can be made (paragraph [0165]).
In regard to claim 18,
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Korogi in view of Wong teaches the IV infusion set of Claim 16, wherein the covering portion is a cap (see figure 39 above) comprising: a top surface (see figure 39 above) configured to cover the access point in the engaged position (see figure 39 above); and a side wall (see figure 39 above) configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 39 above).
A first embodiment of Korogi in view of Wong fails to disclose wherein the side wall comprises one of: one or more slits configured to allow expansion of the side wall when the cap slides onto the needleless connector; a flexible material configured to stretch when the cap slides onto the needleless connector; and internal threads configured to mate with threads of the needleless connector when the cap is screwed onto the needleless connector.
The second embodiment of Korogi teaches wherein the covering portion (figure 6, item 112) is a cap (see figure 6) comprising: a top surface configured to cover the access point in the engaged position (see figure 6); and a side wall configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 6), wherein the side wall comprises one or more slits (figure 6, item 115) configured to allow expansion of the side wall when the cap slides onto the needleless connector (paragraph [0128]; Examiner notes “configured to allow expansion of the side wall when the cap slides onto the needleless connector” is a functional limitation).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the side wall of the first embodiment of Korogi in view of Wong to include wherein the side wall comprises one of: one or more slits configured to allow expansion of the side wall when the cap slides onto the needleless connector, as taught by the second embodiment of Korogi, for the purpose of enabling the cover to be used with variable sized valves (paragraph [0086] of Korogi).
In regard to claim 20,
Korogi in view of Wong teaches the IV infusion set of Claim 16.
A first embodiment of Korogi in view of Wong fails to disclose wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion and configured to contact the access point in the engaged position.
The third embodiment of Korogi teaches wherein the covering portion (removable lidding described in paragraph [0151]) comprises an anti-microbial coating disposed on an inner surface of the covering portion (paragraph [0151]) and configured to contact the access point in the engaged position (paragraph [0151]; “Configured to contact the access point in the engaged position” is a functional limitation. Due to the anti-microbial coating being disposed on an inner surface, it is fully capable of contacting the access point in the engaged position since the covering portion contacts the access point in the engaged position).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the inner surface of the first embodiment of Korogi in view of Wong to include wherein the covering portion comprises an anti-microbial coating disposed on an inner surface of the covering portion and configured to contact the access point in the engaged position as taught by the third embodiment of Korogi, for the purpose of providing an antimicrobial agent to reduce unwanted bacteria (paragraph [0151] of Korogi).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Korogi (U.S. PG publication 20100292673) in view of Wong (U.S. PG publication 20070106229) further in view of Chelak (U.S. PG publication 20140358115).
In regard to claim 3,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 1.
Korogi in view of Wong is silent as to wherein the tail portion comprises a tube connection point encircling the input tube and configured to slidingly move along the input tube.
Chelak teaches wherein the tail portion (item 150) comprises a tube connection point (item 155) encircling an input tube (item 620) and configured to slidingly move along the input tube (paragraph [0049] and [0041]; Examiner notes figure 2A supports the tail portion can be placed on a second input end of a y-site infusion set and figure 6A supports the tail portion can be placed on an input tube. The input tube would be fully capable of being received by the second end of the Y-site infusion set component).
Further Korogi teaches a tail portion that fits around the body of the infusion set component and a tail portion that comprises a tube connection point encircling the input tube, could all be used to achieve the same result (paragraph [0103] of Korogi; Examiner notes the cover may be connected to the body of the infusion set component via a strap around the proximal device/inlet IV tube, or a clip that fits around the body of the infusion set component) and thus were art-recognized equivalents before the effective filing date of the claimed invention.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace the tail portion of Korogi in view of Wong with a tail portion which comprises a tube connection point encircling the input tube (Examiner notes the input tube of Korogi in view of Wong is a proximal device/object that is attached to the second input end) and configured to slidingly move along the input tube since it has been held that substituting parts of an invention involves only routine skill in the art. Furthermore, Korogi discloses modifications can be made (paragraph [0165]).
In regard to claim 4,
Korogi in view of Wong in view of Chelak teaches the anti-snagging assembly of Claim 3, wherein the tube connection point is configured to slide away from the needleless connector along the input tube to disengage the anti-snagging component from the needleless connector (Examiner notes “configured to slide away from the needleless connector along the input tube to disengage the anti-snagging component from the needleless connector” is a functional limitation. See analysis of claim 3 above. When the tube connection point is slid away to remove the tube connection point from the input tube, the anti-snagging component would also be disengaged from the needleless connector since the anti-snagging component is attached to the needless connector via the tube connection point and the covering portion is attached to the tube connection point).
In regard to claim 5,
Korogi in view of Wong in view of Chelak teaches the anti-snagging assembly of Claim 3, wherein the tube connection point is configured to rotate around the input tube to disengage the anti-snagging component from the needleless connector (Examiner notes “configured to rotate around the input tube to disengage the anti-snagging component from the needleless connector” is a functional limitation. See analysis of claim 3 above. When the tube connection point is slid away and rotated to remove the tube connection point from the input tube, the anti-snagging component would also be disengaged from the needleless connector since the anti-snagging component is attached to the needless connector via the tube connection point and the covering portion is attached to the tube connection point).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Korogi (U.S. PG publication 20100292673) in view of Wong (U.S. PG publication 20070106229) further in view of Ishii (U.S. PG publication 20040236311).
In regard to claim 9,
Korogi in view of Wong teaches the anti-snagging assembly of Claim 7.
Korogi in view of Wong fails to disclose wherein the cap comprises a flexible material configured to stretch when the cap is fit over the portion of the needleless connector.
Ishii teaches wherein the cap comprises a flexible material configured to stretch when the cap is fit over the portion of the needleless connector (paragraph [0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the cap of Korogi in view of Wong to include a flexible material configured to stretch when the cap is fit over the portion of the needleless connector, as taught by Ishii, for the purpose of providing a tight seal around a port (paragraph [0038] of Ishii).
In regard to claim 18,
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Korogi in view of Wong teaches the IV infusion set of Claim 16, wherein the covering portion is a cap (see figure 39 above) comprising: a top surface (see figure 39 above) configured to cover the access point in the engaged position (see figure 39 above); and a side wall (see figure 39 above) configured to be disposed around at least a portion of a circumference of the needleless connector in the engaged position (see figure 39 above).
Korogi in view of Wong fails to disclose wherein the side wall comprises one of: one or more slits configured to allow expansion of the side wall when the cap slides onto the needleless connector; a flexible material configured to stretch when the cap slides onto the needleless connector; and internal threads configured to mate with threads of the needleless connector when the cap is screwed onto the needleless connector.
Ishii teaches wherein the side wall comprises a flexible material configured to stretch when the cap slides onto the needleless connector (paragraph [0038]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the cap of Korogi in view of Wong to be a flexible material and to include the side wall comprises a flexible material configured to stretch when the cap slides onto the needleless connector, as taught by Ishii, for the purpose of providing a tight seal around a port (paragraph [0038] of Ishii).
Response to Arguments
Applicant's arguments filed 3/25/2026 have been fully considered but they are not persuasive. A new interpretation of the sliding surface has been applied in the claim rejections above. Applicant argues that none of the guiding device 3, lid 5, and lid loop 52 of Wong contact the alleged input tube 6 or the alleged second input end 12. It is noted that claim 1 and 16 do not require the tail portion to be directly connected/coupled to the input tube/inlet IV tube. Claim 1 requires the tail portion to be “slidingly connected to the input tube”. As detailed in the rejection of claim 1 above, since the tail portion is slidingly connected to the Y-site infusion set component and the input tube is connected to the Y-site infusion set, the tail portion would also be slidingly connected to the input tube via the Y-site infusion set component when the input tube is received by a second input end of the Y-site infusion set component. Claim 16 requires a tail portion “slidingly and rotationally coupled to the inlet IV tube”. As a result of the fluid connector component being modified to be a Y-site infusion set component which has an inlet IV tube coupled to the second inlet port as taught by Wong, the tail portion of Korogi would be slidingly and rotationally coupled to the inlet IV tube via the Y-site infusion set component since the tail portion is slidingly and rotationally coupled to the Y-site infusion set component, and the inlet IV tube is coupled to the Y-site infusion set component. Applicant’s arguments are therefore not found to be persuasive.
Applicant argues that Wong fails to disclose or suggest that the covering portion, the tail portion, and the sliding surface are “an integrally formed anti-snagging component”. As detailed above, Korogi discloses that the covering portion, the tail portion, and the sliding surface are an integrally formed anti-snagging component, as the covering portion, the tail portion, and the sliding surface form a single component/structure/unit. The term “integrally formed” is different from “monolithically formed”. The claim does not require the anti-snagging component to be continuous. Applicant argues that Wong fails to disclose the sliding surface directly coupling the covering portion to the tail portion. As detailed above, this feature is taught by the new interpretation of Korogi applied above.
Applicant argues that the dependent claimed are dependent from the independent claims and are allowable for at least similar reasons as claim 1 and 16. This argument is not found to be persuasive as claims 1 and 16 have not been found to be allowable as detailed in the response to arguments above.
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.
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/ALEXANDRA LALONDE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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