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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/01/2026 has been entered.
Response to Amendment
The amendment filed on 06/15/2026 has been entered. Claims 1, 5, 8, and 18-20 have been amended. Claims 9-12, 15, and 21-27 are in the original/previously presented form. Claims 2-4, 6-7, 13-14, and 16-17 are cancelled. Thus, claims 1, 5, 8-12, 15, and 18-27 remain pending in the application.
Drawings
The drawings were received on 02/13/2026. These drawings are acceptable.
Claim Objections
Claim 20 is objected to because of the following informalities: The claim states “the collar is configured to couple with the mating connector adjacent to the first end of the luer slip”. However, in a previous instance within the same claim, “a mating connector” has been amended to “the female luer connector”. The examiner suggests modifying the later reference of “the mating connector” to “the female luer connector” for continuity purposes.
Claim 21 is objected to because of the following informalities: The claim states "the first tubing". However, in independent claim 1, upon which claim 21 is dependent, the claim refers to said tubing as "a first type of tubing". The examiner acknowledges the two tubings to be the same, and suggests modifying claim 21 to state "the first type of tubing" for continuity purposes. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: The claim states "the third tubing". However, in independent claim 1, upon which claim 23 is dependent, the claim refers to said tubing as "a second type of tubing". The examiner acknowledges the two tubings to be the same, and suggests modifying claim 23 to state "the second type of tubing" for continuity purposes. Appropriate correction is required.
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 12 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.
Regarding claim 12, the claim states “wherein if the tubing is a micro bore tubing or a small bore tubing, the male luer connector is coupled to the infusion set component by disposing the tubing within the lumen at the second end of the luer slip, wherein if the tubing is a standard bore thick wall tubing, a standard bore tubing, or a macro bore tubing, the male luer connector is coupled to the infusion set component by disposing the tubing within the fluid port.” The Applicant describes two ways in which the male luer connector is coupled to the infusion set component using tubing, the tubing being “within the lumen at the second end of the luer slip” for micro or small bore tubing or “within the fluid port” for standard, macro, or standard thick wall bore tubing.
The specification and figures do not add context to how the fluid port and second end of the luer slip are set in relation to one another. The only mention of the relation is in [0006], [0008], [0070], [0085], and [0089]: “the spigot is coupled to the luer slip and the fluid port is in fluid communication with the lumen at the second end of the luer slip.” Claim 12 was also states “a spigot defining a fluid port, wherein the fluid port receives the second end of the luer slip”. The examiner interprets this as the fluid port and the second end of the luer slip meet and the lumens merge into one, thereby joining the two elements as one. FIG. 7 & 8 and FIG. 9 & 10 give insight as to how the various tubing sizes appear to fit in regards to the luer slip and fluid port, but it still remains unclear to the examiner if the two components share a lumen (as show in FIG. 4), how tubing disposed within the fluid port is different than tubing disposed within the lumen at the second end of the luer slip, as the lumens are the same. For the purposes of examination, the examiner will interpret the relation between the fluid port and second end of the luer slip as structurally sharing a lumen with one another. Therefore, tubing that is within the fluid port would also be within the lumen at the second end of the luer slip.
Claim 20 recites the limitation "the mating connector" in the sixteenth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (United States Patent Application Publication No. US 2013/0046287 A1; herein, Davis), and further in view of Kitani et al. (United States Patent Application Publication No. US 2009/0177170 A1; herein, Kitani).
Regarding claim 1, Davis discloses a male luer connector (Fig. 6), comprising:
a luer slip (Fig. 4, male plug 130) comprising a hollow body that extends between a first end and a second end and defines a lumen (Fig. 4, [0024], internal bore 132 stretching from distal opening 136 (first end) to point where diameter of internal bore 132 changes (second end)), wherein the first end is configured to be disposed within a mating connector (Fig. 4 and Fig. 6, male plug 130 with a tapered outer profile can help coordinate connection between male plug 130 and female tubing fitting 102) and the second end is configured to receive a first type of tubing within the lumen ([0043] discusses an exemplary use case where the male tubing fitting 104 is fluidly coupled to a first end of a piece of conventional plastic tubing. Specifically, the first end of the piece of tubing is inserted into internal bore 132 of the male tubing fitting 104 through proximal opening 134. – Tubing inserted into internal bore 132 can abut the second end of the luer slip);
a collar disposed around the luer slip (Fig. 1, retractable locking collar 106), wherein the collar is translatable relative to the luer slip (Fig. 1, [0020], retract, translate, slide, move, and/or rotate) and is configured to couple with the mating connector (Fig. 1, [0020], retractable locking collar 106 can lock male tubing fitting 104 and female tubing fitting 102 together); and
a spigot (Fig. 4, male tubing fitting 104) defining a fluid port (Fig. 4, part of internal bore 132 defined by interior surface 138 within male tubing fitting 104).
Davis does not disclose the spigot circumferentially disposed around the second end of the luer slip, and wherein the fluid port is configured to receive a second type of tubing. However, Kitani teaches the spigot circumferentially disposed around the second end of the luer slip (Fig. 3 and Fig. 5, holding part 113 circumferentially encloses body tube 121 near first opening 121c), and wherein the fluid port is configured to receive a second type of tubing (Fig. 3, holding part 113 receives first tube member T1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the male luer connector disclosed by Davis to have the spigot circumferentially disposed around the second end of the luer slip, as well as the fluid port of the spigot able to receive tubing as taught by Kitani in order for a user to be able to hold the male luer connector ([0061]) and for there to be a leak-free flow path established between the tubing and connector (Fig. 3, [0060]).
Regarding claim 21, in the modified device of Davis, Davis discloses the hollow body comprises a tapered outer profile configured to deform the first tubing to facilitate engagement between the first tubing and the luer slip (Fig. 4, male plug 130 with a tapered outer profile can help coordinate connection between male plug and another connection).
Regarding claim 22, in the modified device of Davis, Davis discloses the collar is configured to be rotated to threadedly engage mating threads of the mating connector (Fig. 4, [0027], threads 158, 160).
Claims 5, 8, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Kitani as applied to claim 1 above, and further in view of Maeda et al. (United States Patent Application Publication No. US 2015/0094658 A1; herein Maeda).
Regarding claim 5, in the modified device of Davis, Davis does not disclose the first type of tubing comprises tubing with an outer diameter of 2.30 mm and an inner diameter between 0.50 mm and 1.00 mm. However, Maeda teaches the first type of tubing comprises tubing with an outer diameter of 2.30 mm and an inner diameter between 0.50 mm and 1.00 mm ([0195], “outer diameter of the inner tube 14 is preferably 0.30 mm to 2.50 mm…and the inner diameter thereof is preferably 0.20 mm to 2.35 mm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first type of tubing of the modified male luer connector disclosed by Davis to have an outer diameter between 0.30 mm to 2.50 mm and an inner diameter between 0.20 mm to 2.35mm as taught by Maeda in order to fit snug against or within a connection point to reduce leaks and promote fluid communication between the lumens. Further, the Applicant appears to have placed no criticality on the claimed range (see Applicant’s specification [0036] indicating the male luer connector 200 can be adapted, adjusted, or otherwise configured to be used with “at least” the following types of tubing).
Regarding claim 8, in the modified device of Davis, Davis does not disclose the second type of tubing comprises tubing with an outer diameter of 3.70 mm and an inner diameter between 1.50 mm and 2.70 mm. However, Maeda teaches the second type of tubing comprises tubing with an outer diameter of 3.70 mm and an inner diameter between 1.50 mm and 2.70 mm ([0200], “outer diameter of the outer tube 12 is preferably 0.50 mm to 4.30 mm…and the inner diameter thereof is preferably 0.40 mm to 3.80 mm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second type of tubing taught by Kitani of the modified male luer connector disclosed by Davis to have an outer diameter between 0.50 mm to 4.30 mm and an inner diameter between 0.40 mm to 3.80 mm as taught by Maeda in order to fit snug against or within a connection point to reduce leaks and promote fluid communication between the lumens. Further, the Applicant appears to have placed no criticality on the claimed range (see Applicant’s specification [0036] indicating the male luer connector 200 can be adapted, adjusted, or otherwise configured to be used with “at least” the following types of tubing).
Regarding claim 23, in the modified device of Davis, Davis does not disclose the third tubing comprises tubing with an outer diameter of 4.20 mm and an inner diameter between 3.00 mm. However, Maeda teaches the third tubing comprises tubing with an outer diameter of 4.20 mm and an inner diameter between 3.00 mm ([0200], “outer diameter of the outer tube 12 is preferably 0.50 mm to 4.30 mm…and the inner diameter thereof is preferably 0.40 mm to 3.80 mm). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the third tubing (“second type of tubing”, see Claim Objection above) taught by Kitani of the modified male luer connector disclosed by Davis to have an outer diameter between 0.50 mm to 4.30 mm and an inner diameter between 0.40 mm to 3.80 mm as taught by Maeda in order to fit snug against or within a connection point to reduce leaks and promote fluid communication between the lumens. Further, the Applicant appears to have placed no criticality on the claimed range (see Applicant’s specification [0036] indicating the male luer connector 200 can be adapted, adjusted, or otherwise configured to be used with “at least” the following types of tubing).
Claims 9-11, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Kitani as applied to claim 1 above, and further in view of Gilson et al. (United States Patent No. US 4,369,781 A; herein, Gilson).
Regarding claim 9, in the modified device of Davis, Davis does not disclose the luer slip is formed from polypropylene. However, Gilson teaches the luer slip is formed from polypropylene (FIG. 3, col. 3 lines 1-5, connector 62 is made of suitable plastic, such as polypropylene). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified luer slip disclosed by Davis to be polypropylene as taught by Gilson as it is a well-known common material in the art for luer connectors that also provides sterilization adaptability.
Regarding claim 10, in the modified device of Davis, Davis does not disclose the collar is formed from polypropylene. However, Gilson teaches the collar is formed from polypropylene (FIG. 1, col. 2 lines 6-17, body 12 is formed of a suitable plastic such as polypropylene, polyethylene or the like (wherein the collar 24 is a part of the body 12)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified collar disclosed by Davis to be polypropylene as taught by Gilson as it is a well-known common material in the art for luer connectors that also provides sterilization adaptability.
Regarding claim 11, in the modified device of Davis, Davis does not disclose the spigot is formed from polypropylene. However, Gilson teaches the spigot is formed from polypropylene (FIG. 1, col. 2 lines 6-17, body 12 is formed of a suitable plastic such as polypropylene, polyethylene or the like; FIG. 3 and col. 3 lines 1-5, connector 62 is made of suitable plastic, such as polypropylene). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified spigot disclosed by Davis to be polypropylene as taught by Gilson as it is a well-known common material in the art for luer connectors that also provides sterilization adaptability.
Regarding claim 25, in the modified device of Davis, Davis does not disclose the collar is formed from polycarbonate, nylon, or polyethylene. However, Gilson teaches the collar is formed from polycarbonate, nylon, or polyethylene (FIG. 1, col. 2 lines 6-17, body 12 is formed of a suitable plastic such as polypropylene, polyethylene or the like (wherein the collar 24 is a part of the body 12)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified collar disclosed by Davis to be polyethylene as taught by Gilson as it is a well-known common material in the art for thermoplastic medical devices that also provides sterilization adaptability.
Regarding claim 26, in the modified device of Davis, Davis does not disclose the spigot is formed from polycarbonate, nylon, or polyethylene. However, Gilson teaches the spigot is formed from polycarbonate, nylon, or polyethylene (FIG. 1, col. 2 lines 6-17, body 12 is formed of a suitable plastic such as polypropylene, polyethylene or the like; FIG. 3 and col. 3 lines 1-5, connector 62 is made of suitable plastic, such as polypropylene). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified spigot disclosed by Davis to be polyethylene as taught by Gilson as it is a well-known common material in the art for thermoplastic medical devices that also provides sterilization adaptability.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Kitani as applied to claim 1 above, and further in view of Hurezan (United States Patent Application Publication No. US 2013/0018248 A1).
Regarding claim 24, in the modified device of Davis, Davis does not disclose the luer slip is formed from polycarbonate, nylon, or polyethylene. However, Hurezan teaches the luer slip is formed from polycarbonate, nylon, or polyethylene (FIG.2, [0038], body which makes up a male slip connector 230 is formed of polycarbonate). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified luer slip disclosed by Davis to be polycarbonate as taught by Hurezan as it is a well-known common material in the art for thermoplastic medical devices that also provides sterilization adaptability.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Kitani as applied to claim 1 above, and further in view of Wilshinsky (United States Patent Application Publication No. US 2021/0009335 A1).
Regarding claim 27, in the modified device of Davis, Davis does not disclose at least one of the collar or the spigot are formed from silicone, polyurethane, or a latex free silicone rubber. However, Wilshinsky teaches at least one of the collar or the spigot are formed from silicone, polyurethane, or a latex free silicone rubber (FIGS. 14A-14E, silicone collar 56). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified collar disclosed by Davis to be silicone as taught by Wilshinsky as silicone is known in the art to have elastomeric properties, providing a tighter seal against harder materials.
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Davis and further in view of Kitani, Kahn (U.S. Patent Application Publication No. US 2010/0228233 A1; herein, Kahn), and Piehl et al. (U.S. Patent Application Publication No. US 2017/0281875 A1; herein, Piehl).
Regarding claim 12, Davis discloses a male luer connector (Fig. 6) comprising:
a luer slip (Fig. 4, male plug 130) comprising a first end and a second end and defining a lumen between the first end and the second end (Fig. 4, [0024], internal bore 132 stretching from distal opening 136 (first end) to point where diameter of internal bore 132 changes (second end)), wherein the first end is configured to engage with a mating connector (Fig. 4 and Fig. 6, male plug 130 with a tapered outer profile can help coordinate connection between male plug 130 and female tubing fitting 102);
a collar disposed around the luer slip (Fig. 1, retractable locking collar 106) and configured to couple with the mating connector to fluidly connect the mating connector to the infusion set (Fig. 1, [0020], retractable locking collar 106 can lock male tubing fitting 104 and female tubing fitting 102 together); and
a spigot (Fig. 4, male tubing fitting 104) defining a fluid port (Fig. 4, part of internal bore 132 defined by interior surface 138 within male tubing fitting 104), wherein the fluid port receives the second end of the luer slip (Fig. 4, male tubing fitting 104 and male plug 130 share internal bore 132), and the male luer connector is coupled to the infusion set component by disposing the tubing within the lumen at the second end of the luer slip ([0043] discusses an exemplary use case where the male tubing fitting 104 is fluidly coupled to a first end of a piece of conventional plastic tubing. Specifically, the first end of the piece of tubing is inserted into internal bore 132 of the male tubing fitting 104 through proximal opening 134. – Tubing inserted into internal bore 132 can abut the second end of the luer slip).
Davis does not disclose an infusion set, an infusion set component, and the male luer connector configured to be coupled to the infusion set component by a tubing, the tubing is a micro bore tubing or a small bore tubing, and the tubing is a standard bore thick wall tubing, a standard bore tubing, or a macro bore tubing, the male luer connector is coupled to the infusion set component by disposing the tubing within the fluid port.
However, Kahn teaches an infusion set (FIG. 1A, [0005]), an infusion set component ([0039], accessory parts 60), and the male luer connector configured to be coupled to the infusion set component by a tubing ([0039], I.V. tubing and tubing 19). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the male luer connector disclosed by Davis with the infusion set as taught by Kahn in order to provide an application of use, such as fluid transfer or control ([0039]), for the device of Davis.
Davis in view of Kahn still does not disclose the tubing is a micro bore tubing or a small bore tubing, and the tubing is a standard bore thick wall tubing, a standard bore tubing, or a macro bore tubing. However, Piehl teaches the tubing is a micro bore tubing or a small bore tubing (FIG. 19C, paragraph [0171], small bore tubing 109 may connect directly to a male luer 112), and the tubing is a standard bore thick wall tubing, a standard bore tubing, or a macro bore tubing (FIG. 19A, [0169], the output of the dual check valve 32 may be or comprise a male luer connection 112, which can allow connection to a multitude of currently available tubing; FIG. 40 and paragraph [0219], a spike 102 may be connected to large bore inlet tubing 100, which leads to the inlet of the dual check valve 31). There is motivation to modify the type of tubing connected to the male luer connector based on the type of application involved. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the conventional plastic tubing suggested in Davis to the small bore tubing taught by Piehl given that the features serve the same purpose of providing a greater precision of fluid delivery as well as low flow dosing for potent drugs. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute conventional plastic tubing suggested in Davis to the large bore tubing taught by Piehl given that the features serve the same purpose of providing a higher volume of fluids at a faster flow rate.
Davis in view of Kahn and Piehl still does not disclose the male luer connector is coupled to the infusion set component by disposing the tubing within the fluid port. However, Kitani teaches the male luer connector is coupled to the infusion set component by disposing the tubing within the fluid port (Fig. 3, holding part 113 receives first tube member T1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified male luer connector disclosed by Davis to have the fluid port of the spigot able to receive tubing as taught by Kitani in order for there to be a leak-free flow path established between the tubing and connector (Fig. 3, [0060]).
Regarding claim 19, in the modified device of Davis, Davis discloses the collar is disposed around the first end of the luer slip (Fig. 1, retractable locking collar 106), translatable relative to the luer slip (Fig. 1, [0020], retract, translate, slide, move, and/or rotate), and configured to couple with the mating connector adjacent to the first end of the luer slip (Fig. 1, [0020], retractable locking collar 106 can lock male tubing fitting 104 and female tubing fitting 102 together).
Claims 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Kitani, Kahn, and Piehl as applied to claim 12 above, and further in view of Maeda.
Regarding claim 15, in the modified device of Davis, Davis does not disclose the tubing comprises micro bore tubing comprises an outer diameter of 2.30 mm and an inner diameter of 0.50 mm, and the small bore tubing comprises an outer diameter of 2.30 mm and an inner diameter of 1.00 mm. However, Maeda teaches the tubing comprises micro bore tubing comprises an outer diameter of 2.30 mm and an inner diameter of 0.50 mm, and the small bore tubing comprises an outer diameter of 2.30 mm and an inner diameter of 1.00 mm ([0195], “outer diameter of the inner tube 14 is preferably 0.30 mm to 2.50 mm…and the inner diameter thereof is preferably 0.20 mm to 2.35 mm). The ranges could create the exact outer and inner diameter dimensions for either the micro or small bore tubing. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the small bore tubing taught by Piehl of the modified male luer connector disclosed by Davis to have an outer diameter between 0.30 mm to 2.50 mm and an inner diameter between 0.20 mm to 2.35 mm as taught by Maeda in order to fit snug against or within a connection point to reduce leaks and promote fluid communication between the lumens. Further, the Applicant appears to have placed no criticality on the claimed range (see Applicant’s specification [0036] indicating the male luer connector 200 can be adapted, adjusted, or otherwise configured to be used with “at least” the following types of tubing).
Regarding claim 18, in the modified device of Davis, Davis does not disclose the standard bore thick wall tubing comprises an outer diameter of 3.70 mm and an inner diameter of 1.50 mm, the standard bore tubing comprises an outer diameter of 3.70 mm and an inner diameter of 2.70 mm, and the macro bore tubing comprises an outer diameter of 4.20 mm and an inner diameter of 3.00 mm. However, Maeda teaches the standard bore thick wall tubing comprises an outer diameter of 3.70 mm and an inner diameter of 1.50 mm, the standard bore tubing comprises an outer diameter of 3.70 mm and an inner diameter of 2.70 mm, and the macro bore tubing comprises an outer diameter of 4.20 mm and an inner diameter of 3.00 mm ([0200], “outer diameter of the outer tube 12 is preferably 0.50 mm to 4.30 mm…and the inner diameter thereof is preferably 0.40 mm to 3.80 mm). The ranges could create the exact outer and inner diameter dimensions for the standard thick wall, standard, for macro bore tubing. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the large bore tubing taught by Piehl of the modified male luer connector disclosed by Davis to have an outer diameter between 0.50 mm to 4.30 mm and an inner diameter between 0.40 mm to 3.80 mm as taught by Maeda in order to fit snug against or within a connection point to reduce leaks and promote fluid communication between the lumens. Further, the Applicant appears to have placed no criticality on the claimed range (see Applicant’s specification [0036] indicating the male luer connector 200 can be adapted, adjusted, or otherwise configured to be used with “at least” the following types of tubing).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davis, and further in view of Kitani, Tieck et al. (United States Patent Application Publication No. US 2016/0015957 A1; herein, Tieck), and Gura-Emerling (United States Patent No. US 5,571,140 A).
Regarding claim 20, Davis discloses an infusion set luer connector assembly, comprising:
a female luer connector (Figs. 1-2, female tubing fitting 102), comprising:
a receiving portion ([0021], proximal end 108);
a first fluid port configured to receive intravenous tubing ([0021], proximal opening 114); and
a female luer connector lumen fluidly coupled between the receiving portion and the first fluid port ([0021], internal bore 112); and
a male luer connector (Fig. 6) configured to be coupled to the female luer connector (Fig. 4 and Fig. 6, male plug 130 with a tapered outer profile can help coordinate connection between male plug 130 and female tubing fitting 102), the male luer connector (Fig. 6) comprising:
a luer slip (Fig. 4, male plug 130) comprising a first end, a second end (Fig. 4, distal opening 136 (first end) to point where diameter of internal bore 132 changes (second end)), and a plurality of protrusions extending radially from a slip surface (Fig. 7, [0029], proximal and distal retention members 140 and 142 to retain and/or hold the retractable locking collar in a predetermined position along exterior surface 144 of male tubing fitting 104), wherein the luer slip defines a lumen extending between the first end and the second end (Fig. 4, [0024], internal bore 132 stretching from distal opening 136 (first end) to point where diameter of internal bore 132 changes (second end)), the first end is configured to engage with the female luer connector ([0023], male plug 130 has a luer tapered and is sized and shaped to be received within internal bore 112 of female tubing fitting 102) and the second end is configured to engage with a first type of tubing ([0043] discusses an exemplary use case where the male tubing fitting 104 is fluidly coupled to a first end of a piece of conventional plastic tubing. Specifically, the first end of the piece of tubing is inserted into internal bore 132 of the male tubing fitting 104 through proximal opening 134. – Tubing inserted into internal bore 132 can abut the second end of the luer slip);
a collar disposed around the luer slip (Fig. 1, retractable locking collar 106), wherein the collar is translatable relative to the luer slip (Fig. 1, [0020], retract, translate, slide, move, and/or rotate), the collar is configured to couple with the mating connector adjacent to the first end of the luer slip (Fig. 1, [0020], retractable locking collar 106 can lock male tubing fitting 104 and female tubing fitting 102 together); and
a spigot (Fig. 4, male tubing fitting 104) and at least one gripping feature (Fig. 3, [0023], flanges 128) and defining a second fluid port (Fig. 4, part of internal bore 132 defined by interior surface 138 within male tubing fitting 104).
Davis does not disclose a plurality of notches corresponding to the plurality of protrusions of the luer slip, the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip, selectively rotationally coupling the collar and the luer slip, and the spigot comprising a teardrop shape, the spigot is circumferentially disposed around the second end of the luer slip and the second fluid port is configured to receive a second type of tubing.
However, Tieck teaches a plurality of notches corresponding to the plurality of protrusions of the luer slip (FIG. 70 & 71, [1018], notches or slots 988 and 987), the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip ([1018], the compressible ring member 980 is provided with one or more (or a plurality) of notches or slots 988 and 987, respectively, that have a shape and size that receive a corresponding one or more (or a plurality) of tabs or protrusions 989 on the body 985 of the cap 984), and selectively rotationally coupling the collar and the luer slip ([1018], the compressible ring member 980 is provided with one or more (or a plurality) of notches or slots 988 and 987, respectively, that have a shape and size that receive a corresponding one or more (or a plurality) of tabs or protrusions 989 on the body 985 of the cap 984). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the collar disclosed by Davis to have the plurality of notches as taught by Tieck, in order for the device of Davis to have improved locking capabilities.
Davis in view of Tieck still does not disclose the spigot comprising a teardrop shape. However, Gura-Emerling teaches a spigot comprising a teardrop shape (FIG. 2 and col. 3 lines 14-16, the rubber body 2 will act as a bulb-like handle, allowing small hands to firmly grasp the device). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the spigot disclosed by Davis to have the teardrop shape as taught by Gura-Emerling, in order for the modified device of Davis to have improved grip functionalities.
Davis in view of Tieck and Gura-Emerling still does not disclose the spigot is circumferentially disposed around the second end of the luer slip and the second fluid port is configured to receive a second type of tubing. However, Kitani teaches the spigot is circumferentially disposed around the second end of the luer slip (Fig. 3 and Fig. 5, holding part 113 circumferentially encloses body tube 121 near first opening 121c) and the second fluid port is configured to receive a second type of tubing (Fig. 3, holding part 113 receives first tube member T1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the male luer connector disclosed by Davis to have the spigot circumferentially disposed around the second end of the luer slip, as well as the fluid port of the spigot able to receive tubing as taught by Kitani in order for a user to be able to hold the male luer connector ([0061]) and for there to be a leak-free flow path established between the tubing and connector (Fig. 3, [0060]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. US 12,551,679 B2 in view of Davis et al. (United States Patent Application Publication No. US 2013/0046287 A1; herein, Davis), Tieck et al. (United States Patent Application Publication No. US 2016/0015957 A1; herein, Tieck), and Kitani et al. (United States Patent Application Publication No. US 2009/0177170 A1; herein, Kitani). Although the claims at issue are not identical, they are not patentably distinct from each other because the amended limitations of the instant application are, still, not patentably distinct from the limitations of the patent. The claims of the instant application and the claims of the patent are compared in the table below.
Instant Application 18/179,656
U.S. Patent No. US 12,551,679 B2
20. An infusion set luer connector assembly, comprising: a female luer connector, comprising: a receiving portion; a first fluid port configured to receive intravenous tubing; and a female luer connector lumen fluidly coupled between the receiving portion and the first fluid port; and
a male luer connector configured to be coupled to the female luer connector, the male luer connector comprising:
a luer slip comprising a first end, a second end, and a plurality of protrusions extending radially from a slip surface, wherein the luer slip defines a lumen extending between the first end and the second end, the first end is configured to engage with the female luer connector and the second end is configured to engage with a first type of tubing;
a collar disposed around the luer slip and defining a plurality of notches corresponding to the plurality of protrusions of the luer slip, wherein the collar is translatable relative to the luer slip, the collar is configured to couple with the mating connector adjacent to the first end of the luer slip, and the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip, selectively rotationally coupling the collar and the luer slip; and
a spigot comprising a teardrop shape and at least one gripping feature and defining a second fluid port, wherein the spigot is circumferentially disposed around the second end the luer slip and the second fluid port is configured to receive a second type of tubing.
17. An infusion set luer connector assembly, comprising:
a female luer connector, comprising:
a receiving portion;
a first fluid port configured to receive intravenous tubing; and
a lumen fluidly coupled between the receiving portion and the first fluid port; and
a male luer connector, comprising:
a luer slip comprising a lumen disposed along an axial length of the luer slip, the luer slip sized and shaped to mate with the receiving portion of the female luer connector;
a collar disposed on an outer surface of the luer slip, the collar comprising a notch and a plurality of first grip features disposed on an outer surface of the collar; and
a tear shaped grip coupled to the luer slip, the grip comprising a second fluid port fluidly coupled to the lumen and configured to receive intravenous tubing, and a plurality of second grip features disposed on an outer surface of the grip in a throwing star configuration,
wherein the luer slip and the tear shaped grip are singularly molded from the same material as an integrally formed component.
Claim 17 of the patent recites all the limitations of claim 20 of the instant application except “a plurality of protrusions extending radially from a slip surface”, “the collar is translatable relative to the luer slip”, “the collar is configured to couple with the mating connector adjacent to the first end of the luer slip”, “the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip, selectively rotationally coupling the collar and the luer slip”, “a spigot”, and “the spigot is circumferentially disposed around the second end of the luer slip”.
However, Davis teaches a plurality of protrusions extending radially from a slip surface (Fig. 7, [0029], proximal and distal retention members 140 and 142 to retain and/or hold the retractable locking collar in a predetermined position along exterior surface 144 of male tubing fitting 104), the collar is translatable relative to the luer slip (Fig. 1, [0020], retract, translate, slide, move, and/or rotate), the collar is configured to couple with the mating connector adjacent to the first end of the luer slip (Fig. 1, [0020], retractable locking collar 106 can lock male tubing fitting 104 and female tubing fitting 102 together), as well as a spigot (Fig. 4, male tubing fitting 104). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the male luer connector of the patent to have the proximal and distal retention members and the collar acting as a translatable relative configured to couple a mating connector as taught by Davis, in order for the device of the patent to have an improved slip resistant design and better locking capabilities for the user. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the tear shaped grip of the patent to the spigot as taught by Davis in order to provide the same gripping functionality.
The patent in view of Davis still does not disclose the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip, selectively rotationally coupling the collar and the luer slip, and the spigot is circumferentially disposed around the second end of the luer slip.
However, Tieck teaches the plurality of notches are configured to engage with the plurality of protrusions when the collar is spaced apart from the first end of the luer slip ([1018], the compressible ring member 980 is provided with one or more (or a plurality) of notches or slots 988 and 987, respectively, that have a shape and size that receive a corresponding one or more (or a plurality) of tabs or protrusions 989 on the body 985 of the cap 984), and selectively rotationally coupling the collar and the luer slip ([1018], the compressible ring member 980 is provided with one or more (or a plurality) of notches or slots 988 and 987, respectively, that have a shape and size that receive a corresponding one or more (or a plurality) of tabs or protrusions 989 on the body 985 of the cap 984). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the collar disclosed by the modified patent to have the plurality of notches corresponding to the plurality of protrusions as taught by Tieck in order for the device of the patent to have improved locking capabilities.
The patent in view of Davis and Tieck still does not disclose the spigot is circumferentially disposed around the second end of the luer slip. However, Kitani teaches the spigot is circumferentially disposed around the second end of the luer slip (Fig. 3 and Fig. 5, holding part 113 circumferentially encloses body tube 121 near first opening 121c). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the male luer connector disclosed by the modified patent to have the spigot circumferentially disposed around the second end of the luer slip as taught by Kitani in order for a user to be able to hold the male luer connector ([0061]).
Response to Arguments
Applicant’s arguments, see pages 9-17 of Applicant’s Remarks filed 06/15/2026, with respect to claims 1, 12, and 20 have been considered but are moot because the arguments do not apply in view of the present rejection.
Applicant argues on page 12 and 16 of the Applicant’s Remarks, regarding claims 1 and 12, that “Davis is silent with respect to the male plug 130 being ‘configured to receive a first type of tubing within the lumen’…Therefore, Davis does not disclose ‘the second end is configured to receive a first type of tubing within the lumen’” and “the cited references are not understood to disclose or teach…’the male luer connector is coupled to the infusion set component by disposing the tubing within the lumen at the second end of the luer slip’”. Applicant's arguments do not show how the amendments avoid such references or objections. In this case, the particular problem of concern is tubing received disposed within the lumen at the second end of the luer slip is not taught by Davis. As seen in Fig. 4 of Davis, the Examiner interprets the male luer connector of Davis to have a shared lumen between the spigot and the second end of the luer slip (the same internal bore 132 exist between the area defined by interior surface 138 within male tubing fitting 104, which has been defined as the fluid port of the spigot in this current rejection, and the area where diameter of internal bore 132 changes (second end)). For that reason, because the same lumen is applied between the two areas, tubing received or disposed within the spigot of Davis is interpreted as also being received or disposed within the lumen of the second end of the luer slip. Therefore, although the rejection of claims 1 and 12 were made moot by the new grounds of rejection, the use of Davis to teach the limitations described above still stands in the current rejection.
Applicant argues on page 15 of the Applicant’s Remarks, regarding claim 12, that “Even assuming for the sake of argument that ‘male tubing fitting 104 and male plug 130 share internal bore 132,’ this does not teach the male tubing fitting 104 defining a fluid port that receives the male plug 130. That is, Davis does not teach ‘a spigot defining a fluid port, wherein the fluid port receives the second end of the luer slip’". Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. In this case, the particular problem of concern is the spigot of Davis does not “receive” the second end of the luer slip. The Examiner interprets the word “receive” as a broad term meaning to accept, take, or assimilate. As seen in Fig. 4 of Davis, the Examiner interprets the location in which the shared lumen (internal bore 132) changes in diameter, which has previously been defined in this rejection as the second end of the luer slip, to be fluidly accepted into the area defined by interior surface 138 within male tubing fitting 104. Therefore, although the rejection of claim 12 was made moot by the new grounds of rejection, the use of Davis to teach the limitation described above still stands in the current rejection.
Conclusion
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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