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 02/13/2026 has been entered. Claims 1, 5, 7-8, 12, 15, and 17-20 have been amended. Claims 9-11 are in the original/previously presented form. Claims 2-4, 6, 13-14, and 16 are cancelled. Claims 21-27 are newly presented. Thus, claims 1, 5, 7-12, 15, and 17-27 remain pending in the application.
Drawings
The drawings were received on 02/13/2026. These drawings are acceptable.
The drawings are objected to under 37 CFR 1.83(a) because they fail to show how the tubing is disposed between the spigot and the luer slip as described in claims 7 and 17, as well as in paragraph [0040] of the specification. as described in the specification.
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 19 are objected to because of the following informalities:
In claim 1, the Applicant has amended the claim to include a first second, and third tubing. However, these tubings were not specified in either the drawings or specification. Further, the specification does not include information regarding the use of number systems, such as labeling items as first, second, and third, as arbitrary. Appropriate correction is required. For the purpose of examination, the examiner will interpret the tubings in the same manner as the previous office action.
In claim 19, the Applicant has amended the claim to state “The infusion set of Claim 12, wherein the collar disposed around the first end of the luer slip, translatable relative to the luer slip, and configured to couple with the mating connector adjacent to the first end of the luer slip.” The grammar used in this amendment is not proper. The examiner suggest amending the claim to state “The infusion set of Claim 12, wherein the collar disposed around the first end of the luer slip and is a translatable relative to the luer slip, and the collar is configured to couple with the mating connector adjacent to the first end of the luer slip. Appropriate correction is required. For the purpose of examination, the examiner will interpret the claim to read as the proposed correction.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an infusion set component” in claim 12. The specification discloses in paragraph [0032] that the infusion set “may include a drip chamber 130, a check valve 140 and a roller clamp 150 connected together by tubing 160. The infusion set 120 may also include a Y-site 170 having a Y-shaped junction with a needleless connector 175, as well as a luer lock connector 180 at the end of the infusion set 120…The infusion set 120 may include additional infusion components and may be formed of any combination of components and the tubing 160.” For the purposes of examination, the examiner will interpret the infusion set component as any infusion element able to couple to the male luer connector.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 7 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 7 and 17, the amendment to claim 7 states “the third tubing is disposed between the spigot and the luer slip” and the amendment to claim 17 states “the tubing is disposed around the second end of the luer slip”, whereas the second end of the luer slip is received by the fluid port which is defined by the spigot as per claim 12. However, there does not appear to be any support in the drawings or specification for this amended limitation. In Applicant Remarks, the Applicant notes paragraphs [0035], [0036], [0047], [0048], [0052], [0053], and [0063]-[0072], as well as Figures 7-10 for support for the claim amendments. These sections of the specifications and the figures do not define the relationship between the tubing and its fitting between the spigot and luer slip. The only mention of the relationship is in [0040], [0064], and [0067]: “Optionally, the tubing can be captured between the luer slip 210 and the spigot 230 to mechanically couple the spigot 230.” FIGS. 7-8 depict tubing fitting inside the luer slip on the second end, and FIGS. 9-10 depict tubing inside the spigot. However, none of these references support how the connection should appear between the elements.
Claim 12 is 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 amendment to 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 amended to state “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. 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 second end of the luer slip.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 21-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Davis et al. (U.S. Patent Application Publication No. US 2013/0046287 A1; herein, Davis).
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), wherein the first end is configured to be disposed within a first tubing (Fig. 4, male plug 130 with a tapered outer profile can help coordinate connection between male plug and another connection) and the second end is configured to receive a second 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 a mating connector that includes the first tubing (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) coupled to the second end of the luer slip (Fig. 4, male tubing fitting 104 and male plug 130 share internal bore 132) and defining a fluid port, wherein the fluid port is configured to receive a third 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).
Regarding claim 21, 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, Davis discloses the collar is configured to be rotated to threadedly engage mating threads of the mating connector (Fig. 4, [0027, threads 158, 160).
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.
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 5, 8, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Davis 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, Davis does not disclose the second 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 second 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 second tubing 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 8, Davis does not disclose the third 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 third 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 third tubing 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, 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 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 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, 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 have modified the male plug of 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, 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 have modified the retractable locking collar of 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, 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 have modified the male tubing fitting of 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, 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 have modified the retractable locking collar of 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, 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 have modified the male tubing fitting of 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 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, 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 have modified the male plug of 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 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, 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 have modified the retractable locking collar of Davis to be silicone as taught by Wilshinsky as silicone is known 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 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), wherein the first end is configured to engage with a mating connector (Fig. 4, male plug 130 with a tapered outer profile can help coordinate connection between male plug and another connection);
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, proximal opening 134 leading into internal bore 132), 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),
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),
the male luer connector is coupled to the infusion set component by disposing the tubing within the fluid port ([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. 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 retractable luer lock system of Davis with the infusion set as taught by Kahn in order to provide an application of use, such as fluid transfer or control, 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 disclosed 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 disclosed by Piehl given that the features serve the same purpose of providing a higher volume of fluids at a faster flow rate.
Regarding claim 19, in the modified device of Davis, Davis discloses the collar 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 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 disclosed by Piehl in the modified 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 disclosed by Piehl in the modified 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 Shirley (United States Patent Application Publication No. US 2008/0140020 A1), 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), the male luer connector (Fig. 6) comprising:
a luer slip (Fig. 4, male plug 130) comprising a first end and a 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), and the luer slip defining a lumen extending between the first end and the second end (Fig. 4, [0024], internal bore 132), wherein the first end is configured to engage with a mating 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 the intravenous 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 fluid port (Fig. 4, proximal opening 134 leading into internal bore 132), wherein the spigot is coupled to the second end of the luer slip (Fig. 4, male tubing fitting 104 and male plug 130 share internal bore 132) and the fluid port is configured to receive the intravenous 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).
Davis does not disclose the male luer connector configured to be coupled to the female luer connector by the intravenous tubing, 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.
However, Shirley teaches the male luer connector configured to be coupled to the female luer connector by the intravenous tubing (FIG.7, male adaptor 40 and female adaptor 10 connector by tubing 96). 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 luer lock system disclosed by Davis to connect the male and female adaptors using tubing as taught by Shirley in order to use the device over a larger surface, while still having the male and female fittings to form strong connections with elements of other medical apparatuses or systems.
Davis in view of Shirley still 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. 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 retractable locking collar of 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 Shirley and 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 male tubing fitting of Davis to have the teardrop shape as taught by Gura-Emerling, in order for the modified device of Davis to have improved grip functionalities.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of co-pending Application No. 17/859,679 in view of
Davis et al. (United States Patent Application Publication No. US 2013/0046287 A1; herein, Davis), Shirley (United States Patent Application Publication No. US 2008/0140020 A1), and Tieck et al. (United States Patent Application Publication No. US 2016/0015957 A1; herein, Tieck). 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 co-pending application. The claims of the instant application and the claims of the co-pending application are compared in the table below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Instant Application 18/179,656
Co-pending Application 17/859,679
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 by the intravenous tubing, the male luer connector comprising:
a luer slip comprising a first end and a second end, and a plurality of protrusions extending radially from a slip surface, and the luer slip defining a lumen extending between the first end and the second end, wherein the first end is configured to engage with a mating connector and the second end is configured to engage with intravenous 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 fluid port, wherein the spigot is coupled to the second end the luer slip and the fluid port is configured to receive the intravenous tubing.
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, 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 20 of the co-pending application recites all the limitations of claim 20 of the instant application except “configured to be coupled to the female luer connector by the intravenous tubing”, “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”, and “a spigot”.
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 co-pending application 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 co-pending application 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 co-pending application to the male tubing fitting as taught by Davis, providing the same gripping functionality.
The co-pending application in view of Davis still does not disclose the male luer connector configured to be coupled to the female luer connector by the intravenous tubing, 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, and selectively rotationally coupling the collar and the luer slip.
However, Shirley teaches the male luer connector configured to be coupled to the female luer connector by the intravenous tubing (FIG.7, male adaptor 40 and female adaptor 10 connector by tubing 96). 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 luer lock system disclosed by Davis to connect the male and female adaptors using tubing as taught by Shirley in order to use the device over a larger surface, while still having the male and female fittings to form strong connections with elements of other medical apparatuses or systems.
The co-pending application in view of Davis and Shirley 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, and selectively rotationally coupling the collar and 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 have modified the collar of co-pending application in view of Davis to have the plurality of notches corresponding to the plurality of protrusions as taught by Tieck, in order for the device of the co-pending application to have improved locking capabilities.
Response to Arguments
Applicant's arguments, see pages 8-9, filed 02/13/2026, with respect to the rejection of claim 1 under 35 U.S.C. 102 have been fully considered but they are not persuasive. The amended feature of “the second end is configured to receive a second tubing within the lumen” is interpreted by the examiner as being anticipated by Davis, as the rest of claim 1 was in the previous office action.
Applicant’s arguments, see pages , filed 02/13/2026, with respect to the rejections of claims 12, and 20 under 35 U.S.C. 103 have been fully considered, but are considered moot because the arguments do not apply in view of the present rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EVELYN A THOMAN/ Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights