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 .
Election/Restrictions
Applicant’s election without traverse of Species b (Fig. 3A-B) in the reply filed on 1/9/26 is acknowledged. However, upon further consideration, the requirement for election of species is hereby withdrawn. All claims are examined as set forth in the office action below.
Claim Objections
Claims 9 and 10 are objected to because of the following informalities: “air vent” in both claims appears to be referring back to previously recited “an air vent” from parent claim 8, and should be amended to “the air vent” in both claims 9 and 10. See, for example, recitation of “the air vent” as presented in claim 11, which also depends from claim 8. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4, 12, and 14-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prager (US 4257416).
Regarding claim 1, Prager discloses a multi-tubing intravenous (IV) extension set (fig. 1), comprising: an outlet tubing 16 comprising a proximal end (towards 18) and a distal end (towards 12); a primary inlet tubing 30 comprising a proximal end (towards 36) having a primary adapter 36 for receiving a fluid (col. 2, ln. 20-24), and a distal end (towards 18) fluidly coupled to the proximal end of the outlet tubing (via 18); at least one secondary inlet tubing (28 or 32) comprising a proximal end (towards 34 or 38) having a secondary adapter (34 or 38), and a distal end fluidly coupled to the proximal end of the outlet tubing (at 18); and a clamp 52 coupled to the outlet tubing, between the proximal and distal ends of the outlet tubing (see fig. 1), and having an open configuration configured to permit fluid to move in a first direction from the proximal end to the distal end of the outlet tubing, and a closed configuration configured to resist movement of the fluid in the first direction and cause the fluid to move in a second direction toward the at least one secondary inlet tubing (col. 2, ln. 12-40).
Regarding claim 2, Prager discloses in any of the open and closed configurations, the primary and secondary inlet tubing are fluidly coupled together (see fig. 1; col. 2, ln. 12-40).
Regarding claim 3, Prager discloses the at least one secondary inlet tubing comprises a plurality of secondary inlet tubings (28 and 32) fluidly coupled to the outlet tubing (at 18, see fig. 1).
Regarding claim 4, Prager discloses a primary multi-tubing connector 18 coupled to the proximal end of the outlet tubing (see fig. 1), wherein the distal ends of the primary inlet tubing and the at least one secondary inlet tubing are coupled to the primary multi-tubing connector (see fig. 1).
Regarding claim 12, Prager discloses a venting cap (40 or 44) coupled to the secondary adapter (34 or 38), the venting cap having a body (body of 40 or 44 visible in fig. 1) with a venting lumen defined therethrough (vent hole 46 or 50; col. 2, ln. 8-11), the venting lumen being fluidly communicated with an adapter lumen of the secondary adapter (col. 2, ln. 8-40).
Regarding claim 14, Prager discloses a multi-tubing intravenous (IV) extension set (fig. 1), comprising: an outlet tubing 16 comprising a proximal end (towards 18) and a distal end (towards 12); a primary inlet tubing 30 fluidly coupled to the proximal end of the outlet tubing (at 18); a secondary inlet tubing (28 or 32) fluidly coupled to the proximal end of the outlet tubing (at 18); and a clamp 52 coupled to the outlet tubing, between the proximal and distal ends of the outlet tubing (see fig. 1), and having an open configuration configured to permit a fluid to move from any of the primary and secondary inlet tubing to the distal end of the outlet tubing, and a closed configuration configured to restrict the fluid from moving to the distal end of the outlet tubing (col. 2, ln. 12-40).
Regarding claim 15, Prager discloses in any of the open and closed configurations, the primary and secondary inlet tubing are fluidly coupled together (see fig. 1; col. 2, ln. 12-40).
Regarding claim 16, Prager discloses the secondary inlet tubing comprises a plurality of secondary inlet tubings (28 and 32) fluidly coupled to the outlet tubing (at 18; see fig. 1).
Regarding claim 17, Prager discloses a primary multi-tubing connector 18 coupled to the proximal end of the outlet tubing (see fig. 1), wherein the distal ends of the primary inlet tubing and the secondary inlet tubing are coupled to the primary multi-tubing connector (see fig. 1).
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.
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.
Claim(s) 5-7 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager in view of Carefusion IV Sets and Accessories Catalogue 2013 (hereinafter “Carefusion”; cited in IDS dated 7/17/23 in the file wrapper; copy provided in the file wrapper of parent application 16578072).
Regarding claims 5-7 and 18-20, Prager discloses the set as claimed, except for the at least one secondary inlet tubing comprises a plurality of secondary inlet tubings fluidly coupled to the primary multi-tubing connector via a secondary multi-tubing connector, wherein each of the plurality of secondary inlet tubings have a distal end fluidly connected to the secondary multi-tubing connector, and an intermediate tubing fluidly coupled between the at least one secondary inlet tubing and the proximal end of the outlet tubing, wherein the primary inlet tubing is fluidly coupled between the intermediate tubing and the outlet tubing. However, Carefusion teaches numerous examples of providing an infusion set with primary and secondary inlet tubings, including arrangements similar to that of Prager (see, for example, option from pg. 57 of Carefusion, reproduced below) and arrangements with a secondary multi-tubing connector for multiple secondary inlet tubings, connected via an intermediate tubing to a primary multi-tubing connector (see, for example, the two options from pg. 17 of the reference reproduced in the image below). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Prager set to utilize multiple secondary inlet tubings connected to the primary multi-tubing connecter via an intervening secondary multi-tubing connector and/or intermediate tubing, as taught by Carefusion, for the purpose of adapting the set of Prager for the intended uses associated with configurations taught at least in pg. 17 of Carefusion, and further since such a modification is the result of selecting from a finite number of identified, predictable solutions (finite number of infusion set configurations provided in Carefusion) to achieve a predictable result (infusion functionality).
From pg. 57:
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154
582
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From pg. 17:
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384
630
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Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager in view of Burkholz et al. (US 20080287906).
Regarding claims 8-11, Prager discloses the set as claimed, including provision for venting of the secondary adaptor by means of a vent cap (40 or 44, fig. 1; col. 2, ln. 8-40), except for disclosing the secondary adapter comprises a body having a proximal end, a distal end, an inner surface defining an adapter lumen therethrough, and an air vent forming a fluid passageway from the inner surface to an outer surface of the body; wherein air vent is formed by a venting lumen that extends through the body, between the proximal and distal ends of the body; wherein air vent is formed by a venting tubing having a proximal end coupled to the body and an inner surface forming a venting lumen; and a permeable membrane disposed over the air vent and configured to permit a gas to move from the adapter lumen to the outer surface of the body. However, Burkholz et al. teaches an adaptor 18 (fig. 22) comprising a body (body of 18) having a proximal end (toward 24), a distal end (toward the bottom of fig. 22), an inner surface (inner surface of 18 visible in fig. 22) defining an adapter lumen 70 therethrough, and an air vent 74 forming a fluid passageway 72 from the inner surface to an outer surface of the body (see fig. 22); wherein air vent is formed by a venting lumen 72 that extends through the body (see fig. 22), between the proximal and distal ends of the body (see fig. 22); wherein air vent 74 is formed by a venting tubing (tube wall of 74, see fig. 22) having a proximal end coupled to the body (near 68) and an inner surface (inner surface of 74) forming a venting lumen 72; and a permeable membrane 78 disposed over the air vent and configured to permit a gas to move from the adapter lumen to the outer surface of the body (par. 0082). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the set of Prager to utilize a venting arrangement such as the one disclosed by Burkholz et al. in order to provide sufficient structure to eliminate the need for a vent cap and provide as-needed venting capability directly through the adaptor.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager in view of Lambert et al. (US 20150080814).
Regarding claim 13, Prager discloses the set as claimed, utilizing a clamp in the form of a slide clamp 52, except for specifically disclosing the clamp configured to be pinched or bent to move from the open configuration to the closed configuration. However, Lambert et al. teaches that slide clamps, such as element 52 of Prager, and clamps that open and close by pinching (“pinch clamp”), are interchangeable in the field of infusion (par. 0003). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a pinch clamp as taught by Lambert et al. instead of a slide clamp initially disclosed by Prager, since such a modification is the result of a simple substitution of one type of clamp for another (types of clamps listed in par. 0003 of Lambert et al.) to achieve a predictable result (selective tube clamping in an infusion line; par. 0003 of Lambert et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783