DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 4/28/26. As directed by the amendment: claims 1, 9, 10, and 14 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-20 are presently pending in this application.
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 8-12 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.
Claims 8-12 have not been amended to reflect the amendments that were made to independent parent claim 1, and appear to recite redundant limitations. It is unclear whether the limitations recited are reciting limitations in addition to those in claim 1, or are reciting limitations already provided in parent claim 1 and thus violating 35 U.S.C. 112(d); and in either case, it is unclear exactly how the limitations in claims 8-12 relate to those already recited in claim 1. Therefore, claims 8-12 are indefinite. The claims will be interpreted, for the purposes of the prior art, as referencing the same structures already recited in claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8-12, as best understood, are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
See the discussion under 35 U.S.C. 112(b) above; as best understood, claims 8-12 only recite limitations already recited in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-4, 8-12, and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager (US 4257416) in view of Burkholz et al. (US 20080287906).
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).
Prager additionally discloses venting of the secondary adaptor by means of a vent cap (40 or 44, fig. 1; col. 2, ln. 8-40), but fails to specifically disclose the secondary adapter comprises a tubular body having a proximal end, a distal end, an outer surface, an inner surface defining an adapter lumen therethrough, a venting tubing having a proximal end coupled to the distal end of the tubular body and a distal end, and a venting lumen extending therebetween, the venting lumen being fluidly communicated with the adapter lumen, and a venting cap disposed at the distal end of the venting tubing for fluidly communicating the adapter lumen with an exterior of the tubular body.
However, Burkoholz 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 outer surface (outer surface of 18 visible in fig. 22) an inner surface (inner surface of 18 visible in fig. 22) defining an adapter lumen 70 therethrough, a venting tubing 74 having a proximal end coupled to the distal end of the tubular body (the end of 74 which is coupled directly to 18 in fig. 22 is the proximal end of 74 as claimed) and a distal end (end of 74 where 78 is located is the distal end as claimed), and a venting lumen extending therebetween (lumen 72 of 74), the venting lumen being fluidly communicated with the adapter lumen (see fig. 22, via actuation of 68), and a venting cap 78 disposed at the distal end of the venting tubing for fluidly communicating the adapter lumen with an exterior of the tubular body (see fig. 22; 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 venting capability directly through the adaptor.
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 claims 8-11, as best understood, 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 venting capability directly through the adaptor.
Regarding claim 12, as best understood, Burkholz et al. further teaches the venting cap 78 coupled to the secondary adapter 18 (see fig. 22), the venting cap having a body (body of 78) with a venting lumen defined therethrough (any porous pathway through 78 as described in par. 0082), the venting lumen being fluidly communicated with the adapter lumen 76 of the secondary adapter 18 (via actuation of 68, see fig. 22).
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), the secondary inlet tubing comprising a proximal end (towards 34 or 38) having a secondary adapter (34 or 38); 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).
Prager additionally discloses venting of the secondary adaptor by means of a vent cap (40 or 44, fig. 1; col. 2, ln. 8-40), but fails to specifically disclose the secondary adapter comprises a tubular body having a proximal end, a distal end, an outer surface, an inner surface defining an adapter lumen therethrough, a venting tubing having a proximal end coupled to the distal end of the tubular body and a distal end, and a venting lumen extending therebetween, the venting lumen being fluidly communicated with the adapter lumen, and a venting cap disposed at the distal end of the venting tubing for fluidly communicating the adapter lumen with an exterior of the tubular body.
However, Burkoholz 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 outer surface (outer surface of 18 visible in fig. 22) an inner surface (inner surface of 18 visible in fig. 22) defining an adapter lumen 70 therethrough, a venting tubing 74 having a proximal end coupled to the distal end of the tubular body (the end of 74 which is coupled directly to 18 in fig. 22 is the proximal end of 74 as claimed) and a distal end (end of 74 where 78 is located is the distal end as claimed), and a venting lumen extending therebetween (lumen 72 of 74), the venting lumen being fluidly communicated with the adapter lumen (see fig. 22, via actuation of 68), and a venting cap 78 disposed at the distal end of the venting tubing for fluidly communicating the adapter lumen with an exterior of the tubular body (see fig. 22; 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 venting capability directly through the adaptor.
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(s) 5-7 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager in view of Burkholz et al., and further 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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582
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From pg. 17:
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384
630
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Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prager in view of Burkholz et al., and further 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.).
Response to Arguments
Applicant's arguments filed 4/28/26 have been fully considered but they are not persuasive.
Applicant appears to argue, on pg. 7-9 of the Remarks, that Burkholz et al.’s elements 72 and 74 are “integral” and therefore do not read on the amended claim language of independent claims 1 and 14. Examiner respectfully disagrees. There is no language in the claims as currently presented that would require any particular type of connection between the argued elements; the claims simply require that the venting tubing be “coupled” to the tubular body. As shown in fig. 22 of Burkholz et al., elements 72 and 74 are clearly coupled together.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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