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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nogle (U.S. Pat. 5,941,270, hereinafter “Nogle”).
Regarding claim 1, Nogle discloses a gravitational flow control device comprising a housing 150 (see Fig. 5) including a primary inlet 160 (see Fig. 5), a secondary inlet 158 (see Fig. 5), and an outlet 170 (see Fig. 5) disposed downstream of the primary and secondary inlets; a chamber 152 (see Fig. 5) disposed within the housing and fluidly connecting the primary and secondary inlets with the outlet; and a valve member 176 (see Fig. 5) pivotally mounted on an upper surface of the chamber. Nogle further discloses that the valve member pivots toward and blocks the primary inlet by fluid pressure in the secondary inlet when fluid pressure into the secondary inlet is higher than fluid pressure into the primary inlet (col. 5, lines 29-38).
Regarding claim 2, Nogle discloses the device of claim 1, wherein the valve member 176 (see Fig. 5) is configured to pivot toward and block the primary inlet 160 (see Fig. 5) when fluid pressure into the secondary inlet 158 (see Fig. 5) is higher than fluid pressure into the primary inlet, and to pivot toward and block the secondary inlet 158 when fluid pressure into the primary inlet is higher than fluid pressure into the secondary inlet (Nogle discloses that the flapper valve 72 is normally rotated clockwise to close inlet aperture 60 or counterclockwise to close inlet aperture 58; see col. 3, lines 47-51).
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Furman (U.S. Pat. 702,195, hereinafter “Furman”).
Regarding claim 3, Nogle discloses the device of claim 1, including a valve member 176 (see Fig. 5) comprising a lever having a first end and a second end and a fulcrum (at creased midportion 126; see Fig. 5) about which the lever pivots.
It is noted that Nogle does not appear to disclose a primary line sealing member disposed on the lever at a position corresponding to the primary inlet and a secondary line sealing member disposed on the lever at a position corresponding to the secondary inlet.
Furman discloses a valve member include sealing members on the ends of the valve element on both sides of its fulcrum F1 (see figure), and thus a primary sealing member E (see figure) disposed on the primary portion (left end of arm F) at a position corresponding to the primary inlet D (see figure); and a secondary line sealing member G (see figure) disposed on the secondary portion (right end of arm F) at a position corresponding to the secondary inlet H (see Furman at pg. 1, lines 51-52 and lines 59-61).
A skilled artisan would have found it obvious, before the effective filing date of the claimed invention, to provide the lever of Nogle with the primary and secondary line sealing members of Furman in order to block fluid flow through an inlet when the corresponding sealing member is engaged with the inlet.
Regarding claim 4, modified Nogle in view of Furman teaches the device of claim 3 , including that the valve member 176 (see Fig. 5) is normally positioned to close either the primary inlet 160 or the secondary inlet 158 (col. 3, lines 47-51). When positioned to close the primary inlet, the primary line sealing member corresponding to the primary inlet would contact the upper surface of the chamber, while the secondary line sealing member would be axially spaced apart from the upper surface of the chamber as shown in Fig. 5.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Furman, further in view of Westburg et al (U.S. Pat. 1,010,834, hereinafter “Westburg”).
Regarding claim 5, modified Nogle in view of Furman teaches the device of claim 3, and Nogle further discloses that the first end and second end of the lever 176 (see Fig. 5) are positioned axially offset from each other.
Regarding claim 6, modified Nogle does not appear to disclose the lever comprising a step having a height corresponding to the axial offset of the first and second ends.
Westburg teaches a flow regulating device comprising a step having a height corresponding to the axial offset of first and second ends of a lever (see annotated Fig. 1, below). The step height corresponds with the axial offset in that both are measurements between the primary and secondary portions of the lever.
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Westburg, Annotated Fig. 1.
A skilled artisan would have found it obvious, before the effective filing date of the claimed invention, to provide the lever of Nogle with a step as taught by Westburg, in order to have accommodated the different positions of the primary and secondary inlets relative to the valve device; doing so would have allowed for equal fluid inlet pressures to block the primary inlet while allowing the secondary inlet to continue to flow.
Regarding claim 7, modified Nogle in view of Furman and Westburg teaches the device of claim 6, and Nogle discloses that that the lever comprises a primary portion extending from the first end of the lever to the step and a secondary portion extending from the step to the second end of the lever (see Nogle at Fig. 1).
Regarding claim 8, modified Nogle in view of Furman and Westburg teaches the device of claim 7, and Westburg further discloses that the fulcrum is positioned on the primary portion of the lever (see Westburg at Fig. 2).
Regarding claim 9, modified Nogle in view of Furman and Westburg teaches the device of claim, and Westburg further discloses wherein the fulcrum is positioned between the first end and the step and is separate from the first end and the step (see Fig. 2).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Furman and Westburg, further in view of Seeburger (6.6: Moments and centers of mass, hereinafter “Seeburger”).
Regarding claim 10, modified Nogle in view of Furman and Westburg teaches the device of claim 8, but does not explicitly describe a distance between the primary line sealing member and the fulcrum being less than a distance between the secondary line sealing member and the fulcrum.
Seeburger discloses a class 1 lever where the fulcrum is disposed between two forces. The position of the fulcrum may be varied along the lever.
A skilled artisan would have found it obvious before the effective filing date of the claimed invention, to position the fulcrum at different locations along the lever without any inventive effort or extraordinary creativity, based on the evidence in Seeburger that it was known to vary the position of a fulcrum to reach a desired distribution of forces in the lever. Therefore, the skilled artisan would have found it obvious to provide the specific distance between the primary line sealing member and the fulcrum to be less than the distance between the secondary line sealing member and the fulcrum, as doing so would have allowed for varying differential fluid pressures to prevent primary fluid flow when the secondary fluid pressure is higher.
Claims 11 and 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Spohn et al (U.S. Pat. 9,526,829, hereinafter “Spohn”).
Regarding claim 11, Nogle teaches the device of claim 1, but does not appear to disclose that the housing comprises a circular housing having an inner circumferential surface defining the chamber as a circular chamber. Further, as per claim 12, Nogle does not appear to disclose that the housing comprises a cylindrical housing comprising a circular outer wall between a flat upper surface and a flat lower surface.
Spohn disclose a fluid delivery system comprising a valve that has a circular housing with an inner circumferential surface defining a valve chamber (see Fig. 4). The circular housing is elongated into a cylinder with flat upper and lower surfaces 104/106 (see Figs. 3-4).
A skilled artisan would have found it obvious before the effective filing date of the claimed invention, to modify the shape of the housing of Nogle to be circular and cylindrical, such that the housing has an inner circumferential surface defining the chamber as a circular chamber between the flat upper and lower surfaces, as doing so would have been a matter of obvious design choice absent any persuasive evidence that the particular configuration of the claimed housing was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Kelly (U.S. Pat. 5,665,074, hereinafter “Kelly”).
Regarding claim 13, Nogle teaches the device of claim 1, but does not appear to disclose that the housing is an octagonal housing with the upper surface comprising a flat top portion between two angled portions, wherein the primary inlet and the secondary inlet are disposed on the two angled portions, respectively.
Kelly discloses a fluid delivery system comprising an octagonal housing (see Fig. 1A, showing an octagonal housing 18 (see Fig. 1A, showing the top of the housing having a flat top where valve stem 27 is inserted, two angled portions with inlets 14 and 16 on either side of the flat portion, along with a further two additional sides along which the piston travels, and then two narrowed sides 44 and a flat side therebetween corresponding to outlet 12).
A skilled artisan would have found it obvious before the effective filing date of the claimed invention, to modify the shape of the housing of Nogle to be octagonal as claimed, as doing so would have been a matter of obvious design choice absent any persuasive evidence that the particular configuration of the claimed housing was significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nogle in view of Bormann (U.S. Pub. 2002/0029021, hereinafter “Bormann”).
Regarding claim 14, Nogle teaches the device of claim 1, but does not appear to disclose an air vent disposed on an upper surface of the housing and fluidly coupled to the chamber.
Bormann discloses an air vent 3 (see Fig. 9) disposed on an upper surface 10b (see Fig. 9) of a housing 14 (see Fig. 9), the air vent 3 fluidly communicated through a gas passageway 5 (see Fig. 9) with a chamber 15 (see Fig. 9) for venting air trapped in fluid entering the chamber through a secondary fluid line 400 (see Fig. 9). Bormann further discloses that the vent can separate gas from the fluid delivery system and that “gas” includes air (see para [0029]).
A skilled artisan would have found it obvious before the effective filing date of the claimed invention, to modify the device of Nogle to provide the air vent taught by Bormann, in order to minimize or eliminate the presence of air or gas from the system and allow liquid to flow more quickly as taught by Bormann (see Bormann at para [0003]).
Regarding claim 15, modified Nogle in view of Bormann teaches the device of claim 14 substantially as claimed, but does not, however, disclose that the air vent comprises a hydrophilic membrane that prevents liquid from passing through the air vent.
Bormann teaches a hydrophilic polyamide membrane 10 (see Fig. 9) that allows air to vent through the air vent and prevents liquid from passing therethrough (see para [0033]).
A skilled artisan would have found it obvious before the effective filing date of the claimed invention, to provide the air vent of modified Nogle with the hydrophilic membrane taught by Bormann, in order to allow air to vent through the air vent while preventing liquid from passing through the air vent.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Butterfield (U.S. Pub. 2020/0038584 A1, hereinafter “Butterfield”), in view of Nogle.
Regarding claim 16, Butterfield discloses an IV set comprising a primary fluid container 204 (see Fig. 2), a secondary fluid container 230 (see Fig. 2), a primary IV fluid line 214 (see Fig. 2), and a secondary IV fluid line 224 (see Fig. 2).
Butterfield does not appear to disclose the gravitational flow control device of claim 1.
Nogle teaches a flow control device as described in claim 1 (see present Action, pgs. 2-3).
A skilled artisan would have found it obvious before the effective filing date of the claimed invention to modify the invention of Butterfield to incorporate the flow control device as taught in Nogle, since the device of Nogle was well-known at the time of the invention for controlling fluid flow from the primary and secondary fluid lines based on differential fluid pressure, and a skilled artisan would have had a reasonable expectation of success in making the modification in order to permit different pressures of fluid flow depending on gravity without requiring a special pump.
Regarding claim 18, modified Butterfield in view of Nogle teaches the IV set of Claim 17, and Butterfield teaches that the height of the two fluid sources relative to one another affects the relative hydrostatic pressure of the sources (see para [0023]).
Accordingly, in modified Butterfield in view of Nogle, the valve member would pivot and block the primary inlet based on a greater hydrostatic pressure on the valve member from secondary fluid in the secondary fluid line than primary fluid in the primary fluid line due to the height difference between the primary fluid container and the secondary fluid container.
Similarly, regarding claim 19, in modified Butterfield in view of Nogle, the valve member would pivot and unblock the primary inlet based on a lower hydrostatic pressure on the valve member from secondary fluid in the secondary fluid line than primary fluid in the primary fluid line due to depletion of the secondary fluid from the secondary fluid container.
Regarding claim 20, modified Butterfield in view of Nogle teaches the IV set of Claim 16, wherein the primary fluid container comprises a primary IV fluid bag containing a primary medical fluid and the secondary fluid container comprises a secondary IV fluid bag containing a secondary medical fluid different from the primary medical fluid (see para [0075], disclosing primary fluid in the primary fluid bag and secondary fluid in the second fluid bag; see also para [0005], disclosing that the IV set is intended to administer multiple substances).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 09/23/2026
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