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 .
Claim Objections
Claims 2-3 and 12-13 are objected to because of the following informalities:
Regarding claims 2 and 12, ”against lower portion” should be corrected to “against the lower portion” for claim language consistency.
Regarding claims 3 and 13, “formed adjacent fingers of the plurality of fingers” should be corrected to “formed adjacent the plurality of fingers” or similarly for clarity.
Appropriate correction is required.
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.
Claim(s) 1-6, 8-9, 11-16, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Truitt (US 20110152787 A1).
Regarding claims 1 and 11, Truitt discloses a fluid delivery Y-site device (connector 2, [0025]-[0026] & Fig. 1 and 3A-3B) comprising: a first flow port, a second flow port, a chamber fluidly coupled between the first and second flow ports (channel portion 24 is being interpreted as the first flow port, [0030] & Fig. 1 and 3A-3B; channel 88 of third port 62 is being interpreted as the second flow port, [0067] & Fig, 1 and 3A-3B; main channel 26 and connecting channel 28, which is being interpreted as the chamber, is fluidly coupled between portion 24 and channel 88, [0030] & Fig. 1 and 3A-3B), wherein a fluid flow pathway extends from the first flow port and through the chamber to the second flow port (fluid pathway from portion 24, through channel 28, to channel 88, [0074] & Fig. 1);
a valve guide positioned in the chamber between the first and second flow ports, the valve guide having a lower portion and an upper portion (support elements 42 and connecting portion 44, which are positioned in main channel 26 and connecting channel 28, are being interpreted as the valve guide, [0039] & Fig. 3A-3B; one or more elements 42 are being interpreted as the upper portion and portion 44 is being interpreted as the lower portion, [0039]), and a peripheral opening extending through a perimeter of the valve guide (the space around one or more support elements 42 is being interpreted as a peripheral opening, which extends through a perimeter defined by a plurality of elements 42, [0039]); and
a valve positioned in the chamber between the first flow port and the lower portion of the valve guide (valve element 6 positioned in channel 26 between channel 24 and portion 44, [0030] and [0039] & Fig. 3A-3B), and configured to move between an occluding configuration and an open configuration based on a level of fluid within the chamber (“In use, the valve element 6 may move between an unflexed position (FIG. 3A), where fluid may be prevented from flowing past the first valve element 6, and a flexed position (FIG. 3B), where fluid may flow past the first valve element 6.”, [0039]; also see [0074] and [0080]),
wherein, in the occluding configuration, the valve is engaged against the first flow port to resist a fluid flow along the fluid flow pathway (“In use, the valve element 6 may move between an unflexed position (FIG. 3A), where fluid may be prevented from flowing past the first valve element 6”, [0039]), and in the open configuration, the valve is separated from the first flow port such that the fluid flow pathway extends around a circumference of the valve and through the peripheral opening of the valve guide (“a flexed position (FIG. 3B), where fluid may flow past the first valve element 6. “, [0039]; in the flexed position, fluid may flow around the disc 6, [0034]-[0035], and through the opening between and around elements 42).
Regarding claims 2 and 12, Truitt discloses all the limitations of claims 1 and 11. Truitt further discloses the fluid delivery Y-site device wherein, in the open configuration, the valve is engaged against lower portion of the valve guide to resist movement of the valve toward the second flow port (valve 6, in the flexed position of Fig. 3B, may be interpreted as operatively engaged against connecting portion 44, as valve 6 presses against the valve guide, preventing movement of valve 6 toward channel 88).
Regarding claims 3 and 13, Truitt discloses all the limitations of claims 1 and 11. Truitt further discloses the fluid delivery Y-site device wherein the upper portion of the valve guide comprises a plurality of fingers, and the peripheral opening is formed adjacent fingers of the plurality of fingers (one or more elements 42, prongs, are being interpreted as a plurality of fingers, the peripheral opening formed adjacent the plurality of elements 42, [0039] & Fig. 3A-3B).
Regarding claims 4 and 14, Truitt discloses all the limitations of claims 1 and 11. Truitt further discloses the fluid delivery Y-site device wherein a passage extends through the lower portion of the valve guide (“the connecting portion 44 may be conical in shape and may have openings (not shown) which allow fluid to flow past connecting portion 44. The connecting portion 44, however, can be any structure, having any shape, that holds one or more support elements 42 within the first port 22.”, [0039]; the openings are being interpreted as the passage).
Regarding claims 5 and 15, Truitt discloses all the limitations of claims 4 and 14. Truitt further discloses the fluid delivery Y-site device wherein the passage is offset from a central axis of the valve guide (the openings in connecting portion 44 would necessarily exist offset from the central axis considering one of elements, prongs, 42 is connected to connecting portion 44 at a center, see Fig. 3A-3B).
Regarding claims 6 and 16, Truitt discloses all the limitations of claims 1 and 11. Truitt further discloses the fluid delivery Y-site device wherein the valve comprises a convex upper surface configured to engage against the first flow port and a concave lower surface configured to engage against the valve guide (valve 6 having a concave lower surface configured to engage against elements 42, [0039] & Fig. 3B; “The first valve element 6 may be any shape (e.g., cylindrical, spherical, square, rectangular, triangular, conical, or polygonal), may have flat surface(s), and/or may have concave/convex surface(s)”, [0035]).
Regarding claims 8 and 18, Truitt discloses all the limitations of claims 1 and 11. Truitt further discloses the fluid delivery Y-site device further comprising a third flow port fluidly coupled to the chamber (channel 64 and proximal channel 66 are being interpreted as a third flow port, [0051] & Fig. 1 and 3A-3B; channel 64 and 66 fluidly coupled to channel 28, [0077]).
Regarding claims 9 and 19, Truitt discloses all the limitations of claims 8 and 18. Truitt further discloses the fluid delivery Y-site device wherein the third flow port is fluidly coupled to the chamber between the first and second flow ports (channel 64 is fluidly coupled to channel 28 between channel portion 24 and channel 88, 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.
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Truitt (US 20110152787 A1) as applied to claims 6 and 16 above, and further in view of Paradis (US 5190067 A).
Regarding claims 7 and 17, Truitt discloses all the limitations of claims 6 and 16. Truitt further discloses that “The first valve element 6 may be any shape (e.g., cylindrical, spherical, square, rectangular, triangular, conical, or polygonal), may have flat surface(s), and/or may have concave/convex surface(s). In addition, the first valve element 6 may have protrusions (e.g., protrusions 56 in FIG. 6C), indentations or ridges on a portion thereof or over its entire surface.” ([0035]) and that “the connecting portion 44 may be conical in shape and may have openings (not shown) which allow fluid to flow past connecting portion 44. The connecting portion 44, however, can be any structure, having any shape, that holds one or more support elements 42 within the first port 22.” ([0039]). Truitt places no criticality on the shape of the valve element 6 nor on the shape of the connecting portion 44.
However, Truitt fails to explicitly disclose the fluid delivery Y-site device wherein the concave lower surface comprises a circumferential edge configured to engage against the lower portion of the valve guide.
However, Paradis teaches a fluid delivery device (flow control device 20, Fig. 2A) wherein the concave lower surface comprises a circumferential edge configured to engage against the lower portion of the valve guide (concave lower surface of valve diaphragm, disc, 26 comprises a circumferential edge, see Col 8 lines 7-19 & Fig. 2A; the circumferential edge of disc 26 configured to engage against lateral extensions 27e as seen in Fig. 2A).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Truitt with Paradis to include a prong and disc configuration in which the concave lower surface comprises a circumferential edge configured to engage against the lower portion of the valve guide since Paradis teaches such a configuration to be an art effective shape for a flexible disc and prong check valve, with the prong having a conical shape with peripheral openings for fluid flow (Col 7 line 6-col 8 line 19 & Fig. 2A). The modification would yield the same predictable results pertaining to directional fluid control. As modified, connection portion 44 would adopt the conical shape of prong 27, with extensions 27e, and valve 6 of Truitt would be configured to engage extensions 27e, like disc 26 of Paradis.
Claim(s) 1, 10-11, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mylrea (US 4256103 A), in view of Alligood (US 3667464 A).
Regarding claims 1 and 11, Mylrea discloses a fluid delivery Y-site device (automatic sequential flow apparatus, col 1 line 55-col 2 line 5 & Fig. 1) comprising: a first flow port, a second flow port, a chamber fluidly coupled between the first and second flow ports, wherein a fluid flow pathway extends from the first flow port and through the chamber to the second flow port (the bottom face of top part 22, the structure denoted with numeral 17 in Fig. 1 (numeral 17 not provided in the written description), is being interpreted as the first flow port, see Fig. 1; drip tube 27 is being interpreted as the second flow port, col 4 lines 3-14 & Fig. 1; calibrated chamber 10 fluidly coupled between top part 22 and tube 27 with a fluid pathway extending from the bottom of top part 22, through chamber 10, to tube 27, col 3 lines 32-61 & Fig. 1);
a valve guide positioned in the chamber between the first and second flow ports, the valve guide having a lower portion and an upper portion (valve guide 24 positioned in chamber 10 between the bottom surface of top part 22 and tube 27, Col 5 lines 21-40 & Fig. 1; the top and bottom halves of guide 24 may simply be interpreted as the lower and upper portion, see Fig. 1), and an opening extending through the valve guide (valve guide 24 having an opening in which fluted shaft 15 is disposed, see Fig. 1); and
a valve positioned in the chamber between the first flow port and the lower portion of the valve guide, and configured to move between an occluding configuration and an open configuration based on a level of fluid within the chamber (fluted shaft 15 positioned in chamber 10 between the bottom of top part 22 and the lower half of valve guide 24, Col 3 lines 22-31 and col 5 lines 21-40 & Fig. 1-2; see col 3 lines 21-61 and Col 5 lines 10-18),
wherein, in the occluding configuration, the valve is engaged against the first flow port to resist a fluid flow along the fluid flow pathway (col 3 lines 48-62 and col 4 lines 26-31), and in the open configuration, the valve is separated from the first flow port such that the fluid flow pathway extends around a circumference of the valve and through the opening of the valve guide (col 3 lines 22-31 and lines 38-42 and col 5 lines 19-42 & Fig. 2; in the open configuration, fluted shaft 15, along with pointed end 16, is removed from the bottom of top part 22, denoted by numeral 17 in Fig. 1, such that fluid flows over and around tip end 16, down flutes 41, and through the opening in valve guide 24).
However, Mylrea fails to explicitly disclose a peripheral opening extending through a perimeter of the valve guide; and in the open configuration, the valve is separated from the first flow port such that the fluid flow pathway extends through the peripheral opening of the valve guide.
However, Alligood teaches a fluid delivery device (abstract) comprising a valve guide including a peripheral opening extending through a perimeter of the valve guide (tubular cylinder 1 provided with a plurality of perforations 8 at the lower end thereof, Col 3 lines 29-35 & Fig. 2); and in the open configuration, the valve is separated from the first flow port such that the fluid flow pathway extends through the peripheral opening of the valve guide (in response to changes in fluid level 11, elongated cylinder 7 moves out of tubular cylinder 1 such that the fluid pathway extends through the ) plurality of perforations 8, Col 3 lines 10-35 & Fig. 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Mylrea with Alligood to include a peripheral opening extending through a perimeter of the valve guide and the fluid flow pathway extending through the peripheral opening of the valve guide since such a modification would provide a secondary outlet for fluid to flow through and out of the valve guide, aiding in evacuation of fluid from the fluid source and helping prevent fluid buildup/occlusion along the flutes of the fluted shaft considering there is “minimum clearance between the exterior walls of fluted shaft 15 and the interior walls of valve guide 24” (see Col 5 lines 28-35 of Mylrea). As modified, a plurality of perforations would be included in the lower half of valve guide 24 of Mylrea.
Regarding claims 10 and 20, Mylrea, as modified, discloses all the limitations of claims 1 and 11. Mylrea further discloses the fluid delivery Y-site device further comprising a float positioned within the chamber between the valve and the second flow port (float 29 positioned within chamber 10 between fluted shaft 15 and tube 27, see Fig. 1 & Col 3 lines 35-62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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