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 6/23/2026 has been entered. Claims 1-15 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112 rejection previously set forth in the Non-Final Office Action mailed 1/26/2026.
Claim Objections
Claims 1, 10, and 13 are objected to because of the following informalities:
Regarding claim 1, “the hemispherical surface” should be corrected to “the substantially hemispherical surface” for claim language consistency.
Regarding claim 10, “the hemispherical surface” should be corrected to “the substantially hemispherical surface” and the second recitation of “an outer diameter” should be corrected to “the outer diameter” for claim language consistency.
Regarding claim 13, the last recitation of “a substantially identical surface of the mating recess” should be corrected to “the substantially identical surface of the mating recess” for claim language consistency. Appropriate correction is required.
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flaherty (US 5213483 A), in view of Nikitina (US 20120209252 A1), with annotated figures taken from Nikitina ‘626 (WO 2012109626 A2).
Regarding claim 1, Flaherty discloses an intravenous (IV) tubing fitment (connector 76, 76a, and key element 72 are all being interpreted as the IV tube fitment, Col 4 lines 50-53 & Fig. 1), comprising: a unitary body comprising (connector 76 and element 72 “may be integral structures,” Col 4 lines 52-53): a first end configured to couple to a first portion of a tubing (bottommost portion of element 72 is connected to tube 13, see Fig. 1), a substantially spherical surface adjacent to the first end (a substantially spherical surface adjacent to the bottommost portion of element 72, see Fig. 1), and a cylindrical body (connector 76 and 76a are being interpreted as the cylindrical body, see Fig. 1), configured to receive a second portion of the tubing at a second end of the unitary body (connector 76A is adapted for connection to tube 14 at a second end, Col 4 lines 47-50 & Fig. 1); and wherein the unitary body is configured to be received into a mating recess of a fluid delivery device such that (element 72 mates with keyway 66 of receiver 24 – keyway 66 and channel 62 are both being interpreted as the claimed mating recess – see Col 5 lines 3-4 & Fig. 1; receiver 24 is part of infusion pump system 10 which is being interpreted as the fluid delivery device):
the substantially spherical surface is uniformly mated with a substantially identical surface of the mating recess, and the cylindrical body is positioned outside of the mating recess (inner surface of keyway 66 and element 72 are cooperatively configured and both shown as being substantially spherical, Col 5 lines 3-4 & Fig. 1; the connectors 76 and 76a are outside the keyway 66, see Fig. 1).
However, Flaherty fails to explicitly disclose an intravenous (IV) tubing fitment comprising: a substantially hemispherical surface adjacent to the first end, wherein the first end is disposed at an apex of the hemispherical surface, and ending at an outer rim defining an outer diameter of the substantially hemispherical surface, and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end,
the cylindrical body including a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end.
However, Nikitina teaches an intravenous (IV) tubing fitment (abstract and [0005]) comprising: a unitary body (fitting 10 being a unitary body, [0021] & Fig. 1-2) comprising: a substantially hemispherical surface adjacent to the first end (fitting 10 comprising a substantially hemispherical surface (SHS), annotated below as “SHS” in Fig. 1, adjacent female luer connector 26, [0021] & Fig. 1-2), wherein the first end is disposed at an apex of the hemispherical surface (connector 26 is disposed at an apex of the SHS, annotated below as “APEX” in annotated Fig. 1), and ending at an outer rim defining an outer diameter of the substantially hemispherical surface (the SHS ends at an outer rim defining an outer diameter of the SHS, see “OUTER RIM” below in annotated Fig. 1), and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex (body 12 adjacent the SHS opposite the “APEX”, see annotated Fig. 1 below and Fig. 2) and disposed at least partially within an interior volume defined by the substantially hemispherical surface (body 12, annotated below in Fig. 1 as “C. BODY”, disposed partially within an interior volume defined by the SHS, annotated below in Fig. 1 as “INTERIOR VOLUME”), the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface (body 12 having a diameter smaller than the outer diameter defined by the outer rim, see annotated Figs. 1-2 below) and defining a lumen extending from the first end through the substantially hemispherical surface to a second end (body 12 having a fluid passage 20/21 extending from connector 26 through the “SHS” to tubular portion 14, see annotated Figs. 1-2 below and [0021]-[0022]), the cylindrical body configured to receive a second portion of the tubing at a second end of the unitary body (body 12 configured to receive tubing at tubular portion 14, [0021]-[0022] and [0024] & Fig. 1-4B),
the cylindrical body including a plurality of wings protruding from the cylindrical body (two wing tabs 13, annotated below as “WING 1” and “WING 2”, see [0021]) and extending from at least partially within the interior volume defined by the substantially hemispherical surface (as annotated below in Fig. 2, wing tabs 13 extend partially within the “INTERIOR VOLUME” defined by the SHS), longitudinally along the cylindrical body toward the second end (wings tabs 31 extend longitudinally along body 12 toward portion 14, see 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 infusion pump system of Flaherty with Nikitina to include a substantially hemispherical surface adjacent to the first end, wherein the first end is disposed at an apex of the hemispherical surface, and ending at an outer rim defining an outer diameter of the substantially hemispherical surface, and a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end, the cylindrical body including a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end,
since such a modification would provide a medical fitting capable of connecting to tubing of various sizes that includes wings to improve gripping capability for users using the fitting, and yield predictable results pertaining to medical tube connection ([0008], [0019], [0021], and [0024]-[0025] of Nikitina).
As modified, fitting 10 of Nikitina would be substituted for connector 76, 76a, and element 72 of Flaherty in the infusion pump system. Flaherty places no criticality on the specific shape of the key elements 70/72, providing multiple examples of shapes in Figures 3A-3B, as long as their respective keyways 64/66 are similarly shaped to allow mating (see Col 4 lines 60-68 and Col 5 lines 1-7 of Flaherty). In the combination, keyway 66 of receiver 24 of Flaherty would be configured to mate with the SHS of Nikitina, like element 72 with keyway 66, leaving body 12 of Nikitina positioned outside keyway 66, like connector 76 of Flaherty.
Additionally, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
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Regarding claim 2, Flaherty, as modified, discloses all the limitations of claim 1. However, Flaherty, in the embodiment of Figure 1, does not explicitly disclose the IV tubing fitment wherein the unitary body, when received by the mating recess, is configured to rotate about a longitudinal axis at least 270 degrees in a clockwise and counterclockwise direction. In the embodiment of Fig. 1 of Flaherty, key element 70 is not shown as including a substantially hemispherical surface.
However, Flaherty teaches that both key elements 70 and 72 may be identical in shape (Col 5 lines 55-59). As modified, element 70 of Flaherty may be another connector of Nikitina. As combined, the connector, received in the mating recess, would be configured to rotate since the connectors of Nikitina at both ends of tube set 22 of Flaherty include a SHS, annotated above in Fig. 1, along with correspondingly shaped keyways 64 and 66.
The combination of the two embodiments above, the embodiment of key elements with different shapes and the embodiment of key elements with the same shape, is suitable since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Regarding claim 3, Flaherty, as modified, discloses all the limitations of claim 1. Flaherty, as modified, further discloses the IV tubing fitment wherein the substantially hemispherical surface includes the outer rim that is configured to engage with a door of the fluid delivery device (surface 28 of Flaherty is being interpreted as the door, see Fig. 1; “receiver 24 mates against a substantially planar coupling surface 28 of a cooperatively directionally keyed peristaltic pump”, Col 3 lines 32-36; the “OUTER RIM”, as annotated above in Fig. 1, would necessarily engage with surface 28 when receiver 24 and surface 28 are mated).
Regarding claim 4, Flaherty, as modified, discloses all the limitations of claim 3. Flaherty, as modified, further discloses the IV tubing fitment wherein the outer rim, when engaged with the door of the fluid delivery device, restricts movement of the unitary body, in at least one of a longitudinal and latitudinal directions (when receiver 24 and surface 28 are mated, the “OUTER RIM”, as annotated above in Fig. 1, would restrain the connector longitudinally and laterally, Col 3 lines 32-36 & Fig. 1 of Flaherty and Fig. 1-2 of Nikitina).
Regarding claim 5, Flaherty, as modified, discloses all the limitations of claim 1. Flaherty, as modified, further discloses the IV tubing fitment wherein the substantially hemispherical surface is uniformly mated with the substantially identical surface of the mating recess only when the first end of the unitary body is received within a pocket of the mating recess preventing the IV tubing fitment from being misloaded (channel 62 is being interpreted as a pocket that connector 26 of Nikitina, as modified, is received in, see Fig. 1 of Flaherty and Figure 1-2 of Nikitina; channel 62 sized to accommodate the first end, as would be apparent to one of ordinary skill in the art; the connector of Nikitina would only be mated with keyway 66 when the first end of the connector would be mated in channel 62 considering the second end is structurally unidentical, see Col 4 lines 60-68 and Col 5 lines 1-7 of Flaherty and Figure 1-2 of Nikitina; this mating relationship prevents the fitment from being misloaded).
Regarding claim 6, Flaherty, as modified, discloses all the limitations of claim 5. Flaherty, as modified, further discloses the IV tubing fitment wherein when the first end of the unitary body is received within the pocket of the mating recess, the first portion of the tubing coupled with the first end of the unitary body is aligned along a center of the mating recess (when connector 26 of Nikitina is mated in channel 62, tube 13 is aligned along a longitudinal center of keyway 66, see Fig. 1 and exemplary embodiments 3A and 3B of Flaherty and Fig. 1-2 of Nikitina).
Regarding claim 7, Flaherty, as modified, discloses all the limitations of claim 1. Flaherty, as modified, further discloses the IV tubing fitment wherein the substantially hemispherical surface has a diameter that is substantially equal to a diameter of the mating recess (the keyway 66 configured to cooperatively mate with the “SHS” of Nikitina, Col 5 lines 3-4 & Fig. 1 of Flaherty and annotated Fig. 1 above of Nikitina; the diameters of both elements would be substantially equal to allow mating),
wherein the diameter of the substantially hemispherical surface prevents the fluid delivery device from closing when the substantially hemispherical surface is not uniformly mated with the substantially identical surface of the mating recess (the dimensions of the “SHS” of Nikitina and keyway 66 are designed to allow cooperative mating, synonymous to the relationship between element 72 and keyway 66; if the “SHS” of Nikitina is incorrectly placed in keyway 66, such that it is not completely mated, offset, or placed upside down, the receiver 24 could not mate with surface 28, see Col 6 lines 28-34 of Flaherty and Fig. 1-2 of Nikitina).
Regarding claim 8, Flaherty, as modified, discloses all the limitations of claim 1. Flaherty, as modified, further discloses the IV tubing fitment wherein the fluid delivery device is an infusion pump (abstract and Col 3 lines 26-28).
Regarding claim 9, Flaherty, as modified, discloses all the limitations of claim 1. Flaherty, as modified, further discloses the IV tubing fitment wherein the unitary body is molded. The limitation of “the unitary body is molded” is considered to be a product-by-process limitation. A product-by-process limitation adds no patentable distinction to the claim, and is unpatentable if the claimed product is the same as a product of the prior art.
Regarding claim 10, Flaherty discloses a system (infusion pump system 10, Fig .1) comprising: an intravenous (IV) tubing fitment (see the rejection of claim 1 above), comprising: a unitary body (see the rejection of claim 1 above) comprising: a first end configured to couple to a first portion of a tubing (see the rejection of claim 1 above), a substantially spherical surface adjacent to the first end (see rejection of claim 1 above), and a cylindrical body (see the rejection of claim 1 above), configured to receive a second portion of the tubing at a second end of the unitary body (see the rejection of claim 1 above), and wherein the unitary body is configured to be received into a mating recess of a fluid delivery device (see the rejection of claim 1 above) such that the substantially spherical surface is uniformly mated with a substantially identical surface of the mating recess, and the cylindrical body is positioned outside of the mating recess (see the rejection of claim 1 above); and a fluid delivery device (receiver 24 and pump 26, Fig. 1) comprising a body forming, in part, a mating recess (receiver 24 including keyway 66 and channel 62, Fig. 1) and a door (surface 28, Col 3 line 35 & Fig. 1), wherein: while the door is in an open position, the mating recess is configured to receive the IV tubing fitment such that the mating recess is uniformly mated with a substantially spherical surface of the IV tubing fitment (receiver 24, while not attached to coupling surface 28, is configured to mate keyway 66 and element 72, Col 5 lines 1-6 & Fig. 1), and a portion of the IV tubing fitment is positioned outside of the body of the fluid delivery device (connectors 76 and 76a are positioned outside the receiver 24, see Fig. 1); and when the door is moved to a closed position, while the IV tubing fitment is mated with the mating recess, the door is configured to couple with the body of the fluid delivery device enclosing the IV tubing fitment in a pocket (surface 28 is configured to mate with receiver 24 enclosing the element 72 between surface 28 and keyway 66 and channel 62, this space is being interpreted as the pocket).
Flaherty does not explicitly disclose the door forming another part of the mating recess. Looking at the provided Figures, Flaherty does not show the surface 28 having another part of the mating recess, but it is implied based on the specification and Figures 3A-3B that there would be cooperative mating recesses on surface 28 to mate with element 72. As is shown in the exemplary embodiments of Figures 3A-3B, key element 72 is not fully enclosed in keyway 66. Therefore, in order for receiver 24 to mate against the substantially planar coupling surface 28, there would need to be a complementary mating recess on surface 28 to account for the portion of key element 72 not already mated in keyway 66. Additionally, the specification notes that coupling surface 28, which is being interpreted as the door, is cooperatively directionally keyed, see Col 3 lines 34-36. The cooperatively directionally keyed elements that would be on surface 28 are being interpreted as part of the mating recess.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to include a mating recess on surface 28 since such a modification would allow for the receiver 24 and surface 28 to mate flush with one another and ensure proper mating of key element 72.
Further, Flaherty fails to explicitly disclose an intravenous (IV) tubing fitment comprising: a substantially hemispherical surface adjacent to the first end, wherein the first end is disposed at an apex of the hemispherical surface, and ending at an outer rim defining an outer diameter of the substantially hemispherical surface, and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end,
the cylindrical body including a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end.
However, Nikitina teaches an intravenous (IV) tubing fitment (abstract and [0005]) comprising: a unitary body (fitting 10 being a unitary body, [0021] & Fig. 1-2) comprising: a substantially hemispherical surface adjacent to the first end (fitting 10 comprising a substantially hemispherical surface (SHS), annotated above as “SHS” in Fig. 1, adjacent female luer connector 26, [0021] & Fig. 1-2), wherein the first end is disposed at an apex of the hemispherical surface (connector 26 is disposed at an apex of the SHS, annotated above as “APEX” in annotated Fig. 1), and ending at an outer rim defining an outer diameter of the substantially hemispherical surface (the SHS ends at an outer rim defining an outer diameter of the SHS, see “OUTER RIM” above in annotated Fig. 1), and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex (body 12 adjacent the SHS opposite the “APEX”, see annotated Fig. 1 above and Fig. 2) and disposed at least partially within an interior volume defined by the substantially hemispherical surface (body 12, annotated above in Fig. 1 as “C. BODY”, disposed partially within an interior volume defined by the SHS, annotated above in Fig. 1 as “INTERIOR VOLUME”), the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface (body 12 having a diameter smaller than the outer diameter defined by the outer rim, see annotated Figs. 1-2 above) and defining a lumen extending from the first end through the substantially hemispherical surface to a second end (body 12 having a fluid passage 20/21 extending from connector 26 through the “SHS” to tubular portion 14, see annotated Figs. 1-2 above and [0021]-[0022]), the cylindrical body configured to receive a second portion of the tubing at a second end of the unitary body (body 12 configured to receive tubing at tubular portion 14, [0021]-[0022] and [0024] & Fig. 1-4B),
the cylindrical body including a plurality of wings protruding from the cylindrical body (two wing tabs 13, annotated above as “WING 1” and “WING 2”, see [0021]) and extending from at least partially within the interior volume defined by the substantially hemispherical surface (as annotated above in Fig. 2, wing tabs 13 extend partially within the “INTERIOR VOLUME” defined by the SHS), longitudinally along the cylindrical body toward the second end (wings tabs 31 extend longitudinally along body 12 toward portion 14, see 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 infusion pump system of Flaherty with Nikitina to include a substantially hemispherical surface adjacent to the first end, wherein the first end is disposed at an apex of the hemispherical surface, and ending at an outer rim defining an outer diameter of the substantially hemispherical surface, and a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than the outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end, the cylindrical body including a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end,
since such a modification would provide a medical fitting capable of connecting to tubing of various sizes that includes wings to improve gripping capability for users using the fitting, and yield predictable results pertaining to medical tube connection ([0008], [0019], [0021], and [0024]-[0025] of Nikitina).
As modified, fitting 10 of Nikitina would be substituted for connector 76, 76a, and element 72 of Flaherty in the infusion pump system. Flaherty places no criticality on the specific shape of the key elements 70/72, providing multiple examples of shapes in Figures 3A-3B, as long as their respective keyways 64/66 are similarly shaped to allow mating (see Col 4 lines 60-68 and Col 5 lines 1-7 of Flaherty). In the combination, keyway 66 of receiver 24 of Flaherty would be configured to mate with the SHS of Nikitina, like element 72 with keyway 66, leaving body 12 of Nikitina positioned outside keyway 66, like connector 76 of Flaherty.
Regarding claim 11, Flaherty, as modified, discloses all the limitations of claim 10. Flaherty, as modified, further discloses the system wherein the door includes one or more coupling members configured to engage with an outer rim of the substantially hemispherical surface of the IV tubing fitment (the mating recess on surface 28, as described above in claim 10, is being interpreted as a coupling member capable of coupling, as modified, to the “OUTER RIM” of Nikitina, see annotated Fig. 1-2 of Nikitina above).
Regarding claim 12, Flaherty, as modified, discloses all the limitations of claim 10. Flaherty, as modified, further discloses the system wherein the door is prevented from closing while the IV tubing fitment is misloaded and the substantially hemispherical surface is not mated with the substantially identical surface of the mating recess (if the “SHS” of Nikitina is incorrectly placed into key element 66, placed in the opposite keyway 64, placed upside down, or offset, the receive 24 would not be in the correct directional orientation and would not be able to couple to surface 28, see Col 6 lines 28-34 and Col 2 lines 5-11 of Flaherty and annotated Fig. 1-2 of Nikitina above).
Regarding claim 13, Flaherty discloses a method for loading an intravenous (IV) set to a fluid delivery device (loading tube set 22 into infusion pump system 10, Col 3 lines 26-36 & Fig. 1), the method comprising: at a fluid delivery device (infusion pump system 10, Fig. 1) comprising a body forming, in part, a mating recess (receiver 24 including keyway 66, Fig. 1) and a door (surface 28, Col 3 line 35 & Fig. 1):
while the door is in an open position, receiving an IV tubing fitment (connectors 76, 76a, and key element 72 are all being interpreted as the IV tube fitment, Col 4 lines 50-53 & Fig. 1) at the mating recess (receiver 24, while not attached to coupling surface 28, is configured to mate keyway 66 and element 72, Col 5 lines 1-6 & Fig. 1) such that a spherical surface of the IV tubing fitment is uniformly mated with a substantially identical surface of the mating recess (keyway 66 and element 72 are cooperatively configured to mate and both shown as being spherical, Col 5 lines 3-4 & Fig. 1),wherein the IV tubing fitment comprises a unitary body (connector 76 and element 72 “may be integral structures,” Col 4 lines 52-53) with the spherical surface at a first end that is configured to couple to a first portion of a tubing (element 72 is connected to tube 13 at a first end, see Fig. 1), and a cylindrical body adjacent to the spherical surface (connector 76 and 76a are being interpreted as the cylindrical body, which is adjacent element 72, see Fig. 1) and
a second end configured to receive a second portion of the tubing (connector 76A is adapted for connection to tube 14 at a second end, Col 4 lines 47-50 & Fig. 1); and closing the door such that the door couples with the body of the fluid delivery device and forms an enclosure that is configured to surround at least a portion of the IV tubing fitment (when surface 28 cooperatively mates with receiver 24, see Col 3 lines 32-36, element 72 becomes enclosed between surface 28 and keyway 66), wherein the spherical surface is configured to be received into the mating recess of the fluid delivery device such as to be uniformly mated with a substantially identical surface of the mating recess (keyway 66 and element 72 are cooperatively configured to mate and both shown as being spherical, Col 5 lines 3-4 & Fig. 1).
connectors 76, 76a, and key element 72 are all being interpreted as the IV tube fitment, Col 4 lines 50-53 & Fig. 1) at the mating recess (receiver 24, while not attached to coupling surface 28, is configured to mate keyway 66 and element 72, Col 5 lines 1-6 & Fig. 1) such that a spherical surface of the IV tubing fitment is uniformly mated with a substantially identical surface of the mating recess (keyway 66 and element 72 are cooperatively configured to mate and both shown as being spherical hemispherical, Col 5 lines 3-4 & Fig. 1
Flaherty does not explicitly disclose the door forming another part of the mating recess. Looking at the provided Figures, Flaherty does not show the surface 28 having another part of the mating recess, but it is implied based on the specification and Figures 3A-3B that there would be cooperative mating recesses on surface 28 to mate with element 72. As is shown in the exemplary embodiments of Figures 3A-3B, key element 72 is not fully enclosed in keyway 66. Therefore, in order for receiver 24 to mate against the substantially planar coupling surface 28, there would need to be a complementary mating recess on surface 28 to account for the portion of key element 72 not already mated in keyway 66. Additionally, the specification notes that coupling surface 28, which is being interpreted as the door, is cooperatively directionally keyed, see Col 3 lines 34-36. The cooperatively directionally keyed elements that would be on surface 28 are being interpreted as part of the mating recess.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to include a mating recess on surface 28 since such a modification would allow for the receiver 24 and surface 28 to mate flush with one another and ensure proper mating of key element 72.
Further, Flaherty fails to explicitly disclose the method wherein the IV tubing fitment comprises the substantially hemispherical surface at a first end that is configured to couple to a first portion of a tubing at an apex of the substantially hemispherical surface, and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than an outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end, the cylindrical body configured to receive a second portion of the tubing at the second end and including
a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end.
However, Nikitina teaches an intravenous (IV) tubing fitment (abstract and [0005]) comprising: a unitary body (fitting 10 being a unitary body, [0021] & Fig. 1-2) comprising: the substantially hemispherical surface at a first end (fitting 10 comprising a substantially hemispherical surface (SHS), annotated above as “SHS” in Fig. 1, adjacent female luer connector 26, [0021] & Fig. 1-2) that is configured to couple to a first portion of a tubing at an apex of the substantially hemispherical surface (female luer connector 26 is configured to couple to tubing, [0005] and [0021]; is disposed at an apex of the SHS, annotated above as “APEX” in annotated Fig. 1), and
a cylindrical body adjacent to the substantially hemispherical surface opposite the apex (body 12 adjacent the SHS opposite the “APEX”, see annotated Fig. 1 above and Fig. 2) and disposed at least partially within an interior volume defined by the substantially hemispherical surface (body 12, annotated above in Fig. 1-2 as “C. BODY”, disposed partially within an interior volume defined by the SHS, annotated above in Fig. 1-2 as “INTERIOR VOLUME”), the cylindrical body having a diameter smaller than an outer diameter of the substantially hemispherical surface (body 12 having a diameter smaller than the outer diameter defined by the outer rim of the “SHS”, see annotated Figs. 1-2 above) and defining a lumen extending from the first end through the substantially hemispherical surface to a second end (body 12 having a fluid passage 20/21 extending from connector 26 through the “SHS” to tubular portion 14, see annotated Figs. 1-2 above and [0021]-[0022]), the cylindrical body configured to receive a second portion of the tubing at the second end (body 12 configured to receive tubing at tubular portion 14, [0021]-[0022] and [0024] & Fig. 1-4B) and including
a plurality of wings protruding from the cylindrical body (two wing tabs 13, annotated above as “WING 1” and “WING 2”, see [0021]) and extending from at least partially within the interior volume defined by the substantially hemispherical surface (as annotated above in Fig. 2, wing tabs 13 extend partially within the “INTERIOR VOLUME” defined by the SHS), longitudinally along the cylindrical body toward the second end (wings tabs 31 extend longitudinally along body 12 toward portion 14, see 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 infusion pump system of Flaherty with Nikitina to include the substantially hemispherical surface at a first end that is configured to couple to a first portion of a tubing at an apex of the substantially hemispherical surface, and a cylindrical body adjacent to the substantially hemispherical surface opposite the apex and disposed at least partially within an interior volume defined by the substantially hemispherical surface, the cylindrical body having a diameter smaller than an outer diameter of the substantially hemispherical surface and defining a lumen extending from the first end through the substantially hemispherical surface to a second end, the cylindrical body configured to receive a second portion of the tubing at the second end and including a plurality of wings protruding from the cylindrical body and extending from at least partially within the interior volume defined by the substantially hemispherical surface, longitudinally along the cylindrical body toward the second end,
since such a modification would provide a medical fitting capable of connecting to tubing of various sizes that includes wings to improve gripping capability for users using the fitting, and yield predictable results pertaining to medical tube connection ([0008], [0019], [0021], and [0024]-[0025] of Nikitina).
As modified, fitting 10 of Nikitina would be substituted for connector 76, 76a, and element 72 of Flaherty in the infusion pump system. Flaherty places no criticality on the specific shape of the key elements 70/72, providing multiple examples of shapes in Figures 3A-3B, as long as their respective keyways 64/66 are similarly shaped to allow mating (see Col 4 lines 60-68 and Col 5 lines 1-7 of Flaherty). In the combination, the SHS of Nikitina would be configured to be received into keyway 66 and complementary mating surface 28 such as to be uniformly mated with keyway 66, like element 72 of Flaherty with keyway 66, leaving body 12 of Nikitina positioned outside keyway 66, like connector 76 of Flaherty.
Regarding claim 14, Flaherty, as modified, discloses all the limitations of claim 13. Flaherty, as modified, further discloses the method wherein receiving the IV tubing fitment at the mating recess comprises: receiving the IV tubing fitment into a mating recess of a fluid delivery device such that the cylindrical body is positioned outside of the mating recess while the substantially hemispherical surface is uniformly mated with the substantially identical surface of the mating recess (as modified, body 12 of Nikitina would be positioned outside receiver 24, see Fig. 1, when the “SHS” of Nikitina and keyway 66 are mated; this relationship is synonymous to connectors 76 and 76a being positioned outside receiver 24 when element 72 and keyway 66 are mated, see Fig. 1 and Figs. 3 of Flaherty and Fig. 1-2 of Nikitina).
Regarding claim 15, Flaherty, as modified, discloses all the limitations of claim 14. Flaherty, as modified, further discloses the method further comprising: uniformly mating the substantially hemispherical surface with the substantially identical surface of the mating recess only when the first end of the unitary body is received within a pocket of the mating recess preventing the IV tubing fitment from being misloaded (channel 62 is being interpreted as the pocket that connector 26 of Nikitina is received in, see Fig. 1 of Flaherty and Fig. 1-2 of Nikitina; channel 62 sized to accommodate the first end, as would be apparent to one of ordinary skill in the art; the connector of Nikitina would only be mated with keyway 66 when the first end of the connector would be mated in channel 62 considering the second end is structurally unidentical, see Col 4 lines 60-68 and Col 5 lines 1-7 of Flaherty and Fig. 1-2 of Nikitina; this mating relationship prevents the fitment from being misloaded), and receiving the IV tubing fitment within the pocket of the mating recess such that the first portion of the tubing coupled with the first end of the unitary body is aligned along a center of the mating recess (when connector 26 of Nikitina is mated in channel 62, tube 13 is aligned along a longitudinal center of keyway 66, see Fig. 1 and exemplary embodiments 3A and 3B of Flaherty).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Cawley (US 20060116660 A1) teaches a medical connector comprising a substantially hemispherical surface, a cylindrical body, and a plurality of wings extending from the cylindrical body (abstract, portion 14, and gripping portion 15, [0025]-[0028] & Fig. 1-2).
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.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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