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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 2nd 2025 has been entered.
Claim Objections
Claims 3 and 11 objected to because of the following informalities: Regarding claims 3 and 11, “an outer rim” should be corrected to “the outer rim” for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 10, and 13 have been amended to include the limitation of “a hemispherical boundary”. This new limitation was not described in the original specification and is not supported by the original disclosure. The original disclosure does not provide detail regarding the boundaries that define “a hemispherical boundary” and does not include detail as to where such a boundary exists. The term “hemispherical boundary” is not present in the original written disclosure and the drawings do not provide clear indication of the bounds of “a hemispherical boundary”. Based on the newly amended claims, the outer rim defines one end of a potential “hemispherical boundary” but there is no clear description of where the boundary ends or if the boundary is open ended. Additionally, the original disclosure appears to include the outer rim as part of the substantially spherical surface (see claim 3). Therefore, the limitation of “a hemispherical boundary” is considered as new matter
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 Marken (US 4875718 A), and further in view of Watkinson (GB 2379253 A).
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 and ending at an outer rim defining a hemispherical boundary, and
a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of the outer rim, the cylindrical body including a plurality of wings, each of the plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end.
However, Marken teaches an intravenous (IV) tubing fitment (swivel connector 10 capable of use in medical treatment and medical fluid systems, abstract, Col 1 lines 34-44 and 53-57 & Fig. 1) comprising: a substantially hemispherical surface adjacent to the first end and ending at an outer rim defining a hemispherical boundary (socket 70 is being interpreted as a substantially hemispherical surface adjacent to sleeve 38, which is configured to couple to tubing 14, Col 3 lines 13-19 and 43-46 & Fig. 1-3; the right half of socket 70, including the portion of socket 70 with the greatest diameter and ending at hole 72, is being interpreted as an outer rim defining a hemispherical boundary, see Fig. 1-3; the Examiner notes that the term “substantially” allows for a broad interpretation of a hemispherical surface), and
a cylindrical body adjacent to the substantially hemispherical surface (sleeve 22 seen being cylindrical and next to, or adjacent, socket 70, Col 4 lines 14-20 & see Fig. 1 and 3) and having a diameter smaller than a diameter of the outer rim (the diameter of sleeve 22 seen being smaller than a diameter of the right half of socket 70, see Fig. 1-3).
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 IV tube fitment of Flaherty with Marken to include a substantially hemispherical surface adjacent to the first end and ending at an outer rim defining a hemispherical boundary, and a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of the outer rim since such a modification would provide a medical connector capable of relative movement in all planes without kinking while still being fluid tight and yield predictable results pertaining to medical tube connection (see Col 1 lines 60-end and Col 2 lines 1-24 of Marken).
As modified, the connector of Marken would be used instead of 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 socket 70 of Marken, like element 72 with keyway 66, leaving sleeve 22 of Marken positioned outside keyway 66, like connector 76 of Flaherty.
Further, Watkinson teaches an intravenous (IV) tubing fitment (coupling for medical fluid delivery, abstract & Fig. 3) comprising: a cylindrical body including a plurality of wings (tubular core 23 with a connection piece 24 at the end for attachment of a supply tube including a plurality of radial wings 25, page 9 paragraph 1 & Fig. 3-7), each of the plurality of wings protruding from the cylindrical body, below the outer rim (radial wings 25 protruding from tubular core 23 below flange 22 and sleeve 5, abstract, page 8 paragraph 2, and page 9 paragraph 1 & Fig. 3-7), and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end (radial wings 25 extending from flange 22 and sleeve 5 longitudinally along tubular core 23 toward connection piece 24, see Figs. 3-7).
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 IV tube fitment of Flaherty, as modified with Marken, with Watkinson to include the cylindrical body including a plurality of wings, each of the plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end, since such a modification would provide structure to assist in gripping the coupler during rotation, connection, and disconnection and give the coupler a distinct visual appearance and feel to facilitate recognition and differentiation from other forms of couplers (see page 9 paragraph 1 of Watkinson).
As modified, radial wings 25 of Watkinson would be included on sleeve 22 of Marken, protruding from sleeve 22 and extending from socket 70 along sleeve 22 toward distal end 28 of sleeve 22.
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.
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 Marken as modified by Watkinson. As combined, the connector, received in the mating recess, would be configured to rotate since the connectors of Marken, as modified, at both ends of tube set 22 of Flaherty include a substantially hemispherical socket 70 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 an 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 right half of socket 70 of Marken 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 right half of socket 70 of Marken would restrain the connector longitudinally and laterally, Col 3 lines 32-36 & Fig. 1 of Flaherty and Fig. 1-3 of Marken).
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 sleeve 38 of the connector of Marken, as modified, is received in, see Fig. 1 of Flaherty and Figure 1-3 of Marken; channel 62 sized to accommodate the first end, as would be apparent to one of ordinary skill in the art; the connector of Marken 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 1-3 of Marken; 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 sleeve 38 of Marken 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. 1-3 of Marken).
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 socket 70 of Marken, Col 5 lines 3-4 & Fig. 1 of Flaherty and Fig. 1-3 of Marken; 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 socket 70 of Marken and keyway 66 are designed to allow cooperative mating, synonymous to the relationship between element 72 and keyway 66; if socket 70 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. 1-3 of Marken).
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.
However, Flaherty fails to explicitly disclose an intravenous (IV) tubing fitment comprising: a substantially hemispherical surface adjacent to the first end and ending at an outer rim defining a hemispherical boundary, and
a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of the outer rim, the cylindrical body including a plurality of wings, each of the plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end.
However, Marken teaches an intravenous (IV) tubing fitment (swivel connector 10 capable of use in medical treatment and medical fluid systems, abstract, Col 1 lines 34-44 and 53-57 & Fig. 1) comprising: a substantially hemispherical surface adjacent to the first end and ending at an outer rim defining a hemispherical boundary (socket 70 is being interpreted as a substantially hemispherical surface adjacent to sleeve 38, which is configured to couple to tubing 14, Col 3 lines 13-19 and 43-46 & Fig. 1-3; the right half of socket 70, including the portion of socket 70 with the greatest diameter and ending at hole 72, is being interpreted as an outer rim defining a hemispherical boundary, see Fig. 1-3; the Examiner notes that the term “substantially” allows for a broad interpretation of a hemispherical surface), and
a cylindrical body adjacent to the substantially hemispherical surface (sleeve 22 seen being cylindrical and next to, or adjacent, socket 70, Col 4 lines 14-20 & see Fig. 1 and 3) and having a diameter smaller than a diameter of the outer rim (the diameter of sleeve 22 seen being smaller than a diameter of the right half of socket 70, see Fig. 1-3).
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 IV tube fitment of Flaherty with Marken to include a substantially hemispherical surface adjacent to the first end and ending at an outer rim defining a hemispherical boundary, and a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of the outer rim since such a modification would provide a medical connector capable of relative movement in all planes without kinking while still being fluid tight and yield predictable results pertaining to medical tube connection (see Col 1 lines 60-end and Col 2 lines 1-24 of Marken).
As modified, the connector of Marken would be used instead of 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 socket 70 of Marken, like element 72 with keyway 66, leaving sleeve 22 of Marken positioned outside keyway 66, like connector 76 of Flaherty.
Further, Watkinson teaches an intravenous (IV) tubing fitment (coupling for medical fluid delivery, abstract & Fig. 3) comprising: a cylindrical body including a plurality of wings (tubular core 23 with a connection piece 24 at the end for attachment of a supply tube including a plurality of radial wings 25, page 9 paragraph 1 & Fig. 3-7), each of the plurality of wings protruding from the cylindrical body, below the outer rim (radial wings 25 protruding from tubular core 23 below flange 22 and sleeve 5, abstract, page 8 paragraph 2, and page 9 paragraph 1 & Fig. 3-7), and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end (radial wings 25 extending from flange 22 and sleeve 5 longitudinally along tubular core 23 toward connection piece 24, see Figs. 3-7).
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 IV tube fitment of Flaherty, as modified with Marken, with Watkinson to include the cylindrical body including a plurality of wings, each of the plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward the second end, since such a modification would provide structure to assist in gripping the coupler during rotation, connection, and disconnection and give the coupler a distinct visual appearance and feel to facilitate recognition and differentiation from other forms of couplers (see page 9 paragraph 1 of Watkinson).
As modified, radial wings 25 of Watkinson would be included on sleeve 22 of Marken, protruding from sleeve 22 and extending from socket 70 along sleeve 22 toward distal end 28 of sleeve 22.
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 right half of socket 70 of Marken, including the portion of socket 70 with the greatest diameter, see Fig. 1-3 of Marken).
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 socket 70 of Marken 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 Fig. 1-3 of Marken).
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 hemispherical, 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).
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, and
a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of an outer rim defining a hemispherical boundary of the substantially hemispherical surface, the cylindrical body including
a plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward a second end.
Further, Marken teaches a method (abstract and Col 2 lines 5-11) wherein the IV tubing fitment (swivel connector 10 capable of use in medical treatment and medical fluid systems, abstract, Col 1 lines 34-44 and 53-57 & Fig. 1) comprises a unitary body with the substantially hemispherical surface at a first end that is configured to couple to a first portion of a tubing (connector 10 is being interpreted as a unitary body (see Fig. 1) including socket 70, which is being interpreted as a substantially hemispherical surface, adjacent to sleeve 38, which is configured to couple to tubing 14, Col 3 lines 13-19 and 43-46 & Fig. 1-3; the Examiner notes that the term “substantially” allows for a broad interpretation of a hemispherical surface), and
a cylindrical body adjacent to the substantially hemispherical surface (sleeve 22 seen being cylindrical and next to, or adjacent, socket 70, Col 4 lines 14-20 & see Fig. 1 and 3) and having a diameter smaller than a diameter of an outer rim defining a hemispherical boundary of the substantially hemispherical surface (the diameter of sleeve 22 seen being smaller than a diameter of the right half of socket 70, see Fig. 1-3; the right half of socket 70, including the portion of socket 70 with the greatest diameter and ending at hole 72, is being interpreted as an outer rim defining a hemispherical boundary, see Fig. 1-3).
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 method of Flaherty with Marken to include the IV tubing fitment comprising the substantially hemispherical surface at a first end that is configured to couple to a first portion of a tubing, and a cylindrical body adjacent to the substantially hemispherical surface and having a diameter smaller than a diameter of an outer rim defining a hemispherical boundary of the substantially hemispherical surface since such a modification would provide a medical connector capable of relative movement in all planes without kinking while still being fluid tight and yield predictable results pertaining to medical tube connection (see Col 1 lines 60-end and Col 2 lines 1-24 of Marken).
As modified, the connector of Marken would be used instead of 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 socket 70 of Marken, like element 72 with keyway 66, leaving sleeve 22 of Marken positioned outside keyway 66, like connector 76 of Flaherty.
Further, Watkinson teaches a method wherein the IV tubing fitment (coupling for medical fluid delivery, abstract and page 5 paragraphs 2-3 & Fig. 3) comprises a cylindrical body including a plurality of wings (tubular core 23 with a connection piece 24 at the end for attachment of a supply tube including a plurality of radial wings 25, page 9 paragraph 1 & Fig. 3-7) protruding from the cylindrical body, below the outer rim (radial wings 25 protruding from tubular core 23 below flange 22 and sleeve 5, abstract, page 8 paragraph 2, and page 9 paragraph 1 & Fig. 3-7), and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward a second end (radial wings 25 extending from flange 22 and sleeve 5 longitudinally along tubular core 23 toward connection piece 24, see Figs. 3-7) configured to receive a second portion of tubing (connection piece 24 configured for attachment of a supply tube, page 9 paragraph 1 & Fig. 3).
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 method of Flaherty, as modified with Marken, with Watkinson to include the cylindrical body including a plurality of wings protruding from the cylindrical body, below the outer rim, and extending from the substantially hemispherical surface longitudinally along the cylindrical body toward a second end, since such a modification would provide structure to assist in gripping the coupler during rotation, connection, and disconnection and give the coupler a distinct visual appearance and feel to facilitate recognition and differentiation from other forms of couplers (see page 9 paragraph 1 of Watkinson).
As modified, radial wings 25 of Watkinson would be included on sleeve 22 of Marken, protruding from sleeve 22 and extending from socket 70 along sleeve 22 toward distal end 28 of sleeve 22.
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, the connector of Marken would be positioned outside receiver 24, see Fig. 1, when socket 70 of Marken 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. 1-3 of Marken).
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 sleeve 36 of the connector of Marken is received in, see Fig. 1 of Flaherty and Fig. 1-3 of Marken; channel 62 sized to accommodate the first end, as would be apparent to one of ordinary skill in the art; the connector of Marken 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. 1-3 of Marken; 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 sleeve 38 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
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783