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
An amendment was filed on 04/22/2026. Claims 1 and 13 have been amended, new claim 52 has been added, and claims 10 and 50-51 have been canceled. Currently, claims 1-2, 12-15, 18, 49, and 52 are pending and are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 have been considered but are not persuasive
In response to the applicant’s argument with respect to Kubulak, wherein the nose of the accessory connector does not include a barb at its terminal distal end, the plate section spaced from the terminal end of the nose, and as such the plate section is not a barb at the terminal distal end, nor does Kubalak disclose a continuous barb extending circumferentially around the entire perimeter of the terminal distal end, the examiner respectfully disagrees.
Examiner clarifies that the connector (80) of Kubalak is the structure with a continuous barb that extends circumferentially around the entire perimeter of the terminal distal end of the body. The plate section of the nose of the accessory connector coincides with the port having a circumferential rib. This rib is also spaced from a terminal proximal end of the port, regardless of which end is described as the terminal proximal end. As currently written, claims 1 and 13 do not require the rib of the port be at the terminal distal end thereof.
In response to the applicant’s arguments that Kubalak discloses the rib is located at a terminal end of the sheath connector, not distally spaced from a terminal proximal end of a port lumen, and does not teach a circumferential rib located within a port lumen and distally spaced from the terminal proximal end, the examiner respectfully disagrees.
The sheath connector in question is equated to the catheter connector as claimed, not the port with a circumferential rib. Moreover, as shown in annotated fig. 5C below, the circumferential rib is spaced apart from both terminal ends of the port.
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While Kubalak does not teach the circumferential rib located within a port lumen, the teachings of Okajima described below cure this deficiency, though it is noted that previously cited Wood has been withdrawn in light of the amendment. Kubalak appears to teach the remaining deficiencies as argued.
In response to the applicant’s arguments that the remaining prior art does not cure the deficiencies of Kubalak, the purported deficiencies have been addressed above.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 12-15, 18, 49, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak (US 20060025753) in view of Okajima (US 4582350), and further in view of Igari.
Regarding claim 1, Kubalak discloses a urinary catheter connector comprising:
a body including a proximal end, a terminal distal end, an outer surface, and a lumen extending therethrough (fig. 5C, connector 80 with a proximal end, terminal distal end, outer surface, and a lumen for communicating with sheath 20), the proximal end being configured to be directly attached to a distal end of a catheter tube such that the lumen of the body is in fluid communication with a drainage lumen of the catheter tube (fig. 5C shows a sheath 20 that is a part of the catheter has the proximal end of connector 80 being directly attached to the catheter tube), the distal end of the body defining an opening for urine drainage (fig. 5C, opening at distal end) and being configured for insertion onto a port of a collection bag (fig. 5C, connector 80 to connect with an accessory 90, which also lets the connector be configured to connect to a collection bag that has the same attachment) the distal end of the body including at least one barb (see annotated fig. 5C below) configured for engagement with a circumferential rib of the port (fig. 5C, plate section 96 engages with barb as described, said plate 96 shown as part of a circumferential cross-section) distally spaced from a terminal proximal end of the port (see annotated fig. 5C below ); and
wherein the at least one barb is a continuous barb that extends circumferentially around the entire perimeter of the terminal distal end of the body (fig. 5C shows the barb at a cross section, and fig. 5B shows this connector 80 as a circumferential structure).
but does not teach wherein the connector distal end is inserted into the port proximal end being configured to mate with the connector, wherein the circumferential rib of the port is located within a lumen of the port, wherein the at least one barb comprises a first surface and a second surface forming an edge at a 90 degree angle, wherein the edge is configured to engage the rib to resist separation of the connector and the port
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However, Okajima teaches a means of connecting two components (abstract) with one end having a rib (6a) configured to engage with a barb (34) to detachably secure the connector to the port (fig. 2, female helically threaded part 6a engaging with a threaded engagement part 26b). The barb (26b) would be interacting with an internal rib (6a), with said rib being within the lumen of the port.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the connector distal end is inserted into the port proximal end being configured to mate with the connector, wherein the port has a rib on an inner surface of the port, wherein the rib is configured to engage the barb of the connector so as to detachably secure the connector to the port, as taught by Okajima, since it has been held that wherein “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” In this instance, effectively reversing the direction on the rib and barb of Kubalak would have a predictable result of still granting a snap fit connection. See MPEP 2143(I)(A).
Kubalak does not teach wherein the at least one barb comprises a first surface and a second surface forming an edge at a 90 degree angle, wherein the edge is configured to engage the rib to resist separation of the connector and the port.
However, Igari teaches a coupling for medical tubing (abstract) wherein the barb (see annotated fig. 1 below) comprises a first surface and a second surface forming an edge at a 90 degree angle (see annotated fig. 1 below), wherein the edge is configured to engage the rib to resist separation of the connector and the port (see annotated fig. 1 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the barb comprises a first surface and a second surface forming an edge at a 90 degree angle, wherein the edge is configured to engage the rib to resist separation of the connector and the port, as taught by Igari, since it has been held that wherein “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” In this instance, one of ordinary skill in the art would appreciate that a square edge would have a stronger connection than a rounded edge that tapers for easier disconnection of a snap-fit connection. See MPEP 2143(I)(A).
Regarding claim 2, Kubalak is silent to wherein the at least one barb is configured to form a liquid tight seal with the rib of the port.
However, if this is not clearly envisioned by the applicant, Kubalak teaches how a liquid tight seal in other components of the assembly is important for preventing urine from leaking (paragraph 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the barb is configured to form a liquid tight seal with the rib of the port, for the purpose of providing a suitable means of preventing urine from leaking from the connector (paragraph 0056).
Regarding claim 12, Kubalak discloses wherein the body includes a selectively removable funnel extension located distal the barb (connector 80 may be attached to a toilet as a drainage receptacle connected through corresponding connectors and/or appropriate fasteners (paragraph 0050), and shows a funnel extension in fig. 5C (fig. 5C, accessory connector 92 serves as a funnel that can be removable from the connector 80).
Regarding claim 13, Kubalak discloses a urinary catheter product (abstract), comprising:
a urinary catheter comprising a catheter tube (fig. 1, catheter as a combination of sheath 20 and urinary catheter 15, with the tube being body of sheath 20), the catheter tube having a catheter tube distal end (fig. 5C, distal end of sheath 20 with a connector 80)
a connector (80) including a connector proximal end, a connector terminal distal end, an outer surface and a connector lumen extending therethrough (fig. 5B shows sheath connector 80 which is shown in more detail in Fig. 5C, said connector 80 having a terminal distal end), the connector proximal end being attached directly to the catheter tube distal end such that the connector lumen of the connector is in fluid communication with a drainage lumen of the catheter tube (fig. 5C shows a sheath 20 that is a part of the catheter has the proximal end of connector 80 being directly attached to the catheter tube ), the terminal distal end of the connector defining an opening for urine drainage and including at least one barb (fig. 5C, barb at lip section 88), wherein the barb continuously extends substantially about the entire perimeter of the connector terminal distal end (fig. 5C, lip section 88 as a cross section of a fully circular barb extending substantially about a perimeter of the connector, thus the barb extend about the entire perimeter of the connector)
a urine collection bag (125) having a port including a port terminal proximal end, a port distal end, and a port lumen extending therethrough (fig. 5B, bag 125 includes a port that is described in fig. 5C, with a terminal proximal end), the connector distal end attaching to the port proximal end being configured to mate with the connector (fig. 5C, port at the proximal end mates with the sheath connector 80), the port having a circumferential rib spaced from the port terminal proximal end (fig. 5C, rib as plate element 96 that connects with a circumferential barb, also see annotated)
Kubalak discloses the use of a barb (see annotated fig. 5C below) to interact with a rib of a connector (fig. 5C, element 80), said rib being distally spaced from the port terminal proximal end (see annotated fig. 5C below) but does not teach wherein the connector distal end is inserted into the port proximal end being configured to mate with the connector, wherein the port has a circumferential rib on an inner surface of the port within the lumen and distally spaced from the port terminal proximal end, wherein the rib is configured to engage the barb of the connector so as to detachably secure the connector to the port, wherein the rib includes a first surface and a second surface forming a rib edge at a 90 degree angle, the barb includes a first surface and a second surface forming a barb edge at a 90 degree angle, and the rib edge and barb edge engaging each other to resist separation of the connector and the port.
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However, Okajima teaches a means of connecting two components (abstract) with one end having a rib (6a) configured to engage with a barb (34) to detachably secure the connector to the port (fig. 2, female helically threaded part 6a engaging with a threaded engagement part 26b). The barb (26b) would be interacting with an internal rib (6a), with said rib being within the lumen of the port.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the connector distal end is inserted into the port proximal end being configured to mate with the connector, wherein the port has a rib on an inner surface of the port within the lumen and distally spaced from the port terminal proximal end, wherein the rib is configured to engage the barb of the connector so as to detachably secure the connector to the port, as taught by Okajima, since it has been held that wherein “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” In this instance, effectively reversing the direction on the rib and barb of Kubalak would have a predictable result of still granting a snap fit connection. See MPEP 2143(I)(A).
Kubalak does not teach wherein the at least one barb comprises a first surface and a second surface forming an edge at a 90 degree angle, wherein the edge is configured to engage the rib to resist separation of the connector and the port.
However, Igari teaches a coupling for medical tubing (abstract) wherein the barb (see annotated fig. 1 below) comprises a first surface and a second surface forming an edge at a 90 degree angle (see annotated fig. 1 below), wherein the edge is configured to engage the rib to resist separation of the connector and the port (see annotated fig. 1 below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the barb comprises a first surface and a second surface forming an edge at a 90 degree angle, wherein the edge is configured to engage the rib to resist separation of the connector and the port, as taught by Igari, since it has been held that wherein “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art.” In this instance, one of ordinary skill in the art would appreciate that a square edge would have a stronger connection than a rounded edge that tapers for easier disconnection of a snap-fit connection. See MPEP 2143(I)(A).
Regarding claim 14, Kubalak discloses wherein the port is attached and extends into an opening in the bag (fig. 5B, port of bag 125 extends into an opening of the bag)
Regarding claim 15, Kubalak is silent to wherein the port is integral with the bag, and wherein the bag and port are made from a single unitary construction
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the port integral with the bag such that the bag and port are made from a single unitary construction, since it has been held that forming in one piece an article which has formerly been formed in two pieces, and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 18, Kubalak does not teach wherein the rib is located within the port lumen.
However, Okajima teaches wherein the rib is located is located within the respective lumen (see Okajima, female threaded part 6a within a lumen,).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Kubalak such that the rib is located within the port lumen, as taught by Okajima, since the two connection means were art-recognized equivalents at the time the invention was made, and as such one of ordinary skill in the art would have found it obvious to substitute the fastening system of Kubalak with the barb and rib fastening system of Okajima.
Regarding claim 49, Kubalak discloses wherein the body includes a selectively removable funnel extension located distal the barb (connector 80 may be attached to a toilet as a drainage receptacle connected through corresponding connectors and/or appropriate fasteners (paragraph 0050), and shows a funnel extension in fig. 5C (fig. 5C, accessory connector 92 serves as a funnel that can be removable from the connector 80).
Regarding claim 52, the embodiment disclosed in fig. 5C of Kubalak is silent to wherein the barb is configured to form a liquid tight seal with the rib of the port.
However, another embodiment of Kubalak teaches that an interface between the catheter connector and introducer tip form a liquid-tight seal (paragraph 0069).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in fig. 5C of Kubalak such that the barn is configured to form a liquid tight seal with the rib of the port, as taught by another embodiment of Kubalak, for the purpose of providing the predictable benefit of preventing leakage between components.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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