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 05/13/2025. Claims 1-2, 10, 12-13, 16 have been amended, claims 3-9, 11, 37 have been canceled, and new claims 40-48 have been added. Currently, claims 1-2, 10, 12-18, and 40-48 are pending and are being examined on the merits.
Terminal Disclaimer
The terminal disclaimer filed on 05/13/2025 with respect to application # 17/768,039 has been acknowledged.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 13 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. Notably, claim 1 now relies on Kubalak to better teach the limitation of connecting to a rib of a port of a collection bag. Moreover, claim 13 now utilizes Wood and/or newly cited Okajima (US 4582350) to teach the newly amended limitations.
However, in response to the applicant’s argument with respect to Kubalak’s sheath connector not being attached to catheter tube distal end, the examiner respectfully disagrees.
The examiner notes that the combination of the catheter (15) and the sheath (20) surrounding the catheter is interpreted to be “a catheter” as defined in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 10, and 12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kubalak (US 20060025753)
Regarding claim 1, Kubalak discloses a urinary catheter connector comprising:
a body including a proximal end, a distal end, an outer surface, and a lumen extending therethrough (fig. 5C, connector 80 with a proximal end, distal end, outer surface, and a lumen for communicating with sheath 20), the proximal end being configured to be located at 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, connector 80 in communication with sheath 20 of a catheter 15 to be in fluid communication with the lumen of the sheath 20 (and therefore the catheter 15)), the distal end of the body defining an opening for urine drainage (fig. 5C, opening at distal end) and being configured for insertion into 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 rib of the port (fig. 5C, plate section 96 engages with barb as described); and
wherein the at least one barb is a continuous barb that extends circumferentially around the body (fig. 5C shows the barb at a cross section, and fig. 5B shows this connector 80 as a circumferential structure).
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Regarding claim 10, Kubalak discloses wherein the at least one barb is a bulb-shaped barb (fig. 5C, barb as interpreted is rounded at its end, thus constituting a bulb-shaped barb).
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).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kubalak.
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).
Claims 13-15, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over 35 U.S.C. 103 as being unpatentable over Kubalak in view of Wood (US 4610468), and alternatively unpatentable over Kubalak in view of Okajima (US 4582350).
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 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), the connector proximal end being connected 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. 5B, connector 80 at the distal end of sheath 20, allowing for connector 80 to be in fluid communication with the catheter within sheath 20 and the catheter 15), the distal end of the connector defining an opening for urine drainage and including at least one barb (fig. 5C, barb at lip section 88)
a urine collection bag (125) having a port including a port 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), 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 connector lumen being in fluid communication with the urine collection bag, such that the urine collection bag is configured to receive fluid from the connector (fig. 5B, connector 80 in communication with bag 125).
Kubalak discloses the use of a barb (see annotated fig. 5C below) to interact with a rib of a connector (fig. 5C, element 80), 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 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.
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However, Wood teaches a means of connecting two tubes together (abstract) wherein the port (50) has a rib (59) configured to engage the barb (34) of the connector so as to detachably secure the connector to the port (fig. 4, annulus 59 engages the legs 34 in a detachable manner shown in fig. 6)
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 Wood, 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 Wood.
Alternatively 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).
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 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 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 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).
Claims 16-17 are rejected under 35 U.S.C. over Kubalak in view of Wood, and further in view of Franca (US 20180280235) and Gaeta (US 20050242115), and alternatively over Kubalak in view of Okajima, and further in view of Franca and Gaeta.
Regarding claims 16-17, Kubalak is silent to wherein the bag comprises a first sheet and a second sheet heat sealed to form a heat seal about their peripheries, wherein the opening is defined through the heat seal and a portion of the heat seal defining the opening is more rigid than at least a second portion of the heat seal, and wherein the opening defines the port [claim 16], and wherein the portion defining the opening is conditioned to be more rigid [claim 17]
However, Franca teaches a bag for medical use (abstract) wherein the bag comprises a first sheet and a second sheet heat sealed to form a heat seal about their peripheries (paragraph 0131, “where two or more films meet and are heat sealed together), wherein the opening is defined through the heat seal (paragraph 0131, “the port seal 102 can be located… where two or more films meet and are heat sealed together) that has a port seal specifically designated as a hard seal (paragraph 0137, “the port seal 102 is a hard seal… A hard seal is designed to remain intact with application of finger pressure or hand pressure to the seal”). While this does not explicitly state that the hard seal at the port/opening is more rigid than a second portion of the heat seal, Gaeta teaches wherein hard seals are made more plausible using more rigid materials (paragraph 0023, “However, the plastic may be rigid enough to provide a hard seal when the sleeves are connected”).
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 bag comprises a first sheet and a second sheet heat sealed to form a heat seal about their peripheries, wherein the opening is defined through the heat seal and a portion of the heat seal defining the opening is more rigid than at least a second portion of the heat seal, and wherein the opening defines the port [claim 16], and wherein the portion defining the opening is conditioned to be more rigid [claim 17], as taught and suggested by Franca and Gaeta, for the purpose of creating a suitable structure that maintains the port in a manner that remains intact with application of finger pressure or hand pressure (see Franca, paragraph 0137).
Claims 18 and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak in view of Okajima.
Regarding claim 18, Kubalak wherein the rib is defined by a distal rim of the port (fig. 5C, plate section 96 defined by distal rim of the port), but Kubalak, as modified by Okajima, does not teach wherein the rib as defined in claim 13 is defined by a distal rim of the port.
However, it would have been obvious to modify the device disclosed in Kubalak in view of Okajima such that the rib is defined by a distal rim of the port, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. In this instance, moving the threads/rib of Okajima closer to the distal rim of the port would not change the fundamental structure of the mechanism in Okajima or Kubalak.
Regarding claim 46, Kubalak does not teach wherein the at least one barb extends substantially about a perimeter of the connector.
However, Okajima teaches wherein a barb (26b) extends substantially about a perimeter of the connector (fig. 2, threaded engagement part 26b).
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 at least one barb extends substantially about a perimeter of the connector, 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 47, Kubalak does not teach wherein the at least one barb is a continuous barb
However, Okajima teaches wherein the at least one barb is a continuous barb (fig. 2, threaded engagement part 26b is threaded around the connector and is thus continuous)
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 at least one barb is a continuous barb, 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.
Claims 40-45 are rejected under 35 U.S.C. 103 as being unpatentable over Kubalak in view of Wood.
Regarding claim 40, Kubalak does not teach wherein the at least one barb comprises a plurality of barbs.
However, Wood teaches wherein the at least one barb comprises a plurality of barbs (fig. 2, at least two outwardly projecting legs 34)
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 at least one barb comprises a plurality of barbs, as taught by Wood, for the purpose of providing a suitable structure
Regarding claim 41, wherein the at least one barb comprises a first barb and a second barb.
However, Wood teaches wherein the at least one barb comprises a first barb and a second barb (fig. 2, two projecting legs 34).
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 at least one barb comprises a first barb and a second barb, as taught by Wood, 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 Wood.
Regarding claim 42, Kubalak does not teach wherein the first and second barbs are opposed to each other.
However, Wood teaches wherein the first and second barbs are opposed to each other (fig. 2, legs 34 opposed from each other)
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 first and second barbs are opposed to each other, as taught by Wood, 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 Wood.
Regarding claim 43, wherein the connector includes a spring mechanism that biases the first and second barbs away from one another.
However, Wood teaches wherein the body includes a spring mechanism that biases the first and second barbs away from one another (col. 3, lines 48-68, “Upon assembly legs 34 of the retainer spring outwardly into the leg receiving annulus with the end of the leg 34 abutting socket contact face 51 such that the tube may not be pulled to the left from the socket body”).
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 includes a spring mechanism that biases the first and second barbs away from one another, as taught by Wood, 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 Wood.
Regarding claim 44, Kubalak does not teach wherein the first barb is located on a first arm of the connector and the second barb is located on a second arm of the connector.
However, Wood teaches wherein the first barb is located on a first arm of the body and the second barb is located on a second arm of the body (fig. 5, first barb located as end of each legs 34, wherein the arms are the rest of the legs 34).
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 first barb is located on a first arm of the connector and the second barb is located on a second arm of the connector, as taught by Wood, 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 Wood.
Regarding claim 45, wherein the first and second arms are biased away from one another.
However, Wood teaches wherein the first and second arms are biased away from one another (col. 3, lines 48-68, “Upon assembly legs 34 of the retainer spring outwardly into the leg receiving annulus”).
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 first and second arms are biased away from one another, as taught by Kubalak, 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 Wood.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Kubalak in view of Okajima, and further in view of Rome (US 20060157984).
Regarding claim 48, Kubalak, as modified by Okajima, does not teach wherein the at least one barb is a bulb-shaped barb
However, Rome teaches another locking luer fitting (abstract) wherein the barb (28) is a bulb-shaped barb (fig. 1A, helical rib 28 is rounded to form a bulb shaped)
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 in view of Okajima such that the at least one barb is a bulb-shaped barb, as taught by Rome, since it has been held that a change in shape absent persuasive evidence that the change in shape is significant would have been obvious, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In this instance, both Okajima and Rome are both threaded/luer lock systems.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached on (571) 270-1775. 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
/NICHOLAS J. WEISS/Supervisory Patent Examiner, Art Unit 3781