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 Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant argues that the amendments to claim 2 distinguish over the spring-based clip structure of Sakakine. Applicant argues that Sakakine teaches a system in which pressing the wings together elastically deforms a spring body to separate clip jaws, whereas the present invention relies on rigid-body rotation about a hinge and mechanical disengagement of the clasp to open the enclosure. This argument is not convincing. First, the examiner notes that Sakakine is relied upon only to teach the shape of the wings having a rectangular portion and an oval portion, the rectangular portion coupled directly to the shell. Therefore, Applicant’s arguments drawn toward the spring mechanism of Sakakine are not germane to the rejection. Second, the examiner is not entirely clear about the meaning of “rigid-body rotation” about the hinge. This language is not in the claim. Regardless, the combination of Gross in view of Schnell in view of Sakakine teach these features. Gross teaches that opening of the enclosure is caused by rotation of the upper and lower shell about the hinge which can occur upon disengagement of the clasp. Schnell teaches that upper and lower wing member can be connected to the upper and lower shell to provide a means for moving the upper and lower shells away from each other to open the clamp using one hand. And Sakakine is relied upon to teach the shape of the wings.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-13, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross et al (US 4,405,312) in view of Filz (US 2017/0065808) in view of Schnell et al (US 8,585,096).
Regarding claim 1, Gross discloses a system comprising a shell that comprises an upper portion 40 and a lower portion 38, the upper portion coupled to the lower portion via a hinge 70 on a first shell side, the upper portion defining a first upper slot and a second upper slot (see fig. 21 annotated below), the lower portion defining a first lower slot and a second lower slot (see fig. 21 annotated below), the upper portion comprising a clasp 46 on a second shell side, the lower portion defining a clasp receptacle 47 on a second shell side (fig. 21; col. 9, lines 21-24), wherein when the upper portion is closably coupled to the lower portion (fig. 20), the clasp is engaged with the clasp receptacle (fig. 20), the first upper slot and the first lower slot defining a first tubing aperture, the second upper slot and the second lower slot defining a second tubing aperture, the first tubing aperture comprises a nipple 142/144, the nipple comprising a cylindrical section and a tapered section, the cylindrical section constructed to surround a fluid line and a tapered section configured to grip a fluid line, thereby maintaining the fluid line in position during use, wherein the nipple is integrally formed with the fluid aperture to provide sealing and strain relief during use (figs. 13, 18, 20; col. 8, lines 14-21: tapered rim members retard passage of fluid from within the clamp meaning they create a seal). Gross further discloses that the upper portion and the lower portion is constructed to substantially surround and enclose a catheter hub or a dialysis line (col. 1, lines 10-12).
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Claim 1 calls for a mechanical bearing hinge. Gross teaching a living hinge 70 (fig. 20). Filz teaches a system including an upper shell and a lower shell for surrounding medical tubing wherein the upper shell and lower shell are hingedly connected via a mechanical bearing hinge on the first shell side (fig. 2). Both living hinges and mechanical bearing hinges are known in the art and have equivalent functions of providing hinged movement between two elements. A person of ordinary skill in the art could have substituted one type of hinge for another and the results would predictably be the elements pivoting on a hinge. 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 hinge of Gross to be a mechanical bearing hinge as taught by Filz because doing so would have been a simple substitution of one known element for another to obtain predictable results.
Claim 1 differs from Gross in calling for an upper wing on the first shell side of the upper portion, and a lower wing on the first shell side of the lower portion, the upper wing and the lower wing being graspable to separate the upper portion from the lower portion. Gross teaches wings 194, 196 (fig. 20) that are grasped and pulled apart to release the clasp, but fails to teach the wings on the second shell sides. Schnell teaches a clamp for medical tubing including an upper portion and a lower portion, the upper portion and the lower portion being coupled via a hinge, and further including an upper wing 325 on the hinge side of the upper portion and a lower wing on the hinge side of the lower portion, the wings allow for the user to grasp the wings and open the clamp for removal from the tubing using one hand (col. 5, lines 5-7; fig. 9). 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 of Gross to include upper and lower wings on the first shell side of the upper and lower portions as taught by Schnell to allow the user to open the device for application to and removal from the tubing with one hand and provide a secure gripping surface to reduce the risk of dropping the device which will contaminate the sterile device.
Regarding claim 3, the catheter hub, dialysis line, or blood line is functionally recited in claim 1 (“is constructed to substantially surround and enclose a catheter hub, dialysis line, or blood line connection”). Therefore, the limitations of claim 3 is interpreted to further limit the functionally recited limitation of claim 1. Since Gross discloses a system constructed to surround and enclose a connection between a first and second fluid line (fig. 1), the system of Gross is capable of surrounding and enclosing a catheter hub having a Luer lock coupling two tube segments.
Regarding claim 4, Gross discloses that the shell is constructed to substantially surround a catheter connection (fig. 1).
Regarding claim 5, Gross discloses that the shell is constructed to securely engage the outer circumference of a fluid line passing through the shell, the outer surface including the top surface and the bottom surface of the fluid line (antileak skirts: col. 8, lines 7-10). The limitation “constructed to securely engage… of a fluid line connected to a hemodialysis catheter hub” is interpreted to be an intended use limitation. The fluid line of Gross is capable of being connected to any type of catheter including a hemodialysis catheter. The shell of Gross surrounds and engages the circumference of the tubing passing therethrough (fig. 2).
Regarding claim 6, Gross discloses that the shell is constructed to substantially surround a dialysis line connection (col. 1, lines 10-12).
Regarding claim 7, “is constructed to substantially surround a blood line connection” is interpreted to be a functional limitation. The shell of Gross is constructed to surround a connection between two catheter lines, and therefore, it capable of surrounding a blood line connection.
Regarding claim 8, Gross discloses that the shell is formed from a thermoplastic material such as acrylic (col. 7, lines 45-47). Acrylic is a rigid material.
Regarding claim 9, Gross discloses that the shell is clear or translucent (col. 7, lines 45-47). A clear or translucent material permits visualization of the connector located within the shell.
Regarding claim 10, Gross discloses that the shell substantially completely encircles/encloses the fluid line to protect it against contaminants (col. 2, line 5).
Regarding claim 11, Gross discloses that the connector is used to peritoneal dialysis to deliver dialysis fluid to a patient (col. 1, lines 10-12). Movement of fluid requires a pressure differential within the system and therefore the system of Gross operates under pressure.
Regarding claim 12, Gross discloses the first tubing aperture comprising a first lip 144 and a second lip 142, the first lip and the second lip constructed to grip a first tube member (fig. 18).
Regarding claim 13, Gross discloses that the second tubing aperture comprising a first lip 148 and a second lip 146, the first lip and the second lip constructed to grip fluid line (fig. 18).
Regarding claim 15, Gross discloses that the second tubing aperture comprising a first lip 148 and a second lip 146, the first lip and the second lip constructed to grip fluid line (fig. 18).
Regarding claim 16, Gross discloses a method comprising causing two tubing segments 14, 22 to be coupled via a device, the tubing segments used on a dialysis line (col. 1, lines 10-12; fig. 1), the device comprising a shell that comprises an upper portion 40 and a lower portion 38, the upper portion coupled to the lower portion via a hinge 70 of a first shell side, the upper portion defining a first upper slot and a second upper slot (see fig. 21 annotated above), the lower portion defining a first lower slot and a second lower slot (see fig. 21 annotated above), the upper portion comprising a clasp 46, the lower portion defining a clasp receptacle 47 (fig. 21; col. 9, lines 21-24), wherein when the upper portion is closably coupled to the lower portion (fig. 20), the clasp is engaged with the clasp receptacle, the first upper slot and the first lower slot defining a first tubing aperture, and the second upper slot and the second lower slot defining a second tubing aperture (fig. 20), the first tubing aperture comprises a nipple 142/144, the nipple comprising a cylindrical section and a tapered section, the cylindrical section constructed to surround a fluid line and a tapered section configured to grip a fluid line, thereby maintaining the fluid line in position during use, wherein the nipple is integrally formed with the fluid aperture to provide sealing and strain relief during use (figs. 13, 18, 20; col. 8, lines 14-21: tapered rim members retard passage of fluid from within the clamp meaning they create a seal)..
Claim 16 calls for a mechanical bearing hinge. Gross teaching a living hinge 70 (fig. 20). Filz teaches a system including an upper shell and a lower shell for surrounding medical tubing wherein the upper shell and lower shell are hingedly connected via a mechanical bearing hinge on the first shell side (fig. 2). Both living hinges and mechanical bearing hinges are known in the art and have equivalent functions of providing hinged movement between two elements. A person of ordinary skill in the art could have substituted one type of hinge for another and the results would predictably be the elements pivoting on a hinge. 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 hinge of Gross to be a mechanical bearing hinge as taught by Filz because doing so would have been a simple substitution of one known element for another to obtain predictable results.
Claim 16 differs from Gross in calling for an upper wing on the first shell side of the upper portion, and a lower wing on the first shell side of the lower portion, the upper wing and the lower wing being graspable to separate the upper portion from the lower portion. Gross teaches wings 194, 196 (fig. 20) that are grasped and pulled apart to release the clasp, but fails to teach the wings on the second shell sides. Schnell teaches a clamp for medical tubing including an upper portion and a lower portion, the upper portion and the lower portion being coupled via a hinge, and further including an upper wing 325 on the hinge side of the upper portion and a lower wing on the hinge side of the lower portion, the wings allow for the user to grasp the wings and open the clamp for removal from the tubing (col. 5, lines 5-7; fig. 9). 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 of Gross to include upper and lower wings on the first shell side of the upper and lower portions as taught by Schnell to allow the user to open the device for application to and removal from the tubing with one hand and provide a secure gripping surface to reduce the risk of dropping the device which will contaminate the sterile device.
Regarding claim 17, Gross discloses the first tubing aperture comprising a first lip 144 and a second lip 142, the first lip and the second lip constructed to grip a first tube member (fig. 18).
Regarding claim 18, Gross discloses that the second tubing aperture comprising a first lip 148 and a second lip 146, the first lip and the second lip constructed to grip fluid line (fig. 18).
Regarding claim 19, Gross discloses a method comprising causing two tubing segments 14, 22 to be coupled via a device, the tubing segments used on a dialysis line (col. 1, lines 10-12; fig. 1), the device comprising a shell that comprises an upper portion 40 and a lower portion 38, the upper portion coupled to the lower portion via a hinge 70 of a first shell side, the upper portion defining a first upper slot and a second upper slot (see fig. 21 annotated above), the lower portion defining a first lower slot and a second lower slot (see fig. 21 annotated above), the upper portion comprising a clasp 46, the lower portion defining a clasp receptacle 47 (fig. 21; col. 9, lines 21-24), wherein when the upper portion is closably coupled to the lower portion (fig. 20), the clasp is engaged with the clasp receptacle, the first upper slot and the first lower slot defining a first tubing aperture, and the second upper slot and the second lower slot defining a second tubing aperture (fig. 20), the second tubing aperture comprising a nipple, the nipple comprising a cylindrical section and a tapered section, the cylindrical section constructed to substantially surround a tubing fitting 18, the tapered section constructed to substantially surround and grip a section of tubing 14, thereby maintaining the fluid line in position during use, and wherein the nipple is integrally formed within the tubing aperture and configured to provide sealing and strain relief during use (figs, 2, 18; col. 8, lines 7-13; figs. 13, 18, 20; col. 8, lines 14-21: tapered rim members retard passage of fluid from within the clamp meaning they create a seal).
Claim 19 calls for a mechanical bearing hinge. Gross teaching a living hinge 70 (fig. 20). Filz teaches a system including an upper shell and a lower shell for surrounding medical tubing wherein the upper shell and lower shell are hingedly connected via a mechanical bearing hinge on the first shell side (fig. 2). Both living hinges and mechanical bearing hinges are known in the art and have equivalent functions of providing hinged movement between two elements. A person of ordinary skill in the art could have substituted one type of hinge for another and the results would predictably be the elements pivoting on a hinge. 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 hinge of Gross to be a mechanical bearing hinge as taught by Filz because doing so would have been a simple substitution of one known element for another to obtain predictable results.
Claim 19 differs from Gross in calling for an upper wing on the first shell side of the upper portion, and a lower wing on the first shell side of the lower portion, the upper wing and the lower wing being graspable to separate the upper portion from the lower portion. Gross teaches wings 194, 196 (fig. 20) that are grasped and pulled apart to release the clasp, but fails to teach the wings on the second shell sides. Schnell teaches a clamp for medical tubing including an upper portion and a lower portion, the upper portion and the lower portion being coupled via a hinge, and further including an upper wing 325 on the hinge side of the upper portion and a lower wing on the hinge side of the lower portion, the wings allow for the user to grasp the wings and open the clamp for removal from the tubing (col. 5, lines 5-7; fig. 9). 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 of Gross to include upper and lower wings on the first shell side of the upper and lower portions as taught by Schnell to allow the user to open the device for application to and removal from the tubing with one hand and provide a secure gripping surface to reduce the risk of dropping the device which will contaminate the sterile device.
Regarding claim 20, Gross discloses the first tubing aperture comprising a first lip 144 and a second lip 142, the first lip and the second lip constructed to grip a first tube member (fig. 18).
Claims 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gross in view of Filz in view of Schnell as applied to claim 1 above and further in view of Sakakine et al (US 7,780,688).
Regarding claim 2, Schnell teaches that the upper wing and the lower wing are disposed on the first shall side so that squeezing the wings together causes the upper shell and the lower shell to pivot outwardly. This teaching applied to Gross results in the wings disposed adjacent the hinge so that the shell can pivot to the open position. As discussed above with regard to claim 1, Schnell teaches that this configuration allows for rapid, one-handed opening of the clamp. Claim 2 further calls for each of the wings to comprise a rectangular portion and an oval portion, the rectangular portion coupled directly to the shell. Schnell does not disclose the shape of the wings. Sakakine teaches wings graspable for opening a clamp, the wings having an oval portion and a rectangular portion (fig. 1), the rectangular portions being coupled to the upper and lower portions of the clamp. 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 of Gross in view of Schnell as discussed with regard to claim 1 above, to include the wings having an oval portion and a rectangular portion, the rectangular portions being coupled directly to the upper and lower portions as taught by Sakakine to allow the user to securely grip the wings and apply pressure to separate the upper and lower portions.
Conclusion
THIS ACTION IS MADE FINAL. 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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783