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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the another ring in claim 8, the luer lock of claim 15 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-6, 8-9, 14, 16, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone US 5,509,911 in view of Bourgignon US 5,735,841.
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Regarding claim 1, Cottone discloses a system for reducing twisting of medical tubing, comprising: a spinning component 22 comprising a first end portion 1, a second end portion 2, an inner surface, labeled inner surface, and an outer surface, labeled outer surface, wherein the first end portion includes a protrusion, labeled pt, that extends from the outer surface in a direction away from the inner surface, pt extends radially outward from the inner surface as a bump out, and the inner surface forms a fluid channel 60 that extends through the first and second end portions; and
a tubing connector 12 comprising a proximal end portion 3, a distal end portion 4, and an inner surface, labeled is, wherein the inner surface forms a fluid channel, see the channel in which 47 is labeled, that extends through the proximal and distal end portions, and the distal end portion forms a male mating portion 54 and a sheath 40, the sheath having an inner surface, labeled sis, that is spaced apart from the outer surface of the male mating portion to form a cavity, labeled cv, therebetween, and a recess, labeled recess that extends into the inner surface of the sheath, the recess is interpreted as the reduced region downstream from the hook snaps 65,
wherein, the distal end portion of the tubing connector is configured to couple with the first end portion of the spinning component such that the male mating portion of the tubing connector is positioned within the fluid channel of the spinning component and the protrusion of the spinning component is positioned within the recess of the sheath, see fig. 7, the protrusion pt is mated between the male connector and the sheathe, and the spinning component is rotatable relative to the tubing connector, see col. 6, lines 31-40 stating that the assembly permits relative rotation between 12 and the stem 22.
Cottone discloses all elements but does not disclose the second end portion comprises a nut that can rotate independently of the spinning component.
Bourgignon teaches a bag 6 having a nut 1b that is configured to connect to a bag to a line to provide aseptic conditions and prevent contamination while remaining reliable. See col. 1, lines 18-29.
It would have been obvious to an ordinary skilled worker to provide the nut 1b and corresponding elements 1 connected to the second end portion of the spinning component of Cottone, as taught by Bourgignon, in order to provide a bag connector that provides aseptic conditions but remains reliable. Id. The nut would be independently rotatable about the spinning component.
Regarding claim 2, Cottone, in view of Bourgignon, discloses the second end portion of the spinning component is configured to couple with an infusion fluid bag. The stem 22 is configured to be used with flexible tubing 125 as shown in fig. 8 where the tubing is capable of being connected to an infusion fluid bag and thus the stem is configured to be coupled to the bag.
Regarding claim 4, Cottone, in view of Bourgignon, discloses the spinning component comprises a ring 56 coupled to the outer surface of the spinning component. See fig. 9. The Examiner notes that figs. 8 and 6, show materially similar embodiments with respect to the spinning component and the tubing connector and that analogous elements labeled in fig. 6 above remain the same in fig. 8.
Regarding claim 5, Cottone, in view of Bourgignon, discloses the ring abuts a first side of the protrusion of the first end portion of the spinning component. Referring to fig. 9 for example, the ring 56 abuts the rear side of the first end portion.
Regarding claim 6, Cottone, in view of Bourgignon, discloses the ring abuts the recess of the tubing connector when the spinning component is attached to the tubing connector. See fig. 9, the ring 14’ touches the distal end of the sheathe of the tubing connector.
Regarding claim 8, Cottone, in view of Bourgignon, discloses the spinning component further comprises another ring 14’ coupled to the outer surface of the spinning component, wherein the other ring abuts a second side of the protrusion, different from the first side of the protrusion, the ring 14’ abuts the outer side of the protrusion opposite the ring 56.
Regarding claim 9, Cottone, in view of Bourgignon, discloses the other ring abuts the recess of the tubing connector when the spinning component is attached to the tubing connector. The radially inner portion of the ring 14’ abuts the recess.
Regarding claim 14, Cottone, in view of Bourgignon, discloses a cross-sectional width of the male mating portion of the tubing connector tapers towards the distal end portion of the tubing connector. Referring to fig. 8 for example, the cross sectional width of the male mating member tapers in a stepwise fashion from 59 to 54.
Regarding claim 16, referring to claim 1, Cottone, in view of Bourgignon, discloses all elements.
Regarding claim 18, Cottone, in view of Bourgignon, discloses the spinning component comprises a ring 56 coupled to the outer surface of the spinning component, the ring is coupled to the spinning component and thus coupled to all surfaces of the spinning component, and the ring abuts a first side of the protrusion of the first end portion of the spinning component, the ring abuts the rear side of the first end portion, and a recess of the tubing connector when the spinning component is attached to the tubing connector, the ring is capable of abutting a recess of the tubing connector.
Regarding claim 19, Cottone, in view of Bourgignon, discloses the spinning component further comprises another ring 14’ coupled to the outer surface of the spinning component, wherein the other ring abuts a second side of the protrusion, the radially outer side, different from the first side of the protrusion and the recess of the tubing connector when the spinning component is attached to the tubing connector, the ring abuts the recess of the tubing connector.
Regarding claim 20, Cottone, in view of Bourgignon, discloses the spinning component that is capable of being connected to the fluid channel of the tubing connecter, the tubing connecter further extends between a proximal port at the proximal end portion and a distal port at the distal end portion; and the tubing connector comprises a collapsible valve positioned within the fluid channel of the tubing connector to resist a fluid flow through the proximal port in a first position, and permit the fluid flow through the proximal port in the second position. The Examiner notes that the claim recites only the spinning component that is capable of being coupled to the tubing connector where the tubing connector isn’t claimed but merely modifies the spinning component to the extent that the claimed tubing connector must be attachable to the spinning component as claimed. Cottone discloses the spinning component structure which is capable of being attached to a tubing connector with a collapsible valve.
Claim(s) 1, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stevens US 5,693,025 in view of Bourgignon.
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Regarding claim 1, Stevens discloses a system for reducing twisting of medical tubing, comprising: a spinning component 24 comprising a first end portion 1, a second end portion 2, an inner surface, labeled inner surface, and an outer surface, labeled outer surface, wherein the first end portion includes a protrusion, labeled pt, that extends from the outer surface in a direction away from the inner surface, pt extends radially outward from the inner surface as a bump out, and the inner surface forms a fluid channel 56 that extends through the first and second end portions; and
a tubing connector 48 comprising a proximal end portion 3, a distal end portion 4, and an inner surface, labeled is, wherein the inner surface forms a fluid channel, see the channel 142, that extends through the proximal and distal end portions, and the distal end portion forms a male mating portion 148 and a sheath 124, the sheath having an inner surface, labeled sis, that is spaced apart from the outer surface of the male mating portion to form a cavity, labeled cv, therebetween, and a recess, labeled recess that extends into the inner surface of the sheath, the recess is the space in which the pt mates in fig. 4,
wherein, the distal end portion of the tubing connector is configured to couple with the first end portion of the spinning component such that the male mating portion of the tubing connector is positioned within the fluid channel of the spinning component and the protrusion of the spinning component is positioned within the recess of the sheath, see fig. 4, the protrusion pt is mated between the male connector and the sheathe, and the spinning component is rotatable relative to the tubing connector, The elements for a luer lock and thus the spinning component is rotatable relative to the tubing connector to lock the luer lock.
Stevens discloses all elements but does not disclose the second end portion comprises a nut that can rotate independently of the spinning component.
Bourgignon teaches a bag 6 having a nut 1b that is configured to connect to a bag to a line to provide aseptic conditions and prevent contamination while remaining reliable. See col. 1, lines 18-29.
It would have been obvious to an ordinary skilled worker to provide the nut1b and corresponding elements 1 connected to the second end portion of the spinning component of Stevens, as taught by Bourgignon, in order to provide a bag connector that provides aseptic conditions but remains reliable. Id. The nut would be independently rotatable about the spinning component.
Regarding claim 15, Stevens discloses the spinning component and the tubing connector couple together to form a luer lock 134.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone, in view of Bourgignon, in view of Yeh US 8,708,976.
Regarding claim 10, Cottone, in view of Bourgignon, discloses the fluid channel of the tubing connector further extends between a proximal port 26 at the proximal end portion and a distal port 54 at the distal end portion but does not teach the tubing connector comprising a collapsible valve positioned within the fluid channel of the tubing connector to resist a fluid flow through the proximal port in a first position, and permit the fluid flow through the proximal port in a second position.
Yeh teaches a collapsible valve 120, see fig. 3, positioned within the fluid channel of a tubing connector to resist a fluid flow through the proximal port in a first portion, and permit the fluid flow through the proximal port in a second position. Yeh shows that the valve can be closed in fig. 3 and open in fig. 4a.
It would have been obvious to an ordinary skilled worker to provide a collapsible valve in the connector of Cottone, in view of Bourgignon, , as taught by Yeh, in order to provide a means to open and close the connector with respect to fluid flow and to provide a self-sealing, needless connector to meet the ISO standard. See col. 2, lines 18-23.
Regarding claim 11, Cottone, in view of Bourgignon and Yeh, discloses the collapsible valve comprises a bellows portion 125 and a heat portion 120 coupled to the bellows portion.
Regarding claims 12-13, Cottone, in view of Bourgignon and Yeh, discloses the heat portion of the collapsible valve is positioned within the proximal port of the tubing connector when the collapsible valve is in the first position and the bellows portion is compressed toward the distal port of the tubing connector when the collapsible valve is in the second portion. Referring to figs. 3, the head portion is in the proximal port 116 in the first closed position and the bellows is compressed toward the distal port 132 in the second open position, see fig. 4a.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottone, in view of Bourgignon, in view of Becker US 2001/0021825.
Regarding claim 7, Cottone, in view of Bourgignon, discloses all elements but does not disclose the ring comprises a lubricant.
Becker teaches an appropriate lubricant can be used with o-rings 29. The lubricants allow for less friction in install and suitable adhering/sealing.
It would have been obvious to an ordinary skilled worker to provide a suitable lubricant to the o-ring of Cottone, in view of Bourgignon, as taught by Becker since Becekr teaches lubricant can be used on o-rings and in addition it is known that lubricant reduce friction and improve sealing.
Response to Arguments
Applicant's arguments filed 6/2/2026 have been fully considered but they are not persuasive.
With regard to the Applicant’s arguments that the drawings are sufficient that the written disclosure is sufficient with the current drawings, the Examiner disagrees. It is unclear what at least the “another ring” is in claim 8. Additionally, a luer lock is appears to be shown in fig. 2 at a distal end; however, the Applicant’s failure to label the element as well as the Applicant’s arguments provide ambiguity as to whether this is the luer lock being disclosed. 37 C.F.R. 1.83 states “the drawing in a nonprovisional application must show every feature of the invention specified in the claims. However, conventional features disclosed in the description and claims, where their detailed illustration is not essential for a proper understanding of the invention, should be illustrated in the drawing in the form of a graphical drawing symbol or a labeled representation (e.g., a labeled rectangular box).” Any structural detail that is of sufficient importance to be described should be shown in the drawing. (Ex parte Good, 1911 C.D. 43, 164 OG 739 (Comm’r Pat. 1911). Here, the another ring and the luer lock are a part of the inventive feature which is the spinning component. Since the Applicant is holding the spinning component as the inventive feature, these features are determined by the Examiner to be of sufficient importance to be required to be shown in the drawings. Even if the Applicant argues that the luer lock is conventional, the element is required to be illustrated in the form of a graphical drawing symbol or labeled representation. However, the Examiner notes that the feature of the another ring must be shown in the drawings as required by rule 1.83.
The Applicant argues that there is no reason to modify the spinning component of Cottone with the nut of Bourgignon. The Examiner agrees there does not appear to be a basis for putting the nut of Bourgignon on the portion of the second end portion shown in the drawing in claim 1 from Cottone. However, the second end portion as claimed doesn’t provide sufficient structure to preclude an interpretation that the second end portion includes the structure up to the bag. The limitation recites “a spinning component comprising a first end portion, a second end portion… the inner surface forms a fluid channel that extends through the first and second end portions… the second end portion comprises a nut that can rotate independently of the spinning component.” The claim notably does not limit the second end portion to a particular structure. Is the structure cylindrical? Is it multiple parts? Is the structure rigid or flexible? Etc. Thus, the claims can be broadly interpreted such that the second “portion” includes the structure of the second end shown in figure 1 including the tubing up to the IV bag of Bourguignon. The rejection previously made did not seek to move the rotatable nut of Bourguignon around the structure shown in Cottone, but rather seeks to import the nut assembly connecting to the bag in addition to the structure of Cottone. A limitation stating that “the second end portion is a cylindrical structure that extends to a proximal/distal end, the nut covering a portion of the second end portion at the proximal/distal end” would appear consistent with the Applicant’s arguments and appear to overcome the art of record.
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 GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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, Devon Kramer can be reached at (571)272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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