Patent Application 15759917 Rejection Details

Title: SYSTEMS AND METHODS FOR STERILE CATHETER CONNECTION

Application Information

Invention Title: SYSTEMS AND METHODS FOR STERILE CATHETER CONNECTION
Application Number: 15759917
Submission Date: 2025-04-07T00:00:00.000Z
Effective Filing Date: 2018-03-14T00:00:00.000Z
Filing Date: 2018-03-14T00:00:00.000Z
National Class: 604
National Sub-Class: 533000
Examiner Employee Number: 93153
Art Unit: 3783
Tech Center: 3700

Rejection Summary

102 Rejections: 0
103 Rejections: 2

Cited Patents

The following patents were cited in the rejection:

US 5582161🔗

Office Action Text

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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11, 2024 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on February 4, 2021. As directed by the amendment: claims 1, 3, 5, 6, 9, 11, 12, 17, and 19 have been amended and claims 2, 4, 7, 8, and 10 have been cancelled. Thus, claims 1, 3, 5, 6, 9, 11-15, 17, and 19 are presently pending in this application.
Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejections previously set forth in the Final Office Action mailed September 4, 2020.

Response to Arguments
Applicant's arguments filed February 4, 2021 have been fully considered but they are not persuasive.
Applicant argues on pg. 10 of the Remarks that Cawthon fails to teach or disclosed the claimed second spring. The examiner respectfully disagrees and notes that Cawthon explicitly teaches an embodiment comprising a spring positioned between the inner and outer members and configured to operate as claimed (paragraph 35, see discussion below).
Applicant’s arguments with respect to the rejection(s) of claim(s) 17 under 102(a)(1) have been fully considered and are persuasive, specifically in regards to Stephens not teaching or disclosing the newly added claim limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
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 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.
Claims 1, 3, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cawthon (US 20100100056) in view of Pajunk (US 20040243059).
Regarding claim 1, Cawthon discloses a sterile connector (fig. 5) comprising:
an inner member (housing 120’ in fig. 5) including a connection fitting configured to couple with a separate component that is to be connected to the sterile connector (exterior surface 150 of inlet end 124 in fig. 2 and 5) and an inner passage through which fluids can travel (fig. 5); and
an outer member in which the inner member is received (moveable collar 104’ in fig. 5), the outer member including an inner sealing mechanism that seals the connection fitting within the outer member to protect the connection fitting from contamination (layers 206 and 208 in fig. 2 and 5), wherein the sealing mechanism includes a gate (layers 206 and 208 form a gate in fig. 5); and
a second spring positioned between the inner and outer members that opposes axial displacement of the inner member relative to the outer member along a distal direction (paragraph 35 discloses a spring which is positioned between the first end 184 and first end 186 in fig. 5 and that when the inner member is moved distally relative to the outer member, the spring is compressed so that the spring would oppose axial displacement as the inner member moves distally relative to the outer member);
wherein the connection fitting and a portion of the inner member passes through the sealing mechanism of the outer member when the inner member is axially displaced relative to the outer member along a the distal direction against the force of the second spring such that the connection fitting pushes the gate open against the force of the gate to place the gate in an open position such that the connection fitting can be extended from the outer member to enable the connection fitting to couple with the separate component (fig. 3 shows that as the inner member moves distally in the upwards direction relative to the outer member, the inner member pushes layers 204/206 open so that the surface 150 is extended from the outer member to enable the surface 150 to couple with a separate component as seen in fig. 4; paragraph 35 discloses that movement of the inner member 120’ in the distal direction relative to the outer member 104’ would cause compression of the spring to provide the return force necessary to enable the device to be biased back to the closed position shown in fig. 5), and wherein the gate returns to the closed position when the inner member is axially displaced relative to the outer member along a proximal direction that is opposite to the distal direction (paragraph 35 discloses the connector returning to the position shown in fig. 5, which shows the gate in a closed position).
However, Cawthon does not teach or disclose the gate is biased toward a closed position by a first spring.
Pajunk teaches a device which utilizes a gate (46 in fig. 5) to close a passageway when an instrument is not inserted (paragraph 26). Upon insertion of an instrument, the gate is pushed open to allow the instrument to pass through the gate (paragraph 26). Pajunk teaches that the gate is biased toward the closed position with a spring (42 in fig. 6; paragraph 26) and returns to a closed position when an inner member is axially retracted relative to an outer member along a proximal direction (paragraph 26). Since the gate of Cawthon serves to prevent contamination, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the connector of Cawthon to have a gate which is biased toward the closed position with a spring, as taught by Pajunk. This modification would ensure the gate remains closed until the needleless connector of Cawthon is ready to be connected.
Once modified with the teachings of Pajunk, modified Cawthon teaches that the connection fitting pushes the gate open against the force of the first spring since the spring of Pajunk biases the gate closed and the gate returns to the closed position under the force of the spring when the inner member is axially displaced along a proximal direction relative to the outer member.
Regarding claim 3, in the modified connector of Cawthon, Cawthon discloses the outer member further includes a transverse inner wall (156’ in fig. 5) having an opening (162 in fig. 2 and 5) through which the connection fitting can pass (fig. 4) and wherein the gate seals the opening in the closed position (fig. 5).
Regarding claim 15, in the modified connector of Cawthon, Cawthon discloses the connection fitting comprises a luer-lock fitting that includes a neck (see below; the examiner notes that the embodiment of fig. 5 as an equivalent structure as shown below) and laterally extending tabs that extend from the neck (see below).

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Claim 17is/are rejected under 35 U.S.C. 103 as being unpatentable over Cawthon in view Kee (US 5582161) and in view of Pajunk.
Regarding claim 17, Cawthon discloses a method for preventing contamination of a catheter connector, the method comprising:
containing an inner member (housing 120’ in fig. 5) including a connection fitting (exterior surface 150 of inlet end 124 in fig. 2 and 5) within an outer member (moveable collar 104’ in fig. 5) that includes a sealing mechanism having a gate (layers 206 and 208 in fig. 2 and 5 form a gate which seals), the inner member being initially maintained behind the gate under the force of a second spring so as to be protected from contamination (paragraph 35);
axially displacing the inner member relative to the outer member in a distal direction against the force of the second spring such that the connection fitting contacts, opens, and passes through the gate when the connection fitting is to be coupled with a separate component (fig. 3 and 4; paragraph 35);
connecting the inner member to the separate component using the connection fitting (fig. 4);
While Cawthon discloses axially displacing the inner member relative to the outer member in a proximal direction so that the connection fitting passes back through the gate and the gate returns to the initial closed position (paragraph 35 discloses returning the assembly to the rest position shown in fig. 5), Cawthon does not explicitly teach or disclose disconnecting the inner member from the separate component. Additionally, Cawthon does not teach or disclose the gate is biased to an initial position by a first spring.
Kee teaches a similar connector (adaptor 10 in fig. 2) comprising an inner component (guide member 36 in fig. 1) which is connected operably to a separate component (tube assembly 13 in fig. 2). Kee further teaches the step of disconnecting the inner member from the separate component (3:54-65). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the method of Cawthon to include the step of disconnecting the inner member from the separate component, as taught by Kee, to disconnect the separate component from the connector to enable a different fluid to be administered to the patient without disconnecting the patient line from the patient.
Pajunk teaches a device which utilizes a gate (46 in fig. 5) to close a passageway when an instrument is not inserted (paragraph 26). Upon insertion of an instrument, the gate is pushed open to allow the instrument to pass through the gate (paragraph 26). Pajunk teaches that the gate is biased toward the closed position with a spring (42 in fig. 6; paragraph 26) and returns to a closed position when an inner member is axially retracted relative to an outer member along a proximal direction (paragraph 26). Since the gate of Cawthon serves to prevent contamination, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the connector of Cawthon to have a gate which is biased toward the closed position with a spring, as taught by Pajunk. This modification would ensure the gate remains closed until the needleless connector of Cawthon is ready to be connected.
Once modified with the teachings of Pajunk, modified Cawthon teaches displacing the inner member passes through the gate against the force of the first spring and the gate returns to the initial closed position under the force of the first spring since the spring of Pajunk biases the gate towards the closed position.

Allowable Subject Matter
Claim 5, 6, 9, 11-14, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 5 and 19, the closest piece of art is Cawthon, as discussed above. However, Cawthon does not teach or disclose the outer member can be rotated relative to the inner member and wherein such rotation causes the connection fitting to be displaced in the distal direction and push the gate open. The examiner notes that while Cawthon teaches embodiment where the inner and outer members are rotatable relative to one another (fig. 3), Cawthon does not teach how to implement this embodiment with an embodiment comprising the claimed second spring.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NATHAN PRICE can be reached on 571-270-5421. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783