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
This office action is responsive to the amendment filed on December 17, 2025. As directed by the amendment: no claims have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-20 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of the species of group I in the reply filed on December 17, 2025 is acknowledged.
Claims 6-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species II - VII, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 17, 2025 for claims 7 and 9-16. Additionally, claims 6 and 8 have been withdrawn by Examiner as being drawn to the non-elected species of group II.
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.
Claims 1, 4 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Panian US 2014/0135738 A1.
Regarding claim 1, Panian discloses a protective cap (capping device 200, P0020 and shown in Figs. 2A-B) engageable with a needle-free connector (medical access connector 100, can be needless P0017) of an intravenous (IV) catheter assembly (P0002-0003), the protective cap comprising: a collar member (second member 203, P0021) defining a central opening within which a portion of the needle- free connector may be received (second member 203 wraps around the medical access connector 100, P0022, and thus second member 203 defines a central opening within which a portion of the needle-free connector may be received); a cover member (cap 201, P0021) attached to the collar member so as to be pivotable (P0023 and Figs. 2A-B) relative thereto, the cover member moveable between a first position where an end connection (top 2, P0021) of the needle-free connector is covered by the cover member (Fig. 2B) and a second position where the end connection of the needle-free connector is uncovered from the cover member (Fig.2A); and a lever member (first member 202, P0021 and shown in Figs. 2A-B including 210, P0025) attached to the cover member and engageable by a user to move the lever member from a non-actuated position (Fig. 2B) to an actuated position (Fig. 2A); wherein with the lever member in the non-actuated position, the cover member is in the first position; and wherein with the lever member in the actuated position, the cover member is in the second position.
Regarding claim 4, Panian discloses the cap of claim 1, comprising a hinge (hinge 204, P0021) connecting the cover member to the collar member, the hinge positioned at a top edge of the collar member (Figs. 2A-B), with the cover member pivoting relative to the collar member via the hinge to move between the first position and the second position (P0023).
Regarding claim 17, Panian discloses the cap of claim 1, wherein the lever member is engageable by a single hand of the user to move the lever member from the non-actuated position to the actuated position (the lever member is fully capable of being engageable by a single hand of the user to move the lever member from the non-actuated position to the actuated position, see P0025).
Claims 1, 4-5 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoang et al. (Hoang) US 2012/0016318 A1.
Regarding claim 1, Hoang discloses a protective cap (Figs. 9A-B) engageable with a needle-free connector (this is being interpreted as an intended use that does not result is a structural difference between the claimed invention and the prior art) of an intravenous (IV) catheter assembly (P0031), the protective cap comprising: a collar member (loop 132, P0043) defining a central opening within which a portion of the needle-free connector may be received; a cover member (cap 100, P0043) attached to the collar member so as to be pivotable relative thereto (P0043), the cover member moveable between a first position (Fig. 9A) where an end connection (proximal end 52, P0043) of the needle-free connector is covered by the cover member and a second position (Fig. 9B) where the end connection of the needle-free connector is uncovered from the cover member; and a lever member (lever member, see annotated Fig. 9A below) attached to the cover member and engageable by a user to move the lever member from a non-actuated position (Fig. 9A) to an actuated position (Fig. 9B); wherein with the lever member in the non-actuated position, the cover member is in the first position; and wherein with the lever member in the actuated position, the cover member is in the second position.
PNG
media_image1.png
682
954
media_image1.png
Greyscale
Regarding claim 4, Hoang discloses the cap of claim 1, comprising a hinge (hinge, see annotated Fig. 9B above) connecting the cover member to the collar member, the hinge positioned at a top edge (top edge, see annotated Fig. 9B above) of the collar member, with the cover member pivoting relative to the collar member via the hinge to move between the first position and the second position (P0043).
Regarding claim 5, Hoang discloses the cap of claim 4, wherein the lever member comprises a downward oriented lever (see annotated Fig. 9A above showing the lever projecting downward) arranged approximately parallel to an outer surface of the collar member (approximate parallel arrangement of an outer surface of the collar member and lever, see annotated Fig. 9B above), the lever member being pullable downward (Fig. 9A to 9B) to move the lever member from the non- actuated position (Fig. 9A) to the actuated position (Fig. 9B), thereby pivoting the cover member from the first position to the second position.
Regarding claim 17, Hoang discloses the cap of claim 1, wherein the lever member is engageable by a single hand of the user to move the lever member from the non-actuated position to the actuated position (the lever member is fully capable of being engageable by a single hand of the user to move the lever member from the non-actuated position to the actuated position, see Figs. 9A-B showing a single lever member).
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Panian in view of Teucher et al. (Teucher) US 2014/0074024 A1.
Regarding claim 2, Panian discloses the cap of claim 1.
Panian does not teach wherein the collar member comprises a friction pad positioned on an inner surface of the collar member configured to secure the collar member on the portion of the needle-free connector.
However, Teucher teaches a drug delivery device comprising a locking member 50 described in P0117 and shown in Figs. 7-8, wherein the locking member includes friction pads 52 and 54 positioned on an inner surface of the locking member and configured to secure the locking member to the drug delivery device housing 68.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the inner surface of the collar member of Panian with friction pads as taught by Teucher for the purpose of providing sufficient gripping and/or frictional engagement, Teucher P0117-0118.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Panian in view of Updegraff et al. (Updegraff) US 2008/0033371 A1.
Regarding claim 3, Panian discloses the cap of claim 1.
Panian does not teach wherein the collar member comprises: a first collar half including a buckle receptacle; and a second collar half including a buckle stem; wherein the first collar half is joinable to the second collar half via insertion of the buckle stem into the buckle receptacle, with positioning of the buckle stem relative to the buckle receptacle being adjustable, such that a diameter of the central opening of the collar member is also adjustable.
However, Updegraff teaches a cover for catheter assembly wherein the collar member comprises: a first collar half (body portion 20, P0041 and shown in Fig. 2) including a buckle receptacle (ledge 28, P0041); and a second collar half (retention strap 50, P0041) including a buckle stem (hook 52, P0041); wherein the first collar half is joinable to the second collar half via insertion of the buckle stem into the buckle receptacle, with positioning of the buckle stem relative to the buckle receptacle being adjustable, such that a diameter of the central opening of the collar member is also adjustable (strap 50 could be adjustable so that the hooks at one end could engage one of various ledges or openings of the body portion to accommodate different diameters and a ratchet type mechanism is also contemplated, P0042).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the collar member of Panian as taught by Updegraff for the purpose of coupling to connectors of varying outer diameters as taught by Updegraff P0042.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Karthikeyan et al. (Karthikeyan) US 2019/0247642 A1 in view of Panian.
Regarding claim 18, Karthikeyan discloses an intravenous (IV) catheter assembly (catheter system 10, P0048 and Fig. 1) comprising: a catheter adapter (catheter adapter 28, P0048); a catheter (catheter 14, P0048) coupled to the catheter adapter and extending out distally therefrom, so as to be positionable intravenously within a patient (P0048); an extension line (extension tubing 16, P0048) coupled to the catheter adapter and extending out proximally therefrom; a luer hub (y-adapter 18 as illustrated in Figs. 2A-E including luer access port 24, P0048 and P0051) positioned at a proximal end of the extension line, the luer hub in fluid communication with the catheter through the extension line and the catheter adapter.
Karthikeyan does not teach a needle-free connector comprising a distal connector end and a proximal connector end, the distal connector end coupled to the luer hub; and a protective cap having: a collar member defining a central opening within which a portion of the needle- free connector may be received, a cover member attached to the collar member so as to be pivotable or slideable relative thereto, the cover member moveable between a first position where an end connection of the needle-free connector is covered by the cover member and a second position where the end connection of the needle-free connector is uncovered from the cover member, and a lever member attached to the cover member and engageable by a user to move the lever member from a non-actuated position to an actuated position; wherein with the lever member in the non-actuated position, the cover member is in the first position, wherein with the lever member in the actuated position, the cover member is in the second position; and wherein the protective cap is coupled to the proximal connector end of the needle-free connector.
However, Panian teaches a capping device for a medical access connector comprising a needle-free connector (medical access connector 100, can be needleless P0017) comprising a distal connector end (port 5, P0015) and a proximal connector end (top 2, P0015); and a protective cap (capping device 200, P0020) having: a collar member (second member 203, P0021) defining a central opening within which a portion of the needle- free connector may be received, a cover member attached to the collar member so as to be pivotable or slideable relative thereto, the cover member moveable between a first position (Fig. 2B) where an end connection of the needle-free connector is covered by the cover member and a second position (Fig. 2A) where the end connection of the needle-free connector is uncovered from the cover member, and a lever member (first member 202, P0021) attached to the cover member and engageable by a user to move the lever member from a non-actuated position (Fig. 2B) to an actuated position (Fig. 2A); wherein with the lever member in the non-actuated position, the cover member is in the first position, wherein with the lever member in the actuated position, the cover member is in the second position; and wherein the protective cap is coupled to the proximal connector end of the needle-free connector.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the IV catheter assembly of Karthikeyan with the needle-free connector of Panian wherein the distal connector end of the needle-free connector of Panian is coupled to the luer hub of Karthikeyan for the purpose of delivering medical fluid to a patient as taught by Panian P0002 and P0018.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Karthikeyan in view of Panian in view of Applicant’s admitted prior art illustrated in Figs. 2A-B and described in P0047-0049.
Regarding claim 19, Karthikeyan in view of Panian teaches the IV catheter assembly of claim 18.
Panian does not explicitly teach wherein the proximal connector end of the needle-free connector comprises a female luer connection comprising a tapered cavity and a threaded outer surface.
However, Applicant’s Figs. 2A-B and P0047-0049 teach a needle-free connector 26 comprising a female luer connection 32 comprising a tapered cavity (see annotated Fig. 2B below) and a threaded outer surface (48).
PNG
media_image2.png
722
927
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the needle-free connector of Panian for the needle-free connector of Applicant’s admitted prior shown in Figs. 2A-B as a simple substitution of one known element for another to obtain predictable results, MPEP 2143(B). Panian contained a needle-free connector which differed from the claimed needle-free connector by the substitution of some components with other components including a female luer connection comprising a tapered cavity and a threaded outer surface. The substituted components and their functions were known in the art as demonstrated by Applicant’s admitted prior art shown in Figs. 2A-B and described in P0047-0049. One of ordinary skill in the art could have substituted one known needle-free connector for another, and the results of the substitution would have been predictable since both needle-free connectors function similarly and could be adapted for use with the protective cap of Panian due to their similar structures.
Regarding claim 20, Karthikeyan in view of Panian in view of Applicant’s admitted prior art teaches the IV catheter assembly of claim 19, wherein the collar member is positioned about the needle-free connector at a location thereon distal from the threaded outer surface (Panian, the embodiment of Fig. 3); and wherein the tapered cavity and threaded outer surface are uncovered from the protective cap when the protective cap is in the first position (Panian, Fig. 3, showing a portion 301 of the cap 302 wraps around the sides of the throat 3, P0033) and are covered by the protective cap when the protective cap is in the second position (functions similarly as the embodiment of Figs. 2A-B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the capping device 200 of Panian for the capping device 300 of Panian as a simple substitution of one known capping device for another to obtain predictable results, MPEP 2143(B). Panian contained a capping device 200 which differed from the claimed device by the substitution of a cap that covers threads. A cap that covers threads and their function to protect the needle-free connector were known in the art as demonstrated by capping device 300 of Panian. One of ordinary skill in the art could have substituted capping device 200 for capping device 300, and the results of the substitution would have been predictable because they are similar embodiments of capping devices for needle-free connectors.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.A.D./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783