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 April 10, 2026. As directed by the amendment: claim 1 has been amended, claims 6-16 have been cancelled, and claims 21-24 have been added. Thus, claims 1-5 and 17-24 are presently pending in this application.
Response to Arguments
Applicant's arguments filed April 10, 2026 have been fully considered but they are not persuasive.
Page 8 of the Remarks at the top provides a summary of the page 6-7 arguments. Applicant first argues that Panian does not disclose a lever member that attaches to a cap member. In response, Examiner notes that the broadest reasonable interpretation for “attached” does not require direct physical contact because two things can be attached by an intermediate link, as is the case in Applicant’s embodiment shown in Figs. 4A-B. Applicant’s lever 56 shown in Figs. 4A-B is attached to the cap 54 by an unlabeled secondary hinge that enables the cap 54 to move from the position shown in Fig. 4A to the position shown in Fig. 4B. Next, Applicant argues that the lever of Panian is not approximately parallel to the cap member, as recited in claim 5. In response, Examiner notes that Panian was not applied to reject claim 5 of the previous action, wherein claim 5 recites this limitation. Finally, Applicant argues newly amended claim 1. In response, Examiner points to the rejection below.
On page 8 of the Remarks below the summary of page 6-7, Applicant argues Hoang and specifically “attached”. These arguments are similar to above in regards to the claim interpretation of the word “attached”. Examiner points to the response above regarding the broadest reasonable interpretation of “attached”.
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 plurality of gradations or bumps included with the buckle stem of claim 22 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the threaded outer portion of the needle-free connector" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 lines 1-2 recites “…wherein the lever member is attached to one side of the cover member and extends downward therefrom…”. It is not clear if “…extends downward therefrom…” means that the lever member extends from one side of the cover member or if the lever member extends from cover member. For purposes of examination, the lever member is interpreted to extend from one side of the cover member.
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, 17, 21 and 23-24 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, the lever member configured to be grasped and pulled downward via a single hand to move the lever member (the lever member is fully capable of being pulled downward via a single hand because a user can grasp at location 210 see P0025, and “downward” is interpreted to be the direction of movement of 210 from its position in Fig. 2B to its position in Fig. 2A, wherein 210 is pulled down relative to 203) 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).
Regarding claim 21, Panian discloses the cap of claim 1, wherein the collar member is configured to not extend up to the threaded outer portion of the needle-free connector when the protective cap is seated on the needle free connector (Fig. 2B).
Regarding claim 23, Panian discloses the cap of claim 1, wherein the lever member 210 is attached to one side of the cover member (attached here includes intermediate 202 and 200, and is shown in Figs. 2A-B) and extends downward therefrom in a direction generally parallel to an outer surface of the collar member (Figs. 2A-B showing 210 extending as claimed).
Regarding claim 24, Panian discloses the cap of claim 1, wherein the lever member has a flexible free end (the capping device is made of a softer plastic, P0030) that is separable away from the cover member and the collar member (Fig. 2A to Fig. 2B).
Claims 1, 4-5, 17, and 21 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).
Regarding claim 21, Hoang discloses the cap of claim 1, wherein the collar member is configured to not extend up to the threaded outer portion of the needle-free connector when the protective cap is seated on the needle free connector (Fig. 9A).
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.
Claims 3 and 22 are 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.
Regarding claim 22, Panian in view of Updegraff teaches the cap of claim 3.
Panian in view of Updegraff does not explicitly teach wherein the buckle stem includes a plurality of graduations or bumps thereon that are configured to selectively control an amount by which the buckle stem is inserted into the buckle receptacle, with the amount by which the buckle stem is inserted into the buckle receptacle controlling the size of the central opening defined by the collar portion.
However, Updegraff P0042 teaches several alterative straps, including a ratchet type mechanism.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the retention strap 50 with a ratchet type mechanism including a plurality of graduations or bumps thereon that are configured to selectively control an amount by which the buckle stem is inserted into the buckle receptacle, with the amount by which the buckle stem is inserted into the buckle receptacle controlling the size of the central opening defined by the collar portion as claimed 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
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 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 /James D Ponton/Primary Examiner, Art Unit 3783
Prosecution Insights