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 Amendments
The Amendment filed 02/10/2026 has been entered.
Claims 3, 5, 8, and 9-10 are cancelled.
Claims 1, 2, 4, 6, 7, and 11-20 remain pending in the application.
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.
Claims 1, 2, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough et al. (WO 2018226515), hereinafter McCullough, in further view of Joshi et al. (U.S. Patent Pub. 20110082422), hereinafter Joshi.
Regarding claim 1, McCullough discloses a primary container assembly (assembly 12, see FIG. 4; the Examiner notes that all reference characters cited below refer to FIG. 4 unless otherwise stated), comprising:
a primary container (barrel 30) comprising:
a proximal end (open proximal end 32) defining an opening configured to receive a plunger (plunger 18, see FIG. 2), and
a distal end (distal end 34) opposite the proximal end and defining an outlet (see FIG. 4), wherein the primary container defines a chamber (interior of barrel 30), extending from the proximal end to the distal end that is configured to receive a medicament (“The syringe barrel 30 receives medicament”, [0038]);
a tube (flexible connection 42) comprising a first end (proximal end 44) and a second end (distal end 46) opposite the first end, the first end being integrally attached to the distal end of the primary container, wherein the tube defines a channel (fluid pathway 47) extending from the first end to the second end (see FIG. 4);
a needle (needle 40) configured to penetrate skin of a patient,
a needle hub (assembly 36) that connects the needle to the second end of the tube (see FIG. 4); and
the tube is in fluid communication with the chamber and the needle (See [0040]) and is configured to direct the medicament from the chamber to the needle. However, McCullough does not expressly state a needle shield disposed over at least a portion of the needle; a cup removably attached to the distal end of the primary container and the needle shield, wherein; the tube is configured to be arranged in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container and is substantially disposed within the cup, and the second end of the tube, in the coiled configuration, is removably connected to the cup via the needle hub and the needle shield.
Joshi teaches a dispensing system for dispensing medicaments to a patient (Abstract) comprising a needle shield (cover 97) disposed over at least a portion of the needle;
a cup (knob 60) removably attached to the distal end of the primary container (shell 54; threaded relationship, see [0104]) and to the needle shield, wherein;
the tube (helix tube 72 and administration line 74) is configured to be arranged in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container and is substantially disposed within the cup (see FIGS. 1-3), and
the second end of the tube, in the coiled configuration, is removably connected to the cup via the needle hub and the needle shield (the Examiner notes knob can be moved due to threaded engagement with shell 54 and cover 97 is removable., see [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the primary container of McCullough to comprise a needle shield disposed over at least a portion of the needle; a cup attached to the distal end of the primary container, wherein; the tube is configured to be arranged in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container and is substantially disposed within the cup, and the second end of the tube, in the coiled configuration, is removably connected to the cup via the needle hub and the needle shield. Doing so provides a removable cover and fluid administration line capable of being wound and unwound, as taught by Joshi (see [0103-0104]).
Regarding claim 2, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 1, and McCullough further discloses wherein the tube (flexible connection 42) is made of a flexible material (“The tube may be coextruded, and the inner layer 49 may include material selected for drug product contact, such as bromobutyl rubber.”, [0041]).
Regarding claim 16, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 1, and McCullough further teaches a medicament dispensing device (drug delivery device 10, see FUG. 1), comprising:
the primary container assembly (syringe assembly 12) according to claim 1; and
an input (hub 38) configured to engage the needle hub such that the tube is in fluid communication (fluid pathway 47) with the input (see [0040]).
Regarding claim 17, McCullough discloses a method (see [0007; 0068]) for assembling a primary container assembly (assembly 12, see FIG. 4; the Examiner notes that all reference characters cited below refer to FIG. 4 unless otherwise stated), comprising:
attaching a first end (proximal portion 62) of a tube (rigid connection 60; “the rigid connection 60 may include a shape memory alloy, such as a Nitinol wire or wires, or external tubing or a tube.”, [0054]) to the distal end of a primary container (distal end 34 of syringe barrel 30; “rigid connection 60 may form a single component together with the syringe barrel 30 and the needle hub 38”, [0053]), which is configured to receive a medicament (“The syringe barrel 30 receives medicament”, [0038]), such that the tube is in fluid communication (fluid pathway 47) with an outlet defined by the distal end of the primary container;
attaching a needle hub (assembly 36) to a second end of the tube (distal portion 64).
attaching a needle (needle 40) to the needle hub (see FIG. 4); However, McCullough does not expressly state covering at least a portion of the needle with a needle shield; attaching a cup to the distal end of the primary container; and arranging the tube in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container, the tube is substantially disposed within the cup, and the second end of the tube is removably connected to the cup via the needle hub and the needle shield.
Joshi teaches a dispensing system for dispensing medicaments to a patient (Abstract) wherein steps include covering at least a portion of the needle with a needle shield (cover 97);
attaching a cup (knob 60) to the distal end of the primary container (shell 54; see FIG. 1); and
arranging the tube (helix tube 72 and administration line 74) in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container, the tube is substantially disposed within the cup (see FIG. 2), and the second end of the tube is removably connected to the cup via the needle hub and the needle shield (the Examiner notes knob can be moved due to threaded engagement with shell 54 and cover 97 is removable., see [0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of McCullough to include steps of covering at least a portion of the needle with a needle shield, attaching a cup to the distal end of the primary container; and arranging the tube in a coiled configuration in which the tube is coiled around a portion of the distal end of the primary container, tube is substantially disposed within the cup, and the second end of the tube is removably connected to the cup via the needle hub and the needle shield. Doing so provides a removable cover and fluid administration line capable of being wound and unwound, as taught by Joshi (see [0103-0104]).
Regarding claim 18, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 17, and McCullough further teaches wherein attaching the tube to the primary container comprises molding the distal end of the primary container over the first end of the tube (“In one example, the proximal portion 62 and the distal portion 64 of the rigid connection 60 may form a single component together with the syringe barrel 30 and the needle hub 38. Molded hinges, such as film hinges, may be used to couple the proximal portion 62 to the distal end 34 of the syringe barrel 30 and the distal portion 64 to the needle hub 38”, [0053]).
Regarding claim 19, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 17, and McCullough further teaches wherein attaching the tube to the primary container comprises monolithically forming the tube and the primary container (“In one example, the proximal portion 62 and the distal portion 64 of the rigid connection 60 may form a single component together with the syringe barrel 30 and the needle hub 38.”, [0053]).
Regarding claim 20, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 17, and McCullough further teaches comprising filling the primary container with the medicament (“method 100 may further include filling the syringe barrel 30 of the syringe assembly 12, 112, 212 with medicament”, [0069]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McCullough et al. (WO 2018226515), hereinafter McCullough, in further view of Joshi et al. (U.S. Patent Pub. 20110082422), hereinafter Joshi, and further in view of Uber et al. (U.S. Patent Pub. 20130060137), hereinafter Uber.
Regarding claim 4, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 1, however, McCullough does not expressly state wherein the distal end of the primary container comprises a Luer connection integrally attached to the first end of the tube.
Uber teaches a device for inserting a catheter into a blood vessel (Abstract) wherein the distal end of the primary container comprises a Luer connection integrally attached to the first end of the tube (“The multi-port fitting head 776 may include any number of ports or fittings, and as illustrated in FIG. 7, the exemplary multi-port fitting head 776 includes a first fitting 780 and a second fitting 781. Such fittings may be any type of fittings known in the art and may be configured to removably attach to any component known in the art. For example, in some embodiments, the fittings may be luer or screw type fittings, which may be configured to attach to, for example, commonly used IV tubes or syringes. In other embodiments, the fittings may be configured to attach directly to other medical devices such as, but not limited to, endoscopes. In still other embodiments, the fittings may be simple pressure fittings or other tube connectors.”, [0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the primary container of McCullough in view of Joshi to comprise a Luer connection integrally attached to the first end of the tube. Doing so helps provides a well know method for removably attaching commonly used features like IV tubes or syringes, as taught by Uber (see [0058]).
Claim 6, 7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over McCullough et al. (WO 2018226515), hereinafter McCullough, in further view of Joshi et al. (U.S. Patent Pub. 20110082422), hereinafter Joshi, and further in view of Mun Chang Soo et al. (KR 2009012043), hereinafter Soo.
Regarding claim 6, McCullough in view of Joshi teaches the claimed invention as discussed above concerning the rejection of claim 1, and McCullough further teaches wherein the needle hub (assembly 36) is an interface between the needle (needle 40) and the tube (flexible connection 42). However, McCullough in view of Joshi does not expressly state comprising a needle shield disposed over at least a portion of the needle and releasably connected to the needle hub so as to maintain the needle in a sterile condition.
Soo teaches a dental clinic anesthetic syringe (Abstract) comprising a needle shield (cap 60) disposed over at least a portion of the needle and releasably connected to the needle hub so as to maintain the needle in a sterile condition (“The cap 60 is fitted to the needle body 50 to accommodate the needle therein so that the sharp needle is not exposed to the outside and safe from contamination.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of McCullough in view of Joshi to comprise a needle shield disposed over at least a portion of the needle and releasably connected to the needle hub. Doing so allows for the needle to be safer from contamination by not exposing it to outside environments, as taught by Soo.
Regarding claim 7, McCullough in view of Joshi in view of Soo teaches the claimed invention as discussed above concerning the rejection of claim 6, and Soo further teaches wherein the needle shield is frictionally connected to the needle hub (“The cap 60 is fitted to the needle body 50 to accommodate the needle therein”, see FIG. 1).
Regarding claim 11, McCullough in view of Joshi in view of Soo teaches the claimed invention as discussed above concerning the rejection of claim 6, and Soo further teaches wherein;
the tube (hose 25) is configured, when the needle shield is detached from the cup, to be transitioned from the coiled configuration to an uncoiled configuration, and
the tube, when in the uncoiled configuration, is uncoiled (“hose 25 is sufficiently extended to a constant length”) from around the portion of the distal end of the primary container (See uncoiled hose 25 in FIGS. 1-2 when cap 60 is detached).
Allowable Subject Matter
Claims 12-15 are allowed.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/10/2026, with respect to the rejection(s) of claim(s) 1, 2, 4, 6, 7, 11, and 16-20 under 35 U.S.C. 103 over McCullough (WO 2018226515) in further view of Joshi (U.S. Patent Pub. 20110082422) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a different interpretation of the previously applied reference, McCullough et al. (WO 2018226515), hereinafter McCullough, in further view of Joshi et al. (U.S. Patent Pub. 20110082422)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
06/17/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights