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 .
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.
Claim(s) 1-4, 9-11, 14-17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2016/0120752 to Bazala et al. (Bazala hereinafter).
Regarding claim 1, Bazala teaches a transport and delivery system comprising a material transport device (10) containing injectable material (within vial 12), a base (40), a material access device (18), a cover (20, 112) positionable over the base and mated with the base and having a mounting arm (112).
Regarding claim 2, Bazala teaches a material delivery system (100) configured to deliver the injectable material to a patient (paragraph 71).
Regarding claim 3, Bazala teaches that the material delivery system may be considered to include the material access device (as in 118 in Fig. 16) and a delivery conduit (116).
Regarding claim 4, Bazala teaches a needle (90) and a tubing (116).
Regarding claim 9, Bazala teaches that the base is configured to permit ejection of the material transport device (specifically 12) therefrom.
Regarding claim 10, Bazala teaches a material access device (18), a material conduit system (100), and a priming cap (17) configured to cover the material access device and maintain a sealed configuration of the material delivery system for priming, and a mounting arm (112).
Regarding claim 11, Bazala teaches a needle (90) and a tubing (116).
Regarding claim 14, Bazala teaches a cover (20) and a mounting arm (112) configured to maintain orientation (paragraph 85).
Regarding claim 15, Bazala teaches delivering the injectable material in a material transport device (10), placing a cover (20) over a base (40) and including a mounting arm (112) which aligns the material delivery system (18) with the cover (20).
Regarding claim 16, Bazala teaches separate delivery (paragraphs 13, 104).
Regarding claim 17, Bazala teaches ejection of the system (e.g. paragraph 104).
Regarding claim 20, Bazala teaches delivery of the system to a medical facility (paragraph 13).
Regarding claim 13, Bazala teaches a cover (20) and a mounting arm (112) configured to maintain orientation (paragraph 85).
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.
Claim(s) 5-8, 12-13 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bazala in view of US Pre-Grant Publication 2011/0275988 to Davis et al. (Davis).
Regarding claim 5, Bazala teaches the limitations of claim 4 from which claim 5 depends, but does not teach inlet and outlet needles. Davis teaches another fluid dispensing system generally, and particularly teaches an inlet needle (30) and an outlet needle (32). Davis teaches that the system may be flushed by passing fluid into the inlet needle (e.g. paragraph 56). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a second needle as taught by Davis to the transport device of Bazala in order to allow the vial to be primed. Furthermore, to any extent which claim 5 may require spaced needles which do not share a wall, the examiner notes that it has been held that merely rendering objects separable is not sufficient to establish patentability (MPEP 2144.04).
Regarding claims 6 and 12, Bazala teaches a priming cap (17) and Davis teaches passing of flushing fluid through the inlet needle and out the outlet needle (paragraph 56).
Regarding claim 7, Bazala teaches a vial (12) and a stopper (17).
Regarding claims 8 and 13, Bazala teaches outlet tubing (116) and Davis teaches inlet tubing (26/44). Bazala further teaches a vertical angle, i.e. 90 degrees below horizontal.
Regarding claim 18, Davis teaches priming the system (paragraph 56) and Bazala teaches a material delivery system (18).
Regarding claim 19, as discussed above with respect to claims 5-8, Bazala as modified in view of Davis teaches the limitations of claim 19.
Response to Arguments
Applicant's arguments filed 12 November 2025 have been fully considered but they are not persuasive.
With respect to the argument that “40 is not a base”, the examiner is not persuaded. “Base” is a broad term that does not meaningfully limit structure. Applicant presents no definition of the term which the second body portion (40) of Bazala does not meet, neither is any feature thereof argued to be inconsistent with the term. Accordingly, the examiner finds no reason that the second body portion is not a “base” as claimed.
With respect to the argument that “20 is not a cover”, the examiner is not persuaded. Applicant again does not present any definitional, structural, or functional distinction between the claimed cover and the body portion of Bazala. With respect to the “positioned over” limitation, the examiner notes that the container is so configured, since the container (10) may be inverted from the position shown in Fig. 11. Additionally, configuration to be held by a first element (e.g. the base) does not preclude configuration to be held by an additional element (e.g. the cover).
With respect to the mounting arm, an “arm” is not a structurally distinct term. Since the body is indeed mounted thereto and vice versa, the examiner continues to hold that the broadest reasonable interpretation of this claim language includes the structure of Bazala. Additionally, the examiner notes that the “mounting arm” is not necessarily a handle, and the system need not be carried or even able to be carried by the mounting arm. The mounting arm merely needs to be graspable by hand, which limitation is met by the docking station (112) of Bazala which is mapped against the claimed mounting arm.
With respect to the argument that material access device being held by the base, this limitation is not present in claim 1 and is therefore not a patentably distinct feature.
With respect to the argument that Bazala does not teach alignment and access of the transport device, the examiner is not persuaded. Alignment is generally a broad term, and in this case, Bazala teaches at least parallel alignment for the purpose of access to the contents of the transport device.
With respect to the priming limitation, Bazala teaches maintaining a seal with the material access device, and such a sealed fluid connection is suitable for priming a fluid system. The examiner notes that an apparatus claim is defined by what it is, rather than what it does, and in particular the examiner is unaware of any structural distinction required by capability for priming.
In view of the above, the examiner maintains that the claimed invention is either anticipated or obvious as discussed above.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 4 March 2026