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
The amendment filed 11/05/2025 has been entered. Claim 1-20 are pending in the application. Applicant’s amendments to the claims have overcome every objection and 112(b) rejection previously set forth in the Non-final Office Action mailed 08/06/2025.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 1-5, 7, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nemoto (US 2008/0300483).
Regarding Claim 1, Nemoto discloses a transport and delivery system comprising: a material transport device (201, Fig 2) containing injectable material (Para 0053); a base (211, Fig 2) configured to hold said material transport device (Para 0063); a material access device (122, 113, Fig 2); and a cover (410, Fig 2) configured to hold said material access device (Para 0093; See Fig 2); wherein: said cover is configured to be positioned over said base to mate said cover with said base to cause said material access device to align with said material transport device to access said material transport device (Para 0064).
Regarding Claim 2, Nemoto discloses said cover (410, Fig 2) includes a material delivery system (110, 113, 120, 122, Fig 2) configured to deliver the injectable material to a patient (Para 0064-0067).
Regarding Claim 3, Nemoto discloses said material delivery system (110, 113, 120, 122, Fig 2) comprises said material access device (122, 113, Fig 2), and a delivery conduit system (110, 120, Fig 2) fluidly coupled with said material access device (Para 0064).
Regarding Claim 4, Nemoto discloses said material access device (122, 113, Fig 2) comprises at least one needle; and said delivery conduit system comprises at least one tubing (Para 0064).
Regarding Claim 5, Nemoto discloses said at least one needle comprises an inlet needle (113, Fig 2) and an outlet needle (122, Fig 2); and said at least one tubing comprises inlet tubing (110, Fig 2) fluidly coupled with said inlet needle, and outlet tubing (120, Fig 2) coupled with said outlet needle (Para 0064).
Regarding Claim 7, Nemoto discloses said material transport device (201, Fig 2) comprises a vial with a stopper (202, Fig 1) defining a septum piercable by said at least one needle of said material access device as a result of mounting said cover on said base (Para 0064).
Regarding Claim 15, Nemoto discloses a method of transporting and delivering an injectable material using the transport and delivery system of claim 1 (See rejection of claim 1 above), said method comprising: delivering the injectable material in the material transport device (201, Fig 2) (Para 0068); and placing the cover (410, Fig 2) over the base (211, Fig 2) which holds the material transport device (Para 0092-0093); wherein the cover includes the material access device (122, 113, Fig 2), so that upon mating the cover and the base, the material access device of the cover is aligned with the material transport device held by the base to access the injectable material for delivery to the patient (Para 0064).
Regarding Claim 18, Nemoto discloses the cover (410, Fig 2) further includes a material delivery system (110, 113, 120, 122, Fig 2), said method further comprising priming said material delivery system to eliminate air within the material delivery system (Para 0091).
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 6, 10, 11, 12, 14, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Shibata (US 2020/0038596).
Regarding Claim 6, Nemoto discloses priming the system before connection of the base to the cover (Para 0091), however, is silent regarding said material delivery system further comprises a priming cap defining a sealed chamber therein and configured to cover sharp ends of said inlet needle and said outlet needle; and passing of flushing solution into said inlet tubing, through said inlet needle, through said sealed chamber, through said outlet needle, and through said outlet tubing results in a primed airless material delivery system primed for coupling with said base.
Shibata teaches an analogous material delivery system comprising an inlet needle (19 connected to tubing 1121, Fig 2), an outlet needle (19 connected to tubing 1161, Fig 2), an inlet tubing (1121, Fig 2), and an outlet tubing (1161, Fig 2), wherein said material delivery system further comprises a priming cap (Cap of Fig 4) defining a sealed chamber (23, Fig 4) therein and configured to cover sharp ends of said inlet needle and said outlet needle (See Fig 2); and passing of flushing solution into said inlet tubing, through said inlet needle, through said sealed chamber, through said outlet needle, and through said outlet tubing results in a primed airless material delivery system primed (Para 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material delivery system disclosed by Nemoto to further include a priming cap as taught by Shibata in order to increase safety and convenience in the priming of the delivery circuit (Para 0009).
Regarding Claim 10, Nemoto discloses an material delivery system comprising: a material access device (122, 113, Fig 2); a material conduit system (110, 120, Fig 2) fluidly coupled with said material access device (Para 0064).
Nemoto is silent regarding a priming cap configured to cover said material access device and to maintain a sealed configuration of said material delivery system for priming.
Shibata teaches an analogous material delivery system comprising an inlet needle (19 connected to tubing 1121, Fig 2), an outlet needle (19 connected to tubing 1161, Fig 2), an inlet tubing (1121, Fig 2), and an outlet tubing (1161, Fig 2), wherein said material delivery system further comprises a priming cap (Cap of Fig 4) defining a sealed chamber (23, Fig 4) therein and configured to cover sharp ends of said inlet needle and said outlet needle (See Fig 2); and passing of flushing solution into said inlet tubing, through said inlet needle, through said sealed chamber, through said outlet needle, and through said outlet tubing results in a primed airless material delivery system primed (Para 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material delivery system disclosed by Nemoto to further include a priming cap and prime the circuit as taught by Shibata in order discharge the air from the circuit while increasing safety and convenience in the priming of the delivery circuit (Para 0009, Para 0059).
Regarding Claim 11, the modified invention of Nemoto and Shibata discloses said material access device (122, 113, Fig 2 -Nemoto) comprises at least one needle; and said material conduit system (110, 120, Fig 2 -Nemoto) comprises at least one tubing (Para 0064 -Nemoto).
Regarding Claim 12, the modified invention of Nemoto and Shibata discloses said at least one needle (122, 113, Fig 2 -Nemoto) comprises an inlet needle (113, Fig 2 -Nemoto) and an outlet needle (122, Fig 2 -Nemoto); said at least one tubing comprises inlet tubing (110, Fig 2 -Nemoto) fluidly coupled with said inlet needle, and outlet tubing (120, Fig 2 -Nemoto) coupled with said outlet needle (Para 0064); said priming cap (100, Fig 2 -Shibata) defines a sealed chamber (23, Fig 4) therein configured to cover sharp ends of said inlet needle and said outlet needle; and passing of flushing solution into said inlet tubing, through said inlet needle, through said sealed chamber, through said outlet needle, and through said outlet tubing results in a primed airless material delivery system (Para 0059 -Shibata).
Regarding Claim 14, the modified invention of Nemoto and Shibata discloses a cover (410, Fig 2 -Nemoto) holding said material access device (Para 0093; See Fig 2 -Nemoto) and said material conduit system (Para 0093; See Fig 2 -Nemoto), said cover being configured to align with a base holding a material transport device to align said material access device with the material transport device to deliver material from within the material transport device to a patient (Para 0064 -Nemoto).
Regarding Claim 19, Nemoto discloses the material access device (110, 113, 120, 122, Fig 2) comprises an inlet needle (113, Fig 2), an outlet needle (122, Fig 2), and a tubing system (110,120, Fig 2); and retaining the material within the tubing system before mating the cover with the base to allow the sharp ends of the inlet needle and the outlet needle to extend into the material transport device to access the injectable material for delivery to a patient (Para 0091; priming can occur before the base is mated to the cover), however, is silent regarding the material delivery system further comprises a priming cap; sharp ends of the inlet needle and the outlet needle extend into a chamber within the priming cap; said priming comprises flushing a material through the inlet needle, through the chamber within the priming cap, through the outlet needle, and through the tubing system to eliminate air from within the material delivery system; and said method further comprises retaining the material within the tubing system and removing the priming cap before mating the cover with the base to allow the sharp ends of the inlet needle and the outlet needle to extend into the material transport device to access the injectable material for delivery to a patient.
Shibata teaches an analogous material delivery system comprising an inlet needle (19 connected to tubing 1121, Fig 2), an outlet needle (19 connected to tubing 1161, Fig 2), an inlet tubing (1121, Fig 2), and an outlet tubing (1161, Fig 2), wherein said material delivery system further comprises a priming cap (Cap of Fig 4); sharp ends of the inlet needle and the outlet needle extend into a chamber within the priming cap (Para 0051; See Fig 2); said priming comprises flushing a material through the inlet needle, through the chamber within the priming cap, through the outlet needle, and through the tubing system to eliminate air from within the material delivery system (Para 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material delivery system disclosed by Nemoto to further include a priming cap as taught by Shibata in order to increase safety and convenience in the priming of the delivery circuit (Para 0009).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Newkirk (US 2004/0232286).
Regarding Claim 8, Nemoto teaches said at least one tubing (110, 120, Fig 2) includes an outlet tubing (120, Fig 2) fluidly coupled with said at least one needle (122, Fig 2) to deliver the injectable material to a patient (Para 0064), however, is silent regarding said cover further comprises a mounting arm configured to maintain said outlet tubing oriented at an angle below horizontal.
Newkirk teaches a cover (10, Fig 1) comprising a mounting arm (26, Fig 1) configured to maintain said outlet tubing oriented at an angle below horizontal (Para 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cover to include a mounting arm as taught by Newkirk in order to be able to hold the position and support the weight of the tubing (Para 0005).
Claims 9, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Chinol (US 2005/0154275).
Regarding Claim 9, Nemoto discloses said base (211, Fig 2), however, is silent regarding said base is configured to permit ejection of said material transport device therefrom.
Chinol teaches an analogous base (1, Fig 1) configured to hold said material transport device (vial 3, Fig 1) wherein said base is configured to permit ejection of said material transport device therefrom (Para 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base to permit ejection of the material transport device as taught by Chinol in order to have a base that is reusable thereby reducing waste and costs (Para 0053).
Regarding Claim 16, Nemoto is silent regarding delivering the material transport device separately from the base and cover.
Chinol teaches an analogous base (1, Fig 1) and material transport device (vial 3, Fig 1), wherein the base is configured to hold said material transport device wherein said base is configured to permit ejection of said material transport device therefrom and be reused (Para 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the base to permit ejection of the material transport device and be reused (thereby having a material transport device delivered separately from the base and cover to be insert in the now empty base to be used again. Examiner notes that it is not specified where the material transport device is to be delivered to, thus Examiner is interpreting it to mean delivered to a processing/manufacturing location wherein the vial is packaged into the base) as taught by Chinol in order to have a base that is reusable thereby reducing waste and costs (Para 0053).
Regarding Claim 17, Nemoto discloses said base (211, Fig 2), however, is silent regarding ejecting the material transport device from the base when delivery of the injectable material to the patient is complete.
Chinol teaches an analogous base (1, Fig 1) configured to hold said material transport device (vial 3, Fig 1), and ejecting the material transport device from the base when delivery of the injectable material to the patient is complete (Para 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method to include ejecting the material delivery system from the base when delivery of the injectable material to the patient is complete as taught by Chinol in order to reuse the base and properly dispose of the radioactive waste (Para 0053).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Shibata (US 2020/0038596) and further in view of Newkirk (US 2004/0232286).
Regarding Claim 13, the modified invention of Nemoto and Shibata discloses a cover (410, Fig 2 -Nemoto) holding said material access device (122, 113, Fig 2 -Nemoto) and said material conduit system (110,120, Fig 2 -Nemoto), however, is silent regarding said cover including a mounting arm configured to maintain said outlet tubing oriented at an angle below horizontal.
Newkirk teaches a cover (10, Fig 1) comprising a mounting arm (26, Fig 1) configured to maintain said outlet tubing oriented at an angle below horizontal (Para 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cover to include a mounting arm as taught by Newkirk in order to be able to hold the position and support the weight of the tubing (Para 0005).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Fazi (US 9,327,886).
Regarding Claim 20, Nemoto is silent regarding delivering the material transport device within the base to a medical facility at which the injectable material is to be delivered to the patient.
Fazi teaches an analogous base (630, Fig 6) and material transport device (140, Fig 1) configured to have a cover (650, Fig 6) placed over the base, wherein the material transport device is delivered within the base to a medical facility at which the injectable material is to be delivered to the patient (Col 3, lines 1-15; Col 7, lines 46-61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Nemoto to deliver the material transport device within the base to a medical facility as taught by Fazi in order to allow safer transport of the vial containing hazardous material without contacting the vial to reduce adverse effects to users (Col 1, lines 15-23; Col 3, lines 7-15).
Response to Arguments
Applicant’s arguments files 11/05/2025, on pages 7-8 , regarding the container cover 211 cannot be reasonably construed as a base and the container cover 211 not being configured to hold the material transport device have been fully considered but is not persuasive. Firstly, Applicant does not provide any reason that the container cover 211 cannot be construed as a base. Since the container cover 211 encompasses an end of the glass container 201 opposite the opening, it can be considered a base or bottom relative to the glass container. The claim does not provide any other structural features that would prevent the container cover 211 from being interpreted as a base. Further, the container cover 211 meets the functional limitations of the base of being configured to hold the material transport device 201. As can be seen in Fig 2 and described in Para 0051, the container cover 211 holds within it the glass container body 201 in order to block radiation from the contrast medium. Applicant also argues that the shield cover 410 is not positioned over the base 211. As seen in Fig 2 and reproduced in the illustration below, at least a portion of the cover is positioned over a portion of the base. The claim language is not specific enough to require an entirety of the base to be within or covered by the cover as the arguments appear to be implying.
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Applicant’s arguments files 11/05/2025, on pages 8-10 , regarding the combination of Nemoto and Shibata would not be obvious because there is no reason to employ a priming cap in Nemoto’s device have been fully considered but are not persuasive. While Nemoto does disclose a way to prime the device with the liquid container attached to the system, one of ordinary skill may still find it advantageous to be able to prime and/or deliver saline without the additional exposure to the radioactive material. Thus, as stated in the rejection, the priming cap of Shibata provides increased safety and convenience (Para 0009) by limiting exposure to the radioactive material. Additionally, Para 0091 points out that the tubes 110 and 120 can be filled with saline before connection to the liquid containers 300 and 200. The priming cap of Shibata provides a means to accomplish this.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783