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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Response to Amendment
The amendment filed 05/26/2026 has been entered. Claim 1-6, 8-10, 13-21 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 § 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 10, 13-14 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 10 recites the limitation “passing of flushing solution into the inlet tubing, through the inlet needle, through the sealed chamber, through the outlet needle, and through the outlet tubing results in a primed airless material delivery system”. It is unclear the meets and bounds of the claim since this limitation appears to be a method step while the claims are directed to an apparatus. For the sake of examination, the limitation will be interpreted as reciting “the airless primed material delivery system is configured for passing of flushing solution into the inlet tubing, through the inlet needle, through the sealed chamber, through the outlet needle, and through the outlet tubing results in a primed airless material delivery system”.
Claims 13-14 are rejected as depending from rejection claim 10.
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 1-5, 15, 18, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Bazala (US 2016/0120752).
Regarding Claim 1, Nemoto discloses a transport and delivery system comprising: a material transport device (201, 202, Fig 2) containing injectable material (Para 0053), the material transport device comprising a vial (201, Fig 1) with a stopper (202, Fig 1) defining a septum (Para 0058); a base (211, Fig 2) configured to hold said material transport device (Para 0063); a material access device (122, 113, Fig 2), the material access device comprising at least one needle (Para 0058); 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 allow the least one needle of said material access device to pierce the septum of the vial of said material transport device to access said material transport device (Para 0064).
Nemoto is silent regarding said cover is configured to be positioned over said base to mate said cover with said base to cause the least one needle of said material access device to pierce the septum of the vial of said material transport device to access said material transport device.
Bazala teaches an analogous system comprising: a material transport device (12, Fig 27) containing injectable material; a base (240, Fig 27) configured to hold said material transport device; a material access device (318, Fig 27), the material access device comprising at least one needle; and a cover (330, Fig 27) configured to hold said material access device; wherein: said cover is configured to be positioned over said base to mate said cover with said base to cause the at least one needle of said material access device to pierce the septum of the vial of said material transport device to access said material transport device (Para 0102).
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 system to comprise the guide elements (tabs 260, slots 324, etc.) as taught by Bazala in order to prevent over-insertion of the pharmaceutical transport container into the docking station (Para 0039).
Regarding Claim 2, the modified invention of Nemoto and Bazala discloses said cover (410, Fig 2 -Nemoto) includes a material delivery system (110, 113, 120, 122, Fig 2 -Nemoto) configured to deliver the injectable material to a patient (Para 0064-0067 -Nemoto).
Regarding Claim 3 the modified invention of Nemoto and Bazala discloses said material delivery system (110, 113, 120, 122, Fig 2-Nemoto) comprises said material access device (122, 113, Fig 2-Nemoto), and a delivery conduit system (110, 120, Fig 2-Nemoto) fluidly coupled with said material access device (Para 0064-Nemoto).
Regarding Claim 4, the modified invention of Nemoto and Bazala discloses said delivery conduit system comprises at least one tubing (Para 0064-Nemoto).
Regarding Claim 5, the modified invention of Nemoto and Bazala discloses said at least one needle comprises an inlet needle (113, Fig 2-Nemoto) and an outlet needle (122, Fig 2-Nemoto); and 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-Nemoto).
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).
Nemoto is silent regarding the material access device of the cover automatically extends into the material transport device
Bazala teaches an analogous system comprising: a material transport device (12, Fig 27) containing injectable material; a base (240, Fig 27) configured to hold said material transport device; a material access device (318, Fig 27), the material access device comprising at least one needle; and a cover (330, Fig 27) configured to hold said material access device; wherein: the material access device of the cover automatically extends into the material transport device held by the base to access the injectable material for delivery to the patient (Para 0102).
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 system and method to comprise the guide elements (tabs 260, slots 324, etc.) such that the material access device of the cover automatically extends into the material transport device as taught by Bazala in order to prevent over-insertion of the pharmaceutical transport container into the docking station (Para 0039).
Regarding Claim 18, the modified invention of Nemoto and Bazala discloses the cover (410, Fig 2-Nemoto) further includes a material delivery system (110, 113, 120, 122, Fig 2-Nemoto), said method further comprising priming said material delivery system to eliminate air within the material delivery system (Para 0091).
Regarding Claim 21, the modified invention of Nemoto and Bazala discloses the stopper (202, Fig 1 -Nemoto) is formed of an elastomeric material (“silicon rubber”), and wherein a portion of the stopper is configured as the septum (Para 0058 -Nemoto).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 2008/0300483) in view of Bazala (US 2016/0120752) and further in view of Shibata (US 2020/0038596).
Regarding Claim 6, the modified invention of Nemoto and Bazala discloses priming the system before connection of the base to the cover (Para 0091 -Nemoto), 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).
Claims 10, 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 10, Nemoto discloses a material delivery system comprising: a material access device (122, 113, Fig 2); the material access device comprising an inlet needle (113, Fig 2) and an outlet needle (122, Fig 2); a material conduit system (110, 120, Fig 2) fluidly coupled with said material access device (Para 0064), the material conduit system comprising at least one tubing, wherein the at least one tubing comprises inlet tubing (110, Fig 2) fluidly coupled with the inlet needle (120, Fig 2), and outlet tubing coupled with the outlet needle (Para 0064).
Nemoto is silent regarding a priming cap defining a sealed chamber, the sealed chamber configured to cover sharp ends of the inlet needle and the outlet needle, the priming cap configured to cover said material access device and to maintain a sealed configuration of said material delivery system for priming; and wherein passing of flushing solution into the inlet tubing, through the inlet needle, through the sealed chamber, through the outlet needle, and through the outlet tubing results in a primed airless material delivery system.
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); the priming cap configured to cover said material access device and to maintain a sealed configuration of said material delivery system for priming; and wherein the airless primed material delivery system is configured for passing of flushing solution into the inlet tubing, through the inlet needle, through the sealed chamber, through the outlet needle, and through the outlet tubing results in a primed airless 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 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 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 Bazala (US 2016/0120752) and further in view of Newkirk (US 2004/0232286).
Regarding Claim 8, the modified invention of Nemoto Bazala discloses said at least one tubing (110, 120, Fig 2 -Nemoto) includes an outlet tubing (120, Fig 2 -Nemoto) fluidly coupled with said at least one needle (122, Fig 2 -Nemoto) to deliver the injectable material to a patient (Para 0064 -Nemtoto), 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 Bazala (US 2016/0120752) and further in view of Chinol (US 2005/0154275).
Regarding Claim 9, the modified invention of Nemoto Bazala discloses said base (211, Fig 2 -Nemoto), 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, the modified invention of Nemoto Bazala discloses all of the elements of the invention as discussed above, however, 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, the modified invention of Nemoto Bazala discloses said base (211, Fig 2 -Nemoto), 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 Bazala (US 2016/0120752) and further in view of Fazi (US 9,327,886).
Regarding Claim 20, the modified invention of Nemoto and Bazala discloses all of the elements of the invention as discussed above, however, 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 05/26/2026, on pages 7-8, regarding Nemoto failing to disclose “upon mating the cover and the base, the material access device of the cover automatically extends into the material transport device held by the base to access the injectable material for delivery to the patient” have been fully considered but are moot in view of the current rejection that relies on Bazala to teach the amended limitations.
Applicant’s arguments files 05/26/2026, on pages 9-11, regarding one of ordinary skill would not be motivated to modify Nemoto’s device with that of Shibata have been fully considered but is not persuasive. Applicant seems to be arguing the Shibata is nonanalogous as Nemoto is directed to a chemical liquid injection system and Shibata is directed to a priming cap for a dialysis system. MPEP 2141.01(a) defines that a reference is analogous if (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention)…. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. Regarding the first prong, Nemoto, Shibata, and the instant application are all classified in A61M5/00+. Therefore, they are at least within the same field of endeavor to one another. Further, Shibata is directed to a priming cap which is reasonably pertinent to the problem faced by the inventor (i.e. priming a system having an inlet and outlet needle). Thus, these references are analogous art to the claimed invention and one of ordinary skill would look to Shibata. Applicant further argues that because Nemoto does not suggest pre-priming its needle and tubing assembly that the benefit can only be derived from applicant’s disclosure. The benefits for the modification are found in Shibata (increase safety and convenience in the priming of the delivery circuit (Para 0009)) and not applicant’s disclosure and therefore, no improper hindsight was used.
Conclusion
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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