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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/26/2026 has been entered.
Claim Objections
Claims 1 and 27 are objected to because of the following informalities:
Claim 1 line 16, “an injection device” should read “the injection device” as it refers to the same injection device introduced in line 2 of the claim.
Claim 27 line 3, “a vial” should read “the vial” as it refers to the same vial introduced in line 1 of the claim.
Claim 27 line 14, “an injection device” should read “the injection device” as it refers to the same injection device introduced in lines 1-2 of the claim.
Appropriate correction is required.
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.
Claim 27-29 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 27 recites the limitation "by the insertion of the vial jacket into the vial receiving station" in lines 6-7. There is insufficient antecedent basis for this limitation (“the vial jacket”) in the claim.
Claims 28-29 are rejected due to their dependency on claim 27.
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) 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lavi et al. (US Patent Pub. 20040069044 hereinafter “Lavi” note this reference was previously cited) in view of Haber et al. (US Patent 5329976 hereinafter “Haber” note this reference was previously cited).
Regarding Claim 27, Lavi teaches (Fig 19a-19d) A method of transferring fluid from a fluid-containing vial (422) to an injection device [0133], the method comprising:
inserting a vial (422) into a vial receiving station (device where vial 422 is located in Fig 19d) whereby at least one access spike (438) is forced through the vial (422);
puncturing a seal of a pre- filled fixed volume pressurized cylinder (430; see [0137] teaching pressurized air within 430) containing a pressurized gas using a puncturing pin (See [0134] teaching how pressurized air moves the diluent; see [0137] teaching pressurized air within 430 and also see Fig 19D with a puncturing pin 482) by the insertion of the vial jacket (the flange of syringe 430 in Fig 19d) into the vial receiving station (it is interpreted that eh vial jacket/flange of the pressurized cylinder 430 is inserted into the vial receiving station at the same time as the pressurized cylinder 430, as such the puncturing of 430 would occur by the insertion of the vial jacket);
introducing pressurized gas from the pressurized cylinder into the vial through a gas entry lumen of the at least one access spike (See [0134] "The spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420.");
flowing fluid from the vial through a liquid outflow lumen of the at least one access spike under pressure from the pressurized gas, where the liquid outflow lumen is separate from the gas entry lumen (See [0134] "The spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420.");
flowing the fluid from the vial into an injection device under the force of the pressurized gas (see [0133-0134]).
Lavi does not specify that the vial contains a septum.
Haber teaches a design of a vial (4,6) that includes a septum that is pierced by a spike (Col 5 lines 20-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vial of Lavi to include a septum as taught by Haber. One of ordinary skill in the art would recognize this as a well-known design of a vial (Haber Col 1 lines 60-63).
Regarding Claim 28, the combination of Lavi and Haber teaches the method of claim 27 wherein the gas entry lumen and the liquid outflow lumen are included in a single access spike (See Lavi [0134] "The spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420.".
Regarding Claim 29, the combination of Lavi and Haber teaches all elements of claim 27 as described above. Lavi does not specify the method wherein the gas entry lumen is included in a first access spike and the liquid outflow lumen is included in a second access spike where the first and second access spikes are separate spikes.
Haber teaches (Figs 3-6) two access spikes (54, 56) forced through a septum (Col 5 lines 20-22) of the vial (4,6) wherein a first access spike (54) is for liquid outflow and a second access spike (56) is for gas entry.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the at least one access spike of Lavi such that the gas entry lumen is included in a first access spike and the liquid outflow lumen is included in a second access spike where the first and second access spikes are separate spikes as taught by Haber. One would be motivated to make this substitution since it would result in a similar device that will have medicament transferred from a vial to the injection device.
Allowable Subject Matter
Claims 1-9, 12-21 and 25-26 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claim 1, the prior art fails to disclose singly or in combination before the effective filing date, the claimed method of transferring fluid from a fluid-containing vial to an injection device.
The closest prior art of record is Lavi et al. (US Patent Pub. 20040069044 hereinafter “Lavi”) in view of Haber et al. (US Patent 5329976 hereinafter “Haber”). , Lavi teaches (Figs 19a, 19b 19d) A method of transferring fluid from a fluid-containing vial (422) to an injection device [0133], the method comprising:
providing the vial (422);
whereby at least one access spike (438) is forced through the vial (422) and a seal of a pre- filled pressurized cylinder (426) containing a pressurized gas is punctured using a puncturing pin (see [0134] teaching how pressurized air moves the diluent; also see Fig 19D with a puncturing pin 482);
introducing pressurized gas from the pressurized cylinder into the vial through a gas entry lumen of the at least one access spike (See [0134] "The spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420.");
flowing fluid from the vial through a liquid outflow lumen of the at least one access spike under pressure from the pressurized gas, where the liquid outflow lumen is separate from the gas entry lumen (See [0134] "The spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420.");
flowing the fluid from the vial into an injection device under the force of the pressurized gas (See [0133-0134]).
Lavi does not specify a vail with a vial jacket, inserting the vial jacket into a vial receiving station or the access spike going through a septum.
Haber teaches (Figs 3-6) a vial (4,6) with a vial jacket (14) that is inserted into a vial receiving station (78), and the access spike (54, 56) piercing a septum (Col 5 lines 20-22) of the vial (4,6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Lavi such that it includes a vial jacket, and inserting the vial jacket into a vial receiving station whereby at least one access spike is forced through a septum of the vial as taught by Haber. One of ordinary skill in the art would have been motivated to do so in order to ensure that different types and configurations of vials may be used with the vial receiving station (Haber Col 4 lines 52-56).
Lavi teaches a seal of a pre- filled pressurized cylinder (426) containing a pressurized gas is punctured using a puncturing pin (see [0134] teaching how pressurized air moves the diluent; also see Fig 19D with a puncturing pin 482). Lavi does not specify puncturing the seal of the pressurized cylinder is “by the insertion of the vial jacket into the vial receiving station”. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Lavi to satisfy these limitations in combination with the rest of the limitations of the claim.
Claims 2-9, 12-21 and 25-26 are dependent on claim 1.
Response to Arguments
Applicant’s arguments with respect to claim(s) 27 have been considered but are moot because the new ground of rejection takes into consideration the amendments filed 1/26/2026.
The examiner notes that adding an amendment to claim 27, which recites a similar limitation as claim 1 line 3, (a recitation that connects the vial with the vial jacket) would help overcome the prior art rejection of Lavi in view of Haber.
Conclusion
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783