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 Arguments
Applicant’s arguments, filed 9 March 2026, with respect to the rejections of the claims, as amended, over Forino and Petit have been fully considered and are partially persuasive. While Forino discloses a filter, it is not in the central passageway of the withdrawal member as claimed by Applicant. The filter in the reconstitution device disclosed by Applicant is configured to filter out particulates as the fluid passes through the withdrawal member 14, ensuring particle-free diliuent in syringe 20 (Specification at ¶0030). Similarly, the filter 20 in the reconstitution device disclosed by Forino is fluidly connected with withdrawal member 7, filtering out particulates before fluid enters syringe 3. The filter in the Forino reference provides the same result as the instantly claimed filter—particulate free diluent in the syringe. A person having ordinary skill in the art would have appreciated that a filter for filtering out particulates resides within the flow path of the reconstitution device from the withdrawal member to the syringe. As such, as a known location, as evidenced by Forino, the claimed location of the filter does not patentably distinguish over the teachings of the prior art of record.
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.
Claims 1-3 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2055291 to Forino in view of US 2016/0318051 to Petit, further in view of US2020/0368433 to Schabbach et al.
In the specification and figures, the cited art discloses the invention substantially as claimed by Applicant. With regard to claims 1, 3, 9-14, Forino discloses a vial adapter 5 with a body with a first and second end and grips, a vial connector 13, 22, a syringe connector 12, 14, a transfer spike 15 with opposite orifices and a lumen, all defining a passageway therethrough. The device further comprises a tapered withdrawal member 7 with a passageway connected to the vial connector, syringe connector and transfer spike, as well as a filter 20 (see FIGS 1-4). While Forino teaches a filter 20 in fluidly connected with withdrawal member 7, the filter is not within the withdrawal member as claimed by Applicant. However, the instantly claimed filter is configured to filter out particulates as the fluid passes through the withdrawal member 14, ensuring particle-free diliuent in syringe 20 (Specification at ¶0030). Similarly, the filter 20 disclosed by Forino is fluidly connected with withdrawal member 7, filtering out particulates before fluid enters syringe 3. The filter in the Forino reference provides the same result as the instantly claimed filter—particulate free diluent in the syringe. A person having ordinary skill in the art would have appreciated that a filter for filtering out particulates resides within the flow path of the reconstitution device from the withdrawal member to the syringe. As such, as a known location, as evidenced by Forino, the claimed location of the filter does not patentably distinguish over the teachings of the prior art of record.
The apparatus disclosed by Forino does not comprise a nozzle spray attachment. However, US Petit et al discloses a reconstitution assembly with a spray head 40 that is connected to the reconstitution assembly after reconstitution of a lyophilisate (see FIGS 13, 14, ¶0037, 39). It would have been obvious to a person having ordinary skill in the art at the time of filing to add a spray nozzle as disclosed by Petit to the reconstitution assembly as disclosed by Forino in order to have a dispensing means, as taught by Petit.
With regard to claim 2, Forino discloses a syringe with a barrel 3 and a plunger rod (unlabeled), as well as an ampoule 2 with diluent (see FIG 2).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2055291 to Forino in view of US 2016/0318051 to Petit, further in view of US 2015/0157801 to Tran et al.
In the specification and figures the cited prior art suggests the apparatus substantially as claimed by Applicant (see rejections above). Forino and Petit do not disclose a dose divider. However, Tran discloses a dose divider 206 attachable to a plunger rod in order to limit the dose of medicament administered to a patient (see ¶0006, 0011). The dose divider comprises first and second grip portions 222, 224, and a c-shaped body (see FIGS 6, 7 and accompanying text). It would have been obvious at the time of filing to add a dose divider as disclosed by Tran to the syringe-based reconstitution assembly suggested by the prior art in order to limit dose amounts, as taught by Tran.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over EP 2055291 to Forino in view of US 2016/0318051 to Petit, further in view of US 2005/0131357 to Denton et al.
In the specification and figures the cited prior art suggests the apparatus substantially as claimed by Applicant (see rejections above). Forino and Petit do not disclose a luer connection. However, Denton discloses that a luer connection makes a conventional slip fit, indicating that luer connections are well known in the art.
Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0318051 to Petit in view of US 2005/0131357 to Denton.
In the specification and figures the cited prior art suggests the method as claimed by Applicant
With regard to claim 15, Petit discloses the method as claimed by Applicant: inserting a withdrawal member 10 into a container 1, withdrawing diluent from the container(see FIGS 3 and 4), attaching the withdrawal member to a mixing vial 2, transferring the reconstituted drug back to member 10, and attaching a spray nozzle to the withdrawal member (see FIGS 5 and 7). Petit does not disclose removal of parts before adding adapters. However, removing parts that aren’t needed during a procedure is within the skill of a worker in the art. To wit, Denton discloses that it is known in the art to use a reconstitution device with an adapter, remove the adapter, then place a discharge element on the dispenser (see ¶0006). Accordingly, the prior art suggests the method as claimed by Applicant.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0318051 to Petit in view of US 2005/0131357 to Denton, further in view of US 2015/0157801 to Tran et al.
In the specification and figures the cited prior art suggests the method as claimed by Applicant (see rejections above).
Petit and Denton do not disclose a dose divider. However, Tran discloses a dose divider 206 attachable to a plunger rod in order to limit the dose of medicament administered to a patient (see ¶0006, 0011). The dose divider comprises first and second grip portions 222, 224, and a c-shaped body (see FIGS 6, 7 and accompanying text). It would have been obvious at the time of filing to add a dose divider as disclosed by Tran to the syringe-based reconstitution assembly suggested by the prior art in order to limit dose amounts, as taught by Tran.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0318051 to Petit in view of US 2005/0131357 to Denton, further in view of EP 2055291 to Forino.
In the specification and figures the cited prior art suggests the method as claimed by Applicant (see rejections above). Petit and Denton do not disclose a glass ampoule. However, Forino discloses reconstituting medicaments from glass vials, teaching that such materials are known in the art. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use glass as disclosed by Forino in the method suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP § 2144.07.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2020/0368433 Schabbach et al
Reconstitution device with filter
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 24 March 2026