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 .
This office action is in response to applicant’s communication of 8/12/2024. Currently claims 1-8 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/14/2025. is being considered by the examiner.
Dose
Claim Objections
Claim 1 is objected to because of the following informalities: the term “wherein” on line 3 of the claim is misspelled. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Py (US 2018/0064606 A1).
Py teaches and discloses a system (as in figure 1-13b) for storing a sterile medicinal solution in a multiple dose container (12/16) and for delivering one dose at a time of the medicinal solution to a disposable syringe (80/20), wherein the multiple dose container (12/16) is an airless container, which consists of a stiff outer container (22) and a contracting inner bag (16), into which no air enters for pressure balancing when delivering medicinal solution, that fastened to the multiple dose container (12/16) there is an adapter (40/44) with a one-way valve (18) and a female Luer container (30) and that the disposable syringe (80) is provided with a matching, male Luer connector (center tip near 84), with which it may be docked with the adapter (40/44) in order to receive a dose of the medicinal solution by pulling up the disposable syringe (see discussion of device as in paras {0046]-[0054]).
Concerning claim 2 and the multiple dose container (see figure 10 and 112) has a container neck (near 168) and that the Luer adapter (near 132) is snap-connected to the container neck (see connection as shown in figure 10 for example).
Concerning claim 3 and the connector is a conically broadening outlet passage in the one way valve (see broadening outlet passage as shown in figures 3-7 and pathway through valve).
Concerning claim 4 and the one way valve (18) has an elastic valve membrane (46), which closes the entire inner flow opening of the one way valve (18) with the exception of a hole (66 as in figure 5 for example) the edge of which valve membrane so rests in the relaxed sate on a valve seat pin (seat of element structure 14 or seat 40 structure as in figure 4 for example) that the one way valve is sealingly closed (see figure 4 for example).
Concerning claim 5 and when the docked disposable syringe (20) is pulled up, the valve membrane (46) is lifted up from the valve seat pin and enables the flow of medicinal solution (see figure 6 for example and note flow).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Py (US 2018/0064606 A1) in view of Korogi et al. (US 9,895,526 B2).
Concerning claim 6-7 and the lid, Py discloses the claimed invention except for the “lid”. Korogi teaches that it is known to provide a “lid” onto an adapter body with a luer connection.as set forth embodiments shown in figures 20-40. Korogi teaches a closeable lid (see figure 20 and 400 for one example), which is connected to two lateral webs (406) which are pivotally connected to the outer side of the adapter (402), whereby the lid (400) is furthermore connected to at least one flexible spring arm (401/404), which is stressed when the lid (6a) is pivoted into the open position; Further the lid (407) has an edge opening, into which the Luer connector (luer of syringe 20 of prior art) on the disposable syringe can engage, in order to move the lid (Korogi 407 and 503 as discussed in para 130 of Korogi) sideways.
Korogi uses this lid to provide a controlled and sterile access connection to the adapter in order to prevent contamination. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Py with a lid as taught by Korogi, since such a modification would provide the system with a lid for providing a controlled and sterile access connection to the adapter in order to prevent contamination
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Py (US 2018/0064606 A1).
Concerning claim 8 and wherein a dead volume within the adapter (40/44) is protected from microbial contamination by an antimicrobial material, Py discloses the claimed invention except for a dead volume within the adapter (40/44) is protected from microbial contamination by an antimicrobial material. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the Py adapter with an anti-microbial contamination material, 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. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Constructing medical devices with material of an anti-microbial material is well known to a PHOSITA in order to maintain a sterile and germ free device and patent environment to not contaminate a patient or patients.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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