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 .
Status of Claims
Claims 1-13 are pending and examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
The Specification assigns two different reference numbers and two different structures to the same term “coupling member.” Based on the drawings, see e.g., Fig. 4E, coupling member 107 forms a threaded coupling with an inner surface of the luer adapter 109 of the syringe 101, whereas coupling member 211 appears to be an upper portion of the adapter body 110 that fits around an outer surface of the luer adapter 109 of the syringe 101, resulting in coupling member 107 and coupling member 211 being concentrically arranged.
There is no confusion for couplings members 111 and 411, shown in Figs. 1 & 8C respectively, because there is only one coupling member in each of these embodiments.
Appropriate correction is required.
Claim Objections
Claims 6, 8, 10, 13 are objected to because of the following informalities:
Re Claim 6, “a pre-fillable device” should be “the pre-fillable assembly”.
Re Claims 8, 10, & 13, “the prefilled syringe device” should be “the pre-fillable assembly”.
Appropriate correction is required.
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 1-7, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Eilertsen et al. (US 2014/0311624) in view of Wong et al. (US 5,385,547).
Re Claim 1, Eilertsen discloses an adapter comprising:
an adapter body (at least distal cap end portion 104a, see Fig. 11) comprising:
a coupling member (syringe holder 130) configured for coupling with a pre-fillable assembly (syringe 110); and
a spike (spike 152) extending from a central body (spike base 154);
at least one conduit (at least comprising lumen 155) extending through the spike, adapter body and the coupling member;
a spike cover (forming sealed spaced 157) sized to receive and seal the spike; and
receiving members (circumferentially distributed edges 191, see Fig. 11 and [0185]) configured to receive a vial shroud (coupling element 140) .
Eilertsen does not disclose that the cover is reversibly securable to the central body. Wong discloses a device for medical fluid transfer, the device having a spike cover (removable cover 47) that is removably secured to a central body (shell 28, col. 4 lines 45-47). It would have been obvious to one skilled in the art at the time of invention to modify Eilertson to include the removable spike cover taught by Wong so as to protect the spike prior to use.
Re Claim 2, Eilertsen and Wong combine to disclose claim 1, and Eilertsen further discloses wherein the at least one conduit includes a vent conduit (lumen 155 allows for balancing of pressure between the syringe and the vial during connection, see e.g., [0171], thus it is interpreted to mean venting).
Re Claim 3, Eilertsen and Wong combine to disclose claim 1, and Eilertsen further discloses wherein the adapter body is configured with generally cylindrical side walls (see e.g., Figs. 11-13).
Re Claim 4, Eilertsen and Wong combine to disclose claim 3, and Eilertsen further discloses wherein the cylindrical side walls extend longitudinally from the central body (see Figs. 11-12, note the claim language does not require the cylindrical side walls be integral to the central body).
Re Claim 5, Eilertsen and Wong combine to disclose claim 4, wherein the coupling member (130) is generally cylindrical and configured to be slidably received within the cylindrical side walls of the adapter body (Figs. 11-13 show the two stages of engagement between 130 and 104a, thus 130 is slidably received within 104a).
Re Claim 6, Eilertsen and Wong combine to disclose claim 1, and Eilertsen further discloses wherein the adapter is configurable to transition from the first state (Fig. 11) to the second state upon coupling of the coupling member with the pre-fillable assembly (Fig. 13).
Re Claim 7, Eilertsen and Wong combine to disclose claim 1, and Eilertsen also discloses wherein the coupling member is configured with locking features (circumferential protrusions 136c) receivable by complementary locking features (146d) of the adapter body in the second state so as to prevent return to the first state ([0207]).
Re Claim 13, Eilertsen and Wong combine to disclose claim 1, and Eilertsen further discloses an elastomeric seal (syringe stopper 160) positioned in the coupling member (130) for providing a resistance fitting for coupling to the pre-fillable assembly (e.g., the stopper resists penetration by spike 153 when syringe is brought closer to the vial to start fluid transfer) .
Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Eilertsen and Wong as applied to claim 1 above, and further in view of Takeuchi (US 2015/0265499).
Re Claim 8, Eilertsen and Wong combine to disclose claim 1, but they do not disclose wherein the adapter body further includes a valve having a cracking pressure, the valve configured to control fluid flow between the at least one conduit of the spike and the coupling member and contain fluid in the pre-fillable assembly, wherein the valve is configured in a first state wherein the fluid flow through the at least one conduit of the spike is prevented.
Takeuchi discloses a vial adapter having an adapter body with a slit valve (42) formed of a slit (42a), which would require a cracking pressure to open. The valve is configured to control fluid flow between the at least one conduit of the spike and the coupling member and contain fluid in the syringe, wherein the valve is configured in a first state wherein the fluid flow through the at least one conduit of the spike is prevented. It would have been obvious to one skilled in the art at the time of filing to modify Eilertsen further with the valve of Takeuchi to allow for selective control of the flow with a needleless system as controlled by the pressure differential across the valve. It would have been obvious to make the proposed modification in view of Takeuchi at least because it has been held that the use of a known technique to yield predictable results establishes a prima facie case of obviousness (see MPEP 2143 (I)(C & G)).
Re Claim 9, Eilertsen, Wong, and Takeuchi combine to disclose claim 8, and Takeuchi further discloses wherein the valve is configurable to transition to a second state and allow fluid flow through the at least one conduit of the spike (Takeuchi’s valve has an open and close state, thus its incorporation into Eilertsen would yield an adapter that meets the limitations of the claim).
Re Claim 10, Eilertsen, Wong, and Takeuchi combine to disclose claim 8, and the combination necessarily results in the adapter being configured in the first state to seal contents of the pre-fillable assembly and/or control contact of the contents of the pre-fillable assembly to the valve (since the valve’s natural state is to stay shut unless a pressure greater than the cracking pressure is exerted).
Re Claims 11 & 12, Eilertsen, Wong, and Takeuchi combine to disclose claim 8. The language “wherein the coupling member is configurable for welding with the central body to contain the valve” and “the coupling member is configurable to snap-fit coupling with the central body to contain the valve” are considered product-by-process language regarding how the valve is attached to the coupling member. As explained in MPEP 2113, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In the instant case, Takeuchi clearly shows that the valve fits snugly within a coupling member (e.g., Fig. 2B) even though the process is not necessarily by “welding” or “snap-fit”. The burden now shifts to the Applicant to come forward with evidence establishing an unobvious different between the claimed product and the prior art product.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kraus et al. (US 2007/0079894) appears to disclose a coupling member, an adapter body extending from a central body, a spike that has a venting lumen, and a vial shroud that fits over the cap of a vial (see e.g., Figs. 6A-6B).
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/SUSAN S SU/Primary Examiner, Art Unit 3781 27 September 2025