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 20FEB2026 have been fully considered but they are not persuasive.
The surface forming the channel of Fangrow, as depicted in Fangrow Annotated Fig. 22E, is considered to possess the annular and linear portions as claimed. A rounded channel will be annular when considering the circumference and linear in length.
The formed channel will similarly face the expandable portion as claimed when considering the portion of the channel most distal from the expandable portion (near the intake opening).
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-9, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20140230932 A1 (Fangrow).
Regarding claims 1-3, 7-9, 11, and 12, Fangrow teaches a vial adapter (3000'') (Fig. 22E) comprising:
a body having a component connection interface (3040) and a vial connection interface (at least 3080), the component connection interface configured to engage a connection interface of a mating component (cap connector 3030 connecting to a vial, [0188] providing description for corresponding 330 and 380);
a pressure equalization assembly (3052”) comprising an equalization housing (at least 3085”), an expandable member (3054) [0294], and a valve member (3095”) [0308], the equalization housing and the expandable member defining a space configured to expand from a first volume (VE1) [0296] to a second volume (VE2) larger than the first volume [0303] (shown in Fig. 22C), the equalization housing defining an equalization opening (at filter retainer 3094a”) in fluid communication with the space and an intake opening (Fangrow Annotated Fig. 22E) in fluid communication with the valve member, the valve member is configured to allow air into the space from the intake opening and prevent air from the space to exit the intake opening [0308], a surface of the equalization housing defining a channel (Fangrow Annotated Fig. 22E) in fluid communication with the equalization opening and the valve member; and
a piercing member (3020”) having a first end connected to the body and a second end positioned opposite the first end (Fangrow Annotated Fig. 22E), the piercing member and the body defining a fluid passageway (3045”) and a pressure equalization passageway (3025”), the fluid passageway is in fluid communication with the component connection interface (Fig. 22E), the pressure equalization passageway is in fluid communication with the equalization opening of the pressure equalization assembly [0285], wherein the channel comprises an annular portion (Fangrow Annotated Fig. 22E) in fluid communication with the equalization opening and a linear portion (Fangrow Annotated Fig. 22E) extending from the annular portion to the valve member; and
wherein the expandable member comprises a film ([0294] describing a flexible and/or stretchable material) configured to move from a first position where the film is positioned within equalization housing (occupying VE1 as seen in Fig. 22E) and a second position where at least a portion of the film is positioned outside of the equalization housing (occupying VE2 as seen in Fig. 22C); and
wherein the channel is configured is provide fluid communication between the intake opening and the equalization opening when the film is in the first position (as seen in Fig. 22E); and
a filter (3061”) positioned between the pressure equalization passageway (3025”) and the equalization opening (at 3094a”) (Fig. 22E); and
wherein the filter comprises a hydrophobic filter [0305]; and
wherein the filter is configured to filter out particles with a diameter larger than 0.45 µm ([0142] describing the corresponding filter 260 which filters particles above 0.3 µm).
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Fangrow Annotated Fig. 22E
Regarding Claim 13, Fangrow further teaches the surface (the interior of the channel shown in Annotated Fig. 22E) faces the expandable member (3054) (the portion of the channel near the intake opening facing the expandable member).
Regarding Claim 14, Fangrow further teaches the equalization opening (at filter retainer 3094a”) is at least partially defined in the surface (forming the channel of Annotated Fig. 22E), and wherein the intake opening is at least partially defined in the surface a distance away from the equalization opening (Fangrow Annotated Fig. 22E).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 4, 5, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fangrow in view of US 20080311007 A1 (Helmerson et al.).
Regarding claim 4, Fangrow further teaches the channel comprising an annular portion in fluid communication with the equalization opening and a linear portion extending from the annular portion (Fangrow Annotated Fig. 22E) to the valve member (3095”), but fails to teach a plurality of equalization openings arranged in a circle.
Helmerson teaches a vial adapter (10) (Fig. 1) wherein the equalization opening (18) comprises a plurality of equalization openings arranged in a circle (as seen in Fig. 5 where a second filter provides openings as claimed).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the equalization opening of Fangrow to incorporate the second filter of Helmerson to ensure gas passing through the device is filtered [0038].
Regarding claim 5, Fangrow teaches the valve member (3095”) comprises a one-way valve [0308], but fails to teach the intake opening comprises a plurality of intake openings.
Helmerson teaches a vial adapter (10) (Fig. 1) wherein the intake opening (20) comprises a plurality of intake openings (Figs. 6 and 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the intake opening of Fangrow to incorporate the plurality of intake openings of Helmerson as a simple substitution of one known element for another to predictably allow air into the device MPEP 2143 I.
Regarding Claim 15, Fangrow further teaches the surface (the interior of the channel shown in Annotated Fig. 22E) faces the expandable member (3054) (the portion of the channel near the intake opening facing the expandable member).
Regarding Claim 16, Fangrow further teaches the equalization opening (at filter retainer 3094a”) is at least partially defined in the surface (forming the channel of Annotated Fig. 22E), and wherein the intake opening is at least partially defined in the surface a distance away from the equalization opening (Fangrow Annotated Fig. 22E).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fangrow in view of Helmerson, as applied to claim 5 above, and further in view of US 8523838 B2 (Tornqvist).
Regarding claim 6, Fangrow in view of Helmerson fails to teach the valve member comprises a diaphragm and a stem.
Tornqvist teaches a vial adapter (10) wherein the valve member (81) comprises a diaphragm and a stem (Col. 6: l. 65 – Col. 7: l. 5), a diaphragm valve considered to necessarily have a stem attached to a saddle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve of Fangrow from being a duckbill or similar valve [Fangrow 0308] to the diaphragm valve of Tornqvist as a simple substitution of one known valve for another to allow flow control in the device MPEP 2143 I.
When the diaphragm valve is placed in the equalization opening, the diaphragm valve is considered to fulfill the requirement wherein the stem is attached to the equalization housing via a valve opening, the valve member having a first position (closed) where the diaphragm seals the plurality of intake openings from the space and a second position (open) where the diaphragm unseals the plurality of intake openings from the space.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fangrow in view of Tornqvist.
Regarding claim 10, Fangrow fails to teach the component connection interface comprises a membrane and is configured to mate with a syringe adapter.
Tornqvist teaches a vial adapter (10) wherein the component connection interface (12) comprises a membrane (40) and is configured to mate with a syringe adapter (where 1 meets 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the component connection interface of Fangrow with the membrane and syringe adapter of Tornqvist to all the user to provide a liquid and gas tight seal, thereby minimizing leakage (Tornqvist Col. 5: ll. 15-19).
Conclusion
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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HANS KALIHER/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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