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 Amendment
This office action is responsive to the amendment filed on 09/29/2025. As directed by the amendment: no amendment was made to the claims. Thus, claims 1 – 19 are presently pending in this application with claims 8 – 19 currently withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 14) and Species A (Figures 5 – 12) in the reply filed on 09/29/2025 is acknowledged.
Under further review, claims 8 – 14 appear to be directed to nonelected Species B (Figure 13 – 15). Specifically, claims 8 – 14 include claim limitations regarding the sealing member 23400 only shown in Figures 13 – 15. Therefore, claims 8 – 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim
Claims 15 – 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group or Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/29/2025.
Specification
The disclosure is objected to because of the following informalities:
“In this manner.” at the end of paragraph [0056] appears to be an incomplete sentence
Applicant is advised to review the entire specification as there could be other similar minor informalities. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 – 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a seal disposed between the first coupling potion and the second coupling portion, …. the seal configured to abut the septum seal when the first coupling portion is removably coupled to the medicament container such that any medicament extracted from the medicament container is limited to the collection area and the fluidic channel” in lines 11 – 17. As currently read, claim 1 requires the extraction member to have a seal disposed between the first coupling portion and the second coupling portion to define a medicament collection area. Claim 1 further requires that this seal abut the septum seal of the medicament container. However, the current Specification does not disclose a seal of the extraction member that is disposed between the first coupling portion and the second coupling portion to define a medicament collection area. Paragraphs [0056] – [0061] discloses a seal 22297 of the cap 22296 of medicament container 22294 that define the collection area between seal 22297 and puncturing member 22291. Seal 22297 is not disclosed to be a part of the extraction device since no other mention of a seal that define a medicament collection area can be found in the Specification. Therefore, the claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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.
Claim(s) 1, 2, and 4 – 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev (U.S. 2012/0220978) in view of Mansour (U.S. 2014/0261727).
Regarding claim 1, Lev teaches an extraction member (fluid transfer device 50, Figures 4 – 8E), comprising:
a first coupling portion (female vial adapter 31, Figures 4 and 5) configured to removably couple the extraction member to a medicament container containing a medicament (snap fit mounting the fluid transfer device 50 onto vial 20 as discussed in paragraph [0030] and shown in Figures 3A – 3E and 8A – 8E) such that the first coupling portion at least partially circumferentially surrounds a septum seal (vial stopper 26, Figure 3A) of the medicament container (as shown in Figure 8E);
a second coupling portion (connector 39, Figure 6) configured to removably couple the extraction member to a medicament injector (connector 39 for mounting of syringe 10 as discussed in paragraph [0021]);
a puncture member (cannula 36, Figure 6, paragraph [0021]) defining a fluidic channel (flow communication lumen 38, Figure 6, paragraph [0021]) and configured to pierce the septum seal to establish fluidic communication between the medicament container and the medicament injector via the fluidic channel as the extraction member is coupled to the medicament container via the first coupling portion (see discussion of cannula tip 37 tear the vial stopper 26 at the puncture site as fluid transfer device 50 is mounted onto vial 20);
and a seal (sealing element 51, Figure 6 – 8E) disposed between the first coupling portion and the second coupling portion, and defining an opening through which the puncture member is disposed and extends therefrom (seal 51 sealingly encircles cannula 36 as discussed in paragraph [0029] and shown in Figure 6) towards the first coupling portion (as shown in Figure 6) thereby defining a medicament collection area (the space between the stopper 25 and the tip 37 as shown in the annotated Figure 8E below) circumferentially surrounding a portion of the puncture member between the seal and a distal end of the puncture member, the seal configured to abut the septum seal when the first coupling portion is removably coupled to the medicament container such that any medicament extracted from the medicament container is limited to the collection area and the fluidic channel (seal 51 is axially compressed between the top wall 32 and the stopper surface 26A as discussed in paragraph [0030] and shown in Figure 8E);
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However, Lev does not specify that the puncture member including an aperture configured to fluidically couple the fluidic channel of the puncture member with the collection area at a low point of the collection area during extraction of medicament from the medicament container to the medicament injector through the fluidic channel to maximize transfer of any medicament from the collection area to the fluidic channel.
Mansour teaches a transfer device similar to Lev and the current application, further including that the puncture member (spike 130, Figure 4) including an aperture (fluid aperture 132A, Figure 4) configured to fluidically couple the fluidic channel of the puncture member with the collection area (collection area is defined as the space between stopper 182 and top 131 as shown in Figure 4) at a low point of the collection area (see aperture 132a at the bottom of the collection area as shown in Figure 4) during extraction of medicament from the medicament container to the medicament injector through the fluidic channel to maximize transfer of any medicament from the collection area to the fluidic channel, specifically see discussion of precisely positioning the fluid aperture 132a adjacent to an interior facing side of the rubber stopper 182 with the vial adapter 100, substantially all of the medication 184 can be extracted from the vial 194 in paragraph [0043].
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Mansour with the device of Lev in order to allow complete extraction of expensive and/or hazardous medications (paragraph [0043] of Mansour).
Regarding claim 2, Lev and Mansour teach claim 1 as seen above.
However, Lev and Mansour do not specify that wherein the aperture extends to a point less than 50 µm from a bottom of the extraction member.
Mansour discloses that the piercing spike is configured to a length sufficient to extend through multiple receiving channel and fluid aperture 132a can be precisely positioned adjacent an interior facing side of the stopper 182 to maximize extraction (paragraphs [0043] and [0046]). Therefore, the position of the aperture is a result effective variable that can be optimized to maximize extraction.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the aperture to extend to a point less than 50 µm from a bottom of the extraction member, for the purpose of maximizing extraction of medication, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(II)
Regarding claim 4, Lev further teaches that wherein the first coupling portion includes a plurality of arms (flex members 34, Figure 6, paragraph [0021]) configured to flex open to secure the extraction member around a cap of the medicament container as shown in Figure 8E.
Regarding claim 5, Lev further teaches that wherein each of the arms includes a ledge (protuberance 41 for snap fitting under the vial rim 22, Figure 2), configured to secure the cap of the medicament container as shown in Figure 8E.
Regarding claim 6, Lev further teaches that wherein the second coupling portion includes a plurality of ridges (ridges defined by Luer lock connector 39) configured to facilitate gripping the second coupling portion (ridges of Luer lock connector 39 can be gripped by a sealing screw thread of a syringe 10 as discussed in paragraph [0021]).
Regarding claim 7, Lev and Mansour teach claim 1 as seen above.
Mansour further teaches that the aperture is a first aperture among a plurality of discrete apertures distributed about the puncture member (fluid aperture 132A and air aperture 132B as shown in Figure 4 an discussed in paragraph [0042]) (claim 7).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of Mansour with the combined device of Lev and Mansour in order to allow complete extraction of expensive and/or hazardous medications (paragraph [0043]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lev (U.S. 2012/0220978) in view of Mansour (U.S. 2014/0261727), and in view of McAffer (U.S. 5,454,409).
Regarding claim 3, Lev and Mansour teach claim 2 as seen above.
However, Lev and Mansour do not specify that the puncture member includes at least one of a hard plastic or a metal.
McAffer teaches a transfer device similar to Lev, Mansour, and the current application, further including that the puncture member includes a metal (metal needle as discussed in Col. 3, lines 46 – 53).
It would have been obvious to one having ordinary skill in the art at the time the application was filed to combine the features of McAffer with the combined device of Lev and Mansour in order to allow autoclaving the transfer adaptor after use for extended reuse (McAffer, Col. 3, lines 54 – 59).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH T BUI whose telephone number is (571)270-1028. The examiner can normally be reached M - F 8 - 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ANH T. BUI
Examiner
Art Unit 3783
/Anh Bui/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783