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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 10, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-8 and 10-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kakinoki (US 2019/0184152).
Regarding Claim 1, Kakinoki discloses a fluid transfer device (Figs. 1-5) for use in medical and/or pharmacological applications (¶ [0002-0004]), comprising a first adapter unit (female connector 2a, Figs. 1-5) comprising a first sealing element (elastic valve body 70, Figs. 1-5) and a second adapter unit (male connector 1a, Figs. 1-5) comprising a second sealing element (valve body 50a, Figs. 1-5), wherein the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are configured to provide a fluid connection between the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) in a connected state (Fig. 5) and to prevent a fluid transfer out of the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) in an unconnected or separated state (Fig. 2), wherein
the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are formed to establish the fluid connection between the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) by a combined pressing movement toward each other and rotational movement with respect to each other only after adjusting a constant or defined pressure, which the first sealing element (70, Figs. 1-5) and the second sealing element (50a, Figs. 1-5) apply against each other (¶ [0056-0059]), wherein
the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are configured to assume, in addition to the connected state (Fig. 5) and the unconnected or separated state (Fig. 2), a transfer state (Fig. 4) in which the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are attached to each other and the first sealing element (70, Figs. 1-5) and the second sealing element (50a, Figs. 1-5) are in contact with each other and apply the constant or defined pressure against each other (Fig. 4; ¶ [0056-0059]), and a fluid connection is not yet provided (Fig. 4, ¶ [0056-0059]) between the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5), and wherein
the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are configured to be transferred from the unconnected or separated state (Fig. 2) to the transfer state (Fig. 4) by pressing on each other and rotating relative to each other by a first predetermined angle, and to be transferred from the transfer state (Fig. 4) to the connected state (Fig. 5) by continued rotation by a second predetermined angle (¶ [0056-0059]).
Regarding Claim 2, Kakinoki discloses the second adapter unit (1a, Figs. 1-5) comprises a hollow needle (tubular member 40a, Figs. 1-5) forming a fluid passage (first flow path 41, Figs. 1-5), and the hollow needle (40a, Figs. 1-5) is received in the second sealing element (50a, Figs. 1-5) in the unconnected state (Fig. 2) or the transfer state (Fig. 4) and penetrates an interface (abutment region 73, Figs. 1-5) between the first sealing element (70, Figs. 1-5) and the second sealing element (50a, Figs. 1-5) only when the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are transferred from the transfer state (Fig. 4) to the connected state (Fig. 5; ¶ [0056-0059]).
Regarding Claim 3, Kakinoki discloses the second adapter unit (1a, Figs. 1-5) comprises a substantially hollow-cylindrical component (housing main body 20a, Figs. 1-5; ¶ [0042]) and a substantially cylindrical component (moving body 30a, Figs. 1-5), wherein the cylindrical component (30a, Figs. 1-5) is received in the hollow-cylindrical component (20a, Figs. 1-5), and wherein rotation of the hollow-cylindrical component (20a, Figs. 1-5) causes translational movement of the hollow-cylindrical component (20a, Figs. 1-5) and the cylindrical component (30a, Figs. 1-5) relative to each other (¶ [0056-0059]).
Regarding Claim 4, Kakinoki discloses the cylindrical component (30a, Figs. 1-5) has a pin-shaped projection (first male screw portion 35, Figs. 1-5) projecting radially outward, and the hollow-cylindrical component (20a, Figs. 1-5) has a motion link (first female screw portion 23, Figs. 1-5) formed like a thread (¶ [0044]), and the pin-shaped projection (35, Figs. 1-5) of the cylindrical component (30a, Figs. 1-5) is received in the motion link (23, Figs. 1-5) of the hollow-cylindrical component (20a, Figs. 1-5).
Regarding Claim 5, Kakinoki discloses the first adapter unit (2a, Figs. 1-5) has a proximal wall (bottom wall of 2a, as see in Fig. 2) having a first through-hole (opening that accepts valve 70, Figs. 1-5), and the first sealing element (70, Figs. 1-5) is received in the first adapter unit (2a, Figs. 1-5) such that a proximally protruding portion (¶ [0055]) of the first sealing element (70, Figs. 1-5) extends through the first through-hole of the proximal wall and is formed to protrude in the proximal direction relative to the proximal wall of the first adapter unit (2a, Figs. 1-5; ¶ [0055]),
the cylindrical component (30a, Figs. 1-5) of the second adapter (1a, Figs. 1-5) has a distal wall (top end of 38, Figs. 1-5) having a through-hole, and the second sealing element (50a, Figs. 1-5) is received in the cylindrical component (30a, Figs. 1-5) of the second adapter unit (1a, Figs. 1-5) such that a distally protruding portion (52, Figs. 1-5) of the second sealing element (50a, Figs. 1-5) extends through the through-hole of the distal wall and is formed to protrude in the distal direction relative to the distal wall of the cylindrical component (30a, Figs. 1-5; ¶ [0050]), and
the first sealing element (70, Figs. 1-5) and the second sealing element (50a, Figs. 1-5) are brought into contact when the first adapter unit (2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) are transferred from the unconnected or separated state (Fig. 2) into the connected state (Fig. 5).
Regarding Claim 6, Kakinoki discloses the cylindrical component (30a, Figs. 1-5) of the second adapter unit (1a, Figs. 1-5) comprises an engagement element (37a, Figs. 1-5) which is transferred from a non-engaged state (Fig. 2) to an engaged state (Fig. 5) by the hollow-cylindrical component (20a, Figs. 1-5) during the translational movement of the hollow-cylindrical component (20a, Figs. 1-5) relative to the cylindrical component (30a, Figs. 1-5) caused by the rotation of the hollow-cylindrical component (20a, Figs. 1-5; ¶ [0056-0059]).
Regarding Claim 7, Kakinoki discloses the first adapter unit (2a, Figs. 1-5) comprises an engagement element receptacle (65a, Figs. 1-5) for the engagement element (37a, Figs. 1-5) and the engagement element (37a, Figs. 1-5) is received in the engagement element receptacle (65a, Figs. 1-5) in the engagement state (Fig. 5), wherein in the engagement state (Fig. 5), the engagement element (37a, Figs. 1-5) holds the first sealing element (70, Figs. 1-5) in contact with the second sealing element (50a, Figs. 1-5) and generates a counterforce (frictional force between both sealing elements) against a pushing-apart force of the two sealing elements (70 and 50a, Figs. 1-5).
Regarding Claim 8, Kakinoki discloses the second adapter unit (1a, Figs. 1-5) comprises a third sealing element (bellows-cylindrical portion 56, Figs. 1-5) and a spacer element (annular flange portion 58, Figs. 1-5) arranged between the second sealing element (50a, Figs. 1-5) and the third sealing element (56, Figs. 1-5).
Regarding Claim 10, Kakinoki discloses the sealing elements (50a, 70, Figs. 1-5) are made of an elastic material, in particular an elastomer (¶ [0051, 0055]).
Regarding Claim 11, Kakinoki discloses the first adapter unit (2a, Figs. 1-5) has a first port (distal end of 2a, Figs. 1-5) and the second adapter unit (1a, Figs. 1-5) has a second port (connection portion 43, Figs. 1-5).
Regarding Claim 12, Kakinoki discloses a method of transferring a medicinal product contained in a first container to a second container (¶ [0002-0005]), the method comprising the steps of:
attaching the fluid transfer device (Figs. 1-5) according to Claim 1 to the first container and the second container (¶ [0002-0005]); and
transferring the medicinal product from the first container to the second container (¶ [0002-0005]).
Regarding Claim 13, Kakinoki discloses a closed medicine transfer system (Figs. 1-5) comprising:
a fluid transfer device (Figs. 1-5) according to Claim 1; and
at least a first container (¶ [0002-0005]),
wherein the fluid transfer device (Figs. 1-5) is configured to provide a fluid connection between the first container and the second container or between the first container and a patient (¶ [0002-0005]).
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.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kakinoki (US 2019/0184152).
Regarding Claim 9, the embodiment of Figs. 1-5 of Kakinoki is silent whether the cylindrical component comprises a guide element, and the first adapter unit comprises a guide-element receptacle for preventing relative twisting between the cylindrical component and the first adapter unit during rotation of the hollow-cylindrical component.
However, the embodiment of Fig. 9 of Kakinoki teaches the cylindrical component (30b, Fig. 9) comprises a guide element (convex portion 37b, Fig. 9) and the first adapter unit (2b, Fig. 9) comprises a guide-element receptacle (concave portion 65b, Fig. 9) for preventing relative twisting between the cylindrical component (30a, Fig. 9) and the first adapter unit (2b, Fig. 9) during rotation of the hollow-cylindrical component (20b, Fig. 9). This allows the two adapters to connect securely together (Figs. 10 and 11; ¶ [0075]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cylindrical component comprises to comprise a guide element, and the first adapter unit to comprise a guide-element receptacle for preventing relative twisting between the cylindrical component and the first adapter unit during rotation of the hollow-cylindrical component, as taught by the embodiment of Fig. 9 of Kakinoki, to ensure the two adapters connect securely to together (as motivated by Kakinoki ¶ [0075]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sanders et al (US 2019/0314583)
Stjernberg et al (US 2019/0275316)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jessica Arble whose telephone number is (571)272-0544. The examiner can normally be reached Mon - Fri 9 AM - 5 PM.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781
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