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 0226/2026 have been fully considered but they are not persuasive. Applicant has amended claim 1 to incorporate the features of claim 2, which is now cancelled. Applicant argues claim 1 now recites a closed system transfer device (CSTD) having a first adaptor, a second adaptor, a carrier, a needle , and a releasable lock. The releasable lock locks the first adaptor inside the second adaptor after the first adaptor is inserted into the second adaptor. Applicant argues the releasable lock elements 22a, 22b are shown on a totally different device; namely a transfer apparatus 10 in Fig. 7, which is completely unrelated to the vial adaptor 160 . Applicant argues the transfer apparatus 10 and vial adaptor 160 appear to be mutually exclusive to one another, with each device representing an alternative component that can by coupled to a vial. Applicant’s arguments are not persuasive. Kriheli teaches the various embodiments and that the invention can be carried out with many modifications, variations, and adaptations (para. 0178). Thus, the locking elements 22a, 22b are capable of being used to releasably secure various adaptors to the transfer apparatus 10. Kriheli teaches vial adaptor 160 is an intermediate connection that is used to connect connector section 25 (second adaptor) to a drug vial 14 or any other component having a suitably shaped and dimensioned port (para. 0160). Kriheli further teaches vial adaptor 160 can also be used with the first embodiment of the fluid transfer device (para. 0160), which includes locking elements 22a, 22b (Figures 1, 2, and 4-7; paras. 0100, 0101, and 0104-0107). Applicant arguments are not persuasive and the rejection is maintained.
DETAILED ACTION
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.
Claims 1, 3-8, 13, 14, 17, 20, 21, and 23-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kriheli US Patent Application Publication 20120046636.
As to claim 1, Kriheli teaches a closed system transfer device (Fig. 13) comprising:
a first adaptor 160 (Fig. 12) configured to attach to a first reservoir 14 (Fig. 12),
the first adaptor defining a first passage 179 (Fig. 12) and comprising a first septum 176 that seals an end of the first passage;
a second adaptor 13 connector 25 (Fig. 8) configured to attach to a second reservoir 10 (Fig 8);
the second adaptor comprising a housing (body 128 Fig. 9) having an interior 19 (Fig. 9), the housing defining a second passage (Fig. 9) and comprising a second septum 143 (Fig. 9) that seals an end of the second passage;
a carrier (actuator 130 Fig. 9) movable in the interior of the second adaptor (Fig. 13 and 16),
the carrier defining a chamber that contains at least a portion of the second septum (Fig. 9; para. 0158); and
a needle 48a (Fig. 9) disposed in the interior of the second adaptor, the needle having a needle opening 112 (Fig. 9),
the interior of the second adaptor adapted to receive the first adaptor in a telescoping manner, with the first adaptor insertable into the second adaptor (Fig. 13-14),
the carrier displaceable in the interior of the second adaptor, and relative to the needle, by the first adaptor when the first adaptor is inserted into the second adaptor (Fig. 14-16), and
a releasable lock that locks the first adaptor inside the second adaptor after the first adaptor is inserted into the second adaptor (para. 0150).
the carrier displaceable within the second adaptor between a first position (Fig. 15), in which the first septum abuts the second septum and the needle opening is sealed inside the second passage, and
a second position (Fig. 16), in which the first septum abuts the second septum and the needle opening in fluid communication with the first passage to connect the first adaptor and the second adaptor in a fluid path open state.
As to claim 3, the releasable lock locks the first adaptor inside the second adaptor when the carrier is displaced to the second position (Fig. 7 and 8).
As to claim 4, the releasable lock comprises a first locking element on the carrier and a second locking element in the housing (Fig. 7 and 8).
As to claim 5, the releasable lock comprises a first locking element on the first adaptor and a second locking element on the second adaptor (Fig. 4, 7-9).
As to claim 6, the releasable lock is released by pressing at least one side of the housing radially inwardly – the claim is directed to an intended use of the article. Regarding the limitations of adapted to and traversing the gluteal fold, these limitations are directed to an intended use of the article. Intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). If the prior art structure is capable of performing the intended use, then it meets the claim limitations. The invention of Kriheli meets the structural limitations of claim 1 in that device comprises a releasable lock (para. 0150).
As to claim 7, the at least one side of the housing comprises at least one push button 22a, 22b (Fig. 2; para 0150).
As to claim 8, the at least one push button 22a, 22b is depressible radially inwardly to disengage a portion of the carrier from a section of the housing (Fig. 2; para. 0150).
As to claim 13, the closed system transfer device according to claim 1, wherein the second adaptor 13/25 comprises a third septum 142 (Fig. 16; para. 0158) that is axially spaced from the second septum 143.
As to claim 14, the needle opening is sealed between the second septum and the third septum when the carrier is in the first position (Fig. 15).
As to claim 17, the closed system transfer device according to claim 1, further comprising a female Luer 222 connector connected to the housing of the second adaptor (Fig. 20, 22).
As to claim 20, the first adaptor comprises a male Luer connector or a vial spike 177 (Fig. 12 18-20).
As to claim 21, the first adaptor and the second adaptor are rectangular (Fig. 8 and 12).
As to claim 23, the needle is fixed in an interior of the female Luer connector (Fig. 12, 18-20)
As to claim 24, the releasable lock comprises a first locking element on the carrier and a second locking element on the first adaptor (Fig. 20-22).
As to claim 25, the releasable lock is released by pressing at least one side of the housing radially inwardly (para. 0150).
As to claim 26, the at least one side of the housing comprises at least one push button 22a, 22b (Fig. 2; para 0150).
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.
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.
Claims 19 and 101-103 are rejected under 35 U.S.C. 103 as being unpatentable over Kriheli US Patent Application Publication 20120046636 in view of Ellstrom et al. US Patent Application Publication 2009/0069783
Kriheli teaches the present invention substantially as claimed. Kriheli does not specifically teach the housing defines at least one locking window configured to retain the carrier in one of the first position and the second position with at least a portion of the carrier visible through the at least one locking window to visually confirm that the carrier is in said one of the first position and the second position. Ellstrom teaches a piercing member protection device from the same field of endeavor comprising a locking window for the benefit of a user to have an indication of whether the locking element is in the locked or unlocked position (Ellstrom para. 0036). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Kriheli with a window for the benefits taught in Ellstrom.
Conclusion
THIS ACTION IS MADE FINAL. 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 JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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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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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781