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 § 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 1-7, 9, 11-13, 15-19 are rejected under 35 U.S.C. 102a1 as being anticipated by U.S. Publication No. 2011/0152822 to Drunk et al. (Drunk).
Drunk teaches an adapter system for a pharmaceutical dispensing device having a connector (20) that receives a septum (41; 0074) of a pharmaceutical cartridge, the adapter system comprising: an adapter body (2; 0067) configured to be slideably received within the connector of the pharmaceutical dispensing device, the adapter body including a neck portion (12; 0067) and a head portion (12a) extending from the neck portion, the neck portion having a first diameter and an end surface (see ex. fig. 1, 2) configured to face the septum of the pharmaceutical cartridge when the adapter body is received within the connector (see fig. 8, 0077), the head portion having a second diameter different than the first diameter (see ex. fig. 2); and an adapter needle (6; 0062) extending from the end surface of the neck portion away from the adapter body and configured to pierce through the septum of the pharmaceutical cartridge when the adapter body is received within the connector (0077).
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Regarding claim 2, Drunk teaches wherein the adapter needle has a constant diameter (see fig.2, where the adapter needle has a constant inner diameter).
Regarding claim 3, Drunk teaches wherein the head portion is cylindrical (see fig. 1).
Regarding claim 4, Drunk teaches wherein the neck portion is cylindrical (see fig .1; the base of the beck at the end surface is cylindrical- note the claim does not require the neck in its entirety be cylindrical).
Regarding claim 5, Drunk teaches wherein the neck portion is conical (see fig. 1).
Regarding claim 6, Drunk teaches wherein the adapter body includes a shoulder portion (see ex. fig. 1) disposed between the head portion and the neck portion, the shoulder portion tapering from the head portion to the neck portion (see ex. fig. 1)
Regarding claim 7, Drunk teaches comprising an adapter conduit (6) extending through the adapter body and the adapter needle (0062).
Regarding claim 9, Drunk teaches wherein the adapter conduit is sized to provide a clearance fit for a needle size associated with the adapter system (see fig. 1, where the adapter conduit is capable of providing a clearance fit for a needle).
Regarding claim 11, Drunk teaches a cap (14/15; 0072) configured to attach to the connector (via element 14)of the pharmaceutical dispensing device when the adapter body is received within the connector.
Regarding claim 12, Drunk teaches wherein the cap is configured to seal the connector (see fig. 8).
Regarding claim 13, Drunk teaches the limitation of claim 12, wherein the cap (14/15 includes an end wall (see fig. 5) and a peripheral sidewall (14) extending from the end wall to define a cavity configured to frictionally receive the connector (14 and 15 are engaged in a frictional fit, 0072; and thus element 15 is in frictional engagement to receive the connector via element 14).
Regarding claim 15, Drunk teaches an adapter system for a pharmaceutical dispensing device (0056), the adapter system comprising: an adapter body (2; 0067) including a head portion (12; 0067) and a neck portion (12a; see ex. fig. 1), the head portion of the adapter body having a first diameter and the neck portion having a second diameter different than the first diameter (see ex. fig. 2); and an adapter needle (6; 0062) extending from the neck portion of the adapter body to a distal end (0077) and having a third diameter that is less than each of the first diameter and the second diameter (see ex. fig. 3).
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Regarding claim 16, Drunk teaches wherein the third diameter is constant (see fig. 1).
Regarding claim 17, Drunk teaches the first diameter of the head portion is greater than the second diameter of the neck portion (see ex. fig 3).
Regarding claim 18, Drunk teaches wherein the first diameter is constant (see ex. fig. 1- note the claim does not require the diameter to be of the entirety of the neck component).
Regarding claim 19, Drunk teaches wherein the second diameter is constant (see fig. 1).
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.
Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Drunk in view of WO2016/196518 to Knapp et al. (Knapp).
Regarding claim 8, Drunk teaches the limitations of claim 7, but fails to explicitly teach wherein the adapter conduit terminates at a tapered opening formed in the adapter body.
Knapp teaches the adapter conduit (30) terminates at a tapered opening formed in the adapter body (see fig. 6; 0064, 0066).
It would have been obvious to have included a tapered opening formed in the adapter body in order to allow for only specific or desired attachments to be connected to the adapter system.
Regarding claim 20, where Drunk teaches the claim limitations of claim 15, but fails to teach wherein the neck portion tapers down from the second diameter to a third diameter.
Knapp teaches a taper down from a second to a third diameter (see fig. 8a-c).
It would have been obvious to have included a tapered opening formed in the adapter body in order to allow for a gradual transition and smoother insertion of the needle into the device septum.
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Drunk.
Drunk teaches the claim limitations of claim 13, but fails to explicitly teach wherein the sidewall of the cap includes a retention feature configured to secure the cap to the connector.
Drunk teaches a retention feature on element 13, which is connected to the cap through elements 14 and 15 which mate with element 21 (see fig. 1).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the retention features of element 13, be placed on the interior of the side wall, and the beaded feature of 21 be placed on the outside of element 20, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA E EISENBERG whose telephone number is (571)270-5879. The examiner can normally be reached M-F 8-5.
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REBECCA E. EISENBERG
Supervisory Patent Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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