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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-31, 34-37, and 39-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-12 of U.S. Patent No. 12,097,476. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are directed to a containment system, comprising: a housing wall defining a channel having a proximal end and a distal end; and at least two pierceable septa sealing the channel, the at least two pierceable septa including a first pierceable septum and a second pierceable septum, wherein the at least two pierceable septa are secured in a fixed relative position with respect to one another when in an undeformed state; a variable-volume chamber in fluid communication with the channel, wherein the variable-volume chamber includes at least one expandable feature such as a collapsible pleat and includes a window except the first pierceable septum being spaced apart by a first distance from the proximal end, the second pierceable septum being spaced apart by a second distance from the proximal end, the first distance being less than the second distance, the first pierceable septum and the second pierceable septum being secured to the vial receiving assembly in a fixed relative position with respect to one another when in an undeformed state.
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 Patent such that the feature of the first pierceable septum being spaced apart by a first distance from the proximal end, the second pierceable septum being spaced apart by a second distance from the proximal end, the first distance being less than the second distance, the first pierceable septum and the second pierceable septum being secured to the vial receiving assembly in a fixed relative position with respect to one another when in an undeformed state were omitted since omission of an element and its function is obvious if the function of the element is not desired, In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975).
Response to Arguments
Applicant's arguments filed 01/21/206 have been fully considered and they are persuasive. However, the outstanding non-statutory Double Patenting rejection remains and must be addressed (as outlined above).
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 KING M CHU whose telephone number is (571)270-7428. The examiner can normally be reached Monday - Friday 10AM - 6PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272 - 4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/King M Chu/Primary Examiner, Art Unit 3735
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