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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`18/182,797
`
`03/13/2023
`
`Dennis Mark MCDAID
`
`4384.0010005
`
`5282
`
`STE
`
`SLI
`
`TEIN&
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1101 K Street, NW
`10th Floor
`WASHINGTON,DC 20005
`
`HUI, SAN MING R
`
`1627
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/19/2024
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`eoffice @sternekessler.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`18/182,797
`MCDAID et al.
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`SAN MING R HUI
`1627
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom the mailing
`date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHSfrom the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)C) Responsive to communication(s) filed on
`CA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon
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`2a)C) This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)() Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`15-18,20-23 27-31 ,33-34,36-39,41,71,73,75-76,91-93,99 and 121-124 is/are pending in the
`
`
`
`Disposition of Claims*
`5)
`Claim(s)
`application.
`is/are withdrawn from consideration.
`5a) Of the aboveclaim(s)
`LJ Claim(s)__ is/are allowed.
`Claim(s) 15-18 ,20-23 27-31 33-34 36-39,41,71,73,75-76,91-93,99 and 121-124 is/are rejected.
`(J Claim(s)__ is/are objectedto.
`Lj Claim(s)__ are subjectto restriction and/or election requirement
`* If any claims have been determined allowable, you maybeeligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the corresponding application. For more information, please see
`http://www.uspto.gov/patents/init_events/pph/index.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`6 7 8
`
`Application Papers
`10)C) The specification is objected to by the Examiner.
`11) The drawing(s) filed on
`is/are: a)(j accepted or b)L)J objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`Priority under 35 U.S.C. § 119
`12)C) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d)or (f).
`Certified copies:
`c)C) None ofthe:
`b)™) Some**
`a)CX) All
`1.1) Certified copies of the priority documents have been received.
`2.) Certified copies of the priority documents have been received in Application No.
`3.1.) Copies of the certified copies of the priority documents have been receivedin this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*“ See the attached detailed Office action for a list of the certified copies not received.
`Attachment(s)
`
`1) [[] Notice of References Cited (PTO-892)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`4)
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`
`Paper No(s)/Mail Date9/12/2023,4/29/20247/0/2024.
`U.S. Patent and Trademark Office
`
`3)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20241214
`
`

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`Application/ Control Number: 18/ 182,797
`Art Unit: 1627
`
`Page 2
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`DETAILED ACTION
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`Notice ofPre-AIA or AIA Status
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`The present application,filed on or after March 16, 2013, is being examined underthe first
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`inventor to file provisions of the AIA.
`
`Claims 15-18, 20-23, 27-31, 33, 34, 36-39, 41, 71, 73, 75-76, 91-93, 99, 121-124 are pending.
`
`Double Patenting
`
`The nonstatutory double patenting rejection ts based onajudicially created doctrine
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`grounded tn public policy (a policy reflected in the statute) so as to prevent the unjustified or
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`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
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`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
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`the conflicting claims are notidentcal, but at least one examined application claim is not patentably
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`distinct from the reference claim(s) because the examined application claim 1s either anticipated by,
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`or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46
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`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,
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`163 USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321(d) may be
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`used to overcome an actual or provisional rejection based on nonstatutory double patenting
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`provided the reference application or patent either is shown to be commonly owned with the
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`examined application, or claims an invention made asa result of activities undertaken within the
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`scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
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`underthe first inventor to file provisions of the ALA as explained in MPEP § 2159. See MPEP §
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`

`

`Application/ Control Number: 18/ 182,797
`Art Unit: 1627
`
`Page 3
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`2146 ef seq. for applications not subject to examination underthe first inventorto file provisions of
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`the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`
`Thefiling of a terminal disclaimer byitself is nota complete reply to a nonstatutory double
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`patenting (NSDP) rejection. A complete reply requires that the terminal disclatmer be accompanied
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`by areply requesting reconsideration of the prior Office action. Even where the NSDPrejection 1s
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`provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final
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`Office action, see 37 CFR 1.111 (a). For a reply to final Office action, see 37 CFR 1.113(c). A request
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`for reconsideration while not provided for in 37 CFR 1.113(c) maybe filed after final for
`
`consideration. See MPEP §§ 706.07(e) and 714.13.
`
`The USPTO Internet website contains terminal disclaimer forms which maybe used. Please
`
`visit www.uspto.gov/patent/ patents -forms. Theactualfiling 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 maybe filled out completely
`
`online using web-screens. An eTerminal Disclaimer that meets all requirements 1s auto-processed
`
`and approved immediately upon submission. For more informaton about eTerminal Disclaimers,
`
`refer to www.uspto.gov/ patents /apply/applying-online/eterminal-disclaimer.
`
`Claims 15-18, 20-23, 27-31, 33, 34, 36-39, 41, 71, 73, 75-76, 91-93, 99, 121-124 are rejected
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`on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of USS.
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`Patent No. 11,826,359 (359). Although the claims at tissue are notidentical, they are not patentably
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`distinct from each other because ‘359 teaches the herein an omeprazole composition, the method of
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`making the same, and the method of inhibiting acid secretion (see claims 1, 12-14).
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`‘359 teaches the
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`ratio of the components and two buffer systems (see claim 1 for example).
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`“359 teaches the devices
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`to release the first chamber mixture into the second chamber(see claims 24-25).
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`

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`Application/ Control Number: 18/ 182,797
`Art Unit: 1627
`
`Page 4
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`Since the scope of “359 is narrowerthan that of the instant invention,this is an anticipatory
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`type of double patenting rejection.
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to SAN MING R HUI whose telephone numberts (571)272-0626. The examiner
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`can normally be reached Mon- Fri 9:30-5:30.
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using a
`
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`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,
`
`Kortney Klinkel can be reached on 571-270-5239. The fax phone numberfor the organization
`
`where this application or proceedingts assigned 1s 571-273-8300.
`
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`USA OR CANADA) or 571-272-1000.
`
`/SAN MING R HUI/
`Primary Examiner, Art Unit 1627
`
`