www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and TrademarkOffice
`Address; COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`15/998,868
`
`08/17/2018
`
`Alexander Oksche
`
`1861.2700007/JMC/MSB
`
`7842
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE NW
`WASHINGTON,DC 20005
`
`RICCI, CRAIG D
`
`PAPER NUMBER
`
`ART UNIT
`
`1611
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/18/2019
`
`ELECTRONIC
`
`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):
`e-office @ sternekessler.com
`
`jcovert @ sternekessler.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`Applicant(s)
`15/998 868
`Oksche etal.
`
`Office Action Summary Art Unit|AIA (FITF) StatusExaminer
`CRAIG D RICCI
`1611
`No
`
`
`
`-- The MAILING DATEofthis communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 2 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of 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)[¥] Responsive to communication(s)filed on 8/17/2018.
`C) A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)(] This action is FINAL.
`2b) C) This action is non-final.
`3)() An election was made bythe 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 meritsis
`closed in accordance with the practice under Exparfe Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`
`
`Disposition of Claims*
`1-14 is/are pending in the application.
`5)
`Claim(s)
`5a) Of the above claim(s)__ is/are withdrawn from consideration.
`C] Claim(s} _is/are allowed.
`() Claim(s)__ is/are rejected.
`Lj] Claim(s)___is/are objected to.
`Claim(s) 1-14 are subject to 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.
`
`Application Papers
`10)() The specification is objected to by the Examiner.
`11) The drawing(s) filed on __is/are: a). accepted or b)(_) 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)() Acknowledgmentis made ofa claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`c)1) None of the:
`b)( Some**
`a)Q All
`1.1) Certified copies of the priority documents have been received.
`2.1.) 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)
`
`2) (Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`
`3) (J Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(7) Other:
`
`4)
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20191014
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 2
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`DETAILED ACTION
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`Election of Species
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`1.
`
`This application contains claims directed to the following patentably distinct species:
`
`Elect a single film dosage form for trans-mucosal administration by defining EACH
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`of the following with specificity:
`
`(1)
`
`(2)
`
`Elect a single non-gelatin polymeric film-forming material (HPMC, HPC, etc);
`
`Elect any additional components (e.g., NONE, the pH modifier citric acid, sodium
`
`dihydrogen,
`
`the flavor orange flavor, etc);
`
`2.
`
`The species are independent or distinct because claims to the different species recite the
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`mutually exclusive characteristics of such species.
`
`In addition,
`
`these species are not obvious
`
`variants of eachother based on the current record. Furthermore, there is anexamination and search
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`burden for these patentably distinct species due to their mutually exclusive characteristics. For
`
`example, the species require a different field of search (e.g., searching different classes/subclasses
`
`or electronic resources, or employing different search queries). Accordingly, Applicant
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`is
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`required under 35 U.S.C. 121 to (i) elect asingle disclosed species for prosecution on the merits
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`to which the claims shall be restricted if no generic claim is finally held to be allowable even
`
`though the requirement may be traversed (37 CFR 1.143); and (ii) identify the claims readable
`
`on the elected species, including any claims subsequently added. An argument that a claim is
`
`allowable or that all claims are generic is considered non-responsive unless accompanied by an
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`election. Currently, claims 1 and 8-10 are generic.
`
`3.
`
`The election of the species may be made with or without traverse. To preserve a right to
`
`petition,
`
`the election must be made with traverse. If the reply does not distinctly and specifically
`
`point out supposed errors in the election of species requirement, the election shall be treated as an
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 3
`
`election without
`
`traverse. Traversal must be presented at the time of election in order to be
`
`considered timely. Failure to timely traverse the requirement will result in the loss of right
`
`to
`
`petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which
`
`of these claims are readable on the elected species.
`
`4,
`
`Should applicant
`
`traverse on the ground that the species are not patentably distinct,
`
`applicant should submit evidence or identify such evidence now of record showing the species to
`
`be obvious variants or clearly admit on the record that this is the case. In either instance, if the
`
`examiner finds one of the species unpatentable over the prior art, the evidence or admission may
`
`be used in a rejection under 35 U.S.C. 103(a) of the other species.
`
`5.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration of claims
`
`to additional species which depend from or otherwise require all the limitations of an allowable
`
`generic claim as provided by 37 CFR 1.141.
`
`6.
`
`The election of the species may be made with or without traverse. To preserve a right to
`
`petition,
`
`the election must be made with traverse. If the reply does not distinctly and specifically
`
`point out supposed errors in the election of species requirement, the election shall be treated as an
`
`election without
`
`traverse. Traversal must be presented at the time of election in order to be
`
`considered timely. Failure to timely traverse the requirement will result in the loss of right
`
`to
`
`petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which
`
`of these claims are readable on the elected species.
`
`7.
`
`Should applicant
`
`traverse on the ground that the species are not patentably distinct,
`
`applicant should submit evidence or identify such evidence now of record showing the species to
`
`be obvious variants or clearly admit on the record that this is the case. In either instance, if the
`
`

`

`Application/Control Number: 15/998,868
`Art Unit: 1611
`
`Page 4
`
`examiner finds one of the species unpatentable over the prior art, the evidence or admission may
`
`be used in arejection under 35 U.S.C. 103(a) of the other species.
`
`8.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration of claims
`
`to additional species which depend from or otherwise require all the limitations of an allowable
`
`generic claim as provided by 37 CFR 1.141.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to CRAIG RICCI whose telephone number is (571) 270-5864. The examiner
`
`can normally be reached Mondaythrough Thursday, and every other Friday, 7:30 am — 5:30 pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization
`
`where this application or proceeding is assigned is 571-273-8300
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR system,
`
`see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system,
`
`contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
`
`If you would like
`
`assistance from a USPTO CustomerService Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/CRAIG D RICCI/
`Primary Examiner, Art Unit 1611
`
`