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`PTO/AlA/lS (03-13)
`Approved for use through 01/31/2014. OMB 0551-0032.
`US, Patent and Trademark Office; 0.5, DEPARTMENT OF COMMERCE
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`First Named Inventor
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`§E§phen J. Baker
`BORONvCONTAlNiNG SMALL MOLECULES
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`Commissioner for Patents
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`33.0. 30% 1450
`ADDRESS TO
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`ACCOMPANYENG APPLlCATlGN PAP’ERS
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`10. [1 Assignment Papers
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`Name of Assignee
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`11. j 57 CPR 3.73m Statement
`(when there Is on assignee)
`12. :1 English Translation Document
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`lnfermaiion Disclosure Statement
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`U Copies of citations attached
`:14. E Preliminary Amendment
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`15‘ L] Return Receipt Pestcard
`(MPEP§ 503) (Should be specifically itemized)
`:164 J Col-lined Copy of Priority Documentls)
`(I'ffarelgn priority is claimed)
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`17. :1 Nonpublicatmh Request
`Under 35 U,S.C. i22ib)i2)lB)li). Applicanl must attach form ”0/58/35
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`[Total Pages 317
`Elozh the claims and abstract must start on a new page
`V“ (See MPEP 9 608.01(a)far mfo,-mnt;on on me preferreflarrangement)
`5. W oraw‘mglsl (35 use. 113)
`[Total Sheets b3
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`6, inventor’s Oath or Declaration
`{Total PagesW] 13. LN]
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`7. E Application Data Sheei
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`a. 1:] CD~ROM or CD-R (2 copies); or
`il. «j Paper
`umun\\\
`
`c. [a Statements verifying identity of above copies
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`
`*Note: (1) Benefit claims under 37 CFR:1.78 and foreign priority claims under 155 must be included in an Application Data Sheet (AIDS).
`(2.) For applications filed under 35 U.S,C,111,the applicalion must contain an ADS specifying the applicant if the applicant is an
`assignee, person to whom the inventor is under an obligation to assign, or person who oiherwise shows sufficient proprietary
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`interest in the matter. See 37 CFR 1.46(bl.
`
`19. connesponoence Appagss
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`if] The address associated with Customer Number:_f}§§§_9nm_"WWWWW on I: Cormspondence addregs below
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`Name
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`This collection of information is required by 37 CPR 1.553(1)). The information is required to obtain or retain a benefit by the public which is to file (and by the USPTO
`{0 process) an application. (Ionfidemialiiy is governed by 35 USS. 122 and 37 CH? 1.11 and 1.14. This coliectionis eslimated to take 12 minutes to complete,
`including gathering, preparing, and submitting the completed application lorm to the USPTO. Time will vary depending upon the individual case. Any comments on.
`the amount of time you require to complete this form and/or suggestions for reducing this burden, should be sent to the fhief information Officer, U.S. Palent and
`Trademark Office. (3.5. Department of Commerce, P.O. 80x1450, Alexandria, VA 22313-1450. 00 NOT SEND FEES OR COMPLETED FORMS TO TiliS ADDRESS‘ SEND
`T0: Commissioner for Patents, 9.0. Box 1458, Alexandria, VA 22313—1450.
`Ifyou need assistance in comp/sling the form, call 1-800»PTO»9199 and select option 2.
`
`FIatWing Ex. 1002, p. 1
`
`FlatWing Ex. 1002, p. 1
`
`
`
`Doc Code: TRACK‘i .REQ
`
`Document Description: TrackCine Request.
`
`PTO/AiA/‘l-24 (0444)
`
`CERTIFECATBQN AND REQUEST FQR PREQRETEED EXAMHNATiON
`UNDER 37 CFR 1.10203) (Page 1 of i)
`
`. FirstNamcd
`1
`Inventor:
`Title of
`invention:
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`'
`
`i Nonprovisionel Application Number (if
`known):
`
`-
`.
`TO b6 agelgned
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`THE ABOVEJDENTEHED APPUCATION.
`
`‘l. The processing fee set forth in .37 CFR t.i‘7(i)(1) and the prioritized examination fee set forth in
`37‘ CFR 117(0) have been filed with the request. The publication fee requirement is met
`because that fee, set forth in 37‘ CPR i.’l8(d), is currently $0. The basic filing fee, search fee,
`and examination tea are filed with the request or have been already been paid.
`i understand
`that any required excess claims fees or application size fee must he paid for the application.
`
`i understand that the application may not contain, or be amended to contain, more than tour
`independent ciaima, more than thirty total claims, or any multiple dependent claims, and that
`any request for an extension of time will cause an outstanding Track I request to be dismissed.
`
`. The applicable box is checked below:
`
`i7 (in inal A) iication Track Cine «Prioritized Examination under
`
`i.
`
`(a) The application ie an original nonprovisional utility application filed under 35 USO. “1(a).
`This certification and request is being filed with the utility application via EFS-uWeh.
`NORM
`(lo) The application is an original nonprovisional plant application filed under 35 USS. tit( ).
`This certification and request is being filed with the plant application in paper.
`
`i
`ii. An executed inventor’a oath or declaration under 37' CFR 1.83 art-37 CFR 1.64 for each
`inventor, or the application data sheet meeting the conditions specified in 37 CPR ‘i.53(f)(3)(i) is ;
`filed with the application.
`
`ii.
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`Re treat for Continued Examination ~ Prioritized Examination under
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`1.102 egg}
`
`.
`
`A request for continued examination has been filed with. or prior to, this form.
`it the application is a utility application, this certification and request is being filed via EFS—Web.
`The application is an original nonprcvisionel utiiity application filed under 35 USO. ’lii(a). or is
`a national stage entry under 35 USC. 371.
`.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination nae been granted prioritized examination status
`under 37 CFR i.’l02(e)(2).
`
`é
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`Siuetiire.........WWW W_W
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`Name
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`Practitioner
`
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`
`46.,690‘”
`
`for signature requirements and certifications.
`Note: This form must be signed in accordance with 37 CFR 133. See 37 CFR 7,4(0’)
`5 Submit multi 1e_forms if more £15m one signature is rcqgigeg1’1
`
`‘ D *Toial of..._._............ forms are submitted.
`
`FIatWing Ex. 1002, p. 2
`
`FlatWing Ex. 1002, p. 2
`
`
`
` vs! “111%
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`15/091,394
`
`04/05/2016
`
`Stephen J. BAKER
`
`064507—5014—US19
`
`7426
`
`MORGAN, LEWIS & BOCKIUS LLP (SF)
`One Market, Spear Street Tower, Suite 2800
`San Francisco, CA 94105
`
`SHIAO’ RBI TSANG
`
`ART UNIT
`
`1628
`
`PAPER NUIVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/20/2016
`
`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):
`
`sfipdocketing @ morganlewis.com
`donald.mixon @ morganlewis.com
`
`PTOL—90A (Rev. 04/07)
`
`FIatWIng EX. 1002, p. 3
`
`FlatWing Ex. 1002, p. 3
`
`
`
`
`
`Applicant(s)
`Application No.
` 15/091,394 BAKER ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1628REI-TSANG SHIAO [SENS
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () MONTHS from 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) MONTHS from 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, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 4/5/2016.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|:l This action is non-final.
`2a)|:l This action is FINAL.
`3)I:I An election was made by the applicant in response to 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
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) 1-26 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`is/are allowed.
`6)I:I Claim(s)
`7)|:| Claim(s)_ is/are rejected.
`8)|:| Claim(s)_ is/are objected to.
`
`9)IXI Claim((s) 1 -26 are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`hit
`:/'I’vaIW.usnI‘.0. ovI’ atentS/init events/
`
`
`
`hI/index.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)I:l The specification is objected to by the Examiner.
`11)I:l The drawing(s) filed on
`is/are: a)I:I accepted or b)I:I 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)I:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:l All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`3.|:| Copies of the certified copies of the priority documents have been received in 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)
`
`3) D Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`.
`,
`.
`Fl atWi figoEaper qmgatpeofiom 7
`
`FlatWing Ex. 1002, p. 4
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 2
`
`Art Unit: 1628
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`1.
`
`Claims 1-26 are pending in the application.
`
`Election/Restriction
`
`2.
`
`The Markush group set forth in the claims includes both independent and distinct
`
`inventions, and patentably distinct compounds (or species) within each invention.
`
`However, this application discloses and claims a plurality of patentably distinct
`
`inventions far too numerous to list individually. Moreover, each of these inventions
`
`contains a plurality of patentably distinct compounds, also far too numerous to list
`
`individually. For these reasons provided below, restriction to one of the following
`
`Groups is required under 35 U.S.C. 121, wherein an Group is a set of patentably distinct
`
`inventions of a broad statutory category (e.g. Compounds, Methods of Use, Methods of
`
`Making, etc.):
`
`I. Claims 1-13, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`ll. Claims 14-19, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`lll. Claims 20-26, drawn to methods of use, classified in classes 514/558, numerous
`
`subclasses.
`
`FlatWing Ex. 1002, p. 5
`
`FlatWing Ex. 1002, p. 5
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 3
`
`Art Unit: 1628
`
`In accordance with the decisions in In re Harnisch, 631 F.2d 716, 206 USPQ
`
`300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984),
`
`restriction of a Markush group is proper where the compounds within the group either
`
`(1) do not share a common utility, or (2) do not share a substantial structural feature
`
`disclosed as being essential to that utility.
`
`In addition, a Markush group may
`
`encompass a plurality of independent and distinct inventions where two or more
`
`members are so unrelated and diverse that a prior art reference anticipating the claim
`
`with respect to one of the members would not render the other member(s) obvious
`
`under 35 U.S.C. 103.
`
`An election of any one of Groups H" is required. Should applicant traverse
`
`on the ground that the compounds are not patentably distinct, applicant should submit
`
`evidence or identify such evidence now of record showing the compounds 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 inventions 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.
`
`All compounds falling outside the class(es) and subclass(es) of the selected
`
`compound and any other subclass encompassed by the election above will be directed
`
`to nonelected subject matter and will be withdrawn from consideration under 35 U.S.C.
`
`121 and 37 C.F.R. 1.142(b). Applicant may reserve the right to file divisional
`
`applications on the remaining subject matter. The provisions of 35 U.S.C. 121 apply
`
`with regard to double patenting covering divisional applications.
`
`FlatWing Ex. 1002, p. 6
`
`FlatWing Ex. 1002, p. 6
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 4
`
`Art Unit: 1628
`
`Applicant is reminded that upon cancellation of claims to a non-elected invention,
`
`the inventors must be amended in compliance with 37C.F.R. 1.48(b) if one of the
`
`currently named inventors is no longer an inventor of at least one claim remaining in the
`
`application. Any amendment of inventorship must be accompanied by a petition under
`
`37 C.F.R. 1.48(b) and by the fee required under 37CFR 1.17(i). If desired upon election
`
`of a single compound, applicants can review the claims and disclosure to determine the
`
`scope of the invention and can set forth a group of compounds which are so similar
`
`within the same inventive concept and reduction to practice. Markush claims must be
`
`provided with support in the disclosure for each member of the Markush group. See
`
`MPEP 608.01 (p). Applicant should exercise caution in making a selection of a single
`
`member for each substituent group on the base molecule to be consistent with the
`
`written description.
`
`Rationale Establishing Patentable Distinctiveness Within Each Group
`
`Each invention set listed above is directed to or involves the use or making of
`
`compounds which are recognized in the art as being distinct from one another because
`
`of their diverse chemical structure, their different chemical properties, modes of action,
`
`different effects and reactive conditions (MPEP 806.04, MPEP 808.01 ). Additionally,
`
`the level of skill in the art is not such that one invention would be obvious over either of
`
`the other inventions, i.e. they are patentable over each other. Chemical structures
`
`which are similar are presumed to function similarly, whereas chemical structures that
`
`are not similar are not presumed to function similarly. The presumption even for similar
`
`FlatWing Ex. 1002, p. 7
`
`FlatWing Ex. 1002, p. 7
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 5
`
`Art Unit: 1628
`
`chemical structures though is not irrebuttable, but may be overcome by scientific
`
`reasoning or evidence showing that the structure of the prior art would not have been
`
`expected to function as the structure of the claimed invention. Note that in accordance
`
`with the holdings of Application of Papesch, 50 CCPA 1084, 315 F.2d 381, 137 USPQ
`
`43 (CCPA 1963) and In re Lalu, 223 USPQ 1257 (Fed. Cir. 1984), chemical structures
`
`are patentably distinct where the structures are either not structurally similar, or the prior
`
`art fails to suggest a function of a claimed compound would have been expected from a
`
`similar structure.
`
`The above Groups represent general areas wherein the inventions are
`
`independent and distinct, each from the other because of the following reasons:
`
`Restriction for examination purposes as indicated is proper because all these
`
`inventions listed in this action are independent or distinct for the reasons given above
`
`and there would be a serious search and examination burden if restriction were not
`
`required because one or more of the following reasons apply:
`
`(a) the inventions have acquired a separate status in the art in view of their different classification;
`
`(b) the inventions have acquired a separate status in the art due to their recognized divergent
`
`subject matter;
`
`(c) the inventions require a different field of search (for example, searching different
`
`classes/subclasses or electronic resources, or employing different search queries);
`
`(d) the prior art applicable to one invention would not likely be applicable to another invention;
`
`(e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35
`
`U.S.C. 112, first paragraph.
`
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a invention to be examined even though the requirement
`
`FlatWing Ex. 1002, p. 8
`
`FlatWing Ex. 1002, p. 8
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 6
`
`Art Unit: 1628
`
`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
`
`the elected invention.
`
`The election of an invention may be made with or without traverse. To reserve 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 restriction 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
`
`invention. If claims are added after the election, applicant must indicate which of these
`
`claims are readable upon the elected invention. Should applicant traverse on the ground
`
`that the inventions are not patentably distinct, applicant should submit evidence or
`
`identify such evidence now of record showing the inventions 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 inventions 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 invention.
`
`Any inquiry concerning this communication or earlier communications from the
`
`Conclusion
`
`examiner should be directed to Rei-tsang Shiao whose telephone number is (571) 272-
`
`0707. The examiner can normally be reached on 8:30 AM - 5:00 PM.
`
`If attempts to
`
`reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston
`
`Shen, can be reached on (571)272-3157. The fax phone number for the organization
`
`where this application or proceeding is assigned is 571 -273-8300.
`
`FIatWing Ex. 1002, p. 9
`
`FlatWing Ex. 1002, p. 9
`
`
`
`Application/Control Number: 15/091 ,394
`
`Page 7
`
`Art Unit: 1628
`
`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://Qairv
`
`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 Customer Service Representative or access to the
`
`automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272—
`
`1000.
`
`/REI-TSANG SHIAO/
`
`Rei-tsang Shiao, Ph.D.
`Primary Examiner
`Art Unit 1628
`
`May 17, 2016
`
`FIatWing EX. 1002, p. 10
`
`FlatWing Ex. 1002, p. 10
`
`
`
`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`PATENT
`
`Attorney Docket No.: 064507-5014-US 19
`
`I hereby certify that this correspondence, including listed enclosures is
`being electronically transmitted in Portable Document Form (PDF) through
`EFS—Web via Hyper Text Transfer Protocol to the United States Patent and
`Trademark Office's Patent Electronic Business Center on:
`
`Dated: {our 17. u 16
`
`MP
`
`eter Roidmaier
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE .
`
`In re application of:
`
`Confirmation No.: 7426
`
`Stephen Baker, et a1.
`
`Examiner: SHIAO, Rei Tsang
`
`Application No.: 15/091,394
`
`Art Unit: 1628
`
`RESPONSE TO RESTRICTION
`
`REQUIREMENT
`
`Filedf April 5, 2016
`
`For: BORON—CONTAINING SMALL
`MOLECULES
`
`Customer No.: 43850
`
`
`
`Commissioner for Patents
`
`PO. Box 1450
`
`Alexandria, VA 22313 — l 450
`
`Commissioner:
`
`In response to the restriction requirement dated May 20, 2016, please enter the following
`
`amendments and remarks.
`
`Amendments to the specification begin on page 2 of this paper.
`
`A listing of claims begins on page 4 of this paper.
`
`Remarks begin on page 8 of this paper.
`
`DB2/30337746.2
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`Page 1 0f 9
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`FIatWing Ex. 1002, p. 11
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`FlatWing Ex. 1002, p. 11
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`
`
`U.S. Pat, App. No. 15/091,394
`.
`.
`Response dated June 27, 2016
`n fin1f
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`Response 10 Remiieuun Requneuici 1 dated l‘vmy 2U, LULO
`
`PATENT
`
`Amendments to the specification:
`
`Please replace the first paragraph in the application with the following:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`.
`.
`.
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`9
`
`filed March 11, 2016, which is a continuation of U.S. Patent Application No. 15/046,322, filed
`
`on February 17, 2016, which is a continuation of U.S. Patent Application No. 14/537,771, filed
`
`November 10, 2014, which is a continuation of U.S. Patent Application No. 14/201,459, filed
`
`March 7, 2014, now U.S. Patent No. 9,353,133, which is a continuation of U.S. Patent
`
`Application No. 13/356,488, filed January 23, 2012, now U.S. Patent No. 8,722,917, which is a
`
`continuation of U.8. Patent Application No, 12/629,753, filed December 2, 2009, now U.S.
`
`Patent No. 8,1 15,026, which is a divisional of U.S. Patent Application No. 11/505,591, filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of U.S. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. U.S. Patent Application No. 1 1/505 ,591 is also a continuation-
`
`in—part of US. Patent Application No. 1 1/3 57,687, filed February 16, 2006, now U.S. Patent No.
`
`7,582,621, which claims the benefit of U.S. Provisional Patent Application No. 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`The present application is also a continuation-in—part of U.S. Patent Application No. 13/874,329,
`
`filed April 30, 2013, now U.S. Patent No. 8,889,656, which is a continuation of U.S. Patent
`
`Application No. 13/224,252, filed September 1, 2011, now U.S. Patent No. 8,440,642, which is a
`
`continuation of U.S. Patent Application No. 12/507,010, filed July 21, 2009, now U.S. Patent
`
`No. 8,039,451, which is a continuation of US Patent Application No, 11/357,687, filed
`
`February 16, 2006, now U.S. Patent No. 7,582,621, which claims the benefit of 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`Page 2 of9
`
`FIatWing Ex. 1002, p. 12
`
`FlatWing Ex. 1002, p. 12
`
`
`
`U.S. Pat. App. No. 15/091,394
`Response dated June 27, 2016
`Response to Restriction Requirement dated May 20, 2016
`
`PATENT
`
`Version showing changes made:
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`The present application is a continuation of U.S. Patent Application No. 15/068,352,
`
`filed March 11, 2016, which is a continuation of U.S. Patent Application No. 15/046,322, filed
`
`on February 17, 2016, which is a continuation of U.S. Patent Application No. 14/537,771, filed
`
`' November 10, 2014, which is a continuation of U.S. Patent Application No. 14/201,459, filed
`
`
`March 7, 2014, now U.S. Patent No. 9 353 133 which is a continuation of U.S. Patent
`
`Application No. 13/356,488, filed January 23, 2012, now U.S. Patent No. 8,722,917, which is a
`
`continuation of U.S. Patent Application No. 12/629,753, filed December 2, 2009, now U.S.
`
`Patent No. 8,1 15,026, which is a divisional of U.S. Patent Application No. 11/505,591, filed
`
`August 16, 2006, now U.S. Patent No. 7,767,657, which claims the benefit of U.S. Provisional
`
`Patent Application No. 60/755,227, filed December 30, 2005, and the benefit of U.S. Provisional
`
`Patent Application No. 60/746,361, filed May 3, 2006, all of which are incorporated by reference
`
`in their entirety for all purposes. U.S. Patent Application No. 11/505,591 is also a continuation—
`
`in—part of U.S. Patent Application No. 11/357,687, filed February 16, 2006, now U.S. Patent No.
`
`7,582,621, which claims the benefit of U.S. Provisional Patent Application No. 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`The present application is also a continuation—in-part of U.S. Patent Application No. 13/874,329,
`
`filed April 30, 2013, now U.S. Patent No. 8,889,656, which is a continuation of U.S. Patent
`
`Application No. 13/224,252, filed September 1, 2011, now U.S. Patent No. 8,440,642, which is a
`
`continuation of U.S. Patent Application No. 12/507,010, filed July 21, 2009, now U.S. Patent
`
`No. 8,039,451, which is a continuation of U.S. Patent Application No. 1 1/3 57,687, filed
`
`February 16, 2006, now U.S. Patent No. 7,582,621, which claims the benefit of 60/654,060, filed
`
`February 16, 2005, all of which are incorporated by reference in their entirety for all purposes.
`
`Page3 of9
`
`_
`FIatWIng Ex. 1002, p. 13
`
`FlatWing Ex. 1002, p. 13
`
`
`
`US. Pat. App. No. 15/091,394
`Response dated June 27, 2016
`Response to Restriction Requirement dated May 20, 2016
`
`PATENT
`
`Listing of Claims:
`
`1.
`
`(Original) A method of inhibiting the growth of Trichophytorz rubrum or
`
`Trichophyz‘on mentagrophytes present in a nail unit of a human, the method comprising:
`
`delivering into the nail unit an amount of l,3-dihydro-5-fluoro—l-hydroxy-2,l-
`
`benzoxaborole or a pharmaceutically acceptable salt thereof effective to inhibit the growth of the
`
`Trichophyion rubrum or Trichophyton mentagrophytes.
`
`2.
`
`(Original) The method of claim 1, wherein the amount of the l,3-dihydro-
`
`5-fluoro-1—hydroxy—2,l -benzoxaborole or the pharmaceutically acceptable salt thereof is
`
`delivered into the nail unit by topically administering to the nail unit a pharmaceutical
`v
`y AA
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`composition comprising ethanol, propylene glycol, and 1,3—dih‘rdro—5—fli‘oro—l—hydrcx‘ 22,1:
`
`benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`i\)U":ALa.)
`
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`
`3.
`
`(Original) The method of claim 1, wherein the 1,3—dihydro-5-fluoro—l-
`
`hydroxy—Z,l=benzoxaborole or the pharmaceutically acceptable salt thereof is delivered into a
`
`nail plate of the nail unit.
`
`4.
`
`(Original) The method of claim 1, wherein the 1,3-dihydro-5—fluoro-1-
`
`hydroxy—2,1—benzoxaborole or the pharmaceutically acceptable salt thereof is delivered into a
`
`nail bed of the nail unit.
`
`5,
`
`(Original) The method of claim 1, wherein the amount of the 1,3—dihydro-
`
`5-fluoro—1-hydroxy-2,1—benzoxaborole or the pharmaceutically acceptable salt thereof is
`
`delivered into the nail unit once a day.
`
`6.
`
`(Original) The method of claim 1, wherein the method inhibits the growth
`
`of Trichophyton rubrum.
`
`7.
`
`(Original) The method of claim 1, wherein the method inhibits the growth
`
`of Trichophyton mentagrophytes.
`
`Page 4 of9
`
`FIatWing Ex. 1002, p. 14
`
`FlatWing Ex. 1002, p. 14
`
`
`
`US. Pat. App. No. 15/091,394
`'
`Response dated June 27, 2016
`Response to Restriction Requirement dated May 20, 2016
`
`PATENT
`
`QMAWNH
`
`\IQU‘I-PUJNH
`
`8.
`
`(Original) A method of inhibiting the growth of Trichophyton rubrum or
`
`Trichophyton mentagrophyz‘es present in a nail unit of a human, the method comprising:
`
`contacting a dorsal layer of a nail plate of the nail unit with a topical solution comprising
`
`a compound that penetrates the nail plate to inhibit the growth of Trichophyl‘on rubrum or
`
`Trichophyton mentagrophytes, the compound being 1,3-dihydro-5—fluoro-l -hydroxy-2,l—
`
`benzoxaborole or a pharmaceutically acceptable salt thereof.
`
`9.
`
`(Original) The method of claim 8, wherein the topical solution comprises
`
`5% w/w of l,3—dihydro—5—fluoro—l-hydroxy-2,l-benzoxaborole, and wherein the topical solution
`
`further comprises ethanol and propylene glycol.
`
`10.
`
`(Original) The method of claim 8, wherein the topical solution further
`
`comprises ethanol and propylene glycol.
`
`11.
`
`(Original) The method of claim 8, wherein the contacting of the dorsal
`
`layer of the nail plate of the nail unit with the topical solution occurs once a day.
`
`12.
`
`(Original) The method of claim 8, wherein the method inhibits the growth
`
`of Trichophyton rubrum.
`
`13.
`
`(Original) The method of claim 8, wherein the method inhibits the growth
`
`of Trichophyton mentagrophytes.
`
`14.
`
`(Original) A method of delivering a compound, in a human, from a dorsal
`
`layer of a nail plate to a nail bed to treat onychomycosis caused by Trichophyton rubrum or
`
`Trichophyton mentagrophyz‘es, the method comprising:
`
`contacting the dorsal layer of the nail plate with a pharmaceutical composition
`
`comprising a compound that penetrates the nail plate, the compound being 1,3-dihydro—5—fluoro—
`
`1-hydroxy—2,1-benzoxaborole or a pharmaceutically acceptable salt thereof, thereby treating
`
`onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes.
`
`Page 5 of9
`
`_
`FIatWIng Ex. 1002, p. 15
`
`FlatWing Ex. 1002, p. 15
`
`
`
`U S Pat App No. 15/091,394
`esponsedated June 27, 2016
`335Z T,
`es o1131::- to Res1111311011 Reqmrement dated May 20, 2016
`
`PATENT
`
`b.)N>-‘
`
`4;
`
`Ux-b-UJNr—d
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`
`‘15,
`
`(Original) The method of claim 14, wherein the pharmaceutical
`
`composition is in the form of a topical solution comprising 5% w/w of 1,3-dihydro-5—fluoro-l-
`
`hydroxy-2,l-benzoxaborole, and wherein the pharmaceutical composition further comprises
`
`16.
`
`(Original) The method of claim 14, wherein the pharmaceutical
`
`composition further comprises ethanol and propylene glycol.
`
`17.
`
`(Original) The method of claim 14, wherein the contacting of the dorsal
`
`layer of the nail plate with the pharmaceutical composition occurs once a day.
`
`18.
`
`(Origina1) T