Exhibit 1018
`
`Coalition For Affordable Drugs XI LLC
`Exhibit 1018
`Coalition For Affordable Drugs XI LLC v Insys Pharma, Inc.
`IPR2015-01799
`
`

`
`
`
`UNITED STATES PATENT AND TRADEMARK OEEICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trzuleinark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www usplo gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONF MATION NO.
`
`13/895.124
`
`05/15/2013
`
`S. George Kottayil
`
`INS 10763P00091US
`
`3808
`
`32ll6
`7590
`01/10/2014
`WOOD, PHILLIPS, KATZ, CLARK&MORTIMER
`500 W. MADISON STREET
`SUITE 1 1 30
`CHICAGO, IL 60661
`
`LANDsMAN,RoBERTs
`
`PAPER NUMBER
`
`ART UN”
`1647
`
`NOT EICATION DATE
`
`DELIVERY MODE
`
`01/10/2014
`
`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):
`
`docketing@woodphillips.com
`
`PTOI.—90A (Rev. 04/07)
`
`

`
`Application No.
`‘I3/895,124
`
`App|icant(s)
`KOTTAYIL ET AL.
`
`Office Action Summary
`
`AIA (First lnventorto File)
`Art unit
`Examiner
`figtus
`1647
`Robert Landsman
`-- 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 Q MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1.136(a).
`after SIX (6) 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 12/17/13.
`I:I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|Zl This action is non—final.
`2a)I: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
`Z; the restriction requirement and election have been incorporated into this action.
`
`4)I:I 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 EX parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IXI Claim(s) fit is/are pending in the application.
`5a) Of the above claim(s) 2 and 3 is/are withdrawn from consideration.
`6)I:I Claim(s) j is/are allowed.
`7) Claim(s) 1 and 4 is/are rejected.
`8)I:I Claim(s) j is/are objected to.
`9)I:I Claim(s) j 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
`
`
`
`if/index.'s , orsend an inquiry to PPI--lfeedbackflusgtogov.
`
`:/.’www.usoto. ow atents/init events/'
`
`htt
`
`Application Papers
`
`10)|X| The specification is objected to by the Examiner.
`11)IXI The drawing(s) filed on 5/15/13 is/are: a)lZl 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:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)—(d) or (f).
`Certified copies:
`
`b)I:l Some** c)I:l None of the:
`a)|:l All
`1.I:l Certified copies of the priority documents have been received.
`2.I:l Certified copies of the priority documents have been received in Application No. ?.
`3.I:l 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 jntervjew summary (pTo-413)
`1) IX] Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date. j
`V
`_
`_
`2)
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 7/22/13. 4) I:I Ome“ :-
`
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Part of Paper No./Mail Date 20140101
`
`Office Action Summary
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 2
`
`DETAILED ACTION
`
`The present application is being examined under the pre-AIA first to invent provisions.
`
`1. Formal Matters
`
`A.
`
`Applicant’s election of Group I in the reply filed on 12/17/13 is acknowledged. Because
`
`applicant did not distinctly and specifically point out the supposed errors in the restriction requirement,
`
`the election has been treated as an election without
`
`traverse (MPEP §818.03(a)). Therefore,
`
`this
`
`restriction is deemed proper and is made FINAL. Claims 1 and 4 are the subject of this Office Aciton.
`
`2. Specification
`
`A.
`
`Trademarks should be capitalized wherever they appears and be accompanied by the generic
`
`terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature
`
`of the marks should be respected and every effort made to prevent their use in any manner which might
`
`adversely affect their validity as trademarks. Trademarks appear in at least paragraph [0005 I.
`
`B.
`
`If applicable, the first line of the specification should be updated to reflect the status (e.g. “now
`
`U.S. Patent No.”, or “now abandoned”) of any parent applications. Similarly, though none could be
`
`found, any U.S. or Foreign Applications cited in the specification which have since issued should be
`
`updated with the corresponding Patent No.
`
`C.
`
`Though none could be found, any listing of references in the specification is not a proper
`
`information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other
`
`information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be
`
`incorporated into the specification but must be submitted in a separate paper." Therefore, unless the
`
`references have been cited by the examiner on form PTO—892, they have not been considered.
`
`D.
`
`Though none could be found, Applicant is advised that embedded hyperlinks and/or other forms
`
`of browser—executable code are impermissible and require deletion. The attempt to incorporate subject
`
`matter into the patent application by reference to a hyperlink and/or other forms of browser—executable
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 3
`
`code is considered to be an improper incorporation by reference. See MPEP 608.01(p), paragraph I
`
`regarding incorporation by reference.
`
`E.
`
`Though no issues could be found, according to 37 CFR 1.821(d) (MPEP § 2422), where the
`
`description or claims of a patent application discuss a sequence listing that is set forth in the "Sequence
`
`Listing" in accordance with paragraph (c) of this section, reference must be made to the sequence by use
`
`of the assigned identifier, in the text of the description or claims, even if the sequence is also embedded in
`
`the text of the description or claims of the patent application.
`
`F.
`
`The specification has not been checked to the extent necessary to determine the presence of all
`
`possible minor errors. Applicants’ cooperation is requested in correcting any errors of which Applicants
`
`may b6C0lT16 aware .
`
`3. Claim Rejections - 35 USC § 112, first paragraph — scope of enablement
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`
`IN GENERAL.—The specification shall contain a written description of the invention,
`(a)
`and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor
`of carrying out the invention.
`
`The following is a quotation of the first paragraph of pre—AIA 35 U.S.C. H2:
`
`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
`
`A.
`
`Claim 1 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being
`
`enabling for a sublingual formulation comprising fentanyl, does not reasonably provide enablement for
`
`sublingual formulations comprising “derivatives thereof”. The specification does not enable any person
`
`skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention
`
`commensurate in scope with these claims.
`
`In In re Wands, 8USPQ2d, 1400 (CAFC 1988) page 1404,
`
`the factors to be considered in
`
`determining whether a disclosure would require undue experimentation include (1)
`
`the quantity of
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 4
`
`experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence
`
`of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of
`
`those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
`
`The breadth of the claims is excessive with regard to claiming any sublingual formulation
`
`comprising any “derivative” of fentanyl. Applicants provide no guidance or working examples of
`
`sublingual formulations comprising anything other than fentanyl. Furthermore, it is not predictable to one
`
`of ordinary skill in the art how to make a therapeutically effective sublingual formulation as taught in the
`
`specification using anything other than fentanyl.
`
`These factors lead the Examiner to hold that undue experimentation is necessary to practice the
`
`invention as claimed.
`
`B.
`
`Given the rejections under 35 USC 102/103 below, currently, no rejection is being made
`
`over clai111s 1 and 4 under 35 U.S.C. 112, first paragraph, regarding the specification being enabling for
`
`the sublingual formulations comprising 20% ETOH and 5% PG and 5 mg/ml fentanyl (~ 10 microns —
`
`e.g. Tables 48 and 49) base which are able to achieve the desired pain management (e. g. Cmax, Tmax,
`
`half—life, AUC), and not for other effective formulations as claimed. The specification does not enable any
`
`person skilled in the art to which it pertains, or with which it is most nearly connected, to make the
`
`invention commensurate in scope with these claims. Ilowever, if Applicants overcome the prior art
`
`rejections, a rejection under 35 USC 112, first paragraph will be considered.
`
`4. Claim Rejections - 35 USC § 112, first paragraph —written description
`
`A.
`
`Claim 1 is rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was
`
`not described in the specification in such a way as to reasonably convey to one skilled in the relevant art
`
`that the inventor(s), at the time the application was filed, had possession of the claimed invention.
`
`The claim is drawn to “derivatives” of fentanyl. This is a genus claim. The specification has only
`
`described sublingual formulations comprising fentanyl. The specification and claims do not indicate what
`
`distinguishing attributes are shared by the members (“derivatives”) of the genus. Thus the scope of the
`
`claims includes numerous structural variants, and the genus is highly variant because a significant number
`
`of structural differences between genus members is permitted. Although these types of changes are
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 5
`
`routinely done in the art, the specification and claims do not provide any guidance as to what changes
`
`should be made. Structural features that could distinguish compounds in the genus from others in the
`
`nucleic acid or protein class are missing from the disclosure. No common structural attributes identify the
`
`members of the genus.
`
`The general knowledge and level of skill in the art do not supplement the omitted description
`
`because specific, not general, guidance is what is needed. Since the disclosure fails to describe the
`
`common attributes or characteristics that identify members of the genus, and because the genus is highly
`
`variant, fentanyl, alone,
`
`is insufficient to describe the genus. One of skill in the art would reasonably
`
`conclude that the disclosure fails to provide a representative number of species to describe the genus.
`
`Thus, Applicant was not in possession of the claimed genus at the time the invention was made.
`
`B.
`
`Given the rejections under 35 USC 102/103 below, currently, no rejection is being made
`
`over clai111s 1 and 4 under 35 U.S.C. 112, first paragraph, regarding the specification containing subject
`
`matter which was not described in the specification in such a way as to reasonably convey to one skilled
`
`in the relevant art that the inVentor(s), at the time the application was filed, had possession of the claimed
`
`invention. The specification describes sublingual formulations comprising 20% ETOH and 5% PG and 5
`
`mg/ml fentanyl (~ 10 microns — e.g. Tables 48 and 49) base which are able to achieve the desired pain
`
`management (e.g. Cmax, Tmax, half—life, AUC), and not for other effective formulations as claimed.
`
`However, if Applicants overcome the prior art rejections, a rejection under 35 USC 112, first paragraph
`
`will be considered.
`
`5. Obviousness-Type 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 claims at issue 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). Scc, c.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); and 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 a nonstatutory double patenting ground provided
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 6
`
`the reference application or patent either is shown to be commonly owned with this application, or claims
`an invention 111ade as a result of activities undertaken Within the scope of a joint research agreement. A
`terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTO internet Web site contains terminal disclaimer forms which may be used. Please
`Visit http://WwW.uspto.goV/forms/. The filing date of the application will determine what form should be
`used. A web—based eTern1inal 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
`eTern1inal
`Disclaimers,
`refer
`to
`
`http://WWW.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
`
`A.
`
`Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable
`
`over claims 1-3 of U.S. Patent No. 8,486,972. Although the claims at issue are not identical, they are not
`
`patentably distinct from each other because both are drawn to sublingual fentanyl formulations having
`
`similar size droplets.
`
`B.
`
`Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable
`
`over claims 1-20 of U.S. Patent No. 8,486,973. Although the claims at issue are not identical, they are not
`
`patentably distinct from each other because the instant claims are drawn to sublingual
`
`fentanyl
`
`formulations, Whereas the patent is drawn to methods of treating using this formulation. It is noted that
`
`the instant application is not a DTV of ‘973 and, therefore, does not receive safe—harbor protection. See
`
`Pfizer Inc. v. Teva Pharmaceuticals USA Inc., 86 USPQ2d 1001 (Fed. Cir. 2008)
`
`C.
`
`Claims 1 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable
`
`over claims 1-3 of U.S. Patent Application No. 13/895,111. Although the claims at issue are not identical,
`
`they are not patentably distinct from each other because both are drawn to sublingual
`
`fentanyl
`
`formulations having similar size droplets.
`
`This is a provisional nonstatutory double patenting rejection because the patentably indistinct
`
`claims have not in fact been patented.
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`6. Claim Rejections - 35 USC § 102/103
`
`Page 7
`
`The following is a quotation of the appropriate paragraphs of pre—AIA 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 —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in the
`United States.
`
`(e) the invention was described in (1) an application for patent, published under section 122(b), by
`another filed in the United States before the invention by the applicant for patent or (2) a patent granted
`on an application for patent by another filed in the United States before the invention by the applicant
`for patent, except that an international application filed under the treaty defined in section 351(a) shall
`have the effects for purposes of this subsection of an application filed in the United States only if the
`international application designated the United States and was published under Article 21(2) of such
`treaty in the English language.
`
`The following is a quotation of pre—AIA 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`The factual inquiries set forth in Graham v. John Deere C0., 383 U.S. 1, 148 USPQ 459 (1966),
`
`that are applied for establishing a background for determining obviousness under pre—AIA 35 U.S.C.
`
`103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`2. Ascertaining the differences between the prior art and the claims at issue.
`3. Resolving the level of ordinary skill in the pertinent art.
`4. Considering objective evidence present
`in the application indicating obviousness or
`nonobviousness.
`
`This application currently names joint inventors. In considering patentability of the claims under
`
`pre—AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was
`
`commonly owned at the time any inventions covered therein were made absent any evidence to the
`
`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
`
`invention dates of each claim that was not commonly owned at the time a later invention was made in
`
`order for the examiner to consider the applicability of pre—AIA 35 U.S.C. 103(c) and potential pre—AIA 35
`
`U.S.C. 102(e), (f) or (g) prior art under pre—AIA 35 U.S.C. 103(a).
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 8
`
`A.
`
`Claims 1 and 4 are rejected under pre—AIA 35 U.S.C. 102(e) as anticipated by or,
`
`in the
`
`alternative, under pre—AIA 35 U.S.C. 103(a) as obvious over McCarty (US 2007/0071806). The claims
`
`are drawn to sublingual formulations of fentanyl having a droplet size of at least about 10 microns.
`
`McCarty teaches
`
`sublingual
`
`fentanyl
`
`formulations which comprise ETOH and PG (e. g.
`
`paragraphs [U002], [O008|, [0043|, [0O61|). McCarty does not teach droplet sizes of at least about 10
`
`microns.
`
`However, since the Office does not have the facilities for examining and comparing applicants’
`
`formulation with the formulation of the prior art, the burden is on applicant to show a novel or unobvious
`
`difference between the claimed product and the product of the prior art (i.e., that the formulation of the
`
`prior art does not possess the same functional (and potentially structural) characteristics of the claimed
`
`formulation). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray, 10 USPQ
`
`2d 1922 1923 (PTO Bd. Pat. App. & Int.).
`
`Even if McCarty does not meet the limitations of the instant invention under 35 USC 103, it
`
`would have still been obvious at the time of the instant invention to have optimized the conditions to
`
`provide a formulation with a rapid/desired onset of action to reduce pain as quickly as possible. Where the
`
`general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
`
`workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA
`
`1955). It is further noted that there is no upper lin1it to the droplet size, so any droplets taught by McCarty
`
`would meet the instant claims.
`
`B.
`
`Claims 1 and 4 are rejected under pre—AIA 35 U.S.C. 102(b) as anticipated by or,
`
`in the
`
`alternative, under pre—AIA 35 U.S.C. 103(a) as obvious over Ross (US 2003/0190290). The claims are
`
`drawn to sublingual formulations of fentanyl. Ross teaches sublingual fentanyl formulations as claimed
`
`(e.g. paragraphs [0015], [0032], [0042]). Ross is silent with regard to droplet size.
`
`However, since the Office does not have the facilities for examining and comparing applicants‘
`
`formulation with the formulation of the prior art, the burden is on applicant to show a novel or unobvious
`
`difference between the claimed product and the product of the prior art (i.e., that the formulation of the
`
`prior art does not possess the same functional (and potentially structural) characteristics of the claimed
`
`formulation). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray, 10 USPQ
`
`2d 1922 1923 (PTO Bd. Pat. App. & Int.).
`
`

`
`Application/Control Number: 13/895,124
`
`Art Unit: 1647
`
`Page 9
`
`Even if Ross does not meet the limitations of the instant invention under 35 USC 103, it would
`
`have still been obvious at the time of the instant invention to have optimized the conditions to provide a
`
`formulation with a rapid/desired onset of action to reduce pain as quickly as possible. Where the general
`
`conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable
`
`ranges by routine experimentation." In re Al/er, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). It
`
`is further noted that there is no upper limit to the droplet size, so any droplets taught by McCarty would
`
`meet the instant claims.
`
`C.
`
`Claims 1 and 4 are rejected under pre—AIA 35 U.S.C.
`
`l02(b) as anticipated by or,
`
`in the
`
`alternative, under pre—AIA 35 U.S.C. 103(a) as obvious over Ross (US 2006/0062812 — reference 27 on
`
`the 1449 dated 7/22/13). The claims are drawn to sublingual formulations of fentanyl. Ross teaches
`
`sublingual fentanyl formulations as claimed (e. g. paragraphs [0014],
`
`[0018]—[0021],
`
`[0036],
`
`[0037],
`
`[0055]). Ross is silent with regard to droplet size.
`
`However, since the Office does not have the facilities for examining and comparing applicants‘
`
`formulation with the formulation of the prior art, the burden is on applicant to show a novel or unobvious
`
`difference between the claimed product and the product of the prior art (i.e., that the formulation of the
`
`prior art does not possess the same functional (and potentially structural) characteristics of the claimed
`
`formulation). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray, 10 USPQ
`
`2d 1922 1923 (PTO Bd. Pat. App. & Int.).
`
`Even if Ross does not meet the limitations of the instant invention under 35 USC 103, it would
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`have still been obvious at the time of the instant invention to have optimized the conditions to provide a
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`formulation with a rapid/desired onset of action to reduce pain as quickly as possible. Where the general
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`conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable
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`ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). It
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`is further noted that there is no upper limit to the droplet size, so any droplets taught by McCarty would
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`meet the instant claims.
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`7. Conclusion
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`A.
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`No claim is allowable.
`
`

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`Application/Control Number: 13/895,124
`
`Art Unit: 1647
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`Page 10
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`Advisory information
`Any inquiry concerning this communication or earlier co111111unications fro111 the examiner should
`be directed to Robert Landsman, Ph.D. whose telephone number is (571) 272-0888. The examiner can
`normally be reached M—F 8 AM — 6 PM (eastern).
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`Joanne Hama, can be reached at 571-272-2911. 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
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`
`/Robert Landsmanl
`
`Primary Examiner, Art Unit 1647