PTO/SB/06 (07-06)
`Approved for use through 1/31/2007. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.
`PATENT APPLICATION FEE DETERMINATION RECORD
`Application or Docket Number
`Filing Date
`10/518,016
`Substitute for Form PT0-875
`
`07/06/2005 D To be Mailed
`
`APPLICATION AS FILED- PART I
`(Column 1)
`
`(Column 2)
`
`SMALL ENTITY D
`
`OR
`
`OTHER THAN
`SMALL ENTITY
`
`NUMBER FILED
`
`NUMBER EXTRA
`
`RATE($)
`
`FEE($)
`
`RATE($)
`
`FEE($)
`
`FOR
`~ BASIC FEE
`(37 CFR 1.16(a), (b), or (c))
`D SEARCH FEE
`(37 CFR 1.16(k), (i), or (m))
`D EXAMINATION FEE
`(37 CFR 1.16(0), (p), or (q))
`TOTAL CLAIMS
`(37 CFR 1.16(i))
`INDEPENDENT CLAIMS
`(37 CFR 1.16(h))
`
`0APPLICATION SIZE FEE
`(37 CFR 1.16(s))
`
`*
`If the specification and drawings exceed 100
`sheets of paper, the application size fee due
`is $250 ($125 for small entity) for each
`additional 50 sheets or fraction thereof. See
`35 U.S.C. 41 (a)(1 )(G) and 37 CFR 1.16(s).
`D MULTIPLE DEPENDENT CLAIM PRESENT (37 CFR 1.16(j))
`* If the difference in column 1 is less than zero, enter "O" in column 2.
`
`N/A
`
`N/A
`
`N/A
`
`minus 20 =
`
`*
`
`N/A
`
`N/A
`
`N/A
`
`minus 3 =
`
`N/A
`
`N/A
`
`N/A
`
`x $
`
`x $
`
`=
`
`=
`
`300
`
`N/A
`
`N/A
`
`N/A
`
`OR
`
`x $
`
`x $
`
`=
`
`=
`
`TOTAL
`
`TOTAL
`
`300
`
`APPLICATION AS AMENDED - PART II
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`SMALL ENTITY
`
`OR
`
`OTHER THAN
`SMALL ENTITY
`
`08/16/2011
`
`RATE($)
`
`RATE($)
`
`ADDITIONAL
`FEE($)
`
`CLAIMS
`REMAINING
`f--
`AFTER
`z
`AMENDMENT
`w
`Total (37 CFR
`* 47
`~ 1.16(i))
`0
`z
`Independent
`* 5
`w
`f37 CFR 1 .16fh\\
`~ D Application Size Fee (37 CFR 1.16(s))
`D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`** 51
`***6
`
`PRESENT
`EXTRA
`
`= 0
`= 0
`
`Minus
`
`Minus
`
`<(
`
`(Column 1)
`
`(Column 2)
`
`(Column 3)
`
`CLAIMS
`REMAINING
`AFTER
`AMENDMENT
`f--
`z
`Total (37 CFR
`*
`w
`1.16(i\\
`~ Independent
`*
`0
`(37 CFR 1.16(hll
`z D Application Size Fee (37 CFR 1.16(s))
`w
`~ D FIRST PRESENTATION OF MULTIPLE DEPENDENT CLAIM (37 CFR 1.16(j))
`
`HIGHEST
`NUMBER
`PREVIOUSLY
`PAID FOR
`
`PRESENT
`EXTRA
`
`Minus
`
`Minus
`
`**
`***
`
`=
`
`=
`
`<(
`
`ADDITIONAL
`FEE($)
`
`x $
`
`x $
`
`=
`
`=
`
`TOTAL
`ADD'L
`FEE
`
`OR
`
`OR
`
`x $52=
`
`x $220=
`
`OR
`
`OR
`
`TOTAL
`ADD'L
`FEE
`
`0
`0
`
`0
`
`RATE($)
`
`ADDITIONAL
`FEE($)
`
`RATE($)
`
`ADDITIONAL
`FEE($)
`
`x $
`
`x $
`
`=
`
`=
`
`OR
`
`OR
`
`x $
`
`x $
`
`=
`
`=
`
`OR
`
`*If the entry in column 1 is less than the entry in column 2, write "O" in column 3.
`** If the "Highest Number Previously Paid For" IN THIS SPACE is less than 20, enter "20".
`*** If the "Highest Number Previously Paid For" IN THIS SPACE is less than 3, enter "3".
`The "Highest Number Previously Paid For" (Total or Independent) is the highest number found in the appropriate box in column 1.
`
`TOTAL
`TOTAL
`ADD'L
`ADD'L
`FEE
`FEE
`Legal Instrument Examiner:
`/GLORIA TRAMMELL/
`
`OR
`
`This collection of 1nformat1on 1s required by 37 CFR 1.16. The 1nformat1on 1s required to obtain or retain a benefit by the public which 1s to file (and by the US PTO to
`process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This collection is estimated to take 12 minutes to complete, including gathering,
`preparing, and submitting the completed application form 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 Chief Information Officer, U.S. Patent and Trademark Office, U.S.
`Department of Commerce, P.O. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND FEES OR COMPLETED FORMS TO THIS
`ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
`If you need assistance in completing the form, call 1-800-PT0-9199 and select option 2.
`
`Exhibit 1002 (Part 2 of 2)
`IPR2017-00807
`ARGENTUM
`
`000502
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/518,016
`
`0710612005
`
`AmarLulla
`
`30652
`7590
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`08/04/2011
`
`PAC/20632 US
`(4137-04700)
`
`4912
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`MAILDATE
`
`DELIVERY MODE
`
`08/04/2011
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`000503
`
`

`

`Interview Summary
`
`Application No.
`
`10/518,016
`
`Examiner
`
`THOR NIELSEN
`
`Applicant(s)
`
`LULLA ET AL.
`
`Art Unit
`
`1616
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) THOR NIELSEN.
`
`(2) Johann Richter.
`
`Date of Interview: 01August2011.
`
`(3)Mr. Rodnev Carroll.
`
`( 4) Ms. Jerrv Walker .
`
`Type: a)~ Telephonic b)O Video Conference
`c)O Personal [copy given to: 1 )0 applicant 2)0 applicant's representative]
`
`Exhibit shown or demonstration conducted: d)O Yes
`If Yes, brief description: __ .
`
`e)~ No.
`
`Claim(s) discussed: 1,2.4-22,26,27,30,35-38.44.45 and 53-56.
`
`Identification of prior art discussed: Cramer (EP07801271.
`
`Agreement with respect to the claims f)0 was reached. g)~ was not reached. h)O N/A.
`
`Substance of Interview including description of the general nature of what was agreed to if an agreement was
`reached, or any other comments: See Continuation Sheet.
`
`(A fuller description, if necessary, and a copy of the amendments which the examiner agreed would render the claims
`allowable, if available, must be attached. Also, where no copy of the amendments that would render the claims
`allowable is available, a summary thereof must be attached.)
`
`THE FORMAL WRITTEN REPLY TO THE LAST OFFICE ACTION MUST INCLUDE THE SUBSTANCE OF THE
`INTERVIEW. (See MPEP Section 713.04). If a reply to the last Office action has already been filed, APPLICANT IS
`GIVEN A NON-EXTENDABLE PERIOD OF THE LONGER OF ONE MONTH OR THIRTY DAYS FROM THIS
`INTERVIEW DATE, OR THE MAILING DATE OF THIS INTERVIEW SUMMARY FORM, WHICHEVER IS LATER, TO
`FILE A STATEMENT OF THE SUBSTANCE OF THE INTERVIEW. See Summary of Record of Interview
`requirements on reverse side or on attached sheet.
`
`8/1 /11
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 04·03)
`
`/Johann R. Richter/
`Supervisory Patent Examiner, Art Unit 1616
`
`I
`I
`
`Interview Summary
`
`Paper No. 20110801
`
`000504
`
`

`

`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in§§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`"Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`-Application Number (Series Code and Serial Number)
`- Name of applicant
`- Name of examiner
`- Date of interview
`- Type of interview (telephonic, video-conference, or personal)
`-Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`-An indication whether or not an exhibit was shown or a demonstration conducted
`-An identification of the specific prior art discussed
`An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`- The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully
`describe those arguments which he or she feels were or might be persuasive to the examiner.)
`6) a general indication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicant's record of the substance of an interview. If the record is not complete and
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`Examiner to Check for Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner's version of the
`statement attributed to him or her. If the record is complete and accurate, the examiner should place the indication, "Interview Record OK" on the
`paper recording the substance of the interview along with the date and the examiner's initials.
`
`000505
`
`

`

`Continuation Sheet (PTOL-413)
`
`Application No. 10/518,016
`
`Continuation of Substance of Interview including description of the general nature of what was agreed to if an
`agreement was reached, or any other comments: Mr. Carroll explained that a product encompassed by the claims has
`been commercialized in India under the name "Duonase" and that the product has been licensed to Meda
`Pharmaceuticals and is in Phase Ill trials. He further provided a preview of intended amendments, supplemental data,
`and topics of forthcoming Declarations. The amendments would remove the term "fluticasone" from claim 1 and leave
`fluticasone esters and would further require that the formulation be suitable for nasal use. He said that the company
`scientists have found that Example 111 of the Cramer reference is inoperable because the formulation is
`inhomogeneous, is delivered as a jet rather than a diffuse spray, and is hypertonic and that this analysis would be
`provided. The Declarations would address surprizing results, commercial success, and a long-felt need in the art. Also,
`some amendments directed to clarifying the specification will be forthcoming. He expects to file the repsonse at or
`before the deadline.
`
`000506
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`10/518,016
`
`0710612005
`
`AmarLulla
`
`7590
`30652
`CONLEY ROSE, P.C.
`5601 GRANITE PARKWAY, SUITE 750
`PLANO, TX 75024
`
`02/16/2011
`
`PAC/20632 US
`(4137-04700)
`
`4912
`
`EXAMINER
`
`NIELSEN, THOR B
`
`ART UNIT
`
`PAPER NUMBER
`
`1616
`
`MAILDATE
`
`DELIVERY MODE
`
`02/16/2011
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`000507
`
`

`

`Office Action Summary
`
`Application No.
`
`10/518,016
`
`Examiner
`
`Applicant(s)
`
`LULLA ET AL.
`
`Art Unit
`
`1616
`THOR B. NIELSEN
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`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).
`
`Status
`1 )IZ! Responsive to communication(s) filed on 24 September 2010.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 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
`
`4)[8J Claim(s) 1.2.4.6-22.26.27.30.35-38.44.45 and 53-56 is/are pending in the application.
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 1.2.4.6-22.26.27.30.35-38.44.45 and 53-56 is/are rejected.
`7)0 Claim(s) __ is/are objected to.
`8)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)0 The specification is objected to by the Examiner.
`10)0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`11 )0 The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PT0-152.
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)O All b)O Some * c)O None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 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)
`1) 0 Notice of References Cited (PT0-892)
`2) 0 Notice of Draftsperson's Patent Drawing Review (PT0-948)
`3) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 912412010; 1011912010.
`
`4) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`5) 0 Notice of Informal Patent Application
`6) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 08·06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20110131
`
`000508
`
`

`

`Application/Control Number: 10/518,016
`Art Unit: 1616
`
`Page 2
`
`DETAILED ACTION
`
`Status of Examination
`
`In brief, the claims were initially reviewed and a non-Final rejection mailed on
`
`January 23, 2009. In that action, the claim set was restricted and claims 23, 24, and 46-
`
`52 were withdrawn from consideration. Then-pending claims 1-4, 7, 9-10, 12-21, 30-32,
`
`and 44-45 were rejected as anticipated by EP 0780127 (Cramer). In that same action,
`
`then-pending claims 5 and 35-38 were rejected as obvious over Cramer; claims 22 and
`
`26-27 were rejected as obvious over Cramer in view of US 6,294, 153 (Modi); claims 1-3
`
`and 6 were rejected as obvious over US 6,391,340 (Malmqvist-Granlund); and claims
`
`28-29 were rejected as obvious over Cramer in view of US 6,017,963 (Alfonso). No
`
`claims were allowed.
`
`In response, Applicant amended the claims, submitted a Declaration under 37
`
`CFR 1 .132, and argued for patentability. Of note, the Applicant incorporated the
`
`limitations of claim 5, which had not been rejected as anticipated, into claim 1.
`
`A Final Office Action was mailed on April 28, 2010, rejecting then-pending claims
`
`1-2, 4, 7-21, 30, 35-38, 44-45, and 53-56 as obvious over Cramer. In addition, claims
`
`22 and 26-27 were rejected as obvious over Cramer in view of Modi; claims 1-2 and 6
`
`were rejected as obvious over Cramer in view of US 6416743 (Fassberg); and claims
`
`1, 25, 28-29 were rejected as obvious over Cramer in view of Alfonso. No claims were
`
`allowed.
`
`000509
`
`

`

`Application/Control Number: 10/518,016
`Art Unit: 1616
`
`Page 3
`
`The current Action is responsive to the Amendment and Response to Final
`
`Rejection filed on September 24, 2010, and the revised Declaration under 37 CFR
`
`1.132 by Geena Malhotra, with Exhibits A-D, dated September 23, 2010.
`
`A Request for Continuing Examination was filed on September 27, 2010.
`
`The examiner in this application has changed. Please address future
`
`correspondence accordingly.
`
`Status of Claims
`
`Claims 1-2, 4, 6-22, 26-27, 30, 35-38, 44-45, and 53-56 are pending. Of these
`
`claims, claims 26, 27, and 30 were amended in the most recent response. The
`
`Amendments are entered of right.
`
`Anticipation rejection, reinstated in part and new in part
`
`In the Office Action that was mailed on January 23, 2009, claim 5, directed to a
`
`steroid range, was not rejected as anticipated by Cramer. That was an error, because,
`
`as discussed further below, Cramer discloses the claimed amounts of steroid. This
`
`examiner recognizes that the correction of the error places an additional burden on the
`
`Applicant.
`
`The rejection of claims 1-2, 9-10, 12-21, 30, 45, and 55-56 as obvious over
`
`Cramer is withdrawn in favor of the following anticipation rejection.
`
`Claim Rejections - 35 USC § 102
`
`000510
`
`

`

`Application/Control Number: 10/518,016
`Art Unit: 1616
`
`Page 4
`
`The following is a quotation of the appropriate paragraphs of 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.
`
`Claims 1-2, 9-10, 12-21, 30, 45, and 55-56 are rejected as anticipated by
`
`Cramer.
`
`Cramer is directed generally to a nasal spray containing a steroid and an
`
`antihistamine. Abstract. The compositions are suitable for treatment of symptoms
`
`associated with seasonal or perennial allergic rhinoconjunctivitits. At page 2,
`
`lines 28-30. Cramer discloses a pharmaceutical composition that can have a safe and
`
`effective amount of Azelastine. At page 2, lines 36-44, esp. line 42. The composition
`
`can also have a safe and effective amount of Fluticasone. Id., esp. line 39. The
`
`Fluticasone can be present in an amount from about 0.001 to about 0.2 wt. % or
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`from about 0.01 to about 0.1 wt. %. At page 3, lines 19-20 and page 2, line 58. The
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`disclosed compositions are prepared in saline or isotonic glucose (see Examples).
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`Such dilute solutions are essentially the same in weight/volume units, because the
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`density of the solution differs little from the density of water. Also, the disclosure uses
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`the broadening term "about." Cramer discloses Azelastine hydrochloride. At page 6,
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`Example II, esp. line 33. The amount of Azelastine can be from about 0.01 to about 4
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`wt. %, preferably from about 0.01 % to about 1 wt. %. At page 3, lines 28-30.
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`Cramer discloses that the composition can have a surfactant, e.g. a polysorbate, in a
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`usual amount from 0.5 to 10 wt. %. At page 5, lines 11-15. The compositions can have
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 5
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`sodium chloride, dextrose/glucose, polypropylene glycol, among other named
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`agents, for controlling isotonicity. At page 4, lines 50-55. Cramer discloses
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`compositions with a thickener which can be a cellulose derivative (page 4, line 56 to
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`page 5, line 2), a buffer (page 3, lines 47-49), and a preservative (Id.). The buffer can
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`have citric acid, and hence citrate. At page 4, lines 50-53. The pH can be from about
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`4.5 to about 9, preferably from about 6 to about 7. At page 2, line 57. Cramer
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`envisions solutions (e.g. page 5, line 57) and suspensions (e.g. page 5, lines 27-30).
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`Cramer discloses the preparation of nasal sprays. See Examples.
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`This rejection is proper under In re Petering, 133 USPQ 275, 280 (CCPA 1962),
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`in which disclosure of a genus of 20 related compounds rendered obvious a claim to
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`one of those compounds. See also In re Schaumann, 197 USPQ 5, 7 (CCPA 1978),
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`which found a claim to one compound obvious over the disclosure of a genus having
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`105 compounds that encompassed the claim.
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`In the instant application, Cramer discloses a genus consisting of the
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`combinations of six steroids and three antihistamines, thus corresponding to eighteen
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`combinations. That the antihistamines are available in various salt forms and that the
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`steroids are available in various esters does not negate the validity of the rejection,
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`because the salts and esters are well-known variants. Moreover, Cramer specifically
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`discloses the chloride salt of Azelastine. In re Ruschig, 145 USPQ 274 (1965) is not in
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`point because Cramer defines a small recognizable class with common properties,
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`unlike the fact situation in Ruschig.
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 6
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`Claim Rejections - 35 USC § 103
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`The rejection of claim 44 over Cramer, as stated in the Office Action of April 28,
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`2010, is withdrawn because the claim depends from a claim not rejected over Cramer.
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`The rejection of claims 1, 25, and 28-29 as obvious over Cramer in view of US
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`6,017,963 (Alfonso) (of record) is withdrawn because of the cancellation of claims 25,
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`and 28-29.
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`The rejection of claims 4, 7, 8, 11, 35, 36, 37, 38, 53, and 54 as obvious over
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`Cramer, as stated in the Office Action of April 28, 2010, is maintained for reasons of
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`record.
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`The rejection of claims 22 and 26-27 as obvious over Cramer in view of
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`US6294153 (Modi) (of record) is maintained for reasons of record.
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`The rejection of claims 1, 2, and 6 as obvious over Cramer in view of US
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`6,416,743 (Fassberg) (of record) is maintained for reasons of record.
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`Claim 44 is newly rejected over Cramer in view of US6294153 (Modi) (of record).
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`Determination of the scope and content of the prior art (MPEP 2141.01)
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`The disclosure of Cramer is discussed above. Modi teaches aerosol
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`formulations for nasal delivery comprising pharmaceutical agents (i.e. anti-
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`inflammatories, steroids, etc.), water, excipients and a propellant. Abstract and column
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`3, lines 30-40. Improved penetration into the nasal cavity and absorption of the
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`Page 7
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`formulations can be achieved by mixing the formulation with propellants such as
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`tetrafluroethane, etc., especially when delivered through aerosol devices (i.e. MDI).
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`Column 2, lines 5-24.
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`Ascertainment of the difference between the prior art and the claims
`(MPEP 2141.02)
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`Cramer does not teach aerosol sprays or metered dose inhalers (MDI). As
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`discussed above, Modi teaches aerosols and MDI and thus, Modi cures the deficiency
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`in Cramer.
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`Finding of prima facie Obviousness Rationale and Motivation
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`(MPEP 2142-2143)
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`One of ordinary skill in the art, familiar with the disclosure of Cramer, would have
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`been motivated to make a composition further comprising a propellant because Modi
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`suggests that adding propellants to nasal formulations can increase penetration and
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`absorption in the nasal cavity. Thus, it would have been obvious to one of ordinary skill
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`in the art at the time the claimed invention was made to make a composition further
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`comprising a propellant for the purpose of increasing penetration of active formulations
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`into the nasal cavity. Therefore, the invention as claimed in claim 44 would have been
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`prima facie obvious to one of ordinary skill in the art at the time the invention was made
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`because the prior art is fairly suggestive of the claimed invention.
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`Response to Remarks and Arguments
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`Applicant's arguments with regard to obviousness of claims 1-2, 9-10, 12-21, 30,
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`45, and 55-56 is mooted by the new or reinstated anticipation rejection. Thus,
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`Application/Control Number: 10/518,016
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`Page 8
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`Applicant's arguments will be considered in view of the remaining claims: 4, 6-8, 11, 22,
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`26-27, 35-38, 44, 53, and 54.
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`A. Argument for lack of establishment of a prima facie case of obviousness
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`Applicant argues that the instant claims as amended are A. patentable over the
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`art of record and B. patentable in view of objective evidence of nonobviousness. In
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`particular, Applicant asserts that the examiner has not established a prima facie case of
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`obviousness and that objective evidence shows that a pharmaceutical formulation
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`comprising Azelastine (an antihistamine) and Fluticasone (a corticosteroid) displays
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`unexpectedly beneficial properties, is commercially successful, and fills a long felt but
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`unsolved need. At page 10. Each of these assertions is discussed in detail below.
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`In the Office Action dated January 23, 2009, the Examiner observed that the prior
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`art reference (Cramer) disclosed a nasal spray comprising the combination of a
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`glucocorticoid and an antihistamine. Moreover, Cramer disclosed six corticosteroids
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`and three antihistamines, but did not exemplify the combination of Azelastine and
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`Fluticasone. The examiner then stated that it was well within the means for one of
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`ordinary skill in the art to try the instant combination as there are a small number of
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`actives to choose from. At pages 14-15.
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`Applicant characterizes the rejection as an obvious-to-try rejection. Amendment
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`of September 24, 2010, at page 11. Applicant, quoting In re Kubin, further asserts that
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`an obvious-to-try rejection requires an indication of which parameters were critical or
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`which of many possible choices is likely to be successful. 90 USPQ2d 1417, 1423
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`(Fed. Cir. 2009) ('[W]here a defendant merely throws metaphorical darts at a board filled
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 9
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`with combinatorial prior art possibilities, court should not succumb to hindsight claims of
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`obviousness.")
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`The Applicant's arguments are mooted by the reinstatement of a rejection for
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`anticipation, above.
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`B. Argument for secondary considerations
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`Applicant argues in the alternative that secondary considerations render the
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`instant claims, as amended, nonobvious over the art of record, and has provided a
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`second Declaration (dated September 23, 2010) under 37 CFR 1.132, which has
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`"amended values [that] represent clarifications and the remedying of typographical
`
`errors in the previously submitted data." At page 13.
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`Both the current and previous Declarations had the statement in which the
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`Declarant "declare[d] that all statements made herein of my own knowledge are true
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`and that all statements made on information and belief are believed to be true; and
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`further that these statements are made with the knowledge that willful false statements
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`and the like so made are punishable by fine, imprisonment, or both ... and that such
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`willful false statements may jeopardize the validity of this application or any patent
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`issuing thereon." E.g., Declaration dated September 23, 2010, page 3.
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`Second Declaration under 37 CFR 1.132
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`In brief, the examiner observes the following items in the second Declaration:
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`1. Table I (of Exhibit A) shows the compositions of the Azelastine, Budesonide,
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`the combination of Azelastine and Budesonide, Fluticasone, and the combination of
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`Application/Control Number: 10/518,016
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`Page 1 O
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`Azelastine and Fluticasone formulations. The values of some of the units and of the
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`actual constituents have been changed from the Exhibit of the previous Declaration.
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`2. Table II (of Exhibit A) shows the initial assay of the five formulations described
`
`in Table I. Table II also shows the level of impurities in the initial formulations and after
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`storage for either 1 month or 3 months under either of two conditions: 25 °C at 60 %
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`relative humidity or 40 °C at 75 % relative humidity. (Note that Budesonide was stored
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`for 2 months, rather than three months, and that no data was presented for Fluticasone
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`