Atty. Dkt. No. 038923-0304
`
`
`
`Applicant:
`
`Lawrence Glen GARY, et al.
`
`Title:
`
`RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-
`ACTIVE COMPOUND
`
`Appl. No.:
`
`l0f937,870
`
`Filing Date:
`
`9/ l 0/2004
`
`Examiner:
`
`Jagadishwar Rao Samala
`
`Art Unit:
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`1 618
`
`Confirmation
`
`1696
`
`Number:
`
`SUBMISSION UNDER 37 CFR 1.115
`
`Mail Stop RCE
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`This submission accompanies Applicants’ Request for Continued Examination and it
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`is in further response to the Non—Final Office Action dated April 30, 2009, concerning the
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`above-referenced patent application.
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`Applicant has enclosed with this amendment a Petition for Extension of Time to make
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`this response timely.
`
`Amendments to the Claims are reflected in the listing of claims which begins on
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`page 2 of this document.
`
`Remarks/Arguments begin on page 6 of this document.
`
`Please amend the application as follows:
`
`WASH__68951 14.2
`
`Amgen Ex. 2019
`
`Complex Innovations v. Amgen
`
`|PR2016-00085
`
`Amgen Ex. 2019
`Complex Innovations v. Amgen
`IPR2016-00085
`
`

`
`Amendments to the Claims
`
`This listing of claims will replace all prior Versions, and listings, of claims in the application.
`
`Application No. 10/937,870
`Atty. Dkt. No. 038923-0304
`
`Listing of Claims:
`
`1-77. (Cancelled).
`
`78.
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`(Previously presented) A pharmaceutical composition comprising
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`(a) from about 10% to about 40% by weight of cinacalcet HC1;
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`(b) from about 40% to about 75% by weight ofmicrocrystalline cellulose;
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`(c) from about 1% to about 5% by weight of povidone;
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`(d) from about 5% to about 35% by weight of starch;
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`(e) from about 1% to about 10% by weight of crospovidone;
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`(i) from about 0.05% to about 1.5% by weight of colloidal silicon dioxide; and
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`(g) from about 0.05% to about 1.5% by weight of magnesium stearate;
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`wherein the percentage by weight is relative to the total weight of the composition.
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`79. — 82. (Cancelled).
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`83.
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`(Original)
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`The composition according to Claim 78 further comprising at least one
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`ingredient chosen from lubricants and clear and color coating materials.
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`84.
`
`(Original)
`
`The composition according to Claim 78 further comprising fiom about
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`1% to about 6% by weight of at least one coating material chosen fi'om clear and color
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`coating materials relative to the total weight of the composition.
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`WASH_68951 14.2
`
`

`
`Application No. 10/937,870
`Atty. Dkt. No. 038923-0304
`
`85.
`
`(Original)
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`The composition according to Claim 78, wherein the cinacalcet HCl is
`
`in a form chosen from amorphous powders, crystalline particles, matrix particles, and
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`mixtures of any of the foregoing.
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`86.
`
`(Original)
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`The composition according to Claim 78, wherein the cinacalcet HCl is
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`in a fonn chosen from needle-shape particles, rod-shape particles, plate-shaped particles, and
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`mixtures of any of the foregoing.
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`87.
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`(Original)
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`The composition according to Claim 78, wherein the particle D59 of the
`
`cinacalcet HCl particles is less than or equal to about 50 um.
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`88.
`
`(Original)
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`The composition according to Claim 78, wherein the composition is in
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`the form of granules.
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`89.
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`(Original)
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`The composition according to Claim 78, wherein the composition is in
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`a form chosen from tablets, capsules, and powders.
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`90.
`
`(Original)
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`The composition according to Claim 88, wherein the granules have a
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`granule D50 measured using a sieve analysis ranging from about 50 pm to about 150 um.
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`91.
`
`(Original)
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`The composition according to Claim 90, wherein the granules have a
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`granule D50 measured using a sieve analysis ranging from about 80 pm to about 130 um.
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`92.
`
`(Original)
`
`The composition according to Claim 78, wherein the cinacalcet HCl is
`
`present in a therapeutically effective amount for the treatment of at least one of
`
`hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus
`
`product.
`
`93.
`
`(Original)
`
`The composition according to Claim 78, wherein the cinacalcet HCl is
`
`present in an effective dosage amount for the treatment of at least one of
`
`hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus
`
`product.
`
`WAS H_68951 14.2
`
`

`
`Application No. 10/937,870
`Atty. Dkt. No. 038923-0304
`
`94.
`
`(Original)
`
`The composition according to Claim 92, wherein the
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`hyperparathyroidism is chosen from primary hyperparathyroidism and secondary
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`hyperparathyroidism.
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`95.
`
`(Original)
`
`The composition according to Claim 93, wherein the
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`hyperparathyroidism is chosen fi'om primary hyperparathyroidism and secondary
`
`hyperparathyroidism.
`
`96.
`
`(Original)
`
`The composition according to Claim 78, wherein the cinacalcet HCl is
`
`present in an amount ranging fiom about 10% to about 30% by weight relative to the total
`
`weight of the composition.
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`97.
`
`(Original)
`
`The composition according to Claim 96, wherein the cinacalcet HCl is
`
`present in an amount ranging from about 15% to about 20% by weight relative to the total
`
`weight of the composition.
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`98. — 102. (Cancelled).
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`103.
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`(Previously presented) The composition according to claim 78, wherein crospovidone
`
`is present intergranularly, intragranularly, or a combination thereof.
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`104.
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`(Previously presented) The composition according to Claim 78, wherein
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`crospovidone is present intergranularly.
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`105.
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`(Previously presented) The composition according to Claim 78, wherein
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`crospovidone is present intragranularly.
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`106.
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`(Previously presented) The composition according to Claim 78, wherein the
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`microcrystalline cellulose and starch are present in a weight ratio ranging from about 1 :1 to
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`about 15:1.
`
`107.
`
`(Previously presented) The composition according to Claim 106, wherein the weight
`
`ratio is about 10:1.
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`WASH_68951 14.2
`
`

`
`108.
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`(Previously presented) The composition according to Claim 106, wherein the weight
`
`ratio ranges from about 1:1 to about 10:1.
`
`109.
`
`(Previously presented) The composition according to Claim 108, wherein the weight
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`Application No. 10/937,870
`Atty. Dkt. No. 038923-0304
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`ratio is about 5:1.
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`110.-118. (Cancelled).
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`119.
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`(Previously presented) A method for the treatment of at least one disease chosen from
`
`hyperparathyroidism, hyperphosphonia, hypercalcemia, and elevated calcium phosphorus
`
`product, comprising administering to a patient in need thereof a pharmaceutical composition
`
`according to claim 78.
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`120.
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`(Previously presented) The method according to Claim 1 19, wherein the patient is
`
`human.
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`WAS H_6-895 1 1 4.2
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`

`
`Application No. 10/937,870
`Atty. Dkt. No. 038923-0304
`
`REMARKS
`
`Applicants gratefiilly acknowledge the PTO’s Notice of Allowability that was mailed
`
`on December 17, 2009. Although Applicants timely paid the issue and publication fees on
`
`March 16, 2010, they file with this submission and accompanying Request for Continued
`
`Examination a petition to withdraw the application from issue pursuant to
`
`37 C.F.R. l.3l3(c)(2). Applicants desire to clarify their response filed on July 24, 2009 that
`
`resulted in the allowance of the application.
`
`No claims are presently amended or cancelled. Therefore, claims 78, 83-97, 103-109,
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`1 19, and 120 are pending.
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`In the Non-Final Office Action dated April 30, 2009, the PTO rejected claims 78, 83-
`
`97, 103-109, I 19, and 120 under 35 U.S.C. § 103 (a) for being allegedly unpatentable over
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`U.S. Patents No. 6,211,244 to Van Wagenen et al. (“Van Wagenen”) and No. 6,656,492 to
`
`Kajiyama et al. (“Kajiyama”) in view of No. 6,316,460 to Creekmore et al. (“Creekmore”)
`
`and US. Patent Application Publication No. 2005/0147670 to Hsu et al. (“Hsu”', Office
`
`Action at page 3). In withdrawing the rejection the PTO stated in the Examiner’s Statement
`
`of Reasons for Allowance that the cited prior art “fails to specifically disclose or render
`
`obvious the combination of components and in the amounts thereof set forth in claim 78”
`
`(emphasis added).
`
`In their response filed on July 24, 2009, Applicants presented a number of arguments
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`and they highlighted evidence in the application to show that the cited references fail to
`
`support a prima facie case of obviousness. While Applicants’ representations are factually
`
`accurate, they wish to clarify the record to affirm the PTO’s stated reason for withdrawal of
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`the rejection and allowance of the application.
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`More specifically, and fully consistent with Applicants’ previous statements,
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`Applicants acknowledge that Van Wagenen teaches cinacalcet, among other compounds and
`
`their encompassing chemical genera.
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`In addition, the reference provides for phannaceutically
`
`acceptable salts of the same, including examples isolated as HCl salts. See, e. g., column 19,
`
`lines 33-63. Van Wagenen also provides for the compounds in Various dosage forms (id. at
`
`wAsH_6895114.2
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`-5-
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`

`
`Application No. 10/93 7,870
`Atty. Dkt. No. 038923-0304
`
`lines 24-32) and for their combinations with carriers or excipients (id. at line 65 to column
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`29, line 6).
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`However, Van Wagenen does not teach or suggest the combination of recited
`
`components (a) — (e), nor does it teach or suggest the respective concentration ranges of these
`
`components as claimed. Nor do Kajiyama, Creekmore, and Hsu together with Van ‘Wagenen
`
`suggest this specific combination or the concentration ranges, either. In light of these
`
`remarks, as before, the claims are patentable over the cited references.
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`Applicants therefore respectfully urge the PTO to indicate afresh the allowability of
`
`the claims. The Examiner is courteously invited to contact Applicants’ undersigned attorney
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`by telephone at the number if the Examiner believes that any issue warrants discussion.
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`Respectfully submitted,
`
`Date
`
`20/U
`
`By
`
`FOLEY & LARDNER LLP
`
`Customer Number: 22428
`Telephone:
`(202) 295-4767
`Facsimile:
`(202) 672-53 99
`
`Steven M. Reid, Ph.D.
`
`Attorney for Applicant
`Registration No. 54,393
`
`The Commissioner is hereby authorized to charge any additional fees which may be required regarding
`this application under 37 C.F-R. §§ 1.16-1.17, or credit any overpayment, to Deposit Account No. 19-0741.
`Should no proper payment be enclosed herewith, as by the credit card payment instructions in EFS-Web
`being incorrect or absent, resulting in a rejected or incorrect credit card transaction, the Commissioner is
`authorized to charge the unpaid amount to Deposit Account No. 19-0741.
`If any extensions of time are
`needed for timely acceptance of papers submitted herewith, Applicant hereby petitions for such extension
`under 37 C.F.R. §1.136 and authorizes payment of any such extensions fees to Deposit Account No. 19-
`0741.
`
`WASH_6895114.2