UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P. O. Box 1450
`'nia 22313-1450
`Alexandria, Vi
`www.uspto.go
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`APPLICATION NO.
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`F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF <MATION NO.
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`10/937, 870
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`09/ 1 0/2004
`
`Glen Gary Lawrence
`
`038923-0304
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`1696
`
`04/30/2009
`7590
`22428
`FOLEY AND LARDNER LLP
`SUITE 500
`3000 K STREET NW
`WASHINGTON, DC 20007
`
`EXAMINER
`
`SAMALA, JAGADISHWAR RAO
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`ART UNIT
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`1618
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`MAIL DATE
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`04/3 0/2009
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev. 04/07)
`
`Amgen Ex. 2007
`
`Complex Innovations v. Amgen
`
`IPR2016-00085
`
`Amgen Ex. 2007
`Complex Innovations v. Amgen
`IPR2016-00085
`
`

`
`Office Action Summary
`
`Application No.
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`App|icant(s)
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`10/937,870
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`LAWRENCE ET AL.
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`Examine,
`
`JAGADISHWAR R. SAMALA
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`A,, Unit
`
`1618 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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).
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`Status
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`1)IXI Responsive to communication(s) filed on 23 December 2008.
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`2a)I:I This action is FINAL.
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`2b)IXI This action is non-final.
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`3)I:I 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 Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IXI C|aim(s) 78 83-97 103-109 119 and 120 is/are pending in the application.
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`4a) Of the above c|aim(s)
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`is/are withdrawn from consideration.
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`5)I:I C|aim(s) j is/are allowed.
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`6)IXI C|aim(s) 78 83-97 103-109 119 and 120 is/are rejected.
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`7)I:I C|aim(s) j is/are objected to.
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`8)I:I C|aim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attach ment(s)
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`1) E Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper N0(S)/IVI3” Data E
`5) I:I Noiice Oi informal Paieiii Appiicaiion
`6) D Other:
`.
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`PTOL-326 (Rev. 08-06)
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`Office Action Summary
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`Part of Paper No./Mail Date 20090324
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`

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`Application/Control Number: 10/937,870
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`Page 2
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`Art Unit: 1618
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`DETAILED ACTION
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`Receipt is acknowledged of Applicant's Amendments and Request for Continued
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`Examination filed on 12/12/2008.
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`Claims 78, 103-109 and 119 have been amended.
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`Claims 1-77, 79-82, 98-102 and 110-118 have been cancelled.
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`Claims 78, 83-97, 103-109, 119 and 120 are pending in the instant application.
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`Continued Examination Under 37 CFR 1.114
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`1.
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`A request for continued examination under 37 CFR 1.114, including the fee set
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`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
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`application is eligible for continued examination under 37 CFR 1.114, and the fee set
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`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
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`has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on
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`12/12/2008 has been entered.
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`Specification
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`2.
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`The specification is objected to as failing to provide proper antecedent basis for
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`the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction
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`of the following is required: Claim 86 recites the cinacalcet HCl is in a form chosen from
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`needle-shaped particles, rod-shaped particles, plate-shaped particles, and mixture as
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`originally filed. The specification only discloses the cinacalcet HCI, the crystalline
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`powders can be in forms including polymorphs, psuedopolymorphs, crystal habits,
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`

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`Application/Control Number: 10/937,870
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`Page 3
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`Art Unit: 1618
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`micromeretics, and particle morphology. As such, the disclosure of the instant
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`specification is not sufficient to support the claimed cinacalcet HCI forms chosen from
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`needle—shaped particles, rod—shaped particles, plate—shaped particles, and mixtures.
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`Claim Rejections - 35 USC § 103
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`3.
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`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
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`obviousness rejections set forth in this Office action:
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`(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.
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`4.
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`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
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`USPQ 459 (1966), that are applied for establishing a background for determining
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`obviousness under 35 U.S.C. 103(a) are summarized as follows:
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`:'‘.°’!\’.—‘
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`Determining the scope and contents of the prior art.
`Ascertaining the differences between the prior art and the claims at issue.
`Resolving the level of ordinary skill in the pertinent art.
`Considering objective evidence present in the application indicating
`obviousness or nonobviousness.
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`5.
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`Claims 78, 83-97, 103-109 and 119-120 are rejected under 35 U.S.C. 103(a) as
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`being unpatentable over Van Wagenen et al (US 6,211,244 B1) as evidenced by
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`Kajiyama et al (US 6,656,492) in view of Creekmore et al (US 6,316,460 B1) and Hsu et
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`al (US 2005/0147670).
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`Van Wagenen discloses a pharmaceutical composition comprising inorganic ion
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`receptor—modulating compounds able to modulate the activity of an inorganic ion
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`receptor that will have beneficial effect (col. 5 lines 25-30). Compound is a calcimimetic
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`

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`Application/Control Number: 10/937,870
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`Page 4
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`Art Unit: 1618
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`(which would read on cinacalcet HCI) acting on a parathyroid cell calcium receptor and
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`reduces the level of parathyroid hormone in the serum of the patient and can be used to
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`treat diseases such as primary hyperparathryroidism and secondary
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`hyperparathyroidism (col. 6 lines 48-51 and col. 11 lines 30-53). Composition can also
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`be formulated as pharmaceutically acceptable salts such as hydrochloride and
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`composition further includes carrier or excipients like microcrystalline cellulose in about
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`15%; colloidal silicon dioxide in about 0.44 %; starch, various sugars to facilitate
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`administration of the compounds (col. 19 lines 44+ and col. 44 lines 15-25). Further,
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`composition can be formulated into conventional oral administration dosage forms such
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`as capsules, tablets and liquid preparations and generally, a therapeutically effective
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`amount is between about 1 nmole and 3 micro mole of the compound, preferably 0.01
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`and 20 mg/kg of the animal to be treated, which would read on from about 10% to about
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`40% by weight of cinacalcet HCI compound (col. 20 lines 32-41). Additional disclosure
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`includes that the pharmaceutical composition contains a sufficient amount of a calcium
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`receptor modulating compound in proper pharmaceutical form (which would read on
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`particulate or granular form) to exert a therapeutic effect on a human and also the
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`preparation of pharmaceutically acceptably salts can facilitate the pharmacological use
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`of a compound by altering its physical characteristics without preventing it from exerting
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`a physiological effect (col. 5 lines 32-47).
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`Note: Van Wagenen does not disclose cinacalcet HCl is in a form of amorphous
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`powders, crystalline particles (needle, rod, plate-shaped particles) or granules having
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`D50 ranging from about 50 microns to about 150 microns.
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`

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`Application/Control Number: 10/937,870
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`Page 5
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`Art Unit: 1618
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`However, Van Wagenen discloses the pharmaceutical composition in the tablet
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`form and tablets may be crushed or grind to obtain amorphous powders, granules, of
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`cinacalcet HCI. With limitation regarding particle size from about 50 pm to about 150
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`pm, as evidence by Kajiyama et al (US 6,656,492) the active agent of inferior fluidity
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`can have a crystal shape that is, for instance needle—shaped or plate shaped, wherein
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`the mean particle diameter of the plurality ofdrug—containing particles is approximately
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`50 pm to 150 um (col. 4 lines 52-55 and col. 6 lines 48-58). Examples of the drugs are
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`osteoporosis drugs, calcium homopantothenate drugs and the like (col. 6 and 7).
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`Van Wagenen fails to disclose required amounts of microcrystalline cellulose;
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`povidone; starch; crospovidone; magnesium stearate; color coating material; and
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`crospovidone is present intergranularly, intragranularly.
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`Creekmore discloses a pharmaceutical composition for oral administration
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`comprising active agent in about 2 to 15%; one or more fillers like microcrystalline
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`cellulose in an amount 30 to 90% by weight; one or more binders like starch in an
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`amount of 2 to 90% by weight; one or more disintegrates like polyvinylpyrrolidone
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`(povidone) in an amount 2 to 10% by weight; one or more lubricants like magnesium
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`stearate in an amount of 0.5 to 3% by weight (col. 2 and 3); coating material comprise
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`titanium dioxide and ferric oxides in an amount 1 to 6% by weight (col. 4 lines 5-7).
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`Hsu discloses a pharmaceutical dosage form (a particle, a tablet) comprising
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`active agent, a binder, a diluents and disintegrants to obtain the desired rapidly
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`disintegrating quality of the ODT formulation (0040). The binders like starch present in
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`about 10 to about 70% by weight (0047); diluents like microcrystalline cellulose present
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`

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`Application/Control Number: 10/937,870
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`Page 6
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`Art Unit: 1618
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`in an amount of up to about 70% (0049); disintegrants such as crospovidone in an
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`amount of about 0.1 % to about 10% by weight and the formulation contains both an
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`intragranular and an intergranular disintegrants (0051 and 0052). The tablet formulation
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`contains additional pharmaceutically acceptable carriers such as glidants, color agents
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`and the like (0054).
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`It would have been obvious to the person of ordinary skill in the art at the time the
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`invention was made to incorporate pharmaceutically acceptable carrier such as
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`microcrystalline cellulose; povidone; starch; crospovidone; magnesium stearate; color
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`coating material; and crospovidone is present intergranularly, intragranularly into
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`pharmaceutical composition as taught by Van Wagenen. The person of ordinary skill in
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`the art would have been motivated to make these modifications, because Van Wagenen
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`teaches that the pharmaceutical composition containing a sufficient amount of a calcium
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`receptor modulating compound (which would be a particulate or granular form),
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`preferably the pharmaceutical composition containing sufficient amount of a calcium
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`receptor modulating compound in a proper pharmaceutical form to exert a therapeutic
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`effect on a human. The person of ordinary skill in the art reasonably would have
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`expected success because Van Wagenen and cited reference teaches pharmaceutical
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`compositions that can be used in the same field of endeavor such as formulating the
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`composition into capsule, tablets to facilitate the pharmacological use of a compound by
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`altering its physical characteristics without preventing it from exerting a physiological
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`effect.
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`

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`Application/Control Number: 10/937,870
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`Page 7
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`Art Unit: 1618
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`The references do not specifically teach adding the ingredients in the amounts
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`claimed by Applicant. The amount of a specific ingredient in a composition is clearly a
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`result effective parameter that a person of ordinary skill in the art would routinely
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`optimize. Optimization of parameters is a routine practice that would be obvious for a
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`person of ordinary skill in the art to employ and reasonably would expect success. It
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`would have been customary for an artisan of ordinary skill to determine the optimal
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`amount of each ingredient to add in order to best achieve the desired results, such as
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`microcrystalline cellulose and starch are present in weight ration that may be used to
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`formulate the composition into tablets for oral administration. Thus, absent some
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`demonstration of unexpected results from the claimed parameters, this optimization of
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`ingredient amount would have been obvious at the time of Applicant's invention.
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`Conclusion
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`No claims are allowed at this time.
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`Any inquiry concerning this communication or earlier communications from the
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`1.
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`2.
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`examiner should be directed to JAGADISHWAR R. SAMALA whose telephone number
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`is (571 )272—9927. The examiner can normally be reached on 8.30 A.M to 5.00 P.M.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Michael G. Hartley can be reached on (571)272-0616. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`

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`Application/Control Number: 10/937,870
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`Page 8
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`Art Unit: 1618
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair—direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll—free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-’| 000.
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`/Jake M. Vu/
`Examiner, Art Unit 1618
`
`SJR
`
`Jagadishwar R Samala
`Examiner
`Art Unit 1618