Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`10/937,870
`
`Examiner
`
`LAWRENCE ET AL.
`
`Art Unit
`
`1618
`JAGADISHWAR R. SAMALA
`-- 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~ 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 04 February 2008.
`2a)[8J This action is FINAL.
`2b)0 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) 1.3-31.39.43.46.47.52-60.78-80.83-97 and 99 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`4a) Of the above claim(s) __ is/are withdrawn from consideration.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) 1.3-31.39.43.46.47.52-60.78-80.83-97 and 99 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) [8J 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 0910612005.
`
`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 20080408
`
`1375
`
`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 2
`
`DETAILED ACTION
`
`Status of Application
`
`1.
`
`Acknowledgement is made of the amendment filed on 02/04/2008. Upon entering
`
`the amendment, claims 1, 3, 12, 60 and 99 are amended and claim 2 is cancelled. The
`
`pending claims are 1, 3-31, 39, 43, 46-47, 52-60, 78-80, 83-97 and 99 and presented
`
`for examination.
`
`Previous rejections that are not reiterated herein are withdrawn.
`
`Claim Rejections - 35 USC § 102
`
`1.
`
`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.
`
`2.
`
`Claims 1-5, 7-11 and 18 are rejected under 35 U.S.C. 102(b) as being
`
`anticipated by Nemeth et al. (US 6,031,003).
`
`With respect to claims 1-5 and 7-11, Nemeth discloses pharmaceutical
`
`composition and use of molecules able to modulate the activity of an inorganic ion
`
`receptor, preferably a calcium receptor (see cool 1, lines 26-29). And also, the inorganic
`
`ion receptor-modulating agents include ionomimetics, ionolyitcs, calcimimetics, and
`
`calcilytics. Preferably, calcimimetics are ionomimetics, which affect one or more calcium
`
`receptor activities and bind to a calcium receptor (see col. 5, line 48-56). Further, the
`
`molecule is a substituted R-phenypropyl-of- phenethylamine derivative, or a substituted
`
`1376
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`

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`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 3
`
`R-benzyl-ot-phenethylamine derivate, having the structure as recited in claim 4 (see col
`
`8, line 21-40). And also the molecule, calcimimetic or calcilytic having an ECsO or IC 50
`
`at a calcium receptor of less than or equal to 5 µM, preferably less than or equal to 1
`
`µM, 100 nmolar, 10 nmolar, or 1 nmolar (see col 8, lines 58-65). And also, the agents
`
`can be formulated as pharmaceutically acceptable salts such as hydrochlorides,
`
`acetate, citrate, methanesulfonate, ethanesulfonate and the like (see col. 62, lines 28-
`
`32). And also, to facilitate administration of the agent, composition includes carriers and
`
`excipients such as calcium phosphate, various sugars, cellulose derivatives, vegetable
`
`oils, and physiologically compatible solvents (see col, 62, lines 47-53). And for oral
`
`administration, the agents are formulated into conventional oral administration dosage
`
`forms such as capsules, tablets, and liquid preparations (see col 63, lines 8-10).
`
`With respect to claims 1 and 7-11, it is the examiner's position that, inherently,
`
`the composition advanced by Nemeth provides pharmaceutically acceptable salts of
`
`various concentrations to facilitate the pharmacological use by altering the physical
`
`characteristic of the agent without preventing it from exerting its physiological effect.
`
`Since the essential elements of the Nemeth composition are identical to the instant
`
`compositions (that is, excipients like cellulose derivatives, starch, oral dosage forms
`
`such as capsules, tablets and further modulation of calcium receptor activity can be
`
`used to treat diseases such as primary hyperparathyroidism and Secondary
`
`hyperparathyroidismO, the composition would inherently have the same physiochemical
`
`properties (e.g. dissolution profile) as the composition set forth in the instant application.
`
`1377
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`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 4
`
`As such, it is the examiner's position that the composition advanced by Nemeth
`
`anticipates the composition enumerated in the instant claim set.
`
`3.
`
`Claims 12, 23-29 are rejected under 35 U .S.C. 102(b) as being anticipated by
`
`William G.Goodman et al. (J. Am: Soc. Nephrology 13, 1017-1024, 2002).
`
`Goodman discloses calcimimetic agents such as AMG 073 agent (cinacalcet
`
`HC1) for lowering the plasma parathyroid hormone levels in hemodialysis patients
`
`suffering from secondary hyperparathyroidism due to ESRD (see abstract). And also,
`
`repeated daily orally administered doses of the calcimimetic agent AMG 073 effectively
`
`reduce plasma PTH levels, decrease serum phosphorus concentrations, and lower the
`
`calcium-phosphorus ion product in hemodialysis patients with secondary
`
`hyperparathyroidism (see page 1023). The bioavailability of AMG 073 after oral
`
`administration is greater and it exhibits a more consistent pharmacokinetic profile.
`
`Cinacalcet HC1 has demonstrated efficacy in controlling the hypercalcemia of severe
`
`primary HPT and in reducing parathyroid hormone levels in patient with secondary HPT
`
`Since all critical elements as required by instant claims are taught by the cited reference
`
`and claims are anticipated.
`
`Applicant's arguments filed on 02/04/2008 have been fully considered but they
`
`are not persuasive.
`
`Applicant asserts that Nemeth and William G. Goodman's reference does not
`
`disclose pharmaceutical composition having a dissolution profile.
`
`This is found not persuasive because, firstly the claims are directed to a
`
`composition comprising and any composition comprising the active ingredients recited
`
`1378
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`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 5
`
`in the claims will inherently meet that composition. Therefore the composition advanced
`
`by Nemeth reference provides pharmaceutically acceptable salts of (calcimimetics and
`
`calcilytics) various concentrations to facilitate the pharmacological use by altering the
`
`physical characteristic of the agent without preventing it from exerting its physiological
`
`effect. Since the essential elements of the Nemeth composition are identical to the
`
`instant compositions (that is, active agent, excipients like cellulose derivatives, starch,
`
`oral dosage forms such as capsules, tablets and further modulation of calcium receptor
`
`activity can be used to treat diseases such as primary hyperparathyroidism and
`
`secondary hyperparathyroidism, the composition would inherently have the same
`
`physiochemical properties (e.g. dissolution profile for releasing the calcimimetic
`
`compound or calcilytic compound from the composition) as the composition set forth in
`
`the instant application. And also, it is known in the art that a pharmaceutical salt exhibits
`
`a higher dissolution rate than the corresponding conjugate acid or base at an equal pH,
`
`even though they may have the same equilibrium solubility. Salts often speed
`
`dissolution by effectively acting as their own buffers to alter the pH of the diffusion layer,
`
`thus increasing the solubility of the parent compound in that layer over its inherent
`
`solubility at the pH of the dissolution medium.
`
`Claim Rejections - 35 USC§ 103
`
`4.
`
`The following is a quotation of 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.
`
`1379
`
`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 6
`
`This application currently names joint inventors. In considering patentability of the
`
`claims under 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`5.
`
`Claims 1-31, 39, 43, 46-4 7, 52-60, 78-80, 83-97 and 99 are rejected under 35
`
`U.S.C.103(a) as being unpatentable over William G. Goodman et al. (J. Am. Soc.
`
`Nephrology 13,1017-1024, 2002) in view of Ault et al (US 2002/0123459) or Black et al.
`
`(US 2001/0051636) or Krumhar et al. (US 6,447,80
`
`Goodman discloses as described above.
`
`Goodman meets the claim limitations as described above but fails in include the
`
`granules within the composition comprising microcrystalline cellulose, a lubricant, and a
`
`color coating materials.
`
`However, it would have been obvious to one of ordinary skill in the art at that time
`
`of the invention was made to incorporate additional additives such as microcrystalline
`
`cellulose, a lubricant, a Color coating materials to increase the therapeutic efficacy
`
`when Goodman is taken in view of Ault or Black and Krumhar together teach a
`
`enhancement of therapeutic efficacy when a combination of pharmacologically active
`
`agents, and to methods of treating and/or preventing diseases particularly
`
`1380
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`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 7
`
`osteomalacia, hypercalcemia of malignancy, osteopenia due to bone metastases arid
`
`hyperparathyroidism (all of these conditions are characterized by bone loss, resulting
`
`from an imbalance between the degradation of bone resorption and the formation of
`
`new healthy bone) is used to increase the calcium receptor-activity where calcimimetic
`
`compounds has undergone thru very same mechanism for the treatment of primary and
`
`secondary hyperparathyroid ism.
`
`6.
`
`Ault discloses a pharmaceutical composition suitable for the oral delivery of
`
`calcitonin in an effective amount commonly employed in the treatment of e.g. paget's
`
`disease; hypercalcemia and postmenopausal osteoporosis (see abstract and 0023).
`
`And composition additionally comprises excipients, diluents such as microcrystalline
`
`cellulose, a lubricant such as magnesium stearate, a colorant, humectants, surfactant or
`
`any combination thereof (see 0048).
`
`7.
`
`Black discloses a pharmaceutical compositions comprising administering a
`
`pharmaceutically active agent, with a bisphosphonate in the treatment of paget's
`
`disease, osteohalisteresis, osteomalacia hypercalcemia of malignancy, osteopenia due
`
`to bone metastases, periodontal diseases, and hyperparathyroidism (see 0001 ). And
`
`also, the compounds are preferably employed in the form of tablets, granules, pills,
`
`powders lozenges, sachets elixirs, emulsions, solutions and soft and hard gelatin
`
`capsules. (see 0110). The composition further includes suitable carriers, lubricants,
`
`diluents, and excipients such as microcrystalline cellulose, talc, magnesium stearate
`
`and thereof (see 0111 ). And also, compositions are preferably formulated in a unit
`
`1381
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`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 8
`
`dosage form, each dosage containing from about 1 to 500 mg of the active ingredient
`
`(see 0113).
`
`8.
`
`Krumhar discloses a composition for use as a dietary supplements that, when
`
`ingested, will reduce bone turnover rate by inhibiting bone resorption while increasing
`
`the retention of calcium, phosphorus, and potassium in the human body (see col 4, lines
`
`30-42). And further, the composition is used for treatment of osteoporosis, paget's
`
`disease, and hyperparathyroidism- conditions of high bone turnover (see col 10, lines
`
`26-30). And further, the composition comprising active ingredient are preferably
`
`employed in the form of tablets containing additional excipients and additives, diluents
`
`and disintegrant such as microcrystalline cellulose (disintegrants are substance that
`
`facilitate the breakup or disintegration of tablet after administration, see col 9, line 23-
`
`29), a lubricant such as talc, magnesium stearate, calcium stearate, stearic acid and
`
`hydrogenated vegetable oils (see col 8, lines 56-64 ), coloring agents (any of the
`
`approved certified water-soluble FD&C dyes, mixtures thereof, see c01 9, lines 8-15) ..
`
`When these references are taken together, one would have been motivated to extend
`
`Goodman's teaching to add additional additives such as microcrystalline cellulose, a
`
`lubricant, a color coating materials to maximize therapeutic efficacy. As suggested by
`
`cited references, one would have reasonably expected successful addition of secondary
`
`ingredients (such as microcrystalline cellulose, a lubricant, a color coating materials)
`
`because the effectiveness, extra benefits (i.e., bone resorption) and safety are already
`
`well proven and are well suggested by latter references cited.
`
`1382
`
`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 9
`
`One would have been motivated to do so, with reasonable expectation of
`
`success because it is always desirable to have extended therapeutic modalities to
`
`improve patient's compliance by enhancing patient satisfaction and increasing the
`
`selection option. The techniques and skills required for making such substitution is
`
`conventional knowledge or well within the skills of ordinary artisan as evidenced by
`
`these references cited.
`
`The daily dosages are well suggested and minor variations (dissolution profile)
`
`can be easily titrated and obtained in order to determine best outcomes, and it is
`
`considered to be routine practice especially having dosage suggestions by Goodman
`
`work. Said difference would not render the claimed invention patentably distinct, it is
`
`obvious because the modification is well within the skilled level of the artisan and
`
`considered to be a routine optimization commonly practiced in the art, as evidenced by
`
`cited references.
`
`One would have been motivated to combine these references and make the
`
`modification because they are drawn to same technical fields (constituted with same
`
`ingredients and share common utilities, and pertinent to the problem which applicant
`
`concerns about. MPEP 2141.01 (a).
`
`Applicant's arguments filed on 02/04/2008 have been fully considered but they
`
`are not persuasive.
`
`Applicant asserts that Goodman et al, in view of Ault, black nor krumhar does not
`
`teach a composition comprising a calcimimetic or a calcilytic compound.
`
`1383
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`

`

`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 10
`
`This argument is not persuasive since this reference is combined for its teaching
`
`of knowledge in the art to provide a combination pharmaceutical formulation and salts,
`
`and also a composition for use as a dietary supplement that benefits human bone
`
`health with oral administration. And the preferred pharmacologically active agent is
`
`pharmacologically active peptide, particularly calcitonin having pharmaceutical utility
`
`and commonly employed in the treatment of e.g. Paget's disease, hypercalcemia and
`
`postmenopausal osteoporosis.
`
`Conclusion
`
`No claims are allowed at this time.
`
`THIS ACTION 15 MADE FINAL. Applicant is reminded of the extension of time
`
`1.
`
`2.
`
`policy as set forth in 37 CFR 1.136(a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`
`MONTHS from the mailing date of this action. In the event a first reply is filed within
`
`TWO MONTHS of the mailing date of this final action and the advisory action is not
`
`mailed until after the end of the THREE-MONTH shortened statutory period, then the
`
`shortened statutory period will expire on the date the advisory action is mailed, and any
`
`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
`
`the advisory action. In no event, however, will the statutory period for reply expire later
`
`than SIX MONTHS from the mailing date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to JAGADISHWAR R. SAMALA whose telephone number
`
`is (571 )272-9927. The examiner can normally be reached on 8.30 A.M to 5.00 P.M.
`
`1384
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`

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`Application/Control Number: 10/937,870
`Art Unit: 1618
`
`Page 11
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Michael G. Hartley can be reached on (571 )272-0616. 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 Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Michael G. Hartley/
`Supervisory Patent Examiner, Art Unit 1618
`
`Jagadishwar R Samala
`Examiner
`Art Un it 1 618
`
`sjr
`
`1385
`
`

`

`Notice of References Cited
`
`Application/Control No.
`
`10/937,870
`
`Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`LAWRENCE ET AL.
`
`Art Unit
`
`*
`*
`*
`*
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`U.S. PATENT DOCUMENTS
`
`Name
`
`JAGADISHWAR R. SAMALA
`
`1618
`
`02-2000
`
`Nemeth et al.
`
`09-2002
`
`Ault et al.
`
`12-2001
`
`Black et al.
`
`09-2002
`
`Krumhar et al.
`
`A US-6,031,003
`US-2002/0123459
`B
`c US-2001/0051636
`D US-6,44 7,809
`E US-
`US-
`
`F
`G US-
`US-
`
`H
`
`Page 1 of 1
`
`Classification
`
`514/579
`
`514/2
`
`514/320
`
`424/602
`
`I
`
`J
`
`K
`
`US-
`
`US-
`
`US-
`
`US-
`
`L
`M US-
`
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Country
`
`Name
`
`Classification
`
`FOREIGN PATENT DOCUMENTS
`
`N
`
`0
`
`p
`
`Q
`
`R
`s
`T
`
`NON-PATENT DOCUMENTS
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`William G Goodman, Gerald A. Hladik, Stewar A. Turner, Peter W. Blaisdell, David A. Goodkin, Wei Liu, Yousir M. Barri,
`u Raphael M Cohen and jack W. Coburn, The Calcimimetic Agent AMG 073 Lowers Plasma parathryoid Hormone levels in
`Hemodialysis patients with secondary hyperparathyroidism, J. Am. Soc. Nephrology, 13, 1017-1024, 2002.
`
`*
`
`*
`
`v
`
`w
`
`x
`
`*A copy of this reference 1s not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`
`U.S. Patent and Trademark Office
`PT0-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20080408
`
`1386
`
`

`

`Application/Control No.
`
`Search Notes
`
`10937870
`
`Examiner
`
`JAGADISHWAR R SAMALA
`
`SEARCHED
`
`Class
`514
`
`I
`Subclass
`I 167; 168; 307; 320;456
`
`Search Notes
`East search and Inventors name search
`
`SEARCH NOTES
`
`Class
`
`I
`I
`
`INTERFERENCE SEARCH
`
`Subclass
`
`Applicant(s)/Patent Under
`Reexamination
`
`LAWRENCE ET AL.
`
`Art Unit
`
`1618
`
`I
`I
`
`I
`I
`
`I
`I
`
`Date
`7/17/2007
`
`I Examiner
`I sjr
`
`Date
`07/17/2007
`
`I Examiner
`I sjr
`
`Date
`
`I Examiner
`I
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20080408
`
`1387
`
`

`

`Index of Claims
`
`Application/Control No.
`
`10937870
`
`Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`
`LAWRENCE ET AL.
`
`Art Unit
`
`JAGADISHWAR R SAMALA
`
`1618
`
`Rejected
`
`Cancelled
`
`N Non-Elected
`
`=
`
`Allowed
`
`Restricted
`
`Interference
`
`A
`
`0
`
`Appeal
`
`Objected
`
`D Claims renumbered in the same order as presented by applicant
`
`D CPA
`
`D T.D.
`
`D R.1.47
`
`CLAIM
`Final
`Original
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`26
`27
`28
`29
`30
`31
`32
`33
`34
`35
`36
`
`0410812008
`,/
`
`DATE
`
`-
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`N
`N
`N
`
`N
`N
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20080408
`
`1388
`
`

`

`Index of Claims
`
`Application/Control No.
`
`10937870
`
`Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`
`LAWRENCE ET AL.
`
`Art Unit
`
`JAGADISHWAR R SAMALA
`
`1618
`
`Rejected
`
`Cancelled
`
`N Non-Elected
`
`=
`
`Allowed
`
`Restricted
`
`Interference
`
`A
`
`0
`
`Appeal
`
`Objected
`
`D Claims renumbered in the same order as presented by applicant
`
`D CPA
`
`D T.D.
`
`D R.1.47
`
`CLAIM
`Final
`Original
`37
`38
`39
`40
`41
`42
`43
`44
`45
`46
`47
`48
`49
`50
`51
`52
`53
`54
`55
`56
`57
`58
`59
`60
`61
`62
`63
`64
`65
`66
`67
`68
`69
`70
`71
`72
`
`DATE
`
`0410812008
`N
`N
`,/
`
`N
`N
`N
`,/
`
`N
`N
`,/
`
`,/
`
`N
`N
`N
`N
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`N
`N
`
`N
`N
`N
`N
`N
`N
`N
`N
`
`N
`N
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20080408
`
`1389
`
`

`

`Index of Claims
`
`Application/Control No.
`
`10937870
`
`Examiner
`
`Applicant(s)/Patent Under
`Reexamination
`
`LAWRENCE ET AL.
`
`Art Unit
`
`JAGADISHWAR R SAMALA
`
`1618
`
`Rejected
`
`Cancelled
`
`N Non-Elected
`
`=
`
`Allowed
`
`Restricted
`
`Interference
`
`A
`
`0
`
`Appeal
`
`Objected
`
`D Claims renumbered in the same order as presented by applicant
`
`D CPA
`
`D T.D.
`
`D R.1.47
`
`CLAIM
`Final
`Original
`73
`74
`75
`76
`77
`78
`79
`80
`81
`82
`83
`84
`85
`86
`87
`88
`89
`90
`91
`92
`93
`94
`95
`96
`97
`98
`99
`
`0410812008
`N
`N
`
`DATE
`
`N
`N
`N
`,/
`
`,/
`
`,/
`
`N
`N
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`,/
`
`N
`,/
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20080408
`
`1390
`
`

`

`BIB DATA SHEET
`
`Page 1 of 1
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`CONFIRMATION N0.1696
`
`SERIAL NUMBER
`
`10/937,870
`
`FILING or 371 (c)
`DATE
`09/10/2004
`RULE
`
`CLASS
`
`514
`
`GROUP ART UNIT ATTORNEY DOCKET
`NO.
`1618
`A-870-US-NP
`
`APPLICANTS
`Glen Gary Lawrence, Thousand Oaks, CA;
`Francisco J. Alvarez, Newbury Park, CA;
`Hung-Ren H. Lin, Oak Park, CA;
`Tzuchi R. Ju, Vernon Hills, IL;
`** CONTINUING DATA *************************
`This appln claims benefit of 60/502,219 09/12/2003
`** FOREIGN APPLICATIONS *************************
`** IF REQUIRED, FOREIGN FILING LICENSE GRANTED **
`11/01/2004
`
`Foreign Priority claimed
`
`Oves ~No
`35 USC 119(a-d) conditions met 0 Yes ~No O Metafter
`
`Allowance
`
`STATE OR
`COUNTRY
`
`SHEETS
`DRAWINGS
`
`TOTAL
`CLAIMS
`
`INDEPENDENT
`CLAIMS
`
`CA
`
`0
`
`118
`
`11
`
`Verified and
`
`/JAGADISHWAR RAO
`SAM ALA/
`Examiner's Signature
`
`Initials
`
`Acknowledged
`ADDRESS
`AMGEN INC.
`1120 VETERANS BOULEVARD
`SOUTH SAN FRANCISCO, CA 94080
`UNITED STATES
`TITLE
`Rapid dissolution formulation of a calcium receptor-active compound
`
`FEES: Authority has been given in Paper
`FILING FEE
`to charge/credit DEPOSIT ACCOUNT
`RECEIVED No.
`No.
`for following:
`7420
`
`D All Fees
`D 1.16 Fees (Filing)
`D 1.17 Fees (Processing Ext. of time)
`D 1.18 Fees (Issue)
`D Other
`D Credit
`
`BIB (Rev. 05/07).
`
`1391
`
`

`

`EAST Search History
`
`EAST Search History
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`file:///Cl/Documents%20and%20Settings/jsarnala/My%20Do ... 7870/EASTSearchHistory.10937870_Accessible Version.htm (1 of 8)4/8/2008 6:00:4 7 PM
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`file:///Cl/Documents%20and%20Settings/jsarnala/My%20Do ... 7870/EASTSearchHistory.10937870_Accessible Version.htm (7 of 8)4/8/2008 6:00:4 7 PM
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`1398
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`EAST Search History
`
`4/ 8/ 2008 6:00:41 PM
`C:\ Documents and Settings\jsamala\ My Documents\ EAST\ Workspaces\ 10937870.wsp
`
`file:///Cl/Documents%20and%20Settings/jsarnala/My%20Do ... 7870/EASTSearchHistory.10937870_Accessible Version.htm (8 of 8)4/8/2008 6:00:4 7 PM
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`

`Atty. Docket No.
`
`Applicant
`
`Filing Date
`
`A-870 <US)
`
`Sheet
`Serial No.
`
`Of
`
`3
`
`10/937.870
`
`GLEN LAWRENCE ET AL.
`Group
`
`Sept. 10, 2004
`U.S. PATENT DOCUMENTS
`NAME
`DATE
`
`1614
`
`CLASS
`
`SUB-
`CLASS
`
`FILING DATE IF
`APPROPRIATE
`
`6/30/1992
`
`11/9/1999
`
`12/14/1999
`
`1/4/2000
`
`2/29/2000
`
`1/9/2001
`
`4/3/2001
`
`5/8/2001
`
`8/21/2001
`
`11/6/2001
`
`1/29/2002
`
`3/26/2002
`
`5/14/2002
`
`6/4/2002
`
`8/13/2002
`
`12/17/2002
`
`21712002
`
`8/8/2002
`
`2/20/2003
`
`3/20/2003
`
`Evenstad et al.
`
`Moe et al.
`
`Nemeth et al.
`
`Nemeth et al.
`
`Nemeth et al.
`
`Cohen et al.
`
`Van Wagenen et al.
`
`Kuchikata et al.
`
`Wright
`
`Van Wagenen et al.
`
`Moe et al.
`
`Manzer et al.
`
`Oshlack et al.
`
`Clancy et al.
`
`Del Mar et al.
`
`Thosar et al.
`
`Hedden et al.
`
`Sakai et al.
`
`Shanghvi et al.
`
`Lemmens et al.
`
`Modified Form PT0-144
`
`NCES Cl
`"~oaA~
`(Use severa s eets if necessary)
`
`DOCUMENT NUMBER
`
`5,126,145
`
`5,981,599
`
`6,001,884
`
`6,011,068
`
`. 6,031,003
`
`6,172,091
`
`6,211,244
`
`6,228,807
`
`6,277,788
`
`6,313,146
`
`6,342,532
`
`6,363,231
`
`6,387,404
`
`6,399,100
`
`6,432,656
`
`6,495,165
`
`2002/0015735
`
`2002/0107406
`
`2003/0035836
`
`2003/0054041
`
`EXAMINER'S
`INITIALS
`/JS/
`
`A1
`
`A2
`
`A3
`
`A4
`
`A5
`
`A6
`
`A7
`
`A8
`
`A9
`
`A10
`
`A11
`
`A12
`
`A13
`
`A14
`
`A15
`
`A16
`
`A17
`
`A18
`
`A19
`
`\ I/
`!JE I A20
`
`EXAMINER:
`
`EXAMINER: Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in conformance and not considered. Include copy of this form with next
`communication to applicant.
`
`1400
`
`

`

`Modified Form PT0-1449
`
`LIST OF REFERENCES CITED BY APPLICANT
`
`Ally. Docket No.
`
`Applicant
`
`Filing Date
`
`A-870 <US)
`
`Sheet
`
`I Serial No.
`
`2 Of
`
`3
`
`10/937.870
`
`GLEN LA WREN CE ET AL.
`I Group
`
`1614
`
`CLASS
`
`sue.
`CLASS
`
`TRANSLATION
`YES
`NO
`
`(Use several sheets if necessary)
`
`EXAMINER'
`INITIALS
`/JS/
`
`\ I/
`/JS/
`
`81
`
`82
`83
`84
`85
`86
`87
`
`DOCUMENT NUMBER
`
`WO 93/04373
`
`WO 94/18959
`
`WO 95/11221
`
`WO 96/12697
`
`WO 97/41090
`
`WO 01/34562
`
`EP 0 933 354
`
`Sept. 10, 2004
`FOREIGN PATENT DOCUMENTS
`COUNTRY
`DATE
`
`3/4/1993
`
`9/1/1994
`
`4/27/1995
`
`5/2/1996
`
`11/6/1997
`
`5/17/2001
`
`8/4/1999
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`PCT
`
`EUROPE
`
`EXAMINER:
`
`Date Considered:
`/Jagadistwvar Samala/ ( )7/i 8/200?)
`
`EXAMINER: Initial if citation considered, whether or not citation is in conformance with MPEP 609; Draw line through citation if not in conformance and not considered. Include copy of this form with next
`communication to applicant.
`A-25b (Rev. 07/01/03)
`
`1401
`
`

`

`·~·
`Modified Form PT0-1449
`
`LIST OF REFERENCES CITED BY APPLICANT
`
`(Use several sheets if necessary)
`
`Atty. Docket No.
`
`Applicant
`
`Filing Date
`
`A-870 <US)
`
`Sheet
`
`I Serial No.
`
`3 Of
`
`3
`
`10/937.870
`
`GLEN LAWRENCE ET AL.
`I Group
`
`Sept. 10, 2004
`
`1614
`
`EXAMINER'S
`INITIALS
`
`/JS/
`
`\ I
`/JS/
`
`C1
`
`C2
`
`C3
`
`C4
`
`cs
`
`C6
`
`C7
`
`CB
`
`C9
`
`OTHER DOCUMENTS (Including Publisher, Author, Title, Date, Pertinent Pages, Etc.)
`Amgen News Release, Internet Article: "Amge·n Submitted New Drug Application for
`Cinecalcet HC1", XP002313388, U~://www.amgen.com/news/news03/press
`Release030908a.odf, September 8,
`2 pages.
`Berge, Step~ et al., "Pharmaceutical Salts," J. Pharm. Sci., Vol. 66, No. 1, pp. 1-
`19, January 1977
`Drugs in R&D, "Cinecalcet: AMG 073, Calcimimetics - Amgen/NPS Pharmaceuticals,
`KRN 1493, NPS 1493," Vol. 4, No. 6, pp 349-351,~
`Goodman, William G., et al., "The Calcimimetic Agent AMG 073 Lowers Plasma
`Parathyroid Hormone Levels in Hemodialysis Patients with Secondary
`-
`Hyperparathyroidism," J. Am. Soc. Nephrol, Vol. 13, pp. 1017-1024, Aprill20o2.'\
`Nemeth, Edward F., et al., "Pharmacodynamics of the Type II Calcimimetic Compound
`CinacalceiJ:l.CI, J. Pharmaco/. Exp Therapeutics, Vol. 308, No. 2, pp. 627-635,
`Februar/2004~
`Pattaragarn, Anirut, et al., "Effect of the Calcimimetic NPS R-467 on Furosemide-
`lndu~~rocalcinosis in the Young Rat," Kidney lnternationa, Vol. 65, pp. 1684-
`1689, 004.
`,.
`U.S. Foocrarld Drug Administration, Internet Article: "FDA Approves First in a New
`Class of Drugs to Treat Hyperparathyroidism Associated with Renal Failure and in
`Patients with Parathyroid Cancer, " FDA Talk Paper, XP-002313389,
`http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01282.html), March 8,@i
`page, (retrieved by EPO Searching Authority on 1/11/2005).
`Rxlist, Inc., Internet Article: "Sensipar (Cinacalcet HCI) Tablets," XP-002313390,
`www.rxlist.com/cgi/gen