UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`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
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`111520,479
`
`09/12/2006
`
`Neil P. Desai
`
`638772000109
`
`8972
`
`12/29/2010
`7590
`25226
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`
`LOVE, TREVOR M
`
`ART UNIT
`
`PAPER NUMBER
`
`1611
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/29/2010
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`EOfficeP A@ mofo.com
`drcaldwell@ mofo.com
`gpaulazzo@mofo.com
`
`PTOL-90A (Rev. 04/07)
`
`Actavis - IPR2017-01100, Ex. 1019, p. 1 of 15
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`

`

`Office Action Summary
`
`Application No.
`
`11/520,479
`
`Examiner
`
`Applicant(s)
`
`DESAI ET AL.
`
`Art Unit
`
`1611
`TREVOR M. LOVE
`-- The MAILING DATE 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 30 September 2010.
`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) 66-68 and 70-84 is/are pending in the application.
`4a) Of the above claim(s) 79-84 is/are withdrawn from consideration.
`5)0 Claim(s) __ is/are allowed.
`6)[8J Claim(s) 66-68 and 70-78 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.
`1 0)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) [8Jinformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 09/30/2010.
`
`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 Off1ce
`PTOL-326 (Rev. 08·06)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20101207
`
`Actavis - IPR2017-01100, Ex. 1019, p. 2 of 15
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`

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`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 2
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`DETAILED ACTION
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`Acknowledgement is made to Applicant's response filed 09/30/2010.
`
`Claims 66-68 and 70-84 are pending.
`
`Claims 79-84 remain withdrawn.
`
`Claims 66-68 and 70-78 are currently under consideration.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) submitted on 09/30/2010 has been
`
`considered except where references are lined through. It is noted that Applicant stated
`
`in a transmittal letter (09/30/201 0) that copies of the pending U.S. Patent Applications
`
`was not provided in conformity with the requirements under 37 CFR 1 .98, however, 37
`
`CFR 1.98 (a)(2)(iii) states that Applicant must provide a legible copy "For each cited
`
`pending unpublished U.S. application, the application specification including the claims,
`
`and any drawing of the application, or that portion of the application which caused it to
`
`be listed including any claims directed to that portion".
`
`Maintained Rejections
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of 35 U.S.C. 1 03(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 1 02 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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`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 3
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`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 1 03(a) are summarized as follows:
`
`1.
`2.
`3.
`4.
`
`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.
`
`This application currently names joint inventors. In considering patentability of
`
`the claims under 35 U.S.C. 1 03(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. 1 03(c) and potential 35 U.S.C. 1 02(e), (f) or (g)
`
`prior art under 35 U.S.C. 1 03(a).
`
`Claims 66-68 and 70-77 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Desai et al (U.S. Patent number 5,439,686, Patent issued Aug.
`
`8, 1995) in view of Shively (U.S. Patent number 5,407,683, Patent issued Apr. 18,
`
`1995).
`
`Desai teaches a pharmaceutical suspension comprising taxol (paclitaxel) and
`
`albumin (see example 4). Said taxol composition of example 4 comprises 13mg of taxol
`
`(2 mg/ml * 6.5ml) and 3ml of 5% human serum albumin (2.85ml water). Desai further
`
`teaches that a higher loading of taxol can be achieved by utilizing an additional solvent
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 4
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`such as ethyl acetate, which is removed. Said taxol suspension is taught as being
`
`protein walled polymeric shells enclosing an oil/taxol solution, said core is not taught as
`
`comprising a substantial amount of polymer. Desai teaches that the composition of
`
`Desai is stable for 27 days at temperatures of 4°C, 25°C, and 38°C (see example 5).
`
`Desai teaches that the crystalline taxol can be ground to a size less than 1 micron,
`
`which allows for intravenous delivery, wherein preferred particle radii for the invention of
`
`Desai are 0.1 to 5 microns (see column 6, lines 14-16). It is noted that the albumin is
`
`taught as being substantially crosslinked by way of disulfide bonds (see claim 1 ),
`
`wherein it is further noted that the remaining (free) albumin would necessarily associate
`
`with the taxol.
`
`Desai fails to directly teach that the concentration of taxol (paclitaxel) is 5 mg/ml.
`
`Shively teaches that "[f]or therapeutic use, emulsions containing between about
`
`0.5 and about 5 mg/ml taxol [ ... ] are[ ... ] administered orally or intravenously" (see
`
`column 9, lines 51-54).
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to utilize 5 mg/ml of taxol in the invention of Desai. One would
`
`have been motivated to do so since Shively teaches that 5 mg/ml is a therapeutically
`
`effective amount, wherein Desai directly teaches methods of obtaining "higher loading
`
`of drug". There would be a reasonable expectation of success since Desai teaches how
`
`to achieve higher amounts of taxol, and Desai teaches the amount (5 mg/ml) one would
`
`desire.
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 5
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`With regard to the limitation of instant claim 67 that the composition is a stable
`
`suspension reconstituted from a sterile lyophilized powder, since Applicant is claiming a
`
`product, wherein the instant final product and the final product of the prior art are
`
`substantially identical, the steps utilized to achieve said final product are not required to
`
`be the same. It is noted that MPEP 2112.01 states: "Where the claimed and prior art
`
`products are identical or substantially identical in structure or composition, or are
`
`produced by identical or substantially identical processes, a prima facie case of either
`
`anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195
`
`USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that
`
`the products of the applicant and the prior art are the same, the applicant has the
`
`burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d
`
`1655, 1658 (Fed. Cir. 1990)."
`
`With regard to the limitation of instant claim 70 that the average diameter of the
`
`nanoparticles is no greater than 220 nm, the preferred particle radii for the invention of
`
`Desai are 0.1 to 5 microns (1 00-5000 nm), which overlaps the instant range. Note that
`
`MPEP 2144.05 states: "In the case where the claimed ranges "overlap or lie inside
`
`ranges disclosed by the prior art" a prima facie case of obviousness exists. In re
`
`Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,
`
`16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d
`
`1362, 1365-66 (Fed. Cir. 1997).
`
`With regard to the features such as no precipitation of taxol or change in particle
`
`size for at least 3 days, since the products are the same, the features are also
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 6
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`necessarily present. It is noted that MPEP 2112 states: ""[T]he discovery of a
`
`previously unappreciated property of a prior art composition, or of a scientific
`
`explanation for the prior art's functioning, does not render the old composition
`
`patentably new to the discoverer." Atlas Powder Co. v. lreco Inc., 190 F.3d 1342, 1347,
`
`51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function,
`
`or unknown property which is inherently present in the prior art does not necessarily
`
`make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433
`
`(CCPA 1977)."
`
`Response to Arguments
`
`Applicant argues in the remarks filed 09/30/2010 that Shively is directed to an oil-
`
`in-water emulsion formulation of paclitaxel that is completely different from that of the
`
`instant invention. Applicant's argument is not found persuasive since Shively, as noted
`
`above, is relied upon for the teaching of the preferred therapeutic amount of taxol,
`
`wherein Desai provides motivation and methods for obtaining "higher loading of drug".
`
`Applicant further argues that the Examiner has taken the teachings of Desai out of
`
`context, namely the loading taught in Desai is directed to taxol in the protein shell (see
`
`Remarks, page 6, last paragraph). Applicant's argument is not found persuasive.
`
`Example 4 of Desai is directed to a composition comprising taxol, soybean oil, and
`
`albumin, said example directly states a method of how to arrive at "a higher loading of
`
`drug [taxol] into the crosslinked protein shell", this would result in a higher concentration
`
`of taxol being present, particularly in view of the additional solvent being removed.
`
`Further, Shively teaches a therapeutically effective amount of taxol includes 5 mg/ml,
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 7
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`therefore, one further has motivation to arrive specifically at 5 mg/ml. Therefore,
`
`Applicant's argument is not found persuasive. Applicant further argues that there is not
`
`a reasonable expectation for an albumin and taxol composition at a concentration of 5
`
`mg/ml. Applicant's argument is not found persuasive since as identified above, Desai
`
`teaches higher loading is not only taught but encouraged by Desai, for example, in
`
`example 4. Also, Shively teaches a known useful therapeutic amount, namely, 5 mg/ml.
`
`It is noted that MPEP 2143.02 states "[o]bviousness does not require absolute
`
`predictability, however, at least some degree of predictability is required. Evidence
`
`showing there was no reasonable expectation of success may support a conclusion of
`
`nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)".
`
`Applicant also points to the exhibit by Ron et al. Said exhibit is not found persuasive to
`
`overcome the instant rejection since Ron et al is comparing three compositions, only
`
`one of which comprises albumin, wherein both the instant claims and the art of record
`
`comprise albumin. It is further noted that example 5 of Desai teaches that the
`
`crosslinked albumin shells of Desai provide good stability under a variety of
`
`temperatures. Therefore, Applicant's arguments are not found persuasive.
`
`Claims 66-68 and 70-78 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over Desai et al (U.S. Patent number 5,439,686, Patent issued Aug.
`
`8, 1995) in view of Shively (U.S. Patent number 5,407,683, Patent issued Apr. 18,
`
`1995) as applied to claims 66-68 and 70-77, and further in view of Klein et al (U.S.
`
`Patent number 5,440,056, Patent issued Aug. 8, 1995).
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 8
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`The teachings of Desai and Shively are set forth above.
`
`Desai fails to directly teach that the taxol is in amorphous form.
`
`Klein is directed to chemotherapeutic compounds, specifically taxol compounds
`
`(see column 1, lines 13-18). Klein teaches "[i]n order to prolong the effect of a drug, it is
`
`often desirable to slow the absorption of the drug from the subcutaneous or
`
`intramuscular injection. This may be accomplished by the use of a liquid suspension of
`
`crystalline or amorphous material with poor water solubility" (see column 6, lines 54-58,
`
`emphasis added).
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to utilize the amorphous form in addition to the crystalline form of
`
`taxol in the invention of Desai. One would have been motivated to do so since Desai is
`
`already teaching the crystalline form, wherein Klein teaches that the amorphous form is
`
`also useful for prolonging the effect of the drug. There would be a reasonable
`
`expectation of success since combining two components which are taught in the art for
`
`the same purpose to arrive at a third composition useful for the same purpose is
`
`obvious. It is noted that MPEP 2144.05 states: ""It is prima facie obvious to combine
`
`two compositions each of which is taught by the prior art to be useful for the same
`
`purpose, in order to form a third composition to be used for the very same purpose ....
`
`[T]he idea of combining them flows logically from their having been individually taught in
`
`the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
`
`(citations omitted). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960);
`
`and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 9
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`Response to Arguments
`
`Applicant argues in the remarks filed 09/30/2010 that for the same reasons as
`
`identified above the instant rejection is improper. Further, Applicant argues that Klein
`
`does not cure the deficiencies of Desai and Shively. Applicant's arguments are not
`
`found persuasive for the reasons set forth above. Further, Applicant argues that Klein
`
`does not make it clear that paclitaxel is being utilized in crystalline or amorphous form in
`
`order to slow absorption of the drug. Applicant's argument is not found persuasive
`
`since Klein directly states "[i]n order to prolong the effect of a drug, it is often desirable
`
`to slow the absorption of the drug from the subcutaneous or intramuscular injection.
`
`This may be accomplished by the use of a liquid suspension of crystalline or amorphous
`
`material with poor water solubility" (see column 6, lines 54-58, emphasis added).
`
`Therefore, Klein is directly teaching that the slow absorption is caused by the use of
`
`crystalline or amorphous material. Therefore, Applicant's arguments are not found
`
`persuasive.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. A nonstatutory
`obviousness-type double patenting rejection is appropriate where the conflicting claims
`are not identical, but at least one examined application claim is not patentably distinct
`from the reference claim(s) because the examined application claim is either anticipated
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140
`F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29
`USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir.
`1985); In re VanOrnum, 686 F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 10
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`F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163
`USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`double patenting ground provided the conflicting application or patent either is shown to
`be commonly owned with this application, or claims an invention made as a result of
`activities undertaken within the scope of a joint research agreement.
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3.73(b).
`
`Claims 66-68 and 70-78 are rejected on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over U.S. Patent No.
`
`6,537,579 (claims 1-53); 5,362,478 (claims 1-16); 5,498,421 (claims 1-30); 5,505,932
`
`(claims 1-36); 5,508,021 (claims 1-23); 5,512,268 (claims 1-37); 5,635,207 (claims 1-
`
`44); 5,639,473 (claims 1-26); 5,650,156 (claims 1-9); 5,665,382 (claims 1-11);
`
`5,665,383 (claims 1-9); 5,916,596 (claims 1-31); 5,560,933 (claims 1-28); and
`
`5,439,686 (claims 1-17) in view of Desai et al (U.S. Patent number 5,439,686,
`
`Patent issued Aug. 8, 1995), Shively (U.S. Patent number 5,407,683, Patent issued
`
`Apr. 18, 1995), and Klein et al (U.S. Patent number 5,440,056, Patent issued Aug.
`
`8, 1995).
`
`Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other because the issued U.S. Patents either directly or indirectly recite
`
`compositions comprising taxol coated with albumin, wherein said albumin is crosslinked
`
`by disulfide bonds.
`
`Several of the above listed U.S. Patents fail to recite that the active is taxol
`
`(5,665,383; 5,665,382; 5,650, 156; 5,639,473; 5,635,207; 5,512,268; 5,508,021;
`
`5,505,932; 5,498,421; 5,362,478), however, it would have been obvious in view of
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 11
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`Desai and Shively not only to utilize taxol as the active, but also to utilize taxol in an
`
`amount of 5 mg/ml (see above discussion under 1 03).
`
`Two of the above identified U.S. Patents fail to recite that the protein is albumin
`
`(5,512,268; 5,650, 156), however, it would have been obvious in view of Desai to utilize
`
`albumin to coat the taxol.
`
`Several of the above listed U.S. Patents fail to recite specific limitations of the
`
`instant claims, such as directly specify whether the taxol is crystalline or amorphous
`
`(5,665,383; 5,665,382; 5,650, 156; 5,639,473; 5,635,207; 5,560,933; 5,512,268;
`
`5,508,021; 5,505,932; 5,498,421; 5,439,686; 5,362,478), however, it would have been
`
`obvious in view of Desai and Klein to utilize amorphous taxol (see above discussion
`
`under 1 03).
`
`Claims 66-68 and 70-78 are directed to an invention not patentably distinct from
`
`commonly assigned patent numbers 5,362,478 (claims 1-16); 5,498,421 (claims 1-30);
`
`5,505,932 (claims 1-36); 5,508,021 (claims 1-23); 5,512,268 (claims 1-37); 5,635,207
`
`(claims 1-44); 5,639,473 (claims 1-26); 5,650,156 (claims 1-9); 5,665,382 (claims 1-11 );
`
`5,665,383 (claims 1-9); 5,916,596 (claims 1-31 ); 5,560,933 (claims 1-28); and
`
`5,439,686 (claims 1-17).
`
`The U.S. Patent and Trademark Office normally will not institute an interference
`
`between applications or a patent and an application of common ownership (see MPEP
`
`Chapter 2300). Commonly assigned 5,362,478; 5,498,421; 5,505,932; 5,508,021;
`
`5,512,268; 5,635,207; 5,639,473; 5,650, 156; 5,665,382; 5,665,383; 5,916,596;
`
`5,560,933; and 5,439,686, discussed above, would form the basis for a rejection of the
`
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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 12
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`noted claims under 35 U.S.C. 1 03(a) if the commonly assigned case qualifies as prior
`
`art under 35 U.S.C. 1 02(e), (f) or (g) and the conflicting inventions were not commonly
`
`owned at the time the invention in this application was made. In order for the examiner
`
`to resolve this issue, the assignee can, under 35 U.S.C. 1 03(c) and 37 CFR 1.78(c),
`
`either show that the conflicting inventions were commonly owned at the time the
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`invention in this application was made, or name the prior inventor of the conflicting
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`subject matter.
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`A showing that the inventions were commonly owned at the time the invention in
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`this application was made will preclude a rejection under 35 U.S.C. 1 03(a) based upon
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`the commonly assigned case as a reference under 35 U.S.C. 1 02(f) or (g), or 35 U.S.C.
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`1 02(e) for applications pending on or after December 10, 2004.
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`Response to Arguments
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`Applicant argues in the remarks filed 09/30/2010 that for the reasons set forth
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`above directed to Desai and Shively, the instant rejection is improper. Applicant's
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`argument is not found persuasive since, as identified above, Applicant's arguments
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`directed to Desai and Shively above are not found persuasive.
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`Conclusion
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`No claims allowed. All claims rejected. No claims objected.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`Actavis - IPR2017-01100, Ex. 1019, p. 13 of 15
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`

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`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 13
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to TREVOR M. LOVE whose telephone number is
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`(571 )270-5259. The examiner can normally be reached on Monday-Thursday 7:30-
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`5:30.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Sharmila Landau can be reached on 571-272-0614. The fax phone number
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`for the organization where this application or proceeding is assigned is 571-273-8300.
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`Actavis - IPR2017-01100, Ex. 1019, p. 14 of 15
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`

`

`Application/Control Number: 11/520,479
`Art Unit: 1611
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`Page 14
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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 571-272-1000.
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`TL
`
`/David J Blanchard/
`Primary Examiner, Art Unit 1643
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`Actavis - IPR2017-01100, Ex. 1019, p. 15 of 15
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`