`
`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
`
`25226
`7590
`03/30/2010
`MORRISON & FOERSTER LLP
`755 PAGE MILL RD
`PALO ALTO, CA 94304-1018
`
`EXAMINER
`
`LOVE, TREVOR M
`
`ART UNIT
`
`PAPER NUMBER
`
`1611
`
`MAIL DATE
`
`DELIVERY MODE
`
`03/30/2010
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL-90A (Rev. 04/07)
`
`Actavis - IPR2017-01100, Ex. 1017, p. 1 of 13
`
`
`
`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 --
`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)[8J Responsive to communication(s) filed on 15 September 2009.
`2a)0 This action is FINAL.
`2b)[8J This action is non-final.
`3)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)[8J Claim(s) 66-68 and 70-84 is/are pending in the application.
`4a) Of the above claim(s) 79-94 is/are withdrawn from consideration.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.
`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) [8Jinformation Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 09/15/2009.
`
`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 20100324
`
`Actavis - IPR2017-01100, Ex. 1017, p. 2 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 2
`
`DETAILED ACTION
`
`Acknowledgement is made to Applicant's response filed 09/15/2009.
`
`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 09/15/2009 was filed
`
`after the mailing date of the Non-Final Rejection on 05/13/2009. The submission is in
`
`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
`
`statement is being considered by the examiner.
`
`Withdrawn Rejections
`
`The rejection of claims 66-68 and 70-76 under 1 03(a) as being unpatentable over
`
`Trissel (US Patent 5,681 ,846) in view of Yen (US Patent 5,725, 804) is withdrawn in
`
`view of the New Grounds of Rejection set forth below.
`
`The rejection of claims 77-78 under 1 03(a) as being unpatentable over Trissel
`
`(US Patent 5,681 ,846) in view of Yen (US Patent 5,725, 804) and further in view of
`
`Ueda et al. (US Patent 5,272, 171; already made of record) is withdrawn in view of the
`
`New Grounds of Rejection set forth below.
`
`The rejection of claims 66-68 and 70-78 on the ground of nonstatutory
`
`obviousness-type double patenting as being unpatentable over claims 1-14 and 17-19
`
`Actavis - IPR2017-01100, Ex. 1017, p. 3 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 3
`
`of US Patent 6,096,331, in view of Trissel (US Patent 5,681 ,846), and further in view of
`
`Yen (US Patent 5,725, 804) is withdrawn in view of the New Grounds of Rejection set
`
`forth below.
`
`The rejection of claims 66-68 and 70-76 on the ground of nonstatutory obvious
`
`double patenting as being unpatentable over claim 34 of US Patent 6,096,331, in view
`
`of Trissel (US Patent 5,681 ,846) and further in view of Yen (US Patent 5,725, 804) is
`
`withdrawn in view of the New Grounds of Rejection set forth below.
`
`The rejection of claims 77-78 on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over claim 34 of US Patent 6,096,331, in view
`
`of Trissel (US Patent 5,681 ,846), and further in view of Yen (US Patent 5,725, 804) and
`
`Ueda et al. (US Patent 5,272, 171) is withdrawn in view of the New Grounds of
`
`Rejection set forth below.
`
`New Grounds of Rejection
`
`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 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.
`
`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. 103(a) are summarized as follows:
`
`Actavis - IPR2017-01100, Ex. 1017, p. 4 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 4
`
`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
`
`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
`
`Actavis - IPR2017-01100, Ex. 1017, p. 5 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 5
`
`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.
`
`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
`
`Actavis - IPR2017-01100, Ex. 1017, p. 6 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 6
`
`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). 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
`
`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
`
`Actavis - IPR2017-01100, Ex. 1017, p. 7 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 7
`
`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)."
`
`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).
`
`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
`
`Actavis - IPR2017-01100, Ex. 1017, p. 8 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 8
`
`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).
`
`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
`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).
`
`Actavis - IPR2017-01100, Ex. 1017, p. 9 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 9
`
`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
`
`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.
`
`Actavis - IPR2017-01100, Ex. 1017, p. 10 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 10
`
`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; 5,639,4 73; 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
`
`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
`
`Actavis - IPR2017-01100, Ex. 1017, p. 11 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 11
`
`invention in this application was made, or name the prior inventor of the conflicting
`
`subject matter.
`
`A showing that the inventions were commonly owned at the time the invention in
`
`this application was made will preclude a rejection under 35 U.S.C. 1 03(a) based upon
`
`the commonly assigned case as a reference under 35 U.S.C. 1 02(f) or (g), or 35 U.S.C.
`
`1 02(e) for applications pending on or after December 10, 2004.
`
`Conclusion
`
`No claims allowed. All claims rejected. No claims objected.
`
`The prior art made of record and not relied upon is considered pertinent to
`
`applicant's disclosure: Liversidge et al (U.S. Patent number 5,399,363, Patent issued
`
`Mar. 21, 1995) (IDS reference). Liversidge teaches crystalline drugs such as taxol,
`
`coated with surface modifier, such as albumin, with an effective average particle size of
`
`less than 300nm.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to TREVOR M. LOVE whose telephone number is
`
`(571 )270-5259. The examiner can normally be reached on Monday-Thursday 7:30-
`
`5:30.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Sharmila Landau can be reached on 571-272-0614. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Actavis - IPR2017-01100, Ex. 1017, p. 12 of 13
`
`
`
`Application/Control Number: 11/520,479
`Art Unit: 1611
`
`Page 12
`
`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.
`
`TL
`
`/David J Blanchard/
`Primary Examiner, Art Unit 1643
`
`Actavis - IPR2017-01100, Ex. 1017, p. 13 of 13
`
`