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
`
`12/424,367
`
`04/15/2009
`
`Edward Yaworski
`
`ATTORNEY DOCKET NO.
`020801-00771 ous
`
`CONFIRMATION NO.
`
`1406
`
`20350
`7590
`07/30/2010
`TOWNSEND AND TOWNSEND AND CREW, LLP
`TWO EMBARCADERO CEN1ER
`EIGHTH FLOOR
`SAN FRANCISCO, CA 94111-3834
`
`EXAMINER
`
`PITRAK, JENNIFER S
`
`ART UNIT
`
`PAPER NUMBER
`
`1635
`
`MAIL DATE
`
`DELIVERY MODE
`
`07/30/2010
`
`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)
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`Office Action Summary
`
`Application No.
`
`Applicant(s)
`
`12/424,367
`
`Examiner
`
`YAWORSKI ET AL.
`
`Art Unit
`
`1635
`JENNIFER PITRAK
`-- 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 )IZ! Responsive to communication(s) filed on 01 June 2010.
`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) 1-5.9. 14.17-26.38.47.48 and 55 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) 1-5.9. 14.17-26.38.47.48 and 55 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 6/8/10.
`
`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 20100721
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`Application/Control Number: 12/424,367
`Art Unit: 1635
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`Page2
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`DETAILED ACTION
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`Election/Restrictions
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`The requirement for election of species presented in the Office Action mailed 3/31/2010
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`has been withdrawn. Upon further consideration, the species are deemed to be patentably
`
`indistinct.
`
`Claims 1-5, 9, 14, 17-26, 38, 47, 48, and 55 are pending and are under examination.
`
`Priority
`
`Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119( e) or
`
`under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or
`
`more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
`
`The later-filed application must be an application for a patent for an invention which is also
`
`disclosed in the prior application (the parent or original nonprovisional application or provisional
`
`application). The disclosure of the invention in the parent application and in the later-filed
`
`application must be sufficient to comply with the requirements of the first paragraph of 35
`
`U.S.C. 112. See Transco Products, Inc. v. Peiformance Contracting, Inc., 38 F.3d 551, 32
`
`USPQ2d 1077 (Fed. Cir. 1994).
`
`The disclosure of the prior-filed application, Application No. 61/045228, fails to provide
`
`adequate support or enablement in the manner provided by the first paragraph of 35 U.S. C. 112
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`Application/Control Number: 12/424,367
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`for one or more claims of this application. Application No. 61/046228 does not provide
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`adequate support for claim 55. Therefore, claim 55 is afforded the benefit of the instant filing
`
`date, 04/15/2009.
`
`Claim Rejections- 35 USC§ 103
`
`The following is a quotation of35 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 ofthis 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.
`
`MacLachlan, et al. (US 2006/0008910, copending application 111148152)
`
`Claims 1-4, 9, 14, 17-26, 38, 47, and 48 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over MacLachlan, et al. (US 2006/0008910, of record, item 10 on 06/08/2010 IDS)
`
`("MacLachlan").
`
`The claims are to a nucleic acid lipid particle comprising a nucleic acid, a cationic lipid, a
`
`noncationic lipid mixture of phospholipid and cholesterol, and a conjugated lipid. The claims are
`
`further directed to the particle wherein the nucleic acid is an siRNA, the relative amounts of
`
`components are specified, and the lipids are specified.
`
`MacLachlan teaches lipid encapsulated interfering RNA in the form of stable nucleic
`
`acid-lipid particles ("SNALP") comprising an siRNA, a cationic lipid, phospholipid, cholesterol,
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`Page4
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`and a conjugated lipid (page 4, paragraph 56; pages 7-11, paragraphs 84-119; claim 5) wherein
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`the siRNA is from about 15-60 nucleotides (claim 6), the conjugated lipid is PEG-DMA and has
`
`an average molecular weight of about 2000 daltons (claim 13; paragraphs 91, 95, and 96), and
`
`the phospholipid is DSPC (paragraphs 62 and 91). MacLachlan also teaches the SNALP
`
`wherein the cationic lipid is from about 2 mol % to about 60 mol % of the total lipid present in
`
`the particle (paragraph 85), the phospholipid is from about 5% to about 90% or from about 10%
`
`to about 85% of the total lipid present in the particle (paragraph 85), the cholesterol is from about
`
`20% to about 55% of the total lipid present in the particle (paragraph 85, top of page 8), and the
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`conjugated lipid is from about 1% to about 20% of the total lipid present in the particle
`
`(paragraph 85). MacLachlan teaches that it will be readily apparent to one of skill in the art that
`
`the proportions of the components of the nucleic acid lipid particles may be varied (p.8,
`
`paragraph 85). MacLachlan teaches that the particles can be formulated in pharmaceutically
`
`acceptable carriers (page 18, paragraphs 205-7). MacLachlan teaches the particles having a
`
`lipid:nucleic acid mass ratio of from 12.5-100 (nucleic acid:lipid ratio from 0.01-0.08, page 15,
`
`paragraph 162) and having a median diameter ofless than about 150 nm (claims 4 and 20).
`
`MacLachlan also teaches that the nucleic acids of the particles can comprise modified
`
`nucleotides (page 6, paragraph 73).
`
`It would have been obvious to one of skill in the art at the time the instant invention was
`
`made to make a nucleic acid lipid particle comprising an siRNA, a cationic lipid, a phospholipid,
`
`cholesterol, and a PEG-conjugate because MacLachlan teaches such a particle. It would have
`
`been obvious to make the particle comprising the instantly claimed components and having the
`
`instantly claimed physical properties of claims 23-25 because MacLachlan teaches the particles
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`comprising such components. It further would have been obvious to formulate the particles with
`
`the instantly claimed amounts of the individual components because MacLachlan teaches
`
`particles formulated with ranges of amounts that overlap with the instantly claimed ranges and
`
`teaches that the proportions of the components can be varied by those of skill in the art. Thus, by
`
`routine experimentation towards optimization, one of skill in the art could arrive at the instantly
`
`claimed proportions. Absent evidence to the contrary, the nucleic acid lipid particles of
`
`MacLachlan would not be substantially degraded after incubation of the particle in serum at
`
`37°C for 30 minutes (claim 22). Therefore, the claims would have been prima facie obvious at
`
`the time the instant invention was made.
`
`MacLachlan, et al. (US 2006/0008910) and Fosnaugh, et al. (US 2003/0143732)
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are rejected under 35 U.S.C. 103(a) as being
`
`unpatentable over MacLachlan, et al. (US 2006/0008910, of record, item 10 on 06/08/2010 IDS)
`
`as applied to claims 1-4, 9, 14, 17-26, 38, 47, and 48 above, and further in view ofFosnaugh, et
`
`al. (US 2003/0143732, of record, item 3 on 06/08/2010 IDS).
`
`Claims 1-4, 9, 14, 17-26, 38, 47, and 48 are described above and are obvious as described
`
`in the preceding rejection.
`
`Claim 5 is to the nucleic acid lipid particle wherein the siRNA of the particle comprises a
`
`2'-0-methyl modification.
`
`MacLachlan teaches SNALPs as described in the preceding rejection. MacLachlan does
`
`not teach the SNALPs wherein the siRNA is 2'-0-methyl-modified.
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`Fosnaugh teaches siRNAs and that siRNAs can be modified with 2'-0-methyl
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`modifications to increase siRNA nuclease resistance (pages 4-5, paragraph 34).
`
`It would have been obvious to make the SNALP of MacLachlan with an siRNA
`
`comprising a 2'-0-methyl modification because Fosnaugh teaches that such modification
`
`enhances siRNA resistance to nuclease degradation. One of skill would recognize that
`
`increasing nuclease resistance of the siRNA would improve the serum stability of the siRNA,
`
`which would add to the serum stability afforded to the siRNA by its inclusion in the SNALP.
`
`Therefore, the claims would have been prima facie obvious at the time the instant invention was
`
`made.
`
`Claim Rejections- 35 USC§ 102
`
`The following is a quotation of the appropriate paragraphs of35 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 -
`
`(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed
`in the United States before the invention by the applicant for patent or (2) a patent granted on an application for
`patent by another filed in the United States before the invention by the applicant for patent, except that an
`international application filed under the treaty defined in section 351 (a) shall have the effects for purposes ofthis
`subsection of an application filed in the United States only if the international application designated the United
`States and was published under Article 21(2) of such treaty in the English language.
`
`Claim 55 is rejected under 35 U.S.C. 102(e) as being anticipated by MacLachlan, et al.
`
`(US 2009/0291131) ("MacLachlan 2").
`
`The applied reference has a common inventor with the instant application. Based upon
`
`the earlier effective U.S. filing date of the reference, it constitutes prior art under 35 U.S.C.
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`102(e). This rejection under 35 U.S.C. 102(e) might be overcome either by a showing under 37
`
`CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the
`
`inventor of this application and is thus not the invention "by another," or by an appropriate
`
`showing under 3 7 CFR 1.131.
`
`Claim 55 is to a nucleic acid lipid particle as described previously wherein the cationic
`
`lipid is DLin-K-C2-DMA.
`
`MacLachlan 2 teaches SNALPs comprising siRNAs, cationic lipid, phospholipid,
`
`cholesterol, and a conjugated lipid. MacLachlan 2 teaches that the cationic lipid can be 2,2 -
`
`dilinoleyl-4 -dimethylaminoethyl-[1,3] -dioxolane (DLin-K-XTC2-DMA), which is the same as
`
`the instantly claimed DLin-K-C2-DMA (page 3, paragraph 22). MacLachlan 2 teaches that the
`
`SNALPs may comprise the cationic lipid from about 50 mol % to about 65 mol %, the
`
`phospholipid from about 4 mol % to about 10 mol %, cholesterol from about 30 mol % to about
`
`40 mol%, and the conjugated lipid from about 0.5 mol% to about 2 mol% of the total lipid in
`
`the particle. Therefore, MacLachlan 2 anticipates the instant claim.
`
`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
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`application claim is not patentably distinct from the reference claim(s) because the examined
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`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 3 7 CFR
`
`3.73(b).
`
`12/343342
`
`Claims 1-5, 14, 17-19, 23-26, 38, and 55 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 24, 25, 26,
`
`30-32, 43, 44, , 120, 123, 124, and 125 of copending Application No. 12/343342. Although the
`
`conflicting claims are not identical, they are not patentably distinct from each other because the
`
`claims of the '342 application are directed to siRNA-lipid particles having the same proportions
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`of components and the same components as instantly claimed, except for the conjugated lipid
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`component, which is limited to about 0.5 mol% to about 2 mol% in the instant case and is
`
`limited to about 1 mol% to about 15 mol% in the '342 claims. The lower limit of the mol% of
`
`the conjugated lipid component in the '342 claims overlaps with the instantly claimed mol %
`
`range. The instant claims would have been obvious by routine optimization of the '342 claims.
`
`The instant claim 55 is obvious over the '342 claims because the '342 application teaches that
`
`DLin-K-XTC2-DMA is one cationic lipid useful in the claimed nucleic acid-lipid particles (see
`
`rejection under 35 USC 102(e) above).
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111148152
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 and 38-
`
`46 of copending Application No. 11/148152 in view of Fosnaugh, et al. (US 2003/0143732, of
`
`record, item 3 on 06/08/2010 IDS). Although the conflicting claims are not identical, they are
`
`not patentably distinct from each other because the claims of the '152 application are directed to
`
`siRNA-lipid particles comprising the instantly claimed components and the disclosure describes
`
`that the components can comprise the particles in proportions that overlap with the instantly
`
`claimed proportions as indicated above in the rejection under 35 USC§ 103. Fosnaugh, et al.
`
`teaches that siRNAs can be modified with 2'-0-methyl groups, rendering the instant claim 5
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`obvious also as indicated above. See rejection under 35 USC 103(a) for the obviousness analysis
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`of the instant claims.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111174453
`
`Claims 1-5, 9, 14, 17-19, 21, 22, 23, 25, 26, 38, 47, and 48 are provisionally rejected on
`
`the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims
`
`10, 11, 13, 14, 15, 16, 17, 18, 19,22,23,24,25,26,27,43,44,45,47,48,49,51,and53of
`
`copending Application No. 11/174453 in view of Fosnaugh, et al. (US 2003/0143732, of record,
`
`item 3 on 06/08/2010 IDS).
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other because the claims of the '453 application are directed to siRNA-lipid particles
`
`comprising the instantly claimed components in ranges of proportions that encompass or overlap
`
`with the instantly claimed proportions. Thus, by routine experimentation towards optimization,
`
`one of skill in the art could arrive at the instantly claimed proportions. Fosnaugh, et al. teaches
`
`that siRNAs can be modified with 2'-0-methyl groups to enhance siRNA stability. Therefore, it
`
`would have been obvious to one of skill in the art to modify the siRNA of the '453 claims with a
`
`2'-0-methyl modification to improve the stability of the siRNA.
`
`This is a provisional obviousness-type double patenting rejection.
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`111283550
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`Page 11
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`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 5, 7, 9,
`
`10, 11, 13, 14, 15, 16, 17, 19,22,24,26,27,29,30,31,32,33,34,35,37,38,39,57,58,59,60,
`
`61, 62, 64, 65, 66, 67, 68, 69, and 71 of copending Application No. 11/283550. Although the
`
`conflicting claims are not identical, they are not patentably distinct from each other because the
`
`claims of the '550 application are directed to siRNA-lipid particles comprising the instantly
`
`claimed components in ranges of proportions that encompass or overlap with the instantly
`
`claimed proportions. Thus, by routine experimentation towards optimization, one of skill in the
`
`art could arrive at the instantly claimed proportions of components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111426907
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6-11, 52,
`
`55-60, 63-66, and 68-76 of copending Application No. 11/426907. Although the conflicting
`
`claims are not identical, they are not patentably distinct from each other because the claims of
`
`the '907 application are directed to siRNA-lipid particles comprising the instantly claimed
`
`components in ranges of proportions that encompass or overlap with the instantly claimed
`
`proportions. Thus, by routine experimentation towards optimization, one of skill in the art could
`
`arrive at the instantly claimed proportions of components.
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`Application/Control Number: 12/424,367
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`Page 12
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`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111511855
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 70, 71, 72, 73,
`
`74, and 75 of copending Application No. 11/511855. Although the conflicting claims are not
`
`identical, they are not patentably distinct from each other because the claims of the '855
`
`application are directed to methods of using siRNA-lipid particles and the disclosure teaches that
`
`the particles may comprising the instantly claimed components in ranges of proportions that
`
`encompass or overlap with the instantly claimed proportions. Thus, by routine experimentation
`
`towards optimization, one of skill in the art could arrive at the instantly claimed proportions of
`
`components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111584341
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 16, 17, 18, 20,
`
`21,22,23,24,25,26,27,28,29,31,33,34,35,36,38-42,44-46, 73, 74, 76, 77, 78,80,and91-
`
`95 of copending Application No. 11/584341. Although the conflicting claims are not identical,
`
`they are not patentably distinct from each other because the claims of the '341 application are
`
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`Application/Control Number: 12/424,367
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`Page 13
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`directed to siRNA-lipid particles comprising the instantly claimed components in ranges of
`
`proportions that encompass or overlap with the instantly claimed proportions. Thus, by routine
`
`experimentation towards optimization, one of skill in the art could arrive at the instantly claimed
`
`proportions of components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111592756
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 59-61, 63-72,
`
`74, 76-79, 81-89, 182,, 183, 184, and 187 of copending Application No. 11/92756. Although
`
`the conflicting claims are not identical, they are not patentably distinct from each other because
`
`the claims of the '756 application are directed to siRNA-lipid particles comprising the instantly
`
`claimed components in ranges of proportions that encompass or overlap with the instantly
`
`claimed proportions. Thus, by routine experimentation towards optimization, one of skill in the
`
`art could arrive at the instantly claimed proportions of components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`111807872
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 44-55 of
`
`Moderna Ex 1016-p. 14
`Moderna v Arbutus
`
`

`

`Application/Control Number: 12/424,367
`Art Unit: 1635
`
`Page 14
`
`copending Application No. 11/807872. Although the conflicting claims are not identical, they
`
`are not patentably distinct from each other because the claims of the '872 application are directed
`
`to siRNA-lipid particles comprising the instantly claimed components in ranges of proportions
`
`that encompass or overlap with the instantly claimed proportions and the disclosure describes
`
`that the components can comprise the particles in proportions that encompass or overlap with the
`
`instantly claimed proportions. Thus, by routine experimentation towards optimization, one of
`
`skill in the art could arrive at the instantly claimed proportions of components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`12/359119
`
`Claims 1-5, 9, 14, 17-26, 38, 47, and 48 are provisionally rejected on the ground of
`
`nonstatutory obviousness-type double patenting as being unpatentable over claims 29-39 of
`
`copending Application No. 12/359119. Although the conflicting claims are not identical, they
`
`are not patentably distinct from each other because the claims of the '119 application are directed
`
`to siRNA-lipid particles comprising the instantly claimed components in ranges of proportions
`
`that encompass or overlap with the instantly claimed proportions and the disclosure describes
`
`that the components can comprise the particles in proportions that encompass or overlap with the
`
`instantly claimed proportions. Thus, by routine experimentation towards optimization, one of
`
`skill in the art could arrive at the instantly claimed proportions of components.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`Moderna Ex 1016-p. 15
`Moderna v Arbutus
`
`

`

`Application/Control Number: 12/424,367
`Art Unit: 1635
`
`Page 15
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to JENNIFER PITRAK whose telephone number is ( 571 )270-3061.
`
`The examiner can normally be reached on Monday-Friday, 8:30AM-5:00PM, EST.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Christopher Low can be reached on 571-272-0951. 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). Ifyou 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.
`
`/Jennifer Pitrak/
`Examiner, Art Unit 1635
`
`Moderna Ex 1016-p. 16
`Moderna v Arbutus
`
`

`

`*
`*
`
`*
`
`*
`
`Notice of References Cited
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Application/Control No.
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`12/424,367
`
`Examiner
`
`JENNIFER PITRAK
`
`U.S. PATENT DOCUMENTS
`
`Name
`
`A
`
`US-2009/0291131
`
`11-2009
`
`Maclachlan et al.
`
`Applicant(s)/Patent Under
`Reexamination
`YAWORSKI ET AL.
`
`Art Unit
`
`1635
`
`Page 1 of 1
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`Classification
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`424/450
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`US-
`B
`c US-
`US-
`D
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`US-
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`US-
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`US-
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`US-
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`US-
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`US-
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`US-
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`US-
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`US-
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`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
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`Country
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`Name
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`Classification
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`FOREIGN PATENT DOCUMENTS
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`NON-PATENT DOCUMENTS
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`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
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`E
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`F
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`*A copy of th1s reference IS not bemg furnished w1th th1s Off1ce act1on. (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. 20100721
`
`Moderna Ex 1016-p. 17
`Moderna v Arbutus
`
`

`

`Search Notes
`
`Application/Control No.
`
`12424367
`
`Examiner
`
`JENNIFER PITRAK
`
`Applicant(s)/Patent Under
`Reexamination
`
`YAWORSKI ET AL.
`
`Art Unit
`
`1635
`
`Class
`
`I
`I
`
`SEARCHED
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`Subclass
`
`SEARCH NOTES
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`Date
`
`I
`I
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`I Examiner
`I
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`Search Notes
`
`EAST
`CAPLUS, MEDLINE, BIOSIS, EMBASE, SCISEARCH
`INVENTOR SEARCH
`
`Date
`07/21-23/2010
`07/26/2010
`07/26/2010
`
`Examiner
`JSP
`JSP
`JSP
`
`Class
`
`I
`I
`
`INTERFERENCE SEARCH
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`Subclass
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`Date
`
`I
`I
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`I Examiner
`I
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`U.S. Patent and Trademark Office
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`Part of Paper No.: 20100721
`
`Moderna Ex 1016-p. 18
`Moderna v Arbutus
`
`

`

`file:///CI/Documents%20and%20Settings/jpitrak/My%20Documents/e-Red%20Fo1der/12424367/12424367-STN-07262010.txt
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`=> D HIS
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`(FILE 'HOME' ENTERED AT 16:05:18 ON 26 JUL 2010)
`
`FILE 'MEDLINE, BIOSIS, CAPLUS, EMBASE, SCISEARCH' ENTERED AT 16:05:30 ON
`26 JUL 2010
`522 S SIRNA AND CATIONIC (W) LIPID
`215960 S LIPOSOME OR (NUCLEIC (W) ACID (W) LIPID (W) PARTICLE)
`194 S L1 AND L2
`98 DUP REM L3 (96 DUPLICATES REMOVED)
`48 S L4 AND PD<20080415
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`L1
`L2
`L3
`L4
`L5
`
`file:/ //CI/Documents% 20and% 20Settings/jpi trak/M y%20Documents/e-Red %20Fo1der/124243 6 7 I 124243 6 7 -STN -07262010. txt7 /26/2010 4:08:26 PM
`
`Moderna Ex 1016-p. 19
`Moderna v Arbutus
`
`

`

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`EAST Search History
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