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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`
`16/ 150,058
`
`10/02/2018
`
`Jeffrey V. Ravetch
`
`38400-0003005
`
`6424
`
`FISH & RICHARDSON P.C. (BO)
`PO. BOX 1022
`MINNEAPOLIS, MN 55440-1022
`
`DAHLE, CHUN WU
`
`ART UNIT
`
`1644
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`06/20/2019
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`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
`PATDOCTC @ fr.com
`
`PTOL-90A (Rev. 04/07)
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`

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`0,7709 A0170” Summary
`
`Application No.
`16/150,058
`Examiner
`CHUN DAH LE
`
`Applicant(s)
`Ravetch et al.
`Art Unit
`1644
`
`AIA (FITF) Status
`No
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS 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.
`|f 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
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`1). Responsive to communication(s) filed on 05/24/2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
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`2b)
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`This action is non-final.
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`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4)[:] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s) Q is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) g is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabie. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)D All
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`b)I:J Some**
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`c)C] None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] 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.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20190615
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`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
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`Page 2
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`DETAILED ACTION
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`1.
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`The present application is being examined under the pre—AIA first to invent provisions.
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`2.
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`Applicant’s amendment filed on May 24, 2019 is entered.
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`Claims 1—22 have been canceled.
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`Claim 23 have been added.
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`Claim 23 are pending and currently under consideration.
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`3.
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`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
`(a) IN GENERAL.7The specification shall contain a written description of the invention, and
`of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor
`of carrying out the invention.
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`The following is a quotation of the first paragraph of pre—AIA 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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`4.
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`Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre—AIA), first paragraph,
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`as failing to comply with the enablement requirement. The claim(s) contains subject matter
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`which was not described in the specification in such a way as to enable one skilled in the art to
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`which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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`Factors to be considered in determining whether undue experimentation is required to
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`practice the claimed invention are summarized In re Wands (858 F2d 73], 737, 8 USPQ2d 1400,
`
`1404 (Fed. Cir.]988)). The factors most relevant to this rejection are the scope ofthe claim, the
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`amount of direction or guidance provided, the lack of sufi‘icient working examples, the
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`unpredictability in the art and the amount of experimentation required to enable one of the
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`skilled in the art to practice the claimed invention.
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`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
`
`Page 3
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`The breath of the claim encompasses a method of treating any inflammation by
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`administering a modified IVIG composition prepared from un modified IVIG, wherein the
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`modified IVIG has increased anti—inflammatory activity as compared to the unmodified IVIG,
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`and a higher content of 0L2,6 linked sialic acid in the N—linked glycans of Fc regions than the
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`unmodified IVIG.
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`The specification discloses examples of anti—platelet antibodies from 6A6 hybridoma
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`expressed in 293 cells and shows that sialylated froms of antibodies has a reduced binding
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`affinity to soluble Fc receptors. The specification discloses that de—sialylation of IVIG decrease
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`the anti—inflammatory effect of IVIG and IVIG fraction with enriched sialic acid content
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`decreases inflammation in mouse in mouse arthritis model, and the increased anti—inflammatory
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`response is mediated by sialylation of the N—linked glycan on the Fc domain (e. g. see pages 27—
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`36 of the specification).
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`However, the specification does not enable any person skilled in the art to which it
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`pertains, or with which it is most nearly connected, to make and use the invention commensurate
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`in scope with these claims.
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`It was known in the art at the time the invention was filed that it was uncertain that
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`whether sialic acid content in IVIG composition play role in the anti—inflammatory effect of the
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`IVIG. Several references listed on the IDS provide contradictory results questioning the link
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`between higher sialic content and higher anti—inflammatory effect of IVIG. For example, in the
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`reference titled “Testing the biological efficacy of sialylated polyclonal or monoclonal antibodies
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`in a murine model of ITP and K/BxN arthritis" (pages 1—7) (authors and date not listed, copy
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`found in parent USSN 12/294,883), it was shown sialylated preparation of IVIG, either through
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`lectin column purification or in vitro treatment with (12,6 SialT, shows significant anti—
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`inflammatory activity but not better than that of native IVIG.
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`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
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`Page 4
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`Leontyev et al. (Transfusion 2012, 52: 1799—1805, reference on IDS, copy found in parent
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`USSN 12/294,883) teach IVIG ameliorates experimental ITP by a mechanism that is
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`independent of sialylation either in the Fc or the Fab region of IVIG (e. g. see page 1799).
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`Guhr et al. (PLoS One, June 2011, 6;6:e21246. Pages 1—8, copy found in parent USSN
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`12/294,883) teach enrichment of sialylated IgG by lectin fractionation does not enhance the
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`efficacy of IgG in murine model of Immune Thrombocytopenia (ITP) (e. g. see page 1).
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`Therefore, based upon the teachings of the references discussed above that higher content
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`of 0L2,6 linked N—sialic acid does not correlate with higher anti—inflammatory activity and the
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`scope of the claimed invention, a person of skill in the art would not be able to make and use the
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`full scope of Applicant's claimed method without first conducting additional research, the results
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`of which are not predictable.
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`5.
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`The nonstatutory double patenting rejection is based on a judicially created doctrine
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`grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or
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`improper timewise extension of the “right to exclude” granted by a patent and to prevent possible
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`harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where
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`the conflicting claims are not identical, but at least one examined application claim is not
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`patentably distinct from the reference claim(s) because the examined application claim is either
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`anticipated by, or would have been obvious over, the reference claim(s). See, e. g., In re Berg,
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`140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d
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`2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van
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`Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
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`(CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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`A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may
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`be used to overcome an actual or provisional rejection based on nonstatutory double patenting
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`provided the reference application or patent either is shown to be commonly owned with the
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`examined application, or claims an invention made as a result of activities undertaken within the
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`scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination
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`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
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`Page 5
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`under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP
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`§§ 706.02(l)(1) — 706.02(l)(3) for applications not subject to examination under the first inventor
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`to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
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`1.32103).
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`The USPTO Internet website contains terminal disclaimer forms which may be used.
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`Please visit www.uspto.gov/patent/patents—forms. The filing date of the application in which the
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`form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or
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`PTO/AIA/26) should be used. A web—based eTerminal Disclaimer may be filled out completely
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`online using web—screens. An eTerminal Disclaimer that meets all requirements is auto—
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`processed and approved immediately upon submission. For more information about eTerminal
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`Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD—info—I.j sp.
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`6.
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`Claim 23 is rejected on the ground of nonstatutory double patenting as being
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`unpatentable over claims 1—7 of US. 8,470,318 (‘3 18 Patent).
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`Although the claims at issue are not identical, they are not patentably distinct from each
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`other because both the instant claims and the claims in the ‘3 18 Patent are drawn to the same or
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`nearly the same method of inhibiting inflammation in a subject by administering IVIG enriched
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`with (12,6 sialic acid linked to the N—glycans in the Fc region of the IVIG. As such, the claims in
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`the ‘3 18 Patent would anticipate the instant invention.
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`7.
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`Claim 23 is rejected on the ground of nonstatutory double patenting as being
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`unpatentable over claims 1—4 of US 10,167,332 (the ‘332 Patent).
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`The instant claim is drawn to a method of treating any inflammation by administering a
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`modified IVIG composition prepared from un modified IVIG, wherein the modified IVIG has
`
`increased anti—inflammatory activity as compared to the unmodified IVIG, and a higher content
`
`of 0L2,6 linked sialic acid in the N—linked glycans of Fc regions than the unmodified IVIG. The
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`claims in the ‘332 Patent are drawn to a modified IVIG composition prepared from an
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`unmodified IVIG, wherein the modified IVIG has a higher content of (12,6 linked sialic acid in
`
`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
`
`Page 6
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`the N—linked glycans of the Fc region compared to the unmodified IVIG. Although the
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`conflicting claims are not identical, they are not patentably distinct from each other because the
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`claims in the ‘332 Patent are drawn to the same pharmaceutical compositions used in the
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`presently claimed method and the specification of the ‘332 Patent supports the instant method of
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`treating inflammation (e.g. see Example 1). As such, the claims in the ‘332 Patent would
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`anticipate or render the instant claim obvious.
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`Further, given the CON relationships between the instant application and the parent ‘332
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`Patent, and Amgen, Inc. v. F. Hofiman-La Roche Ltd., 580 F.3d 1340 (Fed. Cir. 2009) which
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`indicated that the prohibition under 35 U.S.C. 121 does not apply to claims in a pending case
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`which are directed to a non—elected invention of an application and the case is not a divisional of
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`the application, the above obviousness—type double patenting rejection is set forth.
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`8.
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`9.
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`No claim is allowed.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to CHUN DAHLE whose telephone number is (571)272—8142. The
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`examiner can normally be reached on Mon—Fri 6:30am—4:00pm.
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`Examiner interviews are available via telephone, in—person, and video conferencing using
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`a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`encouraged to use the USPTO Automated Interview Request (AIR) at
`
`
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Daniel E Kolker can be reached on 57 1—272—3 181. The fax phone number for the
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`organization where this application or proceeding is assigned is 571—273—8300.
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`

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`Application/Control Number: 16/ 150,05 8
`Art Unit: 1644
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`Page 7
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`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.
`
`/CHUN W DAHLE/
`
`Primary Examiner, Art Unit 1644
`
`