UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/845,487
`
`12/18/2017
`
`Jeffrey V. Ravetch
`
`070413.20317
`
`3903
`
`Fox Rothsch11d, LLP / The Rockefeller Unlvers1ty
`997 Lenox Drive
`Lawrenceville, NJ 08648
`
`SALVOZA. M FRANCO G
`
`ART UNIT
`
`1648
`
`PAPER NUMBER
`
`NOTIFICATION DATE
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`DELIVERY MODE
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`05/02/2019
`
`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
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`following e—mail address(es):
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`ipdocket@foxrothschild.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0/7709 A0170” Summary
`
`Application No.
`15/845,487
`Examiner
`M FRANCO G SALVOZA
`
`Applicant(s)
`Ravetch et al.
`Art Unit
`1648
`
`AIA (FITF) Status
`Yes
`
`- 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
`
`1). Responsive to communication(s) filed on 2/27/2019.
`[: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*
`
`5)
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`Claim(s) fl is/are pending in the application.
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`5a) Of the above claim(s) 2 and 5 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) 1 and 3—4 is/are rejected.
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`E] Claim(s) _ is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* If any claims have been determined allowable, 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
`
`http://www.uspto.gov/patents/init events/pph/index.'sp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10):] The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 12/18/2017; 3/14/2018 is/are: a). accepted or b)[:] 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).
`
`Priority under 35 U.S.C. § 119
`12)C] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)I:] All
`
`b)|:] Some**
`
`c)C] None of the:
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`1.|:] Certified copies of the priority documents have been received.
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`21:] Certified copies of the priority documents have been received in Application No.
`
`3D 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)
`
`Notice of References Cited (PTO-892)
`
`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Datem.
`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)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20190421
`
`

`

`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 2
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined under the
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`first inventor to file provisions of the AIA.
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`DETAILED ACTION
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`Election Restrictions
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`1. Applicant’s election without traverse of Group I in the reply filed on 2/27/2019 is
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`acknowledged.
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`Claims 2, 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
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`being drawn to a nonelected Invention, there being no allowable generic or linking claim.
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`Election was made without traverse in the reply filed on 2/27/2019.
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`Claims 1, 3, 4 are under consideration.
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`Information Disclosure Statement
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`2. The information disclosure statement (IDS) was submitted on 2/27/2019. The
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`submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information
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`disclosure statement is being considered by the examiner.
`
`Claim Rejections - 35 US C § 112
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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`(a) IN GENERAL—The specification shall contain a written description
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`of the invention, and of the manner and process of making and using it, in such
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`full, clear, concise, and exact terms as to enable any person skilled in the art to
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`which it pertains, or with which it is most nearly connected, to make and use the
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`same, and shall set forth the best mode contemplated by the inventor or joint
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`inventor of carrying out the invention.
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`

`

`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 3
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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
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`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
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`which it is most nearly connected, to make and use the same, and shall set forth
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`the best mode contemplated by the inventor of carrying out his invention.
`
`3. Claims 1, 3, 4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre—AIA), first
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`paragraph, as failing to comply with the written description requirement. The claim(s) contains
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`subject matter which was not described in the specification in such a way as to reasonably
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`convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre—AIA the
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`inventor(s), at the time the application was filed, had possession of the claimed invention.
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`Claim 1 recites an isolated nucleic acid comprising a sequence encoding a polypeptide
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`comprising a modified sequence that is at least 75% identical to an IgG Fc region, wherein the
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`modified sequence is free of sialylation and the polypeptide has an anti—inflammatory activity
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`that is higher than that of a parent polypeptide. Claims 3, 4 depend on this claim.
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`Each of the claims is drawn, inherently or explicitly, to any nucleic acid sequence
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`encoding a polypeptide comprising a modified sequence (also reading on a fragment) that is at
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`least 75 % identical to an IgG Fc region, wherein the modified sequence is free of sialylation and
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`the polypeptide has an anti—inflammatory activity that is higher than that of a parent polypeptide.
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`Thus, the claims are drawn to compositions comprising a genus of nucleic acid sequences
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`encoding polypeptide comprising a modified sequence that is at least 75 % identical to an (or
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`“any”) IgG Fc region and that is free of sialylation and has a particular activity (anti—
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`inflammatory activity that is higher than that of a parent polypeptide). It is noted that the instant
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`claims also read upon fragments that are at least 75 % identical to an IgG Fc region.
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`

`

`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 4
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`The following quotation from section 2163 of the Manual of Patent Examination
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`Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112
`
`written description requirement for a generic claim covering several distinct inventions:
`
`The written description requirement for a claimed genus may be satisfied through
`sufficient description of a representative number of species by actual reduction to
`
`practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics,
`i.e., structure or other physical and/or chemical properties, by functional characteristics
`
`coupled with a known or disclosed correlation between function and structure, or by a
`combination of such identifying characteristics, sufficient to show the applicant was in
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`possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A
`"representative number of species" means that the species which are adequately described
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`are representative of the entire genus. Thus, when there is substantial variation Within the
`genus, one must describe a sufficient variety of species to reflect the variation Within the
`genus.
`
`Thus, when a claim covers a genus of inventions, the specification must provide written
`
`description support for the entire scope of the genus. Support for a genus is generally found
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`where the applicant has provided a number of examples sufficient so that one in the art would
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`recognize from the specification the scope of what is being claimed.
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`In the present case, the specification teaches: the modified sequence can be sialylated at
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`different levels or non—sialylated. In some embodiments, it is (a) substantially free of sialylation
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`or (b) sialylated at a level lower than that of IgG of the subject. The IgG Fc region can comprise
`
`the sequence of SEQ ID NO: 1. The modified sequence can be at least 75% (e. g., any number
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`between 75% and 100%, inclusive, e.g., 75%, 80%, 85%, 90%, 95%, 99%, and 100%) identical
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`to SEQ ID NO: 2 [0014]. Beyond such a recitation, the specification only further teaches:
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`Examples 2, 7 reciting the F241A embodiment.
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`As to state of the art, the prior art teaches some known features that lead to anti—
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`inflammatory activity. For example, Anthony et al. (“Identification of a receptor required for the
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`anti—inflammatory activity of IVIG,” PNAS Vol. 105, No. 50: 19571—19578 (2008))(See PTO—
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`

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`Application/Control Number: 15/845,487
`Art Unit: 1648
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`Page 5
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`892: Notice of References Cited) teaches wherein: IgG mediates anti—inflammatory activity when
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`administered at very high doses to patients suffering from autoimmune disease (p. 19571);
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`further, anti—inflammatory activity depended on a minor fraction of IgG Fc that contained the
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`fully processed N—linked glycan terminated in sialic acid, linked in an a2,6—linkage to the
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`penultimate galactose (p. 19572); wherein a2,6—Fc serves as an active component for anti—
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`inflammatory activity of IVIG (p. 19574); wherein DC—SIGN is a lectin required for the anti—
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`inflammatory activity of IVIG (p. 19577); SIGN—R1 displays a similar binding specificity to
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`SIGN—R1 but differs in its cellular distribution, potentially accounting for some of the species
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`differences observed in IVIG protection.
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`More recent art teaches further knowledge but still raises questions about the uncertainty
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`and effects of even minor structural modifications. For example, Ahmed et al.
`
`(“Structural Characterization of Anti—Inflammatory Immunoglobulin G Fc Proteins,” J. Mol.
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`Biol. 426: 3166—3179 (2014))(cited in applicant’s IDS submitted 2/27/2019) teaches that Fc
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`regions of IgGs can function to either promote or suppress the inflammatory response (p. 3175);
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`wherein antiinflammatory properties of ch have been attributed to the effect of sialylation
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`switching the specificity of Fc binding to its receptors (p. 3167); Asp297—linked glycan can
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`affect Fc structure, wherein glycan contributed to open conformation, but enzymatically removed
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`glycan lead to closed state (p. 3167); conformational changes have been observed when
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`individual sugar residues were modified (pp. 3167—3168); IgGs with F241A mutation may be
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`effective anti—inflammatory molecules due to increased sialylation (p. 3175); Fc can adopt a wide
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`range of conformations; a greater flexibility of glycovariant forms of Fc have been documented,
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`however, further structural investigations of how glycan composition and conformational
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`

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`Application/Control Number: l5/845,487
`Art Unit: 1648
`
`Page 6
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`flexibility affect binding to Fc receptors that mediate differential activities will be critical (p.
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`3 176).
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`It is further known in the art that small modifications in proteins can lead to functional
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`differences. For example, even minor changes in the amino acid sequences of heavy and
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`light variable regions, particularly in the CDRs, may dramatically affect binding function as
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`evidenced by Rudikoff et al. ("Single amino acid substitution altering antigen—binding
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`specificity," Proc Natl Acad Sci USA 79: 1979—1983 (1982))(See PTO—892: Notice of References
`
`Cited). Rudikoff et al. teaches that the alteration of a single amino acid in the CDR of a
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`phosphocholine—binding myeloma protein resulted in the loss of antigen—binding function.
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`Further, Kaneko et a1. (“Anti—Inflammatory Activity of Immunoglobulin G Resulting
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`from Fe Sialylation,” Science, Vol. 313: 670—673 (2006))(See PTO—892: Notice of References
`
`Cited) teaches that differential modifications can affect inflammatory activity. Kaneko et al.
`
`teaches wherein differential sialylation may provide a switch from anti—inflammatory activity to
`
`pro—inflammatory (p. 670); sialylation of Asn297 linked glycan structure of IgG resulted in
`
`reduced binding affinities, reduced in vivo cytotoxicity (p. 671); deglycosylated IVIG was
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`unable to mediate anti—inflammatory activity in vivo (p. 672); some deglycosylated or
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`desialylated IVIG variant showed unchanged FcRn binding affinity (pp. 671—2); regulated
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`sialylation of IgG suggests a mechanism for ensuring that steady—state serum IgG antibodies
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`maintain anti—inflammatory state (p. 673).
`
`Thus, although the specification as indicated above identifies a F24lA embodiment,
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`beyond that, the specification only appears to recite peptides with at least 75% identity as
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`claimed in generic terms and does not identify a representative sample of sequences with the
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`percent homology that have the function as related to the percent homology. Thus, the
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`

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`Application/Control Number: l5/845,487
`Art Unit: 1648
`
`Page 7
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`specification does not identify a representative sample of species of nucleic acids as claimed
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`clearly within the breadth of the claimed genus.
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`There is no apparent common conserved structure to the different nucleic acid sequences
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`encoding sequences or fragments that distinguishes those that free of sialylation have anti—
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`inflammatory activity higher than that of a parent polypeptide as compared to those that do not.
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`There is therefore a high level of uncertainty as to which sequences or fragments fall within the
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`scope of the indicated genus.
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`Further, the specification has identified the claimed sequences only by function: the
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`ability to, free of sialylation, have anti—inflammatory activity higher than that of a parent
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`polypeptide.
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`The specification does not provide a specific conserved structure of nucleic acid
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`sequences encoding polypeptides or fragments within the genus that correlates with the required
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`function. Because there is no identification of structures common to each sequence or fragment,
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`nor sufficient representative examples by which such a structure may be determined, the
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`application fails to provide sufficient written description support for the identified genus of
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`sequences or fragments through identification of a structure and function. While the nucleic acids
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`must encode polypeptides that are at least 75% identical to an IgG Fc region and are free of
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`sialylation, this is not alone sufficient structure to correlate with the function. This is because the
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`mere presence of a sequence free of sialylation does not demonstrate that a polypeptide would
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`necessarily have higher anti—inflammatory activity than a parent polypeptide, especially in view
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`of knowledge in the art as to varied structures indicated above.
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`For the reasons above, and in view of the uncertainty as to which nucleic acids encoding
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`modified polypeptides or fragments with at least 75% identity to an IgG Fc region that are free of
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`

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`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 8
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`sialylation have an anti—inflammatory activity higher than that of a parent polypeptide, the
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`application has not provided sufficient written description support for the genus of sequences or
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`fragments identified in claim 1.
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`Claim Rejections - 35 US C § 101
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`Section 33(a) of the America Invents Act reads as follows:
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`Notwithstanding any other provision of law, no patent may issue on a
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`claim directed to or encompassing a human organism.
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`4. Claim 4 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act
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`as being directed to or encompassing a human organism. See also Animals - Patentability, 1077
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`Ofi‘. Gaz. Pat. Ofi‘ice 24 (April 21, 1987) (indicating that human organisms are excluded from the
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`scope of patentable subject matter under 35 U.S.C. 101).
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`Claim 4 recites a host cell comprising a nucleic acid of claim 1.
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`The recitation to a host cell reads on human organisms. To overcome this rejection, the
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`claim should recite “an isolated host cell”.
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`Claim Rejections - 35 US C § 102/103
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(a)(1) the claimed invention was patented, described in a printed publication, or in
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`public use, on sale or otherwise available to the public before the effective filing
`date of the claimed invention.
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`

`

`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 9
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`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`A patent for a claimed invention may not be obtained, notwithstanding that the
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`claimed invention is not identically disclosed as set forth in section 102, if the
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`differences between the claimed invention and the prior art are such that the
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`claimed invention as a whole would have been obvious before the effective filing
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`date of the claimed invention to a person having ordinary skill in the art to which
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`the claimed invention pertains. Patentability shall not be negated by the manner in
`which the invention was made.
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`5. Claims 1, 3, 4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the
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`alternative, under 35 U.S.C. 103 as obvious over Naso et al. (US20100172911)(cited in
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`applicant’s IDS submitted 2/27/2019).
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`See the recitations to claims 1, 4 above.
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`Claim 3 recites an expression vector comprising a nucleic acid of claim 1.
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`The instant claims are interpreted as reading upon a full Fc region or 100% identical to an
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`IgG Fc region.
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`Naso et al. teaches: vectors useful for producing Fc—containing molecules with reduced
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`sialic acid content [0011]; nucleic acids encoding antibodies (as well as vectors and host cells)
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`[0097](as recited in claims 1, 3, 4); including cell line transfected to express polypeptide which
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`falls within the definition of an Fc—containing protein [0096](as recited in claim 1); including
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`IgG [0084]; as well as expression vectors [001 1](as recited in claim 3); including for treating
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`inflammatory disorder (claim 26 of Naso et al.).
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`Naso et al. also teaches wherein the composition of the chains are optimized for Fc
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`receptor binding affinity as compared to nonoptimized methods [0002]; controlling the
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`properties of an Fc—containing molecule comprising minimizing sialylation of the
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`

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`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 10
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`oligosaccharides attached to the Fc region whereby the affinity is optimized [0012]; including
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`preparation of Fc—containing molecules; including antibodies that do not contain sialic acid in the
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`Fc oligosaccharide [0013]; including fully asialyated embodiments [0022]; including asialylated
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`Fc containing proteins [0038]; as well as asialylated Fc—containing proteins [0042]; including
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`asialylated compositions [0153].
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`Thus, since Naso et al. teaches: nucleic acids encoding antibodies; Fc—containing protein
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`as well as Fc—containing molecules, as well as modifying such sequences, as well as those that do
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`not contain sialic acid in the Fc oligosaccharide; as well as fully asialylated embodiments,
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`including asialyated Fc containing proteins, Naso et al. is interpreted as teaching nucleic acid
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`comprising sequence encoding polypeptide comprising modified sequence 100% identical to an
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`IgG Fc region, wherein the modified sequence is free of sialylation. Further, since Naso et al.
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`teaches use of said modified Fc—containing proteins in methods for treating inflammatory
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`disorder as well as all the structural components as recited in claim 1, the peptide is considered to
`
`have anti—inflammatory activity that is higher than that of a parent polypeptide as recited in the
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`claim (See also MPEP 2111.04: The determination of whether each of these clauses is a
`
`limitation in a claim depends on the specific facts of the case. See, e. g., Griffin V. Bertina, 283
`
`F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a
`
`process claim where the clause gave “meaning and purpose to the manipulative steps”); . .. In
`
`Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the
`
`court held that when a “‘whereby’ clause states a condition that is material to patentability, it
`
`cannot be ignored in order to change the substance of the invention.” Id. However, the court
`
`noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the
`
`intended result of a process step positively recited.”’ Id. (quoting Minton v. Nat’l Ass’n of
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`

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`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 11
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`Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this
`
`case, the wherein clause language (“wherein
`
`the polypeptide has an anti—
`
`inflammatory activity that is higher than that of a parent polypeptide”) is considered to follow
`
`from the structure (interpreted as reading upon a full Fc region or 100% identical to an IgG Fc
`
`region) taught or suggested by Naso et al. as claimed.
`
`Thus, in view of such teachings, Naso et al. is interpreted to anticipate or render obvious
`
`the instant claims.
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`6. Claims 1, 3, 4 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the
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`alternative, under 35 U.S.C. 103 as obvious over Ravetch et al. (US20100278808)(See PTO—892:
`
`Notice of References Cited).
`
`See the recitation to claims 1, 3, 4 above.
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`The instant claims are interpreted as reading upon a full Fc region or 100% identical to an
`
`IgG Fc region.
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`Ravetch et al. teaches: preparing polypeptide containing at least one Fc region, said
`
`polypeptide having a higher anti—inflammatory activity than an unpurified antibody; comprising
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`peptide containing at least one Fc region lacking sialic acid (claim 12 of Ravetch et al.); wherein
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`said peptide containing at least one Fc region is provided from expressing a vector comprising a
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`nucleic acid sequence in an expression system (claim 14 of Ravetch et al.).
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`Thus Ravetch et al. is considered to teach or suggest: nucleic acid that is at least 75%
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`identical to an Fc region (“Fc region”; to reiterate, the instant claims are interpreted as reading
`
`upon a full Fc region or 100% identical to an IgG Fc region); lacking sialic acid (“free of
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`sialylation”); wherein expressed peptide has a higher anti—inflammatory activity than unpurified
`
`

`

`Application/Control Number: 15/845,487
`Art Unit: 1648
`
`Page 12
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`antibody (“modified sequence... has an anti—inflammatory activity that is higher than that of a
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`parent polypeptide”); vector (as recited in claim 3); expressing in system (“host cell” [0049]; as
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`recited in claim 4)(See also MPEP 2111.04: The determination of whether each of these clauses
`
`is a limitation in a claim depends on the specific facts of the case. See, e. g., Griffin V. Bertina,
`
`283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited
`
`a process claim where the clause gave “meaning and purpose to the manipulative steps”); . .. In
`
`Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the
`
`court held that when a “‘whereby’ clause states a condition that is material to patentability; it
`
`cannot be ignored in order to change the substance of the invention.” Id. However; the court
`
`noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the
`
`intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of
`
`Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this
`
`case; the wherein clause language (“wherein
`
`the polypeptide has an anti—
`
`inflammatory activity that is higher than that of a parent polypeptide”) is considered to follow
`
`from the structure (interpreted as reading upon a full Fc region or 100% identical to an IgG Fc
`
`region) taught or suggested by Ravetch et al. as claimed.
`
`Thus, in view of such teachings, Ravetch et al. is interpreted to anticipate or render
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`obvious the instant claims.
`
`Double Patenting
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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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`Application/Control Number: 15/845,487
`Art Unit: 1648
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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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`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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`1.321(b).
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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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`Application/Control Number: 15/845,487
`Art Unit: 1648
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`Page 14
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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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`7. Claims 1, 3, 4 are rejected on the ground of nonstatutory double patenting as being
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`unpatentable over claims 1, 8, 10, 13 of US. Patent No. 9845358.
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`See the recitation to claims 1, 3, 4 above.
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`Claims 1, 8, 10, 13 of US. Patent No. 9845358 recite a method of increasing a level of
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`regulatory T (Treg) cells in a subject in need thereof, comprising administering to the subject an
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`effective amount of an isolated polypeptide, or a nucleic acid encoding the isolated polypeptide,
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`comprising a modified sequence, wherein the IgG Fc region comprises the sequence of SEQ ID
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`NO: 1, and wherein the modified sequence is at least 95% identical to SEQ ID NO: 1 and has a F
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`to A mutation at a position corresponding to F32 of SEQ ID NO: 1; wherein the modified
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`sequence is (a) substantially free of sialylation or (b) sialylated at a level lower than that of IgG
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`of the subject; a method of treating a T cell—mediated autoimmune disease in a subject in need
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`thereof, comprising administering to the subject a therapeutically effective amount of an isolated
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`polypeptide, or a nucleic acid encoding the isolated polypeptide, comprising a modified
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`sequence, wherein the modified sequence is at least 95 % identical to SEQ ID NO: land has a F—
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`to—A mutation at a position corresponding to position F32 of SEQ ID NO: 1, and wherein the
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`first or second isolated polypeptide has an ability to bind to DC—SIGN, hFcyRIIA, or hFcyRIIB;
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`wherein the modified sequence is (a) substantially free of sialylation or (b) sialylated at a level
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`lower than that of IgG of the subject.
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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 instant claims 1, 3, 4 and claims 1, 8, 10, 13 of US. Patent No. 9845358
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`Application/Control Number: 15/845,487
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`recite nucleic acid encoding the isolated polypeptide; comprising a modified sequence; wherein
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`the IgG Fc region comprises the sequence of SEQ ID NO: 1; wherein the modified sequence is at
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`least 95% identical to SEQ ID NO: 1; wherein the modified sequence is (a) substantially free of
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`sialylation (See also MPEP 2111.04: The determination of whether each of these clauses is a
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`limitation in a claim depends on the specific facts of the case. See, e. g., Griffin V. Bertina, 283
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`F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) finding that a “wherein” clause limited a
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`process claim where the clause gave “meaning and purpose to the manipulative steps”); . .. In
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`Hoffer V. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the
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`court held that when a “‘whereby’ clause states a condition that is material to patentability, it
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`cannot be ignored in order to change the substance of the invention.” Id. However, the court
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`noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the
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`intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of
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`Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this
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`case, the wherein clause language (“wherein
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`the polypeptide has an anti—
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`inflammatory activity that is higher than that of a parent polypeptide”) is considered to follow
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`from the structure as claimed).
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`Further, the method of using such a product is interpreted as rendering the instant product
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`as claimed obvious.
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`Further, the prohibition (of non—statutory double patenting rejections) does not apply
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`where the divisional application was voluntarily filed by the applicant and not in response to an
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`Office requirement for restriction. The US. Court of Appeals for the Federal Circuit has
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`concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing
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`applications, stating that “the protection afforded by section 121 to applications (or patents
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`Application/Control Number: 15/845,487
`Art Unit: 1648
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`issued therefrom) filed as a result of a restriction requirement is limited to divisional
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`applications.” Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc, 518 F.3d 1353, 1362, 86 USPQ2d
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`1001, 1007—1008 (Fed. Cir. 2008)(See MPEP 804.01).
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`Concl