`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`15/121,623
`
`08/25/2016
`
`Cecilia Anna Wilhelmina GEUIJEN
`
`2183—P13895US
`
`5717
`
`TRASKBRITT, PC.
`1310. BOX 2550
`SALT LAKE CITY, UT 84110
`
`RAWLINGS, STEPHEN L
`
`ART UNIT
`
`1643
`
`PAPER NUIVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/27/2017
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`USPTOMail @traskbritt.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 15/121,623 GEUIJEN ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`1643STEPHEN RAWLINGS $2215
`
`-- The MAILING DA TE 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 g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () 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).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 06 September 2017.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|Z| This action is non-final.
`2a)|:l This action is FINAL.
`3)I:I 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.
`
`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`
`5)IZI Claim(s) 1-4 6-13 18-22 28 30-33 35 36 40 49 and 58-77 is/are pending in the application.
`5a) Of the above claim(s) 36,40,49 and 72-77is/are withdrawn from consideration.
`
`6)I:I Claim(s)
`is/are allowed.
`
`7)|Z| Claim(s) 1-4 6- 13 18-22 28 30-33 35 and58- 71 is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`I/'/\WIIW.USOI.O. ov/ atentS/init events/
`
`
`
`hilndex.‘s or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)IZI The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 25 August 2016 is/are: a)I:I accepted or b)IXI 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)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`SIXI 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)
`
`
`
`3) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`_
`.
`2) E InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`_
`4) m Other. Notice to Comply.
`
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20171114
`
`

`

`Application/Control Number: 15/121 ,623
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`Page 2
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`Art Unit: 1643
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`DETAILED ACTION
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`NOTE: The present application,
`
`filed on or after March 16, 2013,
`
`is being
`
`examined under the first inventor to file provisions of the AIA.
`
`1.
`
`The election without traverse filed September 6, 2017 is acknowledged and has
`
`been entered.
`
`Applicant has elected the invention of Group |, claims 1-13, 18-22, 28—33, and 35,
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`drawn to a bispecific antibody.
`
`Additionally, Applicant has elected the species of the invention of Group |
`
`in
`
`which the bispecific antibody comprises at least the CDR3 of the heavy chain variable
`
`region of the anti-ErbB2 antibody MF3958 and at least the CDR3 of the heavy chain
`
`variable region of the anti-ErbB3 antibody MF3178.
`
`2.
`
`Claims 1-4, 6-13, 18-22, 28, 30-33, 35, 36, 40, 49, and 58-77 are pending in the
`
`application.
`
`Claims 36, 40, 49, and 72-77 have been withdrawn from further
`
`consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention,
`
`there being no allowable generic or linking claim. Election was made without traverse
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`in the reply filed on September 6, 2017.
`
`3.
`
`Claims 1-4, 6-13, 18-22, 28, 30-33, 35, and 58-71
`
`are currently under
`
`prosecution.
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`Information Disclosure Statement
`
`4.
`
`The information disclosures filed to date have been considered. An initialed copy
`
`of each is enclosed.
`
`5.
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`Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 120, 121, or 365(0) for
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`benefit of the filing dates of earlier applications is acknowledged.
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`Priority
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`

`

`Application/Control Number: 15/121 ,623
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`Page 3
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`Art Unit: 1643
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`However claims 19-22 do not properly benefit by the earlier filing dates of the
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`foreign priority documents since the claims do not find written support therein since the
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`documents do not appear to describe the antigen binding domains MF3958 and
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`MF3178 or the claimed bispecific antibody derived from these antigen binding domains
`
`as binding, in particular, to domain I of ErbB2 and domain III of ErbB3, respectively, or
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`more particularly to epitopes comprising the particular amino acid residues to which the
`
`instant claims refer.
`
`Accordingly, the effective filing date of claims 19-22 is deemed the filing date of
`
`the international application, namely February 27, 2015.
`
`Drawings
`
`6.
`
`The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5)
`
`because of
`
`the inclusion of
`
`include reference character(s) not mentioned in the
`
`description. As example the different parts of Figure 16 labeled with the letters A-E are
`
`not mentioned in the brief description of
`
`the figure. Corrected drawing sheets in
`
`compliance with 37 CFR 1.121(d), or amendment
`
`to the specification to add the
`
`reference character(s) in the description in compliance with 37 CFR 1.121(b) are
`
`required in reply to the Office action to avoid abandonment of the application. Any
`
`amended replacement drawing sheet should include all of the figures appearing on the
`
`immediate prior version of the sheet, even if only one figure is being amended. Each
`
`drawing sheet submitted after the filing date of an application must be labeled in the top
`
`margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If
`
`the changes are not accepted by the examiner,
`
`the applicant will be notified and
`
`informed of any required corrective action in the next Office action. The objection to the
`
`drawings will not be held in abeyance.
`
`7.
`
`The drawings are objected to because one or more figures includes multiple
`
`different portions labeled as “Fig. [x], Cont’d”. Figures that continue on more than one
`
`sheet should be labeled by Figure number and then a capital
`
`letter corresponding to
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`how many sheets the figure continues on (i.e., A, B, etc.) See 37 CFR § 1.84.
`
`

`

`Application/Control Number: 15/121 ,623
`
`Page 4
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`Art Unit: 1643
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`Therefore, as an example, the different parts of Figure 34 appearing on separate sheets
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`should be labeled as Fig. 34A and Fig. 348‘. Corrected drawing sheets in compliance
`
`with 37 CFR 1.121 (d) are required in reply to the Office action to avoid abandonment of
`
`the application. Any amended replacement drawing sheet should include all of the
`
`figures appearing on the immediate prior version of the sheet, even if only one figure is
`
`being amended. The figure or figure number of an amended drawing should not be
`
`labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must
`
`be removed from the replacement sheet, and where necessary, the remaining figures
`
`must be renumbered and appropriate changes made to the brief description of the
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`several views of the drawings for consistency. Additional replacement sheets may be
`
`necessary to show the renumbering of the remaining figures. Each drawing sheet
`
`submitted after the filing date of an application must be labeled in the top margin as
`
`either “Replacement Sheet” or “New Sheet” pursuant
`
`to 37 CFR 1.121(d).
`
`If
`
`the
`
`changes are not accepted by the examiner, the applicant will be notified and informed of
`
`any required corrective action in the next Office action. The objection to the drawings
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`will not be held in abeyance.
`
`Appropriate correction is required.
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`8.
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`The drawings set forth as Figures 16 and 37 are objected to because the figures
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`depict nucleotide and/or amino acid sequences, which are not identified by sequence
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`identification numbers, either in the figures or in the brief descriptions of figures at
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`pages
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`72 and 75 of the specification, respectively. Sequences appearing in the
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`specification and/or drawings must be identified by a sequence identifier in accordance
`
`with 37 C.F.R. 1.821 (d); sequence identifiers for sequences appearing in the drawings
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`may appear in the drawings or in the brief description of the drawings.
`
`A replacement drawing sheet,
`
`including the correction,
`
`is
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`required,
`
`if
`
`the
`
`drawings are objected to. See 37 CFR 1.121(d). However, this ground of objection
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`would be withdrawn, so that a replacement drawing would be not be required,
`
`if
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`1 Furthermore as noted above the brief description of the figures should be amended to refer to each
`different part. So as an example the description of Figure 34 should be amended to refer to Fig. 34A and
`B.
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`

`

`Application/Control Number: 15/121 ,623
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`Page 5
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`Art Unit: 1643
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`Applicant were to amend the brief descriptions of the figures to include sequence
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`identification numbers of the nucleotide and/or amino acid sequences depicted by the
`
`figures.
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`Specification
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`9.
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`The specification is objected to because the Brief Description of the Drawings
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`fails to comply with 37 CFR 1.84(p)(5) which requires every reference character to be
`
`described in the brief description.
`
`In this case, the description of the figures do not
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`specifically refer to Figures labeled SB, 88, 8C, 1GB, 100, 10D, 10E, 10F and 11B.
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`10.
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`The disclosure is objected to for the following reason: The specification contains
`
`sequence disclosures that are encompassed by the definitions for nucleotide and/or
`
`amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). Sequences
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`appearing in the specification and/or drawings must be identified by sequence identifier
`
`in accordance with 37 C.F.R. 1.821(d).
`
`According to 37 CFR § 1.821(a), an
`
`unbranched sequence of
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`four or more specifically identified amino acids or an
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`unbranched sequence of ten or more nucleotides must be identified by sequence
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`identification numbers. See MPEP § 2422.01.
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`In this instance, the sequences depicted in Figures 16 and 37 are not identified
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`by sequence identification numbers, either in the figures or in the brief descriptions of
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`figures.
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`Applicant must provide appropriate amendments to the specification or drawings
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`inserting the required sequence identifiers.
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`Sequence identifiers for sequences
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`appearing in the drawings may appear in the drawings or in the brief description of the
`
`drawings.
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`As noted in the attached Notice to Comply, appropriate action correcting this
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`deficiency is required.
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`If necessary to correct the deficiency, Applicant must submit
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`paper and computer-readable copies of a substitute sequence listing, together with an
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`amendment directing its entry into the specification and a statement that the content of
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`both copies are the same and, where applicable, include no new matter.
`
`

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`Application/Control Number: 15/121 ,623
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`Page 6
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`Art Unit: 1643
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`11.
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`The specification is objected to because the use of
`
`improperly demarcated
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`trademarks has been noted in this application. Although the use of trademarks is
`
`permissible in patent applications,
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`the proprietary nature of
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`the marks should be
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`respected and every effort made to prevent
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`their use in any manner that might
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`adversely affect their validity as trademarks. See MPEP § 608.01 (v).
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`An example of such an improperly demarcated trademark appearing in the
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`specification is BiacoreT'V'; see, e.g., paragraph [0282] of the published application2.
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`Appropriate correction is
`
`required.
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`Each letter of a trademark should be
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`capitalized or otherwise the trademark should be demarcated with the appropriate
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`symbol
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`indicating its proprietary nature (e.g., TM, ®), and accompanied by generic
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`terminology. Applicants may identify trademarks using the “Trademark” search engine
`
`under
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`“USPTO
`
`Search
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`Collections”
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`on
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`the
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`Internet
`
`at
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`http://www.uspto.gov/web/menu/search.html.
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`12.
`
`Claim 3 is objected to because of the redundant recitation of “wherein the
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`antibody reduces ligand-induced growth of an ErbB-2 and ErbB-3 positive cell”‘°’.
`
`Claim Objections
`
`13.
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`Claim 3 is objected to because the claim recites, “wherein the cell has at least
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`100.000 ErbB-2 cell-surface receptors per cell”. As the claim refers to only one cell
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`it
`
`makes no sense to refer to the number of receptors per cell.
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`It is suggested that this issue might best be remedied by amending the claim to
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`recite, for example, “wherein the cell is a cell having at least 100,000 copies of ErbB-2
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`on its surface”.
`
`2 U.S. Patent Application Publication No. 2017/0037145-A1.
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`3 Claim 3 depends from claim 2, which recites this same limitation.
`
`

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`Application/Control Number: 15/121 ,623
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`Page 7
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`Art Unit: 1643
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`14.
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`Claims 21 and 22 are objected to as being drawn in the alternative to the subject
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`matter of a non-elected species of invention.
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`15.
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`Claims 21 and 22 are objected to because claims recite, “as depicted in Figure
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`16A or Figure 16E” and “as depicted in Figure 16B or Figure 16E or Figure 27”,
`
`respectively.
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`Claims must, under modern claim practice, stand alone to define
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`invention, and incorporation
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`into
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`claims
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`by express
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`reference to
`
`specification
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`and/ordrawings
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`is not permitted except
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`in very limited
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`circumstances.
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`See
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`Exparte Fresso/a, 27 USPQ2d 1608 (BPAI, 1993). See M.P.E.P. § 2173.05(s)4.
`
`16.
`
`The following is a quotation of 35 U.S.C. 112(b):
`
`Claim Rejections - 35 USC § 1 12
`
`CONCLUSION—The specification shall conclude with one or more claims
`(B)
`particularly pointing out and distinctly claiming the subject matter which the inventor or a
`joint inventor regards as the invention.
`
`17.
`
`Claims 1-4, 6-13, 18-22, 28, 30-33, 35, and 58-71 are rejected under 35 U.S.C.
`
`112(b) as being indefinite for failing to particularly point out and distinctly claim the
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`subject matter which the inventor or a joint inventor regards as the invention.
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`Claims 1-4, 6-13, 18-22, 28, 30-33, 35, and 58-71 are indefinite for the following
`
`reasons:
`
`(a)
`
`The claims use of the designations “ErbB-2” and ErbB-3” as the sole
`
`means of identifying the polypeptides to which the claims refer. The use of laboratory
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`designations only to identify a particular polypeptide renders the claims indefinite
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`because different
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`laboratories may use the same laboratory designations to define
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`completely distinct polypeptides and because the same polypeptide might be known by
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`4 M.P.E.P. 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by
`reference to a specific figure or table “is permitted only in exceptional circumstances where there is no
`practical way to define the invention in words and where it is more concise to incorporate by reference
`than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not
`for applicant's convenience.” Ex parte Fresso/a, 27 USPQ2d 1608, 1609 (Ed. Pat. App. & Inter. 1993)
`(citations omitted).
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`

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`Application/Control Number: 15/121 ,623
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`Page 8
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`Art Unit: 1643
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`any number of different aliases. For example,
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`it appears that the “ErbB-2” might be
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`otherwise known by aliases that include, for example, “HER-2”, “TKR1”, “CD340”, and
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`“neu”; and “Erbb3” may be known by other designations such as “HERB” and “LCCSZ”.
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`In addition,
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`it is aptly noted that the same term is often used in the art to describe not
`
`one polypeptide, but rather a plurality of polypeptides, which might be structurally and/or
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`functionally related, but otherwise distinct. For example, the same terms are often used
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`to describe various isoforms that are encoded by a single gene, which result from
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`translation of alternatively spliced transcripts of that gene; as another example,
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`the
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`same terms are frequently used to identify polypeptides that occur in different species of
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`animals, which although sharing certain structural and/or functional characteristics have
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`distinct structures and/or functions (e.g., orthologs and paralogs).
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`In this instance it
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`appears
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`that
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`structurally and/or
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`functionally disparate polypeptides
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`sharing the
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`designations “ErbBZ” or "ErbBB" occur in many different species of animals including,
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`for example, human, mouse, rat, dog, cat, zebrafish, hamster, chicken, chimpanzee,
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`baboon, pig, and frog.
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`35 U.S.C. § 112, second paragraph, requires the claim define the metes and
`
`bounds of the subject matter that is regarded as the invention with such clarity and
`
`particularity to permit the skilled artisan to know or determine infringing subject matter;
`
`because the terms used to describe the polypeptides to which the claims are directed
`
`do not unambiguously identify those polypeptides, this requirement has not been met.
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`It
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`is suggested that this issue might be remedied by amending the claims to
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`include recitations of the amino acid sequences of the polypeptides to which the claims
`
`refer. The amino acids sequences of these polypeptides may be referred to by
`
`inclusion in the claim of references to the sequence identification number of the amino
`
`acid sequences of the polypeptides as set forth in the Sequence Listing. Doing so
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`would be remedial since the amino acid sequences of the polypeptides are unique
`
`identifiers that unambiguously define the polypeptides.
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`However inasmuch as the claims are not drawn to a bispecific antibody that
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`simply binds to both of these proteins (i.e., "ErbB-2 and “ErbB-3") but rather to particular
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`portions thereof, it is essential that one know the limit or extent of these portions. The
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`

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`Application/Control Number: 15/121 ,623
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`Page 9
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`Art Unit: 1643
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`claimed antibody must bind to "domain I” of the polypeptide designated "ErbB-2” but of
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`what portion of the polypeptide is domain I comprised? The claimed antibody must bind
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`to "domain III” of the polypeptide designated "ErbB-3” but of what portion of the
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`polypeptide is domain lll comprised? In other words, which amino acid residues of the
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`primary structures of “ErbB-2” and “ErbB-3” delimit the N- and C-termini of domains I
`
`and III of these polypeptides, respectively? It appears that neither the term "domain I"
`
`of a polypeptide designated "ErbB-2" nor the term "domain III" of a polypeptide
`
`designated "ErbB-3" is expressly defined by the specification.
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`It would seem likely that
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`the decision to include residues, particularly at either extreme, of these domains might
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`be arbitrary or subjective.
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`If so it stands to reason that the metes and bound of the
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`subject matter that is encompassed by the claims might vary substantially depending
`
`upon one's chosen definition of these domains to which the antibody necessarily binds.
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`Accordingly it is submitted that one skilled in the art is not reasonably apprised by the
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`claims of the metes and bound of the subject matter that is regarded as the invention by
`
`Applicant. Therefore it is suggested that rather than just amending the claims to recite
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`the amino acid sequences of the polypeptides designated "ErbB-2" and "ErbB-3", these
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`issues are best remedied by amending the claims to recite the amino acid sequences of
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`domain I of ErbB-2 and domain III of ErbB-3. This is because the claims once amended
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`in this way would unambiguously point out the particular portions of these polypeptides
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`to which the claimed bispecific antibody must bind.
`
`(b)
`
`Claim 2 recites, “wherein the antibody reduces ligand-induced growth of
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`an ErbBZ- and ErbB-3 positive cell”. This recitation renders the claim indefinite because
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`it cannot be ascertained to which ligand the claim refers5. Notably there are many
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`different “ligands” that might induce the growth (proliferation) of a cell expressing ErbBZ
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`and ErbBB.
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`It is essential that one know or be able to ascertain the identities of the
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`ligands to which the claims refer in order to be apprised of the metes and bounds of the
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`subject matter that is regarded as the invention since the antibody must be an antibody
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`that is capable of reducing the effects of these ligands upon the proliferation of the cells.
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`5 For clarity claim 2 is construed as being directed to a ligand that is not necessarily a ligand of Erst.
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`

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`Application/Control Number: 15/121 ,623
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`Page 10
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`Art Unit: 1643
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`Is the antibody regarded as the invention any antibody that binds to ErbBZ and ErbBB
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`(or more particularly to domain I of ErbBZ and domain III of ErbBB) that is found to be
`
`capable of inhibiting the proliferative effects of any given ligand or just some? If only
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`some, which ones?
`
`(c)
`
`Claims 4, 13, 18, and 62-69 use of the designations “MCF-7”, “SKBR-3”,
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`“NCl-N87”, “BXPC-3”, “BT-474”, and/or “JIMT 1” as the sole means of identifying the
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`particular cells to which the claim refers. The use of laboratory designations only to
`
`identify a particular cell or cell
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`line renders the claims indefinite because different
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`laboratories may use the same laboratory designations to define distinct cells or cell
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`lines and because the same cells or cell
`
`lines might be known by any number of
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`different aliases.
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`As an example of the ambiguous use of one of these designations the prior
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`describes different "MCF-7” cell lines that are engineered to express variable levels of
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`an antigen (e.g., ErbBZ); and although these cells have disparate properties each is
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`referred to using the same designation.
`
`35 U.S.C. § 112(b) requires the claim define the metes and bounds of the subject
`
`matter that is regarded as the invention with such clarity and particularity to permit the
`
`skilled artisan to know or determine infringing subject matter; because the terms used to
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`describe the polypeptides to which the claims are directed do not unambiguously
`
`identify those polypeptides, this requirement has not been met.
`
`It
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`is suggested that this issue might be remedied by amending the claims to
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`include recitations of the depository accession numbers of biological deposits of the
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`different cells or cell
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`lines to which the claim refers.
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`This is because depository
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`accession numbers of biological deposits of cells or cell lines are unique identifiers that
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`unambiguously define particular cells or cell lines.
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`(d)
`
`Claim 10 recites, “wherein the antibody reduces ligand-induced growth of
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`an ErbBZ- and ErbB-3 positive cell”. This recitation renders the claim indefinite because
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`it cannot be ascertained to which ligand the claim refers6. Notably there are many
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`6 For clarity claim 10 is construed as being directed to a ligand that is not necessarily a ligand of ErbBS.
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`different “ligands” that might induce the growth (proliferation) of a cell expressing ErbB2
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`and ErbB3.
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`It is essential that one know or be able to ascertain the identities of the
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`ligands to which the claims refer in order to be apprised of the metes and bounds of the
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`subject matter that is regarded as the invention since the antibody must be an antibody
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`that is capable of reducing the effects of these ligands upon the proliferation of the cells.
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`Is the antibody regarded as the invention any antibody that binds to ErbB2 and ErbB3
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`(or more particularly to domain I of ErbB2 and domain III of ErbB3) that is found to be
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`capable of inhibiting the proliferative effects of any given ligand or just some? If only
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`some, which ones?
`
`(e)
`
`Claim 18 recites the limitations “the ErbB-3 positive cell” and “the ErbB-2
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`positive cell”. However since the preceding claim (i.e., claim 1) only refers to a ErbB-2
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`and ErbB-2 positive cell" it is unclear to which “ErbB-3 positive cell” and to which “ErbB-
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`2 positive cell” claim 18 refers.
`
`(f)
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`Claim 19 refers to multiple different amino acids occurring at particular
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`positions within an amino acid sequence (i.e., the amino acid sequence of "domain I of
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`ErbB-2", but does not include a recitation describing the actual amino acid sequence to
`
`which the claim refers. Therefore it
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`is not evident to which polypeptide or to which
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`domain or to which amino acid residues thereof the claim refers in order to permit one to
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`know or ascertain whether any given antibody is to be regarded as part of
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`the
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`invention7.
`
`(g)
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`Claim 19 recites, “comprising an antigen-binding site that binds at least
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`one amino acid of domain I of ErbB-2 selected from the group consisting of T144, T164,
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`R166, P172, G179, S180 and R181, and surface-exposed amino acid residues that are
`
`located within about 5 amino acid positions from T144, T164, R166, Pl72, G179, 8180
`
`or R181”.
`
`It is unclear if the Markush group consists of the amino acids T144, T164,
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`R166, P172, G179, S180 and R181 or the amino acids T144, T164, R166, P172, G179,
`
`7 Here Applicant is duly reminded that although the claims are interpreted in light of the specification,
`limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26
`USPQ2d 1057 (Fed. Cir. 1993).
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`8180, R181, and any amino acid located within about 5 amino acid positions from T144,
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`T164, R166, PI72, G179, 8180 or R181. Therefore it is unclear if the claimed antibody
`
`is an antibody that binds to at least one amino acid selected from T144, T164, R166,
`
`P172, G179, S180, and R181 of domain I of ErbB-2 or if it is antibody that binds to at
`
`least one amino acid selected from T144, T164, R166, P172, G179, 8180, R181, and
`
`any amino acid located within about 5 amino acid positions from T144, T164, R166,
`
`PI72, G179, 8180 or R181.
`
`(h)
`
`Claim 20 recites, “comprising an antigen-binding site that binds at least
`
`one amino acid of domain III of ErbB-3 selected from the group consisting and R426
`
`and surface-exposed amino acid residues that are located within 11.2 A from R426 in
`
`the native ErbB-3 protein”.
`
`It is unclear how this limitation should be reads.
`
`Nonetheless, inasmuch as it appears the claim is directed to an amino acid at a
`
`particular position within a particular amino acid sequence (i.e.,
`
`the amino acid
`
`sequence of “domain III of ErbB-3”) since the claim does not refer to the actual amino
`
`acid sequence it
`
`is not evident to which polypeptide or to which domain or to which
`
`amino acid residue thereof the claim refers; and as a consequence it is submitted that
`
`the claim fails to clearly and particularly point out the subject matter that is regarded as
`
`the invention, as absent a reference to the particular amino acid sequence in which the
`
`amino acid occurs at the position referred to by the claim it would not permit one to
`
`know or ascertain whether any given antibody is to be regarded as part of the invention.
`
`Lastly the claim indefinite because it is not evident to which particular polypeptide
`
`the claim refers in using of the term “the native ErbB-3 protein”.
`
`Is this protein “native”
`
`to a particular species of animal?
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`If so, which one? Is the use of the term "native"
`
`intended to indicate that the polypeptide is "wild-type", as opposed to "mutant"? What
`
`does it mean that the polypeptide is “the native ErbB-3 protein”?
`
`(i)
`
`Claims 21 and 22 use the terms “MF3958” and “MF3178” to refer to
`
`particular antibodies or perhaps portions of particular antibodies. The use of laboratory
`
`designations only to identify a particular antibody or perhaps a particular polypeptide,
`
`8 Should perhaps the claim read, “selected from the group consisting of R426 and surface-exposed amino
`acid residues that are located within 11.2 A of R426”?
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`Art Unit: 1643
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`which is a part of an antibody (e.g., the heavy chain of an immunoglobulin molecule),
`
`renders the claims
`
`indefinite because different
`
`laboratories may use the same
`
`laboratory designations to define completely distinct antibodies and portions thereof.
`
`Accordingly it is suggested that this issue be remedied by amending claims 21
`
`and 22 to include the depository accession number of the hybridoma or other cell line
`
`that produces the antibody to which the claims refer. This is because deposit accession
`
`numbers are unique identifiers which unambiguously define a given hybridoma or other
`
`cell
`
`line and the antibody that is produced thereby. Alternatively this issue might be
`
`remedied by amending claims 21 and 22 to recite the entirety of the amino acid
`
`sequence(s) of the antibodies or portions thereof to which the claims refer.
`
`For all of
`
`the above reasons it
`
`is submitted that
`
`the claims cannot be
`
`unambiguously construed. Accordingly the claims fail
`
`to delineate the metes and
`
`bounds of the subject matter that is regarded as the invention with the requisite clarity
`
`and particularity to permit the skilled artisan to know or determine infringing subject
`
`matter, so as to satisfy the requirements set forth under 35 U.S.C. § 112(b).
`
`Applicant is reminded that in accordance with a recent decision by the Federal
`
`Circuit (Hal/iburton Energy Services Inc. v. M—l LLC, 85 USPQ2d 1654, 1658 (Fed. Cir.
`
`2008»:
`
`35 U.S.C. § 112, 1] 2 [35 U.S.C. § 112(b)] requires that the specification of a
`patent “conclude with one or more claims particularly pointing out and distinctly claiming
`the subject matter which the applicant
`regards as his invention.” Because claims
`delineate the patentee’s right to exclude, the patent statute requires that the scope of the
`claims be sufficiently definite to inform the public of the bounds of the protected invention,
`i.e., what subject matter is covered by the exclusive rights of the patent. Otherwise,
`competitors cannot avoid infringement, defeating the public notice function of patent
`claims. Athletic Alternatives, Inc. v. Prince Mfg, Inc, 73 F.3d 1573, 1581 (Fed. Cir. 1996)
`(“[T]he primary purpose of the requirement is ‘to guard against unreasonable advantages
`to the patentee and disadvantages to others arising from uncertainty as to their
`[respective] rights.”’) (quoting Gen. Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364,
`369,
`(1938)). The Supreme Court has stated that “[t]he statutory requirement of
`particularity and distinctness in claims is met only when [the claims] clearly distinguish
`what
`is claimed from what went before in the art and clearly circumscribe what
`is
`foreclosed from future enterprise.” United Carbon Co. v. Binney & Smith Co., 317 U.S.
`228, 236 (1942).
`
`In addition Applicant is reminded that in determining whether the claims satisfy
`
`the requirement set forth under § 112(b), M.P.E.P. § 2106 (ll) states:
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`USPTO personnel are to give claims their broadest reasonable interpretation in
`light of the supporting disclosure.
`In