IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
` Control No.:
`
`90/007,542
`
`Confirmation No.:
`
`7585
`
`Group Art Unit:
`
`3991
`
`Examiner:
`
`B. Celsa
`
`Filed:
`
`13 May 2005
`
`Patent Owner:
`
`Genentech, Inc. and
`
`City of Hope
`
`For:
`
`I
`
`Reexamination of U.S. Patent No. 6,331,415
`
`Mail Stop Ex Parte Reexam
`COMMISSIONER FOR PATENTS
`P.O. Box 1450
`
`-
`
`Alexandria, VA 22313-1450
`
`RESPONSE UNDER 37 C.F.R. § l.550[b[
`
`Sir:
`
`This communication is responsive to the Patent Office’s communication mailed
`
`September 13, 2005. Owners note that on October 26, 2005, they filed a petition for
`
`extension of time to respond to the Patent Office’s September 13, 2005 communication. That
`
`petition was granted by James Dwyer, the Director for the Central Reexamination Unit, on
`
`November 7, 2005, extending Owner’s time to respond to the Patent Office’s communication
`
`through November 27, 2005. The owners of U.S. Patent No. 6,331,415 respectfully request
`
`reconsideration of the rejection of the claims in view of the following remarks.
`
`Remarks begin on Page 4.
`
`Genzyme Ex. 1009, pg 257
`
`Genzyme Ex. 1009, pg 257
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`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`Table of Contents
`
`I.
`II.
`
`............................................................... .. '4
`...............................
`Overview of the Response ........
`Information Disclosure Statement ............................................................................................... .. 6
`
`III.
`
`Interview Summary ..................................................................................................................... .. 6
`
`IV.
`
`Summary of Litigation Activity and Related Proceedings Concerning U.S.
`Patent No. 6,331,415 (the ‘415 patent) ....................................................................................... .. 7
`
`7
`A. Medlmmune v. Genentech Proceeding ............................................................................
`B.
`Celltech v. Genentech Interference Proceeding .................................................................. .. 8
`
`l.
`
`2.
`
`Prosecution of the ‘419 Application Prior to Interference .......................................... .. 8
`
`Summary of the ‘S72 Interference ............................................................................ .. 10
`
`C.
`
`3.
`
`Prosecution of the ‘419 Application Subsequent to Termination of
`Interference ............................................................................................................... .. 12
`Past Findings of the PTO During Prosecution of the ‘415, ‘567 and Boss
`Patents Establish that the Claims of the ‘415 Patent Are Patentably Distinct
`from the Claims of the ‘567 Patent ................................................................................... .. 13
`
`V.
`
`Response to Rejections ............................................................................................................. .. 15
`
`A.
`
`Basis of the Rejections as Set forth in the Office Action .................................................. .. 15
`
`B. Observations on the Inventions Defined by the Claims of the ‘567 and ‘415
`Patents ............................................................................................................................... .. 17
`
`1. Claims of the ‘567 Patent Encompass Embodiments that Have an
`Independent and Distinct Utility Relative to Embodiments Encompassed
`by Claims of the ‘415 Patent ..................................................................
`................ .. 17
`The ‘567 Patent Claims Do Not Require Antigen Binding Functionality ................ .. 20
`2.
`The Claims of the ‘415 and ‘567 Patents Are Not Related as Genus and
`Species .......................................... .. .................................................................................. .. 21
`1. Claim 1 of the ‘415 Patent Does Not Define a “Genus” That Includes a
`
`C.
`
`“Species” Defined by Claim 1 of the ‘567 Patent ..................................................... .. 22
`
`(a) A Genus Claim Must Fully Encompass the Species Claim ............................... ..22
`
`(b) Analysis Must Be Based on a Comparison of Each Claim Considered as Whole
`........................................................................................................................... ..23
`
`(c) Comparison of Claim 1 of the ‘S67 Patent to Claim 1 of the ‘415 Patent ......... ..24
`
`(d) Claim 1 of the ‘415 Patent Includes Material Elements Not Required by Claim 1
`ofthe ‘567 Patent .............................................................................................. ..25
`
`(e) Claim 1 and 13 of the ‘415 Patent Can be Infringed Without Necessarily
`Infringing Claim 1 of the ‘567 Patent and Vice Versa ...................................... ..25
`
`(t) Domination is Irrelevant to an Obviousness—Type Double Patenting Analysis ...26
`2. Claim 21 of the ‘41 5 Patent Does Not Define a “Genus” That Includes a
`
`“Species” Defined by Claim 1 of the ‘567 Patent................. ... ................................. .. 28
`3. Claim 33 of the ‘415 Patent Does Not Define a “Genus” That Includes a
`
`“Species” Defined by Claim 1 of the ‘S67 Patent..................................................... .. 29
`4. Claims 15-17 of the ‘41 5 Patent Do Not Define a “Genus” That Includes
`
`a “Species” Defined by Claim 5 of the ‘567 Patent .................................................. .. 30
`5. Claim 18 of the ‘415 Patent Does Not Define a “Genus” That Includes a
`“Species" Defined by Claim 7 of the ‘567 Patent ..................................................... .. 31
`
`2
`
`Genzyme Ex. 1009, pg 258
`
`Genzyme Ex. 1009, pg 258
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`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`E.
`
`The Examiner Has Not Established a Prima Facie Case that Claims 2-12, 14,
`19, 20, 22-31 and 33-36 are Unpatentable for Obviousness-Type Double
`Patenting ........................................................................................................................... .. 32
`1. General Observations on Axel .................................................................................. .. 33
`
`2. General Observations on Rice .................................................................................. .. 38
`
`3. Claims 2, 3 and 25 Were Improperly Rejected and Are Not Obvious
`Based on Claim 1 of the ‘567 Patent Taken in View of Axel [See, OA, 1]
`b, pages 8-9]. ............................................................................................................ .. 43
`
`4. Claims 4 and 5 Were Improperly Rejected and Are Not Obvious Based on
`Claim 1 of the ‘S67 Patent ‘Taken in View of Axel and Kaplan. [See, OA,
`1] b, page 9] ............................................................................................................... .. 44
`
`5. Claims 6-8, 19, and 26 Were Improperly Rejected and Are Not Obvious
`Based on Claims 1 and 21 ofthe ‘567 Patent Taken in View of Axel,
`Rice and/or Kaplan. [See, OA, 1] b, pages 9] ................................ ... ......................... .. 46
`
`6. Claims 9 and 29 Were Improperly Rejected and Are Not Obvious Based
`on Claim 1 the ‘567 Patent Taken in View of Axel and/or Rice. [See, OA,
`1] b, page 9-10] .......................................................................................................... .. 47
`
`7. Claims 10, 27, 28, and 31 Were Improperly Rejected and Are Not
`Obvious Based on Claims 1 and 21 of the ‘567 Patent Taken in View of
`
`Kaplan, Builder and the “admitted prior art." [See, OA, 1] b, pages 10-11] .............. .. 48
`
`8. Claim 16 Was Improperly Rejected and Is Not Obvious Based on Claim 1
`of the ‘567 Patent Taken in View of Axel or Kaplan. [See, OA, 1] b, page
`11] ............................................................................................................................ .. 49
`
`9. Claims 18 and 20 Were Improperly Rejected and Are Not Obvious Based
`on Claim 1 of the ‘567 Patent of Axel and Rice.
`[See, OA, 1] b, page 11] ............... .. 50
`
`10. Claim 22 Was Improperly Rejected and Is Not Obvious Based on Claim 1
`of the ‘567 Patent Taken in View of Accolla (PNAS, 77:563-566, 1980)
`or the admitted prior art of Gold and Van Nagell. [See, OA, 1] b, page 12] .............. .. 51
`
`1 1. Claims 23 and 24 Were Improperly Rejected and Are Not Obvious Based
`on Claim 1 of the ‘567 Patent of Taken in View of Rice. [See, OA, 1]b,
`page 12] ......................................................................................
`............................ .. 52
`12. Claim 30 Was Improperly Rejected and Is Not Obvious Based on Claim 1
`ofthe ‘567 Patent Taken in View of Kaplan. [See, OA 1] b, pages 12-13] ............... .. 53
`
`13. Claim 32 Was Improperly Rejected and Is Not Obvious Based on Claim 3
`of the ‘567 Patent Taken in View of Kaplan and Builder [See, OA 1] b,
`page 13] .................................................................................................................... .. 54
`
`14. Claims 34, 35, and 36 Were Improperly Rejected and Are Not Obvious
`Based on Unspecified Claims of the ‘567 Patent Taken in View of Axel,
`Rice, Kaplan, and Builder. [See, OA 1] b, page 13-14] ............................................. .. 55
`
`VI. Conclusions .............................................................................................................................. .. 56
`
`Genzyme Ex. 1009, pg 259
`
`Genzyme Ex. 1009, pg 259
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`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`I.
`
`Overview of the Response
`
`In the September 13, 2005 Office Action, the Office rejected the independent claims
`
`and certain dependent claims of U.S. Patent No. 6,331,415 (the ‘4l5 patent) for obviousness-
`
`type double patenting solely in view of certain claims of U.S. Patent No. 4,816,567 (the ‘567
`
`patent). The Office also has rejected the remaining dependent claims of the ‘4l5 patent for
`
`obviousness-type double patenting based on certain claims of the ‘567 patent taken in view of
`several printed publications and patents.
`
`The ‘4l5 patent claims are directed to production of immunoglobulin molecules or
`
`immunologically functional fragments comprising at least the variable domains of the heavy
`
`and light immunoglobulin chains. These claims require the production of both heavy @
`light immunoglobulin chains in a single host cell. The ‘567 patent claims, by contrast, do not
`
`require production of an immunoglobulin molecule or an immunologically functional
`
`fragment. They also do not require that both the heavy and the light chains be produced in
`
`one host cell. Instead, they recite, and thus require only that a single chimeric
`
`immunoglobulin light or heavy chain be produced, and that the end result of the process be a
`
`heavy or light chimeric immunoglobulin chain polypeptide.
`
`Each of the rejections is premised on an incorrect characterization of the claims of the
`
`two patents, and on numerous factual and legal errors.
`
`In summary:
`
`-
`
`-
`
`The Examiner improperly construes the claims of the ‘4l5 and ‘567 patents.
`Specifically, the Examiner incorrectly portrays claims of the ’567 patent as
`defining “species” included within the scope of what he believes are “genus”
`claims in the ‘4l5 patent, which, under his logic, would cause the ‘567 patent
`claims to anticipate the ‘415 patent claims. The Examiner’s errs by comparing
`only one feature shared by the claims of the two patents (i.e., whether the
`immunoglobulin chains are “chimeric” or not),'instead of comparing what
`each claim, considered as a whole, defines. When the claims are construed
`
`properly, it is apparent that the inventions claimed in the ‘567 patent and the
`inventions claimed in the ‘4l5 patent are not related as species and genus.
`
`The Examiner improperly focuses on the fact that claims of the ‘567 patent
`“read on” and thus “dominate” subject matter also claimed by the ‘41 5 patent.
`This is legally irrelevant to the question of obviousness-type double patenting.
`Instead, an obviousness-type double patenting analysis must compare what the
`claims of the second patent require relative to what claims of the first patent
`require. The claims of the ‘567 patent and the claims of the ‘41 5 patent recite,
`and therefore require, different elements or features.
`
`Genzyme Ex. 1009, pg 260
`
`Genzyme Ex. 1009, pg 260
`
`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`-
`
`-.
`
`Each of the rejections of the remaining dependent claims of the ‘4l5 patent is
`grounded on the Office’s incorrect finding that the underlying independent
`claim is anticipated by the ‘567 patent. The Examiner engages in an overly
`simplistic exercise of locating in -the prior art references the elements required
`by the ‘4l5 dependent claims that are missing from the ‘567 patent claims.
`The Examiner’s approach mischaracterizes the teachings and suggestions of
`the cited references, and what those references would have suggested to a
`person of skill in the art in early April of 1983. Read properly, none of the
`cited references would have rendered the dependent claims of the ‘415 patent
`obvious to a person of skill in the art in early April of 1983.
`
`The rejections of all of the ‘415 patent claims for obviousness-type double
`patenting contradict numerous past findings by the Board of Patent Appeals
`and Interferences (the “Board”) and different Examiners that claims to
`production of immunoglobulin molecules or immunologically functional
`fragments requiring production of heavy @ light chains in a single host cell
`are separately patentable from claims that do not reguire production of both
`heavy and light chains in a single host cell.
`
`The rejections of the claims of the ‘415 patent thus are plainly improper and should be
`
`withdrawn.
`
`During the interview on October 25, 2005, the Examiners invited Owners to provide
`
`their views on two prior art references, namely, U.S. Patent No. 4,399, 216 to Axel et al
`
`(“Axel”) and Rice et al., Proc. Natl. Acad. Sci. USA 79:7862-7865, December 1982 (“Rice”).
`
`Owners note that the Office has not rejected the independent claims of the ‘415 patent
`
`based on the ‘S67 patent claims, taken in View of 1}, R_ig_e_, or any other prior art. Similarly,
`
`neither the Third Party Requestor nor the Office in its Order for Reexamination has suggested
`
`that the claims of the ‘567 patent, taken in view of $21, Ric_e, or any other prior art, would
`
`have rendered the independent claims of the ‘41 5 patent obvious. Rejecting the independent
`
`claims of the ‘415 patent as being obvious from the ‘567 patent claims taken in view of _./1xe_l
`
`or 1 would contradict repeated findings by the Office that the independent claims of the
`
`‘4l5 patent are not obvious over the ‘567 claims. Doing so would present an entirely new
`
`ground of rejection not suggested in the Office Action of September. 13, 2005, the Order
`
`establishing this reexamination, or even the Third Party Request.
`
`_ Nonetheless, Owners provide comments on Axel and'Rice in response to the
`
`Examiner’s invitation at the interview to do so. As explained below, neither Axel nor Rice
`
`would have suggested to a person of skill in the art, in early April of 1983, that the inventions
`
`defined by the ’4l 5 patent claims are obvious variants of the ’567 claims. Simply put, neither
`
`5
`
`Genzyme Ex. 1009, pg 261
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`Genzyme Ex. 1009, pg 261
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`

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`Control No. 90/007,542
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`Attomey Docket No. 22338-10230
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`Axel nor Rice suggests producing immunoglobulin molecules or immunologically functional
`
`fragments by producing heavy and light immunoglobulin chains in a single transformed host
`
`cell.
`
`II.
`
`Information Disclosure Statement
`
`An information disclosure statement will be filed shortly after this response. The
`
`Examiner is respectfiilly requested to acknowledge receipt and review of the items provided
`
`with the information disclosure statement.
`
`11].
`
`Interview Summary
`
`On October 25, 2005, Representatives of the Owners (“Representatives”) participated
`
`in an interview with Examiners Celsa, Vollano, Huang, Helms and Blanchard. The interview
`
`was requested to discuss the basis of the rejections set forth in the Office Action dated
`
`September 13, 2005.
`
`In addition, per the request of Examiner Blanchard, the interview
`
`addressed questions regarding the distinctions between the processes defined by the claims of
`
`the ‘41 5 patent and those defined by the claims of the ‘567 patent.
`
`During the course of the interview, the Examiners indicated that the primary basis of
`
`the rejections set forth in the Office Action was their view that the claims of the ‘41 5 patent
`
`defined a “genus” that encompassed “species” claimed in the ‘567 patent. The Examiners
`
`also indicated that the other references cited in the Office Action were being relied upon
`
`primarily to address features of the rejected dependent claims of the ‘415 patent that were not
`
`found in the claims of the ‘567 patent.
`
`Representatives provided an overview of the distinctions between the claims of the
`
`‘415 patent and the claims of the ‘567 patent and explained that they are not related as genus
`
`and species, respectively. Representatives also addressed the law governing double patenting.
`
`During the interview, the Examiners invited Owners to address certain issues in
`
`Owner’s response to the Office Action, and information regarding events that occurred during
`
`the prosecution ofthe application that matured into the ‘415 patent (i.e., U.S.S.N. O7/205,419,
`
`or the ‘4l9 application). These included:
`
`Genzyme Ex. 1009, pg 262
`
`Genzyme Ex. 1009, pg 262
`
`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`(i)
`
`(ii)
`
`(iii)
`
`(iv)
`
`a brief summary of the prosecution of the ‘419 application, including the claim
`amendments made, and the substance of the interview conducted on October
`
`4, 2001;
`
`an explanation of the restriction requirements imposed in the ‘419 application,
`including whether these restrictions were at any point withdrawn or mooted by
`claim amendments, and how the various claims presented during the
`prosecution of the ‘419 application related to the restriction requirements;
`
`an overview of the interference proceeding that involved the ‘419 application,
`along with a copy of the judgment rendered in the resulting § 146 action;
`
`an explanation of the meaning of “heavy or light chain having specificity for a
`particular known antigen” as that phrase is used in the claims of the ‘567
`patent; and
`5
`
`(v)
`
`the relevance, if any, of Axel or Rice, to the question of obviousness of the
`processes defined in the ‘415 patent in view the ‘567 patent.
`
`Information responsive to items (i) to (iii) is provided in section IV, below, and in the
`
`Declaration of Wendy M. Lee under 37 C.F.R. § 1.132 (“Lee Declaration”). Information
`
`responsive to items (iv) and (v) is provided in section V, below.
`
`IV.
`
`Summary of Litigation Activity and Related Proceedings Concerning U.S. Patent
`No. 6,331,415 (the ‘415 patent).
`
`A.
`
`Medlmmune v. Genentech Proceeding
`
`The ‘4 1 5 patent was at issue in a Declaratory Judgment action brought against
`
`Genentech, Inc., et al. by Medlmmune, Inc. in the Central District of California (Case No. CV
`
`03-2567). The lawsuit included claims for violation of antitrust and unfair competition laws
`
`and for patent invalidity. The District Court entered summary judgment in favor of
`
`Genentech, et al. on all the antitrust and unfair competition claims and dismissed the patent
`
`invalidity claims as being nonjusticiable under the Declaratory Judgment Act. Sfi,
`
`
`Medlmmune Inc. v. Genentech Inc., CV 03-2567 (C.D. Cal. Jan 14, 2004; February 18,
`
`2004; April 26, 2004). The Court of Appeals for the Federal Circuit affinned the decisions of
`
`
`the District Court. Si, Medlmmune Inc. v. Genentech Inc., No. 04-1300/04-1384 (Fed. Cir.
`
`October 18, 2005). Medlmmune has filed a petition for a writ of certiorari to the United
`
`States Supreme Court in connection with this decision; a decision on that petition is now
`
`pending. Copies of the District Court and Federal Circuit opinions, and the Medlmmune
`
`petition are provided for the convenience of the Office in Exhibit A to this response.
`
`Genzyme Ex. 1009, pg 263
`
`Genzyme Ex. 1009, pg 263
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`

`
`Control No. 90/007,542
`
`Attorney Docket No. 22338-10230
`
`B.
`
`Celltech v. Genentech Interference Proceeding
`
`The application that issued as the ‘4l5 patent (i.e., U.S.S.N. 07/204,419) was involved
`
`in Interference No. 102,572 (the ‘572 interference) with U.S. Patent No. 4,816,397, issued to
`
`Boss et al. (the “Boss” patent) on March 28, 1989. That same day, the PTO issued the ‘567
`
`patent to Cabilly. A brief summary of this interference and its relevance to the present
`
`reexamination proceeding is provided below in response to the invitation of the Examiners at
`
`the October 25, 2005, interview. The Examiner is also invited to consider a simplified
`
`timeline of the prosecution of the ‘4l9 application, provided as Exhibit B to this response, as
`
`well as the Lee Declaration, provided herewith.
`
`1.
`
`Prosecution of the ‘419 Application Prior to Interference
`
`The ‘4l9 application was filed on June 10, 1988 as a Rule 60 continuation application
`
`of U.S.S.N. 06/483,467 that ultimately issued as the ‘567 patent. On March 6, 1990, the PTO
`
`imposed requirements for restriction and election of species in the ‘4l9 application (see paper
`no. 4; Lee Declaration, Exhibit B). The restriction was between processes, vectors and host
`
`cells on the one hand, and compositions of insoluble heavy chain, light chain or Fab
`
`fragments, on the other.
`
`In the election of species requirement, the Examiner found claims to
`
`vectors, transformed host cells and processes for making an immunoglobulin heavy o_r light
`
`chain to be patentably distinct from vectors, host cells and methods of making an
`
`“immunoglobulin heavy chain AND light chain.(capitals in original)”
`
`On March 9, 1990, Owners amended the ‘419 application by canceling the then-
`
`pending claims of the ‘4l9 application (which were the subject of the March 6, 1990
`
`restriction and election of species requirement) and by adding new claims corresponding to
`
`claims 1 to 18 of the Boss patent.
`
`_Sg_e_, ‘419 application, paper no. 5; Lee Declaration,
`
`Exhibits C and D. Owners observed in this amendment that while the method specified in the
`
`copied claims can be used for making chimeric immunoglobulins, it is not necessary to use
`
`that method when practicing the methods claimed in the ‘567 method “since the chimeric
`
`immunoglobulin chains can be produced in host cells transformed @ with heavy or light
`
`chain, but not both” (emphasis in original) as called for in the copied Boss patent claims.
`
`Owners also expressed their View that the Office, by issuing the Cabilly ‘567 patent claims
`
`and the Boss patent claims as separate patents, had concluded that these two sets of claims
`
`defined separately patentable inventions.
`
`Genzyme Ex. 1009, pg 264
`
`Genzyme Ex. 1009, pg 264
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`

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`Control No. 90/007,542
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`Attorney Docket No. 22338-10230
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`On March 30, the Examiner issued a communication indicating that he viewed
`
`cancellation of the then-pending claims as non-responsive to the restriction requirement in
`
`that application.
`_S_e_e, ‘419 application, paper number 6; Lee Declaration, Exhibit E. On May
`2, 1990, owners re-introduced certain of the canceled claims and affirmatively elected the
`
`species conceming “vectors, hosts and methods of making an immunoglobulin heavy chain
`
`AND light chain (in insoluble form).” S3, ‘419 application, paper 8; Lee Declaration,
`
`Exhibit F. To correct typographical errors in the numbering of the claims added to the ‘419
`
`application, two subsequent amendments were made (Si, Lee Declaration, particularly
`
`paragraph 9, and Exhibit C to this response, which provides a detailed summary of the claim
`
`amendments made in the ‘419 application).'
`
`On September 7, 1990, the PTO imposed another restriction requirement. _S_c;§, ‘419
`
`application, paper no. 11; Lee Declaration, Exhibit 1.
`
`In this restriction, the PTO
`
`differentiated claims 67 to 86_(which required independent expression of heavy and light
`
`immunoglobulin chains in a single host cell, and thus corresponded to the claims of the Boss
`
`patent) from claims 87 to 100 (which did not require the heavy and light chains to be
`
`produced in a single host cell). The Examiner provided the following justification:
`
`Inventions Group I and Group II are distinct and independent of each
`
`other, and as such, will support separate patents. The method of Group
`
`I is drawn to immunoglobulin chains which are independently expressed in
`the transformed host cell while the method of the second Group does not
`
`make this distinction. Further Group I refers to the antibody fragment
`
`composed of both heavy and light mime regions whereas Group II refers
`
`to a fragment composed of the either the heavy or light chains with
`
`variable and constant regions present in each chain (underlined emphasis
`
`in original, bold emphasis added).
`
`The Examiner thus held claims corresponding to the ‘4l 5 patent claims were patentably
`
`distinct from claims that did not require production of heavy and light immunoglobulin
`
`chains in a single host cell.
`
`'
`
`'
`
`Claims 88~l 00 of the supplemental amendment filed on July I9, 1990, depended from cancelled claims
`53, 58, 59, or 66, rather than from 87, 92, 93 or 99., The Examiner disregarded these typographical errors
`for purposes of the restriction requirement. The further supplemental amendment filed August 24, I990
`
`Genzyme Ex. 1009_, pg 265
`
`Genzyme Ex. 1009, pg 265
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`

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`Control No. 90/007,542
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`Attorney Docket No. 22338-10230
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`A third supplemental amendment was filed on September 13, 1990 (‘419 application,
`
`‘paper 12) to respond to concerns raised by the Examiner as to formal matters.
`
`In that
`
`amendment, claims 67-100 were canceled and were reintroduced as (renumbered) claims 101-
`
`134. §e_e, Lee Declaration, Exhibit K. Aside from the renumbering of the claims, claims
`
`101-120 were the same as claims 67-86 (Group I claims) and claims 121-134 were the same
`
`as claims 87-100 (Group II claims). _S;e;e, Exhibit C to this response. Thus, following this
`
`third supplemental amendment, claims 101-135 were pending in the ‘419 application. Claims
`
`101-120 corresponded to claims 1-18 of the Boss patent. Claims 121-134, however, were
`
`directed to inventions that did not require the production of both the heavy and the light
`
`immunoglobulin chain in a single host cell.
`
`2.
`
`Summary of the ‘S72 Interference
`
`On February 28, 1991, the Board of Patent Appeals and lnterferences (BPAI) declared
`
`an interference (the ‘S72 interference) between the copied claims (claims 101-120) in the
`
`‘419 application and claims 1-18 of the Boss patent. gag, ‘419 application, paper no. 11; Lee
`
`Declaration, Exhibit L. The count was defined to be claim 1 of the Boss patent, which was
`
`identical to claim 101 of the ‘419 application. As such, the count defined a process in which
`
`a single host cell is transformed to independently express DNA sequences encoding heavy
`
`and light immunoglobulin chains, and further requires that an immunoglobulin molecule or
`
`immunologically functional immunoglobulin fragment result from the process.
`
`When the Board declared the interference, it excluded claims then pending in the ‘419
`
`application that did r_19_t require a single host cell to be transformed with
`
`seguence
`
`encoding both a heavy @ a light immunoglobulin chain.‘ SE, Lee Declaration, Exhibit L.
`
`Specifically, claims 101 to 120 (corresponding to claims 1-18 of Boss)'were designated as
`
`corresponding to the count, while claims 121 to 134 were designated as n_ot corresponding to
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`the count. These undesignated claims were never added to the interference. The Board
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`confirmed this in its “Final Order After District Court Judgment”, (‘419 application, paper no.
`18 and Lee Declaration, Exhibit N). E, particularly paragraphs C.4 to C.6. The Board thus
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`twice confimied that claims that did not require production of heavy and light chains in one
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`host cell did not correspond to the count of the interference, which did require production of
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`heavy and light chains in one host cell.
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`correcting informal errors in claim dependency for claims 88-] 00 was entered afler issuance of the
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`10
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`Genzyme Ex. 1009, pg 266
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`Genzyme Ex. 1009, pg 266
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`

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`Control No. 90/007,542
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`Attorney Docket No. 22338-10230
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`A determination by the Board that claims do not correspond to the interference count
`‘reflects the Board’s determination that such claims are separately patentable over the count.
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`As explained in In re Van Guens, 988 F.2d 1181, 1185 (Fed. Cir. 1993):
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`"When an interference is declared between a patent and an application, the
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`PTO rules require that "[a]ll claims in the application and patent which
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`define the same patentable invention as a count shall be designated to
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`correspond to the count." 37 C.F.R. §1.606. The PTO rules define what
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`is meant by the same patentable invention with the following example:
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`Invention A is the "same patentable invention" as an invention "B" when
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`invention "A" is the same as (35 U.S.C. 102) or is obvious (35 U.S.C. 103)
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`in view of invention "B" assuming invention "B" is prior art with respect
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`to invention "A". 37 C.F.R. § 1.601(n) (emphasis added)."
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`Thus, by not designating claims 121 to 134 of the ‘419 application as corresponding to the
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`count, the Board found that the claims that eventually issued in the ‘4l5 patent were
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`separately patentable in view of claims which did not require the production, in a single host
`cell, of both heavy and light immunoglobulin chains, and vice versa.2
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`Like claims 121 to 134 of the ‘419 application, the claims of the ‘567 patent were
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`never designated as corresponding to the count of the ‘572 interference.
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`In fact, during the
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`interference, the Board was presented with the question of whether to add the ‘567 patent to
`the ‘572 interference, and declined to do so. Specifically, on June 5, 1991, Cabilly requested
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`the Examiner—in-Chief (EIC) to exercise her discretion to add a then-pending Boss
`application. The claims in that application were rejected and had been restricted from the
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`claims in the Boss patent involved in the interference. Boss responded to this request by
`asserting that the claims in the application had not been allowed, but added that if the EIC
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`exercised her discretion to add this Boss application, that she should also add the ‘567 patent
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`to the proceeding.
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`In a July 26, 1991 decision, the Board declined to add either the Boss
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`restriction requirement.
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`See, MPEP 804, subsection ll.B.l, which observes that “[s]ince the analysis employed in an obviousness-
`type double patenting determination parallels the guidelines for a 35 U.S.C. l03(a) rejection, the factual
`inquiries set forth in Graham v. John Deere Co., 383 U.S. l. 148 USPQ 459 (I966), that are applied for
`establishing a background for determining obviousness under 35 U.S.C. I03 are employed when making
`an obvious-type double patenting analysis."
`
`”
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`Genzyme Ex. 1009, pg 267
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`Genzyme Ex. 1009, pg 267
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`

`
`Control No. 90/007,542
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`Attorney Docket No. 22338-10230
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`application or the Cabilly "567 patent to the proceeding. SQ, Lee Declaration, particularly
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`Exhibit M.
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`As noted above, the decision of the Board to not add the ‘567 patent to the
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`interference is an additional consistent finding by the Board that the claims of the ‘S67 patent
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`did not anticipate or render obvious claim 1 of the ‘4l 5 patent. This is the only logical
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`explanation for the Board’s decision to not add the ‘S67 patent claims to the ‘572
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`interference. When the Board decides to not designate claims as corresponding to a count,
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`that decision represents a determination by the Board that the count is separately patentable _
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`over those claims, and vice versa, because the claims and the count do not define the “same
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`invention” (i.e., a claimed invention that is anticipated or rendered obvious by the other
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`claimed invention).
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`On August 13, 1998, the Board issued a final judgment awarding priority to Boss. On
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`October 9, 1998, pursuant to 35 U.S.C. § 146, Owners filed a civil action in the Northern
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`District of California (Case No. C98-3926 MMC).3 Subsequently, Genentech and Celltech,
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`Ltd., the assignee of the Boss patent, entered into an agreement which provided a basis for
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`settling the litigation. On March 16, 2001, the district court entered judgment on the issue of
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`priority in favor of Genentech. A copy of the judgment entered in the § 146 action in the
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`Northern District of California is provided for the convenience of the Office as Exhibit D to
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`this response.
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`As a consequence of the Court’s disposition of the § 146 action, on July 25,
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`2001, the Board vacated its August 13, 1998 decision, awarded priority to Cabilly, and
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`I returned the ‘415 application to the Examiner to take action as dee