`
`Attorney's Docket No. 22338-10230
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`Patent
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`Control Nos.:
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`Confirmation Nos.:
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`90/007,542
`90/007,859
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`7585 (’542)
`6447 (’859)
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`Filed:
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`13 May 2005
`23 December 2005
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`(’542)
`(’859)
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`Patent Owner:
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`Genentech, Inc. and
`City of Hope
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`Group Art Unit:
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`3991
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`Examiner:
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`B.M. Celsa
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`For:
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`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly et al.)
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`RESPONSE UNDER 37 C.F.R. § l.550§b[
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`Mail Stop Ex Parte Reexam
`COMMISSIONER FOR PATENTS
`PO. Box 1450
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`Alexandria, VA 22313-1450
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`Sir:
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`This communication responds to the final Office action mailed February 16, 2007, setting
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`a two-month period for response. Owners timely requested an extension of time to respond
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`under 37 C.F.R. § 1.550(0), and in a Decision dated March 21, 2007, the Office granted an
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`extension to May 21, 2007. As this reply is filed within the extended period for response, it is
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`timely.
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`We believe that no fee is required for this response. Should any fee be required for entry
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`or consideration of this paper, the Director is requested to charge the appropriate amount to our
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`Deposit Account No. 18-1260.
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`Patent Owners (“Owners”) respectfully request reconsideration of the claims in View of
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`the following remarks.
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`Genzyme Ex. 1020, pg 569
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`
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`Reexamination Control Nos 90/007,542 & 90/007,859.(merged proceedings)
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`REMARKS
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`PRELIMINARY MATTERS ..............................................................................................................................5
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`INTERVIEW SUMMARY ................................................................................................................................... .. 5
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`DECISION ON PETITION .................................................................................................................................. A15
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`INFORMATION DISCLOSURE STATEMENTS ..................................................................................................... .. 5
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`WITHDRAWN REJECTIONS ......................... ..
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`E.
`
`STATUS OF LITIGATION INVOLVING THE ‘4 I 5 PATENT .................................................................................. .. 6
`
`OVERVIEW OF OWNERS’ RESPONSE TO NEW REJECTIONS IN FEBRUARY 2007 OFFICE
`ACTION ..............................................
`............................................................................................................6
`
`. THE REJECTION OF CLAIMS I-7, 9-10,14-I8, 2], AND 23-36 AS ANTICIPATED BY THE MOORE
`’545 PATENT IS IMPROPER AND SHOULD BE WITHDRAWN ...............................................................7
`
`A.
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`LEGAL STANDARDS GOVERNING THE EFFECTIVE DATE FOR § I02(E) PRIOR ART OF THE MOORE ’545
`I’A'l‘ENT .......................................................................................................................................................... .. 8
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`B. THE WRITTEN DESCRIPTION OF THE ’4 l4 APPLICATION — THE ONLY APPLICATION FILED PRIOR TO THE
`EFFECTIVE DATE or THE ’4 I 5 PATENT TO WHICH THE MOORE ’545 PATENT CLAIMS BENEFIT UNDER 35
`
`U.S.C. § I20 — DOES NOT DESCRIBE CO-EXPRESSION or HEAVY AND LIGHT CHAIN POLYPEPTIDES IN
`ONE HOST CELL .......................................................................................................................................... ._ 10
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`THE OFFICE IS INCORRECTLY INTERPRETING THE CLAIMS OF THE ’545 PATENT AS REQUIRING CO—
`EXPRESSION OF HEAVY AND LIGHT CHAINS IN ONE HOST CELL................................................................. .. I4
`
`ANOTHER EXPERT INDEPENDENTLY CONCLUDED IN 1996 THAT THE SPECIFICATION OF THE ’545 PATENT
`DOES NOT DESCRIBE CO-EXPRESSION ........................................................................................................ .. I7
`
`THE ’545 PATENT— TO THE LIMITED EXTENT IT CONSTITUTES PRIOR ART — DOES NOT ANTICIPATE THE
`’4 15 PATENT CLAIMS. ................................................................................................................................. .. 19
`
`. TH E REJECTION OF CLAIMS BASED ON OBVIOUSNESS PURSUANT TO 35 U.S.C. § I03(A) IS
`IMPROPER ........................................................................................................................................................20
`
`THE REJECTIONS BASED ON OBVIOUSNESS-TYPE DOUBLE PATENTING ARE IMPROPER ..22
`
`SUMMARY OF THE FOUR GROUNDS OF REJECTION FOR OBVIOUSNESS-TYPE DOUBLE PATENTING ............. .. 22_
`A.
`B. GENERAL ISSUES REGARDING THE OFFlCE’S MULTIPLE BASES FOR OBVIOUSNESS-TYPE DOUBLE
`PATENTING REJECTIONS .............................................................................................................................. .. 23
`
`Overview ofLegal Standards of Obviousness-Type Double Patenting................................................ .. 23
`
`The Correct Perspective for Evaluating Prior Art is a Person of Ordinary Skill In the Art as
`ofEarly April of I983, and the Declarations Submitted by Owners Provide This Perspective ........... .. 26
`
`The Oflice Ignores Distinctions Between the '5 67 and '41 5 Patent Claims Due to an Improper
`and Incorrect Reading ofthe '56 7 Claims and Specification .............................................................. .. 28
`
`The Oflice Improperly Relies on the Disclosures of the '5 6 7 Patent and the Utility ofIts
`Claims to Find a Suggestion or Motivation for C0-Expression Required by the '4I5 Patent
`Claims .................................................................................................................................................. .. 3 0
`
`a.
`
`b.
`
`The Disclosure and Teachings oflhe ’567 Patent May Not Be Used to Hold the ’4I5 Claims
`Unpatentable for Obviousness-Type Double Patenting ................................................................................. ..30
`The Office Continues to Erroneously Construe Terms In the ‘S67 Claims and to Improperly Use
`the Patent Disclosure to Find “Motivation" ................................................................................................... ..35
`
`The Rationale ofIn re Keller and In re Merck & Co. Can Not Justify the Oflice ‘s Failure to
`Consider Multiple Aspects of the Declarant Statements ...................................................................... .. 38
`
`The Oflice Has Improperly Relied on Testimony of an Interested Third Party, Rather Than
`Information In Patents or Printed Publications................................................................................... .. 40
`
`Genzyme Ex. 1020, pg 570
`
`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`C.
`
`THE REJECTION OF CLAIMS l-7, 9-1 I, AND 13-36 FOR OBVIOUSNESS-TYPE DOUBLE PATENTING (AT
`SECTIONS 4-6 OF THE OFFICE ACTION) MUST BE WITHDRAWN BECAUSE IT IS BASED PRIMARILY ON THE
`OFFlCE’S MISUSE AND INCORRECT ANALYSIS OF THE MOORE ’545 PATENT ............................................... .. 43
`
`I.
`
`The Rejection ofClaims 1-7, 9-11, 13-18, 21, and23-36 ls Improper, As It Can Not Be
`Supported by the '545 Patent............................................................................................................... .. 43
`
`2. Rejection ofClaims 19-20 and 22 Is Not Supported by the Additional References Relied Upon
`by the Oflice ......................................................................................................................................... .. 46
`THE REJECTION OF CLAIMS I-36 BASED ON THE ’567 CLAIMS, IN VIEW OF AXEL, RICE, OR KAPLAN, IN
`VIEW OF DALLAS, FURTHER IN VIEW OF DEACON, I981 VALLE, OR OCHI, AND OPTIONALLY IN VIEW OF
`THE ‘S45 PATENT IS IMPROPER .................................................................................................................... .. 47
`
`1.
`
`Axel, Rice, and Kaplan, Considered Alone, Together, or In Combination with Dallas, Would
`Not Provide a Motivation or Suggestion to Modifiz the '5 67 Claims to Transform a Host Cell
`With, and to Express In That Cell, Exogenous DNA Sequences Encoding Both Light and
`Heavy Immunoglobulin Chains................................................................................. .; ......................... .. 48
`a.
`Axel Does Not Describe or Suggest Co-Expression of Heavy and Light Antibody Chains In One
`Host Cell, or Production oflntact or Assembled Antibodies ......................................................................... ..49
`
`i.
`
`Clear and Convincing Evidence Supports Owners’ Reading ofAxel .................................................... .. Sl
`
`The Presumption of Validity and Enablement Law are Not implicated ................................................. .. 54
`ii.
`Rice Does Not Suggest Production of Exogenous Heavy and Light Chain Genes in a Single Host
`Cell 55
`
`i.
`
`Rice Does Not Describe Co-expression of an Exogenous Heavy Chain and an Exogenous
`Light Chain Gene ................................................................................................................................... ..57
`
`Rice Would Not Be Viewed as Being Generally Extendable to Expression of Multiple
`Exogenous Genes in Lymphocytes or Other Host Cell Types ............................................................... ..57
`
`iii. Dr. Baltimore’s Views Do Not Address the Question of Obviousness .................................................. ..59
`
`iv. Conclusions Regarding Rice .................................................................................................................. ..6l
`Kaplan Does Not Teach or Suggest Co-Expression of Heavy and Light Chains in a Single Host
`Cell 6|
`
`Dallas Would Not Have Provided Motivation to a Person ofOrdinary Skill in the Art to Modify
`the Procedures ofthe ’567 Claims Taken in View of Axel, Rice, and/or Kaplan .......................................... ..63
`
`The Deacon, Valle 1981, and Ochi References Would Not Provide a Further Motivation or
`Suggestion to Produce an Immunoglobulin Molecule or immunologically Functional
`Fragment Using the Claimed Processes and Methods. ....................................................................... .. 65
`a.
`The Teachings in Deacon and Valle I981 Are Greatly Limited and Would Not Set Expectations
`Concerning Transformed Host Cells ............................................................................................................. .. 65
`
`i.
`
`ii.
`
`A Xenopus Oocyte Is Not a “Host Cell” Let Alone 21 Transformed Host Cell ....... .3. ............................. ..67
`
`The Differences Between Translation of mRNA in a Xenopus Oocyte and Production of
`Immunoglobulin Chains by Transformed Host Cells Are Significant ................................................... ..68
`
`A Person ofOrdinary Skill in the Art Would Not Have Extrapolated the Results Concerning
`Assembly oflmmunoglobulins in Xenopus Oocyte mRNA Experiments to Transformed Host
`Cells ....................................................................................................................................................... ..70
`
`The Statements in the European Patent Office Opposition Proceedings Are Irrelevant and/or
`lnadmissable in the Present Reexamination Proceedings ...................................................................... ..7l
`Ochi and Oi Would Not Have Set Expectations for Production of an Immunoglobulin from Host
`Cells Transformed with Exogenous Heavy and Light Chain DNA ............................................................... ..73
`THE OFFlCE’S REJECTION OF THE DEPENDENT CLAIMS IS NOT SUPPORTED BY THE CITED REFERENCES .... .. 75
`
`E.
`
`1. Claim 5................................................................................................................................................. .. 75
`
`............................... .. 76
`2. Claims 6-8, 19, 20, and 26 ..................................................................................
`3. Claims 9 and 29 ................................................................................................................................... .. 77
`
`-3-
`
`Genzyme Ex. 1020, pg 571
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`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`Claims 10 and 27—32 ............................................................................................................................ .. 78
`
`Claim I 2............................................................................................................................................... _. 78
`
`Claim 14............................................................................................................................................... .. 79
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`. Claim 22 ............................................................................................................................................... .. 79
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`8. Claims 34-36........................................................................................................................................ .. 79
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`VI. CONCLUSIONS ................................................................................................................................................80
`
`Exhibit List to Res onse Filed Under 37 C.F.R.
`
`1.550 b
`
`-Exhibit A: Medlmmune Inc. v. Genentech Inc., No. 04-1300/04-1384 (Fed. Cir. Mar.
`7, 2007) Order Remanding Case; Medlmmune Inc. V. Genentech Inc., CV 03-2567
`(C.D. Cal. Apr. 12, 2007) Order Setting the Status Conference
`
`-Exhibit B: U.S. Application No. 06/358,414
`
`-Exhibit C: Second Supplemental Examiner’s Answer mailed January 11, 1996 for U.S.
`Application No. 08/165,530
`
`-Exhibit D: Declaration of Geoffrey T. Yarranton filed during prosecution of U.S.
`Application No. 08/165,530
`
`-Exhibit E: Office Action mailed May 30, 1997 for U.S. Application No. 08/165,530
`
`Genzyme Ex. 1020, pg 572
`
`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`Preliminary Matters
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`A.
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`Intcrvicw Summary
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`Representatives of Owners participated in an interview with Examiners Celsa, Jones, and
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`Ponnaluri on March 15, 2007. The interview summary form accurately reflects the subject of the
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`discussions between Owners’ representative and the representatives of the Office.
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`B.
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`Decision on Petition
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`Owners filed a petition under 37 C.F.R. §§ 1.181 and 1.182 on March 6, 2007, requesting
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`that the Office declare a new reexamination or, in the alternative, withdraw the finality of the
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`outstanding Office Action. In a decision mailed on March 21, 2007, the Office dismissed the
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`petition on procedural grounds. The decision indicated the Owners could file a renewed petition
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`under § 1.182 for a “Request for Continued Reexamination,” in accord with the interim policies
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`set forth in the notice regarding changes to reexamination practice published at 1292 Off. Gaz.
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`Pat. & Trademark Office 20 (March 1, 2005). Concurrently with this response, Owners are
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`filing a timely renewed petition under § 1.182, as suggested in the March 21, 2007 decision.
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`C.
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`Information Disclosure Statements
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`Owners acknowledge the indication that the materials provided in the information
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`disclosure statements filed on December 14, 2007 and January 16, 2007 have been fully
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`considered. A further information disclosure statement accompanies this response.
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`Owners also note that the Office has determined that the disclosure in U.S. Patent No.
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`4,642,334 (“the ’334 patent”) is cumulative to that of U.S. Patent No. 5,840,545 (“the ’545
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`patent”).
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`_S_e__e_: February Office Action, pp. 3-4. The ’334 patent was considered during the
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`examination of the application that matured into the patent under reexamination. Thus, the
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`Office fully considered the substance of the ’334 and ’S45 patent disclosures in connection with
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`the original examination of the claims of the ’41S patent.
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`D.
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`Withdrawn Rejections
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`Owners acknowledge and appreciate the decision of the Office to withdraw all previous
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`grounds of rejection imposed on claims 1 to 36.
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`In particular, the Office no longer is
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`maintaining any rejection based on a determination that the term “or” as it appears in one or
`
`Genzyme Ex. 1020, pg 573
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`
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`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`more claims of U.S. Patent No. 4,816,567 (“the ’567 patent”) was used with other than its
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`ordinary meaning (i.e., as referring to alternatives), and not as a “logical or” meaning (i.e., to
`
`mean “and/or”).
`
`Owners also observe that all outstanding rejections based on the ’567 patent; U.S. Patent
`
`No. 4,399,216 (“Aid”); Rice _et;aL, Proc. Nat. Acad. Sci. USA 79: 7862 (1982) (“Q”); Kaplan
`
`§_tLl., EP 0 044 722 (“§aj3_h1_n”); Accolla, Proc. Nat. Acad. Sci. USA 77: 563-566 (1980)
`
`(“Accolla”); Dallas, WO 82/03088 (“Di”); Builder, U.S. Patent No. 4,511,502 (“Builder”);
`
`Valle fig; E, 300: 71-74 (1982) (“Valle 1982”); Valle et al., 1_\I_atur_e_, 291: 338-340 (1981)
`
`(“Valle 1981”); Deacon et al., Biochem. Soc. Trans., 4: 818-20 (1976) (“Deacon”); Ochi LL,
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`i, 302: 340-342 (1983) (“gm”); and Oi gt_al_., Proc. Nat. Acad. Sci. USA 80: 825-829
`
`(1983) (“Q_i”), as imposed in the previous Office Action, were withdrawn:
`
`E.
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`Status of Litigation Involving the ’415 Patent
`
`Owners refer the Office to the previous response where litigation involving the ’41 5
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`patent was described.
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`In addition to that information, Owners note that on January 9, 2007, the
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`Supreme Court issued a decision reversing the decision of the Federal Circuit in Medlmmune
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`Inc. v. Genentech Inc., 427 F.3d 958, 76 U.S.P.Q.2d 1914 (Fed. Cir. 2005) and remanding it to
`
`the lower court. §_<;MedImmune Inc. v. Genentech Inc., 127 S.Ct. 764, 81 U.S.P.Q.2d 1225
`
`(2007). The Federal Circuit then issued a nonprecedential order, recalling the mandate, denying
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`Genentech’s motion for briefing and argument, and remanding the case to the district court for
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`further proceedings consistent with the Court’s opinion. E Medlmmune Inc. v. Genentech
`
`E, No. 04-1300/04-1384 (Fed. Cir. Mar. 7, 2007). The district court issued an order setting a
`
`status conference for June 4, 2007. % Medlmmune lnc. v. Genentech Inc., CV 03-2567 (C.D.
`
`Cal. Apr. 12, 2007). Copies of the Federal Circuit’s order remanding the case to the district
`
`court and the district court’s order setting the status conference are provided for the convenience
`
`ofthe Office in Exhibit A to this response.
`
`I].
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`Overview of Owners’ Response to New Rejections in February 2007 Office Action
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`The February 2007 Office Action, while acknowledging that certain portions of the
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`earlier rejections on August 16, 2007 must be withdrawn in light of the arguments and
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`clarifications provided by the Owners, introduced new grounds for rejecting all claims in the
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`Genzyme Ex. 1020, pg 574
`
`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`’4l5 patent.' Like the earlier rejections, these new rejections are improper. They are premised
`
`on a mistaken view of what the cited references would have taught or suggested to a person of
`
`ordinary skill in the art as of early April of 1983, and a number of incorrect scientific and legal
`
`assumptions. Owners, for the reasons set forth below, respectfully request withdrawal of these
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`new rejections.
`
`In Section 111 of this response, Owners demonstrate that the rejection of claims 1-7, 9-10,
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`14-18, 21, and 23-36 ofthe ’4l5 patent for anticipation under 35 U.S.C. § l02(e) is based on an
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`incorrect interpretation and improper use of the description and claims of the Moore ’545 patent,
`
`and a failure to properly focus on the disclosure of the one and only Moore application filed prior
`
`to the effective filing date of the ’4l5 patent (i.e., U.S. Application Serial No. 06/358,414 (“the
`
`’414 application,” Exhibit B) to which the ’545 patent claims benefit under 35 U.S.C. § 120.
`
`This rejection, being improper, must be withdrawn.
`
`In Section IV, Owners explain that the rejection by the Office of claims 1-7, 9-10, 14-21,
`and 23-36 of the ’41 5 patent pursuant to 35 U.S.C. § l03(a) are again based on this erroneous
`
`use and interpretation of the ’545 patent, and must be withdrawn.
`
`Finally, Section V examines the four theories of obviousness-type double patenting
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`advanced by the Office in its rejections, and explains why each one is without merit.
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`III.
`
`The Rejection of Claims 1-7, 9-10, 14-18, 21, and 23-36 as Anticipated by the Moore
`’545 Patent is Improper and Should Be Withdrawn
`
`Claims 1-7, 9-10, 14-18, 21, and 23-36 have been rejected under 35 U.S.C. § l02(e) as
`
`being anticipated by the Moore ’545 patent. This rejection should be withdrawn because the
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`claims of the Moore ‘S45 patent do not have a £3‘ l02(e) date prior to the effective filing date of
`
`the ’4l 5 patent, and because the specification of the ’545 patent does not describe procedures for
`
`co-expression of heavy and light chain polypeptides in a single transformed host cell.
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`Accompanying this response, and discussed below, are declarations from four qualified
`
`Owners note that the Office offers its views on constmction of various terms in the ’4l5 and ’567 patent claims
`at pages 8-9 of the Office Action. These observations are not accurate in several respects. Since these
`observations are not being made in the context of setting forth rejections (and certain interpretations are
`repeated later in the Office Action), Owners are electing to respond to the inaccuracies only as they arise in
`connection with a specific rejection, infra Owners expressly reserve their right to contest these interpretations
`in any subsequent proceedings.
`
`Genzyme Ex. 1020, pg 575
`
`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`scientists who each provide detailed analyses of the Moore ’545 patent and the Moore ’4l4
`
`application. These experts have concluded that there is no description of co-expression
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`procedures in the Moore ’4l4 application and that the claims of the ’545 patent, as interpreted by
`
`the Office, are not described in the originally-filed Moore specification. Owners also discuss
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`below evidence presented to the Office in unrelated proceedings, involving unrelated parties, that
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`likewise demonstrated (apparently to the satisfaction of the Office) that the originally—filed
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`Moore specification does not disclose co-expression of immunoglobulin heavy and light chains
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`in a single host cell.
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`A.
`
`Legal Standards Governing the Effective Date for § l02(e) Prior Art of the
`Moore ’545 Patent
`
`The law is well settled that the prior art effective date under § l02(e) of a patent which
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`claims the benefit under 35 U.S.C. § 120 to one or more earlier filed applications is the filing
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`date of the earlier application (if any) that provides a disclosure of the claimed invention that
`
`complies with 35 U.S.C. § 112, first paragraph.
`
`In re Wertheim, 646 F.2d 527, 537, 209
`
`U.S.P.Q. 554, 564 (C.C.P.A. 1981); M.P.E.P. § 2l36.03(IV).
`
`ln Wertheim, the court was asked to address the specific questionof the effective prior art
`
`date under §§ l02(e)/103 of a patent which made benefit claims to a series of earlier applications
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`under § l20. 646 F.2d at 536, 209 U.S.P.Q. at 563-64. The Office asserted that the issued patent
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`was prior art under §§ l02(e)/103 as of the filing date of the first of these earlier applications. 1d_.
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`The court reversed, holding that a patent should be entitled to prior art effect under § l02(e) as of
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`the filing date of an earlier application only if the subject matter of the later issued patent claims
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`was disclosed in that earlier application in a manner that would be sufficient under § 1 12, first
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`paragraph. Q at 537-39, 209 U.S.P.Q. at 564-65. (“Thus, the determinative question here is
`
`whether the invention claimed in the Pfluger patent finds a supporting disclosure in compliance
`
`with § 1 12, as required by § 120, in the 1961 Pfluger I application so as to entitle that invention
`
`in the Pfluger patent, as ‘prior art,’ to the filing date of Pfluger 1. Without such support, the
`
`invention, and its accompanying disclosure, cannot be regarded as prior art as of that [Pfluger I
`
`application] filing date”). The court observed that a contrary outcome would extend the secret
`
`prior art doctrine beyond its logical foundation (Q, that the subject matter patented could be
`
`Genzyme Ex. 1020, pg 576
`
`
`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`fairly considered actually disclosed in the earlier application only if the patent claims could have
`
`been issued from that earlier application without dependence on information in the later filings).
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`1; at 537, 209 U.S.P.Q. at 564 (“[W]e will extend the ‘secret prior art’ doctrine of Milbum and
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`Hazeltinc only as far as we are required to do so by logic of those cascs.”)2 The Wertheim court
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`then held that the Pfluger patent “cannot be used as a reference under § 102(e) alone against the
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`Wertheim invention as of the date of a Pfluger application which does not describe the Wertheim
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`invention, as claimed.” Lgl_._ That is, the court held that the § 102(e) effective date of the Pfluger
`
`patent was limited to the filing date of only those earlier applications that described the subject
`
`matter claimed in the Pfluger patent in a manner that met the requirements of 35 U.S.C. § 112,
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`first paragraph.
`
`The written description requirement prevents applicants from using the amendment
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`process to update their disclosures (by claim amendment or amendment of the specification)
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`during their pendency before the Patent Office. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247,
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`1255, 70 U.S.P.Q.2d 1321, 1326 (Fed. Cir. 2004). Ifit were “otherwise[,] applicants could add
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`new matter to their disclosures and date them back to their original filing date, thus defeating an
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`accurate accounting ofthe priority of invention. See 35 U.S.C. 132.” Q at 1255, 70 U.S.P.Q.2d
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`at 1326-27. Accordingly, the law is well settled that a patent is entitled to a prior art effective
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`date under § l02(e) as of the filing date of an earlier application to which a benefit claim is made
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`under § 120 only if that earlier application provides a disclosure for the claimed subject matter
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`that fully complies with the requirements of § 112, first paragraph.
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`The Moore ’545 patent issued from U.S. Application Serial No. 08/461,071 (“the ’071
`
`application”). That application claims the benefit under 35 U.S.C. § 120 to eight earlier
`
`applications.3 The originating application in this chain, U.S. Application Serial No. 06/358,414,
`
`The conceptualjustification for giving a U.S. patent prior art status earlier than the date that the contents of the
`patent become public (so-called “secret prior art”) was first articulated in Alexander Milbum Co. v. Davis-
`Boumonville Co., 270 U.S. (I926).
`
`The ’O7l application was not described as being a continuation-in-part of any of its predecessor applications.
`E ’545 patent, col. 1, lines 4 to 17. However, the labels used by an applicant in describing the relationships of
`the predecessor applications are not conclusive as to whether the predecessor applications provide written
`description support for the later claimed invention. Transco Products Inc. v. Performance Contracting, Inc., 38
`F.3d 551, 556, 32 U.S.P.Q.2d 1077, 1080 (Fed. Cir. 1994) (“[N]o matter what term is used to describe a
`continuing application, that application is entitled to the benefit of the filing date of an earlier application only
`as to common subject matter.”) Thus, what controls for assessing entitlement of one application (or patent
`
`-9-
`
`Genzyme Ex. 1020, pg 577
`
`
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`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`was filed on March 15, 1982. The Moore ’4l4 application is the only one ofthe applications in
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`the chain filed before the effective filing date of the ’4l5 patent. Thus, in order for the ’545
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`patent claims to be prior art under § l02(e), the ’4l4 application must satisfy, inter alia, the
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`written description requirement of 35 U.S.C. § 112, first paragraph, for these two claims. Injre
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`Wertheim, 646 F.2d at 537, 209 U.S.P.Q. at 564. To meet that requirement, the ’414 application
`
`must contain a written description that reasonably conveys to one of ordinary skill in the art that
`
`the inventor possessed the later-claimed subject matter of claims 1 and 2 of the ’545 patent.
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`Tronzo v. Biomet Inc., 156 F.3d 1154, 1158, 47 U.S.P.Q.2d 1829, 1832 (Fed. Cir. 1998). As
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`explained below, it plainly does not.
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`B.
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`The Written Description of the ’4l4 Application — the Only Application Filed
`Prior to the Effective Date of the ’415 Patent to Which the Moore ’545 Patent
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`Claims Benefit Under 35 U.S.C. § 120 — Does Not Describe Co-Expression of
`Heavy and Light Chain Polypeptides In One Host Cell
`
`According to the Office, the claims of the Moore ’545 patent show a host cell and method
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`of making an immunologically functional immunoglobulin fragment that meet the requirements
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`ofclaims 1-5, 14-18, 21, 23-25, and 33 ofthe ’415 patent.
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`Assuming that the Office’s interpretation of the Moore ’545 patent claims is correct (an
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`issue that Owners address in Section III(C) below), those claims are not prior art to the ’415
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`patent. As will be explained below, a person skilled in the art would not find any description
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`within the Moore ’4l4 application of (a) the host cell and process that the Office contends are
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`defined by the two claims of the Moore ’545 patent, or (b) any co-expression concepts. This is
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`demonstrated by the analysis provided in the accompanying declarations under 37 C.F.R. § 1.132
`
`of Dr. Sidney Altman, Dr. Steven McKnight, Dr. Michael Botchan, and Dr. Matthew Scott.
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`Each of these experts, as of the effective filing date of the ’4l5 patent, was practicing in the field
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`of the present invention, and enjoys impeccable scientific credentials. Each of these experts has
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`performed a careful scientific analysis of the contents of the ’4l4 application and explains why
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`the ’4l4 application does not describe any procedure for producing within a single host cell two
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`different polypeptides (g:_.g_., corresponding to heavy and light chain sequences of an
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`issued therefrom) to an earlier effective filing date is whether the earlier-filed application meets the
`requirements of 35 U.S.C. § I12, first paragraph, as to the later-filed application’s claimed invention. M.P.E.P.
`§ 20l.ll(l)(B)). As will be discussed in section lIl(B), M such is not the case between the ’07l application
`and the '4 I4 application.
`
`Genzyme Ex. 1020, pg 578
`
`
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`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`immunoglobulin).
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`Instead, the experts conclusively demonstrate in their respective declarations
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`that the only procedures reasonably conveyed by the ’414 application for producing
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`immunoglobulin light and heavy chain variable domain polypeptides are ones directed to the
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`production of each polypeptide in a separate host cell culture.
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`_S_e§ Botchan Declaration, 111] 32,
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`36; McKnight Declaration, 111] 27-31; Scott Declaration, 111] 8,
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`1 1; Altman Declaration, 1111 7, 1 1,
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`12.
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`The only process described in the ’414 application for producing an rFv binding
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`composition is one where individual light and heavy immunoglobulin variable region
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`polypeptides are produced in sgpag cell cultures, isolated from the separate cell cultures, and
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`then combined i_n_v_ijt_r_o to form the rFv. This is unequivocally set forth at page 16, lines 24-28 of
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`the ’414 application (the ‘S45 patent at col. 10, lines 8-12), where the written description of the
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`’4l4 application plainly states:
`
`The resulting construct is then introduced into an appropriate host to
`provide expression of the heavy or light polypeptide members of the rFv
`and the polypeptides isolated. The heavy and light polypeptide members
`of the rFv are then combined in an appropriate medium to form to the rFv.
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`(emphases added). The “resulting construct” is a plasmid that contains a single DNA insert
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`encoding either a heavy g a light chain variable region polypeptide, not both. See, gg,,
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`McKnight Declaration, 111] 14, 15, 24-25, 27, 45-46, 48; Botchan Declaration, 1111 27, 28, 31-32,
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`36, 39; Scott Declaration 111] 9, 11; Altman Declaration 111] 11-12.
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`Similarly, at pages 17-18 (the ’545 patent at col. 10, line 56, to col. 11, line 6), the
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`application states:
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`Where the light or heavy chain is not secreted, the transformed
`microorganisms containing the appropriate ds cDNA for either light or
`heavy chains are grown in liquid cultures and cleared lysates prepared.
`These lysates are then passed over an immunosorbent affinity column
`prepared as described above, employing the specific polyclonal antisera.
`The bound variable regions are eluted from the column with an
`appropriate denaturing solvent. The eluates from each of the heavy and
`light chain isolations are pooled, followed by treatment to renature the
`polypeptides to form L-rFv and H-rFv respectively. For renaturation, the
`pooled eluates may be dial