IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Patent
`Attorney's Docket No. 22338-10230
`
`Control Nos.:
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`Confinnation Nos.:
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`90/007,542
`90/007,859
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`7585 ('542)
`6447 ('859)
`
`filed:
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`13 May 2005
`23 December 2005
`
`('542)
`('859)
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`Patent Owner:
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`Genentech, Inc. and
`City of Hope
`
`Group Art Unit:
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`3991
`
`Examiner:
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`B.M. Celsa
`
`For:
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`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly eta!.)
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`RESPONSE UNDER 37 C.F.R. § 1.550(b)
`
`Mail Stop Ex Parte Reexam
`COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`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.P.R.§ 1.550(c), 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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`Sanofi/Regeneron Ex. 1010, pg 310
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`Merck Ex. 1010, pg 336
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 {merged proceedings)
`
`REMARKS
`
`I.
`
`PI{ELIMINARY MATTERS .............................................................................................................................. S
`
`INTERVIEW SUMMARY ..................................................................................................................................... 5
`A.
`B. DECISION ON PETITION .................................................................................................................................... 5
`C.
`INFORMATION DISCLOSURE STATEMENTS ....................................................................................................... 5
`
`D. WITHDRAWN REJECTIONS ............................................................................................................................... 5
`
`E. STATUS OF LITIGATION INVOLVING THE '4 15 PATENT .................................................................................... 6
`
`II. OVERVIEW OF OWNERS' RESPONSE TO NEW REJECTIONS IN FEBRUARY 2007 OFFICE
`ACTION ................................................................................................................................................................ 6
`
`Ill. 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 ............................................................... 7
`A. LEGAL STANDARDS GOVERNING THE EFFECTIVE DATE FOR§ I 02(E) PRIOR ART OF THE MOORE '545
`PATENT ............................................................................................................................................................ 8
`B. THE WRITTEN DESCRIPTION OF THE '414 APPLICATION -THE ONLY APPLICATION FILED PRIOR TO THE
`EFFECTIVE DATE OF THE '415 PATENT TO WHICH THE MOORE '545 PATENT CLAIMS BENEFIT UNDER 35
`U.S.C. § 120- DOES NOT DESCRIBE CO-EXPRESSION OF HEAVY AND LIGHT CHAIN POLYPEPTIDES IN
`ONE HOST CELL ............................................................................................................................................ I 0
`
`C. THE OFFICE IS INCORRECTLY INTERPRETING THE CLAIMS OF THE '545 PATENT AS REQUIRING CO-
`EXPRESSION OF I-lEA VY AND LIGHT CHAINS IN ONE HOST CELL. .................................................................. 14
`
`D. ANOTHER EXPERT INDEPENDENTLY CONCLUDED IN 1996 THAT THE SPECIFICATION OF THE '545 PATENT
`DOES NOT DESCRIBE CO-EXPRESSION .......................................................................................................... 17
`
`E. THE '545 PATENT- TO THE LIMITED EXTENT IT CONSTITUTES PRIOR ART- DOES NOT ANTICIPATE THE
`'415 PATENT CLAIMS .................................................................................................................................... 19
`
`IV. THE REJECTION OF CLAIMS BASED ON OBVIOUSNESS PURSUANT TO 35 U.S.C. § 103(A) IS
`IMPROPER ........................................................................................................................................................ 20
`
`V. THE REJECTIONS BASED ON OBVIOUSNESS-TYPE DOUBLE PATENTING ARE IMPROPER .. 22
`
`I.
`2.
`
`A. SUMMARY OF THE FOUR GROUNDS OF REJECTION FOR OBVIOUSNESS-TYPE DOUBLE PATENTING ............... 22
`8. GENERAL ISSUES REGARDING THE OFFICE'S MULTIPLE BASES FOR OBVIOUSNESS-TYPE DOUBLE
`PATENTING REJECTIONS ................................................................................................................................ 23
`Overview of Legal Standards of Obviousness- Type Double Patenting .................. ............................. 23
`The Correct Perspective for Evaluating Prior Art is a Person of Ordinary Skillin the Art as
`of Early April of I 983, and the Declarations Submitted by Owners Provide This Perspective ............. 26
`The Office Ignores Distinctions Between the '567 and '415 Patent Claims Due to an Improper
`and Incorrect Reading of the '567 Claims and Specification ................................................................ 28
`The Office Improperly Relies on the Disclosures of the '567 Patent and the Utility of Its
`Claims to Find a Suggestion or Motivation for Co-Expression Required by the '415 Patent
`Claims ................................................................................................................................................... 30
`a.
`The Disclosure and Teachings of the '567 Patent May Not Be Used to Hold the '415 Claims
`Unpatentable for Obviousness-Type Double Patenting ................................................................................... 30
`b. The Office Continues to Erroneously Construe Terms In the '567 Claims and to Improperly Use
`the Patent Disclosure to Find "Motivation" ..................................................................................................... 35
`The Rationale of In re Keller and In re Merck & Co. Can Not Justify the Office's Failure to
`Consider Multiple Aspects of the Declarant Statements ........................................................................ 38
`The Office Has Improperly Relied on Testimony of an Interested Third Party, Rather Than
`Information In Patents or Printed Publications ..................................................................................... 40
`
`3.
`
`4.
`
`5.
`
`6.
`
`-2-
`
`Sanofi/Regeneron Ex. 1010, pg 311
`
`Merck Ex. 1010, pg 337
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`C. THE REJECTION OF CLAIMS 1-7, 9-11, AND 13-36 FOR OBVIOUSNESS-TYPE DOUBLE PATENTING (AT
`SECTIONS 4-6 OF HIE OFFICE ACTION) MUST BE WITHDRAWN BECAUSE IT IS BASED PRIMARILY ON THE
`OFFICE'S MISUSE AND INCORRECT ANALYSIS OF THE MOORE '545 PATENT ................................................. 43
`I.
`The Rejection ofC/aims 1-7. 9-11, 13-18, 21, and 23-36Is Improper, As It Can Not Be
`Supported by the '545 Patent ................................................................................................................. 43
`2. Rejection of Claims /9-20 and 22 Is Not Supported by the Additional References Relied Upon
`.................. ..................... ........................ .................... .................
`by the Office.....................
`
`. .... 46
`
`D. THE REJECTION OF CLAIMS 1-36 BASED ON THE' 567 CLAIMS, IN VIEW OF AXEL, RICE, OR KAPLAN, IN
`VIEW OF DALLAS, FURTHER IN VIEW OF DEACON, 1981 VALLE, OR OCHI, AND OPTIONALLY IN VIEW OF
`THE '545 PATENT IS IMPROPER ...................................................................................................................... 4 7
`I. Axel, Rice, and Kaplan, Considered Alone, Together, or In Combination with Dallas, Would
`Not Provide a Motivation or Suggestion to Modify the '567 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 of Intact or Assembled Antibodies ........................................................................... 49
`
`i.
`
`Clear and Convincing Evidence Supports Owners' Reading of Axel ..................................................... 51
`
`ii. The Presumption of Validity and Enablement Law are Not Implicated .............................. .
`b. Rice Does Not Suggest Production of Exogenous Heavy and Light Chain Genes in a Single Host
`Cell 55
`
`..54
`
`i.
`
`Rice Does Not Describe Co-expression of an Exogenous Heavy Chain and an Exogenous
`Light Chain Gene ................................................................................................................. .
`
`.. .... 57
`
`ii. 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 of0bviousness .................................................... 59
`
`iv. Conclusions Regarding Rice .................................................................................................................... 61
`c. Kaplan Does Not Teach or Suggest Co-Expression of Heavy and Light Chains in a Single Host
`Cell 61
`d. Dallas Would Not Have Provided Motivation to a Person of Ordinary Skill in the Art to Modify
`the Procedures of the '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. ........................... ........................................
`a.
`The Teachings in Deacon and Valle 1981 Are Greatly Limited and Would Not Set Expectations
`Concerning Transformed Host Cells ............................................................................................................... 65
`
`.. 65
`
`2.
`
`i.
`
`A Xenopus Oocyte Is Not a "Host Cell" Let Alone a Transformed Host Cel1 ........ : ................................ 67
`
`ii. The Differences Between Translation ofmRNA in a Xenopus Oocyte and Production of
`Immunoglobulin Chains by Transformed Host Cells Are Significant ..................................................... 68
`
`iii. A Person of Ordinary Skill in the Art Would Not Have Extrapolated the Results Concerning
`Assembly of Immunoglobulins in Xenopus Oocyte mRNA Experiments to Transformed Host
`Cells ......................................................................................................................................................... 70
`
`iv. The Statements in the European Patent Office Opposition Proceedings Are Irrelevant and/or
`Inadmissable in the Present Reexamination Proceedings ........................................................................ 71
`b. 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
`
`E. THE OFFICE'S REJECTION OF THE DEPENDENT CLAIMS IS NOT SUPPORTED BY THE CITED REFERENCES ...... 75
`I. Claim 5 ................................................................................................................................................... 75
`2. Claims 6-8, /9, 20, and 26 ..................................................................................................................... 76
`3. Claims 9 and 29 ..................................................................................................................................... 77
`
`-3-
`
`Sanofi/Regeneron Ex. 1010, pg 312
`
`Merck Ex. 1010, pg 338
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`4. Claims 10 and 27-32 .............................................................................................................................. 78
`5. Claim 12..... ... . . ... ............... . . .. .......... ..... .. .................... ...................... .. . . . .................... ... ................ . . . 78
`6. Claim I 4 ..... ............................................................................................................................................ 79
`7. Claim 22 ................................................................................................................................................. 79
`8. Claims 34-36 .......................................................................................................................................... 79
`
`VI. CONCLUSIONS ................................................................................................................................................ 80
`
`Exhibit List to Response 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; Medimmune, 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 ofU.S.
`Application No. 08/165,530
`
`-Exhibit E: Office Action mailed May 30, 1997 for U.S. Application No. 08/165,530
`
`-4-
`
`Sanofi/Regeneron Ex. 1010, pg 313
`
`Merck Ex. 1010, pg 339
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`I.
`
`Preliminary Matters
`
`A.
`
`Interview Summary
`
`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 I, 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
`
`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
`
`patent"). See February Office Action, pp. 3-4. The '334 patent was considered during the
`
`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 '545 patent disclosures in connection with
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`the original examination of the claims of the '415 patent.
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`D. 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 I to 36. 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
`
`- 5 -
`
`Sanofi/Regeneron Ex. 1010, pg 314
`
`Merck Ex. 1010, pg 340
`
`

`
`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
`
`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 ("Axel"); Rice et al., Proc. Nat. Acad. Sci. USA 79: 7862 (1982) ("Rice"); Kaplan
`
`et al., EP 0 044 722 ("Kaplan"); Accolla, Proc. Nat. Acad. Sci. USA 77: 563-566 (1980)
`
`("Accolla"); Dallas, WO 82/03088 ("Dallas"); Builder, U.S. Patent No. 4,511,502 ("Builder");
`
`Valle et al., Nature, 300: 71-74 (1982) ("Valle 1982"); Valle et al., Nature, 291: 338-340 ( 1981)
`
`("Valle 1981"); Deacon et al., Biochem. Soc. Trans., 4: 818-20 (1976) ("Deacon"); Ochi et al.,
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`Nature, 302: 340-342 (1983) ("Ochi"); and Oi et al., Proc. Nat. Acad. Sci. USA 80: 825-829
`
`(1983) ("Oi"), as imposed in the previous Office Action, were withdrawn:
`
`E.
`
`Status of Litigation Involving the '415 Patent
`
`Owners refer the Office to the previous response where litigation involving the '415
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`patent was described. In addition to that information, Owners note that on January 9, 2007, the
`
`Supreme Court issued a decision reversing the decision of the Federal Circuit in Medimmune,
`
`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. See 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
`
`Genentech's motion for briefing and argument, and remanding the case to the district court for
`
`further proceedings consistent with the Court's opinion. See Medlmmune, Inc. v. Genentech,
`
`Inc., No. 04-1300/04-1384 (Fed. Cir. Mar. 7, 2007). The district court issued an order setting a
`
`status conference for June 4, 2007. See Medlmmune, Inc. 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
`
`of the Office in Exhibit A to this response.
`
`II.
`
`Overview of Owners' Response to New Rejections in February 2007 Office Action
`
`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
`
`clarifications provided by the Owners, introduced new grounds for rejecting all claims in the
`
`- 6 -
`
`Sanofi/Regeneron Ex. 1010, pg 315
`
`Merck Ex. 1010, pg 341
`
`

`
`Reexamination Control Nos 90!007,542 & 90!007,859 (merged proceedings)
`
`'415 patent. 1 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 III of this response, Owners demonstrate that the rejection of claims 1-7, 9-10,
`
`14-18,21, and 23-36 ofthe '415 patent for anticipation under 35 U.S.C. § 102(e) is based on an
`
`incorrect interpretation and improper use of the description and claims ofthe 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 '415 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 '415 patent pursuant to 35 U.S.C. § 103(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
`
`advanced by the Office in its rejections, and explains why each one is without merit.
`
`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. § 102(e) as
`
`being anticipated by the Moore '545 patent. This rejection should be withdrawn because the
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`claims of the Moore '545 patent do not have a§ 102(e) date prior to the effective filing date of
`
`the '415 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.
`
`Accompanying this response, and discussed below, are declarations from four qualified
`
`Owners note that the Office offers its views on construction of various terms in the '415 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.
`
`- 7-
`
`Sanofi/Regeneron Ex. 1010, pg 316
`
`Merck Ex. 1010, pg 342
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`scientists who each provide detailed analyses of the Moore '545 patent and the Moore '414
`
`application. These experts have concluded that there is no description of co-expression
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`procedures in the Moore '414 application and that the claims ofthe '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.
`
`A.
`
`Legal Standards Governing the Effective Date for§ 102(e) Prior Art of the
`Moore '545 Patent
`
`The law is well settled that the prior art effective date under § 102( e) of a patent which
`
`claims the benefit under 35 U.S.C. § 120 to one or more earlier filed applications is the filing
`
`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. § 2136.03(IV).
`
`In Wertheim, the court was asked to address the specific question of the effective prior art
`
`date under§§ l02(e)/103 of a patent which made benefit claims to a series of earlier applications
`
`under§ 120. 646 F.2d at 536, 209 U.S.P.Q. at 563-64. The Office asserted that the issued patent
`
`was prior art under §§ 1 02( e )/1 03 as of the filing date of the first of these earlier applications. I d.
`
`The court reversed, holding that a patent should be entitled to prior art effect under§ I 02(e) as of
`
`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 § 112, first
`
`paragraph. Id. 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 § 112, 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 I. 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 Ci&., that the subject matter patented could be
`
`- 8 -
`
`Sanofi/Regeneron Ex. 1010, pg 317
`
`Merck Ex. 1010, pg 343
`
`

`
`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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`Id. at 537, 209 U.S.P.Q. at 564 ("[W]e will extend the 'secret prior art' doctrine of Milburn and
`
`Hazeltine only as far as we arc required to do so by logic of those cascs."i The Wertheim court
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`then held that the Pfluger patent "cannot be used as a reference under § 1 02(e) alone against the
`
`Wertheim invention as of the date of a Pfluger application which does not describe the Wertheim
`
`invention, as claimed." Id. That is, the court held that the § I 02(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,
`
`first paragraph.
`
`The written description requirement prevents applicants from using the amendment
`
`process to update their disclosures (by claim amendment or amendment of the specification)
`
`during their pendency before the Patent Office. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247,
`
`1255,70 U.S.P.Q.2d 1321, 1326 (Fed. Cir. 2004). If it were "otherwise[,] applicants could add
`
`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." Id. at 1255,70 U.S.P.Q.2d
`
`at 1326-27. Accordingly, the law is well settled that a patent is entitled to a prior art effective
`
`date under § I 02( e) as of the filing date of an earlier application to which a benefit claim is made
`
`under § 120 only if that earlier application provides a disclosure for the claimed subject matter
`
`that fully complies with the requirements of§ 112, first paragraph.
`
`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 conceptual justification 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 Milburn Co. v. Davis(cid:173)
`Boumonville Co., 270 U.S. (1926).
`
`The '071 application was not described as being a continuation-in-part of any of its predecessor applications.
`See '545 patent, col. I, 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, I 080 (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-
`
`Sanofi/Regeneron Ex. 1010, pg 318
`
`Merck Ex. 1010, pg 344
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`was filed on March 15, 1982. The Moore '414 application is the only one of the applications in
`
`the chain filed before the effective filing date of the '415 patent. Thus, in order for the '545
`
`patent claims to be prior art under § 1 02( e), the '414 application must satisfy, inter alia, the
`
`written description requirement of 35 U.S.C. § 112, first paragraph, for these two claims. In re
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`Wertheim, 646 F.2d at 537,209 U.S.P.Q. at 564. To meet that requirement, the '414 application
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`must contain a written description that reasonably conveys to one of ordinary skill in the art that
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`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.
`
`The Written Description of the '414 Application- the Only Application Filed
`Prior to the Effective Date of the '415 Patent to Which the Moore '545 Patent
`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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`of claims 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
`
`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 '414 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 3 7 C.F.R. § 1.132
`
`of Dr. Sidney Altman, Dr. Steven McKnight, Dr. Michael Botchan, and Dr. Matthew Scott.
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`Each ofthese experts, as ofthe effective filing date ofthe '415 patent, was practicing in the field
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`of the present invention, and enjoys impeccable scientific credentials. Each of these experts has
`
`performed a careful scientific analysis of the contents of the '414 application and explains why
`
`the '414 application does not describe any procedure for producing within a single host cell two
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`different polypeptides (~,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 of35 U.S.C. § 112, first paragraph, as to the later-filed application's claimed invention. M.P.E.P.
`§ 201.11 (l)(B)). As will be discussed in section III(B), infra, such is not the case between the '07 I application
`and the '414 application.
`
`- I 0-
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`Sanofi/Regeneron Ex. 1010, pg 319
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`Merck Ex. 1010, pg 345
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`

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`R~:~:xamimltion Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`immunoglobulin). Instead, the experts conclusively demonstrate in their respective declarations
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`that the only procedures reasonably conveyed by the '4I4 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. See Botchan Declaration, '1!'1!32,
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`36; McKnight Declaration, '11'1!27-31; Scott Declaration, '1!'1!8, II; Altman Declaration, '1!'1!7, II,
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`I2.
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`The only process described in the '4I4 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 separate cell cultures, isolated from the separate cell cultures, and
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`then combined in vitro to form the rFv. This is unequivocally set forth at page 16, lines 24-28 of
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`the '414 application (the '545 patent at col. I 0, lines 8-12), where the written description of the
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`'414 application plainly states:
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`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 or a light chain variable region polypeptide, not both. See, ~.