r
`
`Patent
`Attorney's Docket No. 22338-10230
`
`Group Art Unit:
`
`3991
`
`Examiner:
`
`B.M. Celsa
`
`Control Nos.:
`
`Confirmation Nos.:
`
`90/007,542
`90/007,859
`
`7585 ('542)
`6447 ('859)
`
`Filed:
`
`13 May 2005
`23 December 2005
`
`('542)
`('859)
`
`Patent Owner:
`
`Genentech, Inc. and
`City of Hope
`
`For:
`
`Merged Reexaminations of U.S. Patent No. 6,331,415 (Cabilly et al.)
`
`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 non-final Office action mailed on August 16, 2006,
`
`setting an original due date of October 16, 2006. Owners timely requested an extension of time
`
`to respond. In a Decision mailed on October 17, 2006, the Office granted an extension of two
`
`weeks, to Monday, October 30, 2006, for Owners to file a response. As this reply is filed within
`
`the extended period for response, it is timely filed.
`
`Patent Owners (Owners) respectfully request reconsideration of the claims in view of the
`
`following remarks.
`
`Sanofi/Regeneron Ex. 1022, pg 598
`
`Merck Ex. 1022, pg 624
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`REMARKS
`I. PRELIMINARY MATTERS .............................................................................................................. 4
`A.
`INFORMATION DISCLOSURE STATEMENT ........................................................................................ 4
`
`B.
`
`INTERVIEW SUMMARY ..................................................................................................................... 4
`
`C. OBSERVATION ON THE OFFICE'S DETERMINATION CONCERNING CUMULATIVE PRIOR ART ......... 6
`
`D. PAST PTO ACTIONS SUPPORT FINDING THE '415 CLAIMS SEPARATELY PATENTABLE OVER
`THE 567 CLAIMS ............................................................................................................................... 6
`
`II. RESPONSE TO REJECTIONS .......................................................................................................... 8
`A. SUMMARY OF THE REJECTIONS ........................................................................................................ 8
`B. THE REJECTION OF CLAIMS 1-4. II, 13, 15-18,21,23-25 AND 33 OF THE '415 PATENT BASED
`ON "CLAIM INTERPRETATION I" HAS NO BASIS IN LAW OR FROM THE FILE WRAPPER OF THE
`'567 PATENT ..................................................................................................................................... 9
`1. The Owners Did Not Expressly Redefine the Meaning of the Claim Term "or" as
`Used in the '567 Claims .......................................................................................................... I 0
`2. The Prosecution History of the '567 Patent Shows that "or" as Used in the '567
`Patent Claims Has Its Ordinary Meaning ............................................................................... II
`3. The Specification of the '567 Patent Does Not Expressly or Implicitly "Redefine" the
`Claim Term "or" ..................................................................................................................... 14
`4. The Office Does Not Accurately Identify the Differences Between the '415 and '567
`Claims ...................................................................................................................................... IS
`5. The '567 Claims Do Not "Read On" and Thus Render Unpatentable the '41 5 Patent
`Claims for Reasons of Obviousness-Type Double Patenting .................................................. 17
`6. The Office May Not Use the Disclosure of the '41 5 and '567 Patents to Supply
`Missing Elements of the '41 5 Claims Relative to the '567 Claims .......................................... 21
`(a) Settled Law Holds that the Office May Not Use Owner's Own Disclosure in an
`Obviousness-Type Double Patenting Rejection to the Missing Elements of the
`Later Claim ....................................................................................................................... 21
`(b) The Antigen Binding Language in the '567 Patent Claims Refers to the
`Structure of the Variable Domain of the Claimed Immunoglobulin Heavy or
`Light Chains, and Does Not Require Assembly of the Chains into a Functional
`Immunoglobulin Molecule or Fragment ........................................................................... 22
`7. Conclusion: The Rejection of the '4 I 5 Claims Based on Claim Interpretation 1 of the
`'567 Claims is Factually and Legally Improper and Should Be Withdrawn ........................... 26
`
`C. THEREJECTIONOFCLAIMS 1-4,11, 13, 15-18,21,23-25AND330FTHE'415PATENTBASED
`ON CLAIMS 1-7 OF THE '567 PATENT, TAKEN IN VIEW OF AXEL, RICE OR KAPLAN, FURTHER
`IN VIEW OF DALLAS, AND FURTHER IN VIEW OF DEACON, VALLE 1981 OR 0CHI IS IMPROPER ... 2 7
`1. Obviousness-Type Double Patenting is to be Assessed in a Manner Analogous to
`Obviousness Assessments Under 35 U.S. C. §103 Using a Graham v. John Deere
`Analysis .................................................................................................................................... 27
`2. The '415 Claims Would Not Have Been Considered Obvious to a Person of Ordinary
`Skill in the Art in Early April of 1983 Based on the '567 Claims, Considered Alone or
`in View of the Various Combinations of References Employed by the Office, When a
`Proper Graham v. John Deere Analysis is Employed ............................................................. 29
`
`- 2 -
`
`:·~:':~::j,~:~:':'l(~~~,,:,:l:~:~:~l~,~·~:,:·:·l~·~:·::·m·:l:~ .. ~:.:~::~.:~.m.~~,·'·''··'
`
`Sanofi/Regeneron Ex. 1022, pg 599
`
`Merck Ex. 1022, pg 625
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`a. Differences Between The Claims of the '567 Patent and the Claims of the '41 5
`Patent. ................................................................................................................................ 29
`b. The Correct Perspective for Evaluating Prior Art is a Person of Ordinary Skill in
`the Art as of Early April of 1983 ...................................................................................... 30
`c. The Expectations of a Person of Ordinary Skill in the Art in Early April of 1983
`Would Have Been Shaped by Experiences in Producing Polypeptides Using
`Recombinant DNA Technology, the Nature of the Protein Being Produced, and
`Relevant Insights from Natural Processes in B-Cells ....................................................... 31
`d. The Office May Not Disregard Pertinent Expert Testimony Correcting
`Erroneous Interpretations ofthe Teachings ofthe Prior Art ............................................. 36
`e. The Office's Rejection of the '415 Claims Based on the '567 Claims Taken in
`View of the Various Cited References Rests on a Flawed and Incorrect Analysis
`of the Claims and the Teachings of the Cited References ................................................. 38
`
`(i) The Axel Patent Does Not Motivate One to Produce Heavy and Light Chains
`in a Single Transformed Host Cell ............................................................................. 41
`
`(ii) Because Rice Describes Expression of One Exogenous Gene in One Host
`Cell, It Would Not Have Motivated a Person of Ordinary Skill in the Art to
`Modify the '567 Claims .............................................................................................. 46
`
`(iii) The Hypothetical Kaplan Disclosure Does Not Suggest Production of
`Multiple Immunoglobulin Chains in One Transformed Host Cell ............................. 53
`f. Dallas Would Not Have Provided Any Additional Motivation to a Person of
`Ordinary Skill in the Art in April of 1983 to Modify the '567 Claims in View of
`Axel, Rice or Kaplan ......................................................................................................... 54
`g. Deacon and Valle 1981 Do Not Remedy the Deficiencies of the Office's
`Rejection Based on the '567 Patent, Taken in View of Axel, Rice or Kaplan,
`Taken Further in View of Dallas ....................................................................................... 56
`h. Ochi Does Not Remedy the Deficiencies of the Office's Rejection Based on the
`'567 Patent, Taken in View of Axel, Rice or Kaplan, Taken Further in View of
`Dallas ................................................................................................................................ 62
`D. THE DEPENDENT CLAIMS OF THE '415 PATENT ARE NOT0BVIOUS ............................................. 64
`1. The Rationale for the Rejections of the Dependent Claims is Fundamentally Improper ........ 64
`2. The Cited Subsidiary References Provide No Evidence or Guidance That Makes the
`Dependent Claims Obvious ..................................................................................................... 65
`a. Claim 5 .............................................................................................................................. 65
`b. Claims 6-8, 19, 20, and 26 ................................................................................................ 66
`c. Claims 9 and 29 ................................................................................................................. 67
`d. Claims IO and 27-32 ......................................................................................................... 68
`e. Claim 12 ............................................................................................................................ 68
`f. Claim 14 ............................................................................................................................ 69
`g. Claim 22 ............................................................................................................................ 69
`h. Claims 34-36 ..................................................................................................................... 69
`
`III. CONCLUSION ................................................................................................................................... 70
`
`EXHIBIT A: Illustrative Differences between '567 and '415 Patent Claims
`
`- 3-
`
`Sanofi/Regeneron Ex. 1022, pg 600
`
`Merck Ex. 1022, pg 626
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`I.
`
`Preliminary Matters
`
`A.
`
`Information Disclosure Statement
`
`Owners thank the Examiner for his indication that materials previously submitted to the
`
`Office have been fully considered. Owners request consideration of the additional materials
`
`provided in the accompanying information disclosure statement (PTO Form 1449).
`
`B.
`
`Interview Summary
`
`Owners thank Examiners Celsa, Jones and Padmashri for the courtesy of an interview
`
`held on September 27, 2006. At the interview, as summarized in the interview summary form,
`
`the representatives of Owners and the Examiners discussed a number of issues.
`
`First, the Owners explained that the prosecution history of U.S. Patent No. 4,816,567 (the
`
`'567 patent) demonstrates that the term "or" as used in the claims has its conventional meaning
`
`(i.e., as referring to one of the enumerated alternatives). Owners explained that the actions of the
`
`PTO and of the Owners (then applicants) before and after the amendment which introduced
`
`claims 53, 57 and 63 plainly shows that neither the Owners nor the Office viewed "or" as
`
`meaning the "logical or" (i.e., meaning "and/or"). Owners indicated that they would provide the
`
`Office a summary of the relevant prosecution history of the '567 patent in this response.
`
`Owners also sought a confirmation that "Claim Interpretation l" and rejections premised
`
`on it were contingent on the Examiner's determination that the term "or" was being read as the
`
`"logical or" (i.e., as if the claims had been amended by replacing "or" with the words "and/or").
`
`The Examiners concurred that this was the premise of the rejections under Claim Interpretation
`
`I; namely, that the rejection is premised on the belief that the word "or" actually was intended to
`
`mean "and/or". The Examiners indicated that if the prosecution history and the specification
`
`showed that the term "or" was used with its ordinary meaning (i.e., as referring to alternatives),
`
`the rejections premised on Claim Interpretation l would be withdrawn.
`
`Owners also discussed the relationship between the claims ofthe '415 and '567 patents.
`
`In particular, Owners referred to the explanation in their Response ofNovember 25, 2005, which
`
`explained why the claims of the '415 patent cannot be interpreted as defining a "genus" of
`
`methods that includes "species" methods defined in the '567 patent. The Examiners confirmed
`
`-4-
`!:l~:!l!i::~:~:::::~ijill:m::::~:m:~:m::li~:l:i~i::i:~ni:::::*:'IM'i~i'~i'~'i~'~'~'~'i'li'i',
`
`Sanofi/Regeneron Ex. 1022, pg 601
`
`Merck Ex. 1022, pg 627
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`that rejections in the First Office Action based on such a finding were withdrawn in favor of the
`
`new rejections under the two claim interpretation theories set forth in the Office action mailed
`
`August 16, 2006 ("Second Office Action.")
`
`Second, Owners discussed the obviousness-type double patenting rejections based on
`
`"Claim Interpretation 2." Owners emphasized the importance of using the proper perspective
`
`when considering the teachings of the various references cited in the Office Action; namely,
`
`what the references would have taught or suggested to a person of ordinary skill in the art in
`
`early April of 1983. Owners explained that each of the experts who had previously submitted
`
`declarations under 37 C.P.R.§ 1.132 was qualified to explain this perspective based on their
`
`respective experiences in the relevant time frame. Owners further addressed the teachings of the
`
`various cited prior art references, and explained why the '567 patent claims, considered in view
`
`of any or all of these references, would not have rendered the claims of the '415 patent obvious.
`
`The Examiners agreed that the obviousness-type double patenting questions are to be
`
`evaluated by considering the question of non-obviousness of the '415 claims in view of the '567
`
`patent claims, taken in view of other prior art. The Examiners also agreed that the question of
`
`"obviousness" must be considered from the perspective of a person of ordinary skill in the art in
`
`early April of 1983, including what the references would have taught such a person at that time.
`
`Owners requested that the Examiners review the prosecution histories of the '4 1 5 and
`
`'567 patents. Owners noted, for example, that the Office had previously considered most of the
`
`references now being employed in the obviousness-type double patenting rejections. The
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`Examiners indicated they would consider the prosecution histories ofthe '415 and '567 patents
`
`incidental to the consideration of Owners' response.
`
`Third, Owners discussed the complex physical structure of immunoglobulins and the
`
`limited understanding that persons of ordinary skill in the art had in early April of 1983
`
`regarding the processes of immunoglobulin gene expression and subsequent production and
`
`assembly of immunoglobulin proteins. The Owners also discussed the experiences ofthose
`
`working in the art in the relevant time frame concerning production of monomeric eukaryotic
`
`proteins having molecular weights much lower than those of tetrameric immunoglobulins. The
`
`-5-
`'li~'~'i!i~m'ii'l~'li''i~llimi'~i'~~'l'ii'I'Qi'i'li'~'i~'~i'~'i~i'i~i~~'~'~''i'i'l''i
`
`Sanofi/Regeneron Ex. 1022, pg 602
`
`Merck Ex. 1022, pg 628
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`Examiners indicated they would consider information and evidence provided by Owners related
`
`to these issues.
`
`Fourth, Owners expressed their opinion that a declaration provided by a third party (Dr.
`
`Baltimore) was not a patent or printed publication, and as such, could not serve as a basis for
`
`finding of a substantial new question of patentability, and could not be considered during an ex
`
`parte reexamination proceeding. Owners also referred to the opinions of Dr. Douglas A Rice
`
`provided with the first response concerning the Rice publication.
`
`Finally, Owners sought and received a confirmation that information previously provided
`
`in an Information Disclosure Statement (IDS) had been fully considered, and that no further
`
`information regarding the submitted information was needed by the Office. Owners also
`
`apprised the Examiners of the status of litigation involving the '415 patent-specifically, that
`
`Medlmmune v. Genentech, 427 F.3d 958, 76 U.S.P.Q.2d 1914 (Fed. Cir. 2005), had been
`
`scheduled for argument before the Supreme Court of the United States on October 4, 2006. As
`
`indicated at the interview, Owners provide for the convenience of the Office copies of the merits
`
`briefs filed by the parties in that proceeding in the concurrently filed IDS.
`
`Owners now inform the Office that argument before the Supreme Court did occur on
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`October 4, 2006 and are providing for convenience of the Office a copy of the transcript of that
`
`argument (downloaded from the Supreme Court website) in the accompanying IDS.
`
`C.
`
`Observation on the Office's Determination Concerning Cumulative Prior Art
`
`Owners observe that the Office has fom1d the teachings of 1982 Valle to be cumulative to
`
`the teachings of Deacon, and the teachings of Oi to be cumulative of the teachings of Ochi.
`
`Owners reserve their right to contest the finality of any further Office Action on the basis of
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`information contained exclusively in either 1982 Valle or Oi in view of these findings and the
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`reliance by the Office on Deacon and Ochi.
`
`D.
`
`Past PTO Actions Support Finding the '415 Claims Separately Patentable
`Over the '567 Claims
`
`Owners invite the Office to review the summary of the prosecution events of the '415 and
`
`'567 patents provided in Owner's First Response, dated November 25, 2005 (First Response).
`
`See First Response, pages 8 to 15; Declaration of Wendy Lee. Owners submit that the past
`
`-6-
`'li~'~'i!i~m'ii'l~'li''i~llimi'~i'~~'l'ii'I'Qi'i'li'~'i~'~i'~'i~i'i~i~~'~'~''i'i'l''i
`
`Sanofi/Regeneron Ex. 1022, pg 603
`
`Merck Ex. 1022, pg 629
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`record of actions by the Office in connection with the '415 and '567 patents shows a consistent
`
`pattern of findings by the Office that claims in the form of the '415 patent claims are separately
`
`patentable over the claims in the form of the '567 patent claims, alone or in view of the cited
`
`references.
`
`Indeed, the question of patentability of claims in the form of the '415 patent claims over
`
`claims in the form of the '567 patent claims was considered directly by the Office several times.
`
`The Office issued separate patents with claims corresponding to the '567 and '415
`claims, respectively, to different parties on the same day. Specifically, on March
`29, 1989, the Office issued the '567 patent to Cabilly eta!., and U.S. Patent No.
`4,816,397 to Boss et al.
`
`The Office did not involve the '567 patent claims (as well as other claims that did
`not require heavy and light chains to be produced in one host cell) in the
`interference proceedings based on claims in the form of the '415 patent claims
`(i.e., Interference No. I 02,572). See First Response, pages I 0-12; Lee
`Declaration, Exhibits L; M, and N; application serial no. 07/205,419 (i.e., the
`application that matured to the '415 patent), paper no. 18.
`
`During the prosecution of the '415 patent, the Office imposed a restriction
`requirement differentiating claims to embodiments requiring heavy and light
`immunoglobulin chains from embodiments requiring only one or the other chain.
`See '419 application, paper 11; Lee Declaration, Exhibit I.
`
`In an interview following termination of the interference proceeding held on
`October 4, 2001, the Office indicated that there were no obviousness-type double
`patenting issues raised by the 415 claims relative to the '567 patent claims. See
`'419 application, paper no. 19; Lee Declaration,~~ 20-23.
`
`As Owners explained during the interview on September 27, 2006, these past findings of the
`
`Office reflect a consistent view that the '415 patent claims are separately patentable over, and in
`
`particular, are neither anticipated by nor obvious over the '567 patent claims. These past
`
`findings are probative of the past opinions of the Office as to the non-obviousness of the '415
`
`patent claims relative to the '567 patent claims.
`
`Owners note that, at page 32 of the Second Office action, the Office dismisses this record
`
`of past determinations by the Office by asserting that the substantial new questions of
`
`patentability being addressed in the present reexamination are based on newly cited references
`
`and "a combined teaching with the '567 claims neither of which was considered by the
`
`-7-
`'li~'~'i!i~m'ii'l~'li''i~llimi'~i'~~'l'ii'I'Qi'i'li'~'i~'~i'~'i~i'i~i~~'~'~''i'i'l''i
`
`Sanofi/Regeneron Ex. 1022, pg 604
`
`Merck Ex. 1022, pg 630
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`Examiner" in the earlier proceedings. First, Owners note that the Office is not relying upon prior
`
`art to support the rejections of the independent and certain dependent claims of the '415 patent
`
`under its "Claim Interpretation I" theory of the '567 patent claims. Second, Owners note that
`
`almost all of the references the Office now relies on, as well as various other references that
`
`provide teachings comparable to those in the subsidiary references the Office now cites, were
`
`before the Office during the prosecution ofthe '415 patent. For example, Rice, Q1. Ochi,
`
`Kaplan, Accolla, Deacon, and Valle 1981 were all cited to the Office during the prosecution of
`
`the patent.
`
`Furthermore, publications describing the co-transformation methodology of Axel (~,
`
`Wigler et al., Celll6: 777-85 (1979), which includes the inventors of Axel as co-authors) and the
`
`protein-folding methodology of Builder(~, US 4,512,922 to Jones et al.) were made of record
`
`in the application that matured to the '415 patent. Dallas, as Owners discuss below, is of
`
`marginal relevance. Thus, Owners submit that the Office has in fact previously considered all of
`
`the relevant technical teachings of the references now cited to support the double patenting
`
`rejection, or evidence that is cumulative to those references, with respect to the patentability of
`
`the claims of the '415 patent over the '567 claims.
`
`II.
`
`Response to Rejections
`
`A.
`
`Summary of the Rejections
`
`In the Second Office Action, the Office rejects all of the claims of U.S. Patent No.
`
`6,331,415 for reasons of"obviousness-type" double patenting over the claims of U.S. Patent No.
`
`4,816,567. In doing so, the Office articulates two distinct constructions of the '567 patent
`
`claims.
`
`First, the Office advances a theory that the claims of the '567 patent, through use of the
`
`term "or," actually recite three distinct methods. Two of these three methods- the two that do
`
`not correspond to the actual claim language -are asserted to anticipate, and thus render
`
`unpatentable, claims 1-4, 11, 13, 15-18, 21, 23-25 and 33 of the '415 patent. This rejection
`
`depends on the Office's determination that the term "or" as used in the claims actually means
`
`"and/or."
`
`-8-
`:~:g.:~.,.:~:g:: .. ~n~·m·:·::,:m:QI·~i·l·~·ilii··~·~i··i·i·~::~·i~:::~::~l:~'~'~~m,::::i::::
`Sanofi/Regeneron Ex. 1022, pg 605
`
`Merck Ex. 1022, pg 631
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`Second, the Office sets forth an alternative claim interpretation that employs the
`
`conventional (and correct) meaning of the claim term "or"- namely, that it refers to alternatives.
`
`The Office nonetheless imposes rejections based on a finding that the claims of the '415 patent
`
`are "obvious" over the claims of the '567 patent, either considered alone or in conjunction with a
`
`variety of references. At page 22, the Office rejects claims l-4, 11, 13, 15-18, 21, 23-25 and 3 3
`
`of the '415 patent over the claims of the '567 patent, taken in view of Axel, Rice or Kaplan,
`
`further in view of Dallas, and further in view of Deacon, Valle 1981 or Ochi.
`
`Third, at pages 26-35 of the Office Action, the Office rejects the remaining dependent
`
`claims of the '415 patent (i.e., claims 5-10, 12, 14, 19-20, 22, 26-32 and 34-36). The basis ofthe
`
`rejection is set forth as (i) the finding that claims 1-4, 11, 13, 15-18,21,23-25 and 33 ofthe '415
`
`patent are unpatentable under either "Claim Interpretation 1" or "Claim Interpretation 2," and (ii)
`
`each dependent claim is obvious when taken further in view of the identified prior art.
`
`Owners respectfully traverse the rejections set forth in the Office Action.
`
`B.
`
`The Rejection of Claims 1-4,11, 13,15-18,21,23-25 and 33 of the '415 Patent
`Based on "Claim Interpretation 1" Has No Basis in Law or from the File
`Wrapper of the '567 Patent
`
`At pages 6 to 21 of the Second Office Action, the Office sets forth the first of its two
`
`theories for interpreting the claims of the '567 patent (labeled "Claim Interpretation l "). Under
`
`this rationale, the claim term "or", as used in the '567 patent claims, refers not to alternatives (the
`
`conventional meaning of "or") but to what the Office labels the "logical or" (i.e., that it means
`
`"and/or"). With that interpretation, the Office concludes that the '567 patent claims
`
`"encompass" three distinct methods:
`
`a.
`
`b.
`
`c.
`
`light chain- and heavy chain -encoding DNA is inserted into
`2 separate vectors for individual expression in 2 different
`hosts ("or" embodiment);
`
`light chain- and heavy chain -encoding DNA is inserted into
`2 separate vectors for coexpression of both vectors in 1 host
`("and" embodiment); and
`
`light chain- and heavy chain -encoding DNA is inserted into
`l vector for expression in l host ("and" embodiment).
`
`-9-
`:~:g.:~.,.:~:g:: .. ~n~·m·:·::,:m:QI·~i·l·~·ilii··~·~i··i·i·~::~·i~:::~::~l:~'~'~~m,::::i::::
`Sanofi/Regeneron Ex. 1022, pg 606
`
`Merck Ex. 1022, pg 632
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`The Office then asserts that claims 1-2 and 5-7 of the '567 patent, interpreted in this manner,
`
`"read on" (and thus anticipate) claims I, 13, 15-18,21 and 33 ofthe '415 patent. Relying on this
`
`rationale, the Office rejects claims 1-4, 11, 13, 15-18, 21, 23-25 and 33 solely on the basis of
`
`claims 1-2 and 5-7 of the '567 patent. Owners request reconsideration of this ground of
`
`rejection.
`
`1.
`
`The Owners Did Not Expressly Redefine the Meaning of the Claim
`Term "or" as Used in the '567 Claims
`
`In its ordinary meaning, "or" is understood as stating alternatives. Kustom Signals, Inc.
`
`v. Applied Concepts, Inc., 264 F.3d 1326, 1331,60 U.S.P.Q.2d 1135, 1138 (Fed. Cir. 2001);
`
`Schumer v. Lab. Comp. Sys. Inc., 308 F.3d 1304, 1311, 64 U.S.P.Q.2d 1832, 1838 (Fed. Cir.
`
`2002) ("We have consistently interpreted the word "or" to mean that the items in the sequence
`
`are alternatives to each other"); Brown v. 3M, 265 F.3d 1349, 1352,60 U.S.P.Q.2d 1375, 1377
`
`(Fed. Cir. 2001) (interpretation of"or" involved a "plain reading of the claim text"). In fact, the
`
`Office readily admits as much at page 10 of the Second Office Action: "normally ... 'or' is
`
`interpreted to mean that the items in a sequence recited in a claim are alternatives to each other."
`
`As noted in the M.P.E.P., "the words of the claim must be given their plain meaning
`
`Wlless applicant has provided a clear definition [to the contrary] in the specification." M.P.E.P. §
`
`2111.0 I [I] (emphasis added), citing In re Zietz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed.
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`Cir. 1989); see also Chef America, Inc. v. Lamb-Weston, Inc., 358 F.3d 1371, 1372, 69 USPQ2d
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`1857 (Fed. Cir. 2004) (noting that "ordinary, simple English words whose meaning is clear and
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`Wiquestionable" absent any indication that their use in a particular context changes their
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`meaning, "are construed to mean exactly what they say"). Any special meaning assigned to a
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`term "must be sufficiently clear in the specification that any departure from common usage
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`would be so understood by a person of experience in the field of the invention." M.P.E.P. §
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`211l.Ol.III (emphasis added), citing Multiform Desiccants Inc. v. Medzarn Ltd., 133 F.3d 1473,
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`1477,45 USPQ2d 1429, 1432 (Fed. Cir. 1998); see also Process Control Corp. v. HydReclaim
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`Corp., 190 F.3d 1350, 1357,52 USPQ2d 1029, 1033 (Fed. Cir. 1999); M.P.E.P. § 2173.05(a).
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`No special definition has been set forth for the claim term "or" in the '567 patent
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`specification, and as explained below, the prosecution history, considered properly, does not
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`suggest that Owners redefined the term.
`
`- 10-
`'li~'~':!:~m,::,l~'li''i~ll:m:,~:,~~'l'ii'I'Qi'i'li'~,:~,~:,~,:~:,:~:~~'~'~''i'i'l''i
`
`Sanofi/Regeneron Ex. 1022, pg 607
`
`Merck Ex. 1022, pg 633
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`2.
`
`The Prosecution History of the '567 Patent Shows that "or" as Used in
`the '567 Patent Claims Has Its Ordinary Meaning
`
`The prosecution history of application Serial No. 06/483,457 (the application that
`
`matured to the '567 patent) plainly demonstrates that Owners used the claim term "or" in a
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`conventional manner to refer to alternatives - not, as the Office suggests, as meaning "and/or"
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`(the "logical or").
`
`As originally filed, the '567 patent application contained claims I through 52. Five of
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`these claims were independent method claims. One of them, Claim 51, was directed to a
`"method for preparing heavy chain or light chain." 1 Claims 42, 47 and 49, on the other hand,
`were directed to processes requiring both heavy and light chains to be produced in the same cell. 2
`
`The original claims plainly show that Owners employed the term "or" when alternatives were
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`intended, and the term "and" when conjunctive relationships were intended.
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`In the Office Action mailed on April26, 1985, the Office rejected all of the original
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`claims (i.e., claims 1-52). In a response filed on October 28, 1985, Owners canceled all of the
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`pending claims and presented new claims 53-88. The new set of claims contained several
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`independent method claims, including claims 53, 68 and 78. The first step of each of these new
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`independent claims was directed to preparing a DNA sequence. The options for the prepared
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`DNA, as specified in these claims, were as follows:
`
`Claim 53 recited "preparing a DNA sequence encoding an
`immunoglobulin heavy or light chain, or an immunoglobulin Fab region,
`of known specificity. "3
`
`Claim 68 recited "preparing a DNA sequence encoding a chimeric
`immunoglobulin heavy or light chain of known specificity wherein the
`constant regions are homologous to the corresponding regions of an
`antibody of a first mammalian species and the variable regions thereof are
`
`See' 567 prosecution history, page 60 of original claims and specification.
`
`See '567 prosecution history, pages 57-60 of original specification.
`
`See' 567 prosecution history, April 26, 1985 response at page 2. As with original claim 51, claim 53 recited
`that the transformation of the host cell was with "an immunoglobulin heavy or light chain," as well as reciting
`that the transformation could alternatively be with "an immunoglobulin Fab region" and that "heavy chain, light
`chain or Fab" is recovered from the host cell culture.
`
`- II -
`
`:~:g.:~.,.:~:g:: .. ~n~·m·:·::,:m:QI·~:·I·~·:I::··~·~:··:·:·~::~·:~,:,~::~I:~,~,~~m,::,,:,,,:
`Sanofi/Regeneron Ex. 1022, pg 608
`
`Merck Ex. 1022, pg 634
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
`
`homologous to the variable regions of an antibody derived from a second,
`different mammalian species."4
`
`Claim 78 recited "preparing a DNA sequence encoding an altered
`immunoglobulin heavy or light chain of known specificity wherein the
`amino acid sequence of the immunoglobulin has been varied in
`predetermined fashion from that of mammalian antibody."
`
`Claims 57, 63 and 65 depended from claim 53 and claimed a result that required production of
`both the heavy and the light immunoglobulin chains.5 By contrast, no claims dependent from
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`claims 68 or 78 required production of heavy and light chains. Claim 68 ultimately issued in
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`slightly modified form as claim I of the '567 patent.
`
`In the next Office action, dated February 26, 1986, the Examiner rejected claims