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`Attorney's Docket No. 22338-10230
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`Patent
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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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
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`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. § 1.550gbg
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`Mail Stop Ex Parte Reexam
`COMMISSIONER FOR PATENTS
`P.O. Box 1450
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`Alexandria, VA 22313-1450
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`Sir:
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`This communication responds to the non-final Office action mailed on August 16, 2006,
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`setting an original due date of October 16, 2006. Owners timely requested an extension of time
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`to respond.
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`In a Decision mailed on October 17, 2006, the Office granted an extension of two
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`weeks, to Monday, October 30, 2006, for Owners to file a response. As this reply is filed within
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`the extended period for response, it is timely filed.
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`Patent Owners (Owners) respectfully request reconsideration of the claims in view of the
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`following remarks.
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`Genzyme Ex. 1016, pg 363
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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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`1. PRELIMINARY MATTERS ..............................................................................................................4
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`A.
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`B.
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`INFORMATION DIscLOsURE STATEMENT ......................................................... .: ........................... ..4
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`INTERVIEW SUMMARY ................................................................................................................... .. 4
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`C. OBSERVATION ON THE OFFICE’S DETERMINATION CONCERNING CUMULATIVE PRIOR ART ....... .. 6
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`D. PAST PTO ACTIONS SUPPORT FINDING THE ’4 I 5 CLAIMS SEPARATELY PATENTABLE OVER
`THE 567 CLAIMS ............................................................................................................................. .. 6
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`II. RESPONSE TO REJECTIONS ..........................................................................................................8
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`A. SUMMARY OF THE REJECTIONS ...................................................................................................... .. 3
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`B. THE REJECTION OF CLAIMS 1-4. 11, 13, 15-18, 21, 23-25 AND 33 OF THE ’4l5 PATENT BASED
`ON “CLAIM INTERPRETATION 1” HAS NO BASIS IN LAW OR FROM THE FILE WRAPPER OF THE
`’567 PATENT................................................................................................................................... ..9
`
`l.
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`The Owners Did Not Expressly Redefine the Meaning ofthe Claim Term "or" as
`Used in the ’567 Claims ........................................................................................................ .. 10
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`The Prosecution History ofthe ’56 7 Patent Shows that “or " as Used in the ’567
`Patent Claims Has Its Ordinary Meaning ............................................................................. .,
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`I I
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`The Specification of the ’56 7 Patent Does Not Expressly or Implicitly “Redefine " the
`Claim Term “or ” ................................................................................................................... .. 14
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`The Office Does Not Accurately Identifiz the Differences Between the ’415 and ’56 7
`Claims .................................................................................................................................... .. 15
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`The ’5 67 Claims Do Not “Read On " and Thus Render Unpatentable the ’4I5 Patent
`Claimsfor Reasons of Obviousness—Type Double Patenting ................................................ .. 17
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`The Ofiice May Not Use the Disclosure ofthe ’415 and '567 Patents to Supply
`lllissing Elements ofthe '41 5 Claims Relative to the ’56 7 Claims........................................ .. 21
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`(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 ‘S67 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 ofthe ‘415 Claims Based on Claim Interpretation 1 of the
`‘56 7 Claims is Factually and Legally Improper and Should Be Withdrawn......................... .. 26
`
`. THE REJECTION OF CLAIMS 1-4, 11, 13, 15-18, 21, 23-25 AND 33 OF THE ’4l5 PATENT BASED
`ON CLAIMS I-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 I93 I OR OCHI IS IMPROPER... 27
`
`1. Obviousness-Type Double Patenting is to be Assessed in a Manner Analogous to
`Obviousness Assessments Under 35 US. C. 39103 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 ’56 7 Claims, Considered Alone or
`in View ofthe Various Combinations ofReferences Employed by the Oflice, When a
`Proper Graham v. John Deere Analysis is Employed ........................................................... .. 29
`
`Genzyme Ex. 1016, pg 364
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`Differences Between The Claims of the ’567 Patent and the Claims of the ’415
`Patent ............................................................................................................................... .. 29
`
`The Correct Perspective for Evaluating Prior Art is a Person of Ordinary Skill in
`the Art as of Early April of 1933 .................................................................................... ..30
`
`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
`
`The Office May Not Disregard Pertinent Expert Testimony Correcting
`Erroneous Interpretations of the Teachings of the Prior Art ........................................... .. 36
`
`The Office’s Rejection of the ’4l5 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 ‘S67 Claims ............................................................................................ ..46
`
`(iii) The Hypothetical Kaplan Disclosure Does Not Suggest Production of
`Multiple lmmunoglobulin Chains in One Transformed Host Cell ........................... .. 53
`
`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
`
`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
`
`Ochi Does Not Remedy the Deficiencies of the OfTice’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 or THE ‘M 5 PATENT ARE NOT OBVIOUS ........................................... .. 64
`
`1.
`
`2.
`
`The Rationale for the Rejections ofthe Dependent Claims is Fundamentally Improper ...... .. 64
`
`The Cited Subsidiary References Provide No Evidence or Guidance That Makes the
`Dependent Claims Obvious ................................................................................................... .. 65
`Claim 5 ............................................................................................................................ ..65
`
`Claims 6-8, 19, 20, and 26 .............................................................................................. ..66
`Claims 9 and 29 ............................................................................................................... .. 67
`
`Claims 10 and 27-32 ....................................................................................................... ..68
`
`Claim 12 .......................................................................................................................... ..68
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`Claim 14 .......................................................................................................................... ..69
`
`Claim 22 .......................................................................................................................... .. 69
`
`Claims 34-36 ................................................................................................................... .. 69
`
`III._CONCLUSION ................................................................................................................................. ..70
`
`EXHIBIT A: Illustrative Differences between ’567 and ’415 Patent Claims
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`Genzyme Ex. 1016, pg 365
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`

`
`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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`Information Disclosure Statement
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`Owners thank the Examiner for his indication that materials previously submitted to the
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`Office have been fully considered. Owners request consideration of the additional materials
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`provided in the accompanying information disclosure statement (PTO Form 1449).
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`B.
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`Interview Summary
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`Owners thank Examiners Celsa, Jones and Padmashri for the courtesy of an interview
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`held on September 27, 2006. At the interview, as summarized in the interview summary form,
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`the representatives of Owners and the Examiners discussed a number of issues.
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`First, the Owners explained that the prosecution history of U.S. Patent No. 4,816,567 (the
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`’567 patent) demonstrates that the term “or” as used in the claims has its conventional meaning
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`(i.e., as referring to one of the enumerated alternatives). Owners explained that the actions of the
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`PTO and of the Owners (then applicants) before and after the amendment which introduced
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`claims 53, 57 and 63 plainly shows that neither the Owners nor the Office viewed “or” as
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`meaning the “logical or” (i.e., meaning “and/or”). Owners indicated that they would provide the
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`Office a summary of the relevant prosecution history of the ’567 patent in this response.
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`Owners also sought a confirmation that “Claim Interpretation 1” and rejections premised
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`on it were contingent on the Examiner’s determination that the term “or” was being read as the
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`“logical or” (i.e., as if the claims had been amended by replacing “or” with the words “and/or”).
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`The Examiners concurred that this was the premise of the rejections under Claim Interpretation
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`1; namely, that the rejection is premised on the belief that the word “or” actually was intended to
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`mean “and/or”. The Examiners indicated that if the prosecution history and the specification
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`showed that the term “or” was used with its ordinary meaning (i.e., as referring to alternatives),
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`the rejections premised on Claim Interpretation 1 would be withdrawn.
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`Owners also discussed the relationship between the claims of the ’4l5 and ’567 patents.
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`In particular, Owners referred to the explanation in their Response of November 25, 2005, which
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`explained why the claims of the ’415 patent carmot be interpreted as defining a “genus” of
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`methods that includes “species” methods defined in the ’567 patent. The Examiners confirmed
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`Genzyme Ex. 1016, pg 366
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`that rejections in the First Office Action based on such a finding were withdrawn in favor of the
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`new rejections under the two claim interpretation theories set forth in the Office action mailed
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`August 16, 2006 (“Second Office Action.”)
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`_S_gc(ii_, Owners discussed the obviousness-type double patenting rejections based on
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`“Claim Interpretation 2.” Owners emphasized the importance of using the proper perspective
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`when considering the teachings of the various references cited in the Office Action; namely,
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`what the references would have taught or suggested to a person of ordinary skill in the art in
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`early April of 1983. Owners explained that each of the experts who had previously submitted
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`declarations under 37 C.F.R. § 1.132 was qualified to explain this perspective based on their
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`respective experiences in the relevant time frame. Owners further addressed the teachings of the
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`various cited prior art references, and explained why the ‘S67 patent claims, considered in view
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`of any or all of these references, would not have rendered the claims of the ’41 5 patent obvious.
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`The Examiners agreed that the obviousness-type double patenting questions are to be
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`evaluated by considering the question of non—obviousness of the ’415 claims in view of the ’567
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`patent claims, taken in view of other prior art. The Examiners also agreed that the question of
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`“obviousness” must be considered from the perspective of a person of ordinary skill in the art in
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`early April of 1983, including what the references would have taught such a person at that time.
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`Owners requested that the Examiners review the prosecution histories of the ’415 and
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`’567 patents. Owners noted, for example, that the Office had previously considered most of the
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`references now being employed in the obviousness-type double patenting rejections. The
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`Examiners indicated they would consider the prosecution histories of the ’41 5 and ’567 patents
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`incidental to the consideration of Owners’ response.
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`Third, Owners discussed the complex physical structure of immunoglobulins and the
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`limited understanding that persons of ordinary skill in the art had in early April of 1983
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`regarding the processes of immunoglobulin gene expression and subsequent production and
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`assembly of immunoglobulin proteins. The Owners also discussed the experiences of those
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`I working in the art in the relevant time frame concerning production of monomeric eukaryotic
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`proteins having molecular weights much lower than those of tetrameric immunoglobulins. The
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`Genzyme Ex. 1016, pg 367
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`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`Examiners indicated they would consider information and evidence provided by Owners related
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`to these issues.
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`E_<_>_u_1;t_l_1, Owners expressed their opinion that a declaration provided by a third party (Dr.
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`Baltimore) was not a patent or printed publication, and as such, could not serve as a basis for
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`finding of a substantial new question of patentability, and could not be considered during an g
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`% reexamination proceeding. Owners also referred to the opinions of Dr. Douglas A Rice
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`provided with the first response concerning the Rice publication.
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`%, Owners sought and received a confirmation that information previously provided
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`in an Information Disclosure Statement (IDS) had been fully considered, and that no further
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`information regarding the submitted information was needed by the Office. Owners also
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`apprised the Examiners of the status of litigation involving the ’41 5 patent~specifically, that
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`Medlmmune v. Genentech, 427 F.3d 958, 76 U.S.P.Q.2d 1914 (Fed. Cir. 2005), had been
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`scheduled for argument before the Supreme Court of the United States on October 4, 2006. As
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`indicated at the interview, Owners provide for the convenience of the Office copies of the merits
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`briefs filed by the parties in that proceeding in the concurrently filed IDS.
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`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
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`argument (downloaded from the Supreme Court website) in the accompanying IDS.
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`C.
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`Observation on the Office’s Determination Concerning Cumulative Prior Art
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`Owners observe that the Office has found the teachings of 1982 Valle to be cumulative to
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`the teachings ofL, and the teachings of Q to be cumulative of the teachings of Ochi.
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`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 Q_i in view of these findings and the
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`reliance by the Office on Deacon and Ochi.
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`D.
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`Past PTO Actions Support Finding the ’4l5 Claims Separately Patentable
`Over the ’567 Claims
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`Owners invite the Office to review the summary of the prosecution events of the ’41 5 and
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`’567 patents provided in Owner’s First Response, dated November 25, 2005 (First Response).
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`E First Response, pages 8 to 15; Declaration of Wendy Lee. Owners submit that the past
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`-6-
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`Genzyme Ex. 1016, pg 368
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`

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`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`record of actions by the Office in connection with the ’4l5 and ’567 patents shows a consistent
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`pattern of findings by the Office that claims in the form of the ’415 patent claims are separately
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`patentable over the claims in the form of the ’567 patent claims, alone or in view of the cited
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`references.
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`Indeed, the question of patentability of claims in the form of the ’4l5 patent claims over
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`claims in the form of the ’567 patent claims was considered directly by the Office several times.
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`The Office issued separate patents with claims corresponding to the ’567 and ’4l 5
`claims, respectively, to different parties on the same day. Specifically, on March
`29, 1989, the Office issued the ’567 patent to Cabilly et al., and US. 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 ’4l5 patent claims
`(i.e., Interference No. 102,572). fieg First Response, pages 10-12; Lee
`Declaration, Exhibits L; M, and N; application serial no. 07/205,419 (i.e., the
`application that matured to the ’4l 5 patent), paper no. 18.
`
`During the prosecution of the ’4l5 patent, the Office imposed a restriction
`requirement differentiating claims to embodiments requiring heavy Qt; light
`immunoglobulin chains from embodiments requiring only one Q the other chain.
`E ’419 application, paper 1 1; Lee Declaration, Exhibit 1.
`
`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. g
`’419 application, paper no. 19; Lee Declaration, 111] 20-23.
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`As Owners explained during the interview on September 27, 2006, these past fiilings of the
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`Office reflect a consistent view that the ’415 patent claims are separately patentable over, and in
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`particular, are neither anticipated by nor obvious over the ‘S67 patent claims. These past
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`findings are probative of the past opinions of the Office as to the non-obviousness of the ’415
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`patent claims relative to the ’567 patent claims.
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`Owners note that, at page 32 of the Second Office action, the Office dismisses this record
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`of past determinations by the Office by asserting that the substantial new questions of
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`patentability being addressed in the present reexamination are based on newly cited references
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`and “a combined teaching with the ’567 claims neither of which was considered by the
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`Genzyme Ex. 1016, pg 369
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`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
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`under its “Claim Interpretation 1” theory of the ’567 patent claims. Second, Owners note that
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`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
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`before the Office during the prosecution of the ’4l 5 patent. For example, 1_{;cg, Q OLE,
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`Qplin, Accolla Deacon and Va_lle lg were all cited to the Office during the prosecution of
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`the patent.
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`Furthermore, publications describing the co—transformation methodology of Axel (ggg
`Wiglerlet al., _CLll 16: 777-85 (1979), which includes the inventors of Axel as co-authors) and the
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`protein-folding methodology of mg; (egg, US 4,512,922 to Jones et al.) were made of record
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`in the application that matured to the ’415 patent.
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`1_)_a1_le1_s, as Owners discuss below, is of
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`marginal relevance. Thus, Owners submit that the Office has in fact previously considered all of
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`the relevant technical teachings of the references now cited to support the double patenting
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`rejection, or evidence that is cumulative to those references, with respect to the patentability of
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`the claims of the ’415 patent over the ’567 claims.
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`11.
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`Response to Rejections
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`A.
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`Summary of the Rejections
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`In the Second Office Action, the Office rejects all of the claims of U.S. Patent No.
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`6,331,415 for reasons of “obviousness-type” double patenting over the claims of U.S. Patent No.
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`4,816,567.
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`In doing so, the Office articulates two distinct constructions of the ‘S67 patent
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`claims.
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`First, the Office advances a theory that the claims of the ’567 patent, through use of the
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`term “or,” actually recite three distinct methods. Two of these three methods — the two that do
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`not correspond to the actual claim language — are asserted to anticipate, and thus render
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`unpatentable, claims 1-4, 11, 13, 15-18, 21, 23-25 and 33 of the ’4l5 patent. This rejection
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`depends on the Office’s determination that the term “or” as used in the claims actually means
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`“and/or.”
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`Genzyme Ex. 1016, pg 370
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`Second, the Office sets forth an alternative claim interpretation that employs the
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`conventional (and correct) meaning of the claim term “or” — namely, that it refers to alternatives.
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`The Office nonetheless imposes rejections based on a finding that the claims of the ’4l 5 patent
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`are “obvious” over the claims of the ’567 patent, either considered alone or in conjunction with a
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`variety of references. At page 22, the Office rejects claims 1-4, 11, 13, 15-18, 21, 23-25 and 33
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`of the ’4l 5 patent over the claims of the ’567 patent, taken in view of Axel, Q or ,
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`further in View ofQe_1m1_s, and further in view of Deio_r_1, Valle 1981 or Ochi.
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`Third, at pages 26-35 of the Office Action, the Office rejects the remaining dependent
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`claims of the ’415 patent (i.e., claims 5-10, 12, 14, 19-20, 22, 26-32 and 34-36). The basis ofthe
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`rejection is set forth as (i) the finding that claims 1-4, 11, 13, 15-18, 21, 23-25 and 33 ofthe ’4l5
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`patent are unpatentable under either “Claim Interpretation 1” or “Claim Interpretation 2,” and (ii)
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`each dependent claim is obvious when taken further in view of the identified prior art.
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`Owners respectfully traverse the rejections set forth in the Office Action.
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`B.
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`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
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`At pages 6 to 21 of the Second Office Action, the Office sets forth the first of its two
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`theories for interpreting the claims of the ’567 patent (labeled “Claim Interpretation 1”). Under
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`this rationale, the claim term “or”, as used in the ’567 patent claims, refers not to alternatives (the
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`conventional meaning of “or”) but to what the Office labels the “logical or” (i.e., that it means
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`“and/or”). With that interpretation, the Office concludes that the ’567 patent claims
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`“encompass” three distinct methods:
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`light chain- and heavy chain -encoding DNA is inserted into
`2 separate vectors for individual expression in 2 different
`hosts “or” embodiment);
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`light chain- and heavy chain -encoding DNA is inserted into
`2 separate vectors for coexpression of both vectors in 1 host
`“and” embodiment); and
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`light chain- and heavy chain -encoding DNA is inserted into
`1 vector for expression in 1 host (“and” embodiment).
`
`Genzyme Ex. 1016, pg 371
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`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`The Office then asserts that claims 1-2 and 5-7 of the ’567 patent, interpreted in this manner,
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`“read on” (and thus anticipate) claims 1, 13, 15-18, 21 and 33 of the ’415 patent. Relying on this
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`rationale, the Office rejects claims 1-4, 11, 13, 15-18, 21, 23-25 and 33 solely on the basis of
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`claims 1-2 and 5-7 of the ’567 patent. Owners request reconsideration of this ground of
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`rejection.
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`The Owners Did Not Expressly Redefine the Meaning of the Claim
`Term “or” as Used in the ’567 Claims
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`In its ordinary meaning, “or” is understood as stating alternatives. Kustom Signals, Inc.
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`v. Applied Concepts, Inc., 264 F.3d 1326, 1331, 60 U.S.P.Q.2d 1135, 1138 (Fed. Cir. 2001);
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`Schumer v. Lab. Comp. Sys. Inc., 308 F.3d 1304, 1311, 64 U.S.P.Q.2d 1832, 1838 (Fed. Cir.
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`2002) (“We have consistently interpreted the word “or” to mean that the items in the sequence
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`are alternatives to each other”); Brown v. 3M, 265 F.3d 1349, 1352, 60 U.S.P.Q.2d 1375, 1377
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`(Fed. Cir. 2001) (interpretation of “or” involved a “plain reading of the claim text”).
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`In fact, the
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`Office readily admits as much at page 10 of the Second Office Action: “normally
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`‘or’ is
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`interpreted to mean that the items in a sequence recited in a claim are alternatives to each other.”
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`As noted in the M.P.E.P., “the words of the claim must be given their plain meaning
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`unless applicant has provided a clear definition [to the contrary] in the specification.” M.P.E.P. §
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`2111.01[I] (emphasis added), citing In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed.
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`Cir. 1989); see glg 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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`unquestionable” 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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`21 1 1.01.111 (emphasis added), citing Multiform Desiccants Inc. v. Medzam Ltd., 133 F.3d 1473,
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`1477, 45 USPQ2d 1429, 1432 (Fed. Cir. 1998); s.e_e al_sQ Process Control Com. v. HydReclaim
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`Qprp, 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.
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`Genzyme Ex. 1016, pg 372
`
`

`
`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`The Prosecution History of the ’567 Patent Shows that “or” as Used in
`the ’567 Patent Claims Has Its Ordinary Meaning
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`The prosecution history of application Serial No. 06/483,457 (the application that
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`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”).
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`As originally filed, the ’567 patent application contained claims 1 through 52. Five of
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`these claims were independent method claims. One of them, Claim 51, was directed to a
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`“method for preparing heavy chain or light chain?” Claims 42, 47 and 49, on the other hand,
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`were directed to processes requiring both heavy E light chains to be produced in the same cell.2
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`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 April 26, 1985, the Office rejected all of the original
`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:
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`Claim 53 recited “preparing a DNA sequence encoding an
`immunoglobulin heavy g light chain, g an immunoglobulin Fab region,
`of known specificity.”3
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`Claim 68 recited “preparing a DNA sequence encoding a chimeric
`immunoglobulin heavy g 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
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`' m ‘S67 prosecution history, page 60 of original claims and specification.
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`2 & ’567 prosecution history, pages 57-60 of original specification.
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`3 E ‘S67 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.
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`-11-
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`Genzyme Ex. 1016, pg 373
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`Reexamination Control Nos 90/007,542 & 90/007,859 (merged proceedings)
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`homologous to the variable regions of an antibody derived from a second,
`different mammalian species.”
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`Claim 78 recited “preparing a DNA sequence encoding an altered
`immunoglobulin heavy o_r light chain of known specificity wherein the
`amino acid sequence of the immunoglobulin has been varied in
`predetermined fashion from that of mammalian antibody.”
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`Claims 57, 63 and 65 depended from claim 53 and claimed a result that required production of
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`both the heavy an_d the light immunoglobulin chains.5 By contrast, no claims dependent from
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`claims 68 or 78 required production of heavy gd light chains. Claim 68 ultimately issued in
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`slightly modified form as claim 1 of the ‘S67 patent.
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`In the next Office action, dated February 26, 1986, the Examiner rejected claims 57 and
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`63 under 35 U.S.C. § 112, second paragraph, as being improperly dependent on then-pending
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`claim 53.
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`In particular, the Examiner stated:
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`Claims 57 and 63 are improper dependent claims in that they indicate that
`both heavy an_d light chains are contained in a vector and that they are
`produced together. Claim 53 from which claims 57 and 63 depend is a
`method to clone a light chain, a heavy chain 9_r_ a Fab region, not two
`chains together. (emphasis added).
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`In other words, the Examiner plainly and immediately recognized that independent claim 53,
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`which employed the term “or,” was inconsistent on its face with the requirements specified by
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`dependent claims 57 and 63, which required a conjunctive relationship between the alternatives
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`recited in independent claim 53 (i.e., light chain 9_r heavy chain Q‘ Fab fragment) .
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`In response to this rejection, Owners attempted to fix the perceived problem by amending
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`“or” in claim 53 to read “and/or.” Owners explained:
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`Claims 53 -88 were rejected under 35 U.S.C. 112(b) [sic] as being
`indefinite for various recitations. The amendments to the claims render
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`moot certain elements of this rejection.
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`' §§ ’567 prosecution history, October 28, [985 response at page 3-4.
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`5
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`Added claim 63, which depended from claim Q, recited that heavy Q light chain are recovered fiom the host
`cell culture that has been transformed and are reconstituted to form an immunoglobulin. Dependent claims 57
`and 65, also dependent from claim _5_3, required both heavy chain - and light chain - encoding DNA. Claim 57
`recited