Page 1
`
`..
`I N
`
`WEN-HWA LEE and EVA Y-H.P. LEE, Junior Party, (U.S. Patent 5,998, 134), v.
`THADDEUS P. DRYJA, STEPHEN FRIEND and DAVID W. YANDELL, Senior Party,
`(Application 09/387, 158)
`
`Patent Interference No. 105,182
`
`Board of Patent Appeals and Interferences
`
`2005 Pat. App. LEXIS 38; 81 U.S.P.Q.2D (BNA) 1015
`
`December 7, 2005, Decided
`
`NOTICE:
`
`ROUTINE OPINION. Pursuant to the Patent Trial and Appeal Board Standard Operating Procedure 2, the opinion
`below has been designated a routine opinion.
`
`[*1]
`
`Before: TORCZON, SPIEGEL and LANE, Administrative Patent Judges
`
`COUNSEL:
`
`For LEE:
`Steven W. Parmelee, Esq.
`Kevin L. Bastian, Esq.
`TOWNSEND AND TOWNSEND AND CREW, LLP
`Two Embarcadero Center
`Eighth Floor
`San Francisco, CA 94111-3834
`
`ForDRYJA:
`Leslie Meyer-Leon, Esq.
`IP LEGAL STRATEGIES GROUP P.C.
`1480 Falmouth Road
`P.O. Box 1210
`Centerville, MA 02632-1210
`
`OPINIONBY: Spiegel
`
`OPINION:
`
`The opinion in support of the decision being entered today is not binding precedent of the Board.
`
`FINCHIMICA EXHIBIT 2015
`ADAMA MAKHTESHIM v. FINCH/MICA
`CASE IPR2016-00577
`
`

`

`2005 Pat. App. LEXIS 38, *1; 81 U.S.P.Q.2D (BNA) 1015, **
`
`Page 2
`
`SPIEGEL, Administrative Patent Judge. n1
`
`n1 As part of the Board's efforts under the Government Paperwork Elimination Act, signatures on papers
`originating from the Board are being phased out in favor of a completely electronic record. Consequently, in this
`case papers originating at the Board will not have signatures. The signature requirements for the parties have not
`changed. See e.g., 37 C.F.R. § 10.18.
`
`DECISION - MOTIONS - Bd.R. 125(a)
`
`I. Introduction
`
`This is a decision on the remaining motions in interference 105,182. Lee motion 1 attacks the benefit for the
`purpose of priority accorded to Dryja. Lee motion 2 seeks judgment that Dryja's claims are unpatentable under 35
`U.S.C. §§ 102 [*2] (b)/103(a). Dryja revised motion 2 seeks judgment that Lee's claims are barred on the basis of
`estoppel or res judicata. Dryja motion 4 seeks judgment that Lee's claims are unpatentable under 35 U.S.C. § 102(a)
`and/or 103(a). Dryja revised motion 2 is granted. Since Dryja revised motion 2 is dispositive, the remaining motions
`are dismissed as moot. [**1017]
`
`II. Background n2
`
`n2 This "Background" section is intended as merely a brief overview to provide a context for discussion of
`the subject matter of the interference and is not intended as a comprehensive treatment of either genetic
`predisposition to disease generally or to retinoblastoma specifically. See generally,
`
`U.S. Patent 5,998,134 (Ex 1142, cc. 1-5);
`
`MOLECULAR BIOLOGY AND BIOTECHNOLOGY: A COMPREHENSIVE DESK REFERENCE, R.
`Meyers, ed., VHC Publishers, Inc., New York, NY (1995), pp. 428-431 and 817-820 (copy enclosed);
`
`MOLECULAR CELL BIOLOGY, second edition, Darnell et al., eds., Scientific American Books, Inc.,
`New York, NY (1990), p. 996 (copy enclosed); and
`
`MICROBIOLOGY: AN INTRODUCTION, Tortora et al., The Benjamin/Cummings Publishing Company,
`Inc., Menlo Park, CA (1982), pp. 201-214 (copy enclosed).
`
`[*3]
`
`A. Genetic predisposition to disease
`
`A genome is all the hereditary material possessed by a living organism. The basic unit of hereditary material is the
`gene. A gene is an ordered sequence of nucleotide bases, i.e., DNA (or, for some viruses, RNA), that encodes a
`functional product, e.g., a protein. Typically, a gene has a coding region which determines the sequence of amino acids
`in the protein product. The gene includes regions preceding and following the coding region, as well as intervening
`sequences (introns) between individual coding segments (exons).
`
`In a process called transcription, much of the genetic information in DNA is copied or encoded by a
`complementary base sequence of RNA. The RNA message is then used by the cell to synthesize specific proteins
`through a process called translation. A promoter (a DNA sequence which controls the expression of a gene) directs the
`synthesis of the RNA copy for the gene and splicing signals control the precise removal of the introns. Each end of the
`spliced RNA (now called mRNA) is further modified before it is used as a template for protein synthesis.
`
`

`

`2005 Pat. App. LEXIS 38, *3; 81 U.S.P.Q.2D (BNA) 1015, **1017
`
`Page 3
`
`The human genome includes up to 10<5> genes. Except [*4] for identical twins, no two people have exactly the
`same DNA sequence in their genes. Since less than 5% of the genome contains protein coding sequences, most DNA
`variations between people have no apparent effect. Other DNA differences affect a person's phenotype (observable
`characteristics) and result in normal variable characteristics typically found in natural populations, such as different eye
`and hair colors. A wild-type gene or DNA is a gene or DNA that confers a phenotype considered to be a "normal" type
`commonly found in natural populations. For example, "normal" or "wild-type" genes for hair and eye pigment color
`might confer red hair and blue eye coloring or brown hair and brown eye coloring. Thus, there can be multiple
`"wild-types" of a gene. However, a small percentage of DNA differences result a phenotype that is considered
`abnormal. For example, the genes that confer hair, skin and eye pigment color in albinos are not wild-type genes, since
`albinos have milky or translucent skin, white or colorless hair, and eyes with pink irises and deep-red pupils which is a
`phenotype not commonly found in nature. In other words, a wild-type gene is a non-mutated gene that [*5] is
`commonly found in nature, whereas a mutated or abnormal gene is one that is not commonly found in nature.
`
`Several thousand of the genes in the human genome can cause disease if altered (mutated) in some way. A gene
`mutation that increases an individual's susceptibility to a certain disease or disorder is called a predisposing mutation. A
`gene alteration which occurs in the reproductive cells of sexually reproducing organisms (i.e., in egg or sperm cells)
`becomes incorporated in the DNA of every cell in the organism's body and can be passed to subsequent generations is
`called a germline mutation. Somatic mutations are DNA mutations that occur after conception. Somatic mutations can
`occur in any of the cells of the body except the germ cells (egg or sperm) and therefore are neither inherited nor passed
`on to subsequent generations.
`
`The mutation may be a deletion, insertion, duplication, inversion or some other rearrangement of DNA and may
`involve a single nucleotide or an entire chromosome. n3 For example, if the mutation occurs in the protein coding
`region of a gene, the amino acid sequence of the final gene product may be changed or even shortened if a premature
`[*6] stop codon (a triplet nucleotide sequence in mRNA that signals termination of protein synthesis) [**1018] is
`created. A mutation can also affect the promoter or processing signals, e.g., splicing signals. As a result, the protein
`product of the mutated gene may be an abnormal (e.g., nonfunctional or truncated) protein or the protein may not be
`made at all or the wrong amount of the protein may be made or the protein may be made at the wrong time in the
`organism's development.
`
`n3 A chromosome is a rod-shaped grouping of coiled strands of DNA and proteins in the cell nucleus that
`contain specific genes carrying hereditary information. Most multicellular organisms have several
`chromosomes, which together comprise the genome. Sexually reproducing organisms, e.g., humans, have two or
`more copies of each chromosome, one from each parent.
`
`B. Retinoblastoma
`
`Retinoblastoma ("RB"), the most commonly occurring malignant tumor of the developing retina in infants and
`children, is a classic example of gene mutations that predispose an individual to a specific disease or tumor. Genetic
`evidence suggests that RB occurs as the result of two mutational events. Genetic evidence further suggests that [*7] the
`human retinoblastoma gene is located within chromosome 13 and that absence or inactivation of the retinoblastoma
`gene is the primary cause of RB. Specifically, deletions in the retinoblastoma gene have been associated with
`retinoblastoma tumor.
`
`In hereditary RB the first mutation in the RB gene is a germline mutation, i.e., the mutation occurs in the
`reproductive cells (eggs or sperm) of a parent, and thus is present in all cells of a child. There is a 50% risk that a child
`of a patient with RB will receive an abnormal gene for RB and a 90% chance that a child with the mutated gene will
`develop an RB tumor. There is also an increased risk for development of secondary tumors, particularly osteosarcoma.
`A second single mutation in the somatic target cell (retina cell for RB or bone cell for osteosarcoma) is required for
`development of the tumor. These tumors might be expected to occur at an early age and to be bilateral (i.e., present in
`
`

`

`2005 Pat. App. LEXIS 38, *7; 81 U.S.P.Q.2D (BNA) 1015, **1018
`
`Page 4
`
`both eyes). In non-hereditary RB, both mutations occur in the same somatic cell (retina cell or bone cell) after
`conception. Thus, these tumors might be expected to occur at a relatively later age and to be unilateral.
`
`Therefore, in order to determine [*8] the genetic predisposition in a fetus or the susceptibility at a later age of
`developing RB, it is important to identify the exact location of the RB gene and to isolate, clone and sequence the
`full-length, wild-type RB gene. Isolation, cloning and sequencing of a full-length, wild-type RB gene provides the
`nucleic acid sequence and predicted amino acid sequence of a normal functional RB protein product. It also provides a
`standard against which to determine the presence of mutations, e.g., deletions, in a sample nucleic acid sequence which
`alter the nucleic acid sequence of the sample's RB protein product such that either no, or an "abnormal" (e.g.,
`non-functional or truncated), RB protein product is produced by the mutated gene.
`
`The subject matter of this interference generally relates to isolation and identification of RB genes in order to
`diagnose RB or a predisposition thereto. In particular, the subject matter of the interference is directed a method of
`using a cDNA clone of a full-length, wild-type RB gene as a hybridization probe to detect the presence of a mutated RB
`gene nucleic acid in a test sample. Hybridization is a technique in which the degree of sequence identity [*9] between
`nucleic acids can be determined. The technique measures the ability of one nucleic acid strand (e.g., a cDNA clone of a
`full-length, wild-type RB gene or "probe") to hybridize (bind through complementary nucleic acid base pairing) with
`another nucleic acid strand (e.g., DNA or RNA from a cell sample of a child being tested for the presence of a mutated
`RB gene). For example, a labeled probe specific for the normal RB gene (a cDNA clone of a full-length, wild-type RB
`gene labeled with a detectable marker) may be hybridized to a control DNA sequence from a "normal" individual, i.e.,
`an individual without RB disease, and to a sample nucleic acid, e.g., DNA, from an individual being tested for the
`presence of a mutated RB gene. The absence of hybrid formation between the probe and the sample DNA (no marker
`detected) or the presence of hybrids of a smaller size between the probe and the sample DNA compared to hybrids
`obtained between the probe and the control DNA (less marker detected in the test DNA/probe hybrid vis-a-vis the
`amount of marker detected in the control DNA/probe hybrid) is an indication of a mutated RB DNA (gene) in the test
`individual.
`
`III. Findings of fact (FF) [*10]
`
`The following findings of fact are supported by a preponderance of the evidence.
`
`1. The junior party is WEN-HWA LEE and EVA Y-H.P. LEE ("Lee").
`
`2. Lee is involved in the interference on the basis of U.S. Patent 5,998,134 (the "'134 patent," Ex 1142), issued 7
`December 1999, based on U.S. application [**1019] 08/482,627 ("the '627 application"), filed 7 June 1995.
`
`3. The '134 patent has been accorded benefit for the purpose of priority of
`
`(i) U.S. application 07/951,947 filed 28 September 1992, and
`
`(ii) U.S. application 07/108,749, filed 15 October 1987.
`
`4. Lee's real parties in interest are
`
`(a) its assignee, THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, and
`
`(b) its exclusive licensee, CANJI, INC., a wholly owned subsidiary of Schering-Plough Corporation.
`
`5. The senior party is THADDEUS P. DRYJA, STEPHEN FRIEND and DAVID W. YANDELL ("Dryja").
`
`

`

`2005 Pat. App. LEXIS 38, *10; 81 U.S.P.Q.2D (BNA) 1015, **1019
`
`Page 5
`
`6. Dryja is involved in the interference on the basis of U.S. application 09/387, 158, (the "'158 application") filed 31
`August 1999.
`
`7. The '158 application has been accorded benefit for the purpose of priority of
`
`(i) U.S. application 08/255,572, filed 8 June 1994,
`
`(ii) U.S. application 07/951,342, filed 25 September [*11] 1992,
`
`(iii) U.S. application 07/728,756, filed 8 July 1991,
`
`(iv) U.S. application 07/300,667, filed 23 January 1989,
`
`(v) U.S. application 07/146,525, filed 21 January 1988, and
`
`(vi) U.S. application 06/895, 163, filed 11 August 1986.
`
`8. Senior party's real parties-in-interest are
`
`(a) MASSACHUSETTS EYE AND EAR INFIRMARY,
`
`(b) THE WHITEHEAD INSTITUTE, and
`
`(c) BAYER HEALTHCARE LLC.
`
`9. The subject matter of the interference is defined by one count, which reads:
`
`Count 1
`
`Claim 1 of Lee (5,998,134) or claim 22 of Dryja (09/387,158).
`
`10. Claim 1 of the Lee '134 patent reads (emphasis added):
`
`A method of detecting a mutated retinoblastoma ("RB") nucleic acid in mammals, the method
`comprising the steps of:
`
`(i) hybridizing an isolated, full-length, wild-type RB cDNA probe to a cell sample, wherein the
`full-length, wild-type RB cDNA probe has the nucleotide sequence depicted in Figure 7; and
`
`(ii) detecting a mutated RB nucleic acid.
`
`11. Claim 22 of the Dryja '158 application reads (emphasis added):
`
`A method of detecting a mutated retinoblastoma ("RB") nucleic acid, the method comprising the
`steps of:
`
`(i) hybridizing an isolated full-length, wild-type [*12] RB cDNA probe to a mammalian cell
`sample; and
`
`(ii) detecting a mutated RB nucleic acid.
`
`

`

`2005 Pat. App. LEXIS 38, *12; 81 U.S.P.Q.2D (BNA) 1015, **1019
`
`Page 6
`
`12. The claims of the parties are:
`Lee
`1-4
`Dryja
`22-31, 49 and 50-59
`
`13. The claims of the parties which correspond to Count 1 are:
`Lee
`1-4
`Dryja
`22, 23 and 49
`
`14. The claims of the parties which do not correspond to Count 1, and therefore are not involved in the interference, are:
`Lee
`none
`Dryja
`24-31 and 50-59
`
`["DECLARATION," Paper 1.]
`
`Other findings of fact follow below.
`
`IV. Dryja Revised Substantive Motion 2
`
`Pursuant to 37 CFR §§ 41.121(a)(1) and 41.127(a)(1), Dryja seeks judgment that Lee's involved claims are barred
`by 37 CFR § 41.127 (a)(1) (estoppel, formerly 37 CFR § 1.658(c) (2004)), based on an adverse decision against Lee in
`interferences 103,426 ("the '426 interference") and 104,259 ("the [**1020] '259 interference") (Paper 33, p. 15). Lee
`opposes (Paper 39); Dryja replies (Paper 45).
`
`Dryja's arguments that Lee is not entitled to the claims of U.S. Patent 5,858,771 (Ex 1139) based on estoppel are
`moot because the '771 patent is not involved in this interference. To the extent Dryja is seeking relief with respect to the
`uninvolved '771 patent claims, [*13] the motion is dismissed.
`
`A. The parties' positions
`
`According to Dryja, Lee should not be allowed to obtain patent rights in subject matter that Lee lost in the '426 or
`'259 interference or on subject matter that could have been put in issue during either of those interferences (Paper 33, p.
`26, penultimate P). Dryja argues that Lee had notice of certain subject matter commonly disclosed in the applications
`involved in the '426 and '259 interferences, including methods of using RB nucleic acids as hybridization probes (Paper
`33, p. 4). Dryja further argues that Lee could have put in issue priority of any commonly disclosed subject matter in the
`'426 and/or '259 interference but did not. Since Lee requested and received adverse judgments in both the '426 and '259
`interferences, Dryja contends that Lee is estopped from raising the issue of commonly disclosed subject matter now.
`
`Dryja specifically argues that, having lost its claim to an isolated cDNA encoding a full-length, wild-type RB
`protein in the '426 interference, Lee is estopped from claiming methods of using the isolated cDNA as a hybridization
`probe to detect mutated RB nucleic acids because this is the exact utility [*14] described in Dryja's applications for the
`isolated cDNA (Paper 33, pp. 18-19). Dryja further argues that Lee should have raised the issue of priority of using an
`isolated full-length, wild-type RB cDNA as a hybridization probe to detect mutated RB nucleic acids in the '259
`interference (Paper 33, pp. 25-26).
`
`In its opposition, Lee contends that Dryja's motion is procedurally defective because it does not include a
`comparative claim chart. Lee further contends that Dryja's motion is substantively defective not only because Dryja has
`
`

`

`2005 Pat. App. LEXIS 38, *14; 81 U.S.P.Q.2D (BNA) 1015, **1020
`
`Page 7
`
`not shown that Lee could have earlier raised the issue of priority of using an isolated full-length, wild-type RB cDNA as
`a hybridization probe to detect mutated RB nucleic acids, but also because Dryja had notice that Lee considered an
`isolated full-length, wild-type RB cDNA to be patentably distinct from the subject matter of the '426 interference (Paper
`39, p. 13; p. 18, PP2-3; p. 19, P3; p. 20, P1; p. 21, P3).
`
`B. A brief historical background of interference estoppel
`
`Historically, four types of estoppel have been raised in interference proceedings: (1) estoppel by dissolution, (2)
`estoppel by judgment, (3) equitable estoppel, and (4) estoppel for [*15] failure to move. Woods v. Tsuchiya, 754 F.2d
`1571, 1578, 225 USPQ 11, 15-16 (Fed. Cir.), cert. denied, 474 U.S. 825 (1985).
`
`Estoppel by dissolution prevents a junior party who had access to the senior party's application from
`obtaining claims to common patentable subject matter after an interference is dissolved. Estoppel by
`judgment prevents a losing party in a previous interference between the same parties from making any
`claim (1) not patentably distinct from the counts in issue in that interference, or (2) which reads on the
`disclosure of the winning party to which the losing party had access. Equitable estoppel prevents the
`winning party in a previous interference terminated by judgment (or the senior party in an interference
`which ends in dissolution) from claiming patentably distinct subject matter to which the other party did
`not have access. Estoppel for failure to file a motion to amend would prevent a party who fails to file a
`timely interlocutory motion to amend from later claiming subject matter which could have been added by
`such a motion. [Id., citations omitted.]
`
`[*16]
`
`This case involves an estoppel based on a failure to move. See In re Kroekel, 803 F.2d 705, 709, 231 USPQ 640,
`643 (Fed. Cir. 1986); Ex parte Kimura, 55 USPQ2d 1537 (Bd. Pat. App. & Int. 2000).
`
`The interference rules were revised in 1984 (37 CFR §§ 1.601 through 1.688, "the 1984 rules"), and applied to all
`interferences declared on or after 11 February 1985, except in a limited number of special circumstances. Under §
`1.601, the rules were to be construed to secure the just, speedy and inexpensive determination of interferences. Section
`1.658(c) defined estoppel, i.e.,
`
`A judgment in an interference settles all issues which (1) were raised and decided in [**1021] the
`interference, (2) could have been properly raised and decided in the interference by a motion under §
`1.633(a) through (d) and (f) through (j) or § 1.634, and (3) could have been properly raised and decided
`in an additional interference with a motion under § 1.633(e). A losing party who could have properly
`moved, but failed to move, under § 1.633 or § 1.634, shall be estopped to take ex parte or inter partes
`action in the Patent and Trademark [*17] Office after the interference which is inconsistent with that
`party's failure to properly move, except that a losing party shall not be estopped with respect to any
`claims which correspond, or properly could have corresponded, to a count as to which that party was
`awarded a favorable judgment.
`
`Thus, under the 1984 rules, estoppel could be based on a failure to move. The estoppel rule was designed to encourage
`parties in interference cases to settle as many issues as possible in one proceeding, i.e., to secure the just, speedy and
`inexpensive determination of interferences.
`
`Rule 633 permitted a party to file a variety of motions, including a
`
`(a) motion for judgment that an opponent's claim designated as corresponding to a count was unpatentable;
`
`(b) motion for judgment that there was no interference-in-fact; and
`
`

`

`2005 Pat. App. LEXIS 38, *17; 81 U.S.P.Q.2D (BNA) 1015, **1021
`
`Page 8
`
`(c) motion to redefine the interfering subject matter by (1) adding or substituting a count, (2) amending an
`application claim corresponding to a count or adding a claim in the moving party's application to be designated as
`corresponding to a count, (3) designating an application or patent claim as corresponding to a count, (4) designating an
`application or patent claim [*18] as not corresponding to a count, or (5) requiring an opponent who is an applicant to
`add a claim and to designate the claim as corresponding to a count.
`
`An estoppel would not apply with respect to any claims which correspond, or which properly could have
`corresponded, to a count as to which a party was awarded a favorable judgment. The Notice of Final Rule, Patent
`Interference Proceedings, 49 Fed. Reg. 48416, 48426-27 (Dec. 12, 1984), reprinted in 1050 O.G. 385, 395 (Jan. 29,
`1985) provided a number of examples of how estoppel under Rule 658(c) would apply, including
`
`Example 24. Junior party applicant AL and senior party AK both disclose separate patentable
`inventions "A" and "B" and claim only invention "A" in their respective applications. An interference is
`declared with a single count to invention A. Neither party files a preliminary motion (see § 1.633(c)(1))
`to add a count to invention B. Judgment as to all of AL's claims corresponding to the sole count is
`awarded to junior party AL. Senior party applicant AK would be estopped to thereafter obtain a patent
`containing claims to invention B, because applicant AK failed [*19] to move to add a count to invention
`B in the interference. Junior party applicant AL would not be estopped to obtain a patent containing
`claims to invention B.
`
`Example 25. In this example, the facts are the same as in Example 24 except that the judgment is
`awarded as to all AK's claims corresponding to the count to senior party applicant AK. Junior party
`applicant AL would be estopped to obtain a patent containing claims to invention B in the interference.
`Senior party applicant AK would not be estopped to obtain a patent containing claims to invention B.
`
`Example 26. Junior party applicant AM and senior party applicant AP both disclose separate
`patentable inventions "C", "D", and "E" and claim inventions C and D in their respective applications.
`An interference is declared with two counts. Count 1 is to invention C and Count 2 is to invention D.
`Neither party files a preliminary motion to add a proposed Count 3 to invention E. Judgment as to all
`AM's claims corresponding to Counts 1 and 2 is awarded to junior party applicant AM. Senior party
`applicant AP would be estopped to thereafter obtain a patent containing claims to invention E, because
`applicant AP failed to move to [*20] add a count to invention E in the interference. Junior party
`applicant AM would not be estopped to obtain a patent containing claim to invention E.
`
`Example 27. In this example, the facts are the same as in Example 26 except that judgment is
`awarded as to all AP's claims corresponding to Counts 1 and 2 to senior party applicant AP. Junior party
`applicant [**1022] AM would be estopped to obtain a patent containing claims to invention E, because
`applicant AM failed to move to add a count to invention E in the interference. Senior party applicant AP
`would not be estopped to obtain a patent containing claims to invention E.
`
`The Commissioner also pointed out that
`
`parties in interference cases should recognize, ... that the interference estoppel provisions of § 1.658(c)
`have been expanded with a view to eliminating much of the ex parte maneuvering which has taken place
`in the past after an interference is eliminated. Accordingly, a party who fails to move to place a matter in
`issue runs a considerable risk that the party will not be able to raise the issue ex parte after an
`interference is terminated. [49 Fed. Reg. at 48441, c. 2, P2, reprinted in 1050 O.G. at 410, [*21] c. 2,
`P2.]
`
`To wit,
`
`

`

`2005 Pat. App. LEXIS 38, *21; 81 U.S.P.Q.2D (BNA) 1015, **1022
`
`Page 9
`
`the following comment by the CCPA in its opinion in In re Shimer, 69 F.2d 556, 558, 21 USPQ 161, 163
`(CCPA 1934), accurately expresses the intent of the PTO in promulgating §§ 1.633(e) and 1.658(c):
`
`It may be stated that this rule works no hardship to him who is diligent in pursuit of his
`rights. When an interference is declared, the files of his contestants are open to him. He
`has full cognizance of their disclosures and claims. So advised, it becomes his duty to put
`forward every claim he has. Rule 109 [i.e., Rule 1.633(e)] affords him this opportunity.
`Ifthe rule be not enforced or enforceable, then delays and litigation are greatly increased.
`It is quite obvious that the doctrine of estoppel, as applied in these cases, results in the
`better conduct of the business of the Patent [and Trademark] Office and in the public
`good. [Id. at 48440, c. 2, P2, bracketing added.]
`
`Rule 633(e) is not involved in this case and In re Shimer did not involve a situation where a party failed to move
`under § 1.633(c). However, applying the doctrine of estoppel in cases where, as here, a party fails to avail itself [*22]
`of the opportunity afforded it by Rule 633(c), similarly results in more efficient conduct of the business of the USPTO
`and in the public good.
`
`In 2004, the 1984 interference rules were revised as part of an overhaul consolidating and simplifying the rules
`governing practice before the Board of Patent Appeals and Interferences. An interference was defined as a contested
`case as set forth in 37 CFR §§ 41.200 through 41.208 and 41.100 through 41.158. The current interference rules apply
`to all interferences declared on or after 13 September 2004. Section 41.127(a)(1) recodified the former § 658(c)
`estoppel, i.e.,
`
`A judgment disposes of all issues that were, or by motion could have properly been, raised and
`decided. A losing party who could have properly moved for relief on an issue, but did not so move, may
`not take action in the Office after the judgment that is inconsistent with that party's failure to move,
`except that a losing party shall not be estopped with respect to any contested subject matter for which
`that party was awarded a favorable judgment. 37 CFR § 41.127(a)(1).
`
`Section 41.208(a) defines the "substantive" motions (formerly "preliminary" motions under the 1984 rules) [*23]
`which may be filed in an interference, including motions which (1) raise a threshold issue, e.g., a no interference-in-fact
`issue, or (2) seek to redefine the interfering subject matter, e.g., by adding or amending a count or by changing the
`correspondence of claims to the count. According to § 41.207(b)(2), "A claim corresponds to a count if the subject
`matter of the count, treated as prior art to the claim, would have anticipated or rendered obvious the subject matter of
`the claim." "For the purposes of determining priority and derivation, all claims of a party corresponding to the count are
`presumed to stand or fall together. To challenge this presumption, a party must file a timely substantive motion to have
`a corresponding claim designated as not corresponding to the count." 37 CFR § 41.207(b)(1).
`
`In the Notice of Final Rule, Rules of Practice Before the Board of Patent Appeals and Interferences, 69 Fed. Reg.
`49960, 49994 (Aug. 12, 2004), reprinted in 1286 O.G. 21, 55 (Sept. 7, 2004) the Director noted that § 41.207(b)
`
`simply formalizes the effect of the estoppel arising out of cases like In re Deckler, 977 F.2d 1449, 1452,
`24 USPQ2d 1448, 1449 (Fed. Cir. 1992), [*24] in which a party could not subsequently seek claims that
`were patentably indistinct from the subject matter of the count lost in the interference. [**1023]
`
`In summary, the doctrine of estoppel serves administrative objectives of securing "the just, speedy, and inexpensive
`resolution of every proceeding before the Board." 37 CFR § 41.1(b). Since 1984, estoppel based on a prior judgment or
`on a failure to file a timely motion in a prior interference may be put in issue by filing a motion in the later interference.
`Estoppel benefits three separate entities: (1) the winning party, (2) the PTO and (3) the public. The winning party avoids
`the expense of a second interference directed to commonly disclosed subject matter, whether or not claimed by one or
`both parties, which the losing party could have properly put in issue and litigated in the first interference. Estoppel
`
`

`

`2005 Pat. App. LEXIS 38, *24; 81 U.S.P.Q.2D (BNA) 1015, **1023
`
`Page 10
`
`allows the PTO to expedite patent prosecution, maximize allocation of its resources and improve its administrative
`efficiency. The public gains greater certainty about who, if anyone, is entitled to a patent on commonly disclosed
`subject matter.
`
`C. Estoppel based on the '426 interference
`
`1. the '426 interference
`
`15. [*25] On 31 January 1995, the '426 interference was declared between junior party Lee and senior party Dryja (Ex
`1004, p. 1) and 1 May 1995 was set as the time for filing preliminary statements and preliminary motions. n4
`
`n4 Exhibit 1004 consists of two documents -- two page "Paper 2" and four page "Paper No. 14" -- without
`unique page numbering. Therefore, pages 1-4 of "Paper No. 14" are referred to as pages 3-6, respectively, in this
`decision.
`
`16. Lee was involved in the '426 interference on the basis of application 07/951,947 ("the '947 application," Ex 1006),
`filed 28 September 1992 (Ex 1004, p. 4).
`
`17. Dryja was involved in the '426 interference on the basis of application 07/958,290 ("the '290 application," Ex 1005
`n5) filed 8 October 1992 (Ex 1004, p. 5).
`
`n5 Exhibit 1005 is a multi-document exhibit without unique numbering. The one page filing receipt is
`numbered as p. 1. The three page request for filing a divisional application is numbered as pp. 2-4. The five page
`preliminary amendment is numbered as pp. 5-9. The specification of the '290 application is numbered as pp.
`10-53. The original claims are numbered as pp. 54-58. The abstract is numbered as p. 59. The twenty-three
`pages of drawings, which are not in consecutive figure number are numbered as pp. 60-82. Finally, the
`combined declaration and power of attorney are numbered as pp. 83-85. Paragraph 20.1.1 of the STANDING
`ORDER (Paper 2) expressly instructs parties not to file an entire application file as a single exhibit. When
`multiple documents are filed as a single exhibit, as with Exhibits 1004 and 1005, there are multiple pages with
`the same page number. In Exhibit 1005 there are at least five occurrences of "page 1."
`
`[*26]
`18. The subject matter of the '426 interference was defined by one count, i.e.,
`
`Purified nucleic acid comprising a human retinoblastoma gene, or a fragment thereof comprising 15
`or more bases, said nucleic acid being less than 100kb in size.
`
`[Ex 1004, p. 6.]
`
`19. Lee '947 application claims 15, 16, 45 and 46 (Ex 1006) and Dryja '290 application claims 1-4 and 22-37 (Ex 1005)
`were designated as corresponding to the count (Ex 1004, p. 6).
`
`20. Lee '947 application claim 45 reads: "An isolated retinoblastoma gene DNA molecule consisting of the nucleic
`acid molecule having the sequence shown in Figure 7" (Ex 1032, p. 3, emphasis added).
`
`21. Figure 7 of the '947 application is said to be the nucleotide and predicted amino acid sequences of the
`retinoblastoma gene (Ex 1006, p. 36, II. 7-8).
`
`22. Dryja '290 application claim 26 depends from claims 25 and 1 and is directed to a "Purified nucleic acid comprising
`a human retinoblastoma gene, or a fragment thereof comprising 15 or more bases, said nucleic acid being less than 100
`
`

`

`2005 Pat. App. LEXIS 38, *26; 81 U.S.P.Q.2D (BNA) 1015, **1023
`
`Page 11
`
`kb in size" (claim 1), "wherein the nucleic acid is a cDNA" (claim 25), and "wherein said cDNA comprising a
`sequence of Figure 5" (claim 26) [*27] (Ex 103