Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 SHAKED ET AL. [FN1]
v.
TANIGUCHI ET AL. [FN2]
Patent Interference No. 101,731
October 12, 1990
Final Hearing-Remand August 9, 1990
Patent granted to Ze'ev Shaked and Sidney N. Wolfe on July 23, 1985, Patent No. 4,530,787 filed October 17, 1984, Serial No. 661,902.
Application of Tadatsugu Taniguchi, Masami Muramatsu, Haruo Sugano, Hiroshi Matsui, Nobukazu Kashima and Junji Hamuro, filed December 15, 1983, Serial No. 561,531.
Waddell A. Biggart, J. Frank Osha and Gordon Kit for Shaked et al. Oral argument by Gordon Kit
Norman F. Oblon, Stanley P. Fisher, Marvin J. Spivak, C. Irvin McClelland, Gregory J. Maier, Arthur I. Neustadt, Robert C. Miller, Richard D. Kelly, James D. Hamilton, Eckhard H. Kuesters, Robert T. Pous, Charles L. Gholz, Jorge A. Goldstein and Marvin C. Guthrie for Taniguchi et al. Oral argument by Richard D. Kelly
Before Serota
Chairman
Calvert
Vice Chairman
Sofocleous
Examiner in Chief
Sofocleous
Examiner-in-Chief
INTERLOCUTORY ORDER
This interference involves a patent of Shaked et al. (Shaked), assigned to Cetus Corporation, and an application of Taniguchi et al. (Taniguchi), assigned by an unrecorded assignment to Ajinomoto Company of Japan.
The subject matter in issue concerns interleukin-2 (IL-2) polypeptides. The sole count at issue reads as follows:
Count 1
A cystine-containing IL-2 preparation derived from synthetic microbially produced IL-2 having fully reduced cysteines comprising cystine-containing IL-2 which;
(i) has the same disulfide bridging as native human IL-2;
(ii) is substantially free of oligomers; and
(iii) contains less than about 15 % by weight of isomers having disulfide bridging different from native human IL-2.
The claims of the parties which correspond to the count are:
Shaked: Claims 14 to 18 and 21.
Taniguchi: Claims 7, 8, 12 and 13.
This interference was instituted with the above count as the only count at issue. The respective claims of the parties which were stated in the declaration papers to correspond to the count were as follows:
Shaked: Claims 1 through 22
Taniguchi: Claims 7, 8, 12 and 13.
During the preliminary motion period, Shaked filed, inter alia, a preliminary motion (Paper No. 40) under 37 CFR 1.633(c)(4) to designate his claims 1 to 22 as not corresponding to the count; Taniguchi filed, inter alia, preliminary motions (Paper Nos. 34 and 35) for judgment under 37 CFR 1.633(a) urging that Shaked's claims corresponding to the count were unpatentable under 35 U.S.C. 102/103. In the Decision on Preliminary Motions, the examiner-in-chief (EIC) granted Shaked's preliminary motion only to the extent that Shaked's claims 1 to 13, 19, 20 and 22 were designated as not corresponding to the count. The EIC, however, held that Shaked's claims 14 to 18 and 21 defined the same patentable invention as the count. The EIC granted Taniguchi's preliminary motions (Paper Nos. 34 and 35) only to the extent that he held Shaked's claims 14 to 18 and 21 unpatentable under 35 U.S.C. 102/103.
*2 After rendering the Decision on Preliminary Motions, the EIC placed Shaked under an order to show cause why judgment should not be entered against him in view of the unpatentability of his claims corresponding to the count. Shaked filed a response to the order in which he requested final hearing. The EIC granted the request for final hearing and accordingly set the times for filing briefs. Subsequent to the setting of the brief times, the EIC granted Shaked's unopposed motion (Paper No. 136) for permission for both parties to rely upon the evidence introduced in support of and/or in opposition to the motions filed during the motions period. Thereafter, on June 12, 1989 (three months after the rendering of the Decision on Preliminary Motions), Shaked filed a request for reexamination of his involved patent with respect to claims 14 to 22 (as noted above, claims 14 to 18 and 21 are involved here). On June 21, 1989, Shaked notified the EIC of the filing of the request for reexamination.
After Shaked's reply brief was filed, the interference was placed on a list of cases in condition for final hearing, and the parties were notified on July 3, 1990 that a final hearing was set for August 9, 1990. Thereafter, Shaked filed a motion (Paper No. 176) to suspend the interference because of the reexamination proceeding; the EIC denied the motion; Shaked filed a petition to the Commissioner pursuant to the provisions of 37 CFR 1.565(e); and the Commissioner denied the petition.
Reexamination
On August 21, 1989, the primary examiner granted the Shaked request for reexamination of his patent claims 14 to 22. The present posture of the reexamination proceeding is that claims 1 to 13 of the patent have been held to be patentable, claims 14, 15 and 17 have been canceled, and claims 16, 18, 19, 20, 21, and 22 are under rejection. Patent claims 16, 19 and 22 have been amended. It is noted that claim 16, prior to amendment during the reexamination proceeding, corresponded exactly to the count of the interference. Shaked in support of his arguments for patentability of the claims undergoing reexamination has submitted evidence and arguments which were not submitted in support of or in opposition to the preliminary motions filed in the interference proceeding.
Oral Hearing
Both parties appeared, through counsel, at the hearing. Counsel for Shaked conceded that his involved claim 16 (the count of this interference) was unpatentable but urged that his claim 21 (directed to a mutein of IL-2) was patentable. Counsel for Taniguchi urged that we should issue a judgment against Shaked because of this concession, stating that since all of Shaked's claims correspond to the count, i.e., define the same invention as the count, they are unpatentable. Such a judgment, according to Taniguchi, would operate to cancel claims 14 to 18 and 21 from the Shaked patent and terminate the reexamination.
Each counsel was asked his views as to how this interference should proceed in view of the reexamination and especially in light of Shaked's May 31, 1990, amendment in the reexamination.
*3 Counsel for Shaked urged that this interference should be suspended so that the EIC could have the benefit of the examiner's views concerning patentability in the reexamination and that we should consider all the evidence and arguments presented in the reexamination. Concerning the potential delay of this interference proceeding caused by the filing of the reexamination request, counsel for Shaked urged that he had the right at any time to file a request for reexamination. Counsel urged that if the interference were not suspended, it would be improper to add the reexamination proceeding to this interference.
Counsel for Taniguchi urged that this interference should not be suspended and that the reexamination should not be added to this proceeding. He stated that he did not have the opportunity to participate in the reexamination which was an ex parte proceeding. Therefore, he urged that it would be improper for us to consider any evidence or argument presented in the reexamination but not presented in this interference. Counsel for Taniguchi noted that Shaked could have amended his claims in this interference under the provisions of 37 CFR 1.633(i) which provide for the filing of a motion to redefine under 37 CFR 1.633(c) in response to a preliminary motion for judgment under 37 CFR 1.633(a). According to Taniguchi, Shaked could have filed a reissue application under 37 CFR 1.633(h) coupled with a motion to redefine under 37 CFR 1.633(c)(2) to amend the claims corresponding to the count. Shaked did not file such motions. He also noted that Shaked could have moved to present testimony and evidence, i.e., other than that relied upon during the motions period. In light of the circumstances of this case, Taniguchi characterized Shaked's filing of the reexamination as a "subversion" of the interference rules.
OPINION
This panel is faced with a question of first impression. The purpose of the interference rules is to "secure the just, speedy, and inexpensive determination of every interference" (37 CFR 1.601), and the EIC must exercise control over each interference such that its pendency does not normally exceed two years (37 CFR 1.610(c)). At oral hearing, Shaked conceded that claim 16 (the count of this interference) and claims 14, 15, 17 and 18 were unpatentable but urged that claim 21 was patentable. If Shaked does not show that claim 21 is directed to a separate patentable invention from the count, the concession would also be effective against that claim.
Shaked is correct that the interference rules do not specifically prohibit a party patentee dissatisfied with the EIC's Decision on Preliminary Motions from filing a request for reexamination. Nonetheless, we agree with Taniguchi that by filing such a request, Shaked has subverted the purpose of the interference rules, which is to resolve all controversies between the parties in an inter partes forum. Notice of Final Rule, 49 Fed. Reg. 48416, col. 3 (Dec. 12, 1984), reprinted in 1050 Off. Gaz. Pat. Office 385, col. 3 (Jan. 29, 1985); Kwon v. Perkins, 6 USPQ2d 1747 (BPAI 1988), aff'd, 886 F.2d 325, 12 USPQ2d 1308 (Fed.Cir. 1989). Clearly, Shaked had the opportunity to file a motion to redefine the interfering subject matter by amending the count of this interference and the opportunity to present testimony on the issues of patentability raised in the interference, and should have done so instead of proceeding on an ex parte basis by way of reexamination.
*4 This situation should not be permitted to continue. We consider that Taniguchi should be entitled to cross-examine the witnesses whose evidence was presented by Shaked in the reexamination proceeding before the examiner, and to introduce rebuttal evidence. Accordingly, under the circumstances of this case, the reexamination will be added to this interference. In the order redeclaring this interference by the addition of the reexamination, the EIC will designate which reexamination claims correspond to the count. A preliminary motion period will be set so that either party may present motions which could not have been presented earlier. We consider this action necessary in order to resolve all controversies between the parties in an inter partes forum.
Accordingly, this interference is remanded to the EIC for further proceedings not inconsistent with this opinion.
BOARD OF PATENT APPEALS AND INTERFERENCES
Chairman
Ian A. Calvert
Vice Chairman
Michael Sofocleous
Examiner-in-Chief
FN1. Assignors to Cetus Corporation, Emerycille, California, a corporation of Delaware.
FN2. Assignors to Ajinomoto Co., Inc., of Tokyo, Japan; Hoffman laRoche being the exclusive license.
Harry F. Manbeck, Jr.
Commissioner of Patents and Trademarks
MEMORANDUM OPINION AND ORDER
The Board of Patent Appeals and Interferences (Board) has forwarded to the Commissioner an interlocutory decision in which it proposes to add a reexamination to an interference.
The interference involves a patent to Shaked et al. (Shaked) and an application of Taniguchi et al. (Taniguchi). After an Examiner-in-Chief (EIC) decided preliminary motions, Shaked filed an ex parte request to have his patent reexamined. A primary examiner ordered reexamination; Taniguchi did not participate in the reexamination. When the interference reached final hearing, claims of the Shaked patent corresponding to the count had been amended during reexamination.
The Board correctly enters an interlocutory order remanding the interference to the EIC for the purpose of adding the reexamination to the interference. In doing so, the Board authorizes the EIC to take appropriate action -- action which is well within the scope of the rules. See 37 CFR § 1.610(e). The Board also correctly sets a new preliminary motion period to permit the parties to file preliminary motions which could not have been earlier filed, i.e., any motion which might have been filed had the reexamination been part of the interference at the time preliminary motions were originally filed.
The record reveals that neither party wants the reexamination added to the interference. However, neither party explains how the Patent and Trademark Office (PTO) is to simultaneously carry on (1) a reexamination of a patent involved in an interference (where claims can be amended ex parte) and (2) an interference involving the patent being reexamined (where proceedings are inter partes). Unless the Board's action is implemented to temporarily "merge" the reexamination and interference, a patent owner can render the subject matter of the interference "a moving target" without any input or other participation by its opponent in the interference. It becomes apparent that a patentee, not the EIC or the Board, essentially ends up controlling both the interference and the opponent.
*5 There is no statute which precludes addition of a reexamination to an interference involving the patent sought to be reexamined. It has long been the practice of PTO to add an application to reissue a patent to an interference involving the patent. It is true that reexamination must be carried out with "special dispatch" within PTO. 35 U.S.C. § 305. However, as long as the interference is carried on with "special dispatch," PTO complies with the mandate of § 305. Compare Ethicon, Inc. v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988).
In those cases where a patent sought to be reexamined is involved in an interference, the primary examiner should notify the EIC immediately. In consultation with the EIC, the primary examiner will determine whether a substantial new question of patentability is raised by the reexamination. If reexamination is ordered, and if the EIC determines that issues raised in the reexamination may affect the interference, the EIC has authority to add the reexamination to the interference. If the reexamination is added to the interference, the EIC may give the parties time to take such action as may be appropriate, i.e., filing of preliminary motions, giving due consideration to the fact that a patentee will not be allowed to delay an interference through a belated request for reexamination. Neither the reexamination nor the interference will be stayed. Cf. 37 CFR § 1.565(e). During the interference, if the reexamination is added to the interference, ex parte proceedings in the reexamination are suspended, but the reexamination itself proceeds, along with the interference, with "special dispatch." Compare 37 CFR § 1.615(a). Whether or not the reexamination is added to the interference, amendments filed in the reexamination should not be responded to or any other action taken in the reexamination without consultation with the EIC. Id. After the interference is terminated, the primary examiner should then continue ex parte reexamination proceedings with "special dispatch."
Papers filed by the patent owner in an interference, after a reexamination is added to the interference, are not papers which fall within the scope of 37 CFR § 1.550(e) and need not be served on any third-party requester. Upon termination of the interference, PTO and the patent owner shall resume sending and serving copies of papers entered and filed in the reexamination on any third-party requester.
ORDER
Upon consideration of the record, it is
ORDERED that the Board's proposed action is approved and it is
FURTHER ORDERED that the interference and reexamination are remanded to the EIC, as indicated by the Board, for such action as the EIC may deem appropriate consistent with the reviews expressed in the Board's opinion and this opinion and it is
*6 FURTHER ORDERED that any request for reconsideration of this MEMORANDUM OPINION AND ORDER must be filed in the form of a petition under 37 CFR § 1.644 within fourteen (14) days of the date hereof.
January 10, 1991
Michael Sofocleous
Examiner-in-Chief
RECONSIDERATION
In response to the Interlocutory Order (Paper No. 185) and the Commissioner's Memorandum Opinion and Order (Paper No. 186), both parties filed petitions (Paper Nos. 187 and 188) to the Commissioner and oppositions (Paper Nos. 190 and 193) thereto. Taniguchi et al. (Taniguchi) also requested reconsideration of the Interlocutory Order. This decision will address the Taniguchi request for reconsideration.
Taniguchi requests reconsideration with respect to the scope of evidence on which Shaked et al. (Shaked) will be permitted to rely in this merged proceeding. On pages 1 and 2 of the request, Taniguchi urges that we should limit the evidence solely to the issues raised for the first time in the reexamination by the primary examiner, namely, evidence as it relates to the Devos et al. prior art. We decline to do so.
In our view, Shaked should be permitted to rely upon any evidence and any argument presented in the reexamination which relate to the claims corresponding to the count, especially since Shaked urges on pages 10 to 12 of the opposition that the new evidence relied upon in the reexamination is cumulative to that relied upon in the interference. We perceive of no undue prejudice inuring to either party by this action. We deem that this is necessary so that we can resolve all controversies between the parties in an inter partes forum. As we noted in our Interlocutory Order,
the interference rules [37 CFR 1.601 et seq.] do not specifically prohibit a party patentee dissatisfied with the EIC's Decision on Preliminary motions from filing a request for reexamination. [Page 7]
Accordingly, during the limited preliminary motion period,
either party may present motions which could not have been presented earlier. [Page 8 of the Interlocutory Order]
This interference is remanded to the EIC for further proceedings not inconsistent with this order.
RECONSIDERATION DENIED
Michael Sofocleous
Examiner-in-Chief
REDECLARATION
The interference is redeclared as follows:
The Shaked et al. Reexamination, 90/001,787, filed June 12, 1989, is added to this proceeding.
Count 2 is substituted for count 1.
Count 2 is as follows:
A cystine-containing unglycosylated IL-2 preparation derived from synthetic microbially produced unglycosylated IL-2 having fully reduced cysteines comprising cystine-containing IL-2 which:
(i) has the same disulfide bridging as native human IL-2 with no or minimal overoxidation products;
(ii) is substantially free of oligomers; and
(iii) contains less than about 15% by weight of isomers having disulfide bridging different from native human IL-2.
*7 The claims of the parties which correspond to count 2 are as follows:
Shaked et al. Patent: Claims 14 to 18 and 21.
Shaked et al. Reexamination: Claims 16, 18 and 21.
Taniguchi et al.: Claims 7, 8, 12 and 13.
The time for filing additional preliminary motions and a motion for testimony is set to close within 30 days after the date of mailing of this redeclaration notice.
Since count 2 has been substituted for count 1, each party may file a supplemental preliminary statement. The time for filing and serving such a statement is set to close within 30 days after the date of mailing of this redeclaration notice.
January 10, 1991
Harry F. Manbeck, Jr.
Assistant Secretary and Commissioner of Patents and Trademarks
DECISION ON REQUEST FOR RECONSIDERATION
Shaked et al. (Shaked) petition (Paper No. 187) for reconsideration of an INTERLOCUTORY ORDER (Paper No. 185) entered by the Board of Patent Appeals and Interferences (Board) on October 12, 1990, and a MEMORANDUM OPINION AND ORDER entered by the Commissioner on October 12, 1990 (Paper No. 186).
The rules do not authorize a petition from an interlocutory order entered by the Board. 37 CFR § 1.644. Hence, Shaked's petition will be considered only to the extent it seeks reconsideration of the MEMORANDUM OPINION AND ORDER. Numerous reasons are given by Shaked in support of the request for reconsideration. None are persuasive. Hence, for the reasons given herein, the request is denied.
The request for an oral hearing (petition, page 1) is denied as being unnecessary.
Shaked argues that the Board erroneously held that "Shaked has submitted evidence and arguments which were not submitted in support of, or in opposition to, the preliminary motions in the Interference" (petition, page 3). Shaked's argument is properly made only in a petition filed after entry of a final decision by the Board. 37 CFR § 1.644(a)(2). Whether issues raised in the reexamination are relevant to issues raised in the interference (petition, page 4) and whether Taniguchi has standing to raise particular issues (petition, page 5) are matters which will be determined by the Examiner-in-Chief (EIC) on remand and by the Board in connection with any subsequent final hearing which may take place. Any review on petition is manifestly premature at this point. Since review is premature at this time, there is no need to evaluate the merits of Taniguchi's opposition alleging that Shaked has misstated the record (Paper No. 190, pages 1-3).
The EIC and the Board will determine in the first instance what issues are properly raised on the remand to the EIC. Whether Taniguchi is limited to arguing patentability based only on the "Nature" article (petition, page 6) is a matter which will be resolved by the Board. In considering patentability, it goes without saying that the EIC and the Board will want to consider all relevant evidence. It is not Patent and Trademark Office policy to issue patents without considering all properly submitted material evidence.
*8 Shaked mentions and relies on "holdings" of the Primary Examiner in the reexamination (petition, pages 7-8). These "holdings," however, are not binding on the EIC or the Board at final hearing.
Shaked also argues that there may be matters which are not issues between the parties (petition, pages 8-9). The EIC and the Board will determine what issues are properly raised and resolved in the interference.
Shaked's discussion (petition, page 10) concerning his alleged inability to file a reissue application is moot in view of the fact that claims were amended during reexamination. Shaked is correct that reexamination may be requested at any time (petition, page 13). However, when reexamination is requested after entry of a decision on preliminary motions, it is obvious that reexamination proceedings have a potential to conflict with interference proceedings.
Shaked argues (petition, page 14) that the Commissioner is without "authority to combine" a reexamination and an interference. Shaked, however, points to no statutory provision in support of his argument. An interference is declared when the Commissioner believes an interference exists between two applications or a patent and an application. Reexamination may be requested of a patent. If a patent and an application are involved in an interference and reexamination is requested of the patent, nothing in the interference statute (35 U.S.C. § 135) or the reexamination statute (35 U.S.C. §§ 301-307) precludes simultaneous consideration of the interference and reexamination. Contrary to Shaked's view (petition, pages 14-15), the Board's INTERLOCUTORY ORDER and the Commissioner's MEMORANDUM OPINION AND ORDER do not constitute unlawful rulemaking. First, the rules authorize an EIC to determine a proper course of conduct in an interference for any situation not specifically covered by the rules. 37 CFR § 1.610(e). Second, in unusual situtations -- of which this case is one -- there is nothing to preclude an agency from proceeding ad hoc provided the parties are given notice, as occurred here. See e.g., Securities and Exchange Commission v. Chenery Corp., 332 U.S. 194, 202-203 (1947), reh'g denied, 332 U.S. 784 (1947) (agency has authority to proceed by rule or by ad hoc rulings where appropriate). Thus, the fact that the rules provide specifically only for combining a reissue and an interference is no bar to the action taken by the Board in this case.
The citation of Winkler v. Guglielmino, No. 89-1571 (Fed. Cir. June 19, 1990), is noted. However, Winkler was decided without a published opinion. Unpublished (or non-precedential) opinions of the Federal Circuit are not precedent in the Federal Circuit and will not be cited, considered, or regarded as precedent by the EIC, the Board, or any other tribunal within the Patent and Trademark Office.
*9 Shaked erroneously argues that 37 CFR § 1.565(e) "states that either the interference will be stayed or the reexamination will be stayed." Section 1.565(e) does not require that the reexamination or the interference be stayed. Rather, § 1.565(e) indicates that the Commissioner "may" stay either. [FN1] Nothing in § 1.565(e) precludes simultaneous consideration of a reexamination and an interference. To the extent that § 1.565(e) might be construed to preclude simultaneous consideration of reexaminations and interferences, its provisions would in any event be waived under the precise facts of this case. 37 CFR § 1.183. The reexamination in this particular case had the practical effect of wresting control of the interference from the EIC. As noted earlier in the MEMORANDUM OPINION AND ORDER, however, an interference is controlled by an EIC -- not a party to an interference who happens to file a request for reexamination of a patent involved in the interference.
Shaked seems to contend that combining the reexamination and the interference is not proper because an issue in the interference involves the patentability of Shaked's patent claims over "oral" presentations (petition, page 16). Shaked reasons that "oral" presentations cannot be prior art which can be considered in a reexamination. 35 U.S.C. § 301. While true, the argument is irrelevant. If "oral" presentations are prior art, they may be considered in the interference. 35 U.S.C. § 135(a); 37 CFR § 1.633(a). If "oral" presentations render a patent claim unpatentable, judgment will be entered in the interference holding the patent claim unpatentable. A final judgment disposes of the patent claim. 35 U.S.C. § 135(a). If a claim is cancelled from a patent as a result of an adverse decision in the interference, there would be no occasion to consider the same claim in the reexamination.
Shaked argues that there are no procedures for simultaneously conducting a reexamination and an interference (petition, pages 16-17). Shaked has apparently overlooked pages 3-4 of the MEMORANDUM OPINION AND ORDER. Moreover, there is no basis for concluding, at this time, that the EIC and the Board will not provide for fair and adequate procedures pursuant to 37 CFR § 1.610(e). The alleged lack of procedures for simultaneously handling reexaminations and interferences is a matter better reviewed on petition after a final decision is entered in the interference. Only then can a cogent determination be made as to whether Shaked received fair treatment.
Shaked's request that the interference be suspended (petition, pages 17-19) has been considered. For the reasons given above, as well as those given by the Board in its two orders (Papers Nos. 185 and 194) and in the MEMORANDUM OPINION AND ORDER (Paper No. 186), the request to suspend the interference is again denied.
*10 Taniguchi also filed a request (Paper No. 188) which on its face requests reconsideration of the MEMORANDUM OPINION AND ORDER. However, in a subsequent paper (Paper No. 189), Taniguchi makes clear that Paper No. 188 does not seek any request for reconsideration by the Commissioner. Hence, there is no need to address in this opinion any issue raised by Taniguchi in Paper No. 188.
FN1. In view of Ethicon, Inc. v. Quigg, 849 F.2d 1422, 7 USPQ2d 1152 (Fed. Cir. 1988), it is unlikely that any reexamination would be stayed absent a most unusual factual circumstance.
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