`is not binding precedent of the Board.
`entered
`Paper
`
`Filed by: Trial Section Merits Panel
`Box Interference
`Washington, D.C. 20231
`Tel: 703-308-9797
`Fax: 703-305-0942
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed
`25 July 2001
`
`BEFORE THE BOARD OF PATENT APPEALS
`AND INTERFERENCES
`
`PAT. & T M
`OFFICE
`BOARD OF PATENT APPEALS
`AND INTERFERENCES
`SHMUEL CABILLY, HERBERT L. HEYNEKER, WILLIAM E. HOLMES,
`ARTHUR D. RIGGS and RONALD B. WETZEL,
`Junior Party,
`(Application 07/205,419),
`
`MICHAEL A. BOSS, JOHN H. KENTEN,
`JOHN S. EMTAGE and CLIVE R. WOOD,
`Senior Party
`(Patent 4,816,397).
`
`Patent Interference 102,572 (McK)
`
`Before: McKELVEY, Senior Administrative Patent Judge, and
`SCHAFER and TORCZON, Administrative Patent Judges.
`
`McKELVEY, Senior Administrative Patent Judge.
`
`FINAL ORDER AFTER DISTRICT COURT JUDGMENT
`
`Introduction
`A.
`On 1 June 2001, the board received the following papers
`filed by Cabilly:
`CABILLY REQUEST FOR ASSIGNMENT TO NEW APJ
`ADMINISTRATIVE PATENT JUDGE] (Paper 63).
`
`Sanofi/Regeneron Ex. 1015, pg 442
`
`
`
`2.
`
`3.
`
`4.
`
`Certified copy of a NOTICE OF SETTLEMENT AND JOINT
`REQUEST FOR ENTRY OF SETTLEMENT INSTRUMENTS filed
`on 6 March 2001 in the United States District
`Court for the Northern District of California in
`Genentech, Inc. v. Celltech Therapeutics, Ltd.,
`Civil Action No. C 98-3926 MMC (WDB) (Paper 66).
`Certified copy of an ORDER REGARDING RESOLUTION OF
`INTERFERENCE filed in the district court on
`16 March 2001 (Paper 67).
`Certified copy of a JUDGMENT filed in the district
`court on 16 March 2001 (paper 68).
`
`At some point, the board also received a copy of the docket
`entries in the district court through 16 March 2001 (gaper 65).
`The ORDER REGARDING RESOLUTION OF INTERFERENCE and JUDGMENT
`appear to have been drafted by the attorneys and were thereafter
`presented to the district court for consideration. In drafting
`the order and judgment, it would appear that the attorneys did
`not take into account (1) relevant provisions of 35 U.S.C.
`§§ 135(a) and 146 and (2) binding precedent of the Federal
`Circuit, e.g., Gould v. Quiqq, 822 F.2d 1074, 1079, 3 USPQ2d
`1302, 1305 (Fed. Cir. 1987) and In re Ruschiq, 379 F.2d 990, 154
`USPQ 118 (CCPA 1967). Nevertheless, we will attempt to take
`action consistent with the district court's judgment to the
`extent possible and consistent with law.
`
`Assignment of administrative patent judge (APJ)
`During its pendency before the board, the interference was
`assigned (37 CFR § 1.610) to former Administrative Patent Judge
`Mary F. Downey. Judge Downey recently retired. Accordingly, the
`- 2 -
`
`Sanofi/Regeneron Ex. 1015, pg 443
`
`
`
`interference has been assigned to Senior Administrative Patent
`Judge Fred E. McKelvey. 37 CFR § 1.610(b).
`
`Finding of fact
`The record supports the following findings by at least a
`preponderance of the evidence:
`
`The interference, declared 28 February 1991,
`1.
`involves Cabilly application 07/205,419' versus Boss patent
`4,816,397.
`
`2.
`
`The Cabilly application is owned by Genentech,
`
`The Boss patent is owned by Celltech R&D Ltd.,
`formerly Celltech Therapeutics, Ltd. (Paper 64, page 2).
`The claims of the parties are:
`Cabilly:
`101-134
`a.
`b.
`Boss:
`1-18
`The claims of the parties designated as
`corresponding to the count, and therefore involved in the
`interference (35 U.S.C. § 135(a)), are:
`a.
`Cabilly:
`101-120
`1-18
`b.
`Boss:
`
`We note that the Cabilly application is misidentified as application
`08/205,419 in note 1 on page 1 of a FINAL DECISION entered 13 August 1998
`(Paper 57).
`Cabilly application Paper 12, pages 1-5 (copy attached).
`A count defines the interfering subject matter. 37 CFR § 1.601(f).
`- 3 -
`
`Sanofi/Regeneron Ex. 1015, pg 444
`
`
`
`The claims of the parties designated as not
`corresponding to the count are:
`a.
`Cabilly:
`b.
`Boss:
`
`121-134
`None
`
`On 20 September 1991,. after the interference was
`declared, Cabilly submitted an INFORMATION DISCLOSURE STATEMENT
`(IDS) (Appl'n Papei 17--copy attached) citing prior art not
`previously cited during prosecution before the examiner.
`Insofar as we can tell, the IDS does not appear to
`have been considered by an examiner. Nor is it apparent that the
`examiner has assessed the correctness of allegations In the IDS
`to the effect that certain prior art cited in the IDS is
`"cumulative" to other prior art said to have been considered by
`the examiner.
`
`A final decision (i.e., a final agency action) was
`entered by a merits panel of the board on 13 August 1998.
`Cabilly v. Boss, 55 USPQ2d 1238 (Bd. Pat. App. & Int. 1998)
`(Paper 57).
`
`In its final decision, the board determined that
`Cabilly had failed to sustain its burden of establishing priority
`
`Jurisdiction over the application transfers to the board upon
`declaration of an interference. 37 CFR § 1.614. Hence, there is no reason to
`believe that the examiner would have had occasion to consider papers filed in
`connection with the application after declaration of the interference.
`The merits panel consisted of former Administrative Patent Judges
`Ronald H. Smith and Mary F. Downey (both now retired) and Administrative
`Patent Judge Richard E. Schafer.
`
`Sanofi/Regeneron Ex. 1015, pg 445
`
`
`
`vis-a-vis Boss. Accordingly, the board entered judgment against
`Cabilly.
`
`11. On 9 October 1998, Cabilly timely sought judicial
`review under 35 U.S.C. § 146 by civil action filed in the United
`States Dis trict Court for the Northern District of California
`(district court). Genentech, Inc. v. Celltech Therapeutics,
`Ltd., Civil Action No. C 98-3926 MMC (WDB) (Paper 65, page 2,
`entry 1).
`
`12. On 16 March 2001, the district court entered
`(1) an ORDER REGARDING RESOLUTION OF INTERFERENCE (Paper 67)
`and (2) a JUDGMENT (Paper 68).
`13.
`In its ORDER REGARDING RESOLUTION OF INTERFERENCE,
`the district court determined "that Genen ech is entitled as a
`matter of law to priority over Celltech to the invention
`described by the count" (page 3, lines 27-28). The district
`court's determination appears to have been based on a Cabilly
`draft application, dated 25 February 1983, which (1) is said to
`have been uncovered during discovery and (2) was not presented
`
`We have not proofread the documents drafted by the attorneys for
`consideration by the district court. However, we note at least the following
`error in the ORDER REGARDING RESOLUTION OF INTERFERENCE: on page 2, line 24
`Genentech's issued patent is identified as U.S. Patent 4,816,517 when it
`appears it should have been identified as U.S. Patent 4,816,567. We also note
`at least the following error in the NOTICE OF SETTLEMENT AND JOINT REQUEST FOR
`ENTRY OF SETTLEMENT INSTRUMENTS: on page 1, line 27, the Cabilly application
`is identified as application 07/215,419 when it appears it should been
`identified as application 07/205,419.
`- 5 -
`
`Sanofi/Regeneron Ex. 1015, pg 446
`
`
`
`to, or considered by, the board in entering its final decision on
`13 August 1998.
`In its judgment, the district court "orders
`and adjudges that the following shall occur simultaneously"
`(Paper 64, pages 1-2):
`
`a.
`The United States Patent and Trademark Office
`(USPTO) is directed to vacate the PTO's decision in Cabilly v.
`Boss in Interference 102,572.
`b.
`The USPTO is directed to "revoke and vacate
`United States Patent No. 4,816,397 ***" issued to Boss.
`c.
`The USPTO is directed to "grant and issue to
`Genentech's Inventors (with Genentech as the assignee) with the
`issue date being the same as the date of revocation of United
`States Patent No. 4,816,397, a United States patent having ***
`claims 101-120 that were allowed by the PTO in Genentech's
`pending United States Patent Application No. 07/205,419 ***."
`
`15. A certified copy of the district court's judgment
`was received by the board on 1 June 2001 (Paper 63).
`16. According to Cabilly's request for assignment of a
`new APJ (Paper 63):
`In light of the complexity of the Order accompanying ***
`[the] district court['s] Judgment, the parties ***
`
`See ORDER REGARDING RESOLUTION OF INTERFERENCE, (page 3, lines
`10-26). The parties do not appear to have asked the district court to
`address, and the district court did not appear to have considered, the issue
`of whether Genentech and Cabilly were diligent from the time the interference
`was declared in attempting to find the draft, which is now said to be
`dispositive. We do not address the issue of whether a lack of diligence might
`have been a basis for the district court to have exercised its discretion to
`decline to admit in evidence the draft. See, e.q., Kirschke v. Lamar, 426
`F.2d 870, 165 USPQ 679 (8th Cir. 1970). We will note that if a patent is
`issued to Cabilly, its term will begin to run now and the public has already
`been subject to patents rights of Boss since 1989, and that the interference
`has been pending since 1991.
`
`- 6 -
`
`Sanofi/Regeneron Ex. 1015, pg 447
`
`
`
`respectfully request that after an APJ has been assigned [to
`the interference,] but before the Judgment *** [of] the
`district court is effected, a conference call be scheduled
`so that the parties and the APJ may discuss this matter. -
`
`17. The time for filing an appeal, in this case to. the
`United States Court of Appeals for the Federal Circuit, from the
`judgment of the district court is 30 days. Fed. R. App. P.
`4(a)(1)(A). The time for filing an appeal from the judgment of
`the district court entered 16 March 2001 expired sometime in
`April of 2001.
`
`Discussion
`D.
`As noted earlier, The ORDER REGARDING RESOLUTION OF
`INTERFERENCE and JUDGMENT appear to have been drafted by the
`attorneys and were thereafter presented to the district court for
`consideration. In drafting the order and judgment, we again note
`that it would appear that the attorneys did not take into account
`(1) relevant provisions of 35 U.S.C. §§ 135(a) and 146 and (2)
`binding precedent of the Federal Circuit, e.g., Gould v. Ouiqs,
`822 F.2d 1074, 1079, 3 USPQ2d 1302, 1305 (Fed. Cir. 1987) and In
`re Ruschiq, 379 F.2d 990, 154 USPQ 118 (CCPA 1967). We will
`attempt to take action consistent with the district court's
`judgment to the extent possible and consistent with law.
`
`Order to vacate decision
`The district court's order directs the USPTO (board?) to
`vacate its decision in Cabilly v. Boss in Interference 102,572.
`
`Sanofi/Regeneron Ex. 1015, pg 448
`
`
`
`The judgment does not identify the precise board "decision"
`to be vacated. We believe that the district court sought to have
`the board vacate its final decision awarding priority to Boss. _
`The board's final decision (Paper 57) was entered on 13 August
`1998. Accordingly, an order will be entered vacating the final
`decision entered 13 August 1998.
`
`Order to "revoke and vacate" a patent
`The district court directs the USPTO "to revoke and vacate"
`U.S. Patent 4,816,397, the Boss patent involved in the
`interference.
`Nothing in 35 U.S.C. § 135(a) relating to the board's
`jurisdiction over interferences and nothing in 35 U.S.C. § 146
`relating to judicial review of a decision of the board in
`interference matters, authorizes the board or a court to "revoke
`and vacate" a patent. Section 135(a) provides, however, that
`"[a] final judgment adverse to a patentee from which no appeal or
`other review has been or can be taken or had shall constitute
`cancellation of the claims involved in the patent ***."
`While the matter is not absolutely free from doubt, we have
`construed the district court's judgment as a final decision of
`the district court. The judgment has all the indicia of being
`final in the sense that it rules in favor of Cabilly and against
`Boss. The "judgment" is "set forth on a separate document" as
`
`The only basis of which we are aware for "revoking" a patent would be
`an action by the United States alleging that the patent was procured on the
`basis of a fraud. See, e.g., United States v. Saf-T-Boom Corp., 431 F.2d 737,
`167 USPQ 195 (8th Cir. 1970), and Supreme Court cases cited therein.
`- 8 -
`
`Sanofi/Regeneron Ex. 1015, pg 449
`
`
`
`required by Fed. R. Civ. P. 58. Moreover, as is apparent from
`the ¶ 10 of ORDER REGARDING RESOLUTION OF INTERFERENCE (Paper 67,
`page 3, lines 27-28), the district court held that Genentech
`(i.e., Cabilly) is entitled to priority of invention vis-a-vis
`Celltech (i.e., Boss). .Given that review of the board's priority
`determination was the issue in the civil action under § 146 and
`that issue was resolved in favor of Cabilly, we have construed
`the district court's judgment as being final.
`The time for appeal to the Federal Circuit from the judgment
`of the district court expired sometime in April 2001. A
`certified copy of the district court's judgment was not received
`by the board under 1 June 2001--well after the time for appeal
`had expired. The time for appeal having expired sometime in
`April of 2001, it manifestly follows as a matter of law that the
`claims of the Boss patent designated as corresponding to the
`count, i.e., involved in the interference to use the words of
`35 U.S.C. § 135(a), have been cancelled since sometime in April
`of 2001. The only action which needs to be taken by the USPTO in
`the future is to comply with that part of § 135(a) which
`provides, with respect to cancelled patent claims, that "notice
`of such cancellation shall be endorsed on copies of the patent
`distributed after such cancellation by the Patent and Trademark
`Office."
`
`Sanofi/Regeneron Ex. 1015, pg 450
`
`
`
`Order to grant and issue patent to Genentech
`
`a.
`The attorneys drafted an order for consideration by the
`district court which directs the USPTO to "grant and issue" a
`patent to Cabilly. Under even a most expansive reading of
`35 U.S.C. § 146, nowhere does a district court have jurisdiction
`to order the granting of a patent. What § 146 says is that a
`"[j]udgment of the [district] court in favor of the right of an
`applicant to a patent shall authorize the Director to issue such
`patent on the filing *** of a certified copy of the judgment and
`on compliance with the requirements of law." Similar' language in
`35 U.S.C. § 145 (involving civil actions where the Director is a
`party), has been construed by the Federal Circuit as not
`authorizing a district court to order the Director (then
`Commissioner) to issue a patent. Gould v. Quiqq, 822 F.2d 1074,
`1079, 3 USPQ2d 1302, 1305 (Fed. Cir. 1987). In this particular
`case, compliance with the requirements of law, among other
`things, in this case would involve (1) acting on Cabilly claims
`121-134 which are also present in the Cabilly application
`(35 U.S.C. §§ 131 and 132), (2) issuance of a notice of allowance
`(35 U.S.C. § 151, first paragraph) and (3) timely payment of the
`issue fee required by law (35 U.S.C. § 151, second paragraph).
`
`b.
`Moreover, under well-established principles, a favorable
`decision on judicial review does not mean that the Director may
`
`Sanofi/Regeneron Ex. 1015, pg 451
`
`
`
`not reject claims in an application on the basis of a ground not
`involved in judicial review. See, e.g., In re Ruschiq, 379 F.2d
`990, 154 USPQ 118 (CCPA 1967).
`In this case, it is not clear that an examiner has
`considered additional prior art called to the attention of the
`USPTO by Cabilly after the interference was declared. Upon
`termination of the interference, the application is returned to
`the examiner. At that point the examiner would determine what
`action, if any, might be warranted on the basis of the IDS filed
`by Cabilly. If no further adverse merits action (e.g., a
`rejection) is deemed appropriate by the examiner, then a notice
`of allowance would be issued and Cabilly would be free to pay the
`issue fee.
`
`"Simultaneous" action'
`The district court has ordered that certain action "occur
`simultaneously". The attorneys who presented the draft judgment
`to the district court should have known that they were asking the
`district court (1) to take an action which is for all practical
`purposes not administratively possible, and (2) in effect, to
`mandamus the Director and the board with respect to issues not
`involved in the civil action.
`The claims of the Boss application have now been cancelled
`by operation of law. A patent could not have issued to Cabilly
`until (1) the board's final decision was vacated (which occurs
`
`Ruschiq is binding Federal Circuit precedent. South Corp. v. United
`States, 690 F.2d 1368, 215 USPQ 657 (Fed. Cir. 1982).
`
`Sanofi/Regeneron Ex. 1015, pg 452
`
`
`
`today) and (2) the Boss claims were cancelled (which occurred
`sometime in April of 2001). Basically, the attorneys attempted
`to have the district court superintend the affairs on the USPTO•.
`We cannot imagine that the district court intended to superintend
`the affairs of the USPTO.
`We note that the district court has retained limited
`jurisdiction in this matter. In the event of further proceedings
`in the district court, we recommend that the attorneys consult
`with the Office of the General Counsel of the USPTO so that a
`determination can be made as to whether the Director should
`intervene (§ 146 gives the Director a right to intervene).
`Alternatively, the district court might wish to exercise its
`discretion by inviting the Director to file such papers as the
`district court might deem appropriate to aid it in resolving the
`interference.
`
`Order
`Upon consideration of the relevant record, including:
`
`1.
`
`2.
`
`the CABILLY REQUEST FOR ASSIGNMENT TO NEW APJ
`[ADMINISTRATIVE PATENT JUDGE] (Paper 63);
`the certified copy of a NOTICE OF SETTLEMENT AND
`JOINT REQUEST FOR ENTRY OF SETTLEMENT INSTRUMENTS
`filed on 6 March 2001 in the United States
`District Court for the Northern District of
`California in Genentech, Inc. v. Celltech
`Therapeutics, Ltd., Civil Action No. C 98-3926 MMC
`(WDB) (Paper 66);
`
`- 12 -
`
`Sanofi/Regeneron Ex. 1015, pg 453
`
`
`
`3.
`
`4.
`
`5.
`
`6.
`
`the certified copy of an ORDER REGARDING
`RESOLUTION OF INTERFERENCE filed in the district
`court on 16 March 2001 (Paper 67);
`the certified copy of a JUDGMENT entered in the -
`district court on 16 March 2001 (Paper 68);
`the copy of the docket entries in the district
`court through 16 March 2001 (Paper 65); and
`the INFORMATION DISCLOSURE STATEMENT (Cabilly
`appl'n paper 17),
`
`and for the reasons given, it is
`ORDERED that the request for a conference call with the
`administrative patent judge assigned to the interference is
`denied, without prejudice to a conference call being placed by
`counsel upon receipt of this order.
`FURTHER ORDERED that the FINAL DECISION of the board
`entered in this interference on 13 August 1998 (Paper 57) is
`vacated.
`
`FURTHER ORDERED that, consistent with the judgment of
`the district court (which is now final), judgment on priority as
`to Count 1, the sole count in the interference, is now awarded
`against senior party MICHAEL A. BOSS, JOHN H. KENTEN, JOHN S.
`EMTAGE and CLIVE R. WOOD (Celltech R&D, Ltd.).
`FURTHER ORDERED that senior party MICHAEL A. BOSS, JOHN
`H. KENTEN, JOHN S. EMTAGE and CLIVE R. WOOD is not entitled to a
`patent containing claims 1-18 (corresponding to Count 1) of U.S.
`Patent 4,816,397, issued 28 March 1989, based on application
`06/672,265, filed 14 November 1984.
`
`- 13 -
`
`Sanofi/Regeneron Ex. 1015, pg 454
`
`
`
`FURTHER ORDERED that a copy of this paper shall be made
`of record in files of application 07/205,419 and U.S. Patent
`4,816,397.
`
`FURTHER ORDERED that, no later than 10 August 2001, the
`Clerk shall forward the Cabilly application to the examiner for
`such further action as may be appropriate consistent with the
`views expressed herein, including such action as the examiner may
`deem appropriate with respect to Cabilly claims 121-134 which
`were not involved in the interference.
`FURTHER ORDERED that if there is a settlement
`agreement, attention is directed to 35 U.S.C. § 135(c) and 37 CFR
`§ 1.661.
`
`FRED E. McKELVEY, Senior
`Administrative Patent Judge
`
`RICHARD E. SCHAFER
`Administrative Patent J dge
`
`BOARD OF PATENT
`INTERFERENCES
`
`CHARD TORCZON
`Administrative Pate
`
`dge
`
`Sanofi/Regeneron Ex. 1015, pg 455
`
`
`
`4
`
`102572
`(via fax--without attachments
`and Federal Express--with attachments)
`Attorney for Cabilly
`(real party in interest
`Genentech, Inc.):
`R. Danny Huntington, Esq.
`BURNS, DOANE, SWECKER & MATHIS, L.L.P.
`1737 King Street, Suite 500
`Alexandria, VA 22314
`Tel:
`703-836-6620
`Fax:
`703-836-0028
`Attorney for Boss
`(real party in interest ,
`Calltech R&D, Ltd., formerly
`Calltech Therapeutics, Ltd.):
`Eric S. Walters, Esq.
`MORRISON & FOERSTER LLP
`755 Page Mill Road
`Palo Alto, CA 94304-1081
`Tel:
`650-813-5865
`Fax:
`650-494-0792
`
`Sanofi/Regeneron Ex. 1015, pg 456