09826976 (B.P.A.I. Jun. 21, 2012)

Tobinickv.Tobinick V. Le et al. V. Le et al.

Board of Patent Appeals and InterferencesJun 21, 2012

09826976 (B.P.A.I. Jun. 21, 2012)

-1- Paper 228 Mail Stop Interference P.O. Box 1450 Filed: 21 June 2012 Alexandria VA 22313-1450 Tel: 571-272-4683 Fax: 571-273-0042 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES EDWARD L. TOBINICK Junior Party (Patents 6,419,944 and 6,537,549), v. JUNMING LE, JAN VILCEK, PETER DADDONA, JOHN GHRAYEB, DAVID KNIGHT, and SCOTT SIEGEL, Senior Party (Application Nos. 10/227,488 and 10/665,971). Patent Interference No. 105,841 (Technology Center 1600) JUDGMENT Before RICHARD TORCZON, SALLY GARDNER LANE, and DEBORAH KATZ, Administrative Patent Judges. KATZ, Administrative Patent Judge. Further to the Decision on Order to Show Cause (Paper 227), Tobinick has failed to show that it is not estopped from claiming the subject matter of its Patent 6,419,944 claims 1-23, 30-34, and 37 and Patent 6,537,549 claims 1-20, 23, and 25-33. -2- Accordingly, it is ORDERED that adverse judgment be entered against Tobinick in regard to Patent 6,419,944 claims 1-23, 30-34, and 37 and Patent 6,537,549 claims 1-20, 23, and 25-33. FURTHER ORDERED that the parties are directed to 35 USC § 135(c) and Bd. R. 205 regarding the filing of settlement agreements; and FURTHER ORDERED that a copy of this judgment shall be entered into the administrative record of Tobinick Patents 6,419,944 and 6,537,549 and Le applications 10/227,488 and 10/665,971. cc (via e-mail): Attorney for Tobinick: Robert W. Hahl, Esq. Richard A. Neifeld, Esq. Neifeld IP Law, PC Email: rhahl@neifeld.com Email: rneifeld@neifeld.com Attorney for Le: Joseph Lucci, Esq. S. Maurice Valla, Esq. Woodcock Washburn LLP Email: lucci@woodcock.com Email: svalla@woodcock.com -1- Paper 227 Mail Stop Interference P.O. Box 1450 Filed: 21 June 2012 Alexandria VA 22313-1450 Tel: 571-272-4683 Fax: 571-273-0042 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES EDWARD L. TOBINICK Junior Party (Patents 6,419,944 and 6,537,549), v. JUNMING LE, JAN VILCEK, PETER DADDONA, JOHN GHRAYEB, DAVID KNIGHT, and SCOTT SIEGEL, Senior Party (Application Nos. 10/227,488 and 10/665,971). Patent Interference No. 105,841 (Technology Center 1600) Decision – Tobinick Response to Show Cause Order 1 2 Before RICHARD TORCZON, SALLY GARDNER LANE, and DEBORAH KATZ, 3 Administrative Patent Judges. 4 5 KATZ, Administrative Patent Judge. 6 7 Tobinick was ordered to show why judgment should not be entered against it in 8 regard to the claims remaining in this Interference, specifically claims 1-23, 30-34, and 9 -2- 37 of Tobinick Patent 6,419,944 (“the ‘944 Patent”), and claims 1-20, 23, and 25-33 of 1 Tobinick Patent 6,537,549 (“the ‘549 Patent”). (Order to Show Cause, Paper 175.) 2 Specifically, Tobinick was ordered to show why it is not estopped from claiming the 3 subject matter of these claims because judgment had been entered against it in 4 Interference 105,621 (“the ‘621 Interference”). (Id.) 5 Previously, in this Interference, Tobinick was required to show cause why it is not 6 estopped from claiming the subject matter it lost in the ‘621 Interference. (Order to 7 Show Cause, Paper 3.) In response, Tobinick argued that only claims directed to 8 localized administration of a TNF antagonist remain in the currently involved patents 9 (Tobinick Response to Show Cause Order, Paper 50, p. 6) and that these claims do not 10 interfere with Le’s involved claims, which are not limited to a route of administration (id., 11 pp. 11-16). Tobinick also argued that certain claims directed to treating glaucoma and 12 postherpetic neuralgia do not interfere with Le’s involved claims because of the nature 13 of the disease being treated. (First Show Cause Response, Paper 50, pp. 6 and 16.) 14 The current Interference was allowed to proceed on the preliminary showing that 15 Tobinick had disclaimed claims that clearly encompassed systemic administration and 16 because the remaining claims might not interfere with Le’s involved claims. 17 Tobinick then filed a Motion to Dedesignate Claims (Paper 88), which was 18 unopposed. Tobinick argued that claims 1-21 and 30-34 of the ‘944 Patent and claims 19 1-18 and 25-33 of the ‘549 patent should be designated as not corresponding to the 20 Count because they do not interfere with Le’s claims1 by being limited to administering a 21 TNF antagonist “intralesionally or perilesionally” or “subcutaneously to the area 22 anatomically adjacent to the site of disc herniation.” (Motion to Dedesignate Claims, 23 Paper 88, pp. 3-11.) Tobinick based this argument on their claims, specification, and 24 the testimony of Dr. Tobinick and cited publications. (Id.) Tobinick also relied on the 25 1 The Count in this Interference also includes Tobinick ‘499 patent claim 1 and Tobinick ‘’549 patent claim 1. The argument for “dedesignation” of these claims was fashioned as an argument for no interference-in-fact, presumably because it would not have been possible to argue that Tobinick’s claims do not correspond to a Count that includes the same claims. -3- holding in the ‘621 Interference that some claims did not correspond to that Count 1 because they were limited the “intrathecal” route of administration. (Id., p. 5). 2 In addition, Tobinick argued that claims directed to inhibiting the action of a 3 different biological target, interleukin (‘944 Patent claims 24-29), and claims directed to 4 treating a specific condition, post-herpetic neuralgia (‘944 Patent claim 38 and “549 5 Patent claim 24), should be designated as not corresponding to the Count. (Motion to 6 Dedesignate Claims, Paper 88, p. 3 and 12-23.) 7 Tobinick’s Motion regarding these changes in claim correspondence was granted 8 in part. (Decision on Motion, Paper 173.) The request to designate claims directed to 9 “intralesionally or perilesionally” or “subcutaneously to the area anatomically adjacent to 10 the site of disc herniation” routes of administration in the current Interference was 11 denied because Tobinick failed to present sufficient evidence that any type of local 12 administration would not have been obvious over systemic administration, even if it was 13 previously held that one local route of administration, “intrathecal,” would not have been 14 obvious. (Decision on Motion, Paper 173, pp. 4-11.) The request to have claims 15 directed to inhibiting the action of interleukin and to treating post-herpetic neuralgia 16 designated as not corresponding to the Count was granted because Tobinick provided 17 sufficient evidence to show that these methods would not have been obvious over the 18 subject matter of the Count. (Decision on Motion, Paper 173, pp. 11-14.) 19 At the time it filed its Motion, Tobinick also requested adverse judgment on 20 claims directed to treating glaucoma (‘944 Patent claims 22, 23, and 37, and ‘549 21 Patent claims 19, 20, and 23), contingent on the grant of its Motion to Dedesignate. 22 (Tobinick Contingent Motion for Adverse Judgment, Paper 89.) 23 Tobinick failed to show that claims directed to “intralesionally or perilesionally” or 24 “subcutaneously to the area anatomically adjacent to the site of disc herniation” routes 25 of administration are not obvious over claims that do not specify a route of 26 administration, such as the claims Tobinick lost in the prior ‘621 Interference. Thus, the 27 currently pending Order to Show Cause was issued regarding all of Tobinick’s claims 28 that remain designated as corresponding to the Count in light of the claims that Tobinick 29 lost in the ‘621 Interference. (Order to show Cause, Paper 175.) The claims under the 30 -4- Order to Show Cause include the claims for which Tobinick had contingently requested 1 adverse judgment because Tobinick’s conditions of the contingency, determination of all 2 claims requested as not corresponding to the Count, had not been met. 3 To show that it is not estopped from claiming the subject of the current claims, 4 Tobinick must show that the currently involved claims are patentably distinct from claims 5 it lost in a prior interference. In re Deckler, 977 F.2d 1449 (Fed. Cir. 1992). (See Order 6 to Show Cause, Paper 175, p. 2: “Tobinick is estopped from claiming [the subject matter 7 of claims 1-21 and 30-34 of the Tobinick ‘944 patent and claims 1-18 and 25-33 of the 8 Tobinick ‘549 patent] because judgment on priority was entered against it in the ‘621 9 Interference.”) In the prior ‘621 Interference, adverse judgment was entered against 10 claim 1 of Tobinick’s Patent 6,015,557 (“the ‘557 Patent”), which recites: 11 A method for inhibiting the action of TNF for treating neurological 12 conditions in a human by administering a TNF antagonist for reducing the 13 inflammation of neuronal tissue of said human, or for modulating the 14 immune response affecting neuronal tissue of said human, comprising the 15 step of: 16 a) administering a therapeutically effective dosage level to said 17 human of said TNF antagonist selected from the group consisting of 18 etanercept and infliximab for reducing the inflammation of neuronal tissue 19 of said human, or for modulating the immune response affecting neuronal 20 tissue of said human. 21 22 Tobinick is entitled only to claims that are patentably distinct from claim 1 of the ‘557 23 Patent. But, in its Response to the Order to Show Cause (Paper 178 (“Response”)) 24 Tobinick fails to compare the currently claims to any claims of the ‘557 Patent. 25 Tobinick’s Response considers only the differences between Tobinick’s currently 26 involved claims and Le’s currently involved claims, not the claims Tobinick lost in the 27 ‘557 Patent. Tobinick does not provide support to show that any of its currently involved 28 claims are patentably distinct from claim 1 of the ‘557 Patent. Tobinick has failed to 29 present argument or evidence to persuade us that it is not estopped from claiming the 30 subject matter of any of its currently involved claims. 31 Tobinick states in its current Response that the relief it requests is that certain 32 claims of the ‘944 and ‘549 Patents should be “dedesignated” from the Count. 33 (Response 2.) Tobinick argues that a subset of the claims it previously sought to have 34 -5- designated as not corresponding to the Count in its Motion should be removed from the 1 Interference because, in part, these claims are not directed to neurodegenerative 2 diseases or pathologies or conditions of the central nervous system. (See Response 3 11.) This argument was not put forth in Tobinick’s Motion to Dedesignate Claims. 4 Tobinick cites to evidence not relied upon in that Motion, such as the Declarations of 5 Mel Richardson, M.D. (Exhibits 2099 and 2137), but fails to show excusable neglect for 6 the belated submission. (See Response 12-15, et seq.) To the extent that Tobinick 7 requests a rehearing of the Decision on Motion (Paper 173), the citation of new 8 evidence is inappropriate without such a showing. SO ¶ 125.4. Furthermore, Tobinick 9 fails to state the specific matters that were misapprehended or overlooked in the 10 Decision on Motion and fails to identify specific portions of the Decision on Motion that 11 discuss such matters. See Bd. R. 125(c)(3)(i); SO ¶ 125.2. 12 Tobinick’s reliance on new arguments and evidence demonstrates that it is not 13 requesting us to reconsider the bases for our Decision on Motion. We decline to 14 consider new arguments at this belated point in the Interference, after Tobinick’s motion 15 to redefine it has already been decided. See Bilstad v. Wakalopulos, 386 F.3d 1116, 16 1126-27 (Fed. Cir. 2004) (holding that refusing to consider a belated motion, which had 17 not been authorized because it would have started the interference over, was not an 18 abuse of discretion). 19 Tobinick also relies on the proceedings of other interferences to support its 20 argument that some of its claims do not correspond to the current Count, or, more 21 specifically, do not correspond to the Le claims of the Count that are directed to treating 22 neurodegenerative diseases. (Response 3-9.) Tobinick notes that in the ‘621 23 Interference, not all of the claims of the ‘557 Patent were designated as corresponding 24 to the Count, particularly claims not directed to neurodegenerative diseases. 25 (Response 3-4.) In contrast, Tobinick notes that in the current Interference every claim 26 of the ‘944 and ‘549 Patents, including claims to neurodegenerative diseases, were 27 deemed to correspond to the Count. (Id.) Furthermore, Tobinick notes that in another 28 Interference, 105,842, claims to treating spinal nerve pain conditions mediated by the 29 nucleus pulposus were held to be separately patentable from Le’s claims of the 30 -6- currently involved applications, which are directed to treating neurodegenerative 1 diseases. (Response 9.) 2 A declaration is presumed to be correct, subject to a motion demonstrating a 3 need for relief. Bilstad, 386 F.3d at 1120-21. Differences in the way the '621 4 interference and this interference were declared are not dispositive. The interferences 5 were declared at different times and on the basis of different records and experiences. 6 Even if the records and experiences had been identical, difference alone does not 7 indicate which claim correspondence is objectively best. Similarly, differences in the 8 records, claims and parties of the 105,842 interference and this interference justifed 9 different results. Tobinick's challenge in this case was to justify the relief it sought on 10 the record of this case, The different outcomes in the other interferences do not, by 11 themselves, justify relief, particularly not as a belated argument in a request for 12 reconsideration. Thus, even to the extent that Tobinick requests reconsideration of our 13 Decision on Motion, we are not persuaded that the circumstances of the ‘621 14 Interference or Interference 105,842 indicate facts that were misapprehended or 15 overlooked. 16 Conclusion 17 Tobinick has failed to present sufficient evidence to show that it is entitled to the 18 subject matter of claims 1-23, 30-34, and 37 of Tobinick patent 6,419,944, and claims 1-19 20, 23, and 25-33 of Tobinick patent 6,537,549 by showing that these claims are 20 patentably distinct from the claims it lost in ‘621 Interference. 21 -7- /Richard Torczon/ ) RICHARD TORCZON ) Administrative Patent Judge ) ) /Sally Gardner Lane / ) BOARD OF PATENT SALLY GARDNER LANE ) APPEALS AND Administrative Patent Judge ) INTERFERENCES ) /Deborah Katz/ ) DEBORAH KATZ ) Administrative Patent Judge ) cc (via e-mail): Attorney for Tobinick: Robert W. Hahl, Esq. Richard A. Neifeld, Esq. Neifeld IP Law, PC Email: rhahl@neifeld.com Email: rneifeld@neifeld.com Attorney for Le: Joseph Lucci, Esq. S. Maurice Valla, Esq. Woodcock Washburn LLP Email: lucci@woodcock.com Email: svalla@woodcock.com

Tobinick V. Tobinick V. Le et al. V. Le et al.