90009182 (B.P.A.I. May. 25, 2012)

Ex Parte 6,843,372 et al

Board of Patent Appeals and InterferencesMay 25, 2012

90009182 (B.P.A.I. May. 25, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 90/009,182 06/13/2008 6,843,372 050956/342119 8730 23580 7590 11/01/2012 MESMER & DELEAULT, PLLC 41 BROOK STREET MANCHESTER, NH 03104 EXAMINER TURNER, SHARON L ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 11/01/2012 PAPER Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ALLAN M. WEINSTEIN Appellant ____________ Appeal 2012-002362 Reexamination Control 90/009,182 Patent US 6,843,372 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and RAE LYNN P. GUEST, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING This is a decision on the Request for Rehearing (“Req. Reh’g”) pursuant to 37 C.F.R. § 41.52 following the Board decision dated May 25, 2012 (“Decision”) in which we affirmed the rejections of all pending claims. STATEMENT OF THE CASE The appeal in this case involves an ex parte reexamination of U.S. Patent No. 6,843,372 (hereinafter, “the ‘372 patent”). Patent Owner requests Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 2 reconsideration of Rejections 2 and 5 in which we affirmed the Examiner’s obviousness determinations. See Decision 3 & 20. DISCUSSION • Claims 1, 3, 5-7, and 11-14 (Rejection 2) Representative claim 1 is directed to a therapeutic regimen which comprises two drug components: a) nasal decongestant, and b) nasal decongestant and antihistamine, where the amount of nasal decongestant in b) is less than the amount in the first component a). We affirmed the Examiner’s determination that the therapeutic regimen of claims 1, 3, 5-7, and 11-14 was obvious based on Knudsen, with evidence from Goodman & Gilman, Sunshine, Bye, and Middleton. Decision 3 & 11-17. Patent Owner contends that we erred by selectively looking at only parts of the cited prior art, erroneously determining that component b) would have been obvious to one of ordinary skill in the art. Req. Reh’g 6. Specifically, Patent Owner argues, as in the Appeal Brief, that it would not have been obvious to use a lower dose of decongestant in component b) as compared to component a). Patent Owner contends that Goodman & Gilman would have taught the ordinary skilled worker that to circumvent the sedation effect of an antihistamine: “there are three choices. If only administering antihistamine, then decrease the dosage or use a different antihistamine. If administering a combination, then combine the antihistamine with a stimulant (i.e. a decongestant).” Req. Reh’g 4. Thus, Patent Owner argues that “the premise to ‘decrease the dosage,’ which Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 3 relates to administration of the decongestant alone, is an incorrect premise when logically determining a conclusion for a combination of decongestant and antihistamine. Rather, the correct premise according to the prior art should and must be that the combination of a decongestant and an antihistamine will circumvent the side effect of either drug.” Req. Reh’g 5. We stand by our reasoning in the Decision. Even assuming Patent Owner’s premise is correct regarding the teachings of Goodman & Gilman, we cannot discount the Examiner’s reliance on the teachings of Knudsen. Knudsen teaches administering a nasal decongestant and antihistamine at night (FF9),1 providing a reason to have made a nighttime therapeutic regimen with both the decongestant and antihistamine. Knudsen is not avoiding the sedative effect of the antihistamine. Rather, the combination is administered by Knudsen at night when sedation would be desired. Knudsen said so: “A suitable sedative composition for use in the dosage units comprises an antitussive, a decongestant and an antihistamine.” FF7; emphasis added. Thus, Patent Owner’s argument about circumventing the sedative effect of antihistamine via combination with a decongestant is not consistent with the teachings of the prior art. The “premise” that the combination of antihistamine and decongestant avoids the side effects of either drug would not preclude one of ordinary skill in the art from adjusting the dosage of each to achieve maximal therapeutic benefit with least adverse effects. The prior art explicitly taught this goal. See FF3 (Weinstein: “This regimen attempts to maximize the therapeutic effects of each agent and minimize their side effects.”). 1 “FF9” refers to Finding of Fact 9 in the Decision. Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 4 As admitted by Patent Owner, decongestants were known to produce insomnia at night. Decision 13; the ‘372 patent, col. 1, 11. 35-44. Based on Goodman & Gilman’s teachings, it would have been obvious to administer a lower dosage of a decongestant at night than during the day. Goodman & Gilman teaches that reducing antihistamine dosage circumvents their sedation effects when administered to patients. As Goodman & Gilman is a basic pharmacology textbook, it reflects the knowledge of one of ordinary skill in the art at the time the application was filed that gave rise to the '372 patent. The ordinary skilled worker, such as a pharmacologist or physician, would have understood from Goodman & Gilman's teaching that decreasing dosage was a known way of reducing the undesirable effects of drugs, and not restricted to HI blockers. Decision 12. To put it simply, who doesn’t know to reduce the amount of sugar in their coffee to make it less sweet? Patent Owner also contends that, based on the teachings of Middleton and Goodman & Gilman, the skilled worker would have eliminated the decongestant at night to maximize the advantages of the sedative effects of the antihistamine. Req. Reh’g 6-7. The fact is that the prior art taught more than one approach to treating a cold and allergies. Knudsen taught one approach where a decongestant and antihistamine were administered at night, a combination described as popular by Middleton. Decision 14. Yes, other approaches may have been taken, such as only giving an antihistamine at night. However, Knudsen expressly taught a nighttime composition comprising a decongestant when a decongestant at night is desired for its decongestant properties. FF9. Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 5 Weinstein With respect to Weinstein, Patent Owner contends we erred by saying “Weinstein expressly teaches adjusting the dosage of the diphenhydramine to reduce its sedative effects.” Req. Reh’g 7. We agree we overstated this teaching. Nonetheless, Weinstein expressly stated that a “smaller dose” of the antihistamine is “taken during daytime hours” as compared to the larger dosage at night. Decision 16. Consequently, our conclusion that the same principle would have led the skilled worker to reduce the decongestant dosage at night is still sound. Decongestant in combination Patent Owner takes the position that the skilled worker would not have recognized that the decongestant in the combination of a decongestant and antihistamine would cause insomnia, but that the insomnia could have been attributed to the antihistamine. Req. Reh’g 7-8. Even if this is plausible, Patent Owner has not introduced sufficient evidence that the decongestant when combined with an antihistamine would have lost its well- known insomnia-producing effect. Moreover, even if it were the case that the skilled artisan would have thought that insomnia could be produced by the antihistamine, there are only two drugs to be varied: the decongestant and the antihistamine. It would have been obvious to vary the dosage of either one to achieve the desired effect of sedation and decongestion without insomnia. Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 6 Meltzer With regard to the Meltzer publication discussed at the Oral Hearing, we note that Meltzer was not discussed in the Decision and did not form a basis for the dispositive facts or conclusions. Thus, Patent Owner’s discussion of it in the Request for Rehearing is moot. Req. Reh’g 8-9. • Claims 1-14 (Rejection 5) Claims 1-14 stand rejected under 35 U.S.C. § 103 as obvious in view Gwaltney and either Knudsen or Weinstein. Patent Owner contends that we have either misapprehended Patent Owner’s evidence or imposed a higher evidentiary burden on Patent Owner. Req. Reh’g 9-10. We do not agree. Our statement about the adequacy of Patent Owner’s evidence was made after weighing the teachings in the prior art about the side effects of a decongestant versus Patent Owner’s statement, unsupported by expert testimony or evidence, that there was no recognition or concern with stimulation or insomnia when the combination of an antihistamine and decongestant were administered. See Decision 18-19. DENIED Appeal 2012-002362 Reexamination Control 90/009,182 US Patent 6,843,372 B2 7 THIRD PARTY REQUESTER: ALSTON & BIRD LLP BANK OF AMERICA PLAZA 101 SOUTH TRYON STREET, SUITE 4000 CHARLOTTE, NC 28280-4000 cu