Ex Parte BerlinDownload PDFPatent Trial and Appeal BoardMay 31, 201311055338 (P.T.A.B. May. 31, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ROGER G. BERLIN __________ Appeal 2011-009313 Application 11/055,338 Technology Center 1600 __________ Before TONI R. SCHEINER, ULRIKE W. JENKS, and GEORGIANNA W. BRADEN, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal 1 under 35 U.S.C. § 134 from the rejection of claims 21-36, directed to a pharmaceutical composition comprising ibuprofen and phenylephrine. The claims have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party-In-Interest as Wyeth, a company incorporated in the State of Delaware (App. Br. 4). Appeal 2011-009313 Application 11/055,338 2 STATEMENT OF THE CASE According to the present Specification: [T]he addition of a non-steroidal anti-inflammatory agent to a composition containing an antihistamine or a decongestant enhances the efficacy of the antihistamine or decongestant, thus permitting a reduction in the total dose of antihistamine or decongestant. In particular, the amount of antihistamine or the decongestant can be less than or equal to about 75 % of an amount present in an approved dose of the decongestant or the antihistamine relative to an amount of the NSAID corresponding to about 100% of the amount present in a normal strength dosage form of the NSAID. This combination . . . results in an enhanced effect of the decongestant or antihistamine . . . [and] provides the same or greater symptomatic relief of rhinitis, including allergy, cold, cold-like, and flu symptoms, as conventional products containing the higher amounts of antihistamine and decongestants. This discovery is particularly advantageous because lowering the amounts of antihistamine or decongestant lowers the unwanted side effects of each of these ingredients, such as the stimulatory effect of decongestants, and the sedating effect of antihistamines. (Spec. 4: 2-16.) Claims 21-36 are pending and on appeal. Appellant does not present separate arguments for the claims. Therefore, we select claim 21 as representative of the subject matter on appeal, and the remaining claims will stand or fall accordingly. See 37 C.F.R § 41.37(c)(1)(vii). Claim 21 is as follows: 21. A unit dosage form comprising as active agents 150 to 250 mg ibuprofen and less than or equal to 10 mg phenylephrine and which does not comprise an antihistamine. Claims 21-36 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Sims et al. (WO 92/17171, Oct. 15, 1992). Appeal 2011-009313 Application 11/055,338 3 ISSUE Does the preponderance of the evidence of record support the Examiner‟s conclusion that it would have been obvious for one of ordinary skill in the art to combine ibuprofen and phenylephrine in a unit dosage form, in the amounts required by claim 21, given Sims‟ disclosure? FINDINGS OF FACT The following findings of fact (FF) are supported by a preponderance of the evidence of record. 1. According to the Specification, The present invention is directed to a pharmaceutical composition which includes an effective amount of each of a non-steroidal anti-inflammatory drug (NSAID), [and] a decongestant . . . wherein the effective amount of the decongestant . . . is less than about 75 % of an amount present in an approved dose of the decongestant . . . , relative to an amount of the NSAID corresponding to about 100 % of the amount present in a normal strength dosage form of the NSAID. (Spec. 3: 2-7.) 2. The Specification teaches that: The non-steroidal anti-inflammatory drugs (NSAID's) for use in the pharmaceutical compositions . . . of the present invention may be selected from any of the following categories: (1) The propionic acid derivatives; (2) the acetic acid derivatives; (3) The fenamic acid derivatives (4) The biphenylcarboxylic acid derivatives; (5) The oxicams, and (6) Cox-2 inhibitors (Spec. 7: 18-25). Appeal 2011-009313 Application 11/055,338 4 According to the Specification, “typical effective analgesic amounts of NSAID's are about 100-500 mg diflunisal, about 25-100 mg zomepirac sodium, about 50-450 mg ibuprofen, more preferably 100-250 mg ibuprofen, about 125-500 mg naproxen, . . . [etc.]; however, greater or lesser amounts may be employed if desired or necessary” (Spec. 8: 22-27). 3. Further according to the Specification, “[t]he decongestants for use in the pharmaceutical compositions . . . of the present invention include, but are not limited to, pseudoephedrine, phenylephedrine, [and] phenylpropanolamine” (Spec. 7: 4-6), and “[t]he exact amount [of decongestant] required will vary from subject to subject, depending on age, general condition of the subject, the severity of the condition being treated, and the particular active agent administered, and the like” (id. at 4: 24-5:2). 4. The Specification exemplifies the following pharmaceutical compositions: (Spec. 11). Appeal 2011-009313 Application 11/055,338 5 5. The Specification does not provide any data regarding the effectiveness of any of the exemplified compositions. 6. Dr. Nikhil J. Parekh 2 declares, in relevant part: The pending claims call for pharmaceutical compositions comprising ibuprofen and a decongestant where the amount of decongestant in the composition is less than or equal to about 75% less of an approved dose of the decongestant and the ibuprofen potentiates the activity of the decongestant. The combination of a 100% dose of ibuprofen with a reduced dose of a decongestant results in an enhanced effect of the decongestant, and provides the same or greater symptomatic relief of rhinitis. Until the present invention, it was not known that ibuprofen in combination with a decongestant would potentiate the activity of the decongestant, thereby allowing less decongestant to be used and achieving the same or greater effect. Additionally, the present invention is more than an optimization of dose ranges, but based upon this surprising discovery that the combination of a NSAID and decongestant allows less decongestant to be used and achieves the same or greater relief of symptoms. There are advantages of the claimed composition that contains reduced amounts of decongestant. Decongestants are stimulatory and may cause nervousness, restlessness and insomnia, especially if taken at night. There is a need in the art for effective relief from rhinitis symptoms with a reduction in adverse side effects. The composition of the present claims allows one to take less active with the same or greater result, thus reducing the experienced side effects. (Decl. ¶¶ 7, 8.) 2 Declaration of Dr. Nikhil J. Parekh (“Decl.”) dated December 17, 2007, originally submitted January 7, 2008 under the provisions of 37 C.F.R. § 1.132, and resubmitted with Appellant‟s Reply Brief. Appeal 2011-009313 Application 11/055,338 6 7. Dr. Parekh‟s declaration does not provide any data regarding the effectiveness of any compositions encompassed by Appellant‟s Specification. 8. Sims discloses a “pharmaceutical composition[] for use in the treatment of pain and inflammation and the relief of nasal congestion and sinus pressure symptoms in a mammalian organism” (Sims 2: 21-24). The composition comprises an “analgesically and anti-inflammatory effective amount of (S)-ibuprofen” in combination with a “sympathomimetically effective amount of at least one of the sympathomimetic amine[] [decongestants] phenylephrine, phenylpropanolamine, pseudoephedrine, oxymetazoline, ephinephrine, naphazoline, xylometazoline, propylhexedrine, [and] levo-desoxyephedrine” (id. at 2: 1-5; 2: 26-3: 1). 9. According to Sims, “[a]n effective amount of (S)-ibuprofen . . . for use in an unit dose composition of this invention may range from 50 to 800 mg (S)-ibuprofen” and “[t]he preferred amount . . . is about 100 to 400 mg” (Sims 6: 21-25). Further according to Sims, “[t]he amount of the decongestant useful in the practice of the . . . invention may vary from about 1 mg to 100 mg depending on the specific decongestant” (id. at 7: 7-10). 10. Thus, the amounts of ibuprofen and phenylephrine required by claim 21 (150-250 mg and ≤ 10 mg, respectively) are encompassed by the ranges suggested by Sims for (S)-ibuprofen and decongestant, respectively (see FF9). PRINCIPLES OF LAW “The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citations Appeal 2011-009313 Application 11/055,338 7 omitted). “In cases involving overlapping ranges . . . even a slight overlap in range establishes a prima facie case of obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Moreover, Selecting a narrow range from within a somewhat broader range disclosed in a prior art reference is no less obvious than identifying a range that simply overlaps a disclosed range. In fact, when . . . the claimed ranges are completely encompassed by the prior art, the conclusion is even more compelling than in cases of mere overlap. . . . [A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness. (Id. at 1329-1330.) “These cases have consistently held that in such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” Woodruff, 919 F.2d at 1578. The burden of demonstrating unexpected results rests on the party asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). It is well settled that results must be established by factual evidence. “Mere argument or conclusory statements in the specification does not suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Finally, “„objective evidence of nonobviousness must be commensurate in scope with the claims.‟” In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990). DISCUSSION The Examiner finds that Sims discloses “a composition for pain and inflammation comprising (S) ibuprofen and effective amount of at least one [of] phenylephrine, pseudoephedrine or epinephrine” (Ans. 5). The Examiner finds that Sims teaches that “[a]n effective amount of ibuprofen is Appeal 2011-009313 Application 11/055,338 8 . . . between 50 to 800 mg and preferably 100 to 400 mg,” while “[t]he amount of decongestant varies from about 1 mg to 100 mg depending upon specific decongestant” (id.). The Examiner acknowledges that Sims “does not specifically exemplify [a composition comprising] ibuprofen and phenylephrine” (id.), but concludes that it would have been obvious “to choose phenylephrine decongestant with an expectation to achieve similar results as . . . the art equivalent pseudoephedrine decongestant which has been exemplified” (id.). In addition, the Examiner finds that the required amounts of ibuprofen and phenylephrine fall within the ranges disclosed by Sims for (S)-ibuprofen and decongestant generally, and concludes that it would have been obvious, and within the skill of the ordinary artisan, “to come up with workable ranges” within the broader ranges disclosed by Sims (id. at 8-10). We agree with the Examiner‟s conclusion that the composition of claim 21 would have been obvious over Sims‟ disclosure. We are not persuaded otherwise by Appellant‟s arguments. Appellant contends that Sims “does not disclose and does not suggest using phenylephrine” (App. Br. 12), and the Examiner “provides no secondary reference or other evidence to support and sustain the conclusion that phenylephrine is an „art equivalent‟ of pseudoephedrine” (id. at 13). This argument is not persuasive, as Sims explicitly discloses both phenylephrine and pseudoephedrine as suitable decongestants for its compositions (FF8), even if pseudoephedrine is used in all Sims‟ working examples. That is, Sims itself provides evidence to support the Examiner‟s finding that phenylephrine and pseudoephedrine are “art equivalent” in the context of Sims‟ disclosure. In any case, it is well settled that disclosed Appeal 2011-009313 Application 11/055,338 9 examples and preferred embodiments do not constitute a teaching away from a broader disclosure or even non-preferred embodiments. See In re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Appellant also argues that the particular amounts of ibuprofen and phenylephrine required by the claims were “not obvious until applicant discovered that ibuprofen would potentiate the activity of phenylephrine” (Reply Br. 3), and that the particular amounts required by the claims provide an “unexpected advantage . . . [in] that the decongestant amount may be lowered to reduce side effects without loss of the desired decongestant effect when phenylephrine is combined with ibuprofen” (id.). We are not persuaded. The claimed amounts fall squarely within the ranges suggested by Sims for (S)-ibuprofen and a decongestant in its unit dose composition (FF9). It is well settled that selecting a narrow range from a broader disclosed range is prima facie obvious, absent a demonstration that the selected range is critical, generally by showing that the claimed range achieves unexpected results. See Woodruff, 919 F.2d at 1578; Peterson, 315 F.3d at 1329-1330. However, the burden of demonstrating unexpected results rests on the party asserting them, and must be established by factual evidence. See e.g., Klosak, 455 F.2d at 1080. We have carefully reviewed the Specification and the Declaration of Dr. Parekh, but find no data regarding the effectiveness of any composition comprising an NSAID and a decongestant (much less the claimed composition, which is not exemplified in the Specification or in the Declaration), or any other factual basis for the assertion that the properties of the claimed composition would have been somehow surprising or unexpected to one of ordinary skill in the art. “Mere Appeal 2011-009313 Application 11/055,338 10 argument or conclusory statements in the specification does not suffice.” De Blauwe, 736 F.2d at 705. The preponderance of the evidence of record supports the Examiner‟s conclusion that it would have been obvious for one of ordinary skill in the art to combine ibuprofen and phenylephrine in a unit dosage form, in the amounts required by claim 21, given Sims‟ disclosure. SUMMARY The rejection of claim 21 under 35 U.S.C. § 103(a) as unpatentable over Sims is affirmed, and claims 22-36 fall accordingly, as they were not separately argued. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation