Ex Parte Dharmadhikari et al

Patent Trial and Appeal BoardDec 17, 2012

11790356 (P.T.A.B. Dec. 17, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte NITIN BHALACHANDRA DHARMADHIKARI and YASHORAJ RUPSINH ZALA __________ Appeal 2012-000848 Application 11/790,356 Technology Center 1600 __________ Before ERIC GRIMES, FRANCISCO C. PRATS, and ERICA A. FRANKLIN, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge FRANKLIN. Opinion Dissenting filed by Administrative Patent Judge PRATS. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of alleviating signs and symptoms of spasticity in human patients comprising orally administering a once-a-day controlled drug delivery system comprising baclofen or its pharmaceutically acceptable salt. The Patent Examiner rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2012-000848 Application 11/790,356 2 STATEMENT OF THE CASE Claims 1-4 are on appeal. Claim 1 is representative and reads as follows: 1. A method of alleviating signs and symptoms of spasticity in human patients, said method comprising orally administering to said human patients an once-a-day controlled drug delivery system comprising an effective daily dose of baclofen or its pharmaceutically acceptable salt, wherein the controlled drug delivery system produces a level of sedation lower than a sedation produced by three times a day immediate release tablets, wherein a total daily dosage of the controlled release tablets and a total daily dosage of the three times a day immediate release tablets remain the same. The Examiner rejected the claims as follows: • claims 1 and 2 under 35 U.S.C. §102(b) as anticipated by Khanna; 1 • claims 3 and 4 under 35 U.S.C. § 103(a) as unpatentable over Khanna and Dudhara. 2 ANTICIPATION/OBVIOUSNESS The Examiner relies on Khanna as teaching all of the elements of independent claim 1 with respect to the anticipation rejection of claims 1 and 2, as well as the obviousness rejection of claims 3 and 4. Therefore, we consider these rejections together. The Examiner found that Khanna taught a pharmaceutical composition comprising baclofen in a tablet formulation 1 US Patent No. 5,091,184 issued to Satish C. Khanna, Feb. 25, 1992. 2 Patent Application Publication No. WO 03/011255 A1 by Kamlesh Mohanlal Dudhara et al., published Feb. 13, 2003. Appeal 2012-000848 Application 11/790,356 3 for therapeutic use as a spasmolytic. (Ans. 4.) The Examiner found that Khanna taught that treatment with commercially available dosage forms caused side-effects including daytime sedation. (Id.) Additionally, the Examiner found that Khanna taught that “the object of [its invention was] to provide an improved dosage form for the administration of baclofen, which permits uniform administration at the commencement, as well as the course, of therapy at constant intervals. The improved dosage form will also reduce the number of daily doses administered, preferably to one to two doses a day….” (Id. at 5.) Appellants contend that that Khanna does not specifically disclose all elements of claim 1. (App. Br. 8.) In particular, Appellants assert that Khanna “fails to specifically disclose orally administering a once-a-day controlled drug delivery system” (Id. (emphasis removed).) According to Appellants, Khanna’s disclosed dosage form is meant for adhesion to mucosa of the oral cavity, i.e., applied to the palate, buccally, lingually, or sublingually, which is different from oral administration. (Id. at 9.) In support of this position, Appellants refer to Remington’s Pharmaceutical Sciences, 3 which describes buccal, sublingual and topical application to the skin or mucous membranes as “non-oral” routes of administration. (Id.) The Examiner responds by referring to Dorland’s Illustrated Medical Dictionary 4 as evidence that the term “oral” means “pertaining to the mouth, taken through or applied in the mouth.” (Ans. 7-8.) According to the 3 REMINGTON’S PHARMACEUTICAL SCIENCES 764 (17th ed. 1985). 4 DORLAND’S ILLUSTRATED MEDICAL DICTIONARY 187 (28th ed. 1994). Appeal 2012-000848 Application 11/790,356 4 Examiner, there is “no other way[] to place the Khanna composition in the oral mucosal cavity without using the oral route.” (Id. at 8.) While we agree with the Examiner that the term “oral” means “pertaining to the mouth, taken through or applied in the mouth,” we do not agree that this definition refers to or describes a route of administering a drug. The claimed invention specifically recites “orally administering” baclofen. As described by Appellants’ evidence, such oral administration specifically excludes buccal, sublingual and topical application of a drug to the skin or mucous membranes. (See Remington’s Pharmaceutical Sciences at 764.) Thus, we find that Khanna’s teaching to apply baclofen in the form of an adhesive tablet to the mucosa in the oral cavity did not teach or suggest a method comprising orally administering baclofen to a patient, as required by the claimed invention. Because the Examiner has not shown that a method meeting all of the limitations of the claimed invention was disclosed or would have been suggested based upon the cited prior art, we reverse both the anticipation and obviousness rejections. REVERSED cdc Appeal 2012-000848 Application 11/790,356 5 PRATS, Administrative Patent Judge, dissenting. I respectfully dissent. I would affirm the Examiner’s rejections. As to the second issue Appellants raise (see App. Br. 15-17), because an ordinary artisan would have reasoned that Khanna’s single daily sustained release administration of baclofen would avoid the undesired peaks and valleys of drug plasma concentration in the same way as Appellants single daily sustained release formulation, I agree with the Examiner that there was a reasonable evidentiary basis to find that Khanna’s method inherently met claim 1’s limitation regarding sedation level. See In re Best, 562 F.2d 1252, 1254-1255 (CCPA 1977) (quoting In re Swinehart, 439 F.2d 210, 213 (CCPA 1971): [W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. As to the issue of whether the recitation “orally administering” in claim 1 excludes the buccal/sublingual absorption described by Khanna, while Appellants argue that the term “designates a means of administering when the system is swallowed by the patient and the drug is absorbed upon its release in the gastrointestinal tract” (App. Br. 10), claim 1 does not include any language limiting the claimed process to swallowing or gastrointestinal absorption, and Appellants point to no clear or specific definition in the Specification of the term at issue. Appeal 2012-000848 Application 11/790,356 6 The description, advanced by Appellants, of buccal and sublingual administration as being “non-oral routes” of drug administration is acknowledged (Remington’s Pharmaceutical Sciences 764). The Examiner, however, has advanced evidence supporting the position that “an oral medication” is one that is simply “taken through . . . the mouth” (Dorland Medical Dictionary 187). It is well settled that, during examination, the PTO must interpret terms in a claim using “the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). However, “[a]bsent claim language carrying a narrow meaning, the PTO should only limit the claim based on the specification or prosecution history when those sources expressly disclaim the broader definition.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Thus, “while it is true that claims are to be interpreted in light of the specification and with a view to ascertaining the invention, it does not follow that limitations from the specification may be read into the claims.” Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). As the court explained in In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989), the rationale for this approach to claim interpretation is that “during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.” Appeal 2012-000848 Application 11/790,356 7 In my view, by asking us to adopt the narrower of two undisputedly reasonable interpretations of the claim term at issue, without any amendment of the claim reflecting the narrower claim scope advanced, I am convinced that Appellants are asking us to interpret claim 1 in a manner contrary to that directed by our reviewing court. Thus, I agree with the Examiner that, on this record, the broadest reasonable interpretation of “orally administering” baclofen simply requires the practitioner to place the drug into a patient’s mouth. I also agree with the Examiner that Khanna’s buccal/sublingual administration of baclofen is encompassed by that interpretation. I further agree that the Examiner advanced sufficient evidence to support a finding that Khanna’s daily sustained release would accomplish the same sedation level as that required by claim 1, absent evidence to the contrary. I would therefore affirm the Examiner’s rejections.