Ex Parte Pickar et alDownload PDFBoard of Patent Appeals and InterferencesAug 31, 200910264187 (B.P.A.I. Aug. 31, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES ____________ Ex parte JAMES HARRISON PICKAR and BARRY SAMUEL KOMM ____________ Appeal 2007-004477 Application 10/264,187 Technology Center 1600 ____________ Decided: August 31, 2009 ____________ Before TONI R. SCHEINER, DONALD E. ADAMS, and RICHARD M. LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the Patent Applicants’ appeal from the Patent Examiner’s rejection of claims 1-7 and 9-16 under 35 U.S.C. § 102(e). Jurisdiction for this appeal is under 35 U.S.C. § 6(b). We affirm. Appeal 2007-004477 Application 10/264,187 2 Statement of the Case The claims are directed to a pharmaceutical composition comprising an estrogen, such as 17β-estradiol (Spec. 4:1-2; 16:10-11) and a compound of formula (I) or (II). According to the Specification, the composition is for “alleviating the symptoms of post-menopausal syndrome in women”, “to minimize undesirable side effects of estrogen treatment or therapy”, and “to minimize” amounts of estrogen necessary for a particular regime (Spec. 3: 23-30.) The formula (I) and (II) compounds are stated to be “estrogen agonists/antagonists useful for the treatment of diseases associated with estrogen deficiency.” (Spec. 3:31 to 4:2) Claims 1-7 and 9-16 are pending and stand rejected under 35 U.S.C. § 102(e) as anticipated by Miller (U.S. Pat. No. 5,998,402, issued Dec. 7, 1999; filed Apr. 4, 1997; provisional application filed Apr. 19, 1996) (Ans. 3). The claims were not argued separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative and reads follows: 1. A pharmaceutical composition comprising a pharmaceutically effective amount of one or more estrogens and a pharmaceutically effective amount sufficient to achieve the desired level of antagonism/agonism of said estrogen of a compound having the structure: [of formula (I) or (II)1] or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or excipient. 1 The complete formula (I) and (II) structures are listed on page 16 of the Appeal Brief dated Nov. 11, 2006 (“App. Br.”). Appeal 2007-004477 Application 10/264,187 3 Statement of the Issue The Examiner contends the Miller describes an example of a pharmaceutical composition administered to rats that meets all the limitations of claim 1, including comprising an estrogen combined with a compound having a structure of the claimed formula (I) or (II) (Ans. 3-4). Appellants contend that Miller does not describe or enable a “pharmaceutical composition” comprising the “effective amounts” as claimed (App. Br. 12-15; Reply Br. 2-4). The issue in this appeal is therefore whether Appellants have established that the Examiner erred in finding that Miller’s composition is a “pharmaceutical composition” as recited in claim 1. Principles of Law “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In some cases, the inherent property corresponds to a claimed new benefit or characteristic of an invention otherwise in the prior art. In those cases, the new realization alone does not render the old invention patentable. See Atlas Powder, 190 F.3d at 1347 (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s function, does not render the old composition patentably new to the discoverer.”). Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005). “[W]hile 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 Appeal 2007-004477 Application 10/264,187 4 v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). “[L]imitations are not to be read into the claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” 35 U.S.C. § 112, second paragraph. Claim Interpretation Because Appellants dispute that Miller’s composition administered to rats would be understood by persons of ordinary skill in the art to be a “pharmaceutical composition” as in claim 1, we begin our analysis with claim interpretation. The phrase “pharmaceutical composition” is not defined in the Specification. However, the Specification characterizes the “invention” as a “pharmaceutical composition” for “alleviating the symptoms of post- menopausal syndrome in women” and “to minimize undesirable side effects of estrogen treatment or therapy.” (Spec. 3: 23-30.) The composition comprises an estrogen and a compound of formula (I) or (II). On pages 15- 19, the Specification describes the physiological activities of the estrogen and formula (I) and (II) when administered to subjects. It is therefore evident that a “pharmaceutical composition” must be suitable for administration to a subject for it to achieve a physiological effect. The claims do not recite that the “pharmaceutically effective amount” is for treating a specific disease, symptom, or condition, or a specific subject. Thus, we interpret the claims broadly to include amounts to achieve any discernable physiological effect in a subject produced by administration Appeal 2007-004477 Application 10/264,187 5 of the estrogen and formula (I) or (II) compound. While the claimed “pharmaceutical composition” is disclosed in the Specification for treating post-menopausal syndrome in women, we do not require the “effective amounts” to be restricted to this utility. Claim limitations are not ordinarily imported from a specification into the claims. Sjolund v. Musland, 847 F.2d at 1581; In re Van Geuns, 988 F.2d at 1184. It is the purpose of the claim, not the specification, to point out the subject matter which is regarded as the invention. 35 U.S.C. § 112, second paragraph. Thus, absent express limitations in the claim, we will not interpret “pharmaceutical composition” more narrowly than the claim language mandates. Facts2 Miller 1. Miller describes indole compounds which are stated to be “useful as estrogenic agents, as well as pharmaceutical compositions and methods of treatment utilizing these compounds.” (Abstract.) 2. The Examiner found that Miller’s indole compounds met the limitations of the formula (I) or (II) compounds of the instant claims (Ans. 3-4). Appellants did not dispute this finding. 3. In Method No. 19, Miller describes an assay in which the “estrogenic and antiestrogenic properties of the compounds were determined in an immature rat uterotropic assay” (Col. 101, ll. 35-37). 4. Immature rats were injected daily with: 1) 100 µG compound; 2) 100 µG compound + 1 µG 17β-estradiol; or 3) 1 µG 17β-estradiol. (Col. 101, ll. 38- 60.) 2 Findings and conclusions of fact (“F”). Appeal 2007-004477 Application 10/264,187 6 5. The compounds used in Method No. 19 were indoles, which Appellants did not dispute meet the structural requirements of the claimed formula (I) or (II) compounds. 6. After four days, each animal was sacrificed and the weight of its uterus determined. (Col. 101, ll. 44-47.) 7. As shown in Miller’s Table 17, 17β-estradiol led to an increase in the weight of the rat uterus. (Table 17, compare column titled “1 µG 17β estradiol” to column titled “Vehicle.”) 8. Example Nos. 97 and 98 of Table 17 show compounds which antagonized the effects of the 17β-estradiol. (Table 17, compare column titled “100 µG cmpd + 1 µG 17β-estradiol” to column titled “1 µG 17β estradiol.”) Other examples are also disclosed of compounds which antagonized estradiol activity. (Table 17, Example Nos. 100 & 101.) Comparison between claim 1 and Miller 9. Claim 1 is to a “pharmaceutical composition” comprising: (1) a “pharmaceutically effective amount of one or more estrogens”; and (2) a “pharmaceutically effective amount sufficient to achieve the desired level of antagonism/agonism of said estrogen of a compound having the structure” recited in formula (I) or (II). 10. Miller described an experiment in which a composition (100 µG compound + 1 µG 17β-estradiol) was administered to rats by injection (F3- 4; Miller, Col. 101, “Method No. 19”; F4). 11. The composition administered to the rats by Miller contained 17β- estradiol (F4), which is an estrogen as required by claim 1. Appeal 2007-004477 Application 10/264,187 7 12. The amount of estrogen in the composition was effective in causing an increase in uterus weight (F7) (a physiological effect) and therefore was present in a “pharmaceutically effective amount” as required by claim 1. 13. The composition also contained a compound which, Appellants have not disputed, meets the limitations of a compound having the structure of formula (I) or (II) as recited in claim 1. 14. The amount of the compound in the composition was effective in antagonizing the estrogen (F8) (a physiological effect) and therefore was present in a “pharmaceutically effective amount” as required by claim 1. Analysis Claim 1 was rejected by the Examiner under 35 U.S.C. § 102(b) as anticipated by Miller. A claim is said to be “anticipated” when all its limitations are described in a prior art reference. An anticipated claim is directed to an invention which is not novel, and therefore, unpatentable by statute. Anticipation is a question of fact. In re Gleave, 560 F.3d 1331, 1334-35 (Fed. Cir. 2009). In this case, the Examiner provided adequate factual findings that all the limitations of the claimed invention were described in Miller (Ans. 3-4). As summarized above, we have reviewed these findings and find no fault in them. Therefore, we turn to Appellants’ arguments. Appellants contend that Miller does not describe a “pharmaceutical composition.” Appellants asserted that Miller’s composition – which undisputedly comprises both the estrogen and formula (I) or (II) compound of claim 1 – is a “test condition” to determine antiestrogenicity which would not have been interpreted by one of ordinary skill in the art to be “equivalent Appeal 2007-004477 Application 10/264,187 8 to the Appellants’ inventive pharmaceutical composition.” (Reply Br. 3). Appellants’ position appears to be that because Miller was determining whether its compounds had antiestrogenic activity, Miller was not administering the composition to prevent or treat a disease, and therefore its “test condition” was not a “pharmaceutical composition.” See App. Br. 14-15. The “test condition” disclosed in Miller is a composition which contains effective amounts of estrogen and formula (I) or (II) compound as recited in the claim (F10-14). The composition has a physiological effect in rats and therefore is a pharmaceutical composition as we have interpreted the phrase. While the “test condition” composition is not taught as useful for treating post-menopausal syndrome in a woman, we discern no language in the claim that would limit the claimed pharmaceutical composition to this use. As stated above, it is the purpose of the claims, not the specification, to point out the subject matter which is regarded as the invention. 35 U.S.C. § 112, second paragraph. Appellants have not provided any evidence or testimony that a “pharmaceutical composition” would exclude the composition utilized in Miller’s Method No. 19, which as shown in Table 17, contains an estrogen in an amount which causes the uterus to gain weight and the formula (I) or (II) compound in an amount which antagonizes the estrogen activity (F12, 14). Therefore, contrary to Appellants’ argument, the evidence establishes that composition is an appropriate form to be provided to a subject and to produce discernable physiological effects when so provided. It is therefore a pharmaceutical composition as we have interpreted the phrase. Appeal 2007-004477 Application 10/264,187 9 Appellants argue the “reference does not teach that any effect in treating or preventing a disease, disorder, or symptom (a requirement of a pharmaceutical composition containing effective amounts of compounds as claimed) would be obtained by administering a compound of formula (I) or (II) in conjunction with an estrogen.” (Reply Br. 3-4.) Appellants have interpreted the scope of claim 1 too narrowly. As discussed above, there is no limitation in the claim that would restrict it to a composition to treat or prevent “a disease, disorder, or symptom.” Once again, factual evidence is lacking from the record to establish Appellants’ alternative claim interpretation. It is well-established that during prosecution claims are given their broadest interpretation as they would be understood by a person of ordinary skill in the art having read the Specification. Having read the Specification, it is evident the claimed pharmaceutical composition must be in a form suitable for administration and capable of achieving a physiological effect, but there is no express definition that would limit it to one which must have been used to treat or prevent a disease as asserted by Appellants. Appellants appear to be reading limitations into the claim from the Specification. Appellants also contend that Miller does not disclose an effective amount of the compound of formula (I) or (II) “to achieve the desired level of antagonism/agonism of said estrogen” as recited in claim 1 (Reply Br. 4.) We do not interpret this limitation to demand an appreciation that a specific level of effect was achieved. Rather, we interpret the claim to simply require that a “level of antagonism/agonism” was achieved, i.e., that it be a statement of effect. See Ex parte Batteux, Appeal No. 2007-0622 (BPAI, Mar. 27, 2007, Informative Opinion). Appeal 2007-004477 Application 10/264,187 10 Conclusion of Law and Summary Appellants have not established that the Examiner erred in finding that Miller’s composition is a “pharmaceutical composition” as recited in claim 1. The anticipation rejection of claim 1 is affirmed. Claims 2-7 and 9-16 fall with claim 1 because separate reasons for their patentability were not provided. 37 C.F.R. § 41.37(c)(1)(vii). 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 lp WILMERHALE/WYETH 60 STATE STREET BOSTON MA 02109 Copy with citationCopy as parenthetical citation