Cortright, In re, 98-1258

CourtUnited States Courts of Appeals. United States Court of Appeals for the Federal Circuit
Citation165 F.3d 1353,49 USPQ2d 1464
Docket NumberNo. 98-1258,98-1258
PartiesIn Re Joyce A. CORTRIGHT,
Decision Date19 January 1999

Joseph B. Taphorn, of Poughkeepsie, New York, argued for appellant.

Scott A. Chambers, Associate Solicitor, U.S. Patent and Trademark Office, of Arlington, Virginia, argued for the appellee. With him on the brief were Nancy J. Linck, Solicitor, Albin F. Drost, Deputy Solicitor, and Linda Moncys Isacson, Associate Solicitor.

Before MAYER, Chief Judge, NEWMAN, and RADER, Circuit Judges.

MAYER, Chief Judge.

Joyce A. Cortright appeals the September 23 and November 28, 1997, decisions of the United States Board of Patent Appeals and Interferences sustaining the rejection of claims 1 and 15 of patent application Serial No. 07/849,191 under 35 U.S.C. § 112, p 1 (1994). Because the board erred with respect to claim 1 but not claim 15, we affirm-in-part, reverse-in-part, and remand.

Background

Cortright's patent application, filed in 1992, concerns a method of treating baldness by applying Bag Balm TM, a commercially available product used to soften cow udders, to human scalp. Claims 1 and 15 are the only claims on appeal. Claim 1 recites a method of "treating scalp baldness with an antimicrobial to restore hair growth, which comprises rubbing into the scalp the ointment wherein the active ingredient 8-hydroxy-quinoline sulfate 0.3% is carried in a petrolatum and lanolin base." Claim 15 recites a method of "offsetting the effects of lower levels of a male hormone being supplied by arteries to the papilla of scalp hair follicles with the active agent 8-hydroxy-quinoline sulfate to cause hair to grow again on the scalp, comprising rubbing into the scalp the ointment having the active agent 8-hydroxy-quinoline sulfate 0.3% carried in a petrolatum and lanolin base so that the active agent reaches the papilla."

The examiner rejected the claims under 35 U.S.C. § 101 (1994) as lacking utility. According to the examiner, Cortright's statements of utility, namely, her claims of treating baldness, are suspect because "baldness is generally accepted in the art as being incurable...." The examiner, therefore, required clinical evidence to establish the claimed utility, which Cortright did not supply. Furthermore, with respect to claim 15's recitation of offsetting the effects of lower levels of a male hormone, Cortright "offered no proof that such an off-set occurs and has disclosed that this is only speculation." The examiner also rejected the claims under 35 U.S.C. § 102(a) (1994), arguing that the admitted prior art anticipates the claims because the written description discloses that Bag Balm TM has been applied to human skin and the "scalp is the skin of the head." Cortright appealed these rejections to the Board of Patent Appeals and Interferences.

In its September 23, 1997, decision, the board reversed the section 101 rejection because the examiner did not set out sufficient reasons for finding Cortright's statements of utility incredible. It noted that "there is no per se requirement for clinical evidence to establish the utility of any invention" and the examples in Cortright's application are objective evidence. The board also reversed the section 102(a) rejection because although the prior art discloses the application of Bag Balm TM to human skin, it does not disclose applying it to bald, human scalp.

Despite these reversals, Cortright did not prevail because the board found a new ground for rejecting the claims: that they are based on a non-enabling disclosure in violation of 35 U.S.C. § 112, p 1. The board found that Cortright's written description does not teach those of ordinary skill in the art how to make and use the claimed invention without undue experimentation because it "fails to provide any teachings as to the administration of Bag Balm TM in a manner which (i) restore[s] hair growth (claim 1), or (ii) 'offset[s] the effects of lower levels of male hormone being supplied by arteries to the papilla of scalp hair follicles' (claim 15)." The board explained that Example 1 does not show that applying a teaspoon of Bag Balm TM to the scalp daily for about one month "restored hair growth" and that Examples 2 and 3 do not disclose the amount of Bag Balm TM to apply or how to restore hair growth. With respect to claim 15, the board found that the written description "merely surmis[es] that the active ingredient, 8-hydroxy-quinoline sulfate, even reaches the papilla," which would not enable one of ordinary skill to use the claimed method. Finally, the board observed that the breadth of the claims and the unpredictable nature of the art of hair growth aggravated its finding that those of ordinary skill in the art would not be able to practice the invention without undue experimentation.

Cortright requested reconsideration, which the board denied in a November 28, 1997 opinion. The board explained that claim 1 is not enabled because it claims "restor[ing] hair growth," which the board interpreted as requiring the user's hair "to return to its original state," that is, a full head of hair. Thus, the board's rejection was not based on complete non-enablement, as the original decision had implied, but on the claim not being commensurate with the scope of the disclosure. With respect to claim 15, the board maintained its general non-enablement rejection, adding that "there is no evidence of record that the resultant hair growth is due to (i) the stimulation of the papilla, and (ii) the offsetting [of] the effects of lower male hormone which is supplied by arteries to the papilla, and not due to some other mechanism(s)." Cortright appeals.

Discussion

"Whether making and using an invention would have required undue experimentation, and thus whether a disclosure is enabling under 35 U.S.C. § 112, p 1 (1994), is a legal conclusion based upon underlying factual inquiries." Johns Hopkins Univ. v. Cellpro, Inc., 152 F.3d 1342, 1354, 47 USPQ2d 1705, 1713 (Fed.Cir.1998). Utility is a factual issue, which we review for clear error. See Cross v. Iizuka, 753 F.2d 1040, 1044 n. 7, 224 USPQ 739, 742 n. 7 (Fed.Cir.1985); see also In re Zurko, 142 F.3d 1447, 1449, 46 USPQ2d 1691, 1693 (Fed.Cir.), cert. granted, --- U.S. ----, 119 S.Ct. 401, 142 L.Ed.2d 326 (1998).

Section 112, p 1 provides:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

35 U.S.C. § 112, p 1. A lack of enablement rejection under section 112, p 1 is appropriate where the written description fails to teach those in the art to make and use the invention as broadly as it is claimed without undue experimentation. See In re Vaeck, 947 F.2d 488, 495-96, 10 USPQ2d 1438, 1444 (Fed.Cir.1991).

This rejection takes several forms. The PTO will make a scope of enablement rejection where the written description enables something within the scope of the claims, but the claims are not limited to that scope. See Manual of Patent Examining Procedures ("M.P.E.P.") § 706.03(c), form p 7.31.03 (Rev.3, July 1997). This type of rejection is marked by language stating that the specification does not enable one of ordinary skill to use the invention commensurate with the scope of the claims. On the other hand, if the written description does not enable any subject matter within the scope of the claims, the PTO will make a general enablement rejection, stating that the specification does not teach how to make or use the invention. See M.P.E.P. § 706.03(c), form p 7.31.02.

If the written description fails to illuminate a credible utility, the PTO will make both a section 112, p 1 rejection for failure to teach how to use the invention and a section 101 rejection for lack of utility. See M.P.E.P. § 706.03(a), form p 7.05.04. This dual rejection occurs because "[t]he how to use prong of section 112 incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention." In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed.Cir.1993). Thus, an applicant's failure to disclose how to use an invention may support a rejection under either section 112, p 1 for lack of enablement as a result of "the specification's ... failure to disclose adequately to one ordinarily skilled in the art 'how to use' the invention without undue experimentation," or section 101 for lack of utility "when there is a complete absence of data supporting the statements which set forth the desired results of the claimed invention." Envirotech Corp. v. Al George, Inc., 730 F.2d 753, 762, 221 USPQ 473, 480 (Fed.Cir.1984); see also In re Brana, 51 F.3d 1560, 1564 n. 12, 34 USPQ2d 1436, 1439 n. 12 (Fed.Cir.1995) (The "absence of utility can be the basis of a rejection under both 35 U.S.C. § 101 and § 112 p 1."); In re Fouche, 58 C.C.P.A. 1086, 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA 1971) ("[I]f [certain] compositions are in fact useless, appellant's specification cannot have taught how to use them.").

The PTO cannot make this type of rejection, however, unless it has reason to doubt the objective truth of the statements contained in the written description. See Brana, 51 F.3d at 1566, 34 USPQ2d at 1441 ("[T]he PTO has the initial burden of challenging a presumptively correct assertion of utility in the disclosure. Only after the PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility does the burden shift to the applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility.") (citations...

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