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2111 MANUAL OF PATENT EXAMINING PROCEDURE Sichert,566 F.2d II54, 196 USPQ 209 (CCPA 1977); In re Hartop, 3II F.2d 249, 135 USPQ 419 (CCPA 1962); In re Anthony, 414 F.2d 1383,162 USPQ 594 (CCPA 1969); In re Watson, 517 F.2d 465, 186 USPQ II (CCPA 1975); In re.Krimmel, 292 F.2d 948; 130 USPQ 215 (CCPA 1961); Ex parte Jovanovics, 2II USPQ 907 (Bd. Pat. App. & Inter. 1981). VI; TREATMENT OF SPECIFIC DISEASE CONDITIONS Claims directed to a method of treating or curing a disease for which there have been no previously successful treatments or cures warrant careful review for compliance with 35 U.S.C.l0l. The credibilityofan asserted utility for treating a human disorder may be more difficult to establish where current scientific understanding suggests that such a task would be impossible. Such a determination has alwaysrequired a good understanding of the state of the art.as of the time that the invention was made. For exainple, prior to the 1980's, there were a number of cases where an asserted use in treating cancer in humans was viewed as "incredible." In re Jolles,628F.2d 1322, 206 USPQ 885 (CCPA 1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 1969); Exparte Stevens, 16 USPQ2d 1379 (Ed. Pat. App. & Inter. 1990); Ex parte Busse, 1 USPQ2d 1908 (Bd. Pat. App. & Inter. 1986); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App: & Inter. 1986); Ex parte Jovanovics, 211USPQ 907 (Bd. Pat. App. & Inter. 1981). The fact that there is no known cure for a disease, however, cannot serve as the basis for a conclusion that such an invention lacks utility. Rather, Office personnel must determine if the asserted utility for the invention is credible based on the information disclosed in the application. Only those claims for which an asserted utility is not credible should be rejected. In such cases, the Office should carefully review what is being claimed by the applicant. An assertion that the claimed invention is useful in treating a symptom of an incurable disease may be considered credible by a person of ordinary skill in the art on the basis of a fairly modest amount of evidence or support. In contrast, an assertion that the.claimed invention will be useful in "curing" the disease may require a significantly greater amount of evidentiary support to be considered credible by a person of ordinary skill in the art. In reSichert, 566 F.2d II54, 196 USPQ 209 (CCPA 1977); Inre Jolles, August 2001 2100-46 628 F.2d 1322, 206 USPQ 885 (CCPA 1980). See also Ex parte Ferguson, 117 USPQ 229 (Bd. Pat. App. & Inter. 1957). In these cases, it is important to note that the Food and Drug Administration has promulgated regulations that enable a party to conduct clinical trials for drugs used to treat life threatening and severely-debilitating illnesses; even where no alternative therapy exists. See 21 CFR 312.80-88 (1994). Implicit in these regulations is the recognition that experts qualified to evaluate the effectiveness of therapeutics can and often do find a sufficient basis to conduct clinical trials of drugs for incurable or previously untreatable illnesses.Thus, affidavit evidence from experts in the art indicating that there is a reasonable expectation of success, supported by sound reasoning, usually should be sufficient to establish that such a utility is credible. 2111 Claim Interpretation; Broadest Reasonable Interpretation CLAIMS MUST BE GIVEN THEIR BROADEST REASONABLE INTERPRETATION During patent examination, the pending claims must be "given the broadest reasonable interpretation consistent with the specification." Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly thanis justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550 51 (CCPA 1969) (Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The process comprised selecting the data to be analyzed by subjecting the data to a mathematical manipulation. The examiner made rejections under 35 U.S.C. 101 and 102. In the 35 U.S.c. 102 rejection, the examiner explained that the claim was anticipated by a mental process augmented by pencil and paper markings. The court agreed that the claim was not limited to using a machine to carry out the process siuce the claim did not explicitly set forth the machine. The court explained that "reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from 'reading limitations of the specification into a claim,' to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have
no express basis in the claim." The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F,3d 1048, 1054-55,44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the PrO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the "PrO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the att, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant's specification."). The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach. In re Cortright, 165 F,3d 1353, 1359, 49 USPQ2d 1464, 1468 (Fed. Cir. 1999) (The Board's construction of the claim limitation "restore hair growth" as requiring the hair.to be returned to its original state was held to be an unreasonably broad interpretation of the limitation. The court held that, consistent with applicant's disclosure and the disclosure of three patents from analogous arts using the same phrase to require only some increase in hair growth, one of ordinary skill would construe "restore hair growth" to mean that the claimed method increases the amount of hair grown on the scalp, but does not necessarily produce a full head of hair.). 2111.01 Plain Meaning THE WORDS OF A CLAIM MUST BE GIVEN THEIR "PLAIN MEANING" UNLESS THEY ARE DEFINED IN THE SPECIFICATION While the meaning of claims of issued patents are interpreted in light of the specification, prosecution history, prior art and other claims, this is not the mode of claim interpretation to be applied during examination. During examination, the claims must be interpreted as broadly as their terms reasonably allow.This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zietz, 893 F,2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) PATENTABILITY 2111.01 (discussed below). One must bear in mind that, especially in nonchemical cases, the words in a claim are generally not limited in their meaning by what is shown or disclosed in the specification. It is only when the specification provides definitions for terms appearing in the claims that the specification can be used ininterpreting claim language. In re Vogel, 422 F,2d 438, 441, 164 USPQ 619, 622 (CCPA 1970). There is one exception, and that is when an element is claimed using language falling under the scope of 35 U.S.c. 112, 6th paragraph (often broadly referred to as means or step pius function language). In that case, the specification must be consulted to determine the structure, material, or acts corresponding to the function recited in the claim. In re Donaldson, 16 F.3d 1189,29 USPQ2d 1845 (Fed. Cir. 1994) (see MPEP § 2181- § 2186). In In re Zietz, supra, the examiner and the Board had interpreted claims reading "normally solid polypropylene" and "normally solid polypropylene having a crystalline polypropylene content" as being limited to "normally solid linear high homopolymers ofpropylene which have a crystalline polypropylene content." The court ruled that limitations, not present in the claims, were improperly imported' from the specification. See also In re Marosi, 710 F,2d 799, 218 USPQ 289 (Fed. Cir. 1983) ("Claims are not to be read in a vacuum, and limitations therein are to be interpreted in light of the specification in giving them their 'broadest reasonable interpretation'." 710 F.2d at 802, 218 USPQ at 292 (quoting In re Okuzawa, 537 F.2d 545, 548, 190 USPQ 464, 466 (CePA 1976» (emphasis in original). The court looked to the specification to construe "essentially free of alkali metal" as including unavoidable levels of impurities but no more.). Compare In re Weiss, 989 F.2d 1202, 26 USPQ2d 1885 (Fed. Cir. 1993) (unpublished decision - cannot be cited as precedent) (The claim related to an athletic shoe with cleats that "break away at a preselected level of force" and thus prevent injury to the wearer. The examiner rejected the claims over prior att teaching athletic shoes with cleats not intended to break off and rationalized that the cleats would break away given a high enough force. The court reversed the rejection stating that when interpretiug a claim term which is ambiguous, such as 'a preselected level of force,' we must look to the specification for the meaning ascribed to that term by the 2100-47 August 2001
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