2107
2107 Guidelines for Examination of Applications for Compliance with the Utility Requirement
2107.01 General Principles Governing Utility Rejections [R-5]
NUIJTEN
The specification does not clearly define “tangible” or a “computer readable medium.” The broadest reasonable interpretation of a “tangible computer readable medium” encompasses a transitory, propagating signal. Given that a medium can be both tangible and transitory, we agree with the Examiner’s finding that a “tangible computer readable medium” as broadly claimed encompasses a transitory, propagating signal. Transitory embodiments are not directed to statutory subject matter. Examples include physical but transitory forms of signal transmission such as radio broadcasts, electrical signals through a wire, and light pulses through a fiber-optic cable, that convey encoded information. In re Nuijten, 500 F.3d 1346, 1353-54 (Fed. Cir. 2007).
ZIEGLER
A nonprovisional application is entitled to the benefit of an earlier filed provisional application if, among other things, the later-claimed invention is described in the provisional application in a manner that satisfies the requirements of 35 U.S.C. § 112, first paragraph. 35 U.S.C. § 1 19(e)(l) (2006). The enablement requirement of § 112, ¶ l, in turn, incorporates the utility requirement of § 101. See In re Ziegler, 992 F.2d 1197, 1200—01 (Fed. Cir. 1993). The rejection is based on the Examiner's conclusion that the "provisional application does not disclose a specific and substantial practical utility for the now claimed antibodies" and therefore does not meet the requirements of 101 and 112, ¶ l . (Ans. 6.)
I. SPECIFIC AND SUBSTANTIAL REQUIREMENTS
CROSS, NELSON
It has been held that the in vitro screening for compounds that exhibit a pharmacological activity “may establish a practical utility for the compound in question” because “[s]uccessful in vitro testing will marshal resources and direct the expenditure of effort to further in vivo testing of the most potent compounds, thereby providing an immediate benefit to the public, analogous to the benefit provided by the showing of an in vivo utility.” Cross v. Iizuka, 753 F.2d 1040, 1051 (Fed. Cir. 1985); see also
Nelson v. Bowler, 626 F.2d 853, 856 (CCPA 1980) (“[T]ests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use.”).
see also Nelson v. Bowler, 626 F.2d 853, 856 (CCPA 1980) ("[T]ests evidencing pharmacological activity may manifest a practical utility even though they may not establish a specific therapeutic use.").
A. Specific Utility
FISHER
To comply with the utility requirement of § 101, the claimed invention must “have a specific and substantial utility.” In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). An asserted utility is (1) specific if shows that the “claimed invention can be used to provide a well-defined and particular benefit to the public,” and (2) substantial if it shows that the “claimed invention has a significant and presently available benefit to the public.” Id.
Section 101 requires a utility that is both substantial and specific. A substantial utility requires:
show[ing] that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the “substantial” utility requirement, an asserted use must show that that claimed invention has a significant and presently available benefit to the public.
In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
A specific utility is “a use which is not so vague as to be meaningless.” Id. In other words, “in addition to providing a ‘substantial’ utility, an asserted use must also show that [the] claimed invention can be used to provide a well-defined and particular benefit to the public.” Id. In addition, “[i]t is well established that the enablement requirement of § 112 incorporates the utility requirement of § 101.” In re Fisher, 421 F.3d at 1378.
In order to satisfy the utility requirement of 35 U.S.C. § 101, the disclosed utility must be both substantial and specific. In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). A substantial utility requires showing that the claimed invention “has a significant and presently available benefit to the public.” Id. A specific utility requires showing that “the claimed invention can be used to provide a well-defined and particular benefit to the public.” Id.
[A]n application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the “substantial” utility requirement, an asserted use must show that that claimed invention has a significant and presently available benefit to the public. . . . in addition to providing a “substantial” utility, an asserted use must also show that the claimed invention can be used to provide a well-defined and particular benefit to the public. In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005).
B. Substantial Utility
We do not find this argument persuasive because a "patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion." Brenner v. Manson, 86 S. Ct. 1033, 1042 (1966).
C. Research Tools
II. WHOLLY INOPERATIVE INVENTIONS; “INCREDIBLE” UTILITY
HARWOOD
“An inoperative invention . . . does not satisfy the requirement of 35 U.S.C. 101 that an invention be useful.” In re Harwood, 390 F.2d 985, 989 (CCPA 1968).
SWARTZ, ENZO, FOUCHE, FISHER, NEWMAN
In order for the specification to be enabling, it “must adequately disclose the claimed invention so as to enable a person skilled in the art to practice the invention at the time the application was filed without undue experimentation.” In re Swartz, 232 F.3d 862, 863 (Fed. Cir. 2000) citing, Enzo-Biochem, Inc. v Calgene, Inc., 188 F.3d 1362, 1371–72 (Fed. Cir. 1999). The purpose of the utility requirement of 35 U.S.C. §101 is to limit patent protection to inventions that possess a certain level of “real world” value. In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). A rejection under 35 U.S.C. §101 for lack of utility is tantamount to a rejection under the how-to-use provision of the enablement clause of the first paragraph of 35 U.S.C. § 112. In re Fouche, 439 F.2d 1237, 1243 (CCPA 1971) (“[I]f such compositions are in fact useless, appellant’s specification cannot have taught how to use them.”). As such, the lack of utility because of inoperativeness (a question of fact), and the absence of enablement (a question of law) are thus closely related grounds of unpatentability. In re Swartz, 232 F.3d at 863; see also Newman v Quigg, 877 F.2d 1575, 1581 (Fed. Cir. 1989).
The claimed invention must have “a specific and substantial utility to satisfy § 101.” In re Fisher, 421 F.3d at 1371. The substantial utility requirement means
that an application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the “substantial” utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit the public. Id.
III. THERAPEUTIC OR PHARMACOLOGICAL UTILITY
TRANSCO
“[T]he bottom line is that, no matter what term is used to describe a continuing application, that application is entitled to the benefit of the filing date of an earlier application only as to common subject matter.” Transco Products Inc. v. Performance Contracting, Inc., 38 F.3d 551, 556(Fed. Cir. 1994).
2107.02 Procedural Considerations Related to Rejections for Lack of Utility [R-5]
I. THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENT
II. IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED INVENTION?
A. An Asserted Utility Must Be Specific and Substantial
B. No Statement of Utility for the Claimed Invention in the Specification Does Not Per Se Negate Utility
III. EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY
A. An Asserted Utility Creates a Presumption of Utility
LANGER
In re Langer, 503 F.2d 1380, 1391 (CCPA 1974) (“[A] specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope.”).
As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope. Assuming that sufficient reason to question the statement of utility and its scope does exist, a rejection for lack of utility under § 101 will be proper on that basis; such a rejection can be overcome by suitable proofs indicating that the statement of utility and its scope as found in the specification are true.
In re Langer, 503 F.2d 1380, 1391-92 (CCPA 1974).
MARZOCCHI
In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971) (“[It] is incumbent upon the Patent Office, whenever a rejection on this basis is made, to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement.”)
B. When Is an Asserted Utility Not Credible?
IV. INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE CASE AND PROVIDE EVIDENTIARY SUPPORT THEREOF
V. EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITY
VI. CONSIDERATION OF A REPLY TO A PRIMA FACIE REJECTION FOR LACK OF UTILITY
VII. EVALUATION OF EVIDENCE RELATED TO UTILITY
"[I]f the alleged operation seems clearly to conflict with a recognized scientific principle as, for example, where an applicant purports to have discovered a machine producing perpetual motion, the presumption of inoperativeness is so strong that very clear evidence is required to overcome it." In re Chilowsk[i], 229 F.2d 457, 462 (CCPA 1956).
Bundy
[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. See In re Bundy, 642 F.2d 430, 433 (CCPA 1981).
2107.03 Special Considerations for Asserted Therapeutic or Pharmacological Utilities
Further, “the PTO must do more than merely question operability - it must set forth factual reasons which would lead one skilled in the art to question the objective truth of the statement of operability.” In re Gaubert, 524 F.2d 1222, 1224-25 (CCPA 1975).