2164.06(a) Examples of Enablement Issues-Missing Information [R-08.2017]
It is common that doubt arises about enablement because information is missing about one or more essential claim elements or relationships between elements which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why the missing information is needed to provide enablement.
I. ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES
Enablement serves the dual function of ensuring adequate disclosure of the claimed invention and of preventing claims broader than the disclosed invention. Broad claim language is used at the peril of losing any claim that cannot be enabled across its full scope. For example, in MagSil Corp. v. Hitachi Global Storage Technologies, Inc., 687 F.3d 1377, 103 USPQ2d 1769 (Fed. Cir. 2012), the claim recited a change in resistance by at least 10% at room temperature, but the specification contained no showing that the knowledge of a person of ordinary skill in the art at the time of filing would have been able to achieve resistive changes in values that greatly exceed 10% without undue experimentation (noting that it took nearly 12 years of experimentation to achieve modern values above 600%). Similarly in Auto. Techs. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1283, 84 USPQ2d 1108, 1115 (Fed. Cir. 2007), a claim limitation means responsive to the motion of a mass was construed to include both mechanical and electronic side impact sensors for performing the function of initiating an occupant protection apparatus. The specification did not disclose any details or circuitry for electronic side impact sensors, and thus, failed to apprise one of ordinary skill how to make and use the electronic sensor.
A disclosure of an electrical circuit apparatus, depicted in the drawings by block diagrams with functional labels, was held to be nonenabling in In reGunn, 537 F.2d 1123, 1129, 190 USPQ 402, 406 (CCPA 1976), where there was no indication in the specification as to whether the parts represented by boxes were “off the shelf” or must be specifically constructed or modified for applicant’s system. Also there were no details in the specification of how the parts should be interconnected, timed and controlled so as to obtain the specific operations desired by the applicant. In In reDonohue, 550 F.2d 1269, 193 USPQ 136 (CCPA 1977), the lack of enablement was caused by lack of information in the specification about a single block labeled “LOGIC” in the drawings. See also Union Pac. Res. Co. v. Chesapeake Energy Corp., 236 F.3d 684, 57 USPQ2d 1293 (Fed. Cir. 2001) (Claims directed to a method of determining the location of a horizontal borehole in the earth failed to comply with enablement requirement of 35 U.S.C. 112 because certain computer programming details used to perform claimed method were not disclosed in the specification, and the record showed that a person of skill in art would not understand how to “compare” or “rescale” data as recited in the claims in order to perform the claimed method.).
In reGhiron, 442 F.2d 985, 169 USPQ 723 (CCPA 1971), involved a method of facilitating transfers from one subset of program instructions to another which required modification of prior art “overlap mode” computers. The Board rejected the claims on the basis that, inter alia, the disclosure was insufficient to satisfy the requirements of 35 U.S.C. 112, first paragraph and was affirmed. The Board focused on the fact that the drawings were “block diagrams, i.e., a group of rectangles representing the elements of the system, functionally labeled and interconnected by lines.” 442 F.2d at 991, 169 USPQ at 727. The specification did not particularly identify each of the elements represented by the blocks or the relationship therebetween, nor did it specify particular apparatus intended to carry out each function. The Board further questioned whether the selection and assembly of the required components could be carried out routinely by persons of ordinary skill in the art.
An adequate disclosure of a device may require details of how complex components are constructed and perform the desired function. The claim before the court in In reScarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA 1974), was directed to a system which comprised several component parts (e.g., computer, timing and control mechanism, A/D converter, etc.) only by generic name and overall ultimate function. The court concluded that there was not an enabling disclosure because the specification did not describe how “complex elements known to perform broadly recited functions in different systems would be adaptable for use in Appellant’s particular system with only a reasonable amount of experimentation” and that “an unreasonable amount of work would be required to arrive at the detailed relationships appellant says that he has solved.” 500 F.2d at 566, 182 USPQ at 302.
II. MICROORGANISMS
Patent applications involving living biological products, such as microorganisms, as critical elements in the process of making the invention, present a unique question with regard to availability. For example, in In reArgoudelis, 434 F.2d 1390, 168 USPQ 99 (CCPA 1970), the court considered the enablement of claims drawn to a fermentative method of producing two novel antibiotics using a specific microorganism and claims to the novel antibiotics so produced. As stated by the court, “a unique aspect of using microorganisms as starting materials is that a sufficient description of how to obtain the microorganism from nature cannot be given.” 434 F.2d at 1392, 168 USPQ at 102. It was determined by the court that availability of the biological product via a public depository provided an acceptable means of meeting the written description and the enablement requirements of 35 U.S.C. 112, first paragraph.
To satisfy the enablement requirement a deposit must be made “prior to issue” but need not be made prior to filing the application. In reLundak, 773 F.2d 1216, 1223, 227 USPQ 90, 95 (Fed. Cir. 1985).
The availability requirement of enablement must also be considered in light of the scope or breadth of the claim limitations. The Board considered this issue in an application which claimed a fermentative method using microorganisms belonging to a species. Applicants had identified three novel individual strains of microorganisms that were related in such a way as to establish a new species of microorganism, a species being a broader classification than a strain. The three specific strains had been appropriately deposited. The issue before the Board focused on whether the specification enabled one skilled in the art to make any member of the species other than the three strains which had been deposited. The Board concluded that the verbal description of the species was inadequate to allow a skilled artisan to make any and all members of the claimed species. Ex parteJackson, 217 USPQ 804, 806 (Bd. Pat. App. & Int. 1982).
See MPEP § 2402 – § 2411.03 for a detailed discussion of the deposit rules. See MPEP § 2411.01 for rejections under 35 U.S.C. 112 based on deposit issues.
III. DRUG CASES
See MPEP § 2107 – § 2107.03 for a discussion of the utility requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, in drug cases.