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2164.06(b) Examples of Enablement Issues - Chemical Cases - 2100 Patentability
2164.06(b) Examples of Enablement Issues - Chemical Cases
The following summaries should not be relied on to support a case of lack of enablement without carefully reading the case.
SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS NONENABLING
(A) In Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 52 USPQ2d 1129 (Fed. Cir. 1999), the court held that claims in two patents directed to genetic antisense technology (which aims to control gene expression in a particular organism), were invalid because the breadth of enablement was not commensurate in scope with the claims. Both specifications disclosed applying antisense technology in regulating three genes in E. coli. Despite the limited disclosures, the specifications asserted that the "[t]he practices of this invention are generally applicable with respect to any organism containing genetic material which is capable of being expressed . such as bacteria, yeast, and other cellular organisms." The claims of the patents encompassed application of antisense methodology in a broad range of organisms. Ultimately, the court relied on the fact that (1) the amount of direction presented and the number of working examples provided in the specification were very narrow compared to the wide breadth of the claims at issue, (2) antisense gene technology was highly unpredictable, and (3) the amount of experimentation required to adapt the practice of creating antisense DNA from E. coli to other types of cells was quite high, especially in light of the record, which included notable examples of the inventor's own failures to control the expression of other genes in E. coli and other types of cells. Thus, the teachings set forth in the specification provided no more than a "plan" or "invitation" for those of skill in the art to experiment using the technology in other types of cells.
(B) In In re Wright, 999 F.2d 1557, 27 USPQ2d 1510 (Fed. Cir. 1993), the 1983 application disclosed a vaccine against the RNA tumor virus known as Prague Avian Sarcoma Virus, a member of the Rous Associated Virus family. Using functional language, Wright claimed a vaccine "comprising an immunologically effective amount" of a viral expression product. Id., at 1559, 27 USPQ2d at 1511. Rejected claims covered all RNA viruses as well as avian RNA viruses. The examiner provided a teaching that in 1988, a vaccine for another retrovirus (i.e., AIDS) remained an intractable problem. This evidence, along with evidence that the RNA viruses were a diverse and complicated genus, convinced the Federal Circuit that the invention was not enabled for either all retroviruses or even for avian retroviruses.
(C) In In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993), a 1985 application functionally claimed a method of producing protein in plant cells by expressing a foreign gene. The court stated: "[n]aturally, the specification must teach those of skill in the art 'how to make and use the invention as broadly as it is claimed.' " Id. at 1050, 29 USPQ2d at 2013. Although protein expression in dicotyledonous plant cells was enabled, the claims covered any plant cell. The examiner provided evidence that even as late as 1987, use of the claimed method in monocot plant cells was not enabled. Id. at 1051, 29 USPQ2d at 2014.
(D) In In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the court found that several claims were not supported by an enabling disclosure "[t]aking into account the relatively incomplete understanding of the biology of cyanobacteria as of appellants' filing date, as well as the limited disclosure by appellants of the particular cyanobacterial genera operative in the claimed invention...." The claims at issue were not limited to any particular genus or species of cyanobacteria and the specification mentioned nine genera and the working examples employed one species of cyanobacteria.
(E) In In re Colianni, 561 F.2d 220, 222-23, 195 USPQ 150, 152 (CCPA 1977), the court affirmed a rejection under 35 U.S.C. 112, first paragraph, because the specification, which was directed to a method of mending a fractured bone by applying "sufficient" ultrasonic energy to the bone, did not define a "sufficient" dosage or teach one of ordinary skill how to select the appropriate intensity, frequency, or duration of the ultrasonic energy.
SEVERAL DECISIONS RULING THAT THE DISCLOSURE WAS ENABLING
(A) In PPG Ind. v. Guardian Ind., 75 F.3d 1558, 1564, 37 USPQ2d 1618, 1623 (Fed. Cir. 1996), the court ruled that even though there was a software error in calculating the ultraviolet transmittance data for examples in the specification making it appear that the production of a cerium oxide-free glass that satisfied the transmittance limitation would be difficult, the specification indicated that such glass could be made. The specification was found to indicate how to minimize the cerium content while maintaining low ultraviolet transmittance.
(B) In In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988), the court reversed the rejection for lack of enablement under 35 U.S.C. 112, first paragraph, concluding that undue experimentation would not be required to practice the invention. The nature of monoclonal antibody technology is such that experiments first involve the entire attempt to make monoclonal hybridomas to determine which ones secrete antibody with the desired characteristics. The court found that the specification provided considerable direction and guidance on how to practice the claimed invention and presented working examples, that all of the methods needed to practice the invention were well known, and that there was a high level of skill in the art at the time the application was filed. Furthermore, the applicant carried out the entire procedure for making a monoclonal antibody against HBsAg three times and each time was successful in producing at least one antibody which fell within the scope of the claims.
(C) In In re Bundy, 642 F.2d 430, 434, 209 USPQ 48, 51-52 (CCPA 1981), the court ruled that appellant's disclosure was sufficient to enable one skilled in the art to use the claimed analogs of naturally occurring prostaglandins even though the specification lacked any examples of specific dosages, because the specification taught that the novel prostaglandins had certain pharmacological properties and possessed activity similar to known E-type prostaglandins.
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