Kowalski, T.J. Nat. Biotechnol. 18, 349–350 (2000).
63 FR 32,639 (June 15, 1998); 1212 OG 15 (July 7, 1998).
43 USPQ 1398 (Fed. Cir. 1997). See January 26, 1998 letter of Carl Feldbaum, president, BIO, to the Honorable Bruce Lehman, commissioner, USPTO.
See 64 FR 71,428 (December 21, 1999).
See 64 FR 71,427-71,428 (December 21, 1999): The majority of comments favored written description guidelines, with revisions. Major issues in testimony and comments involved the scope of the guidelines, methods of analyses, and the content of the examples. There was an Extension of Comment Period and Notice of Hearing, 63 FR 50,887 (September 23, 1998), by the PTO that asked for comments regarding ESTs, and “[m]any comments also expressed the opinion that ESTs lacked the utility, enablement and written description necessary to satisfy title 35 of the US Code.” 64 FR 71,428.
169 USPQ 236 (CCPA 1971). The Moore analysis begins with 35 USC $112, second paragraph, that requires that the claims particularly point out and distinctly claim the subject matter the applicant regards as his invention. The question is whether the claims set out and circumscribe a particular area with a degree of precision and particularity. The analysis begins with Section 112, second paragraph, as “invention” and similar terms in Section 112, first paragraph, must be read in view of what is clear and definite under Section 112, second paragraph. Thus, what is claimed clearly and definitely is first determined. Then the analysis continues for compliance with the written description and enablement requirements of Section 112, first paragraph.
But see new Written Description Guidelines, footnote 12.
Indeed, the new Written Description training materials and the new Interim Utility training materials for Examiners are available at the USPTO web site at http://www.uspto.gov/web/offices/pac/utility/utilityguide.pdf and http://www.uspto.gov/web/offices/pac/writtendesc.pdf. See Press Release #00-15, March 1, 2000, “PTO offers training materials for Interim Written Description and Utility Guidelines” (http://www.uspto.gov/web/offices/com/speeches/00-15.htm). “The Written Description training materials contain examples that are applicable to all areas of technology and all types of inventions.” Id. In contrast, “[a]ll of the examples in the utility training materials are in the biotechnology or chemical arts.” Id. The press release renews the invitation “for public comment on the revised Utility guidelines and the revised Interim Written Description guidelines” but invites no comments on the new training materials. Thus, in contrast to the new guidelines, the new training materials are not open to public comment. The separation of the examples into training materials that are not open to comment may add costs and time to patent prosecution, as appeals in individual cases may be the vehicle to change or correct the training materials or their possible misapplication in particular cases. It is respectfully submitted that the public may have been better served by being provided an opportunity to comment on the new training materials so that the PTO may amend or revise them in view of such comments.
Citing Pfaff v. Wells Electronics, Inc., 525 US 55, 58 USPQ2d 1641, 1647 (1998), and noting that an application may show reduction to practice in the case of biological materials by specifically describing a deposit. See also Baggot, B. Nat. Biotechnol. 17, 297–298 (1999).
Footnote 39 of the new Written Description Guidelines states: “For example, the presence of a restriction enzyme map of a gene may be relevant to a statement that the gene has been isolated. One skilled in the art may be able to determine when the gene disclosed is the same as or different from a gene isolated by another by comparing the restriction enzyme map. In contrast, evidence that the gene could be digested with a nuclease would not normally represent a relevant characteristic since any gene would be digested with a nuclease. Similarly, isolation of an mRNA and its expression to produce the protein of interest is strong evidence of possession of an mRNA for the protein. Examples of identifying characteristics include a sequence, structure, binding affinity, binding specificity, molecular weight, and length. Although structural formulas provide a convenient method of demonstrating possession of specific molecules, other identifying characteristics or combinations of characteristics may demonstrate the requisite possession. For example, unique cleavage by particular enzymes, isoelectric points of fragments, detailed restriction enzyme maps, a comparison of enzymatic activities, or antibody cross-reactivity may be sufficient to show possession of the claimed invention to one of skill in the art. See Lockwood [v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)] (‘written description’ requirement may be satisfied by using ‘such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention’). However, a definition by function alone ‘does not suffice’ to sufficiently describe a coding sequence ‘because it is only an indication of what the gene does, rather than what it is.’ Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)).”