715.03 Genus-Species, Practice Relative to Cases Where Predictability Is in Question [R-07.2022]

[Editor Note: This MPEP section is not applicable to applications subject to the first inventor to file provisions of the AIA unless being relied upon to overcome a rejection under pre-AIA 35 U.S.C. 102(g). See 35 U.S.C. 100 (note) and MPEP § 2159. For a discussion of 37 CFR 1.130, affidavits or declarations of attribution or prior public disclosure in applications subject to the first inventor to file provisions of the AIA, see MPEP § 717. For a discussion of affidavits or declarations under 37 CFR 1.131(c), see MPEP § 718.]

Where generic claims have been rejected on a reference or activity which discloses a species not antedated by the affidavit or declaration, the rejection will not ordinarily be withdrawn, subject to the rules set forth below, unless the applicant is able to establish the inventor’s possession of the generic invention prior to the effective date of the reference or activity. In other words, the affidavit or declaration under 37 CFR 1.131(a) must show as much as the minimum disclosure required by a patent specification to furnish support for a generic claim.

I. REFERENCE OR ACTIVITY DISCLOSES SPECIES

A. Species Claim

Where the claim under rejection recites a species and the reference or activity discloses the claimed species, the rejection can be overcome under 37 CFR 1.131(a) directly by showing prior completion of the claimed species or indirectly by a showing of prior completion of a different species coupled with a showing that the claimed species would have been an obvious modification of the species completed by the inventor. See In re Spiller, 500 F.2d 1170, 182 USPQ 614 (CCPA 1974).

B. Genus Claim

The principle is well established that the disclosure of a species in a cited reference is sufficient to prevent a later applicant from obtaining a “generic claim.” In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989); In re Slayter, 276 F.2d 408, 125 USPQ 345 (CCPA 1960).

Where the only pertinent disclosure in the reference or activity is a single species of the claimed genus, the applicant can overcome the rejection directly under 37 CFR 1.131(a) by showing prior possession of the species disclosed in the reference or activity. On the other hand, a reference or activity which discloses several species of a claimed genus can be overcome directly under 37 CFR 1.131(a) only by a showing that the inventor completed, prior to the date of the reference or activity, all of the species shown in the reference. In re Stempel, 241 F.2d 755, 113 USPQ 77 (CCPA 1957).

Proof of prior completion of a species different from the species of the reference or activity will be sufficient to overcome a reference indirectly under 37 CFR 1.131(a) if the species shown in the reference or activity would have been obvious in view of the species shown to have been made by the inventor. In re Clarke, 356 F.2d 987, 148 USPQ 665 (CCPA 1966); In re Plumb, 470 F.2d 1403, 176 USPQ 323 (CCPA 1973); In re Hostettler, 356 F.2d 562, 148 USPQ 514 (CCPA 1966). Alternatively, if the applicant cannot show the inventor’s possession of the species of the reference or activity in this manner, the applicant may be able to antedate the reference or activity indirectly by, for example, showing prior completion of one or more species, placing the inventor in possession of the claimed genus prior to the reference’s or activity’s date. The test is whether the species completed by the inventor prior to the reference date or the activity’s date provided an adequate basis for inferring that the invention has generic applicability. In re Plumb, 470 F.2d 1403, 176 USPQ 323 (CCPA 1973); In re Rainer, 390 F.2d 771, 156 USPQ 334 (CCPA 1968); In re Clarke, 356 F.2d 987, 148 USPQ 665 (CCPA 1966); In re Shokal, 242 F.2d 771, 113 USPQ 283 (CCPA 1957).

It is not necessary for the affidavit evidence to show that the inventor viewed the invention as encompassing more than the species actually made. The test is whether the facts set out in the affidavit are such as would persuade one skilled in the art that the inventor possessed so much of the invention as is shown in the reference or activity. In re Schaub, 537 F.2d 509, 190 USPQ 324 (CCPA 1976).

C. Species Versus Embodiments

References or activities which disclose one or more embodiments of a single claimed invention, as opposed to species of a claimed genus, can be overcome by filing a 37 CFR 1.131(a) affidavit showing prior completion of a single embodiment of the invention, whether it is the same or a different embodiment from that disclosed in the reference or activity. See In re Fong, 288 F.2d 932, 129 USPQ 264 (CCPA 1961) (Where applicant discloses and claims a washing solution comprising a detergent and polyvinylpyrrolidone (PVP), with no criticality alleged as to the particular detergent used, the PVP being used as a soil-suspending agent to prevent the redeposition of the soil removed, the invention was viewed as the use of PVP as a soil-suspending agent in washing with a detergent. The disclosure in the reference of the use of PVP with two detergents, both of which differed from that shown in applicant’s 37 CFR 1.131(a) affidavit, was considered a disclosure of different embodiments of a single invention, rather than species of a claimed genus); In re Defano, 392 F.2d 280, 157 USPQ 192 (CCPA 1968).

II. REFERENCE OR ACTIVITY DISCLOSES CLAIMED GENUS

In general, where the reference or activity discloses the claimed genus, a showing of completion of a single species within the genus is sufficient to antedate the reference or activity under 37 CFR 1.131(a). Ex parte Biesecker, 144 USPQ 129 (Bd. App. 1964).

In cases where predictability is in question, on the other hand, a showing of prior completion of one or a few species within the disclosed genus is generally not sufficient to overcome the reference or activity. In re Shokal, 242 F.2d 771, 113 USPQ 283 (CCPA 1957). The test is whether the species completed by the inventor prior to the reference date or the date of the activity provided an adequate basis for inferring that the invention has generic applicability. In re Mantell, 454 F.2d 1398, 172 USPQ 530 (CCPA 1973); In re Rainer, 390 F.2d 771, 156 USPQ 334 (CCPA 1968); In re DeFano, 392 F.2d 280, 157 USPQ 192 (CCPA 1968); In re Clarke, 356 F.2d 987, 148 USPQ 665 (CCPA 1965). In the case of a small genus such as the halogens, which consists of four species, a reduction to practice of three, or perhaps even two, species might show possession of the generic invention, while in the case of a genus comprising hundreds of species, reduction to practice of a considerably larger number of species would be necessary. In re Shokal, supra.

It is not necessary for the affidavit evidence to show that the inventor viewed the invention as encompassing more than the species the inventor actually made. The test is whether the facts set out in the affidavit are such as would persuade one skilled in the art that the inventor possessed so much of the invention as is shown in the reference. In re Schaub, 537 F. 509, 190 USPQ 324 (CCPA 1976).