Specification Must Be Enabling as of the Filing Date

Whether the specification would have been enabling as of the filing

date involves consideration of the nature of the invention, the state of the prior

art, and the level of skill in the art. The initial inquiry is into the nature of the

invention, i.e., the subject matter to which the claimed invention pertains. The

nature of the invention becomes the backdrop to determine the state of the art and

the level of skill possessed by one skilled in the art.

The state of the prior art is what one skilled in the art would have

known, at the time the application was filed, about the subject matter to which the

claimed invention pertains. The relative skill of those in the art refers to the

skill of those in the art in relation to the subject matter to which the claimed

invention pertains at the time the application was filed. See

MPEP § 2164.05(b)

.

See

Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs.,

Inc.,

996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).

The state of the prior art provides evidence for the degree of

predictability in the art and is related to the amount of direction or guidance

needed in the specification as filed to meet the enablement requirement. The state of

the prior art is also related to the need for working examples in the specification.

The state of the art for a given technology is not static in time.

It is entirely possible that a disclosure which would not have been enabled if filed

on January 2, 1990 might be enabled if the same disclosure had been filed on January

2, 1996. Therefore, the state of the prior art must be evaluated for each application

based on its filing date

.

35 U.S.C.

112(a)

requires the specification to be enabling only to a

person “skilled in the art to which it pertains, or with which it is most nearly

connected.” In general, the pertinent art should be defined in terms of the problem

to be solved rather than in terms of the technology area, industry, trade, etc. for

which the invention is used

luated for each application

based on its filing date

.

35 U.S.C.

112(a)

requires the specification to be enabling only to a

person “skilled in the art to which it pertains, or with which it is most nearly

connected.” In general, the pertinent art should be defined in terms of the problem

to be solved rather than in terms of the technology area, industry, trade, etc. for

which the invention is used.

The specification need not disclose what is well-known to those

skilled in the art and preferably omits that which is well-known to those skilled and

already available to the public.

In re Buchner,

929 F.2d 660, 661,

18 USPQ2d 1331, 1332 (Fed. Cir. 1991);

Hybritech, Inc.

v. Monoclonal Antibodies, Inc.,

802 F.2d 1367, 1384, 231 USPQ 81,

94 (Fed. Cir. 1986),

cert. denied,

480 U.S. 947 (1987); and

Lindemann Maschinenfabrik GMBH

v. American Hoist & Derrick Co.,

730 F.2d 1452, 1463, 221 USPQ

481, 489 (Fed. Cir. 1984).

The state of the art existing at the filing date of the application

is used to determine whether a particular disclosure is enabling as of the filing

date.

Chiron Corp. v. Genentech Inc.,

363 F.3d 1247, 1254, 70

USPQ2d 1321, 1325-26 (Fed. Cir. 2004) (Stating that “a patent document cannot enable

technology that arises after the date of application.”). Information published for

the first time after the filing date generally cannot be used to show what was known

at the time of filing.

In re

Gunn,

537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976);

In re Budnick,

537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976)

(In general, if an applicant seeks to use a patent to prove the state of the art for

the purpose of the enablement requirement, the patent must have an issue date earlier

than the effective filing date of the application.)

d to show what was known

at the time of filing.

In re

Gunn,

537 F.2d 1123, 1128, 190 USPQ 402,405-06 (CCPA 1976);

In re Budnick,

537 F.2d 535, 538, 190 USPQ 422, 424 (CCPA 1976)

(In general, if an applicant seeks to use a patent to prove the state of the art for

the purpose of the enablement requirement, the patent must have an issue date earlier

than the effective filing date of the application.). While a later dated publication

cannot supplement an insufficient disclosure in a prior dated application to make it

enabling, an applicant can offer the testimony of an expert based on the publication

as evidence of the level of skill in the art at the time the application was filed.

Gould v.

Quigg,

822 F.2d 1074, 1077, 3 USPQ2d 1302, 1304 (Fed. Cir. 1987).

In general, the examiner should not use post-filing date references

to demonstrate that a patent is not enabled. Exceptions to this rule could occur if a

later-dated reference provides evidence of what one skilled in the art would have

known on or before the effective filing date of the patent application.

In

re Hogan,

559 F.2d 595, 605, 194 USPQ 527, 537 (CCPA 1977). If a

publication demonstrates that those of ordinary skill in the art would find that a

particular invention was not enabled years after the filing date, the publication

would be evidence that the claimed invention was not possible at the time of filing.

See

In re Wright,

999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14

(Fed. Cir. 1993) (The court found that an article published 5 years after the filing

date of the application adequately supported the examiner’s position that the

physiological activity of certain viruses was sufficiently unpredictable so that a

person skilled in the art would not have believed that the success with one virus and

one animal could be extrapolated successfully to all viruses with all living

organisms. Accordingly, the court held that the applicant’s earlier-filed claims not

limited to the specific virus or the specific animal were nonenabled).