Connecting the Dots or Swiss Cheese: Does Your Patent Application Have Holes? Written Description and Enablement Requirements Unchanged by Patent Reform

“Leahy-Smith America Invents Act” (Public Law 112 - 29), 125 Stat 284 - 125 Stat. 341signed into law by President Barack Obama onSeptember 16, 2011.

Brenner v. Manson, 383 US 519, 535 [86 S.Ct. 1033, 16 L.Ed. 2d 69]. 1966(“[A] patent is not a hunting license, it is not a reward for the search but compensation for its successful conclusion.”)

35 U.S.C. §112, first paragraph provides. “[t]he specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”

See, e.g., Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 922 (Fed. Cir. 2004)(“The written description serves a quid pro quo function ‘in which the public is given ‘meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time.’”); Reiffen v. Microsoft Corp., 214 F.3d 1343, 1345-1346 (“The purpose of the [written description requirement] is to ensure that the scope of the right to exclude…does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.”).

The written description requirement requires “the [patent] applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’, demonstrate that by disclosure in the specification of the patent.”Carnegie Mellon Univ. v. Hoffmann-LaRoche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008).

Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1566 (Fed. Cir. 1997)cert. denied, 523 U.S. 1089 (1998).

Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed Cir 1997)(“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.. Tossing out the mere germ of an idea does not constitute enabling disclosure”).

In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988)(reversing the PTO's determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement).

As summarized in section 2164.08(b) of the USPTO Manual of Patent Examining Procedure“[t]he presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art.” (citing Atlas Powder Co. v. E.I. du Pont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984) (prophetic examples do not make the disclosure nonenabling).

As summarized in section 2164.05(a) of the USPTO Manual of Patent Examining Procedure“[t]he specification need not disclose what is well-known to those skilled in the art, preferably omits that which is well-known to those skilled, already available to the public.” (citing In re Buchner, 929 F.2d 660, 661 [18 USPQ2d 1331] (Fed. Cir. 1991), Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1384 [231 USPQ 81] (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] (Fed. Cir. 1984)).

In re ‘318 Patent Litigation583 F.3d 1317 (Fed. Cir. 2009).

Id.at 1326.

Id.at 1327.

Id.at 1322.

U.S. Patent 4,663,318 was held invalid in a bench trial for lack of enablementIn re ‘318 Patent Infringement Litig., 578 F. Supp.2d 711, 737 (D.Del. 2008) aff'd 583 F.3d 1317 (Fed. Cir. 2009).

In re ‘318 Patent Litigation583 F.3d 1317, 1327 (Fed. Cir. 2009).

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031 (Fed. Cir. 2011).

Id.at 1033.

Id.at 1034.

U.S. Patent 5,674,681 (filed December 6, 1994) issued October 7, 1997Billups later obtained another US Patent 6,355,425 (issued March 12, 2002) held invalid in this case, based on the 6,025,130 patent as prior art.

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031, 1034 (Fed. Cir. 2011).

U.S. Patent 6,025,130 issued February 15, 2000to Winston J. Thomas et al.

Billups-Rothenberg, Inc. v. Associated Reg'l & Univ. Pathologists, Inc.08-CV-21349 (C.D. Cal. May 26, 2010), aff'd Billups-Rothenberg, Inc. v. ARUP. 642 F.3d 1031, 1034 (Fed. Cir. 2011).

Summary judgment is appropriate if the movant can show both the absence of genuine issues of material fact and entitlement to judgment as a matter of lawFed. R. Civ. P. 56(c).

Billups-Rothenberg, Inc. v. ARUP.642 F.3d 1031, 1038 (Fed. Cir. 2011).

Id.at 1037.

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1345 (Fed. Cir. 2011)

Centocor filed U.S. Patent application 07/670,827 on March 18, 1991 (later abandoned)This application became the earliest claimed priority date in a series of 12 subsequently filed patent applications (including 9 continuation-in-part patent applications) culminating in the filing of the patent application granted as the US Patent asserted against the Humira^® product (U.S. Patent 7,070,775). In asserting the 7,070,775 patent, Centocor relied patent applications patent filings filed in 1994 in this chain of priority (these priority patent filings had issued as US Patents 5,656,272, 5,919,452, and 6,284,471).

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1346 (Fed. Cir. 2011)

Id.at 1346–1347.

U.S. Patent 6,090,382 entitled “Human antibodies that bind human TNFα,”issued July 18, 2000 (filed February 9, 1996).

Centocor Ortho Biotech Inc. v. Abbott Lab.636 F.3d 1341, 1346-1347 (Fed. Cir. 2011).

Id.at 1343–1344.

Id.at 1348–1349.

Id.at 1349.

See, e.g., Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008)(“To satisfy the written description requirement, ‘the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.”)

Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006)(“(1) examples are not necessary to support the adequacy of a written description; (2) the written description standard may be met even where actual reduction to practice of an invention is absent; and (3) there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure”); see also “Guidelines for the Examination of Patent Applications Under the 35 U.S.C. - 2100 Patentability,” USPTO Manual of Patent Examining Procedure, Section 2163.

Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc)(“the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus”); Carnegie Mellon Univ. v. Hoffmann La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) (“Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.”)

See, e.g., Carnegie Mellon University v. Hoffmann La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008)(holding invalid patent claims covering a genus of recombinant plasmids that contain coding sequences for certain activity obtained from any bacterial source, based on a narrow specification disclosing only one species within the claimed genus); Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed. Cir. 2004); Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) (holding generic claims directed to recombinant prokaryotic microorganisms comprising any vertebrate and mammalian cDNA were not adequately supported by the specification that only disclosed rat insulin cDNA); see also, “Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,” 76 Fed. Reg. 7162 (February 9, 2011).

“Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,”76 Fed. Reg. 7162 (February 9, 2011); “Guidelines for Examination of Patent Applications under 35 USC 112, P1, “Written Description” Requirement, 66 Fed. Reg. 10-99 (Jan. 5, 2001).

See, e.g., “Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues,”76 Fed. Reg. 7162 (February 9, 2011) and “Guidelines for Examination of Patent Applications under 35 USC 112, P1, “Written Description” Requirement, 66 Fed. Reg. 10-99 (Jan. 5, 2001).

Capon v Eschar418 F.3d 1349, 1358 (Fed. Cir. 2005)

In re Ruschig 54 C.C.P.A. 1551, 379 F.2d 990, 994-995 [1967](“Specific claims to single compounds require reasonably specific supporting disclosure and while…naming [each species] is not essential, something more than the disclosure of a class of 1000, or 100, or even 48 compounds is required.”)

Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed Cir 1996)(“Clearly, however, just because a moiety is listed as one possible choice for one position does not mean ther is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a ‘laundry list’ disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not ‘reasonably lead’ those skilled in the art to any particular species.”).

As summarized by the USPTO Manual of Patent Examining ProcedureSection 2164.06: “[t]he quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether “undue experimentation” is required to make, use the invention. ‘[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance.’ In re Colianni, 561 F.2d 220, 224, 195 USPQ 150, 153 (CCPA 1977). ‘The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed.’” In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (citing In re Angstadt, 537 F.2d 489, 502-04, 190 USPQ 214, 217-19 (CCPA 1976)).”

See, e.g., USPTO Manual of Patent Examining ProcedureSection 2164.06.

In re Wands858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).

As noted in the USPTO Manual of Patent Examining ProcedureSection 2163: “[a]n application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 965, 63 USPQ2d 1609, 1614 (Fed. Cir. 2002) (“reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material”); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989).”