This article provides: 1) a framework for traversing an enablement rejection (35 USC 112, first paragraph) received during the patent prosecution phase of a patent application (with a particular emphasis upon the Examiner establishing a prima facie case); and 2) an analysis of 20 recent BPAI decisions that included an enablement rejection.
Legal | Enablement vs. Written Description | Separate Requirements
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The enablement requirement, in addition to the written description and best mode requirements, is codified in 35 USC 112, first paragraph which states:
“The 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.”
Although there were some in the patent community who questioned whether a separate written description requirement was present in the first paragraph of 35 USC 112, the Federal Circuit sitting en banc in Ariad Pharmaceuticals Inc. v. Elily Lilly and Co. confirmed that written description and enablement are indeed separate requirements.
The enablement requirement concerns the specification enabling a person of ordinary skill in the art to “make and use” the claimed invention, while the written description requirement concerns an inventor having “possession” of the claimed invention. It should be noted that both of these requirements are determined as of the effective filing date of the patent application. Furthermore, the purpose for the enablement requirement (as indicated in MPEP 2164) is “to ensure that the invention is communicated to the interested public in a meaningful way.”
Initial Burden Upon the Examiner
The Examiner bears the initial burden in furthering an enablement rejection:
“[T]he PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by . . . [a] claim is not adequately enabled by the description of the invention provided in the specification . . . this includes . . . providing sufficient reasons for doubting any assertions in the specification as to the scope of enablement. If the PTO meets this burden, the burden then shifts to the applicant to provide suitable proofs indicating that the specification is indeed enabling.” In re Wright, 999 F.2d 1557, 1561-1562 (Fed. Cir. 1993) (also see MPEP 2164.04 – “Burden on the Examiner Under the Enablement Requirement”)
In interpreting the foregoing requirements, the BPAI recently stated:
“In other words, ‘Section 112 does not require that a specification convince persons skilled in the art that the assertions therein are correct.’ In re Armbruster, 512 F.2d 676, 678 (CCPA 1975). Instead, ‘it is incumbent upon the Patent Office . . . to explain why it doubts the truth or accuracy of any statement in a supporting disclosure and to back up assertions of its own with acceptable evidence or reasoning which is inconsistent with the contested statement.’ In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971) … Thus, the threshold issue raised by this rejection is not whether Appellants have established that their Specification is enabling … rather, the issue is whether the Examiner has met his initial burden of providing a reasonable explanation as to why it isn’t.” (Ex parte Liu et al., Appeal No. 2009-15302 (BPAI))
It should be noted that the Federal Circuit in In re. Oetiker stated that “if the examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent. See In re Grabiak, 769 F.2d 729, 733, 226 USPQ 870, 873 (Fed.Cir.1985).” (In re. Oetiker, 977 F.2d 1443 (Fed. Circ. 1992))
Standard | Undue or Unreasonable Experimentation
The primary standard for determining whether a specification enables the claimed invention involves ascertaining whether “undue or unreasonable” experimentation is required to make and use the claimed invention:
“The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) … even though the statute does not use the term ‘undue experimentation,’ it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988)….” (MPEP 2164.01 – Test of Enablement)
As indicated in MPEP 2164.01 : “the fact that experimentation may be complex does not necessarily make it undue, if the art typically engages in such experimentation … the test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” Accordingly, the focus in an enablement inquiry is not upon some experimentation being required; but instead, whether the experimentation is undue.
Furthermore, regarding undue experimentation:
“‘The determination of what constitutes undue experimentation in a given case requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art . . . . 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 to enable the determination of how to practice a desired embodiment of the invention claimed.’ Ex parte Forman, 230 USPQ 546, 547 (BPAI 1986).” (Ex parte Liu et al. Appeal No. 2009-15302 (BPAI))
Accordingly, “the key word is ‘undue,’ not ‘experimentation.’” In re Angstadt, 537 F.2d 498, 504 (CCPA 1976).
Undue Experimentation Factors (Wands Factors)
To adhere to the standard annunciated by the Supreme Court in Mineral Separation re. enablement, the Federal Circuit in In re. Wands adopted a number of factors which are considered in an “undue experimentation” analysis:
“(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)” (MPEP 2164.01(a) – Undue Experimentation Factors)
The Wands court stated:
“Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations … it is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others. The examiner’s analysis must consider all the evidence related to each of these factors, and any conclusion of nonenablement must be based on the evidence as a whole. 858 F.2d at 737, 740, 8 USPQ2d at 1404, 1407.”
The Federal Circuit has described the Wands factors as “a useful methodology for determining enablement . . . .” Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372 (Fed. Cir. 1999).
Artisan’s Knowledge | Gap Filler
The BPAI recently overturned an Examiner’s enablement rejection stating “we are not convinced by the Examiner’s fact finding with respect to the Wands factors and the enablement rejection.” The BPAI cited the following Federal Circuit precedent:
“’[A]s part of the quid pro quo of the patent bargain, the applicant’s specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention … That is not to say that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan’s knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art.’ AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 (Fed. Cir. 2003). ‘The specification need not explicitly teach those in the art to make and use the invention; the [enablement] requirement is satisfied if, given what they already know, the specification teaches those in the art enough that they can make and use the invention without “undue experimentation.”‘ Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir. 2003).” (Ex parte Stuhler et al., Appeal No. 2009-8002 (BPAI))
The Appellants in Ex parte Stuhler et al. submitted multiple declarations which the BPAI relied upon at least in part to reverse the enablement rejection (e.g., “we conclude that upon reading the disclosure and selecting substrates of the CDK2 and ras/raf pathways known in the art … such selection and correlation would not require undue experimentation, especially in view of Dr. Stuhler’s assertion that substrates of the CDK2 and ras/raf pathways were known in the art at the time of filing of the application. (2nd Decl.; FF6.)”
It should be noted that if an Applicant intends to rely upon the knowledge of a person of ordinary skill in the art in an enablement context, the following as articulated by the Federal Circuit in Genentech should be considered:
“It is true, as Genentech argues, that a specification need not disclose what is well known in the art. See, e.g., Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1385, 231 USPQ 81, 94 (Fed. Cir. 1986). However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement. However, when there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required; there is a failure to meet the enablement requirement that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art. It is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement. This specification provides only a starting point, a direction for further research.” (Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997))
The Federal Circuit more recently in Automotive Technologies International cited Genenetech, Inc. and stated “although the knowledge of one skilled in the art is indeed relevant, the “novel aspect” of an invention must be enabled in the patent.” (Automotive Technologies International v. BMW et al., 501 F.3d 1274 (Fed. Cir. 2007))
Recent BPAI Decisions | Enablement Rejections Frequently Reversed
Upon a brief review of 20 recent BPAI decisions (decided between 11.22.10-9.28.10 and excluding reexams/requests for rehearings) that included an enablement rejection, it was discovered that the enablment rejection was reversed in 14 of the decisions (indicating an enablement rejection affirmance rate of 30%). It should be noted that in many of the decisions in which the enablement rejection was reversed, the BPAI usually indicated that the Wands factors were not analyzed properly by the Examiner. To provide the reader with greater detail re. insufficient Wands determinations, key items from a number of recent BPAI decisions that included a reversed enablement rejection have been provided below:
Ex parte Whitson et. al, Appeal No. 2009-9599 (BPAI) : The BPAI found that the Examiner made “sufficient findings” for five of the Wands factors and provided no findings for three of the factors, including: the presence or absence of working examples, the state of the prior art, and the relative skill of those in the art. The BPAI stated that the Examiner’s statement re. “a lack of art on point” did not describe the state of the prior art, and therefore did not allow for ascertaining the relative skill of those in the art. The BPAI held that “a suitable finding here would have been to address the closest prior art” and accordingly did not sustain the enablement rejection.
Ex parte Stromblad et al, Appeal No. 2010-0217 (BPAI) : “A conclusion that undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations. Here, the Examiner has focused on one factual determination … without considering other of the Wands factors, such as the level of skill in the art, the guidance provided in the Specification, and the presence of the working examples presented in the Specification.”
Ex parte Ludtke et al, Appeal No. 2009-1989 (BPAI) : ”Notably, the Examiner has not considered many of the factors set forth in Wands in concluding that undue experimentation is necessary to make and use the claimed … as recited in claim 1. We therefore conclude that an ordinarily skilled artisan armed with this disclosure … would know how to make and use the claimed … as recited in claim 1.”
Ex parte Crnkovich, Appeal No. 2009-10558 (BPAI) : “The Examiner’s rejection does not adequately address the factors set forth in In re Wands … the Examiner’s findings and conclusions here touch on one factor, namely the amount of direction or guidance provided by the Specification, but no connection is made between that and any other enumerated Wands factors, such that a well-grounded conclusion can be reached that undue experimentation would be necessary in order to make and use the claimed invention.”
Ex parte Tsukamoto et al, Appeal No. 2009-9955 (BPAI) : ”In this case, although the Examiner concludes that undue experimentation is needed, the Examiner fails to provide any analysis under the analytical framework set out in In re Wands to determine whether undue experimentation would be required to practice the claimed invention. Specifically, the Examiner fails to provide sufficient factual findings regarding factors such as the amount of direction or guidance presented by Appellants and the quantity of experimentation. Wands, 858 F.2d at 737. In this regard, the Examiner’s analysis relies heavily on the absence of examples and also relies on conclusory statements such as, ‘[the] extraordinary number of possibilities clearly [requires] undue experimentation.’ (Ans. 12). However, as correctly pointed out by Appellants at pages 10 and 11 of the Appeal Brief, the Examiner does not provide sufficient findings or analysis regarding, inter alia, the amount of direction or guidance present in Appellants’ disclosure. In failing to do so, the Examiner’s analysis also does not provide sufficient findings or analysis regarding whether an extended period of experimentation is undue given the amount of direction or guidance present in Appellants’ disclosure. See Colianni, 561 F.2d at 224.”