2404.01 Biological Material That Is Known and Readily Available to the Public [R-07.2015]

In an application where the invention required access to specific biological material, an applicant could show that the biological material is accessible because it is known and readily available to the public. The concepts of “known and readily available” are considered to reflect a level of public accessibility to a necessary component of an invention disclosure that is consistent with an ability to make and use the invention. To avoid the need for a deposit on this basis, the biological material must be both known and readily available - neither concept alone is sufficient. A material may be known in the sense that its existence has been published, but is not available to those who wish to obtain that particular known biological material. Likewise, a biological material may be available in the sense that those having possession of it would make it available upon request, but no one has been informed of its existence.

The Board has held that a description of the precise geographic location of marine tunicates, as a biological material, used in a claimed invention was adequate to satisfy the enablement requirement of 35 U.S.C. 112. See Ex Parte Rinehart, 10 USPQ2d 1719 (Bd. Pat. App. & Int. 1985). The term “readily” used in the phrase “known and readily available” is considered appropriate to define that degree of availability which would be reasonable under the circumstances. If the biological material and its natural location can be adequately described so that one skilled in the art could obtain it using ordinary skill in the art, the disclosure would appear to be sufficient to meet the enablement requirement of 35 U.S.C. 112 without a deposit so long as its degree of availability is reasonable under the circumstances.

By showing that a biological material is known and readily available or by making a deposit in accordance with these rules, applicant does not guarantee that such biological material will be available forever. Public access during the term of the patent may affect the enforceability of the patent. Although there is a public interest in the availability of a deposited biological material during and after the period of enforceability of the patent, there should not be any undue concern about continued access to the public. See 37 CFR 1.806 (the term of deposit is “at least thirty (30) years and at least five (5) years after the most recent request” for a sample; the agreement sufficiently ensures that the deposit will be “available beyond the enforceable life of the patent”). Unless there is a reasonable basis to believe that the biological material will cease to be available during the enforceable life of the patent, current availability would satisfy the requirement. The incentives provided by the patent system should not be constrained by the mere possibility that a disclosure that was once enabling would become non-enabling over a period of time through no fault of the patentee. In re Metcalfe, 410 F.2d 1378, 161 USPQ 789 (CCPA 1969).

If an applicant has adequately established that a biological material is known and readily available, the Office will accept that showing. In those instances, however, the applicant takes the risk that the material may cease to be known and readily available. Such a defect cannot be cured by reissue after the grant of a patent.

On the other hand, Ex parte Humphreys, 24 USPQ2d 1255 (Bd. Pat. App. & Int. 1992), held that the only manner in which applicants could satisfy their burden of assuring public access to the needed biological material, and, thereby, compliance with the enablement requirement of 35 U.S.C. 112, was by making an appropriate deposit. The fact that applicants and other members of the public were able to obtain the material in question from a given depository prior to and after the filing date of the application in issue did not establish that upon issuance of a patent on the application that such material would continue to be accessible to the public. The applicants did not make of record any of the facts and circumstances surrounding their access to the material in issue from the depository, nor was there any evidence as to the depository’s policy regarding the material if a patent would have been granted. Further, there was no assurance that the depository would have allowed unlimited access to the material if the application had matured into a patent.

There are many factors that may be used as indicia that a biological material is known and readily available to the public. Relevant factors include commercial availability, references to the biological material in printed publications, declarations of accessibility by those working in the field, evidence of predictable isolation techniques, or an existing deposit made in accordance with these rules. Each factor alone may or may not be sufficient to demonstrate that the biological material is known and readily available. Those applicants that rely on evidence of accessibility other than a deposit take the risk that the patent may no longer be enforceable if the biological material necessary to satisfy the requirements of 35 U.S.C. 112 ceases to be accessible.

The Office will accept commercial availability as evidence that a biological material is known and readily available only when the evidence is clear and convincing that the public has access to the material. See the final rule entitled “Deposit of Biological Materials for Patent Purposes,” 54 FR 34864, 34875 (August 22, 1989). A product could be commercially available but only at a price that effectively eliminates accessibility to those desiring to obtain a sample. The relationship between the applicant relying on a biological material and the commercial supplier is one factor that would be considered in determining whether the biological material was known and readily available. However, the mere fact that the biological material is commercially available only through the patent holder or the patent holder’s agents or assigns shall not, by itself, justify a finding that the necessary material is not readily available, absent reason to believe that access to the biological material would later be improperly restricted.

The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception (37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).

A deposit of biological material cited in a U.S. patent need not be made available if it was not required to satisfy 35 U.S.C. 112. For this reason, 37 CFR 1.808(c) provides that upon request made to the Office, the Office will certify whether a deposit has been stated to have been made under conditions which make it available to the public as of the issue date. See 37 CFR 1.808(c) and MPEP § 2410.02 for the requirements of the request. The Office will not certify that the aforementioned statement has been made unless:

• (A) the deposit was necessary to overcome a rejection under 35 U.S.C. 112,
• (B) there is, in the record, a statement by the examiner that a rejection would have been made “but for” the deposit (assumes deposit information in record, as filed),
• (C) the record otherwise clearly indicates that the deposit was made under Budapest Treaty, and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent (with the possible exception of requiring the request for the deposit to be in the format specified in 37 CFR 1.808(b)), or
• (D) the record otherwise clearly indicates that an acceptable non-Budapest Treaty deposit was made and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent (with the possible exception of requiring the request for the deposit to be in the format specified in 37 CFR 1.808(b)).

If a deposit is not made under the conditions set forth in 37 CFR 1.808(a), the deposit cannot be relied upon for other purposes, e.g., the deposit cannot be relied upon by a third party to establish “known” and “readily available” in another application. See 37 CFR 1.808 and MPEP § 2410 and § 2410.02.

Once a deposit is made in a depository complying with these rules, and under conditions complying with these rules, a biological material will be considered to be readily available even though some requirement of law or regulation in the United States or in the country where the depository institution is located permits access to the material only under conditions imposed for health, safety or similar reasons. This provision is consistent with the Budapest Treaty (Article 5) and is designed to permit the patenting of inventions involving materials having restricted distribution, where the restrictions are imposed for the public, as opposed to the private, welfare.

2404.02 Biological Material That Can Be Made or Isolated Without Undue Experimentation [R-08.2012]

Applicant may show that a deposit is not necessary even though specific biological materials are required to practice the invention if those biological materials can be made or isolated without undue experimentation. Deposits may be required to support the claims if an isolation procedure requires undue experimentation to obtain the desired biological material. Ex Parte Jackson, 217 USPQ 804 (Bd. App. 1982). No deposit is required, however, where the required biological materials can be obtained from publicly available material with only routine experimentation and a reliable screening test. Tabuchi v. Nubel, 559 F.2d 1183, 194 USPQ 521 (CCPA 1977); Ex Parte Hata, 6 USPQ2d 1652 (Bd. Pat. App. & Int. 1987).

2404.03 Reference to a Deposit in the Specification [R-08.2012]

37 CFR 1.802(c) specifically provides that the mere reference to a biological material in the specification disclosure or the actual deposit of such material does not create any presumption that such referenced or deposited material is necessary to satisfy 35 U.S.C. 112, or that a deposit in accordance with these regulations is or was required. It should be noted, however, that a reference to a biological material, present in an application upon filing, may form the basis for making a deposit, where required, after the filing date of a given application but that the reference to the biological material, itself, cannot be added after filing without risking the prohibited introduction of new matter (35 U.S.C. 132). See the discussion of the Lundak application in MPEP § 2406.01.