This chapter provides guidance on the practices and procedures pertaining to the rules for deposits of biological materials for patent purposes (37 CFR 1.801 - 1.809 ) and the rules for the requirements for patent applications containing nucleotide sequence and/or amino acid sequence disclosures (37 CFR 1.821 - 1.825 and 37 CFR 1.831 - 1.835 ).
For the purposes of these regulations pertaining to the deposit of biological material for purposes of patents for inventions under 35 U.S.C. 101, the term biological material shall include material that is capable of self-replication either directly or indirectly. Representative examples include bacteria, fungi including yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, plasmids, viruses, plant tissue cells, lichens and seeds. Viruses, vectors, cell organelles and other non-living material existing in and reproducible from a living cell may be deposited by deposit of the host cell capable of reproducing the non-living material.
Every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112. Courts have recognized the necessity and desirability of permitting an applicant for a patent to supplement the written disclosure in an application with a deposit of biological material which is essential to meet some requirement of the statute with respect to the claimed invention. See, e.g., Ajinomoto Co. v. Archer-Daniels-Midland Co., 228 F.3d 1338, 1345-46, 56 USPQ2d 1332, 1337-38 (Fed. Cir. 2000), cert. denied, 121 S.Ct. 1957 (2001)(explaining how deposit may help satisfy enablement requirement); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 63 USPQ2d 1609 (Fed. Cir. 2002)(deposit may satisfy the written description requirement); In re Argoudelis, 434 F.2d 666, 168 USPQ 99 (CCPA 1970). To facilitate the recognition of deposited biological material in patent applications throughout the world, the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was established in 1977, and became operational in 1981. The Treaty requires signatory countries, like the United States, to recognize a deposit with any depository which has been approved by the World Intellectual Property Organization (WIPO).
The deposit rules (37 CFR 1.801 - 1.809 ) set forth examining procedures and conditions of deposit which must be satisfied in the event a deposit is required. The rules do not address the substantive issue of whether a deposit is required under any particular set of facts.
See PCT Rule 13bis and MPEP § 1823.01 for the requirements under the PCT for a reference to a deposited biological material in an international application.
37 CFR 1.801 indicates that the rules pertaining to deposits for purposes of patents for inventions under 35 U.S.C. 101 are intended to relate to biological material. For the purposes of these rules, the term "biological material" is defined in terms of a non-exhaustive list of representative materials which can be deposited in accordance with the procedures defined in these rules. These rules are intended to address procedural matters in the deposit of biological material for patent purposes. They are not designed to decide substantive issues such as whether a deposit of a particular organism or material would be recognized or necessary for the purposes of satisfying the statutory requirements for patentability under 35 U.S.C. 112. The issue of the need to make a deposit of biological material typically arises under 35 U.S.C. 112(a) with regard to the enablement requirement, although the issue may also arise under the written description or best mode requirement of the statute. Deposit issues may also arise under 35 U.S.C. 112(b) with respect to the claims.
37 CFR 1.801 does not attempt to identify what biological material either needs to be or may be deposited to comply with the requirements of 35 U.S.C. 112. For the most part, this issue must be addressed on a case-by-case basis. Thus, while the Office does not currently contemplate that there would be any situations where a material that is not capable of self-replication either directly or indirectly would be acceptable as a deposit, an applicant is clearly not precluded by these rules from attempting to show in any given application why the deposit of such a material should be acceptable to satisfy the requirements of 35 U.S.C. 112. The examiner is cautioned against requiring that a specific biological material be deposited where the applicant can show that a deposit of starting material that is currently not available to the public would allow the skilled artisan to make and use the claimed invention. For example, where a claimed invention is drawn to a plant having novel properties produced by the insertion of a proprietary gene at a specific locus, the plant per se need not be deposited if deposit of a vector or hybridoma containing the gene would enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation.
Biological material includes material that is capable of self-replication either directly or indirectly. Direct self-replication includes those situations where the biological material reproduces by itself. Representative examples of materials capable of self-replication are defined in the rule. Indirect self-replication is meant to include those situations where the biological material is only capable of replication when another self-replicating biological material is present. Self-replication after insertion in a host is one example of indirect self-replication. Examples of indirect replicating biological materials include viruses, phages, plasmids, symbionts, and replication defective cells. The list of representative examples of each type of replicating material includes viruses to demonstrate that the two lists in the rule are not intended to be mutually exclusive.
Although plant material is included within the scope of the definition of biological material for purposes of patents for plant inventions under 35 U.S.C. 101, the rules on deposits are not applicable to applications filed under the Plant Patent Act (35 U.S.C. 161 -164 ). The Office is of the view that a deposit is not required under the present provisions of 35 U.S.C. 162. Thus, a deposit is not necessary for the grant of a plant patent under the provisions of 35 U.S.C. 161 -164. See also MPEP § 1605. As with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112.
As with some types of reproducible biological material, seeds can be reproduced only after a growing season which may be relatively long. Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
37 CFR 1.802(a) permits a deposit of a biological material to be referenced in a patent application where an invention is, or relies on, a biological material. The invention may rely on a biological material for the purposes of making or using the invention, either as a preferred mode or an alternative mode of operation. A reference to a deposit may be included in a specification even though the deposit is not required to satisfy the requirements of 35 U.S.C. 112.
There is no necessary implication or presumption that can or should be made about the need for a deposit simply because reference to a deposit is made in an application disclosure, as noted in paragraph (c). As noted in paragraph (b), biological material need not be deposited unless access to such material is necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 and that access is not otherwise available in the absence of a deposit. Where a deposit is required to provide the necessary access, a deposit is acceptable for patent purposes only where it is made in accordance with these regulations. Even where access to biological material is required to satisfy these statutory requirements, a deposit may not be necessary if access sufficient to satisfy these requirements is otherwise available.
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:
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.
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).
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.
37 CFR 1.803 indicates that a depository will be recognized as acceptable for the purposes of these regulations if it is either an International Depositary Authority (IDA) established under the Budapest Treaty, or if it is a depository recognized as suitable by the Commissioner. After the effective date of these regulations, a deposit of biological material which is made in a depository which is not recognized as acceptable under this regulation will not be considered as satisfying the requirements of 35 U.S.C. 112. See Ex parte Humphreys, 24 USPQ2d 1255 (Bd. Pat. App. & Int. 1992). On the other hand, if a deposit is not required to satisfy the requirements of 35 U.S.C. 112, it is permissible to make reference to such a deposit even though it may not be in a depository or made under the conditions which are acceptable under these regulations. As new depositories are recognized as suitable by the Commissioner, their identity will be announced in the Official Gazette.
An organization may be recognized as suitable by the Office if the procedure and conditions specified in 37 CFR 1.803(a)(2) and 37 CFR 1.803(b) are followed. Generally, it is not the intention of the Office to recognize as suitable any organization where the need for a suitable depository for patent purposes is being met by depositories recognized as IDAs under the Budapest Treaty. Suitability will be judged by the Commissioner, based on need and the information supplied by the organization seeking status, and information obtained from other sources that may be consulted.
While there is a desire to provide flexibility to a patent applicant in selecting an appropriate depository, these rules are not intended to permit each patent applicant to become its own depository since both the patent owner and the public have an interest in the continued availability and accessibility of the deposit during the enforceable life of the patent, and the public has a continuing interest in its availability when the patent is no longer enforceable. The concept of a depository independent of the control of the depositor or an IDA as an acceptable depository is based on the need and desire to ensure the safe and reliable storage of a deposited biological material under circumstances that are substantially free of the opportunity for intentional mishandling or negligent handling of the deposited material. The use of an independent depository or internationally recognized depository will tend to preserve the integrity of the deposit process against those that may accidentally alter the deposited material, may wish to tamper with the deposited material or may wish to resume control of its availability when the patent is no longer enforceable, and will tend to preserve the interest of the public in the access to the biological material once the term of the patent expires.
When a depository having status under 37 CFR 1.803(a)(2) seeks to change the kinds of biological materials that it will accept and maintain for the purposes of these rules, a communication requesting such a change should be directed to the Commissioner containing the information requested in 37 CFR 1.803(b). When such a change is requested, the requesting depository should provide a complete list of the kinds of biological materials it will accept.
37 CFR 1.803(d) indicates that once a depository is recognized as suitable for the purposes of this rule, or has defaulted or discontinued its performance under this section, notice thereof will be published in the Official Gazette of the Patent and Trademark Office. The mere fact that a deposit has been made in an IDA recognized under the Budapest Treaty does not mean that the terms of the deposit meet either the requirements of the Budapest Treaty or the deposit regulations. Many of the depositories recognized under the Budapest Treaty have many different arrangements under which biological material may be stored.
The World Intellectual Property Organization (WIPO) publishes a Guide to the Deposit of Micro-organisms under the Budapest Treaty (WIPO Publication No. 661 (E)) on the procedures and requirements concerning the deposit of biological material, including procedures for obtaining a sample of deposited material, in each of the international depository authorities. The Guide and a list of current IDAs under the Budapest Treaty are available at www.wipo.int/treaties/en/registration/budapest/.
37 CFR 1.804 specifies the time for making an original deposit to fulfill the requirements of 35 U.S.C. 112. For the reasons discussed throughout this section, it is recommended that a deposit be made before the filing date of the application. However, for the purposes of complying with the requirements of 35 U.S.C. 112, a deposit of a biological material may be made at any time before filing the application for patent or during the pendency of the application subject to the conditions of 37 CFR 1.809. Where a deposit is needed to satisfy the requirements of 35 U.S.C. 112 and it is made during the pendency of the application, it must be made no later than the time period set by the examiner at the time the Notice of Allowance and Issue Fee Due is mailed. However, a necessary deposit need not be made by an applicant until the application is in condition for allowance so long as the applicant provides a written assurance that an acceptable deposit will be made on or before the payment of the issue fee. This written assurance must provide sufficiently detailed information to convince the examiner that there is no outstanding issue regarding deposits that needs to be resolved. Note that while 37 CFR 1.804 permits making a deposit after the filing date of an application, in many countries the deposit must be made before the filing date of the application. See MPEP § 2406.03.
Insofar as the rules do not permit post-issuance original deposits, the failure to make an original deposit in an application cannot be cured by filing a reissue application or instituting a reexamination proceeding. However, if an amendment of claims in a reexamination proceeding raises the need for a deposit, an original deposit may be made during the reexamination proceeding.
37 CFR 1.804(a) specifies not only a permissible time frame for making an original deposit, but also specifies that the biological material deposited must be specifically identified in the application for patent as filed. The requirement for a specific identification is consistent with the description requirement of 35 U.S.C. 112 and provides an antecedent basis for the biological material which either has been or will be deposited before the patent is granted.
The description in the Lundak application as filed (now U.S. Patent No. 4,594,325) provides a suitable illustration of the specific identification and description which are required in an application as filed. In that application, an immortal B-cell line was disclosed and claimed. The cell line was referred to in the application, as filed, as WI-L2-729 HF2. The methods of obtaining and using this cell line were also described in the application as filed. A deposit of the cell line was made with the American Type Culture Collection (ATCC) about a week after the application was filed in the United States. The United States Court of Appeals for the Federal Circuit held that the requirements of access by the Office to a sample of the cell line during pendency, and public access after grant, were met by Lundak's procedures. The Court further held that the addition of information designating the depository, accession number, and deposit date of the deposited cell line in ATCC after the filing date did not violate the prohibition against new matter in 35 U.S.C. 132. In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985). However, it must be clear from the application as filed that the invention claimed and described in the specification "was fully capable of being reduced to practice (i.e., no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remained in order to obtain an operative, useful process)." Feldman v. Aunstrup, 517 F.2d 1351, 1355, 186 USPQ 108, 113 (CCPA 1975), cert. denied, 424 U.S. 912 (1976).
When the original deposit is made after the effective filing date of an application for patent, an applicant is required to promptly submit a statement from a person in a position to corroborate that the biological material which is deposited is a biological material specifically identified in the application (the filing date of which is relied upon) as filed. The nature of this corroboration will depend on the circumstances in the particular application under consideration, including the length of time between the application filing date and the date of deposit. While few, if any, situations can be imagined where the description requirement of 35 U.S.C. 112 can be satisfied where the biological material was not in existence at the time of filing, the rules will not preclude such a situation as there is no requirement in the patent law that an actual reduction to practice occur as a condition precedent to filing a patent application.
Those applicants intending to file patent applications in a country other than the United States relying upon biological material that must be deposited to satisfy the requirements of 35 U.S.C. 112 when the application is filed in the United States are cautioned that in many countries the deposit must be made before the filing date of the priority application in order to obtain foreign priority rights. Thus, while the deposit of a biological material subsequent to the effective filing date of a United States application may be relied upon to comply with 35 U.S.C. 112, an applicant may not be able to rely on the filing date of such a U.S. application if a patent is sought in certain countries other than the United States.
37 CFR 1.805 relates to the deposit of a biological material to replace or supplement a previous deposit. The term "replacement" is directed to those situations where one deposit is being substituted for another. An applicant may have greater latitude in replacing a deposit during the pendency of an application than after the patent is granted. Replacement will typically take place where the earlier deposit is no longer viable. The term "supplement" is directed to those situations where the earlier deposit is still viable in the sense that it is alive and capable of replication either directly or indirectly, but has lost a quality (e.g., purity, functionality) it allegedly possessed at the time the application was filed.
