Biological Material That Is Known and Readily Available to the Public

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

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

n 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

elevant 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

r’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

ade 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

on 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.