Procedures for the Deposition of a Biological Sample to Overcome a 112 Enablement Rejection

Chuck Meeker

© 2016 Workman Nydegger

Diamond v. Chakrabarty, 447 U.S. 303 (1980) (a live, human-made micro-organism is patentable subject matter under 35 USC § 101)

Technology: a genetically-modified Pseudomonas bacterium (now known as Pseudomonas putida) capable of breaking down crude oil.

- Examiner / Board: living things are not considered patentable eligible subject matter under 35 USC § 101.

- CCPA / SCOTUS: the fact that micro-organisms are alive is without legal significance for purposes of the patent law.

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 . . . 35 USC § 112(a).

The 35 USC § 112 Problem (written description and enablement)

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 USC § 112 . . .

MPEP § 2402 to the Rescue (The Deposit Rule)

. . . 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 . . .

[deposit where? USPTO doesn’t have the resources – so, private

depositories are used instead]

MPEP § 2402 to the Rescue (The Deposit Rule)

- Enter The Budapest Treaty -

. . . 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 . . .

. . . 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).

http://www.wipo.int/treaties/en/text.jsp?file_id=283813#P145_13920

MPEP § 2402 to the Rescue (The Deposit Rule)

. . . either directly or indirectly.

- Direct self-replication = biological material reproduces by

itself (e.g., bacteria, fungi including yeast, algae, protozoa, eukaryotic

cells, cell lines, hybridomas, plant tissue cells, lichens, seeds, etc.).

- Indirect self-replication = where the biological material is

only capable of replication when another self-replicating biological

material is present (e.g., after insertion in a host - virus, phage,

plasmid, symbiont, replication-defective cells, etc.).

FYI – the rules on deposits are not applicable to Plant Patent

applications under 35 U.S.C. 161-164.

MPEP § 2402.01 (Biological Material = Material Capable of Self-Replication )

. . . 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 . . .

. . . 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.

For rules specific to foreign offices, contact your foreign associate and

see:http

://www.wipo.int/export/sites/www/treaties/en/registration/budapes

t/guide/pdf/section_e.pdf

37 CFR 1.802 – 1.809 (The deposit rules)

(a) Where an invention is, or relies on, a biological material, the

disclosure may include reference to a deposit of such biological

material.

(c) The reference to a biological material in a specification disclosure

or the actual deposit of such material by an applicant or patent

owner does not create any presumption that such material is

necessary to satisfy 35 U.S.C. 112 or that deposit in accordance with

these regulations is or was required.

37 CFR 1.802 (Need or opportunity to make a deposit)

(b) Biological material need not be deposited:

- unless access to such material is necessary to satisfy the

statutory requirements for patentability under 35 U.S.C. 112;

- if it is known and readily available to the public; or

- can be made or isolated without undue experimentation.

37 CFR 1.802 (Need or opportunity to make a deposit)

(a) Whenever a biological material is specifically identified in an

application for patent as filed, an original deposit thereof may be

made at any time before filing the application for patent or, subject to

§ 1.809, during pendency of the application for patent.

(b) When the original deposit is made after the effective filing date of

an application for patent, the applicant must promptly submit a

statement from a person in a position to corroborate the fact, stating

that the biological material which is deposited is a biological material

specifically identified in the application as filed.

37 CFR 1.804 (Time of making an original deposit)

Offices that accept deposit after the filing date:

- U.S., Japan, Israel, Mexico - 6 months . . .

Offices that do not accept deposit after the filing date:

- Canada, EPC, Australia, India, Singapore, China, South

Korea . . .

see:http://

www.wipo.int/export/sites/www/treaties/en/registration/budapest/g

uide/pdf/section_e.pdf

WARNING – not all Offices are as nice as the USPTO

(To be safe – make the deposit prior to filing the application)

(a) The examiner shall determine pursuant to § 1.104 in each

application for patent, application for reissue patent or reexamination

proceeding if a deposit is needed, and if needed, if a deposit actually

made is acceptable for patent purposes. If a deposit is needed and

has not been made or replaced or supplemented in accordance with

these regulations, the examiner, where appropriate, shall reject the

affected claims under the appropriate provision of 35 U.S.C. 112 ,

explaining why a deposit is needed and/or why a deposit actually

made cannot be accepted.

37 CFR 1.809 (Examination procedures - Rejection)

(b) The applicant for patent or patent owner shall reply to a rejection

under paragraph (a) of this section by—

(1) either making an acceptable original, replacement, or supplemental

deposit, or assuring the Office in writing that an acceptable deposit will

be made; or

(2) Arguing why a deposit is not needed under the circumstances of the

application or patent considered and/or why a deposit actually made

should be accepted.

37 CFR 1.809 (Examination procedures - Reply)

(c) If an application for patent is otherwise in condition for allowance

except for a needed deposit and the Office has received a written

assurance that an acceptable deposit will be made, the Office may

notify the applicant in a notice of allowability and set a three month

period of time from the mailing date of the notice of allowability

within which the deposit must be made in order to avoid

abandonment. This time period is not extendable under § 1.136 (see

§ 1.136(c) ).

37 CFR 1.809 (Examination procedures – NOA pending deposit)

(d) For each deposit made pursuant to these regulations, the

specification shall contain:

(1) The accession number for the deposit;

(2) The date of the deposit;

(3) A description of the deposited biological material sufficient to

specifically identify it and to permit examination; and

(4) The name and address of the depository.

(e) Any amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of

this section must be filed before or with the payment of the issue fee

(see § 1.312 ).

37 CFR 1.809 (Examination procedures – Specification)

(a) A deposit shall be recognized for the purposes of these regulations

if made in

(1) Any International Depositary Authority (IDA) as established under

the Budapest Treaty on the International Recognition of the Deposit

of Micro-organisms for the Purposes of Patent Procedure, or

(2) Any other depository recognized to be suitable by the Office.

- Suitability will be determined by the Director

See:http://

www.wipo.int/export/sites/www/treaties/en/registration/budapest/

pdf/ida.pdf

37 CFR 1.803 (Acceptable depository)

A deposit made before or during pendency of an application for

patent shall be made for a term of at least thirty (30) years and at

least five (5) years after the most recent request for the furnishing of

a sample of the deposit was received by the depository. In any case,

samples must be stored under agreements that would make them

available beyond the enforceable life of the patent for which the

deposit was made.

37 CFR 1.806 (Term of deposit)

(a) A deposit of biological material that is capable of self-replication

either directly or indirectly must be viable at the time of deposit and

during the term of deposit. Viability may be tested by the depository.

The test must conclude only that the deposited material is capable of

reproduction. No evidence is necessarily required regarding the

ability of the deposited material to perform any function described in

the patent application.

37 CFR 1.807 (Viability of deposit - capable of reproduction)

(b) A viability statement for each deposit of a biological material

defined in paragraph (a) of this section not made under the Budapest

Treaty . . . must be filed in the application and must contain:

(1) name and address of depository and depositor;

(2) identity of deposit and accession number given by the depository;

(3) date of deposit and date of viability test;

(4) procedures used to obtain a sample if test was not done by the

depository; and

(5) statement that the deposit is capable of reproduction.

[Official forms SB/4 and SB/9]

37 CFR 1.807 (Viability of deposit - viability statement)

(a) A deposit must be made under conditions that assure that:

(1) Access to the deposit will be available during pendency of the

patent application making reference to the deposit to one

determined by the Director to be entitled thereto under § 1.14 and

35 U.S.C. 122, and

(2) Subject to paragraph (b) of this section, 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.

37 CFR 1.808 (Furnishing of samples – quid pro quo)

(b) The depositor may contract with the depository to require that

samples of a deposited biological material shall be furnished only if a

request for a sample, during the term of the patent:

(1) Is in writing or other tangible form and dated;

(2) Contains the name and address of the requesting party and the

accession number of the deposit; and

(3) Is communicated in writing by the depository to the depositor

along with the date on which the sample was furnished and the name

and address of the party to whom the sample was furnished.

37 CFR 1.808 (Furnishing of samples – limitations and conditions)

Step 1 – in anticipation of drafting / filing a (first) application, discuss

with the client the advantages and disadvantages of making a deposit.

Step 1’ – in response to receiving a section 112 rejection, discuss with

the client the advantages and disadvantages of making a deposit.

- Note: the Examiner may not recognize that a deposit could

overcome the 112 rejection

- Remember: alternatively, argue deposit not needed

• known and readily available to the public

• can be made or isolated without undue experimentation

Example procedure:

Step 2 – find a suitable depository for the specific biological material

- type of biological material

- delivery conditions

- storage conditions

- timing (filing deadline; respond to OA with “deposit will be made”

statement)

- price

http://www.wipo.int/export/sites/www/treaties/en/registration/buda

pest/pdf/ida.pdf

Example procedure:

Step 3 – contact the depository for instructions before client sends the

biological material

- put client in contact with depository

- request to be cc’d on communications

- confirm suitability of depository for specific biological

material

- obtain and (have client) complete application / accession

forms

Example procedure:

Step 4 – prepare and (have client) ship the biological material to the

depository

- if shipping out of U.S., determine if U.S.D.A. import/export

or sanitary certificate is required by receiving country https://

www.aphis.usda.gov/aphis/resources/permits

- inform depository of shipment

- request and receive confirmation of receipt

[may need to ship more than once]

Example procedure:

Step 5 – receive / submit to the Office:

- official receipt with accession number (Form BP/4 – Recognition of

the Deposit of Microorganism)

- viability statement (Form BP/9) – or assertion that deposit is made under

the Budapest Treaty

- 1.132 declaration (attesting that the claims read on the deposited

material)

Example procedure:

Step 6 – amend specification to include a reference to the deposited

biological material

“Under the provisions of the Budapest Treaty on the International Recognition of the Deposit

of Microorganisms for the Purpose of Patent Procedure, Applicant has deposited biological

material comprising __[quantity and description of type]__ with the International Depositary

Authority __[name and address]__ , on __[date]__ under the accession number

__[number]__. The deposited __[type]__ comprises __[recite claim language]__.”

Example procedure:

- BE PATIENT! It can take over 3 months to finalize everything

- Deposit early – before first filing, if possible

- Beware the Catch 22

- when the biological material is being sold (e.g., a plasmid, seed,

etc.), clients are happy to make a deposit

- but the deposit is less important as it is publically available

and meets the requirements of 112 already

- when the biological material is not being sold (e.g., a cell line

that produces a product that is sold), deposit is more important

- but this is when the client doesn’t want to make a deposit

Final Thoughts: