[Federal Register Volume 66, Number 82 (Friday, April 27, 2001)]
[Rules and Regulations]
[Pages 21090-21092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10188]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

37 CFR Part 1

[Docket No. 010208033-1033-01]
RIN 0651-AB33


Changes to the Time Period for Making Any Necessary Deposit of 
Biological Material

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

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SUMMARY: In a rulemaking to implement the Patent Business Goals, the 
United States Patent and Trademark Office (Office) proposed a change to 
the time period within which a deposit of biological material (if 
needed) must be made. The Office held this proposed change in abeyance 
pending consideration of a study by the Comptroller General of the 
potential risks to the United States biotechnology industry relating to 
biological deposits as required by the American Inventors Protection 
Act of 1999. The Office is now, after consideration of this study, 
adopting a change to the time period within which a deposit of 
biological material (if needed) must be made and the depository 
information added to the specification.

EFFECTIVE DATE: May 29, 2001. This change is effective for any 
application in which a Notice of Allowability is mailed on or after May 
29, 2001.

FOR FURTHER INFORMATION CONTACT: Robert W. Bahr, Karin L. Tyson, or 
Robert A. Clarke by telephone at (703) 308-6906, or by mail addressed 
to: Box Comments--Patents, Commissioner for Patents, Washington, DC 
20231, or by facsimile to (703) 872-9411, marked to the attention of 
Robert W. Bahr.

SUPPLEMENTARY INFORMATION: In October of 1999, the Office proposed a 
number of changes to the rules of practice in title 37 of the Code of 
Federal Regulations to implement the Patent Business Goals. See Changes 
to Implement the Patent Business Goals, 64 FR 53771 (Oct. 4, 1999), 
1228 Off. Gaz. Pat. Office 15 (Nov. 2, 1999) (Proposed Rule). Among the 
proposed changes was a proposal to amend Sec. 1.809 to revise the time 
period within which a deposit of biological material (if needed) must 
be made and the depository information added to the specification. See 
Changes to Implement the Patent Business Goals, 64 FR 53814, 53842, 
1228 Off. Gaz. Pat. Office 52, 78-79.

[[Page 21091]]

    The American Inventors Protection Act of 1999 (Title IV of the 
Intellectual Property and Communications Omnibus Reform Act of 1999 (S. 
1948) as introduced in the 106th Congress on November 17, 1999) was 
incorporated and enacted into law on November 29, 1999, by 
Sec. 1000(a)(9), Division B, of Pub. L. 106-113, 113 Stat. 1501 (1999). 
Section 4805 of the American Inventors Protection Act of 1999 provides 
that the Comptroller General (in consultation with the Office) shall 
conduct a study and submit a report to Congress on the potential risks 
to the United States biotechnology industry relating to deposits of 
biological material in support of biotechnology patents, and that the 
Office shall consider the recommendations of such study in drafting 
regulations affecting deposits of biological material (including any 
modification of Sec. 1.801 et seq.). Therefore, the Office held its 
proposed change to Sec. 1.809 in abeyance pending the completion of the 
study. See Changes to Implement the Patent Business Goals, 65 FR 54603, 
54651 (Sept. 8, 2000), 1238 Off. Gaz. Pat. Office 77, 118-19 (Sept. 19, 
2000) (Final Rule).
    The study required by section 4805 of the American Inventors 
Protection Act of 1999 was completed in October of 2000. See Deposits 
of Biological Materials in Support of Certain Patent Applications, GAO-
01-49 (Oct. 2000). This report may be obtained: (1) By mail addressed 
to U.S. General Accounting Office, P.O. Box 37050, Washington, DC 
20013; (2) in person by visiting Room 1100, 700 4th Street, NW. (Corner 
of 4th Street and G Street, NW.), U.S. General Accounting Office, 
Washington, DC, (3) by telephone at (202) 512-6000, facsimile at (202) 
512-6061, or TDD (202) 512-2537; or (4) via the General Accounting 
Office's Internet Web site at http://www.gao.gov. The study did not 
contain any recommendations related to the Office's proposal to amend 
Sec. 1.809 to revise the time period within which a deposit of 
biological material (if needed) must be made. Therefore, the Office is 
now revising Sec. 1.809 based upon its October 1999 proposal.

Discussion of Specific Rules

    Title 37 of the Code of Federal Regulations, Part 1, is amended as 
follows:
    Section 1.136: Section 1.136(c) is amended to add the period for 
making a deposit set under Sec. 1.809(c) to the time periods that are 
not extendable under Sec. 1.136 if an applicant is notified in a 
``Notice of Allowability'' that an application is otherwise in 
condition for allowance, or in an Office action having a mail date on 
or after the mail date of the ``Notice of Allowability.''
    Section 1.809: Section 1.809(b) is amended to change ``respond'' to 
``reply'' (see Sec. 1.111), and to eliminate the language relating to 
payment of the issue fee.
    Section 1.809(c) is amended to: (1) Provide that 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, applicant will be notified and given a 
period of time within which the deposit must be made in order to avoid 
abandonment; (2) provide that this time period is not extendable under 
Sec. 1.136(a) or (b) if set forth in a ``Notice of Allowability'' or in 
an Office action having a mail date on or after the mail date of a 
``Notice of Allowability'' (see Sec. 1.136(c)); and (3) eliminate the 
language stating that failure to make a needed deposit will result in 
abandonment for failure to prosecute, because abandonment for failure 
to prosecute occurs by operation of law when an applicant fails to 
timely comply with such a requirement (see 35 U.S.C. 133). If an 
application for patent is otherwise in condition for allowance except 
for a needed deposit, the Office will notify applicant in the ``Notice 
of Allowability'' that a deposit is required, and the ``Notice of 
Allowability'' will set a three-month (non-extendable) period within 
which the deposit must be made in order to avoid abandonment of the 
application.
    Section 1.809(e) is added to remind applicants that the amendment 
required by Sec. 1.809(d) must be filed before or with the payment of 
the issue fee. The rules of practice no longer permit amendments to be 
filed after payment of the issue fee. See Sec. 1.312. Therefore, 
applicants need to make any necessary deposit of biological material 
well prior to payment of the issue fee such that the accession number 
is received with sufficient time remaining to amend the specification 
as required by Sec. 1.809(d) on or before the date the issue fee is 
paid. If the amendment required by Sec. 1.809(d) is not filed before or 
with the payment of the issue fee, applicant will need to submit the 
amendment with a petition under Sec. 1.183 to waive the requirement of 
Sec. 1.312 that any amendment after the mailing of a notice of 
allowance be filed before or with the payment of the issue fee so as to 
permit entry of the amendment required by Sec. 1.809(d).
    Finally, applicants are encouraged to make the deposit when filing 
the patent application in order to avoid possible loss of the U.S. 
filing date in other countries. See Manual of Patent Examining 
Procedure Sec. 2406.03 (July 1998).

Classification

    Administrative Procedure Act: This final rule only changes the time 
period within which a deposit under Sec. 1.801 et seq. must be filed 
(if needed). Therefore, this change concerns only rules of Office 
procedure, and prior notice and an opportunity for public comment for 
this change is not required pursuant to 5 U.S.C. 553(b)(A), or any 
other law. However, a notice of proposed rulemaking was published in 
the Federal Register and the Official Gazette, and no comments on the 
proposed change were received. See Changes to Implement the Patent 
Business Goals, 64 FR 53771 (Oct. 4, 1999), 1228 Off. Gaz. Pat. Office 
15 (Nov. 2, 1999) (Proposed Rule).
    Regulatory Flexibility Act: The Assistant General Counsel for 
Legislation and Regulation of the Department of Commerce certified to 
the Chief Counsel for Advocacy of the Small Business Administration 
that this rule will not have a significant economic impact on a 
substantial number of small entities. No comments were received 
regarding the economic impact of this rule. As a result, no regulatory 
flexibility analysis was prepared.
    Executive Order 13132: This final rule does not contain policies 
with federalism implications sufficient to warrant preparation of a 
Federalism Assessment under Executive Order 13132 (August 4, 1999).
    Executive Order 12866: This final rule has been determined to be 
not significant for purposes of Executive Order 12866 (September 30, 
1993).
    Paperwork Reduction Act: This final rule involves information 
collection requirements which are subject to review by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). The collection of information involved in 
this final rule has been reviewed and previously approved by OMB under 
the following control number 0651-0022. The United States Patent and 
Trademark Office is not resubmitting an information collection package 
to OMB for its review and approval because the changes in this final 
rule do not affect the information collection requirements associated 
with the information collection under OMB control number 0651-0022.
    The title, description and respondent description of this 
information collection is shown below with an estimate of the annual 
reporting

[[Page 21092]]

burdens. Included in the estimate is the time for reviewing 
instructions, gathering and maintaining the data needed, and completing 
and reviewing the collection of information. The principal impact of 
the changes in this final rule is a change in the time period for 
filing a deposit under Sec. 1.801 et seq. (if needed).
    OMB Number: 0651-0022.
    Title: Deposit of Biological Materials for Patent Purposes.
    Form Numbers: None.
    Type of Review: Routine submission.
    Affected Public: Individuals or Households, State or Local 
Governments, Farms, Business or Other For-Profit, Federal Agencies or 
Employees, Not-for-Profit Institutions, Small Businesses or 
Organizations.
    Estimated Number of Respondents: 3,300.
    Estimated Time Per Response: 1.0 hour.
    Estimated Total Annual Burden Hours: 3,300 hours.
    Needs and Uses: Information on depositing of biological materials 
in depositories is required for (1) Office determination of compliance 
with the patent statute where the invention sought to be patented 
relies on biological material subject to deposit requirement, which 
includes notifying interested members of the public where to obtain 
samples of deposits, and (2) depositories desiring to be recognized as 
suitable by the Office.
    Comments are invited on: (1) Whether the collection of information 
is necessary for proper performance of the functions of the agency; (2) 
the accuracy of the agency's estimate of the burden; (3) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and (4) ways to minimize the burden of the collection of 
information to respondents.
    Interested persons are requested to send comments regarding these 
information collections, including suggestions for reducing this 
burden, to Robert J. Spar, Director, Office of Patent Legal 
Administration, United States Patent and Trademark Office, Washington, 
DC 20231, or to the Office of Information and Regulatory Affairs, OMB, 
725 17th Street, NW, Washington, DC 20503, (Attn: PTO Desk Officer).
    Notwithstanding any other provision of law, no person is required 
to respond to nor shall a person be subject to a penalty for failure to 
comply with a collection of information subject to the requirements of 
the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Courts, Freedom of 
Information, Inventions and patents, Reporting and record keeping 
requirements, Small Businesses.

    For the reasons set forth in the preamble, 37 CFR Part 1 is amended 
as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

    I. The authority citation for 37 CFR part 1 continues to read as 
follows:

    Authority: 35 U.S.C. 2(b)(2).

    Section 1.136 is amended by revising paragraph (c) to read as 
follows:


Sec. 1.136  Extensions of time.

* * * * *
    (c) If an applicant is notified in a ``Notice of Allowability'' 
that an application is otherwise in condition for allowance, the 
following time periods are not extendable if set in the ``Notice of 
Allowability'' or in an Office action having a mail date on or after 
the mail date of the ``Notice of Allowability'':
    (1) The period for submitting an oath or declaration in compliance 
with Sec. 1.63;
    (2) The period for submitting formal drawings set under 
Sec. 1.85(c); and
    (3) The period for making a deposit set under Sec. 1.809(c).
    Section 1.809 is amended by revising paragraphs (b) and (c) and 
adding paragraph (e) to read as follows:


Sec. 1.809  Examination procedures.

* * * * *
    (b) The applicant for patent or patent owner shall reply to a 
rejection under paragraph (a) of this section by--
    (1) In the case of an applicant for patent, either making an 
acceptable original, replacement, or supplemental deposit, or assuring 
the Office in writing that an acceptable deposit will be made; or, in 
the case of a patent owner, requesting a certificate of correction of 
the patent which meets the terms of paragraphs (b) and (c) of 
Sec. 1.805, 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. Other replies to the examiner's action shall be 
considered nonresponsive. The rejection will be repeated until either 
paragraph (b)(1) of this section is satisfied or the examiner is 
convinced that a deposit is not needed.
    (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, applicant 
will be notified and given a period of time within which the deposit 
must be made in order to avoid abandonment. This time period is not 
extendable under Sec. 1.136(a) or (b) if set forth in a ``Notice of 
Allowability'' or in an Office action having a mail date on or after 
the mail date of a ``Notice of Allowability'' (see Sec. 1.136(c)).
* * * * *
    (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 Sec. 1.312).

    Dated: April 18, 2001.
Nicholas P. Godici,
Acting Under Secretary of Commerce for Intellectual Property and 
Director of the United States Patent and Trademark Office.
[FR Doc. 01-10188 Filed 4-26-01; 8:45 am]
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