Revision to the Time for Filing of a Biological Deposit and the Date of Availability of a Biological Deposit, 9254-9259 [E8-3084]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Proposed Rules]
[Pages 9254-9259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3084]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No.: PTO-P-2005-0027]
RIN 0651-AB99


Revision to the Time for Filing of a Biological Deposit and the 
Date of Availability of a Biological Deposit

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This notice proposes changes to the rules of practice to 
require that any deposit of biological material be made before 
publication of a patent application, and that all restrictions on 
access to the deposited material imposed by the depositor be removed 
upon publication. The proposed changes will provide that the public has 
access to biological materials referenced in the disclosure of a patent 
application to the same extent that access to the remainder of the 
disclosure is available. The public policy basis for allowing access to 
a referenced item is the same whether the item is another patent 
application or a deposited biological material.

DATES: To be ensured of consideration, written comments must be 
received on or before April 21, 2008. No public hearing will be held.

ADDRESSES: Comments should be sent by e-mail addressed to 
AB99.Comments@uspto.gov. Comments may also be submitted by mail 
addressed to: Mail Stop Comments--Patents, Commissioner for Patents, 
P.O. Box 1450, Alexandria, VA, 22313-1450, or by facsimile to (571) 
273-7754, marked to the attention of Kathleen Kahler Fonda. Although 
comments may be submitted by mail or facsimile, the Office prefers to 
receive comments via the Internet. If comments are submitted by mail, 
the Office prefers that the comments be submitted on a DOS formatted 
3\1/2\ inch disk accompanied by a paper copy.
    Comments may also be sent by e-mail via the Federal eRulemaking 
Portal. See the Federal eRulemaking Portal Web site (https://
www.regulations.gov) for additional instructions on providing comments 
via the Federal eRulemaking Portal.
    The comments will be available for public inspection at the Office 
of the Commissioner for Patents, located in Madison East, Tenth Floor, 
600 Dulany Street, Alexandria, Virginia, and will be available via the 
Office Internet Web site (address: https://www.uspto.gov). Because 
comments will be made available for public inspection, information that 
is not desired to be made public, such as an address or phone number, 
should not be included in the comments.

FOR FURTHER INFORMATION CONTACT: Kathleen Kahler Fonda, Legal Advisor, 
Office of the Deputy Commissioner for Patent Examination Policy, by 
telephone at (571) 272-7754; by mail addressed to: Mail Stop Comments--
Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 
22313-1450; or by facsimile to (571) 273-7754, marked to the attention 
of Kathleen Kahler Fonda.

SUPPLEMENTARY INFORMATION: Under 35 U.S.C. 112, first paragraph, the 
disclosure of a patent application must contain a written description 
that enables a person skilled in the art to make and use the claimed 
invention. The Supreme Court has consistently recognized that, in 
exchange for the rights associated with a patent grant, an inventor 
must disclose his invention in such a manner that would allow the 
public to make and use it without undue experimentation. See Universal 
Oil Prods. Co. v. Globe Oil & Refining Co., 322 U.S. 471, 484, 61 USPQ 
382, 388 (1944) (``But the quid pro quo is disclosure of a process or 
device in sufficient detail to enable one skilled in the art to 
practice the invention once the period of the monopoly has expired * * 
*.''); Brenner v. Manson, 383 U.S. 519, 534, 148 USPQ 689, 695 (1966) 
(``The basic quid pro quo contemplated by the Constitution and the 
Congress for granting a patent monopoly is the benefit derived by the 
public from an invention with substantial utility.''); J.E.M. AG 
Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124, 142, 60 
USPQ2d 1865, 1873 (2001) (``The disclosure required by the Patent Act 
is `the quid pro quo of the right to exclude.' '' (quoting Kewanee Oil 
Co. v. Bicron Corp., 416 U.S. 470, 484, 181 USPQ 673, 679 (1974))).
    The American Inventors Protection Act of 1999 (AIPA) (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 1000(a)(9), 
Division B, of Public Law 106-113, 113 Stat. 1501 (1999). The AIPA 
provided for publication of patent applications eighteen months after 
the earliest date for which priority benefit was sought (amending title 
35 of the United States Code to add paragraph (b) to section

[[Page 9255]]

122). In exchange for this pre-issue public disclosure, the AIPA also 
provided a provisional right under 35 U.S.C. 154(d) to obtain a 
reasonable royalty if the invention as claimed in the published patent 
application is substantially identical to the invention claimed in any 
patent that might issue therefrom, and certain other conditions are 
met.
    In amending 35 U.S.C. 122, Congress made it clear that only those 
patent application publications which provide an enabling disclosure of 
the claimed invention would be entitled to provisional rights under 35 
U.S.C. 154(d). Although the AIPA allowed for certain applications to be 
published in redacted form, any redacted application was nevertheless 
required to contain a disclosure that would allow a person skilled in 
the art to make and use the subject matter of the claim. ``The 
provisions of section 154(d) shall not apply to a claim if the 
description of the invention published in the redacted application 
filed under this clause with respect to the claim does not enable a 
person skilled in the art to make and use the subject matter of the 
claim.'' 35 U.S.C. 122(b)(2)(B)(v). By allowing for provisional rights 
only where the patent publication contains an enabling disclosure, 
Congress again reinforced the notion that exchange for the rights 
associated with a patent grant an inventor must disclose his invention 
in such a manner that would allow the public to make and use it without 
undue experimentation.
    When an invention involves biological material, sometimes words and 
drawings alone cannot sufficiently describe how to make and use it. As 
a supplement to the printed written description of an invention, courts 
have sanctioned a procedure in which biological material may be 
deposited with an appropriate holding facility under conditions which 
ensure that the sample is properly maintained, and made available to 
others when appropriate.

    For biological inventions, for which providing a description in 
written form is not practicable, one may nevertheless comply with 
the written description requirement by publicly depositing the 
biological material * * *. Such description is the quid pro quo of 
the patent system; the public must receive meaningful disclosure in 
exchange for being excluded from practicing the invention for a 
limited period of time.

    Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 970, 63 USPQ2d 
1609, 1617 (Fed. Cir. 2002). Internationally, the deposit of biological 
materials is governed by the Budapest Treaty.
    The proposed rule change brings the Office practice regarding 
biological deposits in line with the publication of patent applications 
under AIPA. Courts have consistently recognized that an applicant must 
have provided the Office with an enabling disclosure no later than the 
time an invention is disclosed to the public. Prior to publication of 
patent applications under the AIPA, disclosure occurred simultaneously 
with patent issuance. Thus, earlier court decisions held that deposits 
needed to be perfected at the time the patent became public, i.e., at 
the issue date. For example, in In re Hawkins the court stated that 
``the function of section 112 in ensuring complete public disclosure is 
only violated if the disclosure is not complete at the time it is made 
public, i.e., at the issue date.'' In re Hawkins, 486 F.2d 569, 574, 
179 USPQ 157, 161 (CCPA 1973). In In re Argoudelis, the court 
specifically referred to the regulation concerning conditions for 
making a patent application public, 37 CFR 1.14, when it stated, ``The 
cultures are to be made available to the public upon issuance of a 
United States patent which refers to such deposit and prior to issuance 
of said patent under the conditions specified in Rule 14.'' In re 
Argoudelis, 434 F.2d 1390, 1393, 168 USPQ 99, 102 (CCPA 1970).
    In the era since Hawkins and Argoudelis were decided, Congress 
changed the law to require that most patent applications be published 
eighteen months after filing, and to grant provisional rights under 
certain conditions. Publication of patent applications under the AIPA 
means that the patent issue date is no longer ``the time [the patent 
disclosure] is made public,'' or the time when ``the conditions of Rule 
14 are met.'' At least one commentator has stated that a result of the 
changes brought about by the AIPA is that there is now a requirement 
for release of a biological deposit at publication. See Michelle 
Henderson, ``International Harmonization Brought about by the American 
Inventors Protection Act Compels Early Release of the Biological 
Deposit,'' 42 IDEA: The Journal of Law and Technology 361 (2002).
    In a more recent case involving enablement supported by a 
biological deposit, the Federal Circuit held that ``the availability of 
a sample to the public after the patent has issued will meet the 
enablement requirement.'' In re Lundak, 773 F.2d 1216, 1223, 227 USPQ 
90, 95 (Fed. Cir. 1985). Although on its face Lundak might seem to 
support delaying public access to a deposit until issue, Lundak was 
decided before provisional rights under the AIPA were instituted. Like 
the decisions in Argoudelis and Hawkins, the rule established in Lundak 
is superseded by the AIPA.
    The Office did not implement a rule change requiring unrestricted 
access to biological deposits referenced in published patent 
applications at the time the patent application publication rules were 
put in place because a report to Congress required by the AIPA was 
still pending at that time. Section 4805 of the AIPA required that the 
Comptroller General (in consultation with the Office) conduct a study 
and submit a report to Congress on the potential risks to the 
biotechnology industry in the United States relating to release of 
biological material deposited in support of biotechnology patents, and 
that the Office consider the recommendations of such study in drafting 
regulations affecting deposits of biological material (including any 
modification of Sec.  1.801 et seq.). The study required by Section 
4805 of the AIPA 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 
the Government Accountability Office, 441 G Street, NW., Washington, DC 
20548; (2) by telephone at (202) 512-6000, facsimile at (202) 512-6061, 
or TDD (202) 512-2537; or (3) via the Government Accountability 
Office's Internet Web site at https://www.gao.gov.
    The Office had previously proposed changes to Sec.  1.809 in order 
to reduce delays after allowance of a patent application. 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). The GAO 
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 after allowance 
of an application. Accordingly, the Office has already amended Sec.  
1.809 to provide that the period of time within which the deposit must 
be made in order to avoid abandonment 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 Changes to the Time Period for Making 
any Necessary Deposit of Biological Material, 66 FR 21090 (April 27, 
2001), 1246 Off. Gaz. Patent Office 42 (May 22, 2001) (final rule).
    As to release of the deposit before issuance of the application, 
the GAO study noted the concern of the

[[Page 9256]]

biotechnology industry that the public could obtain the deposit and 
reproduce the invention with minimal effort and expense, but ``found no 
documented cases of a person or an organization having ever obtained a 
sample of a biological deposit and then using it to infringe on the 
patent.'' GAO-01-49 at 4. Nevertheless, the report concluded that ``the 
statute does not require an associated release of a biological deposit 
concurrent with 18-month publication because even though the 
application may refer to the biological deposit, the deposit itself is 
not part of the application.'' GAO-01-49 at 5. Although no reference is 
provided, the report appears to be relying for support of this 
assertion on the CCPA's statement in In re Argoudelis that ``[t]he 
deposits are not a part of the patent application * * *. '' 434 F.2d 
1390, 1394, 168 USPQ 99, 103 (CCPA 1970). The focus in Argoudelis, 
however, appears to have been on an Office position that the Office did 
not control the deposited material for the purpose of ensuring 
continued enablement, and in no way implied that the application 
complied with 35 U.S.C. 112 without the deposit. This passage places 
the quote in context:

    The only rational ground for concern on the part of the Patent 
Office appears to be for the permanent availability of the deposited 
microorganism. The deposits are not a part of the patent 
application, and the Patent Office exercises no control over them. 
This concern may be justified in some situations.

    Id. at 1393-94, 168 USPQ at 103. Moreover, the Argoudelis court 
recognized that the deposit would be withheld from the public in 
accordance with the United States Patent Office Rules of Practice, Rule 
14. Id. at 1391, 168 USPQ at 101 (quoting cover letter from the 
appellant to the depository accompanying the deposit). As a result, 
although the deposit was not physically within the application file, 
the Office's rules related to access to application files still 
governed access to the deposit. Thus, while the GAO's statement is true 
insofar as the deposit is not physically part of the application, a 
deposit is part of the application in the sense that an applicant's 
disclosure may be non-enabling or not adequately described without it.
    The proposed requirement for unrestricted access to a deposited 
biological material upon publication of a patent application that makes 
reference to it will ensure that the public has the same level of 
access to the disclosure of an invention involving biological materials 
as it does to the disclosure of any other category of invention. With 
few limited exceptions, the patent statutes do not distinguish among 
different fields of endeavor. Significantly, section 122 of Title 35 
does not authorize the Office to refrain from making some portion of an 
applicant's disclosure public simply because it is in the form of a 
deposit of biological material. Parity of treatment regardless of the 
type of invention involved has been espoused by the Federal Circuit, 
which stated recently that this court accords the same treatment to all 
forms of invention. Eolas Techs Inc. v. Microsoft Corp., 399 F.3d 1325, 
1339, 73 USPQ2d 1782, 1794 (Fed. Cir. 2005) (citing TRIPs Agreement, 
Part II, Section 5 (1994) (``[P]atents shall be available and patent 
rights enjoyable without discrimination as to the place of invention[ 
][and] the field of technology * * *.'')). By providing for 
unrestricted access to deposited material upon publication, the Office 
will ensure that uniform standards for public release of a patent 
disclosure apply regardless of the field of the invention.
    In order to ensure that the public receives a meaningful disclosure 
of an invention in a patent application publication, provisional rights 
may accrue to the patentee only if the claims in the patent are 
substantially identical to those in the published application. See 35 
U.S.C. 154(d). The specification of a patent application must also 
comply with 35 U.S.C. 112. See 35 U.S.C. 111(b)(1)(A). If a deposit of 
biological material to comply with 35 U.S.C. 112 is necessary to 
preserve the availability of provisional rights under 35 U.S.C. 154(d), 
the disclosure of the invention must contain a specific reference to a 
depository accession number of the biological material, or be amended 
to contain such a reference in sufficient time to allow for the 
accession number to be included in the patent application publication. 
A reference to an accession number which appears in papers related to a 
patent application but not in the disclosure itself is not sufficient. 
Although application-related papers are generally made available to the 
public upon publication of the application, see Sec.  1.14(a)(1)(ii) 
and (iii), such papers are not part of the disclosure of the patent or 
patent application publication itself. As a result, if the patent 
application itself is not originally filed with a reference to the 
accession number, a substitute specification in compliance with Sec.  
1.125(b) should be filed at least four months before the projected 
publication date of the patent application publication in order to 
ensure that the reference to the deposit is included in the patent 
application publication.
    The Office serves as a guardian of the public interest when it 
examines patent applications and issues those which meet statutory 
requirements, including the requirement of an adequate disclosure. See 
In re Russell, 439 F.2d 1228, 1230, 169 USPQ 426, 428 (CCPA 1971) 
(``[T]here is a public interest in granting valid patents * * * .''). 
By instituting the proposed rule changes, the Office will ensure that 
patent application publication documents requiring a deposit of 
biological material to comply with the disclosure requirements of 35 
U.S.C. 112, first paragraph, will be fully available as prior art as of 
the date of publication. If a patent application publication does not 
comply with the disclosure requirements of 35 U.S.C. 112, first 
paragraph, as of its publication date, the patent application 
publication cannot serve as anticipatory prior art under 35 U.S.C. 
102(a) and (b), and possibly (e). See Elan Pharms., Inc. v. Mayo Found. 
for Med. Educ. & Research, 346 F.3d 1051, 1054, 68 USPQ2d 1373, 1375 
(Fed. Cir. 2003) (``To serve as an anticipating reference, the 
reference must enable that which it is asserted to anticipate.'') 
(quoting Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 
1354, 65 USPQ2d 1385, 1416 (Fed. Cir. 2003) (``A claimed invention 
cannot be anticipated by a prior art reference if the allegedly 
anticipatory disclosures cited as prior art are not enabled.''); 
Bristol-Myers Squibb v. Ben Venue Labs., Inc., 246 F.3d 1368, 1374, 58 
USPQ2d 1508, 1512 (Fed. Cir. 2001) (``To anticipate, the reference must 
also enable one of skill in the art to make and use the claimed 
invention.''); PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 
1566, 37 USPQ2d 1618, 1624 (Fed. Cir. 1996) (``To anticipate a claim, a 
reference must disclose every element of the challenged claim and 
enable one skilled in the art to make the anticipating subject 
matter.'').
    Absent a requirement for deposit prior to publication coupled with 
release of the deposited material upon publication, an otherwise 
anticipatory patent application publication could fail to qualify as 
prior art. It is not in the public interest to allow arbitrariness in 
the date of deposit to disqualify a patent application publication as 
prior art, when the publication otherwise fully discloses an invention. 
The proposed rule changes take steps to ensure that patent application 
publications will be available as prior art as of their publication 
date, and can therefore be used to prevent issuance of patents which do 
not represent a contribution to

[[Page 9257]]

public knowledge. See Constant v. Advanced Micro-Devices, Inc., 848 
F.2d 1560, 1564, 7 USPQ2d 1057, 1059 (Fed. Cir. 1988) (``Public policy 
requires that only inventions which fully meet the statutory standards 
are entitled to patents.'').
    A requirement for deposit of the biologic material prior to 
publication would be a significant step toward harmonizing United 
States practice with that of the European Patent Office (EPO). The 
proposed rules require that a deposit necessary for compliance with 35 
U.S.C. 112 be made before technical preparations for publication of the 
application as a patent application publication have begun, whereas in 
Europe any deposit necessary for compliance with the disclosure 
requirement of Article 83 of the European Patent Convention (EPC) must 
have been made at or before filing. EPC Rule 28(1)(a). Thus the timing 
requirements for deposits are not identical, and even under the 
proposed rules it would remain the case that an EP application risks 
losing benefit of a United States priority application unless the 
deposit had been made at or before filing in the United States. 
However, under the proposed changes to Sec.  1.809(e), as well as under 
EPC Rule 28(2)(a), an amendment to a patent application to make 
reference to a deposit must be made in sufficient time so that the 
reference will be included in the patent application publication. Thus 
members of the interested public, for both U.S. applications and those 
filed in the EPO, will be informed of the existence of the deposited 
material and be able to request its release upon publication at 
eighteen months.

Discussion of Specific Rules

    Title 37 of the Code of Federal Regulations, Part 1, is proposed to 
be amended as follows:
    Section 1.77: Section 1.77 is proposed to be amended by revising 
paragraph (b)(1) to delete ``, which may be accompanied by an 
introductory portion stating the name, citizenship, and residence of 
the applicant (unless included in the application data sheet),'' by 
redesignating paragraphs (b)(6) through (b)(12) as paragraphs (b)(7) 
through (b)(13), adding a new paragraph (b)(6), and revising paragraph 
(c). Having the name, citizenship and residence of each applicant on 
the title page suggests that such information should be changed if the 
information changes, and to avoid any need for an amendment, this 
information should not be included on the title page. New paragraph 
(b)(6) would provide a section heading for a reference to a deposit of 
biological material. Paragraph (c) is proposed to be revised to refer 
to paragraph (b) in general rather than each of the numbered paragraphs 
of (b) so that if paragraph (b) is amended in the future, no amendments 
would be required to paragraph (c).
    Section 1.163: Section 1.163 is amended by revising paragraph 
(c)(1) to delete ``, which may include an introductory portion stating 
the name, citizenship, and residence of the applicant,'' redesignating 
paragraphs (c)(6) through (c)(11) as paragraphs (c)(7) through (c)(12), 
and adding a new paragraph (c)(6) to provide a section heading for a 
reference to a deposit of biological material.
    Section 1.804: Section 1.804 is proposed to be amended to provide 
that if a biological material is necessary to preserve the availability 
of provisional rights under 35 U.S.C. 154(d), the deposit of the 
biological material must be made prior to filing an application or 
during the pendency of an application, provided that the deposit is 
made before technical preparations for publication of the application 
as a patent application publication have begun (see Sec.  1.215(a)).
    Section 1.808: Section 1.808(a)(1) is proposed to be amended to 
change ``122'' to ``122(a)'' and to make grammatical corrections. 
Section 1.808(a)(2) is proposed to be amended to provide that all 
restrictions imposed by the depositor will be irrevocably removed upon 
the earlier of publication of the application under Sec.  1.211 and 35 
U.S.C. 122(b) or grant of the patent, and to indicate that the rule 
applies regardless of whether the deposit was made to satisfy a 
statutory provision.
    Section 1.808(b) is amended to add ``before the patent is granted 
or'' before ``term of the patent.''
    Section 1.808(c) is amended to provide that the Office will, on 
request, certify that an application referring to the deposit has been 
filed, that the subject matter of that application involves the 
deposited biological material or the use thereof, that the application 
has been published or patented or is otherwise open to public 
inspection, and that the requesting party has a right to a sample of 
the biological material. This is the certification called for in Rule 
11.3 of the Regulations Under the Budapest Treaty on the International 
Recognition of the Deposit of Microorganisms for the Purposes of Patent 
Procedure. A form, BP/12, is provided on the World Intellectual 
Property Organization's Internet Web site (https://www.wipo.int) for 
this purpose.
    Section 1.808(c)(3) is also proposed to be revised to require the 
application number referring to the deposit, as well as either the 
patent application publication number and publication date, or the 
patent number and issue date of the patent, instead of only the patent 
number and issue date.
    Section 1.809: Section 1.809(a) is proposed to be amended to 
clarify that the examiner's rejection may be under any appropriate 
statutory provision.
    Section 1.809(b)(1) is proposed to be amended to delete ``either'' 
and ``, or assuring the Office in writing that an acceptable deposit 
will be made.'' Section 1.809(b)(2) is proposed to be amended to delete 
the text after ``nonresponsive'' and to insert in place thereof ``A 
request to hold the making of the deposit in abeyance will not be 
considered a bona fide attempt to advance the application to final 
action (Sec.  1.135(c)).''
    Section 1.809(c) is proposed to be amended to delete ``and the 
Office has received a written assurance that an acceptable deposit will 
be made.''
    Section 1.809(e) is proposed to be amended to delete ``before or 
with the payment of the issue fee (see Sec.  1.312)'' and to insert 
``(1) within a period of sixteen months after the date of filing of the 
application or, if the benefit of an earlier filing date is sought 
under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four 
months of the actual filing date of the later-filed application and 
sixteen months from the filing date of the prior-filed application; and 
(2) before or with any request for early publication (Sec.  1.219).'' 
Of course, Sec.  1.312 continues to apply, and the amendment cannot be 
filed after payment of the issue fee. By providing that the amendment 
should be filed at a set time related to publication of the 
application, the application should be published with the required 
deposit information.

Rulemaking Considerations

    Administrative Procedure Act: This notice does not propose to add 
any new fees or new requirements to the rules of practice. Rather, this 
notice proposes to change the time period for compliance with existing 
requirements of the rules of practice in 37 CFR 1.801 et seq. 
Therefore, the changes proposed in this notice involve only rules of 
agency practice and procedure under 5 U.S.C. 553(b)(B). See Bachow 
Communications Inc. v. FCC, 237 F.3d 683, 690 (DC Cir. 2001) (rules 
governing an application process are ``rules of agency organization, 
procedure, or practice'' and are exempt from the Administrative 
Procedure Act's notice and comment requirement) and JEM Broadcasting 
Co. v. FCC, 22 F.3d 320, 327 (DC Cir. 1994)

[[Page 9258]]

(rule under which any flawed application is summarily dismissed without 
allowing the applicant to correct its error is merely procedural 
despite its sometimes harsh effects on applicants); see also Fressola 
v. Manbeck, 36 USPQ2d 1211, 1215 (D.D.C. 1995) (``it is extremely 
doubtful whether any of the rules formulated to govern patent or trade-
mark practice are other than `interpretive rules, general statements of 
policy, * * * procedure, or practice.' '') (quoting C.W. Ooms, The 
United States Patent Office and the Administrative Procedure Act, 38 
Trademark Rep. 149, 153 (1948)). Accordingly, prior notice and 
opportunity for public comment are not required pursuant to 5 U.S.C. 
553(b) or (c) or any other law. Nevertheless, the Office is seeking 
public comment on proposed changes to these rules of practice to obtain 
the benefit of such input.
    Regulatory Flexibility Act: As prior notice and an opportunity for 
public comment are not required pursuant to 5 U.S.C. 553 (or any other 
law), neither an initial regulatory flexibility analysis nor a 
certification under the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.) are required. See 5 U.S.C. 603. Nevertheless, for the reasons set 
forth herein, the Deputy General Counsel for General Law of the United 
States Patent and Trademark Office has certified to the Chief Counsel 
for Advocacy of the Small Business Administration that the changes 
proposed in this notice will not have a significant economic impact on 
a substantial number of small entities. See 5 U.S.C. 605(b).
    The principal impacts of the changes proposed in this notice are 
changes to the rules of practice to: (1) Require that any deposit of 
biological material be made before publication of a patent application; 
and (2) provide that all restrictions on access to the deposited 
material imposed by the depositor be removed upon publication. The 
Office estimates that there are approximately 1,000 patent applications 
filed each year (both small entity and other than small entity) that 
are supplemented (either on filing or later) by a deposit of biological 
material. This notice does not propose any new fees or new requirements 
for such applications, but is simply proposing to change the time 
period for compliance with existing requirements of the rules of 
practice to ensure that the public has access to biological materials 
referenced in the disclosure of a patent application to the same extent 
that access to the remainder of the disclosure is available. Therefore, 
the changes proposed in this notice will not have a significant 
economic impact on a substantial number of small entities.
    Executive Order 13132: This rule making does not contain policies 
with federalism implications sufficient to warrant preparation of a 
Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).
    Executive Order 12866: This rule making has been determined to be 
significant for purposes of Executive Order 12866 (Sept. 30, 1993).
    Paperwork Reduction Act: This notice 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 collections of information involved in 
this notice have been reviewed and previously approved by OMB under OMB 
control numbers 0651-0022 and 0651-0032. The United States Patent and 
Trademark Office is not resubmitting any information collection package 
to OMB for its review and approval because the changes in this notice 
do not affect the information collection requirements associated with 
the information collection under these OMB control numbers. The 
principal impacts of the changes proposed in this notice are changes to 
the rules of practice to: (1) Require that any deposit of biological 
material be made before publication of a patent application; and (2) 
provide that all restrictions on access to the deposited material 
imposed by the depositor be removed upon publication.
    Interested persons are requested to send comments regarding these 
information collections, including suggestions for reducing this 
burden, to Robert A. Clarke, Director, Office of Patent Legal 
Administration, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 
22313-1450, or to the Office of Information and Regulatory Affairs, 
Office of Management and Budget, New Executive Office Building, Room 
10235, 725 17th Street, NW., Washington, DC 20503, Attention: Desk 
Officer for the Patent and Trademark Office.
    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, Inventions and patents, 
Lawyers.

    For the reasons set forth in the preamble, 37 CFR part 1 is 
proposed to be amended as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

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

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

    2. Section 1.77 is amended by redesignating paragraphs (b)(6) 
through (b)(12) as paragraphs (b)(7) through (b)(13), adding a new 
paragraph (b)(6), and revising paragraphs (b)(1) and (c) to read as 
follows:


Sec.  1.77  Arrangement of application elements.

* * * * *
    (b) * * *
    (1) Title of the invention.
* * * * *
    (6) Reference to a deposit of biological material.
* * * * *
    (c) The text of the specification sections defined in paragraph (b) 
of this section, if applicable, should be preceded by a section heading 
in uppercase and without underlining or bold type.
    3. Section 1.163 is amended by redesignating paragraphs (c)(6) 
through (c)(11) as paragraphs (c)(7) through (c)(12), revising 
paragraph (c)(1), and adding a new paragraph (c)(6) to read as follows:


Sec.  1.163  Specification and arrangement of application elements in a 
plant application.

* * * * *
    (c) * * *
    (1) Title of the invention.
* * * * *
    (6) Deposit of biological material.
* * * * *
    4. Section 1.804 is amended by revising paragraph (a) to read as 
follows:


Sec.  1.804  Time of making an original deposit in order to preserve 
availability of provisional rights under 35 U.S.C. 154(d).

    (a) If deposit of a biological material is necessary to preserve 
the availability of provisional rights under 35 U.S.C. 154(d), an 
original deposit of the biological material must be made either before 
the application is filed or during pendency of the application provided 
that the deposit is made before technical preparations for publication 
of the application as a patent application publication have begun (see 
Sec.  1.215(a)).
* * * * *
    5. Section 1.808 is revised to read as follows:

[[Page 9259]]

Sec.  1.808  Furnishing of samples.

    (a) A deposit must be made under conditions that assure that:
    (1) Access to a deposit will be available during pendency of a 
patent application making reference to the deposit to one determined by 
the Director to be entitled thereto under Sec.  1.14 and 35 U.S.C. 
122(a), 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 earlier of 
publication of the application under Sec.  1.211 and 35 U.S.C. 122(b) 
or grant of the patent, and any deposit referenced in a patent 
application publication or patent will be available to the public upon 
publication or patenting, regardless of whether the deposit was 
necessary for compliance with any statutory provision.
    (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, before the patent is granted or 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.
    (c) Upon request made to the Office, the Office will certify that 
an application referring to the deposit has been filed and that the 
subject matter of that application involves the deposited biological 
material or the use thereof, that the application has been published or 
patented or is otherwise open to public inspection, and the certified 
party has a right to a sample of the biological material, provided the 
request contains:
    (1) The name and address of the depository;
    (2) The accession number given to the deposit;
    (3) The application number referring to the deposit and any patent 
application publication number and publication date, or patent number 
and issue date of the patent; and
    (4) The name and address of the requesting party.
    6. Section 1.809 is amended by revising paragraphs (a), (b), (c), 
and (e) to read as follows:


Sec.  1.809  Examination procedures.

    (a) The examiner shall determine pursuant to Sec.  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 statutory provision, explaining why a 
deposit is needed and/or why a deposit actually made cannot be 
accepted.
    (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, making an acceptable 
original, replacement, or supplemental deposit; 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. A request to hold the making of the deposit 
in abeyance will not be considered a bona fide attempt to advance the 
application to final action (Sec.  1.135(c)).
    (c) If an application for patent is otherwise in condition for 
allowance except for a needed deposit, 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) An amendment required by paragraphs (d)(1), (d)(2) or (d)(4) of 
this section for a biological deposit that is necessary to preserve 
provisional rights under 35 U.S.C. 154(d) must be filed:
    (1) Within a period of sixteen months after the date of filing of 
the application or, if the benefit of an earlier filing date is sought 
under 35 U.S.C. 119(e), 120, 121, or 365(c), within the later of four 
months of the actual filing date of the later-filed application and 
sixteen months from the filing date of the of the prior-filed 
application; and
    (2) Before or with any request for early publication (Sec.  1.219).

    Dated: February 13, 2008.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E8-3084 Filed 2-19-08; 8:45 am]
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