(130) 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.
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 (http://frwebgate.
access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=
http://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: http://frwebgate.access.gpo.gov/cgi-
bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://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
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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 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.
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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 § 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 http://frwebgate.access.gpo.gov/cgi-
bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.gao.gov.
The Office had previously proposed changes to § 1.809 in order
to reduce delays after allowance of a patent application. See Changes
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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 § 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 § 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 § 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 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,
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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 § 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 §
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
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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 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 § 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 § 1.215(a)).
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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 § 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
(http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&
log=linklog&to=http://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 (§ 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 § 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 (§ 1.219)."
Of course, § 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
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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)(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 trademark 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
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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:
§ 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:
§ 1.163 Specification and arrangement of application elements in a
plant application.
* * * * *
(c) * * *
(1) Title of the invention.
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* * * * *
(6) Deposit of biological material.
* * * * *
4. Section 1.804 is amended by revising paragraph (a) to read as
follows:
§ 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
§ 1.215(a)).
* * * * *
5. Section 1.808 is revised to read as follows:
§ 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 § 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 § 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:
§ 1.809 Examination procedures.
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(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 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 § 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 (§ 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 §
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 § 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 (§ 1.219).
February 13, 2008 JON W. DUDAS
Under Secretary of Commerce for
Intellectual Property and Director of the
United States Patent and Trademark Office
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