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pdfSUPPORTING STATEMENT
United States Patent and Trademark Office
Patent Term Extension
OMB CONTROL NUMBER 0651-0020
(July 2010)
A.
JUSTIFICATION
1.
Necessity of Information Collection
The patent term restoration portion of the Drug Price Competition and Patent Term
Restoration Act of 1984 (P.L. 98-417), which is codified at 35 U.S.C. 156, permits the
United States Patent and Trademark Office (USPTO) to extend the term of protection under
a patent to compensate for delay during regulatory review and approval by the Food and
Drug Administration (FDA) or Department of Agriculture. Only patents for drug products,
medical devices, food additives, or color additives are potentially eligible for extension. The
maximum length that a patent may be extended under 35 U.S.C. 156 is five years.
Under 35 U.S.C. 156(d), an application for patent term extension must identify the
approved product; the patent to be extended; and the claims included in the patent that
cover the approved product, a method of using the approved product, or a method of
manufacturing the approved product. 35 U.S.C. 156(d) also requires the application for
patent term extension to provide a brief description of the activities undertaken by the
applicant during the regulatory review period with respect to the approved product and the
significant dates of these activities. Under 35 U.S.C. 156(e), an interim extension may be
granted if the term of an eligible patent for which an application for patent term extension
has been submitted would expire before a certificate of extension is issued.
The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791. These rules provide
for the public to, inter alia, submit 35 U.S.C. 156 patent term extension applications to the
USPTO, request interim extensions and review of final eligibility decisions, and withdraw an
application requesting a patent term extension after it is submitted.
Separate from the extension provisions of 35 U.S.C. 156, the USPTO may in some cases
extend the term of an original patent due to certain delays in the prosecution of the patent
application, including delays caused by interference proceedings, secrecy orders, or
appellate review by the Board of Patent Appeals and Interferences or a Federal court in
which the patent is issued pursuant to a decision reversing an adverse determination of
patentability. The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV,
Subtitle D of the Intellectual Property and Communications Omnibus Reform Act of 1999,
require the USPTO to notify the applicant of the patent term adjustment in the notice of
allowance and give the applicant an opportunity to request reconsideration of the USPTO’s
patent term adjustment determination.
The USPTO may also reduce the amount of patent term adjustment granted if delays were
caused by an applicant’s failure to make a reasonable effort to respond within three months
of the mailing date of a communication from the USPTO. Applicants may petition for
reinstatement of a reduction in patent term adjustment with a showing that, in spite of all
due care, the applicant was unable to respond to a communication from the USPTO within
the three month period. The USPTO administers 35 U.S.C. 154 through 37 CFR 1.7011.705.
Table 1 provides the specific statutes and regulations authorizing the USPTO to collect the
information discussed above:
Table 1: Information Requirements for Patent Term Extensions and Adjustments
Requirement
Statute
Rule
Application to Extend Patent Term under 35 U.S.C. 156
35 U.S.C. 156(d)(1)-(4)
37 CFR 1.740-1.741
Request for Interim Extension under 35 U.S.C. 156(e)(2)
35 U.S.C. 156(e)(2)
37 CFR 1.760
Petition to Review Final Eligibility Decision under 37 CFR 1.750
35 U.S.C. 156(d)
37 CFR 1.750
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)
35 U.S.C. 156(d)(5)
37 CFR 1.790
Subsequent Application for Interim Extension under
37 CFR 1.790
35 U.S.C. 156(d)(5)
37 CFR 1.790
Response to Requirement to Elect
35 U.S.C. 156(c)(4)
37 CFR 1.785(b)
Response to Request to Identify Holder of Regulatory Approval
35 U.S.C. 156(d)(1)(E)
37 CFR 1.785(d)
Declaration to Withdraw an Application to Extend Patent Term
35 U.S.C. 156
37 CFR 1.770
Petition for Reconsideration of Patent Term Adjustment
Determination
35 U.S.C. 154(b)(3)(B)(ii)
37 CFR 1.705
Petition for Reinstatement of Reduced Patent Term Adjustment
35 U.S.C. 154(b)(3)(C)
37 CFR 1.705
Petition to Accord a Filing Date to an Application under 37 CFR
1.740 for Extension of a Patent Term
35 U.S.C. 156(d)(1)-(4)
37 CFR 1.741(b)
Request for Recalculation of Patent Term Adjustment in View of
Wyeth
35 U.S.C. 154(b)(2)(A)
37 CFR 1.705
2.
Needs and Uses
The public uses this information collection to file requests related to patent term extensions
and reconsideration or reinstatement of patent term adjustments. The information in this
collection is used by the USPTO to consider whether an applicant is eligible for a patent
term extension or reconsideration of a patent term adjustment and, if so, to determine the
length of the patent term extension or adjustment.
The Information Quality Guidelines from Section 515 of Public Law 106-554, Treasury and
General Government Appropriations Act for Fiscal Year 2001, apply to this information
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collection and comply with all applicable information quality guidelines, i.e. OMB and
specific operating unit guidelines.
This proposed collection of information will result in information that will be collected,
maintained, and used in a way consistent with all applicable OMB and USPTO Information
Quality Guidelines.
Table 2 outlines how this collection of information is used by the public and the USPTO:
Table 2: Needs and Uses of Information Collected for Patent Term Extensions and Adjustments
Form and Function
Form #
Needs and Uses
Application to Extend Patent Term
under 35 U.S.C. 156
No Form
Associated
Used by the public to apply for a patent term extension.
Used by the USPTO and the Department of Health and Human
Services or the Department of Agriculture to determine
eligibility of a patent for extension and to determine the period
of extension.
Request for Interim Extension under
35 U.S.C. 156(e)(2)
No Form
Associated
Used by the public to request an interim extension.
Used by the USPTO to trigger an interim extension before
processing of the application has been completed.
Petition to Review Final Eligibility
Decision under 37 CFR 1.750
No Form
Associated
Used by the public to petition the USPTO to review final
eligibility decisions.
Used by the USPTO to review final eligibility decisions, as long
as the petition is filed within a set time.
Initial Application for Interim Extension
under 35 U.S.C. 156(d)(5)
No Form
Associated
Used by the public to apply for an interim extension.
Used by the USPTO to determine eligibility of a patent for
interim extension.
Subsequent Application for Interim
Extension under 35 CFR 1.790
No Form
Associated
Used by the public to apply for a subsequent interim extension.
Used by the USPTO to determine eligibility of a patent for
subsequent interim extension.
Response to Requirement to Elect
No Form
Associated
Used by the public to elect which patent of more than one
patent to extend.
Used by the USPTO to determine which patent of more than
one patent to extend, or which regulatory review period of more
than one regulatory review period to use in the determination
of the length of patent term extension.
Response to Request to Identify
Holder of Regulatory Approval
No Form
Associated
Used by the public to declare eligibility to apply for a patent
term extension.
Used by the USPTO to determine eligibility of patent owner to
obtain an extension of a patent.
Declaration to Withdraw an
Application to Extend Patent Term
No Form
Associated
Used by the public to withdraw an application to extend a
patent term.
Used by the USPTO to avoid extending patents that the patent
owner no longer seeks to extend.
Petition for Reconsideration of Patent
Term Adjustment Determination
No Form
Associated
Used by the patentee to correct errors in the USPTO’s patent
term adjustment determination.
Used by the USPTO to determine whether its patent term
adjustment determination is in error.
Used by the USPTO to determine the correct patent term
adjustment.
3
Petition for Reinstatement of Reduced
Patent Term Adjustment
No Form
Associated
Used by the patentee to request reinstatement of reduced
patent term adjustment.
Used by the USPTO to determine whether the patentee is
entitled to reinstatement of reduced patent term adjustment.
Petition to Accord a Filing Date to an
Application under 37 CFR 1.740 for
Extension of a Patent Term
No Form
Associated
Used by the patentee to request review of a notice of an
incomplete application for extension of a patent term and to
request a filing date.
Used by the USPTO to determine the filing date for an
application for extension of a patent term.
Request for Recalculation of Patent
Term Adjustment in View of Wyeth
PTO/SB/131
Used by the patentee to request a revised patent term
adjustment based solely on the USPTO’s pre-Wyeth
interpretation of 35 U.S.C. 154(b)(2)(A).
Used by the USPTO to determine the correct patent term
adjustment.
3.
Use of Information Technology
Except for the Application to Extend Patent Term under 35 U.S.C. 156 and the Initial
Application for Interim Extension under 35 U.S.C. 156(d)(5), customers may submit the
items in this information collection electronically through EFS-Web, the USPTO’s online
filing system for patent applications and related documents. EFS-Web is a document
submission system that allows customers to file requests related to patent term extensions
and adjustments through their standard Web browser without downloading special
software, changing their documentation preparation tools, or altering their workflow
processes. Customers may create their requests using the tools and processes that they
already use and then convert those documents into standard PDF files that are submitted
through EFS-Web to the USPTO. The USPTO also provides fillable PDF forms, such as
the Request for Recalculation of Patent Term Adjustment in View of Wyeth (PTO/SB/131),
that can be submitted through EFS-Web. These forms may be downloaded from the
USPTO Web site and do not require special PDF creation software.
Registered and unregistered users can file documents securely through EFS-Web, which is
hosted on secure servers. The documents of registered users are protected using a Public
Key Infrastructure (PKI) system and digital certificates which provide authentication and
encryption security. For filers who are not registered, the documents are submitted to EFSWeb using Transport Layer Security (TLS) or Secure Socket Layer (SSL) protocol.
EFS-Web offers many benefits to filers, including immediate notification that a submission
has been received by the USPTO, automated processing of requests, and avoidance of
postage and other paper delivery costs. After the document has been successfully
submitted through EFS-Web, customers will receive an acknowledgement receipt that lists
the time and date stamp stating when the document was submitted to the USPTO, an
application number, a confirmation number, and other critical information, such as the EFS
ID, a listing of the files and documents associated with the submission, and page counts for
the files and documents. This receipt is the legal equivalent of a postcard in the postcard
receipt practice used for patent application documents that are filed in paper. The USPTO
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recommends that customers print the electronic acknowledgement receipt to keep with
their records.
There are many additional benefits to filing through EFS-Web. Users can access EFS-Web
from any computer with an Internet connection. Since EFS-Web is hosted on the USPTO’s
secure servers and not on the individual’s personal computer, USPTO staff can update
EFS-Web without requiring any action from the user. Customers can submit fee payments
and other requests in real time. The PDF forms can be passed around to multiple users for
collaboration.
EFS-Web integrates with the Patent Application Information Retrieval (PAIR) system, the
USPTO’s online database that is available through the USPTO Web site. PAIR uses digital
certificates to permit only authorized individuals to access information about pending patent
applications and to maintain the confidentiality and integrity of the information as it is
transmitted over the Internet. Information for issued patents, including patent term
adjustments, is available to the general public. The USPTO also publishes determinations
on applications for patent term extensions directly on the USPTO Web site.
4.
Efforts to Identify Duplication
This information is collected only when an applicant submits a request related to a patent
term extension or patent term adjustment. Requests for patent term extensions can only
be filed with the USPTO. The information needed by the USPTO, the Department of Health
and Human Resources, the Department of Agriculture, or other Federal government
agencies to consider such requests is not already available from any other source. This
information is not collected elsewhere and does not result in a duplication of effort.
5.
Minimizing Burden to Small Entities
The USPTO does not expect that this collection will have a significant economic impact on
a substantial number of small businesses or other small entities. Patent term extensions
under 35 U.S.C. 156 are only for patents for drug products, medical devices, food or color
additives, or methods of using or manufacturing such products, devices, or additives.
Patent term extensions are typically requested by large pharmaceutical companies
because of the expense required to develop and obtain marketing approval for such
inventions. The same information is required from every respondent, and this information
is not available from any other source.
6.
Consequences of Less Frequent Collection
The information for a patent term or interim extension is collected only when the applicant
files an application with the USPTO. This information is not found elsewhere and therefore
could not be collected less frequently. If the information were not collected as provided in
35 U.S.C. 156(d)(1) or (d)(5), the Director of the USPTO, the Secretary of Health and
5
Human Services, and the Secretary of Agriculture would not have access to the information
required to determine whether the applicant is eligible for a patent term extension and, if so,
the period of the extension.
There is no requirement that any patent owner apply for an extension. However, if a
request for an extension is made, sufficient information is required by the agencies to
determine whether the statutory requirements for the special benefit have been met. There
is no set frequency of periodic intervals in which the information requested must be
supplied. The submission of a request for a patent term extension is at the discretion of the
patent owner and is normally limited to one submission within 60 days of approval of a
product for commercial use or sale by the Food and Drug Administration or the Department
of Agriculture.
The information for the petitions for reconsideration of patent term adjustment
determination and for reinstatement of reduced patent term adjustment is collected only as
requested and is not found elsewhere. If the information were not collected, the USPTO
would not be able to comply with the statute and regulations that permit applicants to
request reconsideration of a patent term adjustment determination.
7.
Special Circumstances in the Conduct of Information Collection
There are no special circumstances associated with this collection of information.
8.
Consultations Outside the Agency
The 60-Day Notice was published in the Federal Register on April 20, 2010 (75 Fed. Reg.
20561). The comment period ended on June 21, 2010. No public comments were
received.
The USPTO has long-standing relationships with groups from whom patent application
information is collected, such as the American Intellectual Property Law Association, as
well as patent bar associations, independent inventor groups, and users of our public
facilities. Their views are expressed in regularly scheduled meetings and considered in
developing proposals for information collection requirements. There have been no
comments or concerns expressed by these or similar organizations concerning the time
required to provide the information under this program.
9.
Payment or Gifts to Respondents
This information collection does not involve a payment or gift to any respondent.
10.
Assurance of Confidentiality
Confidentiality of patent applications is governed by statute (35 U.S.C. 122) and regulation
(37 CFR 1.11 and 1.14). The USPTO has a legal obligation to maintain the confidentiality
6
of the contents of unpublished patent applications and related documents. Upon
publication of an application or issuance of a patent, the patent application file is made
available to the public, subject to the provisions for providing only a redacted copy of the file
contents. Patent term extensions involve issued patents and therefore typically do not have
confidentiality issues, but there may be confidentiality considerations for patent term
adjustments.
11.
Justification for Sensitive Questions
None of the required information in this collection is considered to be sensitive.
12.
Estimate of Hour and Cost Burden to Respondents
Table 3 calculates the burden hours and costs of this information collection to the public,
based on the following factors:
Respondent Calculation Factors
The USPTO estimates that it will receive approximately 13,586 responses per year
as outlined in the table below.
Burden Hour Calculation Factors
The USPTO estimates that it will take the public from 10 minutes (0.17 hours) to 25
hours, depending on the complexity and type of filing, to gather the necessary
information, prepare the appropriate documents, and submit the information in this
collection to the USPTO.
Cost Burden Calculation Factors
In 2009 the Committee on Economics of Legal Practice of the American Intellectual
Property Law Association published a report that summarized the results of a survey
with data on hourly billing rates. The professional rate of $325 per hour used in this
submission is the median rate for attorneys in private firms as published in that
report. The USPTO expects that the information in this collection will be prepared
by attorneys. This estimate is a fully-loaded hourly rate.
Table 3: Burden Hour/Burden Cost to Respondents for Patent Term Extensions and Adjustments
Item
Application to Extend Patent Term under 35
U.S.C. 156
Request for Interim Extension under 35 U.S.C.
156(e)(2)
Petition to Review Final Eligibility Decision under
37 CFR 1.750
Hours
(a)
Responses
(yr)
(b)
Burden
(hrs/yr)
(c)
(a x b)
Rate
($/yr)
(d)
Total Cost
($/yr)
(e)
(d x e)
25.0
40
1,000
$325.00
$325,000.00
1.0
1
1
$325.00
$325.00
25.0
3
75
$325.00
$24,375.00
7
Initial Application for Interim Extension under
35 U.S.C. 156(d)(5)
20.0
3
60
$325.00
$19,500.00
Subsequent Application for Interim Extension
under 37 CFR 1.790
1.0
1
1
$325.00
$325.00
Response to Requirement to Elect
1.0
5
5
$325.00
$1,625.00
Response to Request to Identify Holder of
Regulatory Approval
2.0
1
2
$325.00
$650.00
Declaration to Withdraw an Application to
Extend Patent Term
2.0
1
2
$325.00
$650.00
Petition for Reconsideration of Patent Term
Adjustment Determination
3.0
1,500
4,500
$325.00
$1,462,500.00
Petition for Reinstatement of Reduced Patent
Term Adjustment
4.0
30
120
$325.00
$39,000.00
Petition to Accord a Filing Date to an Application
under 37 CFR 1.740 for Extension of a Patent
Term
2.0
1
2
$325.00
$650.00
0.17
12,000
2,040
$325.00
$663,000.00
13,586
7,808
- - - - -
$2,537,600.00
Request for Recalculation of Patent Term
Adjustment in View of Wyeth (PTO/SB/131)
Totals
13.
- - - -
Total Annualized (Non-hour) Cost Burden
There are no capital start-up or maintenance costs associated with this information
collection. However, this collection does have annual (non-hour) costs in the form of filing
fees, postage costs, and recordkeeping costs.
This collection has filing fees associated with the requirements for patent term extension
and patent term adjustment. The USPTO estimates that the total filing fees associated with
this collection will be $358,680 per year, as outlined in Table 4 below:
Table 4: Filing Fees to Respondents for Patent Term Extensions and Adjustments
Item
Responses
(a)
Filing
Fees ($)
(b)
Total Non-Hour
Cost Burden
(c)
(a) x (b)
Application to Extend Patent Term under 35 U.S.C. 156
40
$1,120.00
$44,800.00
Request for Interim Extension under 35 U.S.C. 156(e)(2)
1
$0.00
$0.00
Petition to Review Final Eligibility Decision under 37 CFR 1.750
3
$0.00
$0.00
Initial Application for Interim Extension under
35 U.S.C. 156(d)(5)
3
$420.00
$1,260.00
Subsequent Application for Interim Extension under 37 CFR 1.790
1
$220.00
$220.00
Response to Requirement to Elect
5
$0.00
$0.00
Response to Request to Identify Holder of Regulatory Approval
1
$0.00
$0.00
8
Declaration to Withdraw an Application to Extend Patent Term
1
$0.00
$0.00
1,500
$200.00
$300,000.00
30
$400.00
$12,000.00
1
$400.00
$400.00
Request for Recalculation of Patent Term Adjustment in View of Wyeth
(PTO/SB/131)
12,000
$0.00
$0.00
Totals
13,586
......
$358,680.00
Petition for Reconsideration of Patent Term Adjustment Determination
Petition for Reinstatement of Reduced Patent Term Adjustment
Petition to Accord a Filing Date to an Application under 37 CFR 1.740
for Extension of a Patent Term
Customers may incur postage costs when submitting the information in this collection to the
USPTO by mail. The USPTO expects that the Application to Extend Patent Term under 35
U.S.C. 156, the Initial Application for Interim Extension under 35 U.S.C. 156(d)(5), and
approximately 7% of the other responses for this collection will be submitted by mail. The
USPTO estimates that the average first-class postage cost for these 991 mailed
submissions will be 44 cents each, for a total estimated postage cost of $436 per year.
When submitting the information in this collection to the USPTO electronically, the
customer is strongly urged to retain a copy of the acknowledgment receipt as evidence that
the submission was received by the USPTO on the date noted. The USPTO estimates that
it will take 2 minutes (0.03 hours) to print and retain a copy of the acknowledgment receipt
and that approximately 12,595 responses per year will be submitted electronically, for a
total of approximately 378 hours per year for printing this receipt. Using the
paraprofessional rate of $100 per hour, the USPTO estimates that the recordkeeping cost
associated with this collection will be $37,800 per year.
The total annual (non-hour) cost burden for this collection in the form of filing fees
($358,680), postage costs ($436), and recordkeeping costs ($37,800), is $396,916 per
year.
14.
Annual Cost to the Federal Government
The USPTO estimates that it takes a GS-5, step 1 employee between 15 minutes (0.25
hours) and 2 hours to process the various applications, petitions, and requests associated
with patent term extensions and adjustments. The hourly rate for a GS-5, step 1 employee
is currently $16.33. When 30% is added to account for a fully-loaded hourly rate (benefits
and overhead), the hourly rate for a GS-5, step 1 employee is $21.23 ($16.33 + $4.90).
Table 5 calculates the burden hours and costs to the Federal Government for processing
this information collection:
9
Table 5: Burden Hour/Cost to the Federal Government for Patent Term Extensions and Adjustments
Item
Hours
(a)
Responses
(yr)
(b)
Burden
(hrs/yr)
(c)
(a x b)
Rate
($/yr)
(d)
Total Cost
($/yr)
(e)
(d x e)
Application to Extend Patent Term under 35
U.S.C. 156
2.00
40
80
$21.23
$1,698.00
Request for Interim Extension under 35 U.S.C.
156(e)(2)
0.50
1
1
$21.23
$21.00
Petition to Review Final Eligibility Decision under
37 CFR 1.750
0.25
3
1
$21.23
$21.00
Initial Application for Interim Extension under
35 U.S.C. 156(d)(5)
0.50
3
2
$21.23
$42.00
Subsequent Application for Interim Extension
under 37 CFR 1.790
0.50
1
1
$21.23
$21.00
Response to Requirement to Elect
0.25
5
1
$21.23
$21.00
Response to Request to Identify Holder of
Regulatory Approval
0.25
1
1
$21.23
$21.00
Declaration to Withdraw an Application to
Extend Patent Term
0.25
1
1
$21.23
$21.00
Petition for Reconsideration of Patent Term
Adjustment Determination
1.00
1,500
1,500
$21.23
$31,845.00
Petition for Reinstatement of Reduced Patent
Term Adjustment
1.00
30
30
$21.23
$637.00
Petition to Accord a Filing Date to an Application
under 37 CFR 1.740 for Extension of a Patent
Term
0.25
1
1
$21.23
$21.00
Request for Recalculation of Patent Term
Adjustment in View of Wyeth (PTO/SB/131)
0.10
12,000
1,200
$21.23
$25,476.00
13,586
2,819
- - - -
$59,845.00
Totals
15.
- - - -
Reason for Change in Burden
Summary of Changes Since the Previous Renewal
This information collection was previously approved by OMB in February 2008 with a total
of 26,859 responses and 30,905 burden hours per year. OMB also approved an
emergency clearance for the Request for Recalculation of Patent Term Adjustment in View
of Wyeth (PTO/SB/131) in January 2010, which added 12,000 responses and 2,040 hours
for a total burden of 38,859 responses and 32,945 hours for this collection.
For this renewal, the USPTO estimates that the total annual responses will be 13,586 and
the total annual burden hours will be 7,808, which is a decrease of 25,273 responses and
25,137 hours from the currently approved burden for this collection. This decrease in
burden hours is due to administrative adjustments. In addition, the USPTO estimates that
10
the proportion of responses submitted electronically will be approximately 93%, an increase
from the previous estimate of 29%.
The total annual (non-hour) cost burden for this renewal of $396,916 is a decrease of
$5,592,606 from the currently approved total of $5,989,522 in annual costs for this
collection. This decrease in annual costs is due to administrative adjustments.
Changes from the 60-Day Notice
Since the 60-Day Notice for this renewal was published, the USPTO has revised the
estimated time for recordkeeping associated with electronic submissions from 5 seconds
(0.001 hours) to 2 minutes (0.03 hours) per response for printing and retaining the
acknowledgment receipt, increasing the total recordkeeping hours for this collection from 13
to 378 and the associated costs from $1,300 to $37,800 per year. Consequently, the total
estimated annual (non-hour) cost burden has been increased from $360,416 to $396,916
due to the increase in estimated recordkeeping costs.
Change in Respondent Cost Burden
This collection was previously approved in February 2008 using an estimated hourly rate of
$304 for attorneys preparing the information, which yields a respondent cost burden of
$10,015,280 for the currently approved 32,945 burden hours. At the current estimated rate
of $325 per hour for attorneys, the 7,808 burden hours estimated for this renewal yield a
respondent cost burden of $2,537,600, which is a decrease of $7,477,680. This decrease
in respondent cost burden is primarily due to the decrease in total burden hours for the
collection, despite the increase in the estimated hourly rate for attorneys from $304 to
$325.
Changes in Responses and Burden Hours
For this renewal, the USPTO estimates that the total annual responses for this collection
will decrease by 25,273 and the total annual burden hours will decrease by 25,137. This
decrease in burden hours is due to administrative adjustments, as follows:
The USPTO is adjusting the estimated annual responses for the Application to
Extend Patent Term under 35 U.S.C. 156 to 40, which is a decrease of 10 from the
previous estimate of 50. Therefore, this collection takes a burden decrease of
250 hours as an administrative adjustment.
The USPTO is adjusting the estimated annual responses for the Petition to Review
Final Eligibility Decision under 37 CFR 1.750 to 3, which is an increase of 2 from the
previous estimate of 1. Therefore, this collection takes a burden increase of 50
hours as an administrative adjustment.
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The USPTO is adjusting the estimated annual responses for the Initial Application
for Interim Extension under 35 U.S.C. 156(d)(5) to 3, which is an increase of 2 from
the previous estimate of 1. Therefore, this collection takes a burden increase of
40 hours as an administrative adjustment.
The USPTO is adjusting the estimated annual responses for the Response to
Requirement to Elect to 5, which is an increase of 3 from the previous estimate of 2.
Therefore, this collection takes a burden increase of 3 hours as an
administrative adjustment.
The USPTO is adjusting the estimated annual responses for the Petition for
Reconsideration of Patent Term Adjustment Determination to 1,500, which is a
decrease of 22,500 from the previous estimate of 24,000. The USPTO has also
revised the time estimate for preparing this petition, increasing the estimate from 1
hour to 3 hours per response. Therefore, this collection takes a burden
decrease of 19,500 hours as an administrative adjustment.
The USPTO is adjusting the estimated annual responses for the Petition for
Reinstatement of Reduced Patent Term Adjustment to 30, which is a decrease of
2,770 from the previous estimate of 2,800. The USPTO has also revised the time
estimate for preparing this petition, increasing the estimate from 2 hours to 4 hours
per response. Therefore, this collection takes a burden decrease of 5,480
hours as an administrative adjustment.
The USPTO does not expect any changes in the estimated annual responses or
burden hours for the remaining items in the collection.
In sum, this information collection has a total burden decrease of 25,137 hours due
to administrative adjustments.
Changes in Annual (Non-hour) Costs
For this renewal, the USPTO estimates that the total annual (non-hour) costs will decrease
by $5,592,606. This decrease in annual (non-hour) costs is due to administrative
adjustments, as follows:
This collection was previously approved with a total of $5,977,040 in fees. For this
renewal, total estimated fees have decreased to $358,680 due to overall decreases
in the estimated number of responses for items in this collection that have fees.
Therefore, this collection takes a decrease of $5,618,360 in annual (non-hour)
costs as an administrative adjustment.
This collection was previously approved with a total of $11,382 in postage costs.
For this renewal, total estimated postage costs have decreased to $436 primarily
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due to a decrease in the estimated number of responses being submitted by mail.
Therefore, this collection takes a decrease of $10,946 in annual (non-hour)
costs as an administrative adjustment.
This collection was previously approved with a total of $1,100 in recordkeeping
costs. For this renewal, total estimated recordkeeping costs have increased to
$37,800 due to an increase in the estimated number of responses submitted
electronically and an adjustment to the estimated recordkeeping time required per
response. Therefore, this collection takes an increase of $36,700 in annual
(non-hour) costs as an administrative adjustment.
In sum, this collection has a total decrease in annual (non-hour) cost burden of
$5,592,606 due to administrative adjustments.
16.
Project Schedule
The USPTO does not plan to publish this information for statistical use or for any special
purpose. However, plant and utility patents granted are published weekly in the Official
Gazette of the United States Patent and Trademark Office for Patents (Official Gazette for
Patents), which is published in electronic format on the USPTO Web site. The USPTO also
publishes determinations on applications for patent term extension on the USPTO Web site
as required by the Freedom of Information Act and lists any certificates of extension
granted in the Official Gazette for Patents.
17.
Display of Expiration Date of OMB Approval
The form in this information collection will display the OMB Control Number and the
expiration date of OMB approval.
18.
Exceptions to the Certificate Statement
This collection of information does not include any exceptions to the certificate statement.
B.
COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS
This collection of information does not employ statistical methods.
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REFERENCES
A.
B.
B.
The USPTO Information Quality Guidelines
Request for Recalculation of Patent Term Adjustment in View of Wyeth
(PTO/SB/131)
60-Day Notice published in the Federal Register on April 20, 2010 (75 Fed. Reg.
20561)
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| File Type | application/pdf |
| File Title | Microsoft Word - 0651-0020-JustStmt-Jul2010-final.doc |
| File Modified | 2010-07-12 |
| File Created | 2010-07-12 |