SUPPORTING STATEMENT
United States Patent and Trademark Office
Requirements for Patent Applications Containing Nucleotide Sequence
and/or Amino Acid Sequence Disclosures
OMB CONTROL NUMBER 0651-0024
July 2019
A. JUSTIFICATION
1. Necessity of Information Collection
Patent applications that contain nucleotide and/or amino acid sequence disclosures that fall within the definitions of 37 CFR 1.821(a) must include, as a separate part of the application disclosure, a copy of the sequence listing in accordance with the requirements in 37 CFR 1.821-1.825. Applicants may submit sequence listings for both U.S. and international patent applications. Submissions of sequence listings in international applications are in accordance with Patent Cooperation Treaty (PCT) Rules 5.2 and 13ter, as well as the PCT Administrative Instructions, Annex C.
This information collection covers the submission of the sequence listing information itself. Information pertaining to the filing of the initial U.S. patent application is collected under OMB Control Number 0651-0032, and information pertaining to the filing of the initial international application is collected under OMB Control Number 0651-0021.
In particular, this information collection accounts for sequence listings submitted on paper, compact disc (CD), or through EFS-Web, the USPTO’s online filing system. Sequence listings may be submitted via EFS-Web as an ASCII text file or in Portable Document Format (PDF). For U.S. applications, § 1.821(c) permits all modes of submission: paper, CD, or EFS-Web. Sequence listings for international applications may be submitted on paper or through EFS-Web only, though sequence listings that are too large to be filed electronically though EFS-Web may be submitted on CD.
This information collection also accounts for the requirement under § 1.821(e) that a copy of the sequence listing required by § 1.821(c) be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824. Under §§ 1.821(e)–(f), applicants who submit their sequence listings on paper, CD, or as a PDF via EFS-Web must submit a copy of the sequence listing in CRF with a statement indicating that the CRF copy of the sequence listing is identical to the paper, CD, or PDF copy provided under § 1.821(c). Applicants may submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable media as provided in § 1.824. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of §§ 1.824(a)(2)–(6) and (b), and applicant has not filed a sequence listing on paper, CD or as a PDF file, the text file will serve as both the copy required by § 1.821(c) and the CRF required by § 1.821(e). Moreover, the associated statement of identity would not be required.
This information collection also covers the mechanism in § 1.821(e) where an applicant may request, in limited circumstances, a transfer of the CRF from the application already on file to the new application, if the CRF sequence listing in a new application is identical to the CRF sequence listing of another application that the applicant already has on file at the USPTO. In such a case, the applicant may submit a letter identifying the application and CRF sequence listing that is already on file and stating that the sequence listing submitted in the new application is identical to the CRF copy already filed with the previous application. The USPTO provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.
Table 1 provides the specific statute and regulations authorizing the USPTO to collect the information discussed above:
Table 1: Information Requirements
IC Number |
Requirement |
Statute |
Rule |
1 |
Sequence Listing in Application |
35 U.S.C. § 22 |
37 CFR 1.821-1.825 |
2 |
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) |
35 U.S.C. § 22 |
37 CFR 1.821-1.825 |
2. Needs and Uses
The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application. The USPTO also uses the sequence listings to support the publication of applications and issued patents. The USPTO enters the information in the CRF into the USPTO’s database for searching and printing nucleotide and amino acid sequences. Upon publication of the application or issued patent, the associated nucleotide or amino acid sequence listings are disclosed to the public and made available on the USPTO website. Copies of sequence listings from issued patents may be forwarded to the National Center for Biotechnology Information for inclusion in their sequence database. Applicants use sequence listings when preparing both national and international patent applications involving nucleotide or amino acid sequences to provide a written description of the invention and to distinguish the claimed subject matter from the prior art.
The information collected, maintained, and used in this collection is based on OMB and USPTO guidelines. This includes the basic information quality standards established in the Paperwork Reduction Act (44 U.S.C. Chapter 35), in OMB Circular A-130, and in the 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
IC Number |
Item |
Form # |
Needs and Uses |
1 |
Sequence Listing in Application (paper) |
No Form Associated |
|
1 |
Sequence Listing in Application (CD) |
No Form Associated |
|
1 |
Sequence Listing in Application (electronic) |
No Form Associated |
|
2 |
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) |
PTO/SB/93 |
|
3. Use of Information Technology
For U.S. applications, applicants may submit sequence listings on paper, CD, or electronically through EFS-Web. Due to PCT guidelines, sequence listings for international applications may not be submitted on CD, except for oversized listings that are too large to submit online (more detail below). Submissions on CD must follow the guidelines specified in 37 CFR 1.52(e). Applicants who submit their sequence listings on paper, CD, or as a PDF via EFS-Web also are required to submit a CRF copy of the listing, which facilitates the ability of examiners to search sequences and improves the accuracy and efficiency of the publishing process.
Filers submitting sequence listings to the USPTO electronically through EFS-Web upload the listings using the secure EFS-Web interface. EFS-Web will display a warning if the sequence listing does not conform to the proper format.
EFS-Web offers many potential benefits to filers. The system immediately sends customers an electronic receipt and ensures that electronic sequence listings are transmitted securely to the USPTO. The electronic filing of sequence listings also eliminates the inefficiencies of physically mailing, handling, routing, and storing sequence listings on paper or portable electronic media.
Sequence listing files that exceed 100 megabytes may not be submitted online via EFS-Web. These oversized sequence listings should be copied onto CD for submission to the USPTO by mail. Customers are advised to keep a back-up copy of the CD and transmittal information for their own records, and they also may submit a second copy of the CD to the USPTO to be used in case the first copy is unreadable. The acceptance of CDs and electronic submissions is permitted by 35 U.S.C. § 22, which provides that the USPTO “may require papers filed in the Patent and Trademark Office to be printed, typewritten, or on an electronic medium.”
The USPTO provides free PatentIn authoring software that may be used by applicants to create sequence listings that comply with U.S. and international filing standards. The PatentIn software may be downloaded from the USPTO website, and the USPTO offers in-person and online training on how to use the software. In addition, the USPTO provides a CRF Checker software tool that allows applicants to test sequence listings for compliance with format and content rules before submitting them to the USPTO. Use of the Checker utility reduces the number of sequence listings that the USPTO must return to customers for correction of errors.
For CRF copies submitted to the USPTO, the data format is checked for compliance by the CRF receipt system and then uploaded to the Automated Biotechnology Sequence Search (ABSS) System database. ABSS stores electronic sequence listings submitted by applicants and supports searching of biosequences from patent submissions as well as public and commercial databases of published biosequence data. ABSS also supports the publication and dissemination of sequence listings following publication of the associated application or issuance of the patent.
Upon publication of the application or issued patent, the associated nucleotide or amino acid sequence listings are disclosed to the public. Sequence listings that are extremely long (files larger than 600K or approximately 300 printed pages) are published only in electronic form and are available for public viewing or download through the Publication Site for Issued and Published Sequences (PSIPS) on the USPTO website (http://seqdata.uspto.gov). Shorter sequence listings are available through the standard patent and application search systems on the USPTO website.
4. Efforts to Identify Duplication
This collection requires the duplication of a limited amount of identifying information (such as the applicant’s name, address, and phone number), which is also provided on the patent application. However, the duplication of identification information is the most efficient way of accurately associating the sequence listing with the appropriate application case file.
For sequence listings that are submitted on paper, CD, or as a PDF via EFS-Web, the applicant also must submit a separate CRF copy of the listing. However, if the applicant already has an identical CRF sequence listing on file at the USPTO for another application, the applicant may submit a statement referencing the CRF listing already on file rather than having to submit a duplicate copy of the CRF listing for the new application. The USPTO provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.
5. Minimizing Burden to Small Entities
Although the collection may involve small businesses or other small entities, most applications involving sequence listings are filed by entities other than small entities. This collection does not impose a significant economic impact on small businesses or other small entities. The same information is required from every applicant and is not available from any other source.
The information collection involves payment of fees by customers who may qualify as small entities. To reduce this cost burden for small entities, the USPTO offers reduced application size fees for persons, small business concerns, or nonprofit organizations that qualify as small entities (including micro entities) under 37 CFR 1.27 (see 37 CFR 1.29 for micro entity status). No significant burden is placed on small entities, in that small entities are simply required to identify themselves as such in order to obtain these benefits. An assertion of small entity status (or a certification of entitlement to micro entity status) only needs to be filed once in an application or patent.
6. Consequences of Less Frequent Collection
This collection of information is required for the processing and examination of the respondent's patent application involving a nucleotide or amino acid sequence listing. This information could not be collected less frequently. If the information were not collected, the USPTO could not properly examine the associated application as required by 35 U.S.C. § 131. Further, the collection of this information is necessary in order to publish the sequence listings accurately as part of the application or patent.
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 Federal Register Notice was published on April 22, 2019 (84 FR 16652). The comment period ended on May 16, 2016. No comments were received from the public.
The USPTO has long-standing relationships with groups from whom patent application data is collected, such as the American Intellectual Property Law Association (AIPLA), as well as patent bar associations, independent inventor groups, and users of our public facilities. The USPTO also is in frequent contact with groups from whom sequence information is collected, such as BIO, the Biotechnology subgroup of the AIPLA, and the Biotechnology Institute. Views expressed by all of these groups are considered in developing proposals for information collection requirements and during the renewal of an information collection. No views have been expressed regarding the present renewal.
9. Payments or Gifts to Respondents
This information collection does not involve a payment or gift to any respondent.
10. Assurance of Confidentiality
The 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 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.
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 28,850 responses per year for this collection, with approximately 25% of these responses submitted by small entities.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected by these items.
Burden Hour Calculation Factors
The USPTO estimates that it will take the public approximately 6 minutes (0.10 hours) to 6 hours to gather the necessary information, prepare the form or sequence listing, and submit it to the USPTO.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected and the length of time necessary to complete responses containing similar or like information.
Cost Burden Calculation Factors
The USPTO uses a professional rate of $438 per hour for respondent cost burden calculations, which is the mean rate for attorneys in private firms as shown in the 2017 Report of the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association (AIPLA).
The USPTO estimates that a sequence listing will take approximately five hours of paraprofessional time at an estimated rate of $145 per hour and one hour of attorney time at $438 per hour, for a weighted average rate of $193.83 per hour for preparing a sequence listing. The USPTO expects that the Request for Transfer of a CRF will be prepared by a paraprofessional at an estimated rate of $145 per hour.
Table 3: Burden Hour/Burden Cost to Respondents
IC Number |
Item |
Estimated Response Time (Hours) (a) |
Estimated Annual Responses
(b) |
Estimated Annual Burden Hours
(a) x (b) = (c) |
Rate ($/hr)
(d) |
Total Cost ($/yr)
(c) x (d) = (e) |
1 |
Sequence Listing in Application (paper) |
6.00 |
5,000 |
30,000 |
$193.83 |
$5,814,900.00 |
1 |
Sequence Listing in Application (CD) |
6.00 |
300 |
1,800 |
$193.83 |
$348,894.00 |
1 |
Sequence Listing in Application (electronic) |
6.00 |
22,000 |
132,000 |
$193.83 |
$25,585,560.00 |
2 |
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93) |
0.10 |
1,550 |
155 |
$145.00 |
$22,475.00 |
|
Totals |
- - - |
28,850 |
163,955 |
- - - |
$31,771,829.00 |
13. Total Annual (Non-hour) Cost Burden
The total annual (non-hour) respondent cost burden for this collection is calculated in Tables 4 and 5 below. This collection has no capital start-up, maintenance, or recordkeeping costs. It does, however, have a non-hour cost burden in the form of filing fees and postage costs.
Filing Fees
In accordance with 35 U.S.C. § 41(a)(1)(G), the USPTO charges a fee for submitting a sequence listing as part of a U.S. application or as part of an international application entering the U.S. national stage if the sequence listing (i) is not filed via EFS-Web or not filed on an electronic medium in compliance with §§ 1.52(e) and 1.821(c) or (e), and (ii) causes the application to exceed 100 pages. (See 37 CFR 1.52(f)). Under 37 CFR 1.16(s) and 1.492(j) for U.S. applications and international applications entering the U.S. national stage, respectively, if the application, including the sequence listings filed on paper or on a non-compliant electronic medium, exceeds 100 pages, the application size fee is $400 (or $200 for small entities and $100 for micro entities) for each additional 50 pages or fraction thereof. The USPTO estimates the following with respect to the number of applications that will include long sequence listings filed on paper or on a non-compliant electronic medium and the average application size fee that such applications will incur: (i) approximately 160 applications from large entities will incur an average application size fee of $1,200; (ii) approximately 80 applications from small entities will incur an average application size fee of $600; and (iii) approximately 32 applications from micro entities will incur an average application size fee of $300. The estimate corresponds to a total fee cost of $240,000, $60,000, and $12,000, respectively.
As a Receiving Office, the USPTO collects the international filing fee for each international application it receives. The basic international filing fee only covers the first 30 pages of the international application. As a result, a $15 fee per page is added to the international filing fee for each page over 30 pages of an international application including a sequence listing filed on paper or in PDF format. No page fees are triggered by sequence listings that are submitted via EFS-Web in the proper text format. The average length of a sequence listing filed on paper or in PDF format in an international application is 150 pages, which would carry an additional fee of $2,250 if the international application were already at least 30 pages long without the listing. The USPTO estimates that approximately 520 of the 6,000 sequence listings filed per year on paper or in PDF format will be for international applications.
The USPTO charges a fee for the handling of mega sequence listings, i.e., sequence listings of 300 MB or more. Pricing for this fee is divided into two tiers with Tier 1 for file sizes 300 MB to 800 MB and Tier 2 for file sizes greater than 800 MB. The USPTO also charges a fee, i.e., the Late Furnishing Fee for Providing a Sequence Listing in Response to an Invitation Under PCT Rule 13ter, to encourage timely filing of sequence listings in international applications and to facilitate the effective administration of the patent system.
Table 4: Filing Fee Costs
IC Number |
Item |
Estimated Annual Responses (a) |
Fee Amount
(b) |
Total Fees
(a) x (b) = (c) |
1 |
Size fees under 37 CFR 1.16(s) and 1.492(j), large entity |
160 |
$1,200.00 |
$192,000.00 |
1 |
Size fees under 37 CFR 1.16(s) and 1.492(j), small entity |
80 |
$600.00 |
$48,000.00 |
1 |
Size fees under 37 CFR 1.16(s) and 1.492(j), micro entity |
32 |
$300.00 |
$9,600.00 |
1 |
Size fees for international applications |
520 |
$2,250.00 |
$1,170,000.00 |
1 |
Submission of sequence listings of 300MB to 800MB (large entity) |
20 |
$1,000.00 |
$20,000.00 |
1 |
Submission of sequence listings of 300MB to 800MB (small entity) |
13 |
$500.00 |
$6,500.00 |
1 |
Submission of sequence listings of 300MB to 800MB (micro entity) |
2 |
$250.00 |
$500.00 |
1 |
Submission of sequence listings of more than 800MB (large entity) |
1 |
$10,000.00 |
$10,000.00 |
1 |
Submission of sequence listings of more than 800MB (small entity) |
1 |
$5,000.00 |
$5,000.00 |
1 |
Submission of sequence listings of more than 800MB (micro entity) |
1 |
$2,500.00 |
$2,500.00 |
1 |
Late Furnishing Fee for Providing a Sequence Listing in Response to an Invitation Under PCT Rule 13ter (large entity) |
91 |
$300.00 |
$27,300.00 |
1 |
Late Furnishing Fee for Providing a Sequence Listing in Response to an Invitation Under PCT Rule 13ter (small entity) |
312 |
$150.00 |
$46,800.00 |
1 |
Late Furnishing Fee for Providing a Sequence Listing in Response to an Invitation Under PCT Rule 13ter (micro entity) |
3 |
$75.00 |
$225.00 |
|
Totals |
28,536 |
- - - |
$1,538,425.00 |
Postage
Mailed submissions may include the sequence listing on either paper or CD, the CRF copy of the listing on CD, and a transmittal letter containing the required identifying information. The USPTO estimates that the average postage cost for a paper or CD sequence listing submission will be $6.55 (USPS Priority Mail, flat rate envelope) and that 5,300 sequence listings will be mailed to the USPTO per year.
Table 5: Postage Costs
IC Number |
Item |
Estimated Annual Responses (a) |
Postage Rate
(b) |
Total Postage Cost
(a) x (b) = (c) |
1
|
Postage for paper or CD sequence listing submissions |
5,300 |
$6.55 |
$34,715.00 |
|
Totals |
5,300 |
- - - |
$34,715.00 |
With fee costs totaling $1,538,425.00 and postage costs totaling $34,715.00, the USPTO estimates that the total annual non-hourly cost burden for this collection will amount to $1,573,140.00.
14. Annual Cost to the Federal Government
Sequence disclosures are processed in two stages. The USPTO estimates that the first stage takes approximately 8 minutes of processing time by a GS-6, step 1 employee, and that the second stage takes approximately 16 minutes of processing time by a GS-12, step 1 or GS-13, step 1 employee, for a total of 24 minutes (0.40 hours) of processing time per response. The hourly rate for a GS-6, step 1 employee is currently $20.27, and the average hourly rate of a GS-12, step 1 ($39.96) and GS-13, step 1 ($47.52) is currently $43.74. These rates produce a weighted average hourly rate of $33.37, which results in a fully-loaded hourly rate of $46.61 per hour ($35.85 with 30% ($10.76) added for benefits and overhead for processing the sequence disclosures.
The USPTO estimates that it takes a GS-6, step 1 employee an average of 8 minutes (0.13 hours) to process a Request for Transfer of a CRF at an estimated fully-loaded cost of $26.35 per hour (GS hourly rate of $20.27 with 30% ($6.08) added for benefits and overhead).
Table 6 calculates the burden hours and costs to the Federal Government for processing this information collection:
Table 6: Burden Hour/Burden Cost to the Federal Government
IC Number |
Item |
Estimated Response Time (Hours) (a) |
Estimated Annual Responses
(b) |
Estimated Annual Burden Hours (a) x (b) = (c) |
Rate ($/hr)
(d) |
Total Cost ($/yr)
(c) x (d) = (e) |
1 |
Sequence Listing in Application (paper) |
0.40 |
5,000 |
2,000 |
$46.61 |
$93,220.00 |
1 |
Sequence Listing in Application (CD) |
0.40 |
300 |
120 |
$46.61 |
$5,593.20 |
1 |
Sequence Listing in Application (electronic) |
0.40 |
22,000 |
8,800 |
$46.61 |
$410,168.00 |
2 |
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93) |
0.13 |
1,550 |
207 |
$26.35 |
$5,454.45 |
|
Totals |
- - - |
28,850 |
11,127 |
- - - |
$514,435.65 |
15. Reasons for Changes in Burden from the Current Inventory
A. Changes in Collection Since Previous OMB Approval in 2016
OMB previously approved a Change Worksheet of this information collection in July 2016. That renewal contained:
27,200 responses
152,285 burden hours
$ 26,260,375.00 in respondent hourly cost burden
$ 1,815,457.50 in annual (non-hour) costs
There was a Change Worksheet for this collection approved in 2017. There were no changes in burden, except for the non-hour costs, which rose to $1,932,182.
B. Changes proposed to this request to OMB
The proposed collection, as outlined in the tables above, seeks to modify the existing collection. The proposed collection contains an estimated:
28,850 responses
163,955 burden hours
$31,771,829.00 in respondent hourly cost burden
$1,573,140.00 in annual (non-hour) costs
Changes in Respondent Cost Burden
The total respondent cost burden for this collection has increased by $5,511,454.00 (from $26,260,375.00 to $31,771,829.00) from the previous renewal to this collection in July 2016:
Increase in estimated hourly rates. The 2016 renewal used an estimated rate of $410 per hour for respondents to this collection, which was the estimated attorney rate for intellectual property attorneys in private firms. For the current renewal, the USPTO is using updated hourly rates of $438 for attorneys. Additionally, the previous renewal used a $125 rate for paralegals, which has since increased to $145.
Increase in estimated burden hours. The total estimated burden hours have increased from 152,285 in the 2016 renewal to 163,955 for the current renewal due to overall increase in the estimated annual responses for this collection.
Changes in Responses and Burden Hours
For this renewal, the USPTO estimates that the annual responses will increase by 3,600 (from 25,250 to 28,850) and the total burden hours will increase by 25,730 (from 15,285 to 163,955) from the currently approved burden for this collection.
Changes in Annual (Non-hour) Costs
The USPTO estimates that there will be a decrease of $359,042.00 (from $1,932,182 to $1,573,140.00) in the annual (non-hour) cost burden.
16. Project Schedule
The USPTO does not plan to publish this information for statistical use. However, sequence listing information will be published as part of the routine pre-grant publication of applications as well as issued 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. Exception 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.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Styles, Nicholas (AMBIT) |
| File Modified | 0000-00-00 |
| File Created | 2021-01-15 |