Draft Performance Work Statement.pdf

United States Patent and Trademark Office

PISO

Performance Work Statement

Form # USPTO-OP-020 (08/2020) Page 1 of 20

1. Requirement Title:

PCT International Search and Opinion (PISO)

2. Background

The Patent Cooperation Treaty (PCT) is a multilateral treaty administered by the International Bureau (IB) of the World Intellectual Property Organization (WIPO). As of July 2020, there are 153 countries that are party to the PCT (“PCT Contracting States”). The PCT provides applicants with a simplified means for effectively filing patent applications in those countries by filing a single international application (IA).

Upon completion of a formalities review by the Receiving Office (RO), a copy of the IA is forwarded to the International Searching Authority (ISA) that applicant selected for performance of an international-type search and the preparation of the International Search Report (ISR) or Declaration of Non-Establishment of International Search Report together with the Written Opinion (WO) of the ISA.

The United States Patent and Trademark Office (USPTO) in its capacity as an ISA prepares approximately 22,000 ISR/WOs per year. The timely completion of these ISR/WOs is essential in order for the applicants to obtain an international search and opinion prior to their deadline for submission of a national stage application in one (1) or more of the PCT Contracting States.

3. Purpose

The purpose of PISO is to secure professional comprehensive services to provide an International Search Report (ISR) and a Written Opinion (WO) of the International Searching Authority under the provisions of the Patent Cooperation Treaty (PCT) for international applications in which the United States Patent and Trademark Office (USPTO) is the International Searching Authority (ISA).

The USPTO anticipates award of multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts having a one (1) year base period and four (4) one (1) year option periods. The USPTO reserves the right to single award if deemed in the USPTO’s best interest to do so.

In the CLIN table below the estimated (total for all ISA/US filings) quantities are provided. These estimated quantities are based on the FY 2016-2020 actual ISA/US filings and full USPTO funding levels.

The estimate is not a guarantee that the estimated quantity will be required or ordered or that conditions affecting the requirement may be stable or normal. Some factors that may affect the actual quantities include economic factors, including USPTO funding levels, the addition of further competent International Searching Authorities (ISAs) for applications filed with the United States Receiving Office (RO/US), and changes in the search fees required by the ISAs.

3.1 The following tables detail the CLINs for the Base Period and each Option Period.

BASE PERIOD (initial 12 month period)

CLIN DESCRIPTION Est. Unit Price

Extended Price

International Search Report and Written Opinion. 100% of ISA/US filings**

22,341 $ *

Form # USPTO-OP-020 (08/2020) Page 2 of 20

0001A Tier A: 25% of ISA/US filings** 5,709 $ *

0001B Tier B: 45% of ISA/US filings** 10,053 $ *

0001C Tier C: 65% of ISA/US filings** 14,522 $ *

0001D

Additional charge for each additional invention to be searched if lack of unity exists and applicant agrees to pay for search of at least one additional invention

3.90% $ *

0002 IT Security Implementation (ATO and Annual Assessment)***

0003 Withdrawn Applications 0 $350

OPTION PERIOD 1 (12 month period starting at end of Base Period)

CLIN DESCRIPTION Est. Unit Price

Extended Price

International Search Report and Written Opinion. 100% of ISA/US filings**

22,609 $ *

1001A Tier A: 25% of ISA/US filings** 5,777 $ *

1001B Tier B: 45% of ISA/US filings** 10,174 $ *

1001C Tier C: 65% of ISA/US filings** 14,696 $ *

1001D

Additional charge for each additional invention to be searched if lack of unity exists and applicant agrees to pay for search of at least one additional invention

3.90% $ *

1002 IT Security Implementation (ATO and Annual Assessment)***

1003 Withdrawn Applications 0 $350

PISO

Performance Work Statement

Form # USPTO-OP-020 (08/2020) Page 3 of 20

OPTION PERIOD 2 (12 month period starting at end of Option Period 1)

CLIN DESCRIPTION Est. Unit Price

Extended Price

International Search Report and Written Opinion. 100% of ISA/US filings**

22,880 $ *

2001A Tier A: 25% of ISA/US filings** 5,846 $ *

2001B Tier B: 45% of ISA/US filings** 10,296 $ *

2001C Tier C: 65% of ISA/US filings** 14,872 $ *

2001D

Additional charge for each additional invention to be searched if lack of unity exists and applicant agrees to pay for search of at least one additional invention

3.90% $ *

2002 IT Security Implementation (ATO and Annual Assessment)***

2003 Withdrawn Applications 0 $350

OPTION PERIOD 3 (12 month period starting at end of Option Period 2)

CLIN DESCRIPTION Est. Unit Price

Extended Price

International Search Report and Written Opinion. 100% of ISA/US filings**

23,155 $ *

3001A Tier A: 25% of ISA/US filings** 5,917 $ *

3001B Tier B: 45% of ISA/US filings** 10,420 $ *

3001C Tier C: 65% of ISA/US filings** 15,051 $ *

3001D

Additional charge for each additional invention to be searched if lack of unity exists and applicant agrees to pay for search of at least one additional invention

3.90% $ *

Form # USPTO-OP-020 (08/2020) Page 4 of 20

3002 IT Security Implementation (ATO and Annual Assessment)***

3003 Withdrawn Applications 0 $350

OPTION PERIOD 4 (12 month period starting at end of Option Period 3)

CLIN DESCRIPTION Est. Unit Price

Extended Price

International Search Report and Written Opinion. 100% of ISA/US filings**

23,433 $ *

4001A Tier A: 25% of ISA/US filings** 5,988 $ *

4001B Tier B: 45% of ISA/US filings** 10,545 $ *

4001C Tier C: 65% of ISA/US filings** 15,231 $ *

4001D

Additional charge for each additional invention to be searched if lack of unity exists and applicant agrees to pay for search of at least one additional invention

3.90% $ *

4002 IT Security Implementation (ATO and Annual Assessment)***

4003 Withdrawn Applications 0 $350

Notes:

* The Extended Price equals the estimated units times the unit price for CLIN #001-#001C. To obtain the extended price for CLIN #001D, multiply the unit price by the estimated quantity for CLIN #001D using the main CLIN #001 estimated units, i.e. for CLIN 0001 (22341 * 0.039).

** “ISA/US filings” is defined as the number of ISA/US filings that the USPTO is budgeted to outsource for the performance period. The number of ISA/US filings for a given Period of Performance, i.e. Base Period or Option Period, is anticipated to be the total number of ISA/US filings minus a small percentage of ISA/US filings that are completed internally. However, there is the possibility that the estimated volume could be reduced by required line item budget reductions, which would affect the estimated number but not the Tier. Likewise, if ISA/US filings increase higher than currently projected, the estimated volume may be increased. The USPTO will notify the Contractor of which Tier is awarded/exercised at contract award and upon notification of the exercise of any option period along with the estimated total ISA/US filings for the option period. See Section 3.1.1. below.

***CLIN 0002 will be a cost reimbursement CLIN for cost associated with the obtainment of an initial ATO and the annual assessment and IT assessment-based maintenance. The cost reimbursement will be limited to the cost of the independent assessor and other specific items related to the initial ATO and annual assessment (TBD and set forth in the RFP).

Form # USPTO-OP-020 (08/2020) Page 5 of 20

CLIN #001-C consists of eight (8) technical fields. The technical fields are defined in Attachment 1 and may be assigned by the USPTO via mapping to USPC, CPC, or through other means, such as artificial intelligence. The CY17 through CY19 breakdowns by technical field were: 3.0% (TF01), 10.3% (TF02), 20.1% (TF03), 9.3% (TF04), 5.4% (TF05), 13.2% (TF06), 16.5% (TF07), and 22.3% (TF08). The current USPC and CPC classification systems can be found at: https://www.uspto.gov/patents-application-process/patent-search/classification-standards-and-development.

CLIN #001 will be assigned under a specific tier, i.e. CLIN #001, CLIN #001A, CLIN #001B, or CLIN #001C, for each period of performance to set the minimum percentage of main CLIN applications that will be assigned for the given performance period. For example, if the USPTO awards two (2) contracts, the USPTO may assign all work for one (1) Contractor using the Tier A CLIN and the other Contractor may have all work assigned using the Tier C CLIN. However, the USPTO may assign work in excess of the minimum percentage of a given Tier. For example, in the Base Period, the USPTO may award a Contractor Tier A for the base period but assign 35% of the ISA/US filings to this Contractor, estimated to be ~7,727 CLIN 1 applications. If multiple awards are made, before each option period, the USPTO will notify the contractors, consistent with any contract notice requirements, of the assigned average percentage of volumes for that forthcoming option period. Further details regarding the tier assignments and considerations are detailed below in Section 3.1.1.

Due to the nature of Sub-line item 0001D, the Government cannot provide estimated minimum quantities, but the percentage provided is the best estimate in terms of an estimated percentage of CLIN 001 based on historical data. Specifically, the estimate of 3.9% for all of the main CLINs means that it is estimated that 39 additional inventions will be paid for by the applicant per 1000 ISA/US applications.

As shown in the Pricing Table, the percentages of filings will be assigned via the exercise of Option Period CLINs/sub-CLINs, i.e. #001-#001C. The USPTO may unilaterally exercise these Option Period CLINs throughout the life of the contract in accordance with Optional CLIN and Task Clause [TBD inserted in final RFP]. Therefore, Contractor workloads may vary (i.e., move up or down) or stay the same Tier for each performance period of the contract. The USPTO will strive to notify the contractors of their assigned Tier and volume percentage as early as possible before the subsequent option period. See Section 3.1.1.

3.1.1. Tier level details and determinations

At contract award and at the notification of exercise of an option period, the USPTO will notify the contractor of which CLIN, Tier level and the anticipated percentage along with an estimated yearly total of applications expected to be assigned. All applications assigned during that period will be at the USPTO selected Tier pricing level.

The USPTO will provide updated estimated volumes for the upcoming option period no later than 90 days prior to the beginning of the next option period. These estimated volumes will be based on the estimated filing and USPTO funding levels. If desired, the contractor may propose updated Tier pricing, not to exceed the contract pricing, for the upcoming option period up to 60 days prior to the beginning of the next option period for consideration by the USPTO.

If multiple awards are made, the USPTO will use an internal best value analysis to determine the Tier that each contractor will receive for the upcoming option period and notify the contractor no later than 30 days prior to the beginning of the next option period. The USPTO will weigh the following factors in making this determination: quality of deliverables, pricing, and timeliness/capacity (see Section 3.1.3). Quality will be the most highly weighted factor and will be given significantly more weight than the other factors. The quality factors will weigh the following significant sub-factors the highest, listed in order of importance:

level 1 compliance rate (Section 4.5.1) and level 2 (Section 4.5.2), and contractor’s performance with respect to the other acceptance criteria (Section 4.5.3-5). The USPTO will consider the quality data over the entire contract, but weigh the most recent period of performance more heavily. The USPTO consider

PISO

Performance Work Statement https://www.uspto.gov/patents-application-process/patent-search/classification-standards-and-development https://www.uspto.gov/patents-application-process/patent-search/classification-standards-and-development

Form # USPTO-OP-020 (08/2020) Page 6 of 20 the contractor’s technical proposal and capacity (as set forth in the management proposal) when making the base period Tier determinations. Note that the Tier percentages are minimums and the actual volumes assigned may exceed these minimums. Volumes in excess of the stated minimum percentages will be assigned using the same above stated best value analysis and will additionally rely on quality data from the current period of performance. If multiple awards are made, the USPTO may utilize any Tier selection that is deemed in the USPTO’s best interest.

3.1.2. Withdrawn applications (CLIN #003)

CLIN #003 is directed to contractor-assigned applications that no longer need a contractor-prepared final deliverable that the USPTO becomes aware of after the assignment on a work order but prior to the submission of a final deliverable. As soon as the USPTO becomes aware of a possible withdrawn application, the USPTO will contact to contractor to obtain a status update to determine how much work has been completed. If the contractor’s level of effort is deemed to be de minimis, i.e. no search or substantive review has been conducted, the USPTO will issue a no-cost amended work order to remove this application. If the contractor’s level of effort is substantial, i.e. search completed and draft opinion is under-going internal quality review, the USPTO will instruct the contractor to proceed with submission of the final deliverable. If the contractor’s level of effort is somewhere between the above scenarios, i.e.

lack of unity submitted, the USPTO will issue an amended work order than changes the CLIN of this application to a CLIN 0003 assignment. It is noted that this is a rare occurrence as historically only 0.02% of applications required a CLIN adjustment.

3.1.3. Timeliness of Deliverables

The contractor shall have a maximum of 30 net calendar days, hereafter referred to as “the 30-day period” to prepare and deliver a final accepted deliverable to the USPTO for each IA. The 30-day period starts on the day that the USPTO first notifies the contractor that the IA is available for downloading via a VPN or equivalent and will include any day (any portion of a day will be counted as a whole day) that the USPTO has not received an acceptable final deliverable uploaded to the VPN or equivalent minus any suspended days. Suspended days are days in which the 30-day period is paused due to the USPTO completing processing of the IA and/or deliverable and include quality review of the deliverable, sequence search requests, ISA/206 mailing, and ISA/225 mailing.

The contractor’s invoices for the month shall be adjusted in accordance with the chart below for each IA in which final accepted deliverables have been accepted by the USPTO and which the contractor failed to deliver the final accepted deliverable within the 30-day period. It is the contractor’s responsibility to invoice for the correct amount for each IA. The USPTO will verify the amount is prior to payment of the invoice.

Prices listed in the Offeror’s proposal and subsequently incorporated via contract award will be subject to the following performance based adjustments:

Timeliness Disincentive When the final accepted deliverable for the IA is received __ calendar days in excess of the 30-day period.

The following unit price adjustment shall be applied to the CLIN 0001-1D price for the IA.

1-5 days 10% of the CLIN 0001-1D price subtracted from the per application CLIN 0001-1D price for the IA

6-10 days 20% of the CLIN 0001-1D price subtracted from the per application CLIN 0001-1D price for the IA

Form # USPTO-OP-020 (08/2020) Page 7 of 20

11-15 days 30% of the CLIN 0001-1D price subtracted from the per application CLIN 0001-1D price for the IA **

16-20 days 40% of the CLIN 0001-1D price subtracted from the per application CLIN 0001-1D price for the IA **

More than 21 days 50% of the CLIN 0001-1D price subtracted from the per application CLIN 0001-1D price for the IA **

**Contractor performance at this level may lead to reduction in the volume of assignment of work, non-assignment of work, non-exercise of an option period, or termination for default.

4. Scope

The Contractor shall provide the personnel, resources, and facilities, as appropriate, to provide efficient and cost effective support services for the requirements defined below.

All work performed must be in accordance with the PCT International Search and Preliminary Examination Guidelines (a copy of which is posted at http://www.wipo.int/pct/en/texts/pdf/ispe.pdf) and Chapter 1800 of the MPEP (posted at https://www.uspto.gov/web/offices/pac/mpep/mpep-1800.html .

The USPTO will provide fillable Adobe Acrobat PDFs for all of the appropriate ISA forms along with instructions (See Attachments 2-71). The ISA forms may be updated by the IB at any time. Historically, ISA form updates have occurred approximately every 2-3 years. The USPTO will provide the updated ISA forms and revised instructions and/or guidance as they become available. The contractor shall implement any ISA form updates within 30 days of notification from the USPTO. The USPTO may replace and/or supplement the use of fillable PDF ISA forms with xml or equivalent files. The USPTO will supply all appropriate dtd files 2 and instructions at least 90 days prior to implementing the requirement of submission of deliverables using the xml files.

4.1. Formalities Review

The contractor shall perform a formalities review of each source document package for each assigned IA.

The formalities review shall include verifying that the IA is readable, verifying that the IA is complete, including the presence of at least one claim, verifying that the PCT Request (Form PCT/RO/101 or equivalent form) indicates “US” in the “State of residence” or “State of nationality” field for at least one (1) applicant, verifying that no foreign text is present in any document that forms part of the IA (with the exception of Latin words or phrases), and that Box VII of the PCT Request indicates "US” as the ISA (acceptable variations include “USA” or “USPTO”). For IAs that disclose amino acid or nucleotide sequences, the formalities review shall include verification that a proper sequence listing in electronic format is present, if required by Annex C of the PCT Administrative Instructions which are available at http://www.wipo.int/pct/en/texts/. The contractor shall notify the USPTO if the IA is incomplete, unreadable, or defective in any way that would prevent the search and examination of the IA. If the contractor notifies the USPTO within three (3) business days of assignment, the 30-day period will be restarted on the day that the USPTO makes a new or complete IA application available to the contractor.

If the USPTO is notified beyond 3 business days from when the contractor was notified that the IA was available, the 30-day period will be suspended from the day the USPTO receives the notification and will restart the day the USPTO makes a new or complete copy of the IA available to the contractor.

1 Note that attachments 2-7 are provided to this RFI for exemplary purposes only. It is anticipated that these documents will be updated NLT the contract award date to reflect the current versions of the RO and ISA forms.

PISO

Performance Work Statement http://www.wipo.int/pct/en/texts/pdf/ispe.pdf https://www.uspto.gov/web/offices/pac/mpep/mpep-1800.html

Form # USPTO-OP-020 (08/2020) Page 8 of 20

The USPTO will consider pausing the 30-day period and sending a communication to the applicant for IAs containing an excessive number of searchable claims that renders the claims as lacking clarity under PCT Article 6 and PCT Rule 6.1(a). If the Contractor believes an IA having an excessive number of searchable claims are present, the Contractor shall notify the USPTO to request this consideration. The USPTO will typically review these requests within two (2) business days and notify the Contractor of the decision of whether to send a communication requiring the applicant to select up to six independent claims and 75 total claims for search and examination. The applicant will be given (1) month to respond to this communication, and the 30-day period for that application will be temporarily suspended as of the date the Contractor notified the USPTO. Upon response by applicant, any selected claims may also be subject to review under unity of invention (PCT Rule 13). The USPTO will notify the Contractor of applicant’s response to the communication as well as provide a copy, if any. The 30-day period will resume from that date of notification.

4.2. Unity of Invention

After completion of the formalities review, the contractor shall determine if the IA meets the requirement of unity of invention using the Unity of Invention criteria as set forth in Chapter 10 of the PCT International Search and Preliminary Examination Guidelines (a copy of which is posted at http://www.wipo.int/pct/en/texts/pdf/ispe.pdf). The first claimed invention and all claims having unity therewith will always be considered by the contractor when preparing the final deliverable. Where multiple inventions lacking unity are present, the contractor may prepare and deliver a PCT/ISA/206 (Form 206) form to the USPTO, which sets forth the groups of claims present, the supporting rational for making the lack of unity of invention determination, the fee to search the additional invention(s), and will be accompanied by any non-patent literature (NPL), foreign patent, or foreign patent application publication (and translation when necessary) relied upon by the unity of invention analysis. From the date the Form 206 is received by the USPTO, the 30-day period for that application will be temporarily suspended. Instructions for filling out Form 206 are set forth on Attachment 3.

A USPTO official will review the contractor submitted Form 206 for acceptance. The USPTO will reject the contractor-submitted Form 206 if the USPTO determines that Unity of Invention is present. As such, the contractor will be notified that all claims of the IA must be considered in the preparation of the final deliverable and that an error against the quality requirements will be charged as set forth in Section 4.5.4. The 30-day period for the IA will resume from that date of notification. If correction to the Form 206 is required, the contractor will be notified of the need to correct the Form 206 or, at the USPTO discretion, the USPTO will correct the Form 206 and the Contractor will be informed of the necessary corrections for future reference. If the Contractor is notified that correction is required, the 30-day period will resume as of the date of notification and continue to run until a correct Form 206 is received by the USPTO. The necessity for correction will be noted by the USPTO and an error against the quality requirements may be charged to the Contractor irrespective of who makes the correction.

The applicant will be given one (1) month to respond to the Form 206. The USPTO will notify the Contractor of applicant’s response to the Form 206. The 30-day period for the IA will resume from that date of notification. In addition to the first claimed invention and claims having unity therewith, the ontractor shall consider all claims for which additional search fees have been paid by the applicant in the preparation of the final deliverable. If no response to the Form 206 is received from the applicant within the one (1) month time period, the USPTO will notify the Contractor that no response was filed and that the Contractor shall only consider the first claimed invention and claims having unity therewith when preparing the final deliverable. If the Form 206 is mailed but the USPTO later determines that a holding of lack of unity was improper as a result of an applicant’s protest, the USPTO may provide instructions to the contractor to require the search of the invention(s) subject to a justified protest, with the protest and decision returned to the contractor along with said instructions.

Section 4.5.4. provides a list of essential criteria that must be completed correctly on the Form 206 for the deliverable to be considered to have no errors.

PISO

http://www.wipo.int/pct/en/texts/pdf/ispe.pdf

Form # USPTO-OP-020 (08/2020) Page 9 of 20

4.3. Non-establishment of Search

In very rare instances, all the claims in the IA may be held to be unsearchable. Claims are unsearchable if: 1) they are directed to subject matter that the USPTO would not search or examine in a U.S. national application (see MPEP 1843.02); 2) they are so unclear that no meaningful search can be carried out; or 3) they are directed to specific nucleotide and/or amino acids sequences for which applicant has not supplied a sequence listing in electronic form that complies with the standards provided in Annex C of the PCT Administrative Instructions , and a meaningful search of the international application is not possible without the electronic form of the sequence listing.

Where an international application contains disclosure of one (1) or more specific nucleotide and/or amino acid sequences, the description may be required to contain as a separate part a sequence listing complying with the standard set forth in Annex C of the PCT Administrative Instructions. In addition, for purposes of the international search, a sequence listing in electronic form complying with Annex C may be required by the USPTO as an International Searching Authority. A copy of the PCT Administrative Instructions is posted on the Internet http://www.wipo.int/pct/en/texts/index.htm. If the applicant has not provided the sequence listing part of the description or the electronic form of the sequence listing in compliance with Annex C of the PCT Administrative Instructions, the International Searching Authority will typically issue an Invitation to Furnish Nucleotide and/or Amino Acid Sequence Listing, Form PCT/ISA/225, (Form 225), to the applicant that sets forth a time period for response. The Form 225 will be issued by the USPTO. After expiration of the time limit for response, the IA together with a copy of the applicant’s response to the Form 225 (if submitted) will be forwarded to the Contractor. Where all the claims in the international application are directed to specific amino acid and/or nucleotide sequences for which no electronic form of the sequence listing complying with Annex C and 37 CFR 1.445(a)(5) has been provided, and a meaningful search of the international application is not possible without the electronic form, and further provided that a Form 225 was issued by the USPTO and the time limit set therein has expired, the Contractor shall prepare the Form 203 by entering all the data as specified on Attachment 2.

If, after having read the international application, either (1) the subject matter is directed to subject matter that the USPTO would not search or examine in a U.S. national application or (2) the description, claims or the drawings are so unclear that no meaningful search can be performed on all of the claims, the Contractor shall prepare the Form 203 by entering all the data as specified in Attachment 2. The Form 203 shall have the full classification CPC and IPC provided (see Section 4.4.1).

Section 4.5.3. provides a list of essential criteria that must be completed correctly on the Form 203 for the deliverable to be considered to have no errors. The 30-day period will be suspended as of the date that the USPTO receives the Form 203. At the discretion of the USPTO, the USPTO may correct the Form 203 in lieu of requiring the Contractor to make the corrections.

A final deliverable that contains a Form 203 must be accompanied by a PCT/ISA/220 (see Attachment 5) and PCT/ISA/237 (see Attachment 6). Given the extreme rarity of the issuance of a Form 203, the contractor is encouraged to obtain confirmation from a USPTO technical lead prior to submitting a Form 203 final deliverable. Note that if a Form 203 submission is made in an IA that the USPTO determined should have been searched, this may result in a 4.5.1. error if the USPTO discovers any relevant art.

4.4. International Search and Opinion

Where at least one (1) claim is searchable, the contractor shall prepare an International Search Report (PCT/ISA/210, see Attachment 4), a Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority, or the Declaration (PCT/ISA/220), and a Written Opinion of the International Searching Authority (PCT/ISA/237). In addition to the ISA forms, the contractor shall provide the USPTO a Recordation of Search History.

PISO

http://www.wipo.int/pct/en/texts/index.htm

Form # USPTO-OP-020 (08/2020) Page 10 of 20

4.4.1. Classification

The contractor shall review and analyze each IA’s content and shall classify any invention information in Cooperative Patent Classification (CPC) and International Patent Classification (IPC). Invention information is technical information in the total disclosure of a patent document (for example, description, drawings, claims) that represents an addition to the state of the art. The invention information is determined in the context of the state of the art, using guidance provided by the claims of the patent document, with due regard given to the description and the drawings.

“An addition to the state of the art” means all novel and unobvious subject matter specifically disclosed in a patent application, which subject matter does not represent part of the prior art, i.e., the difference between the subject matter in a patent application and the collection of all technical subject matter that has already been placed within public knowledge. All invention classification symbols shall be included in the final deliverable and specified as such (i.e. invention information).

See IPC Guide, Section VIII (https://www.wipo.int/edocs/pubdocs/en/wipo_guide_ipc_2019.pdf).

The contractor shall review and analyze each IA’s content and shall classify any additional information in CPC and IPC. Additional information is non-trivial technical information which does not in itself represent an addition to the state of the art but might constitute useful information for a searcher looking for such information. The additional information complements the invention information by identifying, for example, the constituents of a composition or mixture, or elements or components of a process or structure, or use or applications of classified technical subjects.

Specific guidance for assigning additional classification symbols may be provided by the USPTO for certain technologies during the contract. All additional classification symbols shall be included in the final deliverable and specified as such (i.e. additional information). See IPC Guide, Section VIII (https://www.wipo.int/edocs/pubdocs/en/wipo_guide_ipc_2019.pdf).

Updated CPC and IPC classification schemes can be found at:

https://www.cooperativepatentclassification.org/index and https://www.wipo.int/classifications/ipc/en/.

At some point during the performance of this contract, the USPTO may provide the full expert classification picture along with the source document for incorporation into the appropriate ISA form fields on the ISA/203, ISA/210 and ISA/237. The USPTO will provide notification and test data at least 60 days prior to implementing this requirement.

4.4.2 Search Functions

The purpose of the search is to discover the most relevant art by searching US and foreign patent documents and non-patent literature (NPL). For each IA assigned (except IAs where a Form 203 has been accepted by the USPTO), the contractor shall be responsible for performing a comprehensive search in accordance with MPEP Chapter 904 and PCT Rule 34 (Minimum Documentation).

For applications containing a valid electronic sequence listing, the USPTO will perform the sequence searching for the contractor. Any submitted sequence search request must be submitted in Microsoft Word format and meet the following criteria: (1) request must identify the sequence or fragment by SEQ ID NO, (2) request must not include any sequence or fragment that exceeds 10,000 bases, (3) request should not be submitted in an application that does not require a sequence search, (4) requests should be submitted in an efficient manner, i.e. request should not contain an unreasonable number of sequences or fragments (5) any fragment/substitute search request should be clearly identified; and (6) any single search request must not exceed 20 SEQ ID Nos or 20,000 bases. Sequences that do not require a SEQ ID NO per Annex C will be required to be searched by the contractor, as appropriate.

PISO

Performance Work Statement https://www.wipo.int/edocs/pubdocs/en/wipo_guide_ipc_2019.pdf https://www.wipo.int/edocs/pubdocs/en/wipo_guide_ipc_2019.pdf https://www.cooperativepatentclassification.org/index https://www.wipo.int/classifications/ipc/en/

Form # USPTO-OP-020 (08/2020) Page 11 of 20

C.4.4.3 References

The contractor shall list relevant art references on the international search report. These references may also be applied against the claims in the written opinion of the ISA.

Relevant art is defined as everything which is made available to the public anywhere in the world and which is capable of being of assistance in determining that the claimed invention is or is not novel and that it does or does not involve an inventive step (i.e., that it is or is not obvious), provided that the making available to the public occurred prior to the “relevant date.” For the purposes of the international search report, the relevant date is the international filing date.

However, the definition of “relevant date” changes for the purposes of the written opinion established by the ISA. Specifically the “relevant date” for the purposes of that written opinion is either the international filing date, or where the international application validly claims priority of an earlier application, the filing date of such earlier application. Where a reference has been published between the international filing date and the claimed priority date, it is necessary to look at the priority application (if available) in order to determine if the claimed invention was adequately described in the earlier application. The USPTO may provide the contractor with copies of US priority applications so that the contractor can determine whether the claimed invention was adequately described and enabled in the priority application. Because the time limit for adding and/or correcting a priority claim and for furnishing a certified copy of priority applications may not yet have expired at the time that the written opinion is prepared, if a copy of the priority application is not provided, the written opinion is to be prepared as though the claimed priority date is valid. See PCT Rules 64.1(b) and 43bis.1(b).

Any relevant published patent applications or patents that would constitute relevant art, except that the publication date is the same or later than international filing date, will be cited on the international search report, where the filing date or claimed priority date is earlier than the international filing date. However, these published applications or patents are not considered prior art for the written opinion. The written opinion of the ISA must draw attention to such documents since they may be relevant to the determination of novelty and inventive step by designated or elected Offices. See PCT Rule 64.3.

When any written disclosure refers to an oral disclosure, use, exhibition, or other means whereby the contents of the written disclosure were made available to the public, and such making available to the public occurred on a date prior to the international filing date, the international search report shall separately mention that fact and the date on which it occurred if the making available to the public of the written disclosure occurred on a date which is the same as, or later than, the international filing date. These written disclosures are not considered prior art for the written opinion. The written opinion of the ISA must draw attention to such documents since they may be relevant to the determination of novelty and inventive step by designated or elected Offices. See PCT Rule 64.2.

The contractor must categorize each reference cited. A reference may have multiple categories.

The contractor must determine the relevant claims for each category of a reference. Category “X” is applicable where a reference is such that when the reference is taken alone, the relevant claims cannot be considered novel or cannot be considered to include an inventive step.

Category “Y” is applicable where a reference is such that when the reference is taken in combination with one or more other such cited references, the relevant claims cannot be considered to include an inventive step, such combination of references being obvious to a person skilled in the art. Category “A” used as a reference defines the general state-of-the-art.

As appropriate X/Y/A shall be cited as “D” “E” “P” and “O” references as appropriate (see WIPO Search and Examination Guidelines, paragraphs 16.70-16.74).

Form # USPTO-OP-020 (08/2020) Page 12 of 20

In selecting the references to be cited and categorized, the Contractor should carefully compare the references with one another and with the disclosure of the IA to avoid the citation of an unnecessary number of references. The contractor is not called upon to cite all references that may be available, but only the "best." The number of “state-of-the-art” references (category A), which are cited, should be limited. In some IAs, only one state-of-the-art reference may need to be cited per claimed invention. Only in rare instances should there be more than five state-of-the-art references cited per claimed invention. Citing multiple references where any one reference is as good as, but no better than, the others should be avoided. The most relevant prior art reference should always be applied against each claim in the written opinion of the ISA.

4.4.4 ISA Form Instructions

A final deliverable shall consist of an ISA/210, ISA/220, ISA/237, Search recordation form and a printable PDF of any cited foreign patent, foreign patent application publication,or NPL document.

For any provided foreign patent, foreign patent application publication,or NPL document, the contractor should avoid the citation and submission of entire references in excess of 100 page when possible. Specifically, when possible for such references, only the relevant sections/pages/portions should be cited and provided along with bibliographic pages indicating the title, author(s), date of publication, etc.

4.4.4.1 ISA/210 Form

See Attachment 4 for instructions on how to complete this ISA form.

4.4.4.2 ISA/220 Form

See Attachment 5 for instructions on how to complete this ISA form.

4.4.4.3 ISA/237 Form

See Attachment 6 for instructions on how to complete this ISA form.

4.4.4.4 Search Recordation form

Supplemental to the PCT Forms, the Contractor shall document the search history in such detail that the complete extent of the search (e.g. field of search, search strategy, details of classification, non-patent literature and database searches, etc.) performed by the contractor can be immediately envisaged and recreated by the USPTO. The recordation of the search history is intended to provide the USPTO with the necessary information to assess contractor quality with respect to the search. The items listed in Attachment Recordation of Search History (see Attachment 8) are required items for the recordation of the search, and must be provided in the final deliverable. The search recordation document will be scanned into the USPTO’s electronic file wrapper system and mailed to the applicant and should not include any reference to the Contractor company or any employee’s full name.

4.5 Acceptance Criteria of Deliverables

The below acceptance criteria will be applied to the Contractor supplied deliverables. The acceptance criteria correspond to the content of the deliverable which must be correct for the USPTO to accept the deliverable. The USPTO will use the acceptance criteria to determine if the deliverable contains errors that require correction.

4.5.1. Most Relevant Art Identification

The Contractor will be assessed a single level 1 error if the USPTO holds that any deliverable for a given IA is deficient in this criterion. If the USPTO holds that an IA contains a level 1 error, the deliverable will be returned to the Contractor for correction and the 30-day period will resume, or, at the option of the USPTO, the USPTO will correct the error(s) and notify the contractor of the errors for future reference.

Form # USPTO-OP-020 (08/2020) Page 13 of 20

An error for the most relevant art identification will be held when:

(1) The USPTO found art, which was more relevant to the inventive concept or claimed invention then what was cited in the International Search Report or that reads on a claim that the contractor incorrectly held unsearchable.

4.5.2. Application of Art

The Contractor will be assessed a single level 2 error if the USPTO holds that any deliverable for a given IA is deficient in any one of the below acceptance criteria. If the USPTO holds that an IA contains a level 2 error, the deliverable will be returned to the Contractor for correction and the 30-day period will resume, or, at the option of the USPTO, the USPTO will correct the error(s) and notify the Contractor of the errors for future reference.

An error for the application of art will be held in any of the below instances::

(1) The best prior art cited on the International Search Report was not applied against the claims in the International Search Report and/or Written Opinion.

(2) An improper negative opinion regarding lack of novelty or inventive step was applied in Written Opinion of the ISA. An improper or deficient motivation statement in a lack of inventive step opinion would be considered an application of art error.

(3) A lack of inventive step opinion was raised on a claim that lacks novelty over the same prior art reference.

4.5.3. Formalities

The Contractor will be assessed a level 3 error if the USPTO holds that any deliverable for a given IA is deficient in any one of the below acceptance criteria. If the USPTO holds that an IA contains a level 3 error, the deliverable will be returned to the contractor for correction and the 30-day period will resume, or, at the option of the USPTO, the USPTO will correct the error(s) and notify the Contractor of the errors for future reference.

An error for formalities will be held in any of the below instances::

(1) An improper opinion regarding lack of industrial applicability was raised or a proper holding of lack of industrial applicability was missed in the Form 237.

(2) A claim was searched that should have been held as unsearchable or any claim was improperly held as unsearchable.

(3) The application was improperly classified.

(4) The “Category”, “Citation of document”, or “Relevant to claim No.” field for any document listed on the Form 210 was improper and/or inconsistent with the Form 237.

(5) The search recordation was not in proper form or was not submitted

(6) Any priority claim was treated improperly.

(7) Any inappropriate defect was raised or appropriate defect missed related to the form or content of the International Application, such as spelling errors, incorrect drawings, typographical errors, etc.

(8) Any inappropriate observation was raised or appropriate observation missed relating to the clarity of the claims, the description, the drawings, or whether the claims are fully supported by the description.

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(9) Any opinion or observation was not clearly explained using language appropriate to examination under the Patent Cooperation Treaty.

(10) Any PCT form was not filled out properly.

(11) Any bibliographic data errors including:

Mailing address International filing date International application number Applicant’s name Priority date Agent’s file reference number

(12) Any other formality errors, such as:

Improper CPC or IPC codes Inappropriate Figure to be published with abstract Improper or missing Abstract Failure to provide a printable copy of a cited non-patent literature, foreign patent, foreign patent application publication, or translation of a cited non-English document, where necessary

(13) An improper or unreasonable sequence search request was submitted, such as:

(a) Request does not identify sequence or fragment by SEQ ID No

(b) Request includes a sequence or fragment that exceeds 10,000 bases

(c) Request is submitted in an application that does not require a sequence search

(d) Request contains an unreasonable number of SEQ ID Nos or fragments or bases

(e) Request contains a fragment search that is not clearly identified

(f) Request is submitted after contractor has been notified that there is no valid electronic copy of the sequence listing

4.5.4. Lack of Unity Acceptance Criteria

If the USPTO holds that a lack of unity deliverable contains a level 4 error, the deliverable will be returned to the contractor for correction and the 30-day period will resume, or, at the option of the USPTO, the USPTO will correct the error(s) and notify the Contractor of the errors for future reference.

An error under lack of unity will be held in any of the below instances: criteria are:

(1) Improper allocation and accounting for all searchable claims and claimed embodiments

(2) Improper identification of the technical features of each invention grouping

(3) Failure to recognize the technical feature shared between/among inventions

(4) Improper determination that an identified shared technical feature is not a special technical feature

(5) Failure to provide a copy of a cited non-patent literature, foreign patent, foreign patent application publication, or translation of a cited non-English document, where necessary

4.5.5. USPTO Quality Review Process

At a high level, the USPTO will randomly select final deliverables throughout each month for a robust review for level 1-3 errors. For lack of unity deliverables (level 4), the USPTO will employ various different reviews ranging from a full review to a cursory review. The USPTO will provide

Form # USPTO-OP-020 (08/2020) Page 15 of 20 regular feedback, i.e. weekly or biweekly, to the contractor for any non-complaint deliverables.

Quality assessment reports will be provided to the Contractor at least quarterly.

4.5.6. Rebuttal Procedures

The contractor may rebut any finding of non-compliance by submitting a written statement to the COR or designated technical lead no later than one (1) week after the notification of the non-compliant deliverable. Any rebuttal submitted after one (1) week may be deemed untimely and may not be considered by the USPTO. The USPTO will typically notify the Contractor of the final decision on any rebuttal within one (1) week.

If a deliverable is returned for correction, the 30-day period resumes and runs until a new deliverable or rebuttal is received. If new deliverable is not acceptable or the rebuttal is not persuasive, the clock will resume and runs until a new final deliverable or rebuttal is received.

This continues until an acceptable final deliverable or persuasive rebuttal is received.

4.5.7. Required Quality Compliance Standards

The contractor shall be held to specific compliance rates for level 1 and level 2 evaluation criteria.

Acceptable performance is defined as a compliance rate of 95.0% for level 1 and 95.0% for independent claims and 92.0% for independent or dependent claims for level 2. The compliance rate percentage for level 1 will be calculated by first dividing the number of level 1 errors held by the USPTO by the total number of deliverables reviewed by the USPTO for a level 1 error (a review which included an independent prior art search), then converting the quotient to a percentage and subtracting from 100%. The compliance rate for level 2 will be calculated by first dividing the number of level 2 errors held by the USPTO by the total number of deliverables reviewed by the USPTO for level 2 errors (a review which included an analysis of the art applied in the opinion), then converting the quotient to a percentage and subtracting from 100%.

Contractor performance below the acceptable compliance rates for level 1 or level 2 will result in required -COR-approved modifications of the Quality Management System (QMS). Repeated contractor performance below the acceptable compliance rates may lead to reduction in the volume of assignment of work, non-assignment of work, non-exercise of an option period, or termination for default.

Level 3 and level 4 errors must be corrected in order for the deliverables to be accepted by the USPTO but no specific error rate will be applied. However, if the COR determines that the performance of evaluation criteria for these errors is unsatisfactory, the contractor will be required to submit and enact COR-approved modifications of the QMS.

4.6 Other Deliverables

4.6.1 Quality Management System

The Contractor shall establish, document and maintain a quality management system (QMS) that meets the requirements of Chapter 21, paragraphs 21.03-21.08, 21.15 (first sentence) and 21.20 (wherein the customer is limited to the USPTO) of the PCT International Search and Preliminary Examination Guidelines. The QMS shall be submitted to the COR and technical leads within 60 days of contract award and at any subsequent time upon request.

4.6.2 Monthly pending submissions report

The Contractor shall provide the COR or designate technical lead a monthly…