Final_PLS_RFP-Resonses_to_Questions.Feb.4.19.pdf

Questions and Response for RFP NIH-OD-OLAO-OA-(PLS)-2019

February 4, 2019

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1. Is it acceptable for the initial (US or foreign) patent to be drafted outside the United States where the final attorney review, correct and edit is in the US?

RESPONSE: NIH will consider an Offeror’s plan describing the procedures and mechanisms that will support their firm’s ability to produce patent applications that are cohesively drafted, including high quality claim sets, and meet the legal standards of the countries in which prosecution is anticipated within the allowable timeframe and costs.

2. Is it acceptable for the office action responses to be drafted outside the United States where the final attorney review, correct and edit is in the US?

RESPONSE: NIH will consider an Offeror’s plan describing the procedures and mechanisms that will support their firm’s ability to produce responses to office actions that are cohesively drafted, demonstrate sound prosecution strategy, and demonstrate a thorough understanding of applicable patent law and the invention’s technology within the allowable timeframe and costs.

3. In section L, e. Appendices, d. “not more than three opinions (optional)” are requested. Is a patentability opinion acceptable?

RESPONSE: Yes, a patentability opinion is acceptable as is a freedom to operation opinion.

4. In section L, e. Appendices, e. two examples of “market analyses” are requested. Is a market analysis similar to a patent landscape analysis?

RESPONSE: A patent landscape analysis is one component of a market analysis. A market analysis also generally includes (i) analysis of similar and competing products in development and on the market, (ii) valuation of intellectual property, (iii) analysis of market trends, and (iv) market sector analysis to identify potential licensees.

5. In section L, e. Appendices, f. “three references from existing or former clients” are requested. Is contact information for each client sufficient or is a letter from the client required?

RESPONSE: A letter is required.

6. Does requirement apply just for filing patents or does it also apply to FTOs?

RESPONSE: As set forth in the Statement of Work attached to the published RFP, freedom to operate (FTO) opinions apply to the patent legal services sought.

7. Is the NIH solely looking for Patent Legal Services or is it looking to separate out Patent Search/Intelligence software from Patent Legal Services.

RESPONSE: NIH is seeking only Patent Legal Services under this RFP.

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8. We are reviewing this RFP and have determined that our firm is not FAR compliant. Is it still possible to bid successfully for this work?

RESPONSE: No.

9. Are certificates of good standing needed from state bars only or from the US Patent and Trademark Office also? Are the certificates required for every jurisdiction where each lawyer/agent is barred?

RESPONSE: Certificates of Good Standing are required from the USPTO and from any U.S. state bar that an attorney listed in the proposal is a member of.

10. Are scanned copies of the certificates of good standing sufficient for submission? If not, how should the certificates be submitted through the online portal?

RESPONSE: Scanned copy is acceptable and should be included as part of the proposal. Offerors should be prepared to provide originals upon request.

11. Regarding Article H.7. of the RFP, which states all Contractor staff that has access to NIH email must identify themselves as contractors on all outgoing email, does this include all email to parties having no relationship with the NIH? And is there any language that should or should not be used in the emails?

RESPONSE: No, to both questions.

12. Regarding the requested examples of market analyses to be provided, do these have to relate to a specific patent, can they relate to a general technology area, or otherwise? Can you provide any further guidance on the types of market analyses you are looking for?

RESPONSE: See response to question 4.

13. Regarding the preferred foreign associates to be listed as subcontractors, are there specific jurisdictions of interest for which we should be sure to include foreign associates? Do specific sub-contracts with each foreign associate need to be included with the submission?

RESPONSE: NIH cannot predict in advance which foreign countries in which it will pursue patenting for its inventions. Such decisions are based on the nature of the invention and the relevant market(s). No, subcontracts for foreign associates do not need to be provided. Just a listing of the anticipated foreign firms that may be used.

14. Are the certificates of good standing and other supporting documentation included in the listed page limit?

RESPONSE: No.

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15. For “Key Personnel”, it is indicated advance notice must be provided to NIH should any key personnel be diverted to other programs or contracts. Does this mean key personnel can only work on NIH matters during the term of the contract?

RESPONSE: Key Personnel can work on other law firm matters.

16. Will Task Orders placed via telephone be confirmed in writing? Should work not commence on a telephonic or oral Task Order until it is confirmed in writing?

RESPONSE: The task ordering contracting officer at the institute level will make such determinations. Task orders under the current contract are confirmed in writing.

17. In Article L.1.(e) of the RFP, Offerors are encouraged to submit multiple offers. Does this mean Offerors are encouraged to submit offers for more than one of the technology categories, or to submit multiple offers for each separate technology category?

RESPONSE: LAW FIRMS HAVING THE CAPABILITY AND EXPERTISE IN ONE OR MORE TECHNOLOGY AREA, ARE

WELCOME TO SUBMIT A SEPARATE PROPOSAL FOR ONE OR EACH OF THE TECHNICAL AREAS.

18. The Statement of Work indicates Contractor shall bring unelected or withdrawn subject matter to the attention of the lead inventor and the NIH Technical Representative. Should this be done during active prosecution of the original patent application or after a Notice of Allowance is received?

RESPONSE: Identification of unelected or withdrawn subject matter should be brought to the attention of the NIH Technical Representative and NIH lead inventor no later than with the reporting of receipt of a Notice of Allowance unless otherwise indicated by the NIH Technical Representative. Specific processes for this requirement will be addressed at the task order level.

19. For the past performance questionnaires, how should Offeror handle these if the relevant personnel remain unavailable due to the pending U.S. government shutdown?

RESPONSE: Offerors are responsible for obtaining past performance documents and submitting by proposal the due date.

20. For invoices submitted to and accepted by NIH, in what time period should the Contractor expect payment?

RESPONSE: Specific invoice instructions will be provided by the Contracting Officers at the task order level.

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21. Will Contractor have access to an NIH credit card in order to pay U.S. Government fees?

RESPONSE: No, credit cards will not be issued by the Government. Additionally, a task order will be issued for all patent-legal services activities. In addition, no law firm is allowed or shall accept credit card payments for patent-legal services associated with this requirement.

22. We have two questions about Section B.3.5. The RFP states: “Should a contractor's actual year standard billing rate for their best customers be lower than the rate listed on the contract, the lower rate must be used.”

a. Under Question 25 in the Questions and Response for Pre-solicitation NIH-OD-OLAO-OA-(PLS)- 2019, NIH states that it will not incorporate a “Most Favored Nation” clause. Article B.3.5 appears to be such a clause. Will this be removed through an amendment to the RFP?

b. If this clause is not removed, please respond to the following question(s): Due to likely work volume and compliance with the FAR, the indirect rate cost elements may be higher in the loaded rates for work under this RFP.

i. If the contractor’s cost elements in the “build-up” of its loaded rates for the RFP and TORFPs differs from how it “builds up” its loaded rates for its commercial clients, how will the NIH determine the “standard billing rate?”

ii. Will the NIH only examine base labor prices/cost element for each position (a portion of the loaded rate) or will the analysis only involve a basic comparison of the loaded rates for NIH and the contractor’s best customers?”

RESPONSE: The Government restates their position. The Government will not incorporate a “Most Favored Nation” clause. The language under Article B.3.5 is deleted.

23. Will the contractor’s vendors be considered “subcontractors,” subject to FAR 52.244-2 (Subcontracts) if the vendor’s fees to the contractor in support of the prime contract exceed the amounts set out in the FAR clause ($250,000 for fixed price agreements and any time & materials-type agreements)? For example, a contractor may technically meet the elements of the cited FAR clause if they are using a payroll and benefits administration service (e.g. ADP) or a document management consultant/vendor to support the contractor’s efforts under the prime contract where the vendor’s costs will make up portion of the contractor’s loaded rates to NIH.

RESPONSE: Yes.

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24. Under question 17 of the Pre-Solicitation Questions and Responses, NIH stated that the following language would appear in the in RFP:

“The Offeror shall provide statistics for the past (3) years on the number of provisional and nonprovisional domestic and foreign patent applications, including PCT applications, prosecuted by the proposed Personnel in the relevant Technology Category. Of those prosecuted foreign and domestic applications, the Offeror shall indicate how many of them were prosecuted to allowance. Of those allowed applications, the Offeror shall indicate how many of those patent applications were drafted by the proposed Personnel.”

This exact language does not appear in the RFP. A variation appears under Section L.2.b.1.b., but the NIH’s requested statistics are still somewhat unclear. This section instructs offerors to detail certain patent processing-related statistics from the past three years. When an offeror is disclosing their patent processing statistics, should they list the firm-wide patent statistics or should the offeror only list patent statistics related to the category they are pursuing (i.e. biotechnology, mechanical engineering, etc.)?

RESPONSE: The language for sections 2.2.b. and 2.2.c. is revised to read as follows:

2.2.b. Personnel Expertise (18 points): The Offeror shall demonstrate the legal, medical, and scientific expertise of each of their proposed Personnel to the Technology Category each proposal pertains to:

Biotechnology, Chemistry, Mechanical Engineering, or Software. The Offeror shall demonstrate the recent patent prosecution experience and good standing of proposed Personnel.

2.2.c. Prosecution Statistics (15 points): The Offeror shall provide statistics for the past (3) years on the number of provisional and non-provisional domestic and foreign patent applications, including PCT applications, prosecuted by the proposed Personnel in the relevant Technology Category. Of those prosecuted foreign and domestic applications, the Offeror shall indicate how many of them were prosecuted to allowance. Of those allowed applications, the Offeror shall indicate how many of those patent applications were drafted by the proposed Personnel.

25. What are the countries of interest for foreign filings?

RESPONSE: See response to question 13.

26. Please provide the percentage break down of T&M task orders vs. FFP task orders under the existing contract.

27. What is the forecasted percentage break down of T&M task orders vs. FFP task orders under this solicitation?

RESPONSE to 26 and 27: Under the current centralized setup and contracts, 100% of the task orders are T&M.

However, this percentage of the T&Ms under the current contracts will no longer be relevant for future task orders under the new contracts. Task ordering under the new contracts will be decentralized. Therefore, Government intends to issue task orders that are T&M, Firm-Fixed Price w/wo equitable adjustments, or a combination. The Government cannot forecast the percentages under the decentralized setup.

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28. This Solicitation for legal services before the U.S. Patent and Trademark Office (“USPTO”) appears to be inconsistent with USPTO and other ethics regulations.

Unlike general services, providing legal services (i.e., practicing law) is heavily regulated at the state level. The highly specialized field of patent law is separately regulated at the federal level. These federal regulations are promulgated by the USPTO and found at 37 C.F.R. § 11.101, et seq. Adherence to the Solicitation’s subcontracting requirement encourages violations of these regulations.

Part IV, Section L.2.c.3 (Solicitation at pp.59-61) mandates a highly specific Subcontracting Plan. The goals for that Plan are set forth in the HHS Subcontracting Plan Template. It requires commitment to subcontract 49% of the value of the contract to five different types of set asides businesses.

This Solicitation is for patent prosecution legal services provided by law firms. See Article B.1. To meet the 49% subcontracting directive, therefore, the awardee will, necessarily, have to engage multiple subsidiary law firms. First, because of the highly specialized nature of patent law in these technological areas, there is no reason to believe that there are even professionally qualified law firms in all five categories. Second, subcontracting legal work from one law firm to another creates an environment in which prohibited conflicts of interest will proliferate.

37 C.F.R. §§ 11.107, 11.108 and 11.110 prohibit conflicts of interest. Distilled to its essence, this prohibits a law firm from doing something for one client that inures to the detriment of a past or current client.

Part IV, Section M, the Evaluation Factors for Award, recognizes the importance of avoiding conflicts of interest of avoiding conflicts of interest. As part of the 25 available points for Prosecution Management, Section M.2.1.a(a) requires the Offeror to describe how Personnel “perform conflict checks on new matters and how identified conflicts are resolved….” It is seemingly impossible to provide a meaningful response to this requirement where, as here, the solicitation requires the use of subcontracted law firms with which there cannot be an integrated conflicts data base. Moreover, key information from conflict databases cannot be shared among law firms because that would violate the requirement to maintain client confidences found in 37 C.F.R. § 11.106.

a. In establishing the subcontracting goals, upon what information does NIH rely that there are even qualified patent prosecution law firms in these areas of technology that exist in each of the specified categories (e.g., is there any data to suggest that any patent prosecution firms in these areas of technology are in the 8(a) program, are an Alaska Native Corporation, are an Indian Tribe, are an SDVOSB or are located in a HUBZone)?

b. Please specify how NIH envisions that an Awardee can subcontract patent prosecution work to multiple, entirely unrelated law firms without risking violations of 37 C.F.R. §§ 11.106 - 11.108 and 11.110?

RESPONSE: The Government is not requiring law firms to subcontract. The Government is stating that it is not only encouraged but permissible to subcontract. It is the Offeror’s responsibility to specify how they envision subcontracting, if there is any possibility. See FAR—19.202-1.

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29. What were the specific subcontracting goals for the previous contract vehicles for patent legal services?

RESPONSE: The Government will not provide previous subcontracting goals. This is not public information. It is the responsibility of the Offerors to provide subcontracting goals as part of their business strategy.

30. To what extent were the subcontracting goals met in the previous contract vehicles for patent legal services?

RESPONSE: The Government will not provide previous subcontracting goals. This is not public information. It is the responsibility of the Offerors to provide subcontracting goals as part of their business strategy.

31. Article B.6, the Option Pricing Table, requires labor categories by position. The positions, in turn, must be filled by specifically identified individuals with expansive background information. Substituting or otherwise changing any individual requires the approval of the Contracting Officer. Because the Solicitation is for ten years, the junior and senior associates will no longer be qualified for their specific categories with the ordinary passage of time. For example, a junior associate in the first year of the contract will be a senior associate by the fifth year, and a senior associate may be a partner in that same time. How does NIH envision accommodating the inevitable progression of attorneys in experience levels and law firm positions?

RESPONSE: Prior to the start of each option year, current key personnel will be reassessed to determine if their current experience level requires elevation to a different position. Based on this assessment, NIH may require that some key personnel be removed, or others added to maintain the labor mix desired by NIH for the upcoming option year.

32. Under Section L.2.b.1.b.1(f), the RFP requests figures on “average number of office actions and amendments per patent application allowed.” What does the phrase “per patent application allowed” mean with respect to the number of U.S. allowances under L.2.b.1.b.1(c) and non-US allowances under L.2.b.1.b.1(d)?

RESPONSE: The average number of office actions/amendments per patent application can be calculated by dividing the total number of office actions/amendments for all patent applications allowed in a period by the total number of patent applications allowed during the same period. If available, respondents are encouraged to provide data for US allowances only, non-US allowances only, and total allowances (US + Non-US).

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33. Under Section L.2.b.1.b.1(g), the RFP requests figures on “percentage of granted [patents] without a request for continued examination (RCE).” Should the use of “granted” be considered synonymous with “patent application allowed” or should this be read literally?

“Allowed patent applications” are generally those applications in which a Notice of Allowance has issued.

“Granted patents” are allowed patent applications in which the issue fee has been paid and the patent has actually issued.

Allowed patent applications are sometimes withdrawn from issuance for varying reasons, and thus while the metrics derived using allowed patent applications and granted patents will be similar, they may not be the same.

RESPONSE: Patent applications allowed.

34. Under Section L.2.b.1.c.2, the contractor is required to produce resumes for proposed personnel that detail, among other items, “documented time commitments.” What does NIH mean by the phrase “documented time commitments?” Does the phrase mean time already otherwise committed to performing work for the firm that is unrelated to the work under the RFP?

RESPONSE: Yes.

35. Under Section L.2.c.7.b(a) (General Experience) and Under Section L.c.7.b(b) (Organizational Experience Related to the RFP), the requirements in these two sections are identical. Is this an intentional requirement that requires offerors to include the exact same information in each section? If not, will NIH provide additional context to help contractors distinguish between what should be detailed in each section?

RESPONSE: Page 63 of the RFP. The following correction to the description for item b. Organization Experience Related to the RFP is incorporated via this modification:

The description below replaces the description in the RFP:

b. Organizational Experience Related to the RFP

Organizational experience is defined as the accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP.

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36. Under Section L.2.e.e [sic] (2.e.5), the RFP asks contractors to provide “two (2) examples of market analyses in the Technical Category….” Can NIH provide a specific definition of “market analyses” that the contractor should use?

RESPONSE: See response to question 4.

37. Article B.6. Option Pricing Table - Page 6: States an Excel workbook is included in the RFP. Can you please send or direct us to where we may find this document?

RESPONSE: An Excel workbook is not included. The language is deleted.

38. Article B.6. Option Pricing Table - Page 6: Example Labor Category Charts. Can we include a range of rates for each level or should we list a maximum rate?

RESPONSE: It is the responsibility of potential offerors to provide their best business strategy, this includes their fair and reasonable rates.

39. Technical Discussions, e. Appendicies Page 58: e. Two (2) examples of market analyses in the Technical Category of the proposal prepared by the Personnel proposed by the Contractor demonstrating experience and competence in conducting market analyses. Can you please advise what is meant by “market analyses”?

RESPONSE: See response to question 4.

40. Section III.3 states:

Contractors and their foreign associate subcontractors shall have relevant secured computer systems and procedures in place to enable electronically filing all required correspondence with Patent Offices including electronic signatures, throughout the duration of this contract. Contractors shall have practices for updating software required to affect such electronic filings. Paper correspondence is only to be used when U.S. or foreign jurisdictions provide Letters Patent or required documents with original ink signatures. Contractors and their foreign associate subcontractors shall demonstrate proficiency using modern word processing and portable document format software, and specifically Microsoft Word and Adobe Acrobat, in ways that generate documents that are easily navigable and searchable.

Please elaborate on which major countries or regions where foreign associate subcontractors will be needed.

RESPONSE: See response to question 13.

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Please also elaborate on the particular information regarding the software and technological capabilities of foreign subcontractors being sought.

RESPONSE: The above quote is in the Statement of Work and describes NIH’s expectations as to the information technology capabilities of both the US law firms and foreign law firms that work on NIH or CDC patent applications. This excerpt is not requesting information.

41. SECTION L; c. Business proposal Instructions; 7. Qualifications of the offeror; b. states:

Organizational Experience Related to the RFP General experience is defined as general background, experience and qualifications of the offeror. A discussion of proposed facilities which can be devoted to the project may be appropriate.

Please elaborate on the information the proposal is seeking. The general experience and background seems to have been covered in the technical proposal and “general experience” category listed above the cited section.

Further, the “proposed facilities which can be devoted” does not seem to be related to past organizational experience.

RESPONSE: See response to question 35. Additionally, all Offerors shall provide the experiences and information requested by the Government in the Business Proposal. The Technical Proposal is assessed by a Technical Evaluation Panel (TEP). The Business Proposal is reviewed but not scored, separately, by Contracting Officials. The proposed facilities are applicable. Potential offerors are to provide some information about their facility (ies)/office(s).

42. SECTION L; 8. Past Performance Information; a. states:

Offerors shall submit the following information: A list of 3 contracts completed during the past Five (5) years and the three (3) contracts currently being performed that are similar in nature to the solicitation workscope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns.

Please elaborate on what would qualify as “commercial concerns.” The plain meaning of the wording seems to indicate that any commercial or business experience is applicable.

RESPONSE: Correct. All contracts listed shall demonstrate applicable patent-legal experience in Biotechnology and/or Chemistry and/or Mechanical Engineer and/or Software. Such contracts may be with federal, state, or local governments or with businesses in the private sector.

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43. In the evaluation factors for award section on page 66 of the technical proposal, the text of part 2.b (Personnel Expertise) and part 2.c (Prosecution Statistics) appears to be incorrect in view of the response to question 17 of the Questions and Response for Presolicitation NIH-OD-OLAO-OA-(PLS)-2019. It is believed that the current text of part 2.c should be replaced with the current text of part 2.b, and that the current text of part 2.b should be replaced with the corresponding text of part 2.b from the draft RFP posted on November 15 (“The Offeror shall demonstrate the legal, medical, and scientific expertise of each of their proposed Personnel to the Technology Category each proposal pertains to: Biotechnology, Chemistry, Mechanical Engineering, or Software. The Offeror shall demonstrate the recent patent prosecution experience and good standing of proposed Personnel.”)

RESPONSE: See response to question 24.

44. In the quick reference chart on page 57 of the technical proposal, some of the column headings appear to be inconsistent with the corresponding text in section 3 on page 56 and also the response to question 17 of the Questions and Response for Presolicitation NIH-OD-OLAO-OA-(PLS)-2019. To make them consistent it is believed that:

(1) The column heading “Patent Applications Drafted & Prosecuted in Past 3 years” should be changed to “Patent Applications Prosecuted in Past 3 years”;

(2) The column heading “Percent of Drafted Non-Provisionals Allowed” should be changed to “Percent of Prosecuted Applications Allowed”; and

(3) A new column should be added for “Percent of Allowed Applications Drafted by Proposed Personnel”

RESPONSE: Thank you for the recommendation of the required quick reference chart. The Government accepts the recommendation. See the required revised chart is below:

Labor Category

(minimum)

Number of Years at the Firm

Earliest Date of

Admission with a State

Bar

Date of Admission by the USPTO

OED

Key Areas of Expertise/ Advance Technical Degree(s)

Patent Applications

Prosecuted in Past 3 years

% of Prosecuted Application s Allowed

% of Allowed Applications Drafted by Proposed Personnel

Partner Name

(i.e.

Vaccines, CAR-T, immunology, optical devices, ELSA kits, microarrays)

Sr. Associate Name

Jr. Associate

Patent Agent

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45. For the purposes of preparing a Small Business Contracting Plan (SBC), are foreign associates to be considered subcontractors? The purpose of the SBC is to promote small businesses in the United States, and not in foreign countries so it would seem foreign associates should not be considered a subcontractor at least for the purposes of the SBC plan. In any event, large portions of the foreign associate fees are payments to foreign patent offices. Are patent office fees (in the US or foreign countries) included in any subcontracting calculations in the small business subcontracting plan that must accompany the Business Proposal?

RESPONSE: See responses to questions 13, 23, 28, 29, and 30.

46. The response to question 5 of the Questions and Response for Presolicitation NIH-OD-OLAO-OA-(PLS)- 2019 requested only a list of foreign law firms with the Business Proposal and noted that the use of subcontracts would be addressed at the task order level. The response to Question 51 indicated foreign associates should be considered for the “Subcontracts” category, and it is unclear what that response means and if it contradicts the request for only a list of foreign associates in the Business Proposal. Pages 63-64 (Item

8) of the current RFP requires that subcontractors include a commitment letter from subcontractors addressing their willingness to perform the work, priority the work will be given, amount of time and facilities available to the project, information on cognizant field audit offices, and a complete cost proposal in same format as offeror’s proposal. Please confirm that the foreign associates are not subcontractors for purposes of this requirement, and that the requirements of Item 8 at pages 63-64 only apply to domestic subcontractors (such as domestic small entity law firms) who are joining with the prime contractor in making a joint submission in response to the RFP. Given the large number of foreign associates typically used around the world, and different prevailing hourly rates and rates of inflation in different countries, it would be impractical or impossible to obtain such letters of commitment and complete cost proposals from all those foreign associates. The response to prior question 5 suggests that the only requirement at this time for foreign associates is to provide a list naming them, and that any subcontracting to them will be handled at the task order level. Please confirm that list is all that is required.

RESPONSE: See responses to questions 13, 23, 28, 29, and 30.

47. The response to question 58 of the Questions and Response for Presolicitation NIH-OD-OLAO-OA-(PLS)- 2019 is inconsistent with the language of the current RFP. The current RFP requires “a copy of the organization’s most recent annual report.” The response to question 58 adds the requirement that the annual report be certified. Would the government reconsider its position and instead accept an uncertified report since the RFP itself does not specify that an audited report is required? Also, would the government accept a 2017 annual report if that is the most recent report, or is a 2018 annual report required? Our fiscal year began January 1, 2019, and we do not have an audited annual report yet for FY 2018; the audited 2018 report will not be available until after the March 1, 2019 submission date. Can we supplement our proposal with the audited report when it becomes available, if it is required?

RESPONSE: The Government will accept the “most recent annual report”. If the most recent certified annual report is 2017, then, we will accept the 2017 and the 2018 draft.

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48. The RFP requires 8 years of experience for partners, 6 years for senior associates, and 3 years for junior associates and patent agents. Are the years of experience to be calculated from the March 1, 2019 response date to the RFP, or the September 1, 2019 start date of the contract?

RESPONSE: Years of experience should be calculated as of the response date to the RFP

49. The Section 508 Product Assessment Template was recently updated in December 2018, and there are now multiple forms that can be used to comply with the Section 508 requirement. Is the relevant form VPAT

2.3 508 or VPAT WCAG? See https://www.itic.org/policy/accessibility/vpat for the most recent forms.

RESPONSE: Yes

50. Page 64, C9 – Proposer’s Annual Financial Report: is this a request for an internally-prepared firm annual report (e.g., profit/loss statement, balance sheet, etc.), federal tax returns, a CPA prepared review, compilation, or a formal audit?

a. If a CPA-prepared report is required, what accounting standard is required - GAAP or Yellow Book?

b. Should the report be on a cash basis or accrual basis?

RESPONSE: Your firm’s annual report.

51. Is a labor mix of attorneys as requested, but who have different titles within our firm (i.e., junior partner, of-counsel, etc.), and with a billing-rate stratification similar to a traditional partner/senior associate/junior associate labor mix acceptable?

RESPONSE: Per the RFP, “If Offerors are unable to propose the minimum labor categories listed below, Offerors may propose an alternative labor mix.”

52. In the Business Proposal instructions, the description of section 7b (Organizational Experience Related to the RFP) is identical to the description of section 7a (General Experience). What information is the Government looking for under section 7b?

RESPONSE: See response to questions 35 and 41. Offerors shall respond to both sections as requested in the

RFP.

53. Following up on the Response to Question #61 of the Question and Response for Presolicitation NIH-OD- OLAO-OA-(PLS)-2019: Regarding patent search projects, is it the Government’s position that the actual search component (i.e., keyword and class searching of patent databases) of a patent search project must be done in-house by the firm and cannot be sent out to a patent search company?

RESPONSE: It is preferred that patent searches are done in-house. The Offeror is ultimately responsible for the thoroughness of the search and its analysis.

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54. Does the Proposal Response Intent Form on Page 20 of the Statement of Work document suffice as the Letter of Intent requested by January 30, 2019, or is a Letter of Intent required in addition to the Proposal Response Intent Form?

RESPONSE: Only the Proposal Response Intent form is required.

55. Page 59 of the RFP solicitation (Part IV, Section L, 2. Instructions to Offerors, c. Business Proposal Instructions, 2. Proposal Cover Sheet, 6. Proposed cost and/or price; profit or fee; and total): what exactly does the Government require? The grand sum dollar amount of work the firm can do on an annual contract basis, or over a 10-year period, or both? The cost per project (patent application, response to office action, etc.)? A presentation of the labor mix with billing rates?

a. What is meant by “profit/or fee”; and “total”?

RESPONSE: See FAR 15.404-4.

56. Based on the following portions of the NIH RFP, we understand that the RFP is referencing the calendar year-to-year percent increase of projected CPI-U values listed in the 10-year Economic Projection of April 2018 (which are the same as the projected inflationary growth of the CPI-U values in the Long Term Budget Projection dated from June 2018). Is this understanding correct?

RESPONSE: Yes

57. Are the following values correctly recited for the annual percentage increases per the CBO projections?

2019: 2.2% 2020: 2.4% 2021: 2.5% 2022: 2.5% 2023: 2.4% 2024: 2.4% 2025: 2.4% 2026: 2.4% 2027: 2.4% 2028: 2.4%

RESPONSE: See response to 62.

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58. Do the requirements of NIH RFP Part I, Section H, Article H.5.1. at NIH RFP page 20 apply to every subcontractor, including foreign associates, outside (i.e., not in-house) patent figure preparation personnel, document delivery services, etc.? NIH RFP Part I, Section H, Article H.5.1. at NIH RFP page 20 states:

(a) “Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the ‘Commitment to Protect Non-Public Information - Contractor Employee Agreement’ ….”

(b) “All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable HHS/NIH Contractor Information Security Awareness, Privacy, and Records Management training course…;”

(c) “The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS policy,” and

(d) “The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, and comply with the NIH Information Technology General Rules of Behavior.”

RESPONSE: The Government is asking that each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the ‘Commitment to Protect Non-Public Information – contractor Employee Agreement’

59. Does NIH RFP Part IV, Section L, item 2.c.8. (Business Proposal instructions – Subcontractors) at NIH RFP page 63 (which states “If subcontractors are proposed, please include a commitment letter from the subcontractor detailing :….”) only apply to subcontractors of patent legal services or to all subcontractors, including foreign associates, outside (i.e., not in-house) patent figure preparation personnel, document delivery services, etc.?

RESPONSE: The language applies to subcontractors of patent-legal services. Whether or not you need subcontractors at the master level or task order level. The master contract must contain the regulation required to permit subcontracting.

60. The headings of the two columns on the right-hand side of the table under NIH RFP Part IV, Section L, Article L.2.b.1.c.4 (NIH RFP page 57) (“table”) do not reflect the information requested in the text of NIH RFP Part IV, Section L, Article L.2.b.1.c.3 (NIH RFP page 56) (“text”). Should the two columns on the right-hand side of the table be replaced with three columns having the headings below to correspond with the information requested in the text?

(X) number of patent applications prosecuted by indicated person in past 3 years

(Y) number of patent applications of (X) allowed

(Z) number of patent application of (Y) drafted by indicated person

RESPONSE: See response to question 44.

61. On page 55 of the RFP, Part IV, Section L.2.b.1. various statistics are requested of the Offeror. Should those statistics be determined on a firm-wide basis or should the statistics be determined based only on the

16 | P a g e persons identified in the response to the RFP? In other words, does the term “offeror” in the NIH RFP mean “the firm” or only the particular personnel of the firm identified in the response to the NIH RFP?

RESPONSE: At a minimum, firm-wide statistics should be provided. If available, statistics based on the personnel identified in the response to the RFP should also be provided.

62. Under Article B.3. Prices/Costs on page (4) of the RFP, it states: “Offerors may allow an inflationary increase per year that not exceed more than 1% of the given year's CPI”. Where exactly within the provided link do we find the projected CPI’s for the next 10 years? (https://www.cbo.gov/about/products/budget-economic-data#3) Also, for clarification purposes, if the CPI from 2019 to 2020 is 2.5%, does this mean our annual increase for that year is not to exceed 1% of 2.5% (=0.00025) or does this mean our annual increase is not to exceed 3.5%?

RESPONSE: Shown below are the projected percentage changes in the Consumer Price Index, All Urban Consumers (CPI-U):

2017 2.1 2018 2.2 2019 2.2 2020 2.4 2021 2.5 2022 2.5 2023 2.4 2024 2.4 2025 2.4 2026 2.4 2027 2.4 2028 2.4

Source: Congressional Budget Office, 10-Year Economic Projections April 2018, https://www.cbo.gov/about/products/budget-economic-data#3.

63. For the Labor Mix sections, are we able to classify title by experience and rates? For example, we have an attorney that has over six years of legal experience however, he has roughly two years of patent legal experience. His patent litigation rate reflects the two years of experience so we would like to list him as a junior associate rather than a senior associate. Would this be okay?

RESPONSE: Yes. Years of experience are based on the practice of patent law, not general legal experience.

64. As it pertains to the RFP for NIH, please clarify whether foreign attorneys acting as patent prosecution counsel in ex-U.S. applications would be considered subcontractors for the purposes of this proposal. If so, in which countries does NIH typically nationalize applications?

https://www.cbo.gov/about/products/budget-economic-data#3 https://www.cbo.gov/about/products/budget-economic-data#3 https://www.cbo.gov/about/products/budget-economic-data#3

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RESPONSE: Yes, foreign associates would be considered subcontractors. See also response to question 13.

65. In the RFP document, Section L, subsection 2, item 8, “Past Performance Information,” page 54, does this section require contracts with government or commercial entities, or are references to clients whose work is not formally contracted also acceptable?

RESPONSE: Government and commercial entities.

66. If we are preparing a proposal for the Biotechnology category, do the contracts/clients that we reference need to be in the Biotechnology category?

RESPONSE: Yes.

67. Can we use one or more NIH investigators as references?

RESPONSE: No.

68. Can we use NIH patents we have drafted and prosecuted as work examples?

RESPONSE: Yes.

69. When analyzing statistics for each attorney, do continuations and divisional applications that were originally drafted prior to 2016 count as “drafted applications?”

RESPONSE: No.

70. Will our responses to this RFP along with the documentation we are required to provide, including the firm’s annual financial report, be made part of the public record? If yes, may we request that certain sections or information be redacted or not included?

71. Does the NIH have a policy or particular stance on providing its law firms with an advance waiver for prospective conflicts of interest in connection with potential matters that are entirely unrelated to the subject matter that the firm handles for the NIH?

RESPONSE: NIH does not intend to execute any waivers to absolve a contractor or subcontractor of a conflict of interest or other ethical conflict.

72. Our firm receives an annual financial review of our financial statements prepared by an outside independent accounting firm. Will that meet the requirements of an “annual report”?

RESPONSE: Yes, as long as it is certified. See response to question 47.

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73. Can NIH give some guidance on the type of writing sample that would be most useful to include with each resume?

RESPONSE: The writing sample should be reflective of the proposed person’s (1) understanding of patent law principles, (2) understanding of patent prosecution strategy, (3) technical understanding of an invention, and

(4) ability to write persuasively and clearly.

74. Is a completed HHS Section 508 Product Assessment Template required for submission along with the proposal?

RESPONSE: Yes.

75. While the RFP is largely directed to prosecution services, the Statement of Work states that Patent legal services may include “Contentious proceedings (worldwide).” Will there be separate RFPs (and contracts) for contentious proceedings, or will all contentious proceedings work fall under this RFP?

RESPONSE: No, there will not be separate RFPs for Contentious Proceedings. Contentious proceedings will fall under this RFP. See the Statement of Work.

76. The “Labor Mix” section of the Statement of Work uses the phrases:

a. “cumulative patent prosecution experience”

b. “cumulative experience as a registered practitioner before the USPTO”

Would it be possible to elaborate on the meaning of these phrases? For example, does “patent prosecution experience” specifically refer to experience in the activities enumerated in III.1.5 and III.1.6 of the Statement of Work? Is a year of experience in such activities a year in which 100% of a person’s time is devoted to such activities, or is it something less?

RESPONSE: Patent prosecution experience refers to experience actively prosecuting patent applications either at the level of (1) formulating patent prosecution strategy and drafting the resulting response to an office action or new patent application or (2) reviewing such work. Experience as a registered practitioner before the USPTO includes patent prosecution work and any other work before the USPTO, including post-grant proceedings, derivation proceedings, and interferences.

77. Would you please describe what you mean by “marketing analyses”?

RESPONSE: See response to question 4.

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78. Is there any way to pre-submit the proposed labor mix and the personnel statistics called for on pages 56- 57 of the RFP, and to get an indication of whether threshold experience requirements have been met?

Obviously submission of a proposal under this RFP will be a significant undertaking. It would be undesirable to undertake such and effort only to discover later that minimum experience requirements had not been met.

RESPONSE: No, offerors are not permitted to pre-submit information.

79. Does the contracting agency require a Certificate of Good Standing for every state the attorneys are licensed with, along with the courts they’re licensed in? How current will the certificate need to be?

RESPONSE: A Certificate of Good Standing is typically good for 3 months from the date of issuance.

80. For question 7 under the business proposal, you ask for general experience and organizational experience.

For both, you have the same descriptive paragraph. Can you clarify?

RESPONSE: See response to questions 35 and 41.

81. Will we need a subcontracting plan for each foreign law firm that we might use for foreign patents?

RESPONSE: No. Please read the instructions on how to submit a small business subcontracting plan.

82. We are a small, private law firm and, therefore, do not have an annual financial report. Are there any documents you’ll accept in lieu of one?

RESPONSE: No.

83. The instructions for the Technical Proposal Section (c)(2)(3) indicate the offerer shall “provide statistics for the past (3) years on the number of provisional and non-provisional domestic and foreign applications, including PCT applications, prosecuted” and indicate of how many of the foreign and domestic applications were prosecuted to allowance. As PCT applications are not prosecuted in such a way to result in an allowance, it seems that the inclusion of PCTs in this statistic would create a misleading statistic relating to allowance numbers for firms having filed a significant number of PCT applications over the requested period. For example, if a single PCT application is filed which culminates in a single domestic and foreign application (3 total applications) and the domestic and foreign application are allowed, the statistic would appear as if the allowance rate was 67%, when, in fact, it was 100%. It would seem that a separate number for foreign and domestic applications prosecuted (excluding PCT applications) would alleviate this discrepancy.

RESPONSE: By referencing PCT applications, NIH is referring to national stage applications prosecuted under each PCT application.

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84. In the instructions for the Technical Proposal Section (c)(2)(4) the “quick reference chart” has a column for “percent of drafted non-provisionals allowed,” is the intent for the percentage over the entire career of the practitioner or just for the past 3 years as was requested for patent applications drafted and prosecuted?

Item (c)(2)(3) would seem to indicate that the past 3 years is the relevant time period, but clarification is requested.

RESPONSE: See response to question 69. The time period is 3 years. How many applications were prosecuted during the 3 years? Of those, how may were allowed, and of those allowed applications, how many were originally drafted by the person?

85. What do you mean by “fully-loaded” rates? Is this just the hourly rate that will be billed? Also, the table requires other expenses and subcontracts to be listed, but those are negotiated at the task order level and not hourly rates. How would you like us to account for this?

RESPONSE: “Fully-loaded” rates means labor rates including all direct, indirect, general and administrative costs, fringe, benefits, and profit associated with providing required skill.

86. Section L, item 2.a.8, “Past Performance Information” - request for total of 6 contracts “that are similar in nature to the solicitation workscope”

• Can you explain the purpose of this information? Is it to review the terms of the previous contracts in comparison to the RFP response? Or is it to determine if a firm is qualified to work on large scale patent prosecution portfolios?

RESPONSE: See FAR Subpart 15.101 – Best Value Continuum

• Can we provide redacted contracts as examples?

RESPONSE: No, the Government is not requesting copies and/or examples of redacted contracts. Please review the section carefully.

• Will the submitted contracts ever be subject to publication by the NIH, via a FOIA request or similar?

RESPONSE: No, the Government is not requesting examples of redacted contracts. Please review the section carefully.

• If we are unable to provide a total of 6 contracts as part of the RFP response, will the entirety of the response be deemed incomplete?

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87. Statement of Work - Lobbying Disclosure Form: Does this questionnaire pertain to our firm’s current lobbying work?

RESPONSE: Offerors are to provide current lobbying activities.

88. Statement of Work – FAR Provisions: These provisions do not appear to be applicable to legal services.

Would we be subject to these provisions, or are some of these not applicable to law firms?

RESPONSE: The FAR provisions and articles are applicable to the acquiring of services under a task order.

Contracting officials placing orders under an IDIQ will need these regulations, provisions, and clauses in order to issue awards under a multiple award IDIQ. See FAR 16.505.

89. It appears much of the RFP and Statement of work is geared toward contractors that do not provide legal services. Can we strike out portions that are not pertinent to legal services?

RESPONSE: No, the Government will not strike out portions of the RFP or Statement of Work. See response to question 88.

90. Is the NIH amenable to signing an advance consent waiver and agree to our terms regarding conflicts of interest?

RESPONSE: See response to question 71.

91. The RFP appears to include an indemnity provision (p. 25).