36C24E21R0024_1.docx

Special Notice Special Notice

GENERAL INFORMATION

Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319

POINT OF CONTACT*

Mr. Robin A. Simmons, Contract Specialist robin.simmons@va.gov robin.simmons@va.gov

(412) 822-3483

ADDITIONAL INFORMATION

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1. OVERVIEW

The Veterans Health Administration (VHA), Office of Research and Development (R&D), Regional Procurement Office (RPO) – East in Pittsburgh, PA intends to negotiate on a sole source basis with Ballard Spahr, LLP.

The requirement is for Ballard Spahr, LLP to provide the VA Technology Transfer Program (TTP), within the Office of Research and Development (ORD), with portfolio management and patent legal services. This action would be awarded as a follow-on contract. The result would be the Department of Veterans Affairs entering into a firm fixed price IDIQ contract with Ballard & Spahr LLP, an international law firm based in Atlanta, Georgia.

The requirement is for one (1) contractor to provide patent legal services including but not limited to patent drafting, filing, prosecution, docketing, and maintenance for 5 years (base period with 4 option periods). The law firm must possess the capabilities to handle the sheer volume of the VA’s patent portfolio. VA’s patent portfolio is unusually large and complex because it originates from research and development performed at over 100 VA Medical Centers (ORD), each one a Federal Laboratory with its own goals and interests. The current Contractor (Ballard Spahr, LLP) is responsible for 977 different patent matters, of which 635 are actively managed. This includes a mix of US (662), Patent Cooperation Treaty (PCT) (119), and foreign cases (196), the latter of which require careful coordination with foreign counsel.

This procurement is being conducted IAW FAR 6.302-1, Only one responsible source and no other services will satisfy agency requirements. This is because the Government asserts that awarding a follow-on contract to Ballard Spahr is critical to ensure the VA maintains continuity, thereby preventing a substantial duplication of cost and unacceptable delays to VA’s technology transfer efforts.

SCOPE OF WORK: VA requires that the contract awardee have the legal capability, training, and resources necessary to prosecute domestic, international, foreign regional and foreign national patent applications. The work under this contract will require patent preparation and patent prosecution in specific scientific and technical areas of interest to VA. Therefore, contractors must have scientific education or training in the scientific areas in which the contractor will be performing legal services for VA. Specifically, the contractor must have an attorney expert with Partner level experience to lead technical teams of PhD level scientific technical experts, junior attorneys and/or patent agents in, at least, the technical areas including, mechanical devices, computer software, computer engineering and electronics, medical devices, biological compounds/processes, chemical compounds/processes and medicinal chemistry, pharmaceuticals, and pharmacology.

Refer to Section 2, Contractor Requirements and Tasks. Interested contractors must be able to meet all Requirements and Tasks. It is the responsibility of the interested contractor to adequately demonstrate to the Government within their capability statement that they can perform all Requirements and Tasks.

This notice of intent is not a request for competitive proposals. However, any responsible source who believes it is capable of meeting the requirement may submit a capability statement and supporting documentation to the Contract Specialist no later than Friday, July 23, 2021, 4:00 PM, EST. Interest/capability statements may be sent by email to Mr. Robin Simmons at robin.simmons@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

2. CONTRACTOR REQUIREMENTS AND TASKS

Potential contracting firms responding to this Solicitation must demonstrate a thorough understanding and have significant experience in the practice of U.S. patent law. All firm attorneys or agents assigned to handle matters under this contract must be in good standing to practice before the United States Patent and Trademark Office (USPTO) and, if a firm practitioner is an attorney, be an active member in good standing with his or her respective state bar licensing organization. Contracting firms will be responsible for identifying competent attorneys in foreign jurisdictions for foreign national and foreign regional patent filings. Contractors shall be responsible for directing foreign associates subject to VA guidance and approval. The Contractor shall file, or ensure foreign associates file, patent applications which include all parts necessary to meet statutory requirements for obtaining a priority date as of the date of filing, or an earlier date, if earlier filed applications are claimed as priority documents. The following list of tasks is provided as a minimum, non-exhaustive, description of the kinds of US, international and foreign patent prosecution tasks that will be required of Contractors. The Contractor in submitting its capability statement must ensure it clearly communicates its ability to meet all Requirements and Tasks, as well as the volume of patents mentioned in Section 1.

Selection as a VA contracted law firm under this Solicitation will entail the transfer of all or a substantial fraction of VA’s currently existing legal docket of matters to the contracting firm.

The Contractor shall, as directed by TTP Contracting Officer, perform all necessary and appropriate services in connection with the filing and prosecution of U.S. national, international (PCT), foreign regional (e.g. European Patent Office) and foreign national patents. Domestic patent matters shall be handled in compliance with Title 35, US Code, and with Volume 37, Code of Federal Regulation and other applicable laws, regulations and current case law. The preparation and filing of provisional, utility, plant, or design patent applications shall be based on invention disclosures in light of known prior art and any contemplated prosecution strategy. All foreign patent matters shall be handled by the Contractor or foreign associates under the direction of the Contractor, in accordance with the applicable statues, regulations, and case law of the particular foreign jurisdiction. All required responses to U.S. and foreign patent office actions should be filed within foreign filing deadlines or shortened U.S. statutory periods such that extension of time or patent revival fees are avoided unless specifically authorized by TTP. For all applications claiming a priority date to an application filed prior to March 16, 2013, the law firm will provide notice to TTP when it believes new matter is being added to the claims of a new or existing application in a patent family.

VA reserves the right to specify staffing requirements and limit the amount of time for partner/senior attorney review in a specific task order.

· Search patent and/or non-patent literature databases, including ,where requested chemical structure databases, for disclosures relevant to subject matter identified by TTP.

· Provide freedom to operate searches of issued and pending patent claims. When requested, provide written summary and analysis of the search results.

· Provide prior art searches of patent and/or non-patent literature databases, including, where requested chemical structure databases to assist in patent application filing and prosecution decisions.

· Provide infringement/non-infringement and patent validity opinions.

2.1.2 File U.S. Design Patent Application and Corresponding International Design Registrations.

· When and as directed by TTP, draft design patent applications by reviewing invention disclosure materials, discuss with TTP Technology Transfer Specialist responsible for VA ID number, and speak with VA investigators as appropriate.

· File the U.S. design patent application with the USPTO prior to any known public disclosure dates;

· When specifically instructed by TTP, the Contractor shall direct foreign associate(s) to file corresponding international design registration applications per the requirements of the Hague Convention or the law of the foreign jurisdiction, as appropriate.

· Contractor will provide copies of all foreign associate and foreign Patent Office correspondence and reminders of prosecution deadlines per the schedule specified in Section 3.

2.1.3 File U.S. Provisional Application.

· When and as directed by TTP, prepare draft provisional patent applications including a specification, draft claim(s) and applicable drawings, based upon invention disclosure, manuscripts, drawing(s), discussions with TTP Technology Transfer Specialist responsible for VA ID number and conduct inventor interview(s) as necessary.

· File U.S. provisional applications with the USPTO by TTP’s requested deadline and/or prior to any known public disclosure dates.

2.1.3.1 Provide Notice of U.S. Provisional Application Conversion and Other Filing Deadlines to the TTP.

· Contractor will notify TTP of U.S. provisional application expiration and conversion deadline per the schedule specified in Section 3.

2.1.4 File U.S. Non-Provisional Utility Patent Application.

· When and as directed by TTP, prepare draft non-provisional patent applications, for TTP review, prior to filing applications.

· Review pending provisional application(s), invention disclosure materials, known and disclosed prior art, and manuscripts. Consult with TTP Technology Transfer Specialist responsible for application and, if approved by TTP in advance, interview VA inventors when preparing non-provisional application.

· File the U.S. non-provisional application with the USPTO, as directed by TTP, so the application is filed prior to:

· the one (1) year anniversary of a provisional application to which the non-provisional application will claim priority;

· any known investigator or third party public disclosures dates; and/or

· the one (1) year anniversary of any known public disclosures.

· Request expedited prosecution (such as Prioritized Examination, Accelerated Examination) as directed by TTP.

2.1.5 File International Applications under the Patent Cooperation Treaty (PCT).

· When and as directed by TTP, draft international applications in compliance with the Patent Cooperation Treaty.

· Utilize the invention disclosure materials, known and disclosed prior art, filed parent patent applications, such as provisional applications or non-provisional application, design registrations and applications, and information provided by inventors.

· File PCT applications in a PCT designated receiving office. Unless otherwise directed by TTP, filings shall be during the pendency of any earlier filed application to which the PCT application may claim priority under foreign, domestic or international law.

2.1.5.1 Provide TTP Notice of PCT Request, Response, and National Stage Conversion Filing Deadlines.

· Contractor will notify TTP of PCT Requests, Written Opinion Response, and national stage conversion filing deadlines per the schedule specified in Section 3.

2.1.6 File U.S. National Stage Application under PCT.

· When and as directed by TTP, prepare for TTP review a U.S. national stage patent application based on a prior filed PCT application.

· File, as directed by TTP, the U.S. national stage application within U.S. and international filing deadline requirements in order to maintain the earliest claimed priority date for the subject matter disclosed in the parent application(s).

· File supplemental information necessary to perfect the national stage filing.

2.1.7 Provide Notice to TTP of Paris Convention Application Filing Deadlines.

· Contractor will notify TTP of Paris Convention application filing deadlines per the schedule specified in Section 3

2.1.7.1 File Patent Application under Paris Convention.

· When and as directed by TTP, prepare for TTP review English-language patent applications including proposed claim sets, meeting the legal requirements of the Paris Convention.

· Utilize invention disclosure materials, known and disclosed prior art, prior filed parent applications and information provided by investigators to prepare the Paris Convention application.

· As requested by TTP, provide translation cost estimates for each country in which the Paris Convention application may be filed. As requested by TTP, secure translation services to have the Paris Convention applications translated in the countries designated by TTP.

· File as directed by TTP, the Paris Convention application in specified foreign or regional Patent Offices.

2.1.9 File Foreign Regional or Foreign National Stage Application based on PCT filing.

· When and as directed by TTP, prepare for TTP review English-language patent applications including the proposed claims meeting the legal requirements for each foreign regional or foreign national jurisdiction.

· Utilize invention disclosure materials, known and disclosed prior art, prior filed parent applications and information provided by inventors to prepare the foreign regional or foreign national stage application(s).

· As requested by TTP, provide translation cost estimates for each country or region in which the foreign regional or foreign national patent application may be filed. Have translated the patent applications into languages requested by TTP.

· File foreign regional or national application(s) so as to maintain the benefit of the earliest claimed priority dates in parent application(s).

2.1.10 Instructions to Foreign Associate to file and prosecute National and/or Regional Applications.

· When specifically instructed by TTP, the Contractor shall direct foreign associate(s) to file foreign regional or foreign national applications.

· Contractor will provide copies of all foreign associate and foreign Patent Office correspondence and reminders of prosecution deadlines per the schedule specified in Section 3.

· When and as specifically instructed by TTP, the Contractor shall provide instructions to foreign associate(s) on national or regional patent prosecution matters being handled by the foreign associate.

2.1 TASK 2 – Formal Patent Documents and Application Parts

2.2.1 Prepare and File Power of Attorney/Revocation of Power of Attorney Forms.

· Contractor will use USPTO Power of Attorney forms.

· For foreign prosecution, Contractor will ensure that foreign associates provide and file jurisdictionally valid Powers of Attorney.

· Contractor will correspond with appropriate parties and TTP and acquire all necessary authorizing signatures on Power of Attorney documents. All Power of Attorney documents shall include the VA ID number, the Contractor’s docket number, and the patent application serial number, if available.

2.2.2 Evaluate Inventorship, Ownership and Prepare Inventor Declaration or Supplemental Statement.

· Contractor will investigate and determine inventorship based on proposed patent claims and TTP input and, as directed by TTP, inventor interviews or statements.

· Prepare the inventor declarations or, as necessary, a supplemental statement, and have appropriate parties sign all documents. All inventor declarations or supplemental statements shall include the VA ID number, the Contractor’s docket number, and the patent application serial number, if available.

2.2.3 File Inventor Declaration, Correct Inventorship during Prosecution, or File Supplemental Statement.

· Where all inventors are named on the USPTO Application Data Sheet (ADS), Contractor may file inventor declarations prior to a Notice of Allowance or in response to a Notice of Allowability.

· Where inventors are not named in the USPTO ADS, Contractor will file executed inventor declaration or corrected ADS forms with the USPTO as early in prosecution of the application as possible, within statutorily required periods and prior to publication of the application.

· Where inventorship changes during the course of prosecution, Contractor will obtain necessary signatures and file all required documentation in order to reflect the change of inventorship. Inventorship should be confirmed and corrections should be completed prior to payment of the Issue Fee.

· When necessary and directed by TTP, Contractor will file corrected or revised ADS.

2.2.6 Prepare and File Amino Acid and/or Nucleic Acid Sequence Listings.

· Where necessitated by the subject matter of an application, Contractor will prepare and file amino acid and/or nucleic acid sequence listings compliant with USPTO or foreign Patent Office requirements.

2.2.7 Prepare and File Drawings.

· Where necessitated by the subject matter of an application, Contractor will prepare and file accurate drawings compliant with USPTO or foreign Patent Office requirements.

· Contractor will review application Filing Receipts for accuracy and file for corrections as necessary and as directed by TTP.

2.2.9 File Request for Corrected Filing Receipt.

· When necessary and directed by TTP, Contractor will file a Request for Corrected Filing Receipt.

2.2.10 Prepare and Record Domestic and Foreign Assignments.

· Contractor will prepare legally valid domestic assignment documents and obtain assignment document signatures of all requisite parties. Assignment document(s) requiring VA signatories should be directed to the Technology Transfer Specialist responsible for the application and must include the VA ID number, Contractor docket number, patent application serial number and inventor name(s).

· Contractor will file for recordation executed assignment document(s) with the USPTO, preferably at the time of patent application filing, but in any event within 60 days of receipt of the executed assignment document(s).

· Correspond and consult with foreign associates regarding foreign assignment requirements. Ensure jurisdictionally valid and correct foreign assignment documents are filed within required national periods. Assignment document(s) requiring VA signatories should be directed to the Technology Transfer Specialist responsible for the application must include the VA ID number, Contractor docket number, patent application serial number and inventor name(s).

2.2.11 Record Corrected Assignments.

· When necessary and directed by TTP, Contractor will prepare and file corrected assignment document(s), for domestic and foreign applications. All corrected assignment document(s) will be subject to the same requirements set forth in Section 2.2.10 above.

2.2.12 Report Notice to File Missing Parts/Missing Requirements and Prepare and File Responses to Notice to File Missing Parts/Missing Requirements.

· Contractor will notify TTP of the receipt of a Notice to File Missing Parts per the schedule specified in Section 3.

· The Contractor shall file a Preliminary Amendment in an application, when necessary or instructed to do so by TTP, at the time a 35 USC 371 U.S. Patent application is filed or prior to issuance of the first Office Action.

2.3.3 Report Office Actions (Domestic and Foreign).

· Report to TTP all Office Actions no later than five (5) days after the Contractor receives it from the office of the patent examining authority per the schedule specified in Section 3 at 3.3.3.

· Send reminders to TTP of upcoming Office Action response due dates per the schedule specified in Section 3 at 3.3.3.

2.3.4 Prepare and File Office Action Response for Domestic and Foreign Prosecution.

· When specifically directed by TTP, review Office Action and prepare draft response.

· Review Office Action, the specification, prior art, and, with prior notification to TTP, speak with the VA investigators when preparing the response.

· Office Action responses must address all rejections or objections raised by the Patent Office in the Office Action and must be drafted in view of applicable statutes, regulations and current case law.

· Timely file the response to the Office Action with the USPTO or foreign Patent Office; extensions of time may be taken only when authorized by TTP.

· The Contractor shall provide TTP with a copy of any Notices of Interference of Derivation Proceedings per the schedule set forth in Section 3.

2.3.18 File Continuation and Divisional Patent Applications.

· The Contractor will prepare and file continuation and divisional applications when and as directed by TTP; the Contractor will ensure that any divisional or continuation applications are filed prior to the payment of issue fee in the parent application unless expressly instructed to do otherwise by TTP.

· The Contractor will be presumptively responsible for any unavoidably or unintentionally abandoned patent applications and will solely bear the costs of revival.

· Prior to paying any issue fee, the Contractor shall:

· Review and confirm that inventorship is accurate;

· Confirm that priority is accurately claimed;

· To the best of Contractor’s ability, ensure that all relevant art has been cited in an IDS initialed by the examiner;

· Review examiner’s amendments (if any) and communicate amendments to TTP; and

· Prepare and file necessary corrections to the application.

· The Contractor will promptly communicate the notice of opposition proceedings to TTP according to the schedule set forth in Section 3.

· The Contractor will coordinate meetings with TTP and the foreign associate(s) in order to formulate a strategy for responding to the opposition.

· The Contractor will arrange and manage representation before foreign opposition boards.

· On IP related issues dealing with possible patent litigation. Patent litigation matters are handled by Department of Justice in coordination with VA’s Office of General Counsel.

· On U.S. patent prosecution strategy and portfolio management.

· On patent valuation and licensing strategy.

· On enforcement of VA’s Intellectual Property licenses and agreements including joint Intellectual Property.

· On international and foreign patent prosecution strategy and portfolio management.

· Filing and registration of other VA-owned intellectual property, including but not limited to trademark applications and copyright registrations.

· On other IP issues not directly related to pending patent applications or issued patents.

• Maintain and update electronic database containing information on all VA matters, including VA reference numbers, patent and patent application numbers, attorney docket numbers, filing documents, action deadlines, total and monthly fees and costs per matter. Database must be accessible by TTP staff and matters can be filtered by responsible TTP case manager. Contractor database must allow for streamlined review of invoices submitted on a monthly basis by responsible TTP case manager and must have data integration with separate 3rd-party-hosted TTP database so that patent expenditures and pdf invoices are updated on applicable patent and patent application records in TTP database on a regular, monthly basis with no manual data input or other effort required on the part of TTP staff.

Special Notice