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First to Invent vs. First to File: The Importance of Keeping a Proper Laboratory First to Invent vs. First to File: The Importance of Keeping a Proper Laboratory Notebook Edwin V. Merkel Carissa R. Childs Le. Clair. Ryan A Professional Corporation 290 Linden Oaks, Suite 310 Rochester, NY 14625

What You Will Learn Today § Something About Patent Law and the Likely Changes What You Will Learn Today § Something About Patent Law and the Likely Changes to the Law § Why Your Notebook Matters • Use your notebook to remove rejections raised during prosecution of your patent application • Use your notebook to win a contest with another party trying to patent the same invention § What You Can Do to Make Sure Your Notebook is Acceptable as Evidence 2

Patent Reform: The End of the First to Invent System? § Current Law = Patent Reform: The End of the First to Invent System? § Current Law = First to Invent: Inventor with earliest date of invention is entitled to a patent (if all other requirements of patentability are met) • Unique to U. S. Patent System vs. § Proposed Law = First Inventor to File: The inventor with the earliest patent filing date is entitled to a patent (if all other requirements of patentability are met) • Single exception under new law 3

Patent Reform: The End of the First to Invent System? § Pending Legislation • Patent Reform: The End of the First to Invent System? § Pending Legislation • March 2011: Senate passed Patent Reform bill • June 2011: House passed revised version of bill • This week: Senate voted to end debate on the revised House bill and move ahead with a vote § Effective Date of Pending Legislation • 18 months after enactment (for aspects related to first inventor to file) • Current laws will still apply to all patent application (and patent) claims having an effective filing date before the date the new laws take effect 4

Requirements for Patentability § Patentable Subject Matter • Any new and useful process, machine, Requirements for Patentability § Patentable Subject Matter • Any new and useful process, machine, article of manufacture, or composition of matter § Prior Art Identified Under Section 102 of Current Patent Law • 102(a) identifies prior art “known or used by others in this country, or patented or described in a printed publication in this or a foreign country before the invention thereof by the applicant” 5

Requirements for Patentability cont. § Prior Art Identified Under Section 102 cont. • 102(e) Requirements for Patentability cont. § Prior Art Identified Under Section 102 cont. • 102(e) identifies “secret” prior art: published U. S. patent application (or PCT application designating the U. S. ) or issued U. S. patent filed by another before the invention by the applicant • 102(g) identifies as prior art any subject matter of a lost interference between two or more parties; basically, the other party establishes during an interference proceeding that they invented the claimed subject matter before you 6

Importance of Keeping a Proper Laboratory Notebook § Laboratory Notebook is an Evidentiary Record Importance of Keeping a Proper Laboratory Notebook § Laboratory Notebook is an Evidentiary Record That Can Be Used to Establish: • Patentability of Invention – Establish date of invention to remove prior art under 102(a), (e) – Establish priority of invention during an interference proceeding− 102(g) • Determine Inventorship 7

First to Invent vs. First to File A Date of Filing B Date of First to Invent vs. First to File A Date of Filing B Date of Invention Date of Filing § First to File System (Pending Law) • A is entitled to patent § First to Invent System (Current Law) • B may be entitled to patent if B’s date of invention predates A’s filing date or date of invention 8

First to Invent: Eliminating Prior Art A Date of Filing B Date of Invention First to Invent: Eliminating Prior Art A Date of Filing B Date of Invention Date of Filing § If A is Cited as Prior Art, B May Still Be Entitled to Patent if B’s Date of Invention Predates A’s Filing Date 9

First to Invent: Eliminating Prior Art cont. § Prior Art (recap) • Any printed First to Invent: Eliminating Prior Art cont. § Prior Art (recap) • Any printed publication, use, or knowledge of invention by another before applicant’s date of invention • “Secret” prior art—a published patent application or issued patent by another that is filed before your application § Filing Date of Your Patent Application is Considered Date of Invention Until Proven Otherwise § Eliminating Prior Art • Submission of a sworn declaration by all inventors along with notebook evidence corroborating a date of invention that antedates the date of the prior art (publication or filing date) • This is not available for those publications having a publication date that is more than one year before your filing date 10

First to Invent: Interference A Date of Invention Date of Filing B Date of First to Invent: Interference A Date of Invention Date of Filing B Date of Invention Date of Filing § If A and B Are Claiming the Same Patentable Subject Matter, then B May Be Entitled to Patent if B’s Date of Invention Predates A’s Date of Invention § Statistics Suggest That the Party Who is First to File is Usually, but Not Always, the First to Invent 11

First to Invent: Interference cont. § Interference • Contested proceeding in the U. S. First to Invent: Interference cont. § Interference • Contested proceeding in the U. S. Patent and Trademark Office (PTO) between at least one patent application and either another patent application or patent claiming the same patentable subject matter to determine who is entitled to a patent § Presumption at Outset • First to file (Senior Party) is first to invent unless the party who is later to file (Junior Party) can demonstrate priority of invention § To Win • Junior party must overcome presumption and prove earlier date of invention; if not successful, Senior party wins • No abandonment, suppression, or concealment 12

Date of Invention § Conception of Invention (Mental Part) • Recognition of a definite Date of Invention § Conception of Invention (Mental Part) • Recognition of a definite and permanent idea of the complete and operative invention § Reduction to Practice (Physical Part) • Actual: making and testing the invention • Constructive: filing of a patent application § Diligence • Establishing applicant’s continual work to reduce the invention to practice after conception § Corroboration • Evidence and witnessed testimony that independently confirms the facts presented by the inventor(s) 13

Winning an Interference A Conception Actual reduction to practice B Conception Actual reduction to Winning an Interference A Conception Actual reduction to practice B Conception Actual reduction to practice U. S. filing date Inventor B Entitled to Patent 14

Winning an Interference A Actual Conception reduction to practice U. S. filing date Commencement Winning an Interference A Actual Conception reduction to practice U. S. filing date Commencement of Diligence B Conception Actual reduction to practice U. S. filing date Inventor B Entitled to Patent if Commencement of Diligence is PRIOR to Inventor A’s Conception and CONTINUOUS (no unexcused time gaps) until the later reduction to practice 15

Establishing Date of Invention: The Laboratory Notebook § The Laboratory Notebook Should: • • Establishing Date of Invention: The Laboratory Notebook § The Laboratory Notebook Should: • • Establish Conception of the Invention Support Reduction to Practice Demonstrate Diligence Establish the Basis for Corroboration by a Noninventor 16

The Proper Laboratory Notebook § § § A Bound Notebook Written in Ink Does The Proper Laboratory Notebook § § § A Bound Notebook Written in Ink Does Not Contain Eraser Marks Does Not Contain Modifications of Prior Entries Has All Pages Numbered 17

The Proper Laboratory Notebook § Has No Blank Pages and No Pages Removed § The Proper Laboratory Notebook § Has No Blank Pages and No Pages Removed § Printouts, Photos, etc. Permanently Attached to Notebook Page § All Figures and Calculations are Labeled § All Abbreviations Defined § Is Indexed by Number, Author and Subject Matter 18

The Proper Laboratory Notebook § Contains Outlines of All Experiments • Notations to failed The Proper Laboratory Notebook § Contains Outlines of All Experiments • Notations to failed experiments are important for diligence § Detailed Description of Data without Overly Speculative Interpretation § Records Discussion with Collaborators & Colleagues § Every Entry is Signed and Dated by Inventor and Witness • Witness is a non-inventor who fully comprehends work • Without a proper witness to corroborate the asserted dates of invention, the priority case will likely fail unless there is some other basis of corroboration 19

Example: Sufficient Corroboration • Inventor’s notebook included work performed by lab technician and was Example: Sufficient Corroboration • Inventor’s notebook included work performed by lab technician and was periodically witnessed by co-workers familiar with the inventor’s work. • Technician working on behalf of inventor provided testimony concerning particular experiments that he performed, the data for which was recorded in the inventor’s notebook. Donohue v. Baudry, 223 USPQ 823, 826 -827 (Bd. Pat. App. & Interfer. 1984) 20

Example: Sufficient Corroboration • Inventor’s notebook was unsigned and unwitnessed, but corroborated sufficiently by Example: Sufficient Corroboration • Inventor’s notebook was unsigned and unwitnessed, but corroborated sufficiently by later documents (record of invention and application) containing identical disclosures. • Witness testimony, by a now disinterested party, also provided corroboration. Witness had viewed two experiments in their entirety. Blicharz v. Hays, 496 F. 2 d 603, 606 (CCPA 1974) 21

Example: Sufficient Corroboration • Inventor notebooks and testimony were provided (but not clear whether Example: Sufficient Corroboration • Inventor notebooks and testimony were provided (but not clear whether notebooks were witnessed) • Corroboration provided by testimony of an associate and independent circumstantial evidence of inventor’s withdrawal of supplies to practice the invention, as well as by testimony of co-worker who examined a product produced by the recited process. Lacotte v. Thomas, 758 F. 2 d 611, 613 (Fed. Cir. 1985) 22

Example: Insufficient Corroboration • Unwitnessed laboratory notebook containing experimental evidence performed by technicians unaware Example: Insufficient Corroboration • Unwitnessed laboratory notebook containing experimental evidence performed by technicians unaware of what they were testing, provided evidence of conception but not actual reduction to practice. Singh v. Brake, 222 F. 3 d 1362, 1370 (Fed. Cir. 2000) • Affidavits by non-inventors who merely aver that they had read and understood experimental data (provided with inventor affidavit) were insufficient. Hahn v. Wong, 892 F. 2 d 1028, 1031 (Fed. Cir. 1989) 23

What About Electronic Notebooks? § Electronic Evidence Accepted by USPTO • Relevant • Authenticated What About Electronic Notebooks? § Electronic Evidence Accepted by USPTO • Relevant • Authenticated • Corroborated § Authentication Difficult to Prove • Data can be easily changed or modified • Dates can be modified • Electronic signatures can be modified 24

Electronic Notebooks – Some Guidelines • Adopt an Official Laboratory Procedure for Electronic Record Electronic Notebooks – Some Guidelines • Adopt an Official Laboratory Procedure for Electronic Record Keeping • Generate Hard Copies of all Entries which are Signed, Dated and Witnessed and Permanently Attach in Bound Notebook • Use Electronic/Digital Signature Software • Use Automated Digital Time-Stamp Software • Use Hardware or Software that Prevents Editing Original Research Descriptions • Use Security Tools to Prevent Unauthorized Access 25

Is There a Role for Laboratory Notebooks with Proposed Patent Reform? § YES! § Is There a Role for Laboratory Notebooks with Proposed Patent Reform? § YES! § Notebooks Are Important For Establishing Inventorship • Correct inventorship is critical to obtaining a valid patent • Honest mistakes in inventorship can be corrected, but there must be some evidence to support the correction § Notebooks Will Be Important for Establishing Derivation of an Invention § Basis for Asserting Patent Invalidity in Post-Grant Review Proceeding 26

Inventorship § “Determining ‘inventorship’ is nothing more than determining who conceived the subject matter Inventorship § “Determining ‘inventorship’ is nothing more than determining who conceived the subject matter at issue, whether that subject matter is recited in a claim in an application or in a count in an interference. ” § Inventorship ≠ authorship § Joint Inventorship • Joint inventors need not physically work together or at the same time • Joint inventors need not contribute to the same degree • Inventive contribution to a single claim is sufficient for joint inventorship 27

Determining Inventorship: The Role of Notebooks § A Proper Notebook Should: • Identify source, Determining Inventorship: The Role of Notebooks § A Proper Notebook Should: • Identify source, date, and content of instructions or ideas of others • Identify inventive contribution of yourself and others § Notebook Can Be Important to: • Determine inventorship • Correct inventorship • Establish ownership (which follows from assignment by inventors) • Provide a basis for the allocation of royalties 28

Determining Derivation § Applicant having later filing date entitled to patent if he can Determining Derivation § Applicant having later filing date entitled to patent if he can show applicant having earlier filing date derived the invention from him § Derivation Can Be An Issue in Current Interference Proceedings § Derivation Proceedings are Provided for in the Pending Legislation § To Prove Derivation, the Later-filing Applicant Must Show: • Earlier conception of the invention; conception must be complete (nothing else to do before reducing it to practice) • Communication of the invention to the party who filed the earlier application 29

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