Recent Trends at the Patent Office: Strategies for Improving Your Outcome

1. Recent Trends at the Patent Office:Strategies for Improving Your Outcome Edwin V. Merkel Carissa R. Childs Ph.D. LeClairRyan 290 Linden Oaks, Suite 310 Rochester, NY 14625 US 585.270.2100 W W W . L E C L A I R R Y A N . C O M

2. Overview Purpose of obtaining a patent Anatomy of a patent application Requirements of patentability What to expect during patent prosecution and strategies for successfully obtaining a patent

3. Purpose of Obtaining a Patent Patent system designed to incentivize innovation Patent grants rights to inventor – exclude, but not use Bayh-Dole encourages technology commercialization of government funded inventions Provide a means to commercialize inventions, i.e. bridge the transition from bench-to-bedside Why is this relevant? Not all good science is patentable The value of a patent depends on its commercial utility

4. Anatomy of a Patent Application • U.S. patents are obtained by filing a written application which includes the following components: • Specification  • Background of the invention • Summary of the invention • Detailed description of invention • Claims • Drawings, if any

5. Patentable Subject Matter • A process or method • e.g. Method of treating or diagnosing cancer

6. Patentable Subject Matter

7. Patentable Subject Matter • A process or method • e.g. method of treating or diagnosing cancer • A machine • e.g. devices, gadgets • An article of manufacture • e.g. gene array, antibodies, genetically altered cell line

8. Patentable Subject Matter

9. Patentable Subject Matter • A process or method • e.g. method of treating or diagnosing cancer • A machine • e.g. devices, gadgets • An article of manufacture • e.g. gene array, antibodies, genetically altered cell line • Composition of matter • e.g. pharmaceutical composition, chemical compound

10. Requirements for Patentability Utility – specific substantial utility; must be credible Novel – no public knowledge or use that predates your date of invention Non-Obvious – the invention as a whole cannot be obvious to one of skill in the art at the time it was made Complete description of the invention Enables one of skill in the art to make and use the invention Written Description that shows the applicant is in possession of the full scope of the claimed subject matter Best Mode for carrying out the invention

11. Claims Define the scope of the invention Broadly cover all commercial embodiments Focus of examination for patentability Example: Your invention = discover protein X is overexpressed in cancer cells and inhibition of X inhibits cell proliferation & survival Method of treating a patient having cancer comprising… Method of diagnosing cancer… Pharmaceutical composition for treating cancer comprising…. Requirements of Patentability

12. The Patent Process • Filing – the application is submitted to the U.S. Patent and Trademark Office (“PTO”), along with a fee and an oath executed by the inventor stating certain required facts

13. The Patent Process (cont.) • Examination: • The application is reviewed by a patent examiner • The examiner searches prior art patents and publications and decides either to allow claims or to reject them • Written rejections are mailed out to the applicant • Responses are filed by applicant

14. The Patent Process (cont.) • Issuance of a patent: • An allowed application issues as a patent once an issue fee is paid • Maintenance fees must be paid during the fourth, eighth, and twelfth years of the patent term

15. Strategies for Success: Prevent Public Disclosure Public disclosure of invention prior to filing patent application = jeopardizes patent rights Most foreign countries – absolute novelty U.S. – one year grace period Abstracts and manuscripts Be aware of early online publications Be conscientious of “future-aim” statements when discussing the implications of research findings TIP: Contact Tech Transfer Office before you publish, preferably before you submit a manuscript for publication

16. Strategies for Success:Disclose Invention to OTT Early Invention disclosure should contain: Complete description of the invention – including various embodiments Experimental data and figures Expected dates of public disclosure Late disclosure  last minute filing may impact rights Lose benefit of filing date - provisional application may fail to support claimed invention, prior art references published during the pendency of provisional application can be prior art

17. Example 1 – Intervening Art • Timeline • Rush provisional filed in U.S. with minimal disclosure (covering use of γ-aminobutyric acid (GABA) analogs in treating hot flashes; two compounds disclosed) • Publication occurs after provisional filing date • One year later, file formal applications in U.S. and PCT • Intervening publication not problematic in U.S. • One year grace period in U.S. • Method of treating hot flashes in a patient by administering a compound which binds an α2δ subunit of a voltage-gated calcium channel (VGCC)….

18. Example 1 – Intervening Art (cont.) • Intervening publication problematic in Europe • Intervening publication was cited against all claims that were not supported in the provisional (or immediately derivable therefrom) • Use of a compound that is structurally related to GABA in the manufacture of a medicament for treating hot flashes….

19. Strategies for Success: Review, Disclose, and Distinguish Prior Art Perform a search of patent literature USPTO - http://patft.uspto.gov/ WIPO - http://www.wipo.int/ipdl/en Novelty and non-obviousness Allows for drafting claims of appropriate scope Ensures that distinguishing characteristics are emphasized Identify problems or deficiencies in prior art Duty to disclose references materially relevant to the patentability of invention TIP: Disclose to OTT all references that are even closely related to invention

20. Strategies for Success: Overcoming Inherent Anticipation Rejection • Inherent anticipation is often seen in context of pursuing method of treatment claims for a known class of compounds • Requires that the prior disclosure necessarily would have involved practicing the claimed subject matter • Ways to overcome: • Define patient population • Define mode, timing, or frequency of administration

21. Example 2 – Inherent Anticipation • Claims directed to a method of treating or preventing atherosclerosis using Growth Hormone Releasing Peptides (GHRPs) • Prior Art taught single administration of hexarelin (a GHRP) during by-pass surgery • PTO asserted same class of patients, same class of drug, would inherently have treated atherosclerosis • Overcame by specifying frequency of use (daily) in one set of claims and extent of use (for six or more weeks) in another set of claims

22. Strategies for Success:Overcoming an Obviousness Rejection • An invention is not patentable even if it is not identically disclosed or described in a prior art reference, if the differences between the invention to be patented and the prior art are such that the invention as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art • Assessed based on number of factors

23. Strategies for Success:Overcoming an Obviousness Rejection (cont.) • Scope and content of the prior art • Level of ordinary skill in the art • Differences between the claimed invention and the prior art • Objective evidence of non-obviousness • commercial success • long-felt but unsolved needs and • failure of others • Explain in application itself why the invention would not have been obvious (unexpected results; failure of others, if aware)

24. PTO GuidelinesRationale for Finding of Obviousness • There is a teaching, suggestion, or motivation to combine prior art elements • Combining prior art elements to yield predictable results • Simple substitution of one known element for another to obtain predictable results • Use of a known technique to improve similar devices, methods, products in the same way

25. PTO GuidelinesRationale for Finding of Obviousness • Obvious to try – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success • Known work in one field of endeavor may prompt variation of it for use in either the same field or a different one based on design incentives or other market forces

26. Example 3 - Obviousness • Claims directed to method of analyzing blood/bone marrow using flow cytometry and three reagents to identify subpopulation • Obvious in view of the combination of: • First reference, same purpose as claimed method, but only using two reagents • Second reference, taught use of third reagent to identify specific population of cells • PTO asserted: combining prior art elements to yield predictable results

27. Example 3 – Obviousness (cont.) • Rebuttal • References provided no reason to modify method of 1st reference, there was no recognized problem to be solved • Persons of skill would have expected that there would have been no problem in absence of third reagent • Incorporating the third reagent provided unexpected improvements over the prior method • Presented evidence of commercial success

28. What constitutes a “complete written description” Patent law requires “that the specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms, as to enable any person skilled in the art to which it pertains . . . to make and use the same . . .” How is the adequacy of written description determined? Strategies for Success: Providing a Sufficient Written Description

29. Strategies for Success:Providing a SufficientWritten Description • Determine scope of the claimed invention • Determine whether claim scope is supported by application • Detailed description of the invention • Sets forth all possible embodiments of claimed invention • Different classes of agents to be used (therapeutic/diagnostic) • Different uses (indications/diagnostics) • Examples • Experimental data supporting claimed invention • Biological deposits (ATCC) – for cell lines, hybridomas

30. Example 4 – Written Description Claims directed to method of enhancing plant growth using class of plant pathogen proteins that cause a particular plant response (designated as “hypersensitive response elicitor proteins”). Specification identified four specific proteins and indicated that others were known to exist (they just had not been isolated and sequenced). PTO asserted that the four specific proteins and demonstrated results with only two of them did not show that applicants were in possession of the full scope of claimed subject matter.

31. Example 4 – Written Description (cont.) • Overcame rejection by presenting evidence that persons of skill in the art appreciated that the protein elicitors were recognized in the art—before the filing date—as having structural diversity at the amino acid level, but sharing conserved structural features and properties • Isolated from bacterial plant pathogen • Contain structural domains that share some homology even though overall homology may be low • High glycine content, low (or no) cysteine content • Heat stable • Induces same plant response

32. The Enablement Requirement Purpose: allow one of skill in the art to make and use the invention “Test” of Enablement : whether undue experimentation is required for one of skill in the art to make & use the invention Biotechnology patents particularly prone to enablement rejections because of the gap between experimental data and claimed invention

33. Example 5 - Enablement Claims directed to a method of treating a condition mediated by a deficiency or loss of myelin involving the administration of oligonucleotide progenitor cells Specification showed myelination of dysmyelinated axons in the hypomyelinated shiverer mouse model upon intraventricular administration of progenitor cells PTO asserted that remyelination alone was not indicative of therapeutic benefit

34. Example 5 – Enablement (cont.) To overcome the rejection submitted evidence showing that progenitor cell transplantation into the hypomyelinated shiverer mice achieved not only whole neuroaxis myelination, but also prolonged the survival of the mice and resolved their neurological deficits Strategy: To the extent possible: Validate initial in vitro findings in vivo Consider using different classes of therapeutic agents (RNAi, small molecules, antibodies, etc.) when designing experiments Submission of post-filing evidence Inventor’s own work or work by others

35. Strategies for Success: Participate in Patent Application Preparation Read drafts of application for accuracy and thoroughness New material cannot be added to specification After formal filing Do not hesitate to provide comments Ask questions

36. Strategies for Success: Summary • When designing experiments, keep in mind the need to support the breadth of the invention • Preferably obtain some in vivo data during your initial experimental work • Consider using different classes of reagents in parallel • Keep good records – we may need them • Contact OTT before you disclose and keep them updated • Conduct your own literature and patent searches • Be involved in the claim and application drafting processes

37. Thank You