1 May 13, 2014 University of Utah TVC University of Utah Technology and Venture Commercialization Group In partnership with A. Terrece Pearman J.D./Ph.D. Stoel Rives LLP Developing Valuable Intellectual Property May 13, 2014 University of Utah TVC

2 Today’s Discussion: The nature of a patent The patenting process Working with your University-appointed patent attorney Best practices

3 May 13, 2014 University of Utah TVC The nature of a patent: Anatomy

4 May 13, 2014 University of Utah TVC Anatomy: Figures

5 May 13, 2014 University of Utah TVC Anatomy: Claims 1. An esophageal catheter system comprising: a catheter including an open end, for removably mounting one of a pressure transducer and a stylet assembly, a closed end, a balloon affixed to an exterior surface of the catheter, the balloon usable as a pressure sensor, and a balloon inflation lumen extending through the catheter in communication wth the interior of the balloon through at least one aperture extending through the catheter; a stylet assembly, which can be removed from and inserted into the open end of the catheter, the assembly comprising a stylet for providing appropriate rigidity to the catheter to aid insertion into the esophagus, and a port for removably mounting a pressure transducer; and a pressure transducer, which can be removed from and inserted into the open end of the catheter, and which can be removed from and inserted into the port of the stylet assembly; wherein the stylet assembly further includes a coupler and a closure sealing an end of the coupler, and the stylet has an end affixed to a portion of the closure.

6 May 13, 2014 University of Utah TVC The nature of a patent: What Does a Patent Get You? Right to exclude others from: making, using, selling/offering to sell, importing Time-limited Geographically-limited No right to practice the invention may need a license on other technology to practice your patented invention!

7 May 13, 2014 University of Utah TVC The patenting process: TVC Disclosure – Online portal through Evaluation by your TVC Manager Application drafting – Supplemental disclosure meeting with attorney – Application review and revisions – Filing and signature documents – Subsequent filings/portfolio development

8 May 13, 2014 University of Utah TVC The patenting process: Your University-appointed patent attorney

9 May 13, 2014 University of Utah TVC Your University patent attorney Things you need to know: – We work for the University to protect inventions by developing intellectual property such as patents – We protect your disclosures – you can share confidential information with us – We speak your language: we have a background in your discipline – We respect your timing and needs – let us know when you’re publishing/presenting, and we’ll work with you and the TVC to develop a patent strategy

10 May 13, 2014 University of Utah TVC Disclosure to your University attorney

11 May 13, 2014 University of Utah TVC The patenting process: What must I have to get a patent? New Useful Discovery versus Invention Non-obvious Written description Describe what it is Enabling description Describe how to make/use it

12 May 13, 2014 University of Utah TVC Disclosure to your University attorney “Enable” your invention – Prepare a document that would allow someone with skills similar to your own to practice your invention “Reduced to practice” – Can you show that you can work the invention “Best mode” – To your knowledge at the time of filing Variations on a theme What have other people done? – Obligation to disclose to the U.S. Patent and Trademark Office

13 May 13, 2014 University of Utah TVC The patenting process: The Draft

14 May 13, 2014 University of Utah TVC The patenting process: The Draft Draft Application—what to expect? – Legal document – Very unfamiliar format – Attempts to explore and expand scope of disclosure Comments and revisions welcome! Filing and signature documents Subsequent filings/portfolio development

15 May 13, 2014 University of Utah TVC The patenting process: Other Things to Consider Timing? – When do you plan to publish or present? – What data is available to show utility of the invention? – Potential partnerships/investment interest?

16 May 13, 2014 University of Utah TVC Patent prosecution timeline: Steps and timing

17 May 13, 2014 University of Utah TVC Types of Patent Applications Utility Provisional PCT (International) Foreign Design Plant

18 May 13, 2014 University of Utah TVC U.S. Applications Utility Formal Requirements More Expensive—higher filing fees Examined Eligible to Issue into a Patent Provisional Fewer formalities; no claims required Less expensive – lower filing fees Establishes filing date for subject matter disclosed EXPIRE IN ONE YEAR Must Convert to a Utility Application or lose priority date

19 May 13, 2014 University of Utah TVC Protection Outside U.S. PCT Member countries Examined by International Body (U.S., Europe, Korea) Does not Issue; Nationalized in each member country Foreign Different than PCT Filed in a specific foreign country Subject to that country’s IP laws

20 May 13, 2014 University of Utah TVC Best Practices: Keep good lab notebooks Develop data/alternate embodiments Disclose your invention to the TVC early – Keep them apprised of updates and improvements Work to file your provisional application before disclosing Keep track of your co-inventors Sign documents early

21 May 13, 2014 University of Utah TVC Claims Claims define the inventions described in a patent like the property description defines a piece of real estate in a deed Recite the least elements & limitations in the claim needed for patentability start with broad claim may need to narrow during negotiation with examiner often go multiple rounds during negotiation

22 May 13, 2014 University of Utah TVC Example of Broad Claim-Round #1 Claim: A peptide that is 80% homologous to the sequence of My Favorite Peptide (MFP). Examiner: Too many peptides come under this description. Your specification doesn’t show that you have possession of all the peptides covered by this claim. These references show peptides fitting the description

23 May 13, 2014 University of Utah TVC Sequence of “My Favorite Peptide”: Glu-Ala-Val-Leu-Ile-Met-Phe-Pro-Trp-Ser-Thr The inventor has been studying the use of the peptide to treat lung cancer. Example of Peptide Invention

24 May 13, 2014 University of Utah TVC Amend to Narrow Claim–Round #2 Amended Claim: A peptide that is 80% homologous to the sequence of My Favorite Peptide (MFP) wherein the peptide binds and activates the MFP receptor. Examiner: One of skill in the art can’t know which peptides are covered by the claim. Amended claim is rejected under new references

25 May 13, 2014 University of Utah TVC Amend to Narrower Claim-Round #3 Amended Claim: A peptide comprising the formula: Xaa1-Ala-Val-Leu-Ile-Met-Phe-Pro-Xaa2-Ser-Thr wherein Xaa1 is an acidic amino acid, and Xaa2 is an aromatic amino acid; and wherein the peptide binds and activates the MFP receptor Response: Cited references do not read on the claim as amended The specification describes an assay to determine receptor binding and biological activity

26 May 13, 2014 University of Utah TVC Broad Method of Use Claim-Round #1 Claim: A method of using the MFP peptide of claim 1 to treat a person suffering from or at risk of developing a hyperproliferative disease. Examiner: One of skill in the art can’t determine who is at risk of developing the disease No support in specification for treating all hyperproliferative diseases with MFP

27 May 13, 2014 University of Utah TVC Narrower Method Claim-Round #2 Claim: A method of using the MFP peptide of claim 1 to treat a person suffering from or at risk of developing a hyperproliferative cancer disease. Response: We have amended the claim to recite “cancer.” The specification describes known risk factors for developing cancer.

28 May 13, 2014 University of Utah TVC Narrower Method Claim-Round #3 Examiner: You don’t have support in specification for all cancer. Your experiment only includes colon cancer studies. Response: The specification shows that MFP is involved in all known cancers. The specification describes known risk factors for developing cancer.

29 May 13, 2014 University of Utah TVC Scope of Claims Inventor studies the role of MFP in colon cancer Are there other uses? Treat other diseases Diagnostic assays Screening assays Combination therapy What about variations of the peptide? Are there amino acids that can/cannot vary? Adding functional groups to the peptide? Com

30 May 13, 2014 University of Utah TVC Creating a Patent Family Divisional Claim matter disclosed in parent but not claimed Different invention from parent Continuation Claim matter disclosed in parent but not claimed Same invention as parent Continuation in Part (CIP) Can add subject matter not disclosed in parent New matter gets new priority date

31 May 13, 2014 University of Utah TVC Best Practices: Time Bars to Patent More than 1 year before filing date: Public disclosure or use of invention; or Product incorporating invention sold or offered for sale Invention must be “ready for patenting” “Commercial sale” AIA – No grace period except for inventor-derived disclosures Foreign countries often require “absolute novelty”