09-The U.S. Patent Process: Conception to Filing

The U.S. Patent Process: Conception to Filing Kristine H. Johnson MacMillan, Sobanski & Todd, LLC [email_address]

Overview Patentability rules: technical and unforgiving Dates are critical Delay is a significant risk Prior art Barring events Activities of inventor may foreclose patent protection U.S. vs. non-US activities

Overview The patent process should be handled very carefully!

Good idea  Patent Filing General timeline Scientific research and discovery Disclosure of the discovery to TTO Evaluation of the disclosure by TTO Drafting of patent application Final draft of patent application Filing provisional or PCT or national application

Scientific research and discovery Funding If US funded, need to state in patent Record keeping Sign and countersign, date Reporting Not usually a tech transfer function (grants & contracts admin)

Record Keeping Notes Schedule regular reminders and instruction on patent-worthy recordkeeping for researchers (some attorneys will do this for free) Intellectual property policy should address notebook and data retention Notebooks and data “walk away” fairly often – at least have a copy!

Disclosure of the discovery to TTO This is a money-saving stage – if done right Get documents in editable form (MSWord, not PDF) Ask for all of the elements of a patent application – details! Ask for licensing contacts Ask patent attorneys for suggestions on time saving measures at this stage A good offense is better than a good defense! Great disclosure equals

Evaluation of the disclosure by TTO Science value Patentability Market value Are interrelated but do not fully overlap. It takes “experience” to judge market value!

Evaluation of the disclosure by TTO Don’t be misled by who is talking Scientists value science Patent attorneys are sometimes scientist-thinking Patent attorneys are often noncommittal on the law First adopters love everything Risk adverse people hate everything Most important: actual value in today’s market Licensable, profitable scope Social-only valuation is legitimate for US universities (Bayh-Dole – “for the benefit of the public”)

Patentability Evaluation What is “Prior Art?” Determined by law , not strictly time Anything that is publicly known, published, publicly used, or sold in this country Anything published or patented here or elsewhere in the world That came BEFORE your invention (applies to both above) DANGER: Using the term “prior art” is an admission / statement against legal interest! Get in the habit of saying “reference” or “disclosure”

Patentability Evaluation Duty to disclose prior art Not a duty to search Why search? May give the inventors a “better idea” Helps the patent attorney and the inventor define the invention in the specification Uncovers what the Examiner may find Saves time and money

Patentability Evaluation Two Ways that Prior Art is Created: Things the inventor does Things that others do

Patentability Evaluation Things the inventor does What starts the “clock” ticking? 4 “triggering events” Public Disclosures Public Use Sale Offers for Sale Fact Specific Inquiry Once the clock starts, it can’t be stopped!

Patentability Evaluation Things others do Publicly Known Before the date of your invention One year before the U.S. filing date You can’t do anything about this Best to know what’s out there lowers costs helps identify what your “patentable invention” can be

Patentability Evaluation What does obviousness mean to an inventor? Almost always, different from what it means in patent law. Their answer depends on their ego and scientific indoctrination Either ask the patent attorney to evaluate obviousness or file without asking

Patentability Evaluation What information will help overcome an obviousness rejection? Teaching away, long-felt need, superior results over closest comparator, great difficulty in obtaining, etc. Get this information during the disclosure stage (saves money!) But watch out for admissions / statements against interest

Patent Searching U.S. Patent and Trademark Office (uspto.gov) Wealth of information Key word searching ep.espacenet.com for non-US patents Google Patents (3 month lag) Searcher in Wash. DC

What to Look for in a Search Would my invention infringe patents of others? Look at claims Unexpired patents only Is my invention patentable? All U.S. patents back to 1790 Worldwide patents and publications Any language

Choosing a patent drafter Who is allowed by law to draft a patent application? Anyone! Scientist Technology transfer professional In-house attorney or agent Outside attorney or agent Patent litigator Trained (or untrained) monkey Who is allowed by law to file a patent application? An applicant A registered patent agent or patent attorney

Choosing a patent drafter Who should draft your patent application? A “patent prosecutor;” a registered patent agent or attorney who specializes in patent drafting With a pertinent science background Who understands your organization and the PTO Who communicates the way you prefer Do not hire a patent litigator for patent drafting – too expensive and less effective Do not hire based solely on scientist preference Patent prosecutors are notoriously introverted, so do not judge their drafting effectiveness by their personality

How I, a lawyer, hire lawyers Do they have the appropriate technical and legal background? Do they listen and reflect back to me what my goals are? Do they offer their opinion, not just options? Do they find ways to save me money? Do they tell me when they do not know something? Do they return my emails and phone calls promptly? Am I important to them as a client? Do they know the “right” people for my goals? Do they demonstrate an ethical worldview? I have hired $150/hour lawyers for litigation who were just as effective as a $500/hour regulatory lawyer (who was also effective for the particular job at hand).

The Parts of a Patent: Drawings Specification Background Summary of the invention Description of the drawings Detailed description of the invention Claims Each claim written as one sentence Describe the “metes and bounds” of the invention Independent and dependent forms

Choosing a patent application type “Cover sheet” provisional Provisional with added disclosure Provisional with added claims Fully-prepped application, filed as provisional Fully prepped application, filed as PCT or US only

“ Cover sheet” provisional File a manuscript/powerpoint/poster Only in emergencies Often contain admissions/statements against interest “As, expected, our results confirm…” Causes problems later (102, 103, 112) Not much marketing value Creates confusion with inventors Attorneys fret about the liability/benefit Sometimes the only option Requires immediate follow-up Can be done in-house, cheap Attorney Report Card Effort: D Effectiveness: D Expense: A

Provisional with added disclosure File manuscript/power point/poster and a document that describes pertinent processes, generically Some attorneys advocate this as preferred method – no claims May still have problems with later claim amendments Can be done in-house, but a bit more difficult than a cover sheet provisional Attorney Report Card Effort: C Effectiveness: C Expense: B Better than cover sheet only

Provisional with added claims Focuses discussion on a licensable scope Better marketing tool Forces use of words that might not otherwise be included – antecedent basis Might have other 112 problems later Best to have a patent agent/attorney draft claims Best practice, given little time to file  Attorney Report Card Effort: B Effectiveness: B Expense: B

Fully-prepped application, filed as provisional More expensive More likely to meet statutory requirements and not cause problems in the future Doesn’t create (as much) confusion with inventors as cover sheet provisionals do Ordinarily not prepared in-house Anything less than two weeks lead time is often considered a rush on these, but a decent patent application can be accomplished in twenty to sixty hours. Attorney Report Card Effort: A Effectiveness: A Expense: C

Fully-prepped application, filed first as PCT or US-only Same lawyer/draftsman/sequence listing service fees as filing provisional Higher government filing fees Will be reviewed by PTO Not a good strategy for pharmaceuticals (need the extra year at the end of the patent life) Might be very important to speed prosecution for other technologies Attorney Report Card Effort: A Effectiveness: A Expense: C

The well-written patent application Describes the invention so one of ordinary skill can understand it Discloses the best mode Provides support for claims of unknown scope Claims narrow enough to avoid prior art and prove literal infringement Claims broad enough to hamper design around A variety of claims to different uses, to create marketing and licensing options

The well-written patent application Claims clear enough to provide notice of infringement Factually accurate Suitable vehicle for foreign filing But is impossible to comply fully with all countries’ requirements in one document Tells a compelling story

The well-written patent application Tells a compelling story of The cast of characters The prior art (don’t call it that, though!) Likely users of the technology Our hero - the inventor(s)

The well-written patent application The “Background of the Invention” provides the setting Unfulfilled needs Failures of others Problems with the prior art Serious nature of the problem

The well-written patent application But . . . “what you say may be used against you in a court of law” Three pitfalls to avoid in the background Disclaimer via “criticism and disavowal” Written description – failure of claimed subject matter to address at least one state problem or object Use of stated problems to support allegations of obviousness

The well-written patent application A patent may have its own dictionary “ As used herein, the term X means Y” Applicant’s definition controls claim interpretation This is a good quality control item for reviewing patent prosecutor’s work: Do the claims have key terms that are not defined or discussed in the specification? Is this omission intentional? If a term is not defined, then the meaning that one of ordinary skill in the art would give it applies. Sometimes, this is actually a better strategy than defining the term.

Disclosed but unclaimed subject matter Disclosed but unclaimed subject matter is “dedicated to the public” Maxwell v. J. Baker, Inc. Solution is preparation of a comprehensive set of claims

37 C.F.R. §1.56 Duty of candor Misrepresentations, misleading statements, and omissions violate the duty of candor and good faith. Result is that the patent may be held unenforceable due to “inequitable conduct” This is why patent attorneys get jumpy about filing cover sheet provisional patent applications! More cover sheet provisionals? Did I pay my malpractice insurance premium?

Inequitable conduct is scary! Hoffman-La Roche, Inc. v. Promega Specification contained an “example” implying that an experiment had been conducted and results obtained The “example” was theoretical (prophetic) and never actually performed Result was that the patent was held unenforceable due to inequitable conduct

Note on US / non-US patent drafting interface EPO and JPO - problem/solution approach to determine inventive step (obviousness) Telling the story of invention in the application will provide a good basis to meet this requirement EPO - strict interpretation of “new matter” Limited ability to amend Solution is to draft comprehensive claim set

Final draft of patent application Inventors need to review the final draft Scientific accuracy To check if all potential uses are indicated To check if anyone else should be named as an inventor To check for false statements or omissions Because they must attest to being an inventor of the filed document

Deadlines U.S. -- file by one year from sale or offer for sale public or commercial use or disclosure World -- file before public use or disclosure

Provisional Applications §111(b) Act as a “placeholder” Never substantively examined Automatically lapse or mature one year from the filing date Once filed, applicants can mark “patent pending” Can not claim priority from another appln. Patent term measured from filing date of subsequent non-provisional application (bonus year!)

Provisional filing requirements Required A specification A drawing (if required to understand the invention) A cover sheet or cover letter naming inventors Fee NOT Required A claim An oath or declaration (37 C.F.R. §1.63) An IDS

Provisionals as a basis for priority US Priority 35 U.S.C. §119(e) Non-US Priority (PCT and National) Article 4 of the Paris Convention

Provisionals & US Priority Requirements to perfect priority to provisional Non-provisional application (35 U.S.C. §111(a)) filed within 12 months of the filing date of the provisional At least one common inventor Reference to the provisional application Provisional application must satisfy §112 ¶1 for 112, the invention claimed in the subsequent non-provisional application

Yet another crazy warning about cover sheet provisionals New Railhead Manufacturing Patent claimed drill bit with certain angle between the bit and its housing *Sales >1 Yr.* Jan 96 Jan 98 Jan 97 Sales spring/ summer 96 2/97 - File Provisional 11/97- File Utility

New Railhead Provisional Court found that the disclosure of the provisional application did not meet the written description requirement with respect to the subsequently claimed drill bit angle Applicant not entitled to priority back to the filing date of the provisional application (limited to 11/97 filing date) Sales occurred more than one year prior to the 11/97 date, thus patent invalid under 35 U S C §102(b) Invalid!

Provisionals & Non-US Priority Article 4 of the Paris Convention A “regular national filing” in one country provides a basis for a priority claim in an application filed within 12 months in another member country Governs priority claims in PCT applications Provisional applications are considered a regular national filing Must file PCT/foreign application(s) within 1 year of the filing date of the provisional application.

Patent filing procedures Choices for accomplishing a filing: USPS First Class Mail (Date Received at USPTO) Hand Delivery (Date Received at PTO Window) USPS Express Mail (Date Received at Post Office) in accordance with 37 CFR 1.10 Itemized Post Card with Return Postage as proof of mailing e-Filing (EFS Filing Receipt EST) A new initial application may not be filed via fax.

Best Filing Practices – Non-provisional filing Specification with at least one claim Abstract Oath and Declaration of inventors, naming all, with home address and citizenship (Executed) Fee (with Fee Transmittal) Priority Claim (if appropriate) Assignment (may wait until after filing) Post Card if Filing Express Mail ADS-Application Data Sheet (if e-filed) Transmittal (if paper filing) IDS- Information Disclosure Statement

Note on Order of Inventors Order of inventors is of NO legal consequence But make no mistake – it is of significant social/political consequence Petition may be made under 37 CFR 1.183 to change order. Communicate inventor order preference to patent drafter Consider having an “alphabetical order” policy, but it won’t eliminate all problems

Application Data Sheet What is an “ADS”? Applicant Information Correspondence Information Application Information Representative Information Domestic Priority Information Foreign Priority Information Assignee Information Reduces Filing Receipt Errors By getting data directly into USPTO computers Old way- OCR & Scanned form Current Way – metadata in special PDF form USPTO Form SB14 Application Data Sheet

Why use an ADS Not mandatory, however: Reduces Filing Receipt Errors Ensures complete application Allows Direct Input of Information Allows some guidance as to Technology Center/Class

File an Application in EFS Benefits of EFS Drawings come in perfectly Instant serial number No chance of mailing loss Eliminates Transmittals (for the most part) No Pesky Postcards to look for Pay Fees Instantly

E-Filing - Procedural Suggestions Print Online Receipt and Place in File Check IFW files in PAIR to see what was filed with the USPTO Print THAT Copy & put into the File Jacket Directory (redundant-Word & IFW) Print PDF Receipt in IFW and Place in File

More information on electronic filing The EBC http://www.uspto.gov/ebc/index.html EFS Web http://www.uspto.gov/ebc/efs_help.html USPTO EFS Sandbox (practice) http://www.uspto.gov/ebc/portal/tutorials.htm

Questions? Please ask! Thank you to Ms. Jenna Cogswell at MST who helped prepare these slides! Contact us at [email_address] or 419.255.5900 for permission to use these slides, or to ask questions. We are happy to let others use these slides, but we would like to know who they helped.

09-The U.S. Patent Process: Conception to Filing

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09-The U.S. Patent Process: Conception to Filing