The New US Patent Law - From a Medical Device Perspective

The The The The NewNewNewNew US Patent LawUS Patent LawUS Patent LawUS Patent LawMedical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing Medical Device & Manufacturing –––– Florida 2013Florida 2013Florida 2013Florida 2013

Clark WilsonClark WilsonClark WilsonClark Wilson

[email protected]@[email protected]@gardnergroff.com

www.gardnergroff.com

2018 Powers Ferry Road

Suite 800

Atlanta, GA 30339

770-984-2300


[email protected]@[email protected]@gardnergroff.com

Clark WilsonClark WilsonClark WilsonClark Wilson

• Registered Patent Attorney & Partner at IP Law Firm (see website)

• Board Certified in IP Law by the Florida Bar Association

• Licensed Attorney in Florida & Georgia

• Master’s Degree in Bioengineering (May, 2013)

• Previously In-house Patent Attorney at Medical Device Company


• Previously In-house Patent Attorney at Medical Device Company

• Clients Include Medical Device: Startups � Multinationals

• US & Global Patent + Trademark Application Prep/Prosecution

• Freedom-to-Operate & Non-Infringement Opinions

• Patent + Trademark Infringement Litigation

• www.linkedin.com/in/clarkadwilson

Recent Med Device Patent InfringementRecent Med Device Patent InfringementRecent Med Device Patent InfringementRecent Med Device Patent Infringement

• Stent, $1.73 billion (part of the “Stent Wars”)

• Translateral Spinal Implant, $101.2 million

• Valve Prothesis for Implanation, $74 million

• So, it’s not just smart phones!


General Patent TerminologyGeneral Patent TerminologyGeneral Patent TerminologyGeneral Patent Terminology

• Patentable subject matter: what is allowed to be patented

• Prior art: information relevant to the invention & available to the public before patent application filed

• Novelty: the claimed invention is not disclosed in a single prior art reference

• Non-obviousness: the claimed invention could not be readily be deduced from prior art by a person of ordinary skill in the art


from prior art by a person of ordinary skill in the art

• 12 month grace period: allows exactly 12 months to file a patent application after a first public disclosure/use/sale of the invention.

• Provisional patent application: temporary application for patent lasting 12 months (non-extendable) from the filing date. The 12-month pendency period cannot be extended.

• Freedom-to-Operate: opinion provided by a patent attorney that a proposed product or process does or does not infringe a patent

NewNewNewNew USA Patent LawUSA Patent LawUSA Patent LawUSA Patent Law

• September 16, 2011-President Obama Signs America-Invents-Act (AIA)

– First major overhaul in over 50 years

– Most measures already in effect

– All measures to be in full effect by March 19, 2013


US Patent Law US Patent Law US Patent Law US Patent Law postpostpostpost----AIAAIAAIAAIA(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)(of particular importance to Med Device Industry)

• Subject Matter Eligibility

• What is “Prior Art”

• First Inventor to File

• Derivation Proceedings

• Prioritized Examinations


• Pre-issuance Submissions

• Post-Issuance Procedures

• Increase in Fees + Micro Entity Discount

• Obtaining Advice of Counsel

• Prior User Rights

• Virtual Marking of Products/Packaging

• Alternative Design Patent Strategies

Subject Matter Eligibility Subject Matter Eligibility Subject Matter Eligibility Subject Matter Eligibility

• Eligible under 35 USC § 101

– “A” patent – only one patent granted for each “invention.” (MPEP 804)

– “Useful” – a specific, substantial, and credible utility. (MPEP 2107)

– “Process, Machine, Manufacture, Composition of Matter”

• Not Eligible

– Laws of nature, abstract ideas, naturally occurring phenomena, mental


– Laws of nature, abstract ideas, naturally occurring phenomena, mental

processes, and mathematical algorithms

– Claims directed to or encompassing a human organism

• If a human organism is a claimed element of the invention

– Natural Principle (see next slide)

• The handiwork of nature that occurs without the hand of man

Subject Matter Eligibility, cont’d… Subject Matter Eligibility, cont’d… Subject Matter Eligibility, cont’d… Subject Matter Eligibility, cont’d…

• Natural Principle

– Ex: the relationship between blood glucose levels and diabetes

– Examples of methods that focus on natural principles:

• Diagnosing a condition based on a naturally occurring correlation of

levels of a substance produced in the body when a condition is

present


present

• Identifying a disease using a naturally occurring relationship between

the presence of a substance in the body and incidence of disease

– TIP to make the claim eligible:

• Integrate the natural principle into the claimed invention such that the

natural principle is practically applied, and ensure that the claim

amounts to significantly more than the natural principle itself

Subject Matter Eligibility, cont’d... Subject Matter Eligibility, cont’d... Subject Matter Eligibility, cont’d... Subject Matter Eligibility, cont’d...

• Natural Principle

– Example outlined by USPTO:

• A claim that uses the natural disinfecting properties of sunlight

would require additional steps beyond merely exposing an item

requiring disinfection to sunlight to be eligible.

• Must limit its reach to a particular, inventive application of the law


• Must limit its reach to a particular, inventive application of the law

• The additional steps to make it eligible could involve:

– Constructing a sanitizing device that uses ultraviolet light for

disinfection with steps that integrate the ultraviolet light into

the device and are sufficient to confine the use of the

ultraviolet light to a particular application (not so broad as to

cover all practical ways of applying ultraviolet light).

What is What is What is What is nownownownow “Prior Art”“Prior Art”“Prior Art”“Prior Art”

• Prior Art:

– Information used against you during patent application examination

– Assists a defense of invalidity in allegations of patent infringement

• So, what is it?

– For applications filed before March 16, 2013


• Printed publications as of their publication date;

ex: patents/applications (global)

– Ok if own pub. within 12 month grace period (US pat. only)

• Public use or sale of the invention (only within the USA)

– If your own use/sale, ok within 12 month grace period

– Ok if use is for experimental purposes (strict guidelines)

• USA patents or patent applications as of their filing date

What is now “Prior Art”What is now “Prior Art”What is now “Prior Art”What is now “Prior Art”

• For applications filed on/after March 16, 2013

– Printed publications as of their publication date (global)

• Exceptions:

• Own pub. within 12 month grace period (US pat. only)

• Can anticipate third party publication with your own publication


– Public use or sale of the invention (now global)

• Exceptions:

• Own use/sale within 12 month grace period (US pat. only)

• Can anticipate third party use/sale with your own use/sale

– US patents/applications with foreign priority as of foreign filing date

• Includes PCT international applications

FirstFirstFirstFirst----InventorInventorInventorInventor----ToToToTo----FileFileFileFile

• What applications are still under pre-AIA First-to-Invent system

– Claim scope with priority to application filed before March 16, 2013

– Ex: New applications based on provisional; continuation; divisional

• What applications are under the new First-Inventor-To-File System


– Applications with claim scope beyond any pre-March 16, 2013 priority

– New applications; Continuation-in-Part Applications; etc.

FirstFirstFirstFirst----InventorInventorInventorInventor----ToToToTo----File, cont’d...File, cont’d...File, cont’d...File, cont’d...

• So, going forward in the AIA system:

• A person shall be entitled to a patent unless—

– § 102(a)(1) —the claimed invention was patented, described in a

printed publication, or in public use, on sale, or otherwise

available to the public before the effective filing date of the

claimed invention (i.e., PRIOR ART); or


claimed invention (i.e., PRIOR ART); or

– § 102(a)(2) —the claimed invention was described in a patent

issued under section 151, or in an application for patent published

or deemed published under section 122(b), in which the patent or

application, as the case may be, names another inventor and was

effectively filed before the effective filing date of the claimed

invention.


• In other words, you can have a patent unless another entity does one of

these before you file an application:

• File a US patent application describing the invention

– If priority to foreign application, then as of that filing date

• Publish something describing the invention

– Article, Patent, Patent Application (anywhere in the world)


– Article, Patent, Patent Application (anywhere in the world)

• Use the invention in public (anywhere in the world)

• Put a product (including the invention) on sale (anywhere in the world)


• Exceptions to the § 102 provisions above:

• § 102(b)(1) —A disclosure made 1 year or less before the effective

filing date of a claimed invention shall not be prior art to the claimed

invention under subsection (a)(1) if

– (A) the disclosure was made by the inventor or joint inventor or by

another who obtained the subject matter disclosed directly or


another who obtained the subject matter disclosed directly or

indirectly from the inventor or a joint inventor; or

– (B) the subject matter disclosed had, before such disclosure, been

publicly disclosed by the inventor or a joint inventor or another

who obtained the subject matter disclosed directly or indirectly

from the inventor or a joint inventor.


• Exceptions to the § 102 provisions above:

• § 102(b)(2) — A disclosure shall not be prior art to a claimed invention under subsection (a)(2) if —

– (A) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor;

– (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been


– (B) the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

– (C) the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.


• In other words, it will not be “prior art” against you if:

• The disclosure was made by the inventor, or was derived directly or

indirectly from the inventor

• The inventor publicly disclosed before the third-party disclosure

(within grace period)

• The subject matter disclosed and the invention, at the application’s


• The subject matter disclosed and the invention, at the application’s

effective filing date, were co-owned or subject to an obligation of

assignment to the same owner

• However, this will exclude foreign patent protection

– Note: Derivation proceedings in slide below

FirstFirstFirstFirst----InventorInventorInventorInventor----ToToToTo----File, cont’d...File, cont’d...File, cont’d...File, cont’d...B’s grace period

May 1, 2013 May 1, 2014


• B’s publication is prior art under 102 (a)(1), but knocked out by the

exception in 102(b)(1) as a grace period inventor disclosure.

B publishes Y B files patent

application

claiming Y

FirstFirstFirstFirst----InventorInventorInventorInventor----ToToToTo----File, cont’d...File, cont’d...File, cont’d...File, cont’d...B’s grace period

May 1, 2013 May 1, 2014


• B’s publication is prior art under 102 (a)(1), but knocked out by the

exception in 102(a)(2)(A) as a grace period inventor disclosure.

• C’s publication is prior art under 102(a)(1), but knocked out by the

exception in 102(a)(2)(B) as a grace period intervening disclosure


application

claiming Y

C publishes Y

FirstFirstFirstFirst----InventorInventorInventorInventor----ToToToTo----File, cont’d...File, cont’d...File, cont’d...File, cont’d...A’s grace period

May 1, 2013 May 1, 2014


• B’s publication is prior art under 102 (a)(1), but knocked out by the exception in

102(a)(2)(A) as a grace period inventor disclosure.

• C’s publication is prior art under 102(a)(1), but knocked out by the exception in

102(a)(2)(B) as a grace period intervening disclosure as to subject matter Y only;

C’s publication is prior art as to subject matter Z per proposed rule.


application

claiming Y

C publishes

Y and Z


• PRACTICAL TIP:

– File Provisional Applications Early and Often

• Ongoing piggybacking provisional applications for design changes

– Improve the invention disclosure process

• Incorporate IP focus into product development life cycles

• Schedule regular IP review meetings

• Strive to improve quality/completeness of invention disclosures


• Strive to improve quality/completeness of invention disclosures

– Detailed disclosures improve patent attorney efficiency

– Review patent filing processes and strategies

• Can your patent attorney(s) complete high quality applications reasonably quickly?

– If not, my email address is [email protected] and phone number is (770) 984-2300 ☺☺☺☺


• PRACTICAL TIP:

– The 12 month grace period is not a strategy, but a last option

• Educate inventors to file patent applications (e.g., provisional)

prior to publicly disclosing the invention

• If the invention is publicly disclosed, you may still be able to obtain

US patent protection if within grace period (US only)

– Public disclosure must fully support the claimed invention in


– Public disclosure must fully support the claimed invention in

order to be entitled to anticipatory priority

– If no patent protection is desired, publish often and quickly

• Might prevent 3rd parties from gaining patents

Derivation ProceedingsDerivation ProceedingsDerivation ProceedingsDerivation Proceedings

• Ensures the person obtaining a patent is a true inventor and did not

derive the invention from another.

– Dispute between two applicants to determine who is the true inventor

– May only be requested by an inventor who has filed a patent

application claiming the same or substantially the same invention as

another applicant.


another applicant.

• PRACTICAL TIP:

– Maintain an inventor’s journal with dates and witnesses

• This could provide evidence that you are the true inventor

Prioritized ExaminationsPrioritized ExaminationsPrioritized ExaminationsPrioritized Examinations

• Procedure for expedited review of a patent application

– Goal to provide a final disposition within 12 months of prioritized

status being granted

– Maximum of 10k Priority applications per year will be granted

– Eligible at the time of filing an original (non-provisional) or RCE if:

• Application contains a limited number of claims


• Application contains a limited number of claims

• Application is filed electronically with the Request Form

• Payment of $4800 fee (50% reduction for small entity)

• PRACTICAL TIP:

– Consider filing for Prioritized Examination for high-priority applications

• Ex: If infringer is identified

PrePrePrePre----issuance Submissionissuance Submissionissuance Submissionissuance Submission

• Third parties’ right to submit prior art for consideration in another’s

patent application examination:

– Must be filed before the earlier of: (1) a Notice of Allowance or (2) the

Later of 6 months after publication or the date of first rejection

– Any member of the public may file a third-party submission, including

private persons and corporate entities


private persons and corporate entities

– A third party may file any patents, published patent applications, or

other printed publications of potential relevance

– A fee of $180 unless qualify for the exception

• PRACTICAL TIP

– Offense: monitoring competitor’s applications & file submissions

– Defense: consider expediting examination to beat any submissions

PostPostPostPost----issuance Proceduresissuance Proceduresissuance Proceduresissuance Procedures

• POST GRANT REVIEW

– Third party right to challenge the validity of a patent application within

9 months after it is granted

• Only available for patents subject to First-Inventor-to-File

• Can request to cancel one or more claims of a patent on any

ground relating to invalidity (i.e., novelty, obviousness, written


ground relating to invalidity (i.e., novelty, obviousness, written

description, enablement, indefiniteness, but not best mode).

• Filing fee at least $35,800. Non-refundable if petition denied

• Warning: Once final disposition, cannot raise same issue again in

USPTO or in court

• PRACTICAL TIP: If your competitor just received an issued patent, this can

be an alternative to litigation if your chances of success are high

PostPostPostPost----issuance Procedures, cont’d...issuance Procedures, cont’d...issuance Procedures, cont’d...issuance Procedures, cont’d...

• INTER PARTES REVIEW

– Third party right to request to cancel one or more claims of the patent

only on the grounds of novelty or obviousness based on prior art

patents or publications

• Must not have previously filed a civil action challenging the validity

of a claim of the patent


of a claim of the patent

• Cannot be filed until after the later of 9 months after patent is

issued or the date of termination of a post-grant review

• Filing fee of at least $27,000. Non-refundable if petition denied

• Warning: Once final disposition, cannot raise same issue again in

USPTO or in court

• PRACTICAL TIP: If your competitor is asserting some old patents against

you, this may be an alternative to litigation if your changes are high.

PostPostPostPost----issuance Procedures, cont’d...issuance Procedures, cont’d...issuance Procedures, cont’d...issuance Procedures, cont’d...

• SUPPLEMENTAL EXAMINATION

– The patent owner may request a supplemental examination for a patent so that the Office can consider, reconsider, or correct information believed to be relevant to the patent.

– Filing fee of $21,260, but $16,120 is refunded if no re-examination

– The patent owner can immunize the patent against allegations of


– The patent owner can immunize the patent against allegations of inequitable conduct by completing a supplemental examination.

• PRACTICAL TIP:

– If you become aware of information relevant to your patent after issuance, consider filing a supplemental examination to clear up doubts

– If you discover prior art relevant to a competitor’s patent, consider whether or not to disclose it to them because they might file a S.E. and make their patent stronger

Increase in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity DiscountIncrease in Fees + Micro Entity Discount

• Fee Changes

– Total filing fees: ↑ $1,260 to $1,600 (50% Small EnQty Discount)

– Issue Fees: ↓

– Maintenance Fees: ↑

– Many other fees have either ↑ or ↓


• Micro-Entity Discount

– USPTO will reduce certain fees by 75% if either:

• Small entity status + < 4 previous patent application filings, income

limits (< 3x average national household income) + and no

assignment/licensing/conveyance obligations to a large entity; or

• Employment by assignment/licensing/conveyance obligations to

an institution of higher education

Obtaining Advice of CounselObtaining Advice of CounselObtaining Advice of CounselObtaining Advice of Counsel

• Codification of case law, §298

– The failure of an infringer to obtain the advice of counsel with respect

to any allegedly infringed patent, or the failure of the infringer to

present such advice to the court or jury, may not be used to prove that

the accused infringer willfully infringed the patent…


• PRACTICAL TIP:

– If you are planning to make/use/sell a new product or process, have an

independent patent attorney conduct a Freedom-to-Operate patent

search/opinion before you begin. This can only benefit you:

• If infringing, do not have to provide it to court

• If not infringing, show to court to prove not willful or intentional

Prior User RightsPrior User RightsPrior User RightsPrior User Rights

• Defense to allegations of patent infringement

– Based on earlier commercial use of the patented technology in the

U.S. by the alleged infringer

– Can only be asserted by the person who performs, or directs the

performance of, the allegedly infringing acts

– Prior use must be at least 1 year prior to earlier of first effective filing


– Prior use must be at least 1 year prior to earlier of first effective filing

date of patent or first exception-based publication

– Exceptions: if the patent was owned by a University or Govt. funded

• PRACTICAL TIP:

– If you are alleged to have infringed a patent, determine the date of

your earliest commercial use of the subject matter in the patent

Virtual Marking of Product/PackagingVirtual Marking of Product/PackagingVirtual Marking of Product/PackagingVirtual Marking of Product/Packaging

• Into the 21st century

– Constructive notice of patent protection can be made by marking

“patented” on the article in combination with a web address

• The website includes information about the patent and the

product


• PRACTICAL TIP:

– Make sure your product or packaging has adequate patent markings,

so that you maximize your rights

Alternative Design Patent StrategyAlternative Design Patent StrategyAlternative Design Patent StrategyAlternative Design Patent Strategy

• Design Patents

– Protects the way something looks, not functions

• Ex: A new design shape of an old lancet product

– Consider whether unique design elements are equally important to a

product’s identity and market-share.

• If so, consider securing design patent protection.


• If so, consider securing design patent protection.

• Combination of filing for both utility and design patent protection

will serve the purpose of protecting not only the functional

aspects of your products but their unique appearances as well.

• Design patents provide good protection now and are no longer

considered weaker alternatives to utility patents

Some Hypothetical ScenariosSome Hypothetical ScenariosSome Hypothetical ScenariosSome Hypothetical Scenarios

• A Medical Device Designer/Manufacturer (MDDM)

– The MDDM makes/sells, or is proposing, one or several products

• If not yet making/selling, have counsel perform Freedom-to-Operate

• If already making/selling, have counsel perform Freedom-to-Operate

– If you find a competitor’s patent that covers your product:

• Use Freedom-to-Operate to attempt to design-around the patent


• Use Freedom-to-Operate to attempt to design-around the patent

• Conduct invalidity search for the competitor’s patent

– If you identify prior art that invalidates competitor’s patent

• Evaluate the benefits/pitfalls of staying quiet until contacted

• If within 9 months from issuance, consider Post Grant Review

• If beyond 9 months from issuance, consider Inter Partes Review

• If contacted, consider filing Declaratory Judgment Action

Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...

• You Own A Patent for Technology that is not Being Used Anymore

– Consider seeking a third party to license the patent

– Make sure that the patent is not invalid

• Conduct an invalidity search of your patent

• If you find some potentially damaging prior art:


– Evaluate leaving it alone vs. Supplemental Examination

• The analysis is similar for preparing to file a lawsuit against an infringer

– If the infringer provides you with damaging prior art

• Leave it alone and sue or Supplemental Examination?

Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...Some Hypothetical Scenarios, cont’d...

• The Careless Inventor

– Inventor describes the invention at a trade show on May 1, 2013

– Competitor files patent app. describing the invention on July 1, 2013

– Inventor files patent app. for invention on September 1, 2013

– You discover the competitor application on December 1, 2013


– What do you do?

• Find out if the competitor learned of the invention at the May 1

trade show. If so, Derivation Proceeding

– If not, provide evidence to Patent Office of May 1 disclosure

• Final Tip: If/when you invent, start considering patent issues early,

at least before you plan to publicly disclose the invention

Congrats! You made it through!Congrats! You made it through!Congrats! You made it through!Congrats! You made it through!

Thank You!Thank You!Thank You!Thank You!

Clark Wilson


2018 Powers Ferry Road

Suite 800

Atlanta, GA 30339

770-984-2300


Clark Wilson

[email protected]

Real Estate

The New US Patent Law - From a Medical Device Perspective