The New US Patent Law - From a Medical Device Perspective

The New US Patent Law
Medical Device & Manufacturing – Florida 2013

Clark Wilson
cwilson@gardnergroff.com

2018 Powers Ferry Road
Suite 800
Atlanta, GA 30339
770-984-2300
www.gardnergroff.com www.gardnergroff.com

Clark 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
• 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

www.gardnergroff.com

Recent 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 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
• 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


New USA 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 post-AIA
post-
(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
• 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
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…

• 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
• 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...

• 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
• 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 now “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”

• 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


First-Inventor-To-
First-Inventor-To-File

• 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.


First-Inventor-To-
First-Inventor-To-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
– § 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.


First-Inventor-To-

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


First-Inventor-To-

• 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
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.


First-Inventor-To-

• 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
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.


First-Inventor-To-

• 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
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


First-Inventor-To-
B’s grace period

May 1, 2013 May 1, 2014

B publishes Y B files patent
application
claiming Y
• 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.


First-Inventor-To-
B’s grace period

May 1, 2013 May 1, 2014

B publishes Y C publishes Y B files patent
application
claiming Y

• 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


First-Inventor-To-
A’s grace period

May 1, 2013 May 1, 2014

B publishes Y C publishes B files patent
Y and Z application
claiming Y
• 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.


First-Inventor-To-
• 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
– 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 cwilson@gardnergroff.com and
phone number is (770) 984-2300 ☺


First-Inventor-To-
• 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
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 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.

• PRACTICAL TIP:
– Maintain an inventor’s journal with dates and witnesses
• This could provide evidence that you are the true inventor


Prioritized 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 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


Pre-
Pre-issuance 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
– 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


Post-
Post-issuance 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
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


Post-
Post-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
• 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.


Post-
Post-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
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 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 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 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
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/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 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.
• 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 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
• 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...

• 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...

• 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!

Thank You!

Clark Wilson
cwilson@gardnergroff.com

2018 Powers Ferry Road
Suite 800
Atlanta, GA 30339
770-984-2300
www.gardnergroff.com www.gardnergroff.com

The New US Patent Law - From a Medical Device Perspective

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