Patent Subject Matter Eligibility: Navigating the New - - PowerPoint PPT Presentation

Patent Subject Matter Eligibility: Navigating the New "Myriad" Guidelines

Analyzing Subject Matter and Avoiding Rejection Under the USPTO's Detailed Framework

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Presenting a 90-Minute Encore Presentation of the Teleconference with Live, Interactive Q&A Donna M. Meuth, Associate General Counsel, Eisai, Andover, MA Leslie McDonnell, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA Amelia Baur, Finnegan Henderson Farabow Garrett & Dunner, Boston, MA

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Patent Subject Matter Eligibility: Navigating the New Myriad Guidelines Analyzing Subject Matter and Avoiding Rejection Under the USPTO’s Detailed Framework

May 15, 2014

Donna Meuth Leslie McDonell Amelia Baur

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Disclaimer

• These materials are public information and have been prepared

solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials should not be taken as individualized legal advice and do not reflect the views of FINNEGAN or EISAI, It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, FINNEGAN, EISAI, and the panelists cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with FINNEGAN, EISAI, or the panelists. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

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The §101 Roller Coaster

• New guidelines are the USPTO’s sixth

attempt in five years to define patentable subject matter:

• 1. August 2009 (machine-or-transformation)
• 2. January 2010 (computer-readable media)
• 3. July 2010 (Bilski)
• 4. July 2012 (Process Claims Involving Laws of Nature; Mayo)
• 5. June 2013 (Memorandum re Myriad)
• 6. March 2014 Procedure for Subject Matter Eligibility Analysis of Claims

Reciting or Involving Laws of Nature/Natural Principles, Natural Phenomena, and/or Natural Products

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Interim Guidelines Released

• 2012 Mayo Guidance; MPEP 2106.01: Process claims

involving Laws of Nature.

• June 13, 2013 Memo

– Noted Supreme Court decision in Myriad: claims to isolated DNA not patent-eligible.

• “As of today, naturally occurring nucleic acids are not patent eligible

merely because they have been isolated.”

• March 4, 2014 Memo: New Guidance Replaces Both

– “all claims (i.e., machine, composition, manufacture and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products should be examined using the Guidance.” – “examination procedure set forth in the Guidance is effective today and supersedes the June 13,2013 memo[.]”

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USPTO Guidance to Examiners

• Not a statute
• Important USPTO policy document

– Used to train patent examiners.

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USPTO: The New Subject Matter Eligibility Guidance

• “For use in subject matter eligibility

determinations of all claims (i.e., machine, composition, manufacture, and process claims) reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products.”

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USPTO: Three-Step Analysis

“walk through the three questions in the flowchart … to determine whether the claim is drawn to patent- eligible subject

• matter. If not, then

the claim is prima facie ineligible, and the claim should be rejected[.]”

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USPTO: Three-Step Analysis

• 1. Does a claim reciting one of the four statutory

categories of patent eligible subject matter?

(process, machine, manufacture, composition)

• 2. Does the claim recite or involve one or more

judicial exceptions?

(abstract ideas, laws of nature/natural principles, natural phenomena, natural products)

• 3. Does the claim as a whole recite something

significantly different from the judicial exceptions?

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USPTO: Three-Step Analysis

• “Recite or involve” appears to mean -- looks like,

sounds like, smells like, or is somehow derived from or related to, a natural product, law, phenomenon -- even if it is but a single component in a multi-component composition.

• It is not enough that the claim is directed to a

product or composition that is non-naturally

• ccurring – it must also be significantly different in

structure from naturally occurring products.

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USPTO: Three-Step Analysis

• What does “significantly different” mean?

– Markedly different – More than nominally, insignificantly, or tangentially related – More than well understood, purely conventional, or routine in the relevant field – Not insignificant extra-solution activity

• Words such as “synthetic”, “isolated”,

“recombinant”+ “cDNA”, “composition”, “primer”, “purified”, “vector” recited in a claim do not influence the determination of significant difference (Guidelines) (added in Training Slides)

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USPTO: How to Analyze “Significantly Different”

• Factor-based analysis of whether claim as a

whole is “significantly different” from the judicial exception

• Not a single, simple determination, but a

conclusion reached by weighing the relevant factors, varying the weight accorded each factor based on the facts of the application – “[S]imilar to the Wands factor-based analysis”

• On balance, does the totality of the relevant

factors weigh toward eligibility?

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Prometheus: “Significantly Different”

• “A process that focuses on the use of a natural law

also [must] contain other elements...an ‘inventive concept,’ sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” ‒ Prometheus, citing Flook, Bilski, Diehr

• “Too broad an interpretation of this exclusionary

principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” ‒ Prometheus

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USPTO Factors – Natural Product

Weigh Against Eligibility Weigh Towards Eligibility

g) claim recites a product that is not markedly different in structure from naturally occurring products a) claim recites something that is non-naturally occurring and markedly different in structure from naturally occurring products

• Grounded in Chakrabarty?
• “Here...the patentee has produced a new bacterium with markedly different characteristics

from any found in nature and having the potential for significant utility. His discovery is not nature’s handiwork, but his own.”

• The combination of bacteria in Funk Brothers was merely “the handiwork of nature.”
• Grounded in Myriad?
• “Separating [a BRCA] gene from its surrounding genetic material is not an act of invention.”
• “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from

which it was derived...except insofar as very short series of DNA may have no intervening introns”

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USPTO Factors – Preclusion

Weigh Against Eligibility Weigh Towards Eligibility

h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception

• Grounded?
• Precedent “warn[s] us against upholding patents to processes that too broadly

preempt the use of a natural law.” – Prometheus, Benson, Flook

• A process must contain other elements “sufficient to ensure that the patent in

practice amounts to significantly more than a patent upon the natural law itself” – Prometheus

• Diehr sought only to foreclose the use of an equation in conjunction with all of the
• ther steps of the claimed process – Prometheus

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USPTO Factors – Significant Limits

Weigh Against Eligibility Weigh Towards Eligibility

k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception

• Grounded?
• “Flook stands for the proposition that the prohibition against patenting abstract

ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity.’” – Bilski

• MPEP 2106 - Use of a machine or apparatus that contributes only nominally or

insignificantly to the execution of the claimed method (e.g., in a data gathering step

• r in a field-of-use limitation) would weigh against eligibility.

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USPTO Factors – General/Particular Application

Weigh Against Eligibility Weigh Towards Eligibility

i. claim recites elements that must be used in order to apply the judicial exception d) claim recites elements that do more than provide general instructions to apply or use the judicial exception i. claim recites elements that amount to nothing more than a mere field of use e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application

• Grounded in Prometheus?
• The three process steps amount “to nothing significantly more than an instruction

to doctors to apply the applicable laws when treating their patients.”

• It is not enough to limit the use of the natural law or formula to a particular

technological environment ‒ citing Bilski and Diehr

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More Process Cases?

• “[T]he machine-or-transformation test is a useful

and important clue, an investigative tool, for determining whether some claimed inventions are processes under §101” ‒ Bilski

• The claimed elements in Mayo are steps that

must be taken by anyone who wants to make use of the natural law ‒ Prometheus

• Steps in Flook’s process did not limit the claim to a

particular application of the concept of hedging ‒ Prometheus

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USPTO Factors – Well-Understood, Conventional, Routine

Weigh Against Eligibility Weigh Towards Eligibility

j) claim recites elements that are well-understood, purely conventional or routine in the relevant field f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field

• Grounded in Prometheus?
• The claimed elements “add nothing specific to the laws of nature other

than what is well-understood, routine, conventional activity, previously engaged in by those in the field”

• “[D]etermining” step merely tells doctors to engage in well-understood,

routine, conventional activity - citing Flook

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USPTO 12 Factors

Weigh Against Eligibility Weigh Towards Eligibility

g) claim recites a product that is not markedly different in structure from naturally occurring products a) claim recites something that is non-naturally

• ccurring and markedly different in structure

from naturally occurring products h) claim recites elements at a high level of generality such that substantially all practical applications of the judicial exception are covered b) claim recites elements that impose meaningful limits on scope, such that others are not substantially foreclosed from using the judicial exception k) claim recites elements that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception c) claim recites elements that are more than nominally, insignificantly, or tangentially related to the judicial exception i) claim recites elements that must be used in

• rder to apply the judicial exception

d) claim recites elements that do more than provide general instructions to apply or use the judicial exception l) claim recites elements that amount to nothing more than a mere field of use e) claim recites elements that include a particular machine or transformation of a particular article or integrates the judicial exception into a particular practical application j) claim recites elements that are well-understood, purely conventional or routine in the relevant field f) claim recites elements that add a feature that is more than well-understood, purely conventional or routine in the relevant field

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USPTO Examples

• Natural Products
• Combination of Natural Products
• Process/Diagnostic Claims

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Example A: Composition Reciting a Natural Product

• Claim 1: A stable energy-generating plasmid,

which provides a hydrocarbon degradative pathway. – Background: Such plasmids exist in nature in bacteria. – Analysis:

• Step 1: yes
• Step 2: yes
• Step 3: No. There is no structural difference between the

claimed plasmid and naturally occurring plasmids.

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Example B: Composition Reciting a Natural Product

• Claim 1: Purified amazonic acid
• Claim 2: Purified 5-methyl amazonic acid

Amazonian cherry tree Amazonic acid

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Example B: Analysis for Purified Natural Product

• Claim 1: Purified amazonic acid

– No marked difference in structure between purified acid and acid in plant. – “Isolated”, “recombinant”, “synthetic” do not confer eligibility.

Not eligible

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• Claim 2: Purified 5-methyl amazonic acid

Example B: Analysis for Laboratory Derivative

• f Natural Product
• Recites or involves judicial exception?

Yes, natural product

Analysis:

• Derivative is structurally different from acid in plant.
• Structural difference has created a functional difference.

“[W]hile not necessary to find a marked difference, the presence

• f a functional difference makes a stronger case that structural

difference is a marked difference.”

Eligible

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USPTO Examples

• Combination of Natural Products

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Example A: Combination of Natural Products

• Claim 2: A bacterium from the genus Pseudomonas

containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

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Example D: Combination of Natural Products

– Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)

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Claim: A fountain-style firework comprising: (a) a sparking composition, (b) calcium chloride, (c) gunpowder, (d) a cardboard body having a first compartment containing the sparking composition and the calcium chloride and a second compartment containing the gunpowder, and (e) a plastic ignition fuse having one end extending into the second compartment and the other end extending out of the cardboard body.

Example C: Manufacture Claim Reciting Natural Products

(saltpeter, sulfur, charcoal)

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Example C: Manufacture Claim Reciting Natural Products

• The PTO’s analysis is based on “broadest reasonable

interpretation” of “gunpowder”

– Type I: A mixture of three naturally occurring materials: potassium nitrate, sulfur and charcoal. Such a mixture is not markedly different because none of the components have been changed. – Type II: A glazed powder formed from four naturally occurring materials: sodium nitrate, sulfur and charcoal are mixed and then granulated, and then the granulated particles are coated with a thin layer of graphite. -- This glazed powder is structurally different from what exists in nature, because the materials have been combined in a particular way to yield a manufacture that is entirely different from a mere mixture of the raw materials from which it was formed. In addition, the structural difference results in a change to the properties of the powder (it can no longer deliquesce due to the graphite coating). The USPTO considers this powder to be markedly different from what exists in nature.

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Training Example: Composition Claim Reciting Natural Products

2. A beverage composition comprising: a) 99.5% pomelo juice; and b) 0.5% vitamin E. 3. A beverage composition comprising pasteurized pomelo juice. 4. A beverage composition comprising: a) pomelo juice; and b) preservative X [non-natural]. 1. A beverage composition comprising: a) pomelo juice; and b) a preservative.

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Training Example: Alloy

No marked difference: factor (g) satisfied

Marked difference: factor (a) satisfied

• No structural difference
• Mere mixture or aggregation of naturally
• ccurring metals together as a “composition” does

not change the metals from what exists in nature.

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Training Example: Alloy

Marked difference: factor (a) satisfiedrked difference: factor (g) satisfied Marked difference: factor (a) satisfied

• Markedly different in structure:
• structural difference (the alloy is a solid solution of tin in copper,

which has a different crystalline arrangement of atoms than in the natural metals)

• structural difference results in change to properties of alloy (the

alloy has a different color, tensile strength, hardness, and melting point than either natural metal).

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Example E: Composition Reciting Two Natural Products

• Claim 1: A pair of primers, the first primer having the

sequence of SEQ ID NO:1 and the second primer having the sequence of SEQ ID NO:2. – Consider claim as a whole; – Not found in nature together; – Functionally different than individual pieces; – Application not found in nature.

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Hypothetical Variations

• USPTO has said that primers in a kit are not patent eligible.
• What if the primer pairs are in a test tube with buffer?
• What if the primer pairs are in a test tube with a

nonnaturally occurring buffer?

• What if the primer pairs are bound to their template DNA in

a first step of a PCR reaction?

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You Put Da Lime In Da Coconut

You can drink it all up, but it may not be a patent- eligible composition!

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USPTO Examples

• Process/Diagnostic Claims

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USPTO Subject Matter Eligibility Training Slides

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Example B: Analysis for Method of Using Purified Natural Product

• Claim 3: A method of treating colon cancer, comprising

administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of from 10 days to 20 days, wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid

Analysis:

• Recites or involves judicial exception?

Yes, natural product

• Significant, non-conventional limitations, limited foreclosure
• Administration step is significant, particular manipulation
• Administration is more than general instruction to use
• Additional elements are more than routine and conventional

Eligible

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Example F: Process Involving Natural Principle

• A method for determining whether a human patient

has degenerative disease X, comprising: – Obtaining a blood sample from a human patient; – Determining whether misfolded protein ABC is present … by contacting the blood sample with antibody XYZ and detecting ABC … using flow cytometry…; and – Diagnosing the patient as having degenerative disease X if misfolded protein ABC was determined to be present.

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Example F: Hypothetical Variations

• Flow Cytometry

– March 2014 PTO Training Materials suggest “flow cytometry” is generic because no description of whether it is a desk top or high speed machine or the number of lasers used. – What if spelled out the steps of flow cytometry, as with the PCR example?

• Novel Ab vs. Known Ab

– Importing an obviousness analysis – What if Ab XYZ is the only known Ab, or the only “commercially viable Ab”? – Prior USPTO guidelines of July 3, 2012

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Example F: Hypothetical Variations

• Non-routine use of a known product

– What makes a reagent or method step conventional? – The ordering of the steps? – If a reagent had only been used once before and for an unrelated assay?

• If the Ab is new, consider removing the

stated natural correlation

– A method of detecting mutant protein ABC by contacting a sample with Ab XYZ.

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Example E: Method Claim Involving Natural Product

• Claim 2: A method of amplifying a target DNA sequence

comprising: – Providing a reaction mixture comprising a double- stranded target DNA, the pair of primers of claim 1…, Taq polymerase, and a plurality of free nucleotides… – Heating and cooling the reaction mixture to predetermined temperatures for predetermined time periods – Repeating steps (b) and (c) at least 20 times

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Example E: Hypothetical Variations

• Why is heating to a “predetermined temperature”

for a “predetermined time” considered a narrowing element?

• What if claim indicated use of “PCR” rather than

spelling out the steps?

• What if claim more generally referred to a

polymerase rather than specifying Taq?

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Reaction from Patent Community

• “USPTO May Reject Wide Range Of Patents Under New

Rules,” IP360, March 5, 2014.

• “10 Problems In The USPTO's New Training Memo,”

IP360, March 10, 2014.

• “Uncertainty Looms as PTO Expands Reach Of Myriad

Genetics Ruling, Attorneys Say,” IPLAW.BNA.COM, March 17, 2014.

• “IP Practitioners ‘Horrified’ By USPTO Guidelines On

Myriad,” Managing IP, March 27, 2014.

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Litigation Update

• District Courts:

– Myriad v Ambry Genetics, Gene-by-Gene, GeneDx, Quest Diagnostics, InVitae, and Lab Corp of America (D. Utah) (preliminary injunction denied) – Ariosa v. Sequenom (N.D. Cal.) (summary judgment granted) – Genetic Technologies v. Agilent Technologies (N.D. Cal.) (motion to dismiss denied) – Genetic Technologies v. BMS, Pfizer, General Genetics

• Corporation. Lab. Corp. of America

– Quest Diagnostics and InVitae v. Myriad (N.D. Cal.)

• Federal Circuit:

– In re Roslin Institute

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Affirmative Uses of the New §101 Guidelines

• Licensing

– Rely on new §101 interpretation as basis for getting out from under a usurious license.

• Freedom-to-operate

– Revisit invalidity analyses and opinions. – Consider offensive strategies.

• PGR for recently-filed applications.
• Declaratory judgment possibilities.
• Litigation strategies.

– New § 101 defenses available.

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Defenses to §101 Rejections

• Add specificity to claims to narrow “scope of foreclosure” or

“impose meaningful limits on claim scope.”

• Add features that are more than well-understood, purely

conventional or routine to the claims.

• Include a particular machine or particular transfomation to

the claims.

• Recite structural differences between claimed subject

matter and natural product.

• Argue that Examiner has not accorded proper weight to

factors weighing toward eligibility.

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§101 Rejections

• Interpretation of key Supreme Court cases:
• USPTO Guidelines

– “Myriad relied on Chakrabarty as “central to the eligibility inquiry, and reaffirmed the Office’s reliance on Chakrabarty’s criterion for eligibility of natural products (i.e., whether the claimed product is a non-naturally

• ccurring product of human ingenuity that is markedly

different from naturally occurring products).”

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§101 Rejections

• USPTO Guidelines:

– “Thus, while the holding in Myriad was limited to nucleic acids, Myriad is a reminder that the claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.”

• Does Chakrabarty hold that a “marked

difference” is necessary to show patent eligibility?

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§101 Rejections

• The only question before the Chakrabarty Court

was whether a living organism is excluded under §101 from patent eligibility.

• Chakrabarty’s bacteria was found by the Board not

to be a product of nature – this issue was not appealed by the PTO.

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§101 Rejections

• Chakrabarty’s “markedly different”

– Distinguishing Funk Bros. the Chakrabarty Court stated “Here, by contrast, the patentee produced a new bacterium with markedly different characteristics from any found in nature . . . His discovery is not nature’s handiwork, but his own, accordingly it is [patent eligible]”

• Statement of fact vs. required threshold?

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§101 Rejections

• Chakrabarty refers to the invention as a product of

human ingenuity ‘having a distinctive name, character [and] use.’ Hartranft v. Wiegmann, 121

• U. S. 609, 121 U. S. 615” (1887).
• Hartranft v. Wiegmann: “having a distinctive name,

character OR use.” Hartranft v. Wiegmann

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§101 Rejections

• USPTO Guidelines:

– “Myriad also clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., ‘isolated’) in the claims does not automatically confer eligibility.”

• The Myriad Court refers to “genes and the

information they encode” not being patent eligible “simply because they have been isolated from their surrounding material.”

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§101 Rejections

• The Prometheus Court distinguished the claims at issue from claims

directed to a new drug or a new way of using an existing drug.

• PTO agrees that claims to a new way of existing drug do not involve a

law of nature

• PTO indicates that a new way of using a natural product must be

analyzed for patent eligibility

• Do examples suggest that if a natural product is involved, the method

must be limited to narrow applications requiring specific dosages and/or treatment regimens to avoid foreclosure?

• Myriad Court: “[T]his cases does not involve patents on new

applications of knowledge about the [BRCA] genes.”

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§101 Rejections

• “The Patent Act of 1952 (35 U.S.C.A. §101), as its

predecessors, authorizes a patent for ‘any new and useful … composition of matter …, provided only that the conditions for patentability, which are specified in succeeding sections are met. There is nothing in the language of the Act which precludes the issuance of a patent upon a ‘product of nature’ when it is a ‘new and useful composition of matter’ …” – Merck & Co. v Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958).

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Internal Portfolio Examination

• Drafting new applications

– Disclosure of non-routine or non-conventional modifications. – Specific methods of use or applications of discoveries.

• Pending applications

– Consider multiple layers of claims to account for possible litigation

• utcomes and changes in law.

– Identify applications appropriate for appeal. – Maintain pending applications in important families.

• Issued patents with no pending U.S. counterparts.

– Consider scope of issued claims. – Possible reissue to add dependent claims.

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New Patent Profanity

• Carefully consider use of the following terms:

– In the specification

• Routine
• Conventional
• Well-understood
• Well-known

– In claims

• Analyze
• Compare
• Determine

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Where Does This Leave Us?

• Inconsistent district court decisions
• Even more erratic and inconsistent examination for the

foreseeable future–increasingly reduced predictability, increasing need to take cases through appeal process.

• Substantially increased uncertainty and IP expense for

biotechnology and other industries that rely on natural products, methods of diagnosis, or methods of treatment.

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Speaker Information

Leslie McDonell leslie.mcdonell@finnegan.comel 617.646.1650 Amelia Baur. amelia.baur@finnegan.com 617.646.1650 Donna Meuth. Donna_Meuth@eisai.com ; Tel 617.646.1650