Short review of practices at the USPTO and the EPO

US IPR Update Seminar 10 April 2018Hetti Palonen

Patentability requirements USPTO EPO35 U.S.C. § 101: Utility and subject matter eligibility

Judicially Created Exceptions to § 101: "laws of nature, physical phenomena, and abstract ideas."

Art 52(1) EPC The general patentability criteria Art 57 EPC Industrial application

Art. 53 (b),(c) EPC; e.g. methods of treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body are excluded from patentability.

35 U.S.C. § 102: Anticipation (Novelty) Art 54 EPCArt 54 (4) and (5) ”first and furthermedical use” A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods

USPTO EPO35 U.S.C. § 103: Obviousness (Inventive Step)

Art 56 EPC Inventive step

35 U.S.C. § 112, 1st paragraph :Enablement, written description and best mode

Art 83 EPC Disclosure of theinvention; Sufficiency of disclosure

35 U.S.C. § 112, 2nd paragraph:Definiteness

Art 84 EPC Claims; clarity

Patentability requirements

Supreme Court decisions

Abstract Ideas – Bilski v. Kappos (2010)Method drawn to the concept of hedging is ineligible because it claims an abstract idea

Abstract Ideas – Alice v. CLS Bank (2014)Scheme for mitigating settlement risk is ineligible because it claims an abstract idea

Laws of Nature – Mayo v. Prometheus (2012)Method drawn to a naturally occurring correlation is ineligible because it effectively claims nothing more than a law of nature

Natural Products – AMP v. Myriad (2013)Isolated genomic DNA is ineligible because it is a product of nature (not markedly different from naturally occurring DNA)

KSR v. Teleflex (2007)“rationals” A-G

Subject mattereligibility

Obviousness

Rejections at USPTO

Years 2005-2015

Lähde: http://www.ipwatchdog.com/2017/05/09/112-rejections-applicants-handle/id=82668/

101 102 103 112(a) 112(b)

Examining practice in USPTOExaminers should refer to court decisionsregardless of the technical field

Chart of subject matter eligibility court decisions

Instructions publicly availableThe Manual of Patent Examining Procedure, MPEP• The most recent revision: the January 2018 MPEP Publication)Reference sheets, flowchartsExamples of eligible claimsLists of factors to be weighed (KSR rationals, Wandsfactors …)Training materials

Claim interpretation

During patent examination, the pending claims must be given their broadest reasonable interpretationconsistent with the specification.

giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified

During examination, the claims must be interpreted as broadly as their terms reasonably allow. This means that the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification.

Utility analysisDoes the invention have utility?

Three-pronged test is used1. Specific,

a utility that is not too general2. Substantial

a utility that defines a "real world" use3. Credible

a credible utility is assessed from the standpoint of whether a person of ordinary skill in the art would accept that the recited or disclosed invention is currently available for such use

OR the invention can have a well-established utility”In general, unless the well established utility is immediately evident, if no specific, substantial, and credible utility is present, USPTO examiner will shift the burden to applicant to provide the well established utility along with supporting evidence”

Utility example: Alternative UsesSpecification:

The specification relates to the prevention and treatment of microbe X infection, a common infection, by administering compound A.

Claims1. A method for preventing or treating microbe X

infection comprising administering to an animal in need thereof an effective amount of compound A.

2. A method for preventing microbe X infection comprising administering to an animal in need thereof an effective amount of compound A.

Utility example 1: Alternative UsesIs there a "well established utility" for the claimed invention?

Since each claim is directed to a specific method of use, the utility of each of these claims is limited to that use and the examiner should not look to a "well established utility" for the composition used in the claimed method.NO

Has the applicant made any assertion of utility for the specifically claimed invention?

YES, Claim 1(1) preventing microbe X infection(2) treating microbe X infection

Claim 2:(1) preventing microbe X infection.

Utility example 1: Alternative UsesIs the asserted utility specific?

Since microbe X infection is a known infection, and the treatment claimed is directed to a particular combination of treatment and agent, the utilities of preventing or treating the infection define specific and particular uses.YES.

Is the asserted utility substantial?The characterization of the disease as a common infectionestablishes the presumption that the asserted utilities have a “realworld” context.YES.

Is the asserted specific and substantial utility credible?Since infections are conventionally treatable, the answer to this question would be yes regarding the treatment of microbe X infection.However …

Utility example 1: Alternative Uses

The claims also recite preventing microbe X infection.The broadest reasonable interpretation of the term infection merely requires that one microorganism gain entry into the cells of a host. There is no evidence that entry would be prevented.NO -> therefore that utility would not be credible

Claim 1Claim 1 meets the criteria for a specific, substantial, and credible utility whereas the prevention of microbe X infection is not a credible utility.No rejection under 35 U.S.C. § 101 should be made against claim 1. The presence of the utility that is not credible in claim 1 (preventing microbe X infection) should be addressed in a rejection under 35 U.S.C. §112, paragraph (a), scope of enablement.

Claim 2Both a 35 U.S.C. § 101 rejection and a 35 U.S.C. § 112, paragraph (a), utility rejection should be made since the prevention utility is not credible.

Example 2: Claim interpretation

Claim 1. A martianase compound.

The Specification: Martianase compounds are useful for the release of water from ancient Martian soil. A martianase compound is a compound having the structure, or derivatives or metabolites thereof.

Methylphenol group

The Prior ArtThe prior art discloses a series of compounds that are useful for treating hair loss (alopecia). The compounds of the prior art have the following structure:

wherein R1 is a substituted aryl group.

The prior art patent does not disclose a specific embodiment wherein R1 is a methylphenyl group. There are, however, a number of synthetic schema disclosed,

R1

Analysis

Based upon the above facts, the prior art would fail to anticipate the specific martianase compound disclosed in the subject application since there are no specific blaze marks in the prior art patent that would lead one to the instantly claimed compound.However, because the definition of a martianasecompound disclosed in applicant’s specification includes “derivatives” and “metabolites”, the term martianase would, absent evidence to the contrary, include the compounds of the prior art

Sample RejectionClaim 1 is anticipated under 35 USC 102(x) over U.S. Patent No. 9,876,543. U.S. Patent No. 9,876,543 discloses a series of compounds that anticipate the claimed martianase compound (see, e.g., column C, lines d-f). It is noted that the patent does not disclose the explicitly exemplified martianase compound. However, the instant specification defines a martianase compound as a particular compound (see structure) or derivatives or metabolites thereof (see, e.g., page X, lines y-z). The compounds disclosed in the prior art patent are considered to be derivatives of the specifically exemplified martianase compound and, therefore, anticipate the claim that recites a “martianase compound,” absent evidence to the contrary.

Claim 1. A vaccine comprising an isolated protein comprising SEQ ID NO:1 or a portion thereof which is antigenic

A reference which discloses the composition comprising the recited protein in a pharmaceutically acceptable carrierwould anticipate the claimed invention.Composition comprising a deleterious substance (sodium

azide) would not usually be considered a vaccine. A reference which contains a composition comprising an antigenic portion of the recited protein would anticipate the claimed invention if the portion elicits a protective immune response

Role of preamble: ExampleAn intended use

From: Claim Interpretation - Intermediate Exercises: TC1600 Product-by-Process, September 2015

35 U.S.C §112(a)

The specification shall contain a written description of the invention, and of the manner and process of making andusing it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and usethe same, and shall set forth the best modecontemplated by the inventor or joint inventor of carryingout the invention.

35 U.S.C. 112(a)(2012)

§ 112(a): Three separate and distinct requirements

1. the written description requirement

2. the enablement requirement

3. the best mode requirement

§ 112(a) rejections

Typical in Biotechnologyand Chemical engineering

TC1600 Biotechnologyand Organic ChemistryTC1700 Chemical and Materials Engineering

Lähde: http://www.ipwatchdog.com/2017/05/09/112-rejections-applicants-handle/id=82668/

35 U.S.C §112(a) Written description

Can one skilled in the art reasonably conclude that the inventor had possession of the claimed invention as of the effect filing date of the application. Factual considerations

Level of skills and knowledge in the art

Predictability in the art

Description of sufficient relevantidentifying characteristics- Complete or partial structure- Physical and/or chemical properties- Functional characteristics- Correlation between structure and function- Method of making

Disclosure of a representative number of species that fairly represents the variation across the genus being claimed

35 U.S.C §112(a) Written description

The written description requirement applies to all claims, both original and amended claims“Written description” is not limited to words in the specificationCan be provided in the body of the specification along with the figures (e.g., in words, structures, figures, diagrams, and formulas)

35 U.S.C §112(a) Written description

Original claims may lack written description ifBroad (genus) claim (e.g. claiming “derivatives”) but only one/narrow species disclosedFunctional claim language specifying a desired result but the specification does not sufficiently identify how the function is performed or result is achieved

Problems if:The structure of a claimed compound/biomolecule is not disclosedCorrelation of structure and function is missingThe “core” structure responsible for the function is not defined

35 U.S.C §112(a)New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure do not satisfy the written description requirement and are appropriately rejected under §112(a) for lack of written description

If amendments to the specification/abstract/drawings add features not originally disclosed, the specification/abstract/drawing should be objected to under 35 U.S.C. 132 as new matter and applicant should be required to cancel the new matter

35 U.S.C §112(a) written descriptionClarity of the Prosecution Record

Any deficiencies in the disclosure should be addressed during prosecution and clearly explained in an Office actionThe prosecution record will provide a map for the public to understand the boundaries of the patent protection and provide clear notice of patent rightsThe PTAB and courts will be informed as to what the examiner and the applicant understood the claims to mean

35 U.S.C §112(a) Enablement

For enablement, the critical inquiry is: Does the specification provide enough information so that one of ordinary skill in the art can make and/or use the full scope of the claimed invention without “undueexperimentation”?

Enablement can be shown by disclosing at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claimWhen a compound or composition is limited by a particular use, enablement of that claim should be evaluated based on that limitation

35 U.S.C §112(a) EnablementWands factors

Factors to be weighed when evaluating whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” 1. Breadth of the claims;2. Nature of the invention;3. State of the prior art;4. Level of one of ordinary skill;5. Level of predictability in the art;6. Amount of direction provided by the inventor;7. Existence of working examples; and8. Quantity of experimentation needed to make or use the invention basedon the content of the disclosure

MPEP 2164.01(a)

re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) “Obtaining antibodies”

35 U.S.C §112(a) EnablementExample: Peptides for Treating ObesitySpecification:The specification discloses an anti-obesity peptide having the amino acid sequence SEQ ID NO 1. The specification also discloses a pharmaceutical formulation comprising the peptide of SEQ ID NO 1 and a pharmaceutically acceptable carrier, diluent, and/or excipient, as well as a method of treating obesity by administering the peptide of SEQ ID NO 1 to an obese mammal, such as mice or humans. Several routes of administration are disclosed but no dosages, not even general ranges, are disclosed. The specification states that the peptide can be made by recombinant DNA technology or well known peptide synthesisprocedures.

The specification states that the peptide is able to control body weight gain in normal and obese subjects. The specification discloses that suitable test animals include normal mice and obese mice, especially the ob/ob mouse model of obesity and diabetes, which is disclosed as being generally accepted in the art as being indicative of the obesity condition. The specification discloses how to carry out the animal model tests but fails to disclose whether such tests were done using the peptide of the invention. The specification also goes on to state that the peptide is also useful as feed additives for animals.

35 U.S.C §112(a) EnablementExample: Peptides for Treating Obesity

Claims:1. A peptide consisting of the sequence SEQ ID NO 1.2. A pharmaceutical composition comprising the peptide of claim 1 and a pharmaceutically acceptable carrier.3. A method of treating obesity, which comprises administering to a mammal in need thereof the peptide of claim 1.

State of the Prior Art:There are no structurally similar peptides known in the art for treating obesity. There are other proteins that the art suggests play a role in obesity

35 U.S.C §112(a) EnablementPeptides for Treating Obesity

Claims:1. A peptide consisting of the sequence SEQ ID NO 1.

When a product claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude a rejection based upon a lack of enablement.

The fact that the specification discloses that the peptides can be used as an additive to animal feed in combination with the fact that it is well established in the art how to use proteins and peptides as additives in animal feed leads to a conclusion that the specification also teaches how to use the peptide recited in claim.

→ ENABLED

35 U.S.C §112(a) EnablementEsimerkit: Peptides for Treating Obesity

2. A pharmaceutical composition comprising the peptide of claim 1 and a pharmaceutically acceptable carrier.3. A method of treating obesity, which comprises administering to a mammal in need thereof the peptide of claim 1.

The "pharmaceutical composition” language in combination with the fact that the only disclosed pharmaceutical use of the compositions is for treating obesity leads to the conclusion that this claim should be evaluated in terms of whether the specification teaches how to use the compositions for treating obesity. Since method claim 3 must be evaluated in terms of the recited use, treating obesity, claims 2 and 3 should be evaluated together

• prior art suggests a lack of predictability in this art• lack of guidance with respect to dosages and lack of working examples• One skilled in the art could not use the inventions of claims 2 and 3 without undue

experimentation → ENABLEMENT REJECTION

35 U.S.C §112(a)

Rule 132 (37 CFR 1.132)

The rule permits applicants to provide evidence to overcome a ground of rejection or an objection

Subject matter eligibility

35 U.S.C. § 101: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.The 3-Step Patent Eligibility Analysis is based on Mayo (2012) and Myriad (2013)Applies to all types of claims (i.e., machine, composition, manufacture and process claims) that recite or involve:

Abstract ideasLaws of nature/natural principles,Natural phenomena, and/or Natural products.

Streamlinedanalysis

MPEP

2A: Is the claimDIRECTED to a judicial exception?

2B: Does the claim as a whole amount tosignificantly more than the exception?

Is The Claim Directed To One Of The Four Statutory Categories of 35 U.S.C. § 101?

Streamlined example 1

1. A hip prosthesiscomprising: a femoralcomponent and an acetabular cup, whereinthe acetabular cup hasan inner concavesurface for engaging thefemoral component, and an outer convex surfacefor engaging a patient’sacetabulum, and wherein the outerconvex surface is coatedwith hydroxyapatite.

The claim recites a nature-based product (hydroxyapatite is a naturally occurring mineral).

However, the claim clearly does not seek to tie up the mineral. Instead, the claim is focused on the assembly of the femoral component and the cup that together form the hip prosthesis.

No need to perform the markedly different characteristics analysis on the mineral.

The claim qualifies as eligible subject matter without a full analysis.

RAPID LITIGATION MANAGEMENT v. CELLZDIRECT, INC. Improved process for freezing cells July 5, 2016

A method of producing a desired preparation of multi-cryopreserved hepatocytes, said hepatocytes being capable of being frozen and thawed at least two times, and in which greater than 70% of the hepatocytes of said preparation are viable after the final thaw, said method comprising:(A) subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from nonviable hepatocytes, (B) recovering the separated viable hepatocytes, and(C) cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and second cryopreservations, and wherein greater than 70% of the hepatocytes of said preparation are viable after the final thaw.

The claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims are directed to a new and useful laboratory technique for preserving hepatocytes.

The claim qualifies as eligible subject matter without a full analysis.

Markedly different characteristics analysis for products

If the claimed formulation/product is “a nature-based product” that must be compared to its closest naturally occurring counterpart to determine if it has markedly different characteristics than the counterpart.2A: Consider whether any of the following characteristics were changed:

biological and pharmacological functions or activitiesstructure or formphenotypechemical or physical properties

Markedly different characteristics analysis: Examples of eligible claims (step 2A)

A yogurt starter culture comprising goat milk mixed with Streptococcusthermophilus and Lactobacillus alexandrinus.

Neither S. thermophilus nor L. alexandrinus occur naturally in goat milk, and these bacteria do not occur together in nature. The mixture of the bacteria and milk has different functional characteristics (lower fat content) than the naturally occurring bacteria (or milk) by itself. → not a product of nature (2A) exception

A vaccine comprising live attenuated Pigeon flu virus

The attenuated virus has mutations; a structural difference, which has resulted in a different functional characteristics (reduced virulence) → not a product of nature (2A) exception

A dietary sweetener comprising texiol in a controlled release formulation.

Texiol is a sweetener obtained from plant (i.e. from nature). The claimed formulation has altered time release properties due to a change in form/structure or being mixed with other substances → not a product of nature (2A) exception

Subject matter eligibility of methodclaims

A correlation that is the consequence of natural processes, e.g., how a certain compound is metabolized by the body (Mayo) is a “natural law” exception

Diagnosing a patientComparing gene sequences, detectingdifferences

Significantly more analysis (2B)In Step 2B of the USPTO's SME guidance, examiners should consider the additional elements in combination, as well as individually, when determining whether a claim as a whole amounts to significantly more, as this may be found in the nonconventional and non-generic arrangement of known, conventional elements.

Diagnosing and treating julitis (Life science example 29, 2016)7. A method of treating a patient with julitis, the method comprising administering an effective amount of anti-TNF antibodies to a patient suffering from julitis.

6. A method of diagnosing and treating julitis in a patient, said method comprising:a. obtaining a plasma sample from a human patient;b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody; andc. diagnosing the patient with julitis when the presence of JUL-1 inthe plasma sample is detected; andd. administering an effective amount of anti-tumor necrosis factor (TNF) antibodies to the diagnosed patient.

Claim 7: The recited step of administering antibodies to a patient suffering from julitis does not recite or describe any recognized exception.Step 2A: no exception

Claim 62A: yes2B: no, since thecombination of steps a, b, notroutine and conventional; ensures accurate diagnosisand proper treatment

Thank youQuestions?

All the examples are from USPTO training materials