Short review of practices at the USPTO and the EPO. US IPR Update Seminar 10 April 2018 Hetti Palonen

Transcription

1 Short review of practices at the USPTO and the EPO US IPR Update Seminar 10 April 2018 Hetti Palonen

2 Patentability requirements USPTO 35 U.S.C. 101: Utility and subject matter eligibility Judicially Created Exceptions to 101: "laws of nature, physical phenomena, and abstract ideas." EPO 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 EPC Art 54 (4) and (5) first and further medical use A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods

3 Patentability requirements USPTO 35 U.S.C. 103: Obviousness (Inventive Step) EPO Art 56 EPC Inventive step 35 U.S.C. 112, 1st paragraph : Enablement, written description and best mode Art 83 EPC Disclosure of the invention; Sufficiency of disclosure 35 U.S.C. 112, 2nd paragraph: Definiteness Art 84 EPC Claims; clarity

4 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 Subject matter eligibility 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 Obviousness

5 Rejections at USPTO Years (a) 112(b) Lähde:

6 Examining practice in USPTO Examiners should refer to court decisions regardless of the technical field Chart of subject matter eligibility court decisions Instructions publicly available The Manual of Patent Examining Procedure, MPEP The most recent revision: the January 2018 MPEP Publication) Reference sheets, flowcharts Examples of eligible claims Lists of factors to be weighed (KSR rationals, Wands factors ) Training materials

7 Claim interpretation During patent examination, the pending claims must be given their broadest reasonable interpretation consistent 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.

8 Utility analysis Does the invention have utility? Three-pronged test is used 1. Specific, a utility that is not too general 2. Substantial a utility that defines a "real world" use 3. 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

9 Utility example: Alternative Uses Specification: The specification relates to the prevention and treatment of microbe X infection, a common infection, by administering compound A. Claims 1. 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.

10 Utility example 1: Alternative Uses Is 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.

11 Utility example 1: Alternative Uses Is 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 infection establishes the presumption that the asserted utilities have a real world 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

12 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 1 Claim 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 2 Both 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.

13 Example 2: Claim interpretation Claim 1. A martianase compound. Methylphenol group 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.

14 The Prior Art The 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: R1 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,

15 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 martianase compound 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

16 Sample Rejection Claim 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.

17 Role of preamble: Example An intended use 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 carrier would 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 From: Claim Interpretation - Intermediate Exercises: TC1600 Product-by-Process, September 2015

18 112(a): Three separate and distinct requirements 35 U.S.C 112(a) The specification shall contain a written description of the invention, and of the manner and process of making and using 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 mode contemplated by the inventor or joint inventor of carrying out the invention. 1. the written description requirement 2. the enablement requirement 3. the best mode requirement 35 U.S.C. 112(a)(2012)

19 112(a) rejections Typical in Biotechnology and Chemical engineering TC1600 Biotechnology and Organic Chemistry TC1700 Chemical and Materials Engineering Lähde: rejections-applicants-handle/id=82668/

20 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 relevant identifying 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

21 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 specification Can be provided in the body of the specification along with the figures (e.g., in words, structures, figures, diagrams, and formulas)

22 35 U.S.C 112(a) Written description Original claims may lack written description if Broad (genus) claim (e.g. claiming derivatives ) but only one/narrow species disclosed Functional 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 disclosed Correlation of structure and function is missing The core structure responsible for the function is not defined

23 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

24 35 U.S.C 112(a) written description Clarity of the Prosecution Record Any deficiencies in the disclosure should be addressed during prosecution and clearly explained in an Office action The prosecution record will provide a map for the public to understand the boundaries of the patent protection and provide clear notice of patent rights The PTAB and courts will be informed as to what the examiner and the applicant understood the claims to mean

25 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 undue experimentation? 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 claim When a compound or composition is limited by a particular use, enablement of that claim should be evaluated based on that limitation

26 35 U.S.C 112(a) Enablement Wands 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; and 8. Quantity of experimentation needed to make or use the invention based on the content of the disclosure MPEP (a) re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) Obtaining antibodies

27 35 U.S.C 112(a) Enablement Example: Peptides for Treating Obesity Specification: 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 synthesis procedures. 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.

28 35 U.S.C 112(a) Enablement Example: Peptides for Treating Obesity Claims: 1. A peptide consisting of the sequence SEQ ID NO 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

29 35 U.S.C 112(a) Enablement Peptides 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

30 35 U.S.C 112(a) Enablement Esimerkit: 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

31 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

32 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 ideas Laws of nature/natural principles, Natural phenomena, and/or Natural products.

33 Streamlined analysis Is The Claim Directed To One Of The Four Statutory Categories of 35 U.S.C. 101? 2A: Is the claim DIRECTED to a judicial exception? 2B: Does the claim as a whole amount to significantly more than the exception? MPEP

34 Streamlined example 1 1. A hip prosthesis comprising: a femoral component and an acetabular cup, wherein the acetabular cup has an inner concave surface for engaging the femoral component, and an outer convex surface for engaging a patient s acetabulum, and wherein the outer convex surface is coated with 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.

35 RAPID LITIGATION MANAGEMENT v. CELLZDIRECT, INC. Improved process for freezing cells July 5, 2016 A method of producing a desired preparation of multicryopreserved 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.

36 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 activities structure or form phenotype chemical or physical properties

37 Markedly different characteristics analysis: Examples of eligible claims (step 2A) A yogurt starter culture comprising goat milk mixed with Streptococcus thermophilus 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

38 Subject matter eligibility of method claims 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 patient Comparing gene sequences, detecting differences

39 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 nongeneric arrangement of known, conventional elements.

40 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; and c. diagnosing the patient with julitis when the presence of JUL-1 in the plasma sample is detected; and d. administering an effective amount of antitumor 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 6 2A: yes 2B: no, since the combination of steps a, b, not routine and conventional; ensures accurate diagnosis and proper treatment

41 Thank you Questions? All the examples are from USPTO training materials