1. §101 Update Moderator: Mark Flanagan, WilmerHale Peter Menell
Koret Professor of Law
Director, BCLT
Bhanu Sadasivan
McDermott Will & Emery
Michael Schallop
Van Pelt, Yi & James

2. Disclosure NOVELTY UTILITY Obviousness Subject Matter US Patent Claims
Term: 20
years from
filing
Disclosure
Obviousness
NOVELTY
UTILITY
Subject
Matter

3. SUBJECT MATTER § 101 Inventions Patentable
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.
Patent Ineligible Subject Matter
• Law of Nature
• Natural Phenomena
• Abstract Idea

4. § 101 District Court Invalidity Rulings
110
100 90 80 70 60 50
Bilski v. Kappos 40 30
Note: shift toward earlier resolution. 20 10
2007
2009
2011
2008
2010
2012

5. Patentable Subject Matter Limitations
• Law of Nature
• Natural Phenomena
• Abstract Idea
1. Patent Ineligible Subject Matter
• Rationale: Pre-emption – “patent law may not inhibit
further discovery by improperly tying up the future use” of
basic building blocks of human ingenuity; could impede
cumulative creativity.
2. Inventive Application Doctrine: To be patentable, a claim
directed to a patent ineligible concept must contain an
inventive concept sufficient to transform the patent ineligible
concept into a patent-eligible application of the concept.
Ironic that the Supreme Court stood in the way of the Federal Circuit’s Seagate and TSM/103 test, but then imposes its own complex non-textual test in Mayo/Alice. Leads one to believe that the explanation is that only the Supreme Court legislate.
• Must be more than well-understood, routine, conventional
activity already engaged in by the scientific community.
• requires “more than simply stat[ing] the [abstract idea]
while adding the words ‘apply it.’ ”

6. § 101 District Court Invalidity Rulings
110
100 90 80 70 60 50
Bilski v. Kappos 40 30
Note: shift toward earlier resolution. 20 10
2007
2009
2011
2013
2015
2017
2008
2010
2012
2014
2016

7. Disclosure NOVELTY UTILITY Obviousness Subject Matter US Patent Claims
Term: 20
years from
filing
Disclosure
Obviousness
NOVELTY
UTILITY
Subject
Matter

8. § 101 Patent Eligibility § 103 Nonobviousness
Step 2. Inventive Application Doctrine: Treat laws of nature/algorithms – even if newly discovered, as existing in the prior art.
Are “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains”?
• Is there an “inventive concept”
that is more than well-
understood, routine, or
conventional activity already
engaged in by the scientific
community.
• Analysis does not treat
laws of nature/algorithms
as existing in the prior art.

9. § 101 Patent Eligibility § 112 Scope/Preemption
Section 112 provides the tools for ensuring that patents do
not extend beyond their proper scope.
That an inventor’s claim might practically preempt
all use of a discovery will “show more clearly the great importance of his discovery,
but it will not invalidate his patent.” Dolbear v. Am. Bell Tel. Co., 126 U.S. 1, 535 (1888).
“patent law may not inhibit
further discovery by improperly tying up the future use” of basic building blocks of human ingenuity; could impede cumulative creativity.
Mayo, 566 U.S. at 85.

10. The Mayo/Alice Fallout
Bioscience Industries
Clear ineligibility of path-breaking applied discoveries
Software Industries
Vague ineligibility of abstract software-related inventions
Justice
Potter Stewart
Jacobellis v. Ohio, 378 U.S. 184 (1964) (Powell, J., concurring)
“I know it when I see it”
intermingling
§§ 101, 103, 112

11. § 101 Patentable Subject Matter:
Facts
Law
§ 101 Patentable Subject Matter:
Case Management
Interplay with § 103 Analysis
Question of Law
Timing
Early / Late(r)
Claim Construction
MSJs (§§103, 112)
Trial
12(c)
12(b)(6)
MSJ §101

12. v.
Berkheimer
1. A method of archiving an item in a computer processing system comprising:
presenting the item to a parser;
parsing the item into a plurality of multipart object structures wherein portions of
the structures have searchable information tags associated therewith;
evaluating the object structures in accordance with object structures previously stored in an archive;
presenting an evaluated object structure for manual reconciliation at least where there is a predetermined variance between the object and at least one of a predetermined standard and a user defined rule.
The district court construed “parser” as “a program that dissects and converts source code into object code” and “parsing” as using such a program. J.A. 47. It construed “evaluating the object structures in accordance with object structures previously stored in an archive” as “analyzing the plurality of multi-part object structures obtained by parsing and comparing it with object structures previously stored in the archive to determine if there is variance between the object and at least one of a predetermined standard and a user defined rule.” Id. These constructions are not challenged on appeal.

13. v.
Berkheimer
The question of whether a claim element or combination of elements is well-understood, routine and conventional to a skilled artisan in the relevant field is a question of fact
[N]ot every § 101 determination contains genuine disputes over the underlying facts material to the § 101 inquiry Whether a claim recites patent eligible subject matter is a question of law which may contain disputes over underlying facts. Patent eligibility has in many cases been resolved on motions to dismiss or summary judgment. Nothing in this decision should be viewed as casting doubt on the propriety of those cases. When there is no genuine issue of material fact regarding whether the claim element or claimed combination is well-understood, routine, conventional to a skilled artisan in the relevant field, this issue can be decided on summary judgment as a matter of law.
1. A method of archiving an item in a computer processing system comprising:
presenting the item to a parser;
parsing the item into a plurality of multipart object structures wherein portions of
the structures have searchable information tags associated therewith;
evaluating the object structures in accordance with object structures previously stored in an archive;
presenting an evaluated object structure for manual reconciliation at least where there is a predetermined variance between the object and at least one of a predetermined standard and a user defined rule.
The district court construed “parser” as “a program that dissects and converts source code into object code” and “parsing” as using such a program. J.A. 47. It construed “evaluating the object structures in accordance with object structures previously stored in an archive” as “analyzing the plurality of multi-part object structures obtained by parsing and comparing it with object structures previously stored in the archive to determine if there is variance between the object and at least one of a predetermined standard and a user defined rule.” Id. These constructions are not challenged on appeal.
Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018)

14. v.
Berkheimer
Whether a particular technology is well-understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something is disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.
The specification describes an inventive feature that stores parsed data in a purportedly unconventional manner. This eliminates redundancies, improves system efficiency, reduces storage requirements, and enables a single edit to a stored object to propagate throughout all documents linked to that object. The improvements in the specification, to the extent they are captured in the claims, create a factual dispute regarding whether the
invention describes well-understood, routine, and conventional activities.
1. A method of archiving an item in a computer processing system comprising:
presenting the item to a parser;
parsing the item into a plurality of multipart object structures wherein portions of
the structures have searchable information tags associated therewith;
evaluating the object structures in accordance with object structures previously stored in an archive;
presenting an evaluated object structure for manual reconciliation at least where there is a predetermined variance between the object and at least one of a predetermined standard and a user defined rule.
The district court construed “parser” as “a program that dissects and converts source code into object code” and “parsing” as using such a program. J.A. 47. It construed “evaluating the object structures in accordance with object structures previously stored in an archive” as “analyzing the plurality of multi-part object structures obtained by parsing and comparing it with object structures previously stored in the archive to determine if there is variance between the object and at least one of a predetermined standard and a user defined rule.” Id. These constructions are not challenged on appeal.
Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018)

15. v.
1. A data processing system for designing, creating, and importing data into, a viewable form viewable by the user of the data processing system, comprising:
(a) a form file that models the physical representation of an original paper form and establishes the calculations and rule conditions required to fill in the viewable form;
(b) a form file creation program that imports a background image from an original form, allows a user to adjust and testprint the background image and compare the alignment of the original form to the background test-print, and creates the form file;
(c) a data file containing data from a user application for populating the viewable form; and
(d) a form viewer program operating on the form file and the data file, to perform calculations, allow the user of the data processing system to review and change the data, and create viewable forms and reports.

16. v.
1. A data processing system for designing, creating, and importing data into, a viewable form viewable by the user of the data processing system, comprising:
(a) a form file that models the physical representation of an original paper form and establishes the calculations and rule conditions required to fill in the viewable form;
(b) a form file creation program that imports a background image from an original form, allows a user to adjust and testprint the background image and compare the alignment of the original form to the background test-print, and creates the form file;
(c) a data file containing data from a user application for populating the viewable form; and
(d) a form viewer program operating on the form file and the data file, to perform calculations, allow the user of the data processing system to review and change the data, and create viewable forms and reports.
The proposed second amended complaint contains allegations that at a minimum raise factual disputes underlying the § 101 analysis, such as whether the claim term “data file” constitutes an inventive concept, alone or in combination with other elements, sufficient to survive an Alice/Mayo analysis at the Rule 12(b)(6) stage
Aatrix’s proposed second amended complaint presents specific allegations directed to “improvements and problems solved by the Aatrix patented inventions.” . . .
The complaint also alleges that “[t]his invention increased the efficiencies of computers processing tax forms.” . . .
Aatrix Software, Inc. v. Green Shades Software, 882 F.3d 1121 (Fed. Cir. 2018)

17. v.
1. A data processing system for designing, creating, and importing data into, a viewable form viewable by the user of the data processing system, comprising:
(a) a form file that models the physical representation of an original paper form and establishes the calculations and rule conditions required to fill in the viewable form;
(b) a form file creation program that imports a background image from an original form, allows a user to adjust and testprint the background image and compare the alignment of the original form to the background test-print, and creates the form file;
(c) a data file containing data from a user application for populating the viewable form; and
(d) a form viewer program operating on the form file and the data file, to perform calculations, allow the user of the data processing system to review and change the data, and create viewable forms and reports.
Below, even on the motion to dismiss, Aatrix argued the district court should have held claim construction proceedings to obtain a full understanding of the claims prior to granting Green Shades’ motion to dismiss We need not decide whether it was proper on that record for the court to grant the motion to dismiss without claim construction: the need for claim construction might be apparent just from the claim terms themselves, to arrive at “a full understanding of the basic character of the claimed subject matter.
Aatrix Software, Inc. v. Green Shades Software, 882 F.3d 1121 (Fed. Cir. 2018)

18. v.
1. A data processing system for designing, creating, and importing data into, a viewable form viewable by the user of the data processing system, comprising:
(a) a form file that models the physical representation of an original paper form and establishes the calculations and rule conditions required to fill in the viewable form;
(b) a form file creation program that imports a background image from an original form, allows a user to adjust and testprint the background image and compare the alignment of the original form to the background test-print, and creates the form file;
(c) a data file containing data from a user application for populating the viewable form; and
(d) a form viewer program operating on the form file and the data file, to perform calculations, allow the user of the data processing system to review and change the data, and create viewable forms and reports.
REYNA, Circuit Judge, dissenting-in-part.
I respectfully disagree with the majority’s broad statements on the role of factual evidence in a § 101 inquiry. Our precedent is clear that the § 101 inquiry is a legal question. In a manner contrary to that standard, the majority opinion attempts to shoehorn a significant factual component into the Alice § 101 analysis.
[This approach] opens the door in both steps of the Alice inquiry for the introduction of an inexhaustible array of extrinsic evidence, such as prior art, publications, other patents, and expert opinion. Similarly, the majority opinion strongly suggests that the district court must require
claim construction The problem is that the 12(b)(6) procedure is converted into a full blown factual inquiry on the level of § 102, § 103, and § 112 inquiries. Clearly, this approach would turn the utility of the 12(b)(6) procedure on its head, in particular in the context of § 101, which is
primarily focused on the “allegations” in the patent—the claims and written description.
Aatrix Software, Inc. v. Green Shades Software, 882 F.3d 1121 (Fed. Cir. 2018)

19. v. )
Petition for
Rehearing En Banc
Berkheimer
Rejected

20. Berkheimer v. . . . I believe the law needs clarification by higher
Judge Alan Lourie
Ph.D. (Chemistry) v.
Berkheimer
. . . I believe the law needs clarification by higher
authority, perhaps by Congress, to work its way out
of what so many in the innovation field consider are
§ 101 problems
But why should there be a step two in an abstract idea analysis at all? If a method is entirely abstract, is it no less abstract because it contains an inventive step? . . .
Thinking further concerning § 101, but beyond these cases, steps that utilize natural processes, as all mechanical, chemical, and biological steps do, should be patent-eligible,
provided they meet the other tests of the statute, including novelty, nonobviousness, and written description.
The district court construed “parser” as “a program that dissects and converts source code into object code” and “parsing” as using such a program. J.A. 47. It construed “evaluating the object structures in accordance with object structures previously stored in an archive” as “analyzing the plurality of multi-part object structures obtained by parsing and comparing it with object structures previously stored in the archive to determine if there is variance between the object and at least one of a predetermined standard and a user defined rule.” Id. These constructions are not challenged on appeal.
Berkheimer v. HP Inc., 890 F.3d 1374 (Fed. Cir. 2018)
(Lourie, J., with Newman, J. concurring in denial of rehearing en banc)

21. v.
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day
The '610 patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient's genotype. The cytochrome P450 2D6 gene (“CYP2D6”) encodes an enzyme known to metabolize a large number of drugs, including iloperidone.
he '610 patent teaches “that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug[, such as iloperidone,] that is pre-disposed to cause QT2 prolongation and is metabolized by the CYP2D6 enzyme, can be accomplish[ed] more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.” Id. col. 2 ll. 15–21. QT prolongation can lead to serious cardiac problems. The '610 patent refers to patients who have lower than normal CYP2D6 activity as CYP2D6 poor metabolizers. It provides examples of dose reductions for poor metabolizers compared to the dose given to someone with a wildtype genotype.
The QT interval is the time between the Q and T waves of the heart rhythm. When corrected for the patient's heart rate it is abbreviated QTc.

22. v. The Supreme Court has cautioned that “too broad an
Judge Alan Lourie
Ph.D. (Chemistry) v.
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day
The Supreme Court has cautioned that “too broad an
interpretation of “ineligible subject matter “could
eviscerate patent law” because “all inventions at some
level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Mayo, 566 U.S. at 71. Accordingly, at step one, “it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is ‘directed to.’” Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016). If the claims are not directed to a patent ineligible concept at step one, we need not address step two of the inquiry. See Enfish, 822 F.3d at That is the case here.
The '610 patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient's genotype. The cytochrome P450 2D6 gene (“CYP2D6”) encodes an enzyme known to metabolize a large number of drugs, including iloperidone.
he '610 patent teaches “that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug[, such as iloperidone,] that is pre-disposed to cause QT2 prolongation and is metabolized by the CYP2D6 enzyme, can be accomplish[ed] more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.” Id. col. 2 ll. 15–21. QT prolongation can lead to serious cardiac problems. The '610 patent refers to patients who have lower than normal CYP2D6 activity as CYP2D6 poor metabolizers. It provides examples of dose reductions for poor metabolizers compared to the dose given to someone with a wildtype genotype.
The QT interval is the time between the Q and T waves of the heart rhythm. When corrected for the patient's heart rate it is abbreviated QTc.
Vanda Pharma. v. West-Ward Pharma. , 887 F.3d 1117 (Fed. Cir. 2018)

23. v.
This case, however, is not Mayo. First, the claims in Mayo were not directed to a novel method of treating a disease. Instead, the claims were directed to a diagnostic method based on the “relationships between concentrations of
certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” Id. This “relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.” Id.
Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed to the application of a drug to treat a particular disease. See id. at 74, 87. Importantly, the Supreme Court explained that the administering step was akin to a limitation that tells engineers to apply a known natural relationship or to apply an abstract idea with computers. See id. at 78 (comparing the claim in Mayo to “Einstein telling linear accelerator operators
about his basic law and then trusting them to use it where relevant”).
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day
The '610 patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient's genotype. The cytochrome P450 2D6 gene (“CYP2D6”) encodes an enzyme known to metabolize a large number of drugs, including iloperidone.
he '610 patent teaches “that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug[, such as iloperidone,] that is pre-disposed to cause QT2 prolongation and is metabolized by the CYP2D6 enzyme, can be accomplish[ed] more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.” Id. col. 2 ll. 15–21. QT prolongation can lead to serious cardiac problems. The '610 patent refers to patients who have lower than normal CYP2D6 activity as CYP2D6 poor metabolizers. It provides examples of dose reductions for poor metabolizers compared to the dose given to someone with a wildtype genotype.
The QT interval is the time between the Q and T waves of the heart rhythm. When corrected for the patient's heart rate it is abbreviated QTc.
Vanda Pharma. v. West-Ward Pharma. , 887 F.3d 1117 (Fed. Cir. 2018)

24. PROST, Chief Judge, dissenting. v.
Chief Judge
Sharon Prost
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day
PROST, Chief Judge, dissenting.
I would find the asserted patent claims to be
directed to a law of nature. The majority finds the claims herein
are not directed to a natural law at step one of the § 101
analysis, but its efforts to distinguish Mayo cannot withstand
scrutiny
. . . This is no more than an optimization of an existing treatment of schizophrenia, just as the claims in Mayo concerned “optimizing therapeutic efficacy” of thiopurine drugs. Mayo warned against “drafting effort[s] designed to monopolize the law of nature itself.” 566 U.S. at 77. The majority does not heed
that warning.
The '610 patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient's genotype. The cytochrome P450 2D6 gene (“CYP2D6”) encodes an enzyme known to metabolize a large number of drugs, including iloperidone.
he '610 patent teaches “that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug[, such as iloperidone,] that is pre-disposed to cause QT2 prolongation and is metabolized by the CYP2D6 enzyme, can be accomplish[ed] more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.” Id. col. 2 ll. 15–21. QT prolongation can lead to serious cardiac problems. The '610 patent refers to patients who have lower than normal CYP2D6 activity as CYP2D6 poor metabolizers. It provides examples of dose reductions for poor metabolizers compared to the dose given to someone with a wildtype genotype.
The QT interval is the time between the Q and T waves of the heart rhythm. When corrected for the patient's heart rate it is abbreviated QTc.
Vanda Pharma. v. West-Ward Pharma. , 887 F.3d 1140 (Fed. Cir. 2018)

25. PROST, Chief Judge, dissenting. v.
Chief Judge
Sharon Prost
A method for treating a patient with iloperidone, wherein the patient is suffering from schizophrenia, the method comprising the steps of:
determining whether the patient is a CYP2D6 poor metabolizer by:
obtaining or having obtained a biological sample from the patient;
and
performing or having performed a genotyping assay on the biological sample to determine if the patient has a CYP2D6 poor metabolizer genotype; and
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day,
wherein a risk of QTc prolongation for a patient having a CYP2D6 poor metabolizer genotype is lower following the internal administration of 12 mg/day or less than it would be if the iloperidone were administered in an amount of greater than 12 mg/day, up to 24 mg/day
PROST, Chief Judge, dissenting.
I would find the asserted patent claims to be
directed to a law of nature. The majority finds the claims herein
are not directed to a natural law at step one of the § 101
analysis, but its efforts to distinguish Mayo cannot withstand
scrutiny
. . . This is no more than an optimization of an existing treatment of schizophrenia, just as the claims in Mayo concerned “optimizing therapeutic efficacy” of thiopurine drugs. Mayo warned against “drafting effort[s] designed to monopolize the law of nature itself.” 566 U.S. at 77. The majority does not heed
that warning.
The '610 patent relates to a method of treating schizophrenia patients with iloperidone wherein the dosage range is based on the patient's genotype. The cytochrome P450 2D6 gene (“CYP2D6”) encodes an enzyme known to metabolize a large number of drugs, including iloperidone.
he '610 patent teaches “that treatment of a patient, who has lower CYP2D6 activity than a normal person, with a drug[, such as iloperidone,] that is pre-disposed to cause QT2 prolongation and is metabolized by the CYP2D6 enzyme, can be accomplish[ed] more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity.” Id. col. 2 ll. 15–21. QT prolongation can lead to serious cardiac problems. The '610 patent refers to patients who have lower than normal CYP2D6 activity as CYP2D6 poor metabolizers. It provides examples of dose reductions for poor metabolizers compared to the dose given to someone with a wildtype genotype.
The QT interval is the time between the Q and T waves of the heart rhythm. When corrected for the patient's heart rate it is abbreviated QTc.
Vanda Pharma. v. West-Ward Pharma. , 887 F.3d 1140 (Fed. Cir. 2018)

26. Treatment v. Diagnostic claim Dichotomy
Treatment claims found patent eligible
Vanda v Westward (Fed. Cir. Apr. 13, 2018)
Pernix v. Alvogen (D. Del. June 8, 2018)
Bayer v. Biogen (D.N.J. Sept. 28, 2018)
Diagnostic claims found patent ineligible
Roche v. Cepheid (Fed. Cir. Oct. 9, 2018)
Genetic Veterinary v. LABOklin (E.D. Va May 14, 2018)
Athena v. Mayo (D. Mass. Aug. 4, 2017) (currently on appeal)

27. Treatment v. Diagnostic claim Dichotomy
Pernix v. Alvogen (D. Del. June 8, 2018)
A method of treating pain in a patient having mild or moderate hepatic impairment, the method comprising:
administering to the patient having mild or moderate hepatic impairment a starting dose of an oral dosage unit having hydrocodone bitartrate as the only active ingredient,
wherein the dosage unit comprises an extended release formulation of hydrocodone bitartrate, and wherein the starting dose is not adjusted relative to a patient without hepatic impairment.

28. Treatment v. Diagnostic claim Dichotomy
Pernix v. Alvogen (D. Del. June 8, 2018)
“Although the inventions recited in those claims were based upon a natural law—the physiological response to hydrocodone in individuals with or without mild or moderate hepatic impairment—the claims do more than merely report those physiological responses. Rather, like the claim discussed in Vanda, the claims asserted in this case describe a specific dosing regimen to treat a specific condition based on the patient’s medical status.”

29. Treatment v. Diagnostic claim Dichotomy
Pernix v. Alvogen (D. Del. June 8, 2018)
“the Court does not adopt, a per se rule that all method of treatment claims satisfy section In this case, as in Vanda, the invention is a ‘new way of using an existing drug’ . . ., i.e., by treating a special subpopulation of patients with a limited genus of formations of a particular pharmaceutical.”

30. Treatment v. Diagnostic claim Dichotomy
Bayer v. Biogen (D.N.J. Sept. 28, 2018)
A method for immunomodulation or treating a viral conditions, a viral disease, cancers or tumors comprising the step of administering to a patient in need of such treatment a therapeutically effective amount of a composition comprising:
a recombinant polypeptide produced by a non-human host transformed by a recombinant DNA molecule comprising a DNA sequence selected from the group consisting of:
(a) DNA sequences and which code for a polypeptide displaying antiviral activity, and
(b) DNA sequences which are degenerate as a result of the genetic code to the DNA sequences defined in (a); said DNA sequence being operatively linked to an expression control sequence in the recombinant DNA molecule.

31. Treatment v. Diagnostic claim Dichotomy
Bayer v. Biogen (D.N.J. Sept. 28, 2018)
The Court construed claim 1 as reciting a “one-step method of ‘administering’ to a patient in need the specified recombinant HuIFN-β.”
“Here, the claims at issue are method of treatment claims, not claims to DNA or polypeptides. Moreover, no reasonable jury could conclude that the recombinant protein administered in the claimed method is identical to the protein found in nature.”

32. Treatment v. Diagnostic claim Dichotomy
Roche v. Cepheid (Fed. Cir. Oct. 9, 2018)
A method for detecting Mycobacterium tuberculosis in a biological sample suspected of containing M. tuberculosis comprising:
(a) subjecting DNA from the biological sample to polymerase chain reaction [PCR] using [certain primers]; and
(b) detecting the presence or absence of an amplification product, wherein the presence of an amplification product is indicative of the presence of M. tuberculosis in the biological sample and wherein the absence of the amplification product is indicative of the absence of M. tuberculosis in the biological sample.

33. Treatment v. Diagnostic claim Dichotomy
Roche v. Cepheid (Fed. Cir. 2018)
“the method claims are directed to a relationship between the eleven naturally occurring position specific signature nucleotides and the presence of MTB in a sample This relationship is a phenomenon that exists in nature apart from any human action . . .”
“In contrast [to Vanda], Roche’s method claims are not directed to a method of treatment. Every time an investigator practices Roche’s claimed invention she is simply rediscovering a preexisting natural phenomenon.”

34. Treatment v. Diagnostic claim Dichotomy
Genetic Veterinary v. LABOklin (E.D. Va. May 14, 2018)
An in vitro method for genotyping a Labrador Retriever comprising:
a) Obtaining a biological sample from the Labrador Retriever;
b) Genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO:1 and
c) Detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO:2.

35. Treatment v. Diagnostic claim Dichotomy
Genetic Veterinary v. LABOklin (E.D. Va. May 14, 2018)
“Vanda is distinguishable from this case because the ‘114 Patent does not claim a method of applying the discovery– the presence [of] a point mutation in the SUV39H2—to a new method of treating Labrador Retrievers.”
“Claim 1 amounts to nothing more than ‘observing or identifying’ the natural phenomenon of a mutation in the SUV39H2 gene.”

36. Treatment v. Diagnostic claim Dichotomy
Athena v. Mayo (D. Mass. Aug. 4, 2017)
A method for diagnosing neurotransmission or developmental disorders related to muscle specific tyrosine kinase (MuSK) in a mammal comprising the step of detecting in a bodily fluid of said mammal autoantibodies to an epitope of muscle specific tyrosine kinase (MuSK).
7. A method according to claim 1, comprising contacting MuSK or an epitope or antigen determinant thereof having a suitable label thereon with said bodily fluid, immununoprecipitating And monitoring for said label, wherein the presence of said label indicative of said mammal is suffering from said [MuSK] disorder.

37. Treatment v. Diagnostic claim Dichotomy
Athena v. Mayo (D. Mass. Aug. 4, 2017)
“Although the patented method uses man-made 125I-MuSK, the use of man-made complex does not transform the subject matter of the patent.”
“what is new and useful here is the discovery that some patients with Myasthenia Gravis have MuSK autoantibodies in their bodily fluid.”
“Plaintiffs’ method seeks to measure autoantibodies that have attached to a receptor protein, an interaction which is a [] natural process.”
On appeal; oral arguments heard on October 4, 2018.

38. §101 District Court Invalidity Decisions 2017 vs. Post-Berkheimer60
Grant
Deny 55
Deny 50 45 40
Grant 35 30 25 20
Partial
Partial 15 10 5
2017
Post-Berkheimer

39. * Post-Berkheimer Year-to-Date
§101 District Court Invalidity Decisions 2017 vs. post-Berkheimer by district 40 35
Partial 30 25
Partial
Deny 20
Deny
Grant 15 10 5
Grant
2017
2018*
2017
2018*
2017
2018*
2017
2018*
D Del
ED Tex
ND Cal
CD Cal
* Post-Berkheimer Year-to-Date

40. Percentage of Grants and Partial Grants of §101 Motions
*Through November 25, 2018

41. Why Have Dismissal Rates Not Plummeted Following Berkheimer?
The Berkheimer court stated that it was not overruling precedent that patent ineligibility can be determined at the pleading stage
Berkheimer v. HP Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018)
“Patent eligibility has in many cases been resolved on motions to dismiss or summary judgment.  Nothing in this decision should be viewed as casting doubt on the propriety of those cases.” 
Federal Circuit decisions immediately following Berkheimer affirmed Rule 12 dismissals on § 101 grounds
SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161 (Fed. Cir. 2018)
(affirming § 101 ineligibility under Rule 12(c))
Voter Verified, Inc. v. Election Sys. & Software LLC, 887 F.3d 1376 (Fed. Cir. 2018)
(affirming § 101 ineligibility under Rule 12(b)(6))

42. Why Have Dismissal Rates Not Plummeted Following Berkheimer?
For Alice Step 2, improvements or non-conventional components described in the specification, even if pleaded in the complaint, may create a fact issue:
• only if they are “captured in the claims”
Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018);
Distefano Patent Trust III, LLC v. LinkedIn Corp., No LPS-CJB (D. Del. Sept. 28, 2018) (“To save a patent at step two [of Alice], an inventive concept must be evident in the claims.”)

43. Why Have Dismissal Rates Not Plummeted Following Berkheimer?
For Alice Step 2, improvements or non-conventional components described in the specification, even if pleaded in the complaint, may create a fact issue:
• only if they are “captured in the claims”
• only if they are different from the abstract idea or
ineligible concept to which the claims are directed
BSG Tech LLC v. Buyseasons, Inc., 899 F.3d 1281, 1290 (“a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept”);
Maxell, Ltd. v. Fandango Media, LLC,  CV AG (C.D. Cal. Sept. 11, 2018) (granting motion for judgment on the pleadings under § 101 where only “unconventional” limitation in claims was abstract idea of “control information”)

44. Avoiding Dismissal On The Pleadings: More Detailed Complaint
Recite factual allegations in the complaint to show that the invention is unconventional:
• Recite descriptions from the specification of technological
improvements
Visual Effect Innovations, LLC v. Sony Electronics Inc., No LPS (Sept. 30, 2018) (in denying motion to dismiss under § 101, court stated that it “has no basis not to take these factual representations” about unconventional and innovative nature of claims “as true at this stage”)
• Plead how the claims are different from conventional/prior
art approaches
Nike, Inc. v. Puma North A., Inc., No LTS (D. Mass. Oct. 10, 2018) (denying dismissal under § 101 where “[b]oth the complaint and the patents themselves identify ways in which the inventions improved upon the conventional methods of manufacturing shoes”)

45. Avoiding Dismissal on the Pleadings: Claim Construction/Judicial Notice
• Propose claim constructions that embed unconventional
components or solutions into the claims
• Ask the Court to take judicial notice of patents and printed
publications that show disparate approaches in the prior art,
such as the patent’s file history.
Cywee Group, Ltd. v LG Electronics, Inc., 17-cv BEN-RBB
(S.D. Cal. June 15, 2018)

46. [Bases for Rejection:] Available to court at 12(b)(6) stage
MEMORANDUM
[A]n examiner should conclude that an element (or combination of elements) represents well-understood, routine, conventional activity only when the examiner can readily conclude that the element(s) is widely prevalent or in common use in the relevant industry.
[Bases for Rejection:]
Available to court at 12(b)(6) stage
1. [E]xpress statement in the specification or to a statement made by an applicant during prosecution . . .
2. A citation to one or more of the court decisions noting the well-understood, routine, conventional nature of the additional element(s).
So when can you conclude that a claim element is well-understood, routine, conventional?
Can take judicial notice of file wrapper components; specification; treatises; . . .
3. A citation to a . . .book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. . .
4. A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). This option should be used only when the examiner is certain, based upon his or her personal knowledge . . .

47. PTO § 101 Trends
Source:

48. PTO § 101 Guidance Documents
Source:

49. PTO § 101 Guidance Documents
Source:

50. PTO § 101 Guidance Documents
Source:

51. PTO § 101 Guidance Documents
Source:

52. Ex Parte Barous, 10397778 (PTAB Apr
Ex Parte Barous, (PTAB Apr. 25, 2014) (TC 3600) (reversing rejections)

53. METHOD FOR NODE RANKING IN A LINKED DATABASE

54. ELECTRONIC MAIL SYSTEM WITH RF COMMUNICATIONS TO MOBILE PROCESSORS

55. METHOD AND APPARATUS FOR CORRELATION-SENSITIVE ADAPTIVE SEQUENCE DETECTION
Assignee: Carnegie Mellon University

56. METHODS AND COMPOSITIONS FOR RNA-DIRECTED TARGET DNA MODIFICATION AND FOR RNA-DIRECTED MODULATION OF TRANSCRIPTION

57. FINDING RELATIVES IN A DATABASE
Assignee: 23 and Me

58. Trying a § 101 Defense to a Jury
6.6 Eligibility
ZTE contends that the elements of the following claims describe activities and/or components that were well understood to a person of ordinary skill in the art at the time of the priority dates [of the pertinent patent claims]. You must decide if the elements in each of these claims taken individually or as a combination involve well-understood, routine, and conventional activity previously engaged in by researchers in the field, or well-understood, routine, and conventional or components previously known to the industry. Whether a particular technology was well-understood, routine, and conventional goes beyond what was simply known in the prior art. The mere fact that something was disclosed in a piece of prior art, for example, does not mean it was well-understood, routine, and conventional.
Conjunctive? “well-understood, routine, and conventional”
- something that is routine/conventional likely to be well-understood; but things that are well-understood might not be routine/conventional?
Maxell, Ltd. v. ZTE USA, Inc., No. 16-cv RWS (E.D. Tex. June 29, 2018)

59. Trying a § 101 Defense to a Jury
What should the verdict form ask?
Conjunctive? “well-understood, routine, and conventional”
- something that is routine/conventional likely to be well-understood; but things that are well-understood might not be routine/conventional?
Maxell, Ltd. v. ZTE USA, Inc., No. 16-cv RWS (E.D. Tex. June 29, 2018)