American Intellectual Property Law Association
Alice Sat on Prometheus and Met Dolly the Sheep
Who Said Baaaaaahhhh to Myriad
or
Myriad and the Aftermath of the USPTO Guidelines
Mercedes K. Meyer, Ph.D.
Japan Practice Committee
Washington, D.C.
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October 22, 2014
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The Talk
• How did we get here?
– Timelines & History
• Where are we now?
– Method claims after
Prometheus and Myriad
– Myriad Guidelines Flux
• Thoughts & Strategies
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Timeline
10/17/90
MCK announces
genetic linkage to
breast/ovarian cancer
on chr. 17
1/5/2001
Utility Guidelines
issued by USPTO
1988
Aug. 1994
Search for genetic
BRCA1 discovered by
basis for breast /
Mark Skolnick at
ovarian cancer starts
Myriad
5/12/09
NYDC strikes down Myriad
patents for ineligible subject
matter
2006
Labcorp
Cert dismissed as
improvidently granted
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7/29/11
Fed. Cir.
Reverses Dist.
Ct.
10/8/09
HHS SACGHS Report
On Gene Patents &
Licensing Practices
Dec. 1995
BRCA2 sequence
published by UK, M.
Stratton
Mar. 1996
Myriad publishes paper
indicating Stratton’s
1980
gene of BRCA2 is
Diamond v. Chakrabarty
1997/1998
incomplete
BRCA1/BRCA
1994
st
2 patents
1 BRCA1 patent by U.
granted
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Utah, NI Env.
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Sci. & Myriad
1995
1st BRCA2 patent
filed by U. Utah
1982
Patent for
human Growth
Hormone cDNA
issues to UC
3/26/12
Supremes remand in
view of Prometheus v.
Mayo #2
2011
Classen
remanded in
view of Bilski
4/15/13
Supremes hear
Myriad #2
7/20/12
Fed. Cir. Orders oral
arguments
6/13/13
Myriad - genes not
patentable subject
matter; 9-0
J. Thomas
8/16/12
Fed. Cir. Decide Myriad #2
3/4/14
3/20/12
USPTO issues
Prometheus
Myriad
decided
Guidelines
9-0, J. Breyer
11/30/12
Supremes grant
cert #2
9/16/11
AIA passed; SS. 27 & 33
6/16/12
Results to have been
published as
mandated by statute
S.27; still MIA
USPTO Town Hall
5/9/2014 - Myriad
5/8/2014
In re Roslin Institute
(CAFC)
6/19/2014
Alice Corp. v.
CLS Bank
6/2/14
Akamai
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Eligibility History
• 1952 Patent Act - added “methods or process” v. “art”
– “The legislative history indicates that Congress intended ‘anything under
the sun that is made by man’ to be eligible for patenting.”
• Utility Guidelines, 66 Fed. Reg. 1093 citing to S. Rep. No. 1979 82d Cong., 2d Sess., 5
(1952); H.R. Rep. No. 1923, 82 Cong., 2s Sess., 6 (1952)
• TRIPS - allows member countries to exclude subject matter – Art. 27,
see, e.g., EPC 52(2)
• AIA - excludes tax strategies and human organisms – §§ 14 & 33
respectively
• Eligibility ≠ Utility
• Compounds – an arrangement of atoms is a composition of matter
– The compound could not be found in nature and was not previously
synthesized - Schering Corp. v. Gilbert (2nd Cir. 1946)
• Isotopes and atoms – not eligible; Compound stability does not provide eligibility
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– In re
Breslow (CCPA 1980)
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Judge Rich’s Worst Nightmare
• 1941 Roosevelt Commission – “One of the greatest
technical weaknesses of the patent system is the lack of a
definitive yardstick as to what is invention…”
• Judge Rich – “…the so-called standard of invention…is
an unmeasurable quantity having different meanings
for different persons. It left every judge practically scottfree to decide this often controlling factor according to his
personal philosophy of what inventions should be patented,
whether or not he had any competence to do so or any
knowledge or the patent system as an operative
socioeconomic force. This was too great a freedom
because it involved national policy which should be
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declared by Congress, not by individual judges or even
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groups of judges on multiple-judge courts.”
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Legislative Reminder
• 35 USC §100
– When used in this title unless the context otherwise indicates—
– (a)The term “invention” means invention or discovery.
– (b)The term “process” means process, art or method, and includes a new
use of a known process, machine, manufacture, composition of matter, or
material.
• 35 USC §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.
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• 1952 Patent Act added S. 101.
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Legislative History: House Report 82-1923
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Approved Drugs By Year
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http://www.patentdocs.org/2014/10/sherry-knowles-addresses-real-world-impact-of-myriad-mayo-guidance-at-bio-symposium.html
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USPTO §101 Statistics
• Depends On The Art Unit:
– Art 3621 (transportation): 1602 P / 2050 Abn / 1319 P
25% 101
– Art 2191 (computer architecture & software): 3222 P /
1097 Abn / 695 P 50% 101
– Art 2198 (computer architecture & software): 938 P / 233
Abn / 821 P 60.3% 101
– 1630’s – (biotech) more abandoned than patented
• Art 1631: 2110 P/ 3833 Abn / 1899 P 36%
– 1670’s
– (diagnostics) more patented than abandoned
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(~x2) More pending than patented (~x4)
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What to do going forward?
• Do I argue?
• How do I argue
• What do I argue?
– Structure?
CONFLATING §101
§102
• Do I delay, hoping this
will all just go away?
• How do I write an
application now?
• Do I delay writing an
application?
• Can we
sue?
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grounds?
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§103
§101
Preemption or §112
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What to do……
Do NOT stop claiming
compositions derived from
nature based on the
Guidelines. The Guidelines
DO NOT have the force of law
• Craft with pre-emption in
mind – targeted crafting not
narrow crafting
• Demonstrate novelty and
nonobviousness
• Go Case – by – Case &
Fact – by – Fact
• Delay & Laches?
– 18Firm
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month Rules of
Thumb
– Appeal = 2 yrs
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CONFLATING §101
§102
§103
§101
Preemption or §112
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Eligible Compositions?
• Modified bacteria – Myriad, Slip Op. 12.
– Would include eukaryotic organisms and transgenic animals
– Chakrabarty & Animal League Defense Fund
• Transgenic Plants & Animals, but caution on clones?
– Chakrabarty & Animal League presumably would find this eligible
– BUT would the Harvard mouse patent be so broad to hit a pre-emptive
button?
• Animal Cultured Cells
– Generally immortalized, lack heterogeneity, and may dedifferentiate
– Limited to biological deposit
• Stem cells
– Immortalized and biological deposit (Bergy)
– BUT….Product by process – you do not have the benefit of the process
• Eukaryotic cDNA
– notFirm
naturally
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alone insufficient to make it eligible
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Eligible Compositions? – cont’d
• Antisense RNA
– a ssRNA mirroring an mRNA, therefore not natural
• siRNA
– dsRNA
– Generally chemically modified
• Modified Proteins/DNA
– Non-natural amino acids, pegylation, addition of chemical moieties
– Lack of glycosylation by production in another cell line
• Fusion proteins
– Humanized antibodies and other modified forms
– Chimeric protein drugs
• Semi-synthetic modification of natural compounds – See Ex.
B, claim 2
• But, what about: Protein Fragments of natural proteins??
Firm
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– Look
at Bergy
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Eligible??
• Protein Fragments of natural proteins??
– Antibody fragments, hormones
– Not naturally occurring fragments in the quantities obtained
• Biofuel mixtures, industrial greases
– See Exxon Chemical (1995)
• Isolated, naturally occurring enzymes, proteins made
synthetically, oils, and chemicals?
– Purified oils - Bergy and Parke Davis
– Mixtures – Exxon
– Proteins lacking post-translational modification or having non-natural modifications
• DNA – non-methylated
– What about? Introns, microsatellite DNAs, polymorphisms linked to altered states,
methylation patterns
– An unmodified cDNA of a polycistronic organism lacking introns (e.g., some
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restriction
enzymes)
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Dolly the Sheep said Baaaaahhh
In re Roslin Inst., 110 USPQ2d 1668 (Fed. Cir. 2014)
• In re Roslin Inst., 110 USPQ2d 1668 (Fed. Cir. 2014)
– Dolly the sheep is not patent eligible because a “cloned
farm animal is exact genetic replica of another animal
and does not possess ‘markedly different
characteristics’ from any farm animals found in nature.”
– Some cloned mammals, including Dolly, have shorter telomeres than other
animals of the same age. Telomeres are pieces of DNA that protect the
ends of chromosomes. They shorten as cells divide and are therefore
considered a measure of ageing in cells. New Scientist 17: 56 14 Feb.
2003
– Dolly was not quite a clone because the mitochondrial DNA came from the
oocyte and not from the somatic cell. Schon, E.A. et al. Mitochondrial DNA
genotypes in nuclear transfer-derived cloned sheep, Nature Genetics 23:
90 - 93 (1999).
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….Is it a case of poor claiming?
Dolly is clearly created by the hand of man….but……
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Judicially created exceptions: abstract idea, laws of nature, natural
phenomenon – Diamond v. Diehr, 450 US, 185 (1981)
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Dolly would be a new exception?
Would a product by process claim be better?
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Claim 155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the
mammal is selected from cattle, sheep, pigs, and goats.
Claim 164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.
The process claims were not in question
Why require features such as mitochondrial DNA, shortened telomeres, and
phenotypic DNA differences when they are
inherent to the product?
• Doesn’t the outcome try to conflate the legal
doctrine of inherent anticipation with eligibility?
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Myriad DNA Claims
USPN 5,747,282
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Claim 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide
having the amino acid sequence set forth in SEQ ID NO:2.
–
•
Claim 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide
sequence set forth in SEQ ID NO:1.
–
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INELIGIBLE
Claim 6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.
–
•
ELIGIBLE
Claim 5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
–
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INELIGIBLE
PROBABLY INELIGIBLE – Because primers / probes may be exon only DNA
Claim 7. An isolated DNA selected from the group consisting of:
– (a) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having T at
nucleotide position 4056;
– (b) a DNA having the nucleotide sequence set forth in SEQ ID NO:1 having an extra
C at nucleotide position 5385;
– (c) a DNA having the nucleotide sequence set forth in SEQ ID NO: 1 having G at
nucleotide position 5443; and, (d) a DNA having the nucleotide sequence set forth in
SEQ ID NO:1 having 11 base pairs at nucleotide positions 189-199 deleted.
– PROBABLY ELIGIBLE
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• Don’t claims 5&6 violate 35 USC 112, P4?
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Akamai Killed? Diagnostic Hopes
• Divided infringement - A
patent claim is a description
of the invention in one
sentence
• Decided June 2, 2014
– High tech won their position
• How do you write a claim that
is patentable and enforceable
and only acted upon by one
actor?
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Writing & Prosecuting
• Perhaps demonstrate how difficult it is to obtain the compound /
composition from nature in the specification
– Maple syrup – Quebecol is in the syrup but not the raw sap, but what
about an ethanol extract with 42 different compounds? Exxon
– Do it in prosecution or in the specification
• Perhaps demonstrate that the compounds is produced
synthetically and the synthetic form perhaps acts differently
– Biologic activity, half-life, etc. in the specification or via Dec
– Argue the adrenalin and aspirin cases
• Address the Steps:
–
–
–
–
Factors A/G - Modify the compound – structure change
Factors B/H - Have claim limitations that introduce field pre-emptions
Factor H – Have claim limitations that reduce generality of the claim
Example D – demonstrate that the mixture of known materials
produces a synergy or feature not present in each individually
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• 101 Declaration?
– if the Examiner can use post-filing evidence,
then so can applicant presumably
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Change of Practice - PROFANITY
• The Guidelines do not have the rule and effect of
LAW
– DO NOT change licensing, freedom to operate,
PGR/IPR practice, litigation practice / strategy
without making sure whether you have case law
to support your position
• New Patent Profanity When Writing Specs
– BAD WORDS IN SPEC: routine, conventional,
well-understood, well known
– BAD WORDS IN CLAIMS: analyze, compare,
determine
– BAD WORDS IN PROSECUTION: Any of the
above
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Method Claiming Solutions?
• Claim the method at least independently in a picture claim
– You will avoid written description and enablement issues in the
US and globally
– Novozymes A/S v. DuPont Nutrition Biosciences APS (Fed. Cir.
2013)
• Limit the method to steps taken by one actor
– Akamai issue
• Recite a step applying the information obtained by the method
or transforming a material to something non-naturally occurring
• If it has a device involved, it may be better?
– See P.E. Sharpless and the Roquefort cream cheese – process
patentable!
• Trade secrecy is not an option if global patenting is sought – a
TRIPS
problem
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– PPH won’t save you either for fast tracking
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Will the Myriad Guidance Hold Up?
• Revisions have been promised….
• Final Bulletin for Agency Good Guidance Practices, Bulletin No.
07-02
– No notice for a comment period or public participation on the final Myriad
Guidance
– Significant Guidance Document
• Lead to an annual effect on the economy of $100M or more, OR
• Create serious inconsistencies with actions by other agencies, OR
• Materially alter budgetary impact of entitlements, grants, or the rights of recipients thereof
– Under § IV, after the agency prepares a draft of an economically significant
guidance document, the agency must publish a notice in the Federal Register
announcing that the draft guidance document is available for comment. OMB
Bulletin No. 07-02, p. 16
– OMB approved this, but it is not published in the Federal Register
– No rule or effect of law, THEREFORE cite cases that disagree with the USPTO
position (but not the Supreme Court) in office actions
– Appears to contradict the Utility Guidelines (2001) which are still effective?
– Contradicts the Legislative History of the 1952 Patent Act, see comments for
Utility
Guidelines
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I am Not Your Lawyer
• 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 and practice. These
materials reflect only the personal views of the speakers and are not
individualized legal advice. It is understood that each case is factspecific, and that the appropriate solution in any case will vary.
Therefore, these materials may or may not be relevant to any particular
situation. Thus, Drinker Biddle & Reath LLP, and the speakers cannot
be bound either philosophically or a representative 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 the speakers and members of
the firm or anyone else. 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.
• And, nothing
represents the views of any sentient life form on the earth
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or universe, or any parallel universe, alive or dead, fictitious or real!
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This is for entertainment purposes only.
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Thanks for your attention! Questions?
Mercedes K. Meyer, Ph.D.
Partner
Drinker, Biddle & Reath LLP
Washington, DC 20005
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202.842.8821
Mercedes.Meyer@dbr.com
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Extra Stuff
American Intellectual Property Law Association
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Case Materials
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Akamai Technologies Inc. v. Limelight Networks Inc. ,692 F.3d 1301 (Fed. Cir. 2013); Limelight Networks, Inc. v. Akamai Techs., Inc., Slip Op. 12-786 (Jun. 2,
2014)
American Fruit Growers, Inc. v. Brogdex. Co., 283 US 1 (1931) [aka Borax-impregnated Orange case]
American Wood Paper Co. v. Fiber Disintegrating Co., 90 U.S. 566 (1874)
Amgen Inc. v. Hoechst Marion Roussel, Inc. 314 F.3d 1313 (CAFC. 2003)
Animal Legal Def. Fund v. Quigg, 932 F.2d 920 (CAFC 1991)
Ariosa Diagnostics, Inc. v. Sequenom, Inc. 2013 U.S. Dist. LEXIS 156554 (N.D. Cal. 2013)
Ariosa Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296 (Fed. Cir. 2013)
Association for Molecular Pathology v. Myriad Genetics Inc., 133 S.Ct. 2107 (2013)
Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (CAFC 2011)
Benjamin Menu Card v. Rand, McNally & Co., 210 F. 285 (N.D. Ill. 1894)
In re Bergy, 563 F.2d 1031 (CCPA 1977), remanded sub. nom., Parker v. Bergy, 438 US 902, (1978), on remand, 596 F.2d 952 (CCPA 1979), aff’d sub. nom.
Diamond v. Chakrabarty, 447 U.S. 303 (1980)
Bilski v. Kappos, 130 S.Ct. 3218 (2010)
In re: BRCA1—and BRCA2—Based Hereditary Cancer Test Patent Litigation, MDL No. 2510, 2014 U.S. Dist. LEXIS 27312 (Feb. 28, 2014)
In re Breslow, 616 F.2d 516 (CCPA 1980)
Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (CAFC 2011)
CLS Bank Int’l v. Alice Corp. Pty Ltd., 717 F.3d 1269 (Fed. Cir. 2013) (en banc)
Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293 (1884)
In re Comiskey, 499 F.3d 1365 (CAFC 2007)
Diamond v. Chakrabarty, 447 U.S. 303 (1980)
Diamond v. Diehr, 450 U.S. 175 (1981)
Digitech Image Techs., LLC v. Sigma Corp., 2013 U.S. Dist. LEXIS 107893 (C.D. Cal. July 31, 2013)
Digitech Image Techs., LLC v. Pentax Ricoh Imaging Co., Ltd., 2013 U.S. Dist. LEXIS 107900 (C.D. Cal. July 31, 2013)
Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 2013 U.S. Dist. LEXIS 108008 (C.D. Cal. July 31, 2013)
Digitech Image Techs., LLC v. Fujifilm Corp., 2013 U.S. Dist. LEXIS 108007 (C.D. Cal. July 31, 2013)
Digitech Image Techs., LLC v. Konica Minolta Holdings, Inc., 2013 U.S. Dist. LEXIS 108010, July 31, 2013 (C.D. Cal. July 31, 2013)
Dolbear v. American Bell Telephone Company, 126 U.S. 1 (1888)
Exxon Chemical Patents Inc. v. Lubrizol Corp., 64 F.3d 1553 (CAFC 1995), reh’g denied, suggestion for reh’g in banc declined, 77 F.3d 450, (CAFC 1995),
cert. denied, 518 U.S. 1020 (1996), further appeal, 137 F.3d 1475 (CAFC 1998), cert. denied, 525 U.S. 877 (1998)
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Case Materials (cont’d)
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Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)
Ex parte Hibberd, 227 USPQ 443 (BPAI 1985)
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J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001)
In re Kratz, 592 F.2d 1169 (CCPA 1979)
Kuehmsted v. Farbenfabriken of Elberfeld , 179 F. 701 (7th Cir. 1910), cert denied , 31 S.Ct. 724 (1911)
Labcorp. v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006)
Ex parte Latimer, 1889 Comm’n Dec. 13 (1889)
In re Mancy, 499 F.2d 1289 (CCPA 1974)
Markman v. Westview Instruments, Inc., 517 US 370 (1996)
Mayo Collaborative Services, DBA v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)
Morton v. New York Eye Infirmary, 17 F. Case 879 (SDNY 1862)
In re Merz, 97 F.2d 599 (CCPA 1938)
Novozymes A/S v. DuPont Nutrition Biosciences APS , 723 F.3d 1336 (Fed. Cir. 2013)
Oleksy v. General Electric, 2013 U.S. Dist. LEXIS 89351 (N.D. Ill. 2013)
O’Reilly v. Morse, 56 U.S. (15 How.) 62 (1854)
Parker v. Flook, 437 U.S. 584 (1978)
Parke-Davis & Co. v. H.K. Mulford & Co., 196 F. 496 (2nd Cir. 1911)
PerkinElmer, Inc. v. Intema Limited, 105 USPQ2d 1960 (CAFC 2012) (nonprecedential)
P.E. Sharpless Co. v. Crawford Farms, Inc. , 287 F. 655 (2nd Cir. 1923).
Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 628 F.3d 1347 (CAFC 2010)
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In re Roslin Inst., 110 USPQ2d 1668 (Fed. Cir. 2014)
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Schering Corporation v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (CAFC 2003)
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Schering Corporation v. Gilbert, 153 F.2d 428, 68 USPQ 84 (2nd Cir. 1946)
Smartgene, Inc. v. Advanced Biological Lab., 2104 U.S. App. LEXIS 1357 Unpublished (CAFC 2014); 915 F. Supp. 2d 69 (D.D.C.
2013) │ 852 F. Supp. 2d 42 (D.D.C. 2012)
Steinfur Patents Corp. v. William Beyer, Inc. 62 F.2d 238 (2nd Cir. 1932)
United States Credit System Co. v. American Credit Indemnity Co., 59 F. 139 (2nd Cir. 1893)
Wall v. Leck, 66 F. 552 (9th Cir. 1895)
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Other Materials
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Chisum, Chapter 1, “Eligible Subject Matter”, Chisum on Patents
Cook-Deegan et al., Annu. Rev. Genomics Hum. Genet. 11:383- 425 (2010)
Celia Henry Arnaud, “More than Just Sugars,” Chem. & Eng. News, April 14, 2014, p10-13.
David Newman et al., “Natural Products as Sources of New Drugs over the 30 Years from 1981 to 2010,” J. Nat. Prod. 75(3): 311-335 (2012)
Final Bulletin for Agency Good Guidance Practices, Bulletin No. 07-02
King, M-C. and Wilson, A.C. "Evolution at two levels in humans and chimpanzees." Science 188, 107-116 (1975).
Kevin Davies and Michael White. "Breakthrough: The Race to Find the Breast Cancer Gene." (New York: John Wiley & Sons, 1996).
Hall, J.M. et al. "Linkage of early-onset familial breast cancer to chromosome 17q21." Science 250, 1684-89 (1990).
http://www.facebook.com/pages/Decoding-Annie-Parker/218537534833277?sk=info
McNary, Dave (December 4, 2013). "Samantha Morton-Helen Hunt’s ‘Decoding Annie Parker’ Gets U.S. Distribution (EXCLUSIVE)". Variety
(PMC). Retrieved December 30, 2013
Online Mendelian Genetics in Man (OMIM) - http://www.ncbi.nlm.nih.gov/omim
OMB Guidance on Guidance: http://www.whitehouse.gov/sites/default/files/omb/memoranda/fy2007/m07-07.pdf
Public Consultation Draft Report on Gene Patents and Licensing Practices and their Impact on Patient Access to Genetic Tests” 74 F.R. 11730
Questions about the BRCA1 and BRCA2 Gene Study and Breast Cancer - http://www.cancer.gov/cancertopics/factsheet/Risk/BRCA
Holman Amicus Brief: http://keionline.org/sites/default/files/Amicus_Holman_AMPvUSPTO_remand.pdf
SDIPLA Brief in Ariosa: http://patentdocs.typepad.com/files/sdipla-amicus-brief.pdf
IPO Myriad and Mayo: The New USPTO Examination Guidelines, March 20, 2014 webinar
High Court May Put Brakes on Induced Infringement Suits, IPLAW360, April 29, 2014
Sherry Knowles, “Sherry Knowles Responds to USPTO Comments on New Myriad Guidelines”
http://www.managingip.com/Article/3334160/Managing-Patents-Archive/Guest-post-Sherry-Knowles-responds-to-USPTO-comments-on-newMyriad-guidelines.html
USPTO Training Slides - http://www.uspto.gov/patents/law/exam/myriad-mayo_slides_20140319.pdf
USPTO Guidelines for Mathematical Algorithms or Computer Programs, MPEP §2110 (4th ed.)
USPTO Examination Guidelines for Computer Related Inventions, 61 F.R. 7478 (Feb. 28, 1996)
USPTO Bilski Guidance, MPEP § 2106
USPTO Mayo Guidance of 2012, MPEP § 2106.01
USPTO Myriad Preliminary Memo issued June 13, 2013
USPTO Myriad Guidelines issued March 4, 2014: http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf
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