Patent Docs

Webinar on USPTO Post-Grant Proceedings

August 24, 2012

Strafford will be offering a webinar/teleconference
entitled "New USPTO Rules for Post-Grant Proceedings: Meeting the New Requirements for Post-Grant
and Inter Partes Reviews and Supplemental Examination" on September 18,
2012 from 1:00 – 2:30 pm (EDT). Scott A.
McKeown, Greg H. Gardella, and Jessica J. Harrison of Oblon Spivak McClelland
Maier & Neustadt will provide guidance for counsel to IP owners on changes
to implement inter partes review
proceedings, post-grant review proceedings, and the transitional program for
covered business method patents, and outline strategic considerations for
post-grant practice. The webinar will
review the following questions:

•
How has post-grant practice been transformed since the America Invents Act?
•
How do the new rules impact the strategic use of post-grant proceedings
parallel to litigation?
•
What are the relevant deadlines and best practices for the new post-grant
review process?

An
interactive Q&A session will follow the presentation.

The
registration fee for the webinar is $297 ($362 for registration and CLE
processing). Those registering by August
31, 2012 will receive a $50 discount.
Those interested in registering for the webinar, can do so here.
CBI Life Sciences Congress on Paragraph IV Disputes

August 24, 2012

The Center for
Business Intelligence (CBI) will be holding its 4th Life Sciences Congress on
Paragraph IV Disputes on October 25-26, 2012 in Washington, DC. The conference will offer presentations on the
following topics:

• Through the
looking glass — Fine-tune fundamentals of Hatch-Waxman and anticipate future
developments in patent litigation;
• The next big wave
— Understand the inner workings of the FDA's biosimilars pathway;
• Interpretation of
Supreme Court's ruling for patent use codes;
• Examine the new
era of label carve-outs;
• Navigate new
provisions and procedures of the America Invents Act — to be presented by
Teresa Stanek Rea, Deputy Deputy Director of the U.S. Patent and Trademark Office
• Understand the
impact of the changing bio/pharma business model on Paragraph IV litigation
(panel);
• Generic —
Essential considerations and necessary requirements for the letter;
• Branded —
Strategic first steps before and after a PIV letter is received;
• Today's courtroom
— A Judge's perspective — to be presented by the Honorable Tonianne
Bongiovanni of the U.S. District Court for the District of New Jersey;
• Defining
inequitable conduct in today's PIV suits;
• Qualification of
combination products under Hatch-Waxman and the biosimilars pathway; and
• Recent
developments on FTC settlements and pay-for-delay agreements — to be presented
by Mark Woodward of the Health Care Division, Federal Trade Commission.

An agenda for the
Congress on Paragraph IV Disputes can be found here.

The registration
fee is $2,495 (vendor) or $2,295 (pharma/biotech) for those registering by
October 25, 2012. Those interested in
registering for the conference can do so here.
Patent Eligibility and Biology

August 23, 2012

By
Kevin E. Noonan —

Earlier this month we
asked for examples of instances where claims to isolated DNA interfered with
basic research (see "The Proper Scope of DNA (or "Gene")
Patent Claims"). We posited that the claim would be something
like this one:

An isolated (human) nucleic acid (or
DNA molecule or gene (specified by name)), encoding an amino acid sequence
identified by SEQ ID NO: X,

where the portions
of this claim in parentheses are optional, used in some cases but not necessary
to properly recite the claimed subject matter. This type of claim has the following features:

• It must use the term "isolated" in the claim, to distinguish
it from naturally occurring molecules in their natural state, so as to evince
the "hand of man" in its creation (Diamond v. Chakrabarty)
to satisfy 35 U.S.C. § 101;

• It cannot read on
the natural molecule (i.e., the claim scope cannot be broad enough to encompass
the natural molecule) so that it satisfies the novelty requirement of 35
U.S.C. § 102
(Wood-Paper Patent,
90 U.S. 566 (1874), and Cochrane v. Badische Anilin Soda Fabrik,
111 U.S. 293 (1884));

• Infringement will lie only if the entire
amino acid sequence-encoding isolated nucleic acid recited in the claim is made, used, sold, offered to be
sold, or imported;

• Portions of the gene can be isolated,
sequenced, and characterized and not infringe, and such portions can be changed
and then introduced into the gene to produce another gene that does not
infringe;

• The gene product (typically, a protein)
can be isolated from the cell and studied without infringement, as can
antibodies raised against the gene product; and

• The sequence itself can be identified in
individuals and compared to wildtype or disease-associated mutations without
infringing unless the entire DNA is isolated intact.

Recent posts provide an opportunity to further distinguish what
is patent eligible from what is not (see "Dolphin Genes Show Relationships
between Large Brains and Energy Metabolism Similar to Humans and Elephants"
and "Genetic
Marker Map of Sunflower Species Reported"). In
the former, researchers have identified a number of genes that have been
subjected to positive selection, presumably due to their usefulness in adapting
to the aquatic lifestyle. This
information was developed by comparing dolphin genes with their orthologs in
related species, including cow, horse, dog, mouse,
elephant, opossum, platypus, chicken, and man. And none of this information is, per se, eligible for patenting, being
(like the capacity for certain species of Rhizobium to grow together) to be "part
of the storehouse of knowledge of all men [and]
manifestations of laws of nature, free to all men and reserved
exclusively to none."
Funk
Brothers Seed Co. v. Kalo Inoculant Co.,
333 U.S. 127 (1948).

However, the paper does posit that
dolphins may be large animal models for type 2 diabetes in humans

During the course of primate evolution, metabolism evolved to provide a
constant supply of energy to the increasing demands of a larger brain.
[Leonard et al., 2003, "Metabolic correlates
of hominid brain evolution," Comp.
Biochem. Physiol. A 136: 5–15]. Humans have evolved several
adaptations, including an increase in visceral fat and the evolution of
tissue-specific insulin resistance in the brain that protects nervous tissue
from energy shortage; however, malfunctions of this system in humans can cause
type 2 diabetes (Kuzawa, 2010 Beyond feast-famine: brain evolution, human life
history, and the metabolic syndrome. In Human evolutionary biology (ed.
Muehlenbein M.), pp. 518–527. Cambridge, UK: Cambridge University Press).
Interestingly, recent research has proposed that dolphins should be seen as a
model for type 2 diabetes, as they possess all the hallmarks of the disease
[Venn-Watson et al., 2011, "Dolphins as animal
models for type 2 diabetes: sustained, post-prandial hyperglycemia and
hyperinsulinemia," Gen. Comp.
Endocrinol. 170: 193–99)]. Here, we find genomic signatures of
adaptive evolution in dolphin genes related to control of food intake such as
genes involved in glycerol uptake and/or glucose metabolism (AQP9, OSTN,
SOCS6), and a neuropeptide AGRP that is expressed in the
hypothalamus and involved in increasing appetite, decreasing metabolism and
regulating leptin. In addition, we found several genes under selection related
to lipid transport and metabolism [] that may be associated with the large fat
reserves found in cetaceans.

Thus, methods for testing compounds as
potential drugs for treating human type 2 diabetes using dolphins may be patent
eligible, in a claim such as this one:

A method for identifying a compound that is effective in treating type 2
diabetes in the human, comprising the step of administering the compound to a
bottlenose dolphin and detecting an antiglycemic effect in the dolphin.

The other paper, on the sunflower genome
identified more than 10,000 genetic loci (by virtue of small nucleotide
polymorphisms or SNPs) to provide a genetic map of the sunflower genome. That genome was represented graphically as
follows:

Like the dolphin genome, this map is also
not patent eligible. However, sunflowers
are of great economic importance, being the fourth largest source of cultivated
vegetable oils worldwide (www.fas.usda.gov). In addition to these maps, the "sunflower
genome project" is under active pursuit (Kane et al. 2011, "Progress
towards a reference genome for sunflower," Botany-Botanique 89:
429–37), wherein genes that may increase yield or resistance to insect
predation or aridity may be mapped to portions of the sunflower genome close to
one of these SNPs. In such a case,
methods for identifying sunflowers having a desirable trait associated with one
of these polymorphisms may be patentable:

A method for producing sunflowers having [a desirable trait], wherein
the trait is genetically linked to [a particular SNP], the method comprising
the step of identifying the SNP in said sunflower and cultivating said
sunflower.

These examples are
not meant to be exhaustive. But they are
intended to illustrate the difference between patent eligible and ineligible
subject matter, and to show that the mere intersection of patents and biology
should not be the occasion to disqualify patent eligible subject matter.

This is illustrated by the drawing below, which discloses relationships between gene expression in mammalian development. If you squint a little looking at the drawing (or click on the image), these inter-relationships look somewhat like a circuit drawing, and in some ways they are. These interrelationships are not, per se, eligible for patenting. But components thereof, and methods taking advantage of the elucidation of these interrelationships should be, and their provenance in the natural world should not be enough to categorically exclude them from patent eligibility.

Figure from Ellis, "Animal Evolution: A View from the Genome," Engineering & Science 3/4: 42-51 (2001).
Genetic Marker Map of Sunflower Species Reported

August 22, 2012

By
Kevin E. Noonan —

Long
before DNA sequencing technology existed (indeed, long before Watson and Crick
proposed that DNA was the genetic material and proposed a structural basis for
its ability to be replicated), scientists were able to study genome structure
using strictly genetic approaches. Genetic linkage maps, for example, date from
the work of Thomas Hunt Morgan and Hermann Mueller on fruit flies at Columbia
University and later at Cal Tech. Traditionally,
these maps have been generated using phenotypic markers, much like Mendel did
with his pea plants (in relative obscurity) a generation before.

Marker
density is a limitation using traditional methods, however. But an improvement in this aspect of the
methodology was achieved in the 1980's with the advent of restriction fragment
length polymorphism (RFLP) methods. These methods used physical changes in DNA sequence (specifically at
restriction enzyme recognition sites) to greatly expand the scope of linkage
analysis. This is because the "phenotype"
of a RFLP is a polymorphism that can be identified using electrophorectic
separation of fragments having different lengths; unlike traditional
phenotypes, unless the RFLP happens to be associated with an amino acid change
in a protein it is unlikely to be subject to natural selection, and thus will
fall within the "neutral" sequence variation that has been
appreciated to exist in natural populations since the work of Motoo Kimura in
the 1960's. The RFLP method was used to
great effectiveness by David Botstein, Ray White, Mark Skolnick, and Ronald
Davis in identifying the chromosomal location of genes associated with, inter alia, Huntington's disease, and
notably by Mary Claire King in identifying the locus of the BRCA1 gene and in forensic
studies used to identify Argentines "disappeared" by the military
dictatorship during the co-called "dirty war."

Since
the completion of the Human Genome Project, the existence of single nucleotide
polymorphisms (SNPs), which are RFLPs without being limited to restriction
enzyme recognition sites, has expanded the extent and number of generic markers
useful for genome mapping. These SNPs
have been used to construct a high-density linkage map for the sunflower (Helianthus annus) in a paper by John
E. Bowers, Eleni
Bachlava, Robert
L. Brunick, Loren
H. Rieseberg, Steven
J. Knapp and John
M. Burke from the Department of Plant Biology and Center for Applied
Genetic Technologies, University of Georgia, the Department of Crop and Soil
Science, Oregon State University, the Department of Botany, University of
British Columbia, and the Department of Biology, Indiana University. The study, "Development of a 10,000 Locus Genetic Map of the Sunflower Genome Based on
Multiple Crosses" was reported in the online journal Genes/Genomes/Genetics (G3), 2:
721-729 (July 1, 2012). These researchers identified 10,080 polymorphic
genetic loci in the approximately 3.5 Gbp sunflower genome using a high
throughput SNP genotyping array in developing their map, but also noted areas
of the sunflower genome (up to 26 centiMorgans in size) having no markers that
could be detected in individual crosses, the result, the authors speculate, of
genetic identity between individuals in the four populations studied. However, none of these regions were in common
in the four populations as a whole, permitting a "gapless" map of the
sunflower genome to be elucidated.

Interestingly,
the economic importance of sunflowers (being the fourth largest source of
cultivated vegetable oils worldwide; www.fas.usda.gov) is such that earlier
genomic mapping technologies have been applied (including RFLP maps; Berry
et al. 1995, "Molecular marker analysis of Helianthus-annuus L. 2. Construction
of an RFLP linkage map for cultivated sunflower," Theor. Appl. Genet. 91: 195–99; Gentzbittel et al. 1995, "Development
of a consensus linkage RFLP map of cultivated sunflower (Helianthus-annuus L)," Theor. Appl. Genet. 90: 1079–108) and
others. These efforts, however, have
been directed towards "traits of agronomic importance" as well as
comparisons with genomic structure of related Helianthus species according to the authors. But these traditional efforts suffered from
the same limited marker density deficiencies noted earlier (although SNPs and
other markers identified using these methodologies were integrated into the
high-density map). Compared with the
marker density in these earlier studies (one marker per 2 Mbps) other species (Arabidopsis, rice, sorghum) were
previously mapped at a density of ~160 bp per marker (i.e., a ~12,500-fold
higher marker density). These efforts
were also hampered by the fact that no plant species closely related to
sunflower (family Asteraceae) have been fully sequenced (the closest sequenced
relative is the potato), although other related species (tomato, lettuce) are
currently subject to genomic sequencing efforts.

Markers were analyzed from multiple
genetic crosses between members of the four populations. The study reports crosses between individuals
from an oilseed maintainer line with high oleic acid content and an oilseed "restorer"
line, while other crosses involved individuals from the oilseed maintainer line
and a wild sunflower line; an oilseed restorer line and a confectionery
restorer line; and an oilseed restorer line that segregates for nuclear male
sterility and a non-oilseed landrace line. From these four populations, four individual maps of ~3500-5500 marker
loci were created, falling into 17 linkage groups which was consistent with the
17 chromosomes in the sunflower species (although crosses with the landrace
species showed genetic heterogeneity that required additional analysis). Analyses of genotyping errors showed that the
"raw allele calls" made from the data were "highly robust"
(i.e., having an error rate ranging from ~0.14-1%). Turning to these results, the authors report that
the maps were "largely collinear with an average of 88.7% of all shared
loci being syntenic in pairwise combinations." "Not surprisingly," according to
the study, "the cross that showed the most and largest regions of reduced
recombination was the only cross that involved wild sunflower," a
phenomenon that had been previously seen in maize (McMullen et al. 2009, "Genetic properties of the maize
nested association mapping population," Science
325: 737–40). The study also reports that 762 of the 5694 mapped loci could be
ascribed to two different chromosomal locations in different crosses (and 21
markers were found at three genomic locations), a phenomenon the authors
suggest could be due to the existence of multicopy genes, wherein the mapped
markers were the result of detecting the different paralogs that were located
at different loci in the sunflower genome. This corresponded to <14% of all detected SNPs being associated with multicopy
genes.

The combined consensus
map reported in this paper comprised 10,080 loci spanning 1380 cM. The authors state that the existence of this
SNP map represented "over 5 million molecular data points" made
possible by using multiple mapping populations simultaneously and that can be
used to help assemble a map from the "sunflower genome project"
currently underway (Kane et al. 2011, "Progress towards a reference genome for sunflower," Botany-Botanique 89: 429–37). The relevance and
utility of this marker map for understanding and improving sunflower species,
subspecies and economically important variants remains a task for the future.
Dolphin Genes Show Relationships between Large Brains and Energy Metabolism Similar to Humans and Elephants

August 21, 2012

By
Kevin E. Noonan —

"Genome
projects" for a variety of species (comprising a complete sequence
determination of a species' genomic DNA) has been underway for the past dozen or
so years, in the wake of the completion of the Human Genome Project at the turn
of the century. While such a sequence
determination remains the "gold standard" for a full appreciation of
the gene structure and complement of a species, partial genome sequences,
focusing on an animal's protein-coding sequences can also be useful in deriving
phylogenetic relationships and understanding how genes are associated with (if
not directly responsible for) shared phenotypic characteristics.

Such
a study was reported recently for the bottlenose dolphin, Tursiops truncates in a paper by Michael McGowen, Lawrence Grossman
and Derek Wildman of the Center for
Molecular Medicine and Genetics, Wayne State University School of Medicine (Proceedings of the Royal Society: Biological Sciences, 279: 3643-3651). The
paper,"Dolphin genome provides evidence for adaptive evolution of nervous system genes and a molecular rate slowdown,"
reports the results of a comparison of 10,025 protein-coding genes from
bottlenose dolphins and orthologous genes from cow (Bovis taurus, the closest living mammalian species in the Order
Cetartiodactyla), horse (Equus caballus),
dog (Canis familiaris) (together,
these four species comprising the laurasiatherian species), mouse (Mus muscalus), elephant (Loxodonta africana), opossum (Monodelphis domestica), platypus (Ornithorhynchus anatinus), chicken (Gallus gallus) and man. The comparison was limited to coding
sequences (CDS) ranging from 26335 bp (SYNE1)
to 150 bp (C20orf196 and FDPS).

Dolphin
genes were found to have the slowest rates of synchronous substitution between
the laurasiatherian species and comparable to rates seen in elephants and humans. The mean ratio of the number of
non-synonymous substitutions per non-synonymous site to the number of
synonymous substitutions per synonymous site (dN/dS) were highest in
dolphins of all laurasiatherian species, and again close to human rate
ratios. Within the dolphin genome, 228
genes were identified as having (dN/dS)
>1 (shown in Table 2), which was interpreted to indicate positive selection
at levels (2.26%) significantly higher than seen in other species (horse, 48 or
0.51%; cow, 32 or 0.32%; dog, 11 or 0.12%). Moreover, while at least 46% of genes in all other lineages studied were
subject to "purifying selection" (genes having a (dN/dS)
<0.1), only 36.4% (or 3646 dolphin genes) were found with this ratio,
compared with 44-51% in other species.

Of
the 228 dolphin genes (2.26% of total genes sequenced) under positive selection
(having dN/dS > 1), 27 of these genes are related to the nervous system
including genes homologous to human genes known to be involved in sleep,
synaptic plasticity and, when defective, cognitive disability. These include "[s]even genes [that] are
identified as being involved in intellectual disabilities and/or microcephaly (ERCC8,
AP4S1, MCPH1, TTR), schizophrenia (MAL) or
Alzheimer's susceptibility (AGER, RNF182)[; f]ive genes []
involved in neuroendocrine function, neuropeptide hormonal activity, or
function as hormones that affect the brain (AGRP, C2orf40, EDN2,
NMU, TTR)[; ] genes [that] function in the development of myelin (MAL),
neuronal or brain development (CNPY1, ZNF597, PCP4L1, MCPH1), neural
potassium channel function (KCNK18), neurite growth (CD47, LRFN1,CNPY2)
and synaptic function (BAALC, DBI, SYPL1, AP4S1, LRFN1)." These results were consistent with
morphological characteristics of dolphin brains, including "high level of
gyrification (cortical folding), expansion of the insular and cingulate
cortices, specialized von Economo neurons, high glia to neuron ratio increase
in synapse number, reduction of the olfactory system and the large relative
size of the cerebral cortex." This
suggests to the authors that a genetic analysis might uncover evidence of "convergent
evolution" among large-brained mammals. Further, consistent with the source, the authors report that genes "putatively
related to cetacean adaptations" were also identified, including "the
cardiovascular system (TSPO2, EPGN, PLN, EDN2, PLA2G5,
KCNJ2), sperm function and spermatogenesis (TNP1, USP26,SPAG4,
NANOS3, SPATA9, CDYL, SOX30, SPATA7, AKAP4, SPATA3, GTSF1),
lung development and respiratory function (SCGB3A2, PLUNC, TMPRSS11D),
dermal development and function (KRTDAP, SPINK5, SPINK6, IL20,
PSORS1C2, DMKN), hair (KRT84), olfaction (OR6B1, OR2AK2),
vision (CRYGN), milk (CSN2), glucose and/or glycerol metabolism (OSTN,
SOCS6, AQP9), vitamin B-1 and B-12 binding and metabolism (TCN1, THTPA)
and a multitude of genes involved in lipid transport and metabolism (APOA2,
APOC4, APOO, FABP4, SERINC4, CCDC129, PLA2G5, PNLIPRP3, RARRES2,
NR1I3)."

The
study also examined metabolism-associated genes (a total of 548 genes),
particularly the mitochondrial cellular (genomic) component genes (i.e., genes
residing in the cellular chromosome whose gene products localize in the
mitochondrion). These genes are believed
to be important for energy metabolism. 8.5%
of these genes (compared with 1.5-5% for other species) were found to have (dN/dS) > 0.5, including the gene for
cytochrome c (CYCS). This is consistent with the increased energy
needs of mammals with large brains, it being known that "basal metabolic
rates [are correlated] with relative [larger] brain size" [Isler et al., 2006, "Metabolic costs of brain size evolution," Biol. Lett.
2, 557–560] as has been observed in humans [Grossman et al., 2004, "Accelerated evolution of the electron transport chain
in anthropoid primates," Trends Genet. 20, 578–585]. These
results were consistent with increased brain size, which like in humans is
larger than expected when body size is considered.

The
authors conclude that their data is consistent with a slower rate of mutation
that other species (1.4 x 10^-9 substitutions/per site per year
compared with an average mammalian mutation rate of 2.2 x 10^-9
substitutions/per site per year). These
results are also consistent with "adaptive evolution" of both the
dolphin nervous system and brain, and although the authors have not established
a definitive link between any of the brain-related genes they identified and "morphological
or behavioral" traits in dolphins. But they point out that they identified six genes (AP4S1encoding a membrane protein
associated with AMPA glutamate receptors; SYPL1encoding a synaptic
molecule differentially regulated during human development; LRFN1encoding a synaptic adhesion molecule;
BAALC encoding a component of postsynaptic complexes; and DBI encoding
a modulator of signal transduction at type A gamma-aminobutyric acid receptors
with implications in sleep regulation) that are thought to be involved in
synaptic function; similar genes "have been implicated in the evolution of
the brain in humans" according to the report.

Genes
involved in DNA repair and associated with intellectual disabilities in humans
were also identified in the study, including "ERCC8 is a gene
involved in transcription-coupled DNA damage repair; mutations in this gene
result in Cockayne's syndrome, whose symptoms include microcephaly,
neurological defects and premature ageing [Rapin et al., 2006, "Cockayne syndrome in adults: Review with clinical and
pathological study of a new case," J. Child Neurol. 21, 991–1006]. ERCC8 shows evidence of positive selection in recent human populations [Voight
et al., 2006, "A map of recent positive
selection in the human genome," PLoS Biol. 4, e72]. MCPH1 is another gene with evidence of function in DNA damage repair as
well as cell cycle regulation. MCPH1 dysfunction can cause microcephaly
and has been documented to be under positive selection along the human lineage."

Regarding
genes involved in energy metabolism, the positive selection observed by these
authors is consistent with an oxygenation rate of 6.0 mL kg/min, greater than
in humans or elephants. In this regard
the paper makes the following interesting observation:

During the course of primate evolution,
metabolism evolved to provide a constant supply of energy to the increasing
demands of a larger brain. [Leonard et al.,
2003, "Metabolic correlates of hominid brain evolution," Comp. Biochem.
Physiol. A 136, 5–15]. Humans have evolved several adaptations,
including an increase in visceral fat and the evolution of tissue-specific
insulin resistance in the brain that protects nervous tissue from energy
shortage; however, malfunctions of this system in humans can cause type 2
diabetes (Kuzawa, 2010 Beyond feast-famine: brain evolution, human life
history, and the metabolic syndrome. In Human evolutionary biology
(ed.
Muehlenbein M.), pp. 518–527. Cambridge, UK: Cambridge University
Press). Interestingly, recent research has proposed that dolphins
should be seen as a
model for type 2 diabetes, as they possess all the hallmarks of the
disease [Venn-Watson et al., 2011, "Dolphins as animal models for type 2 diabetes:
sustained, post-prandial hyperglycemia and hyperinsulinemia," Gen. Comp.
Endocrinol. 170: 193–99)]. Here, we find genomic signatures of
adaptive evolution in dolphin genes related to control of food intake such as genes
involved in glycerol uptake and/or glucose metabolism (AQP9, OSTN,
SOCS6), and a neuropeptide AGRP that is expressed in the
hypothalamus and involved in increasing appetite, decreasing metabolism and
regulating leptin. In addition, we found several genes under selection related
to lipid transport and metabolism [] that may be associated with the large fat reserves
found in cetaceans.

This paper is just one example of how elucidating
genomic DNA structure can provide insights (including, as set forth above
regarding the relationship between energy metabolism and diabetes, unexpected
insights) into genotype/phenotype relationships in evolutionarily related
species. These results also indicate
that the "golden age" of genomics is still, really, in its infancy.
In re Antor Media Corp. (Fed. Cir. 2012)

August 20, 2012
By Kevin E. Noonan —

In a case otherwise of little interest to the biotech/pharma community, the Federal Circuit last month increased the burden on proving patentability created by prior art references for patent applicants and patentees. This was accomplished by defining a presumption of enablement not only for prior patents and published patent applications but also for all prior printed publications, regardless of source of provenance.

The case involved an appeal from a U.S. Patent and Trademark Office rejection (in five ex parte reexaminations merged for consideration by the Office) of claims in U.S. Patent No. 5,734,961 directed to "to a method and apparatus for transmitting information recorded on digital disks from a central server to subscribers via a high data rate telecommunications network." For completeness, independent method claim 1 is set forth as follows:

1. Method of receiving information from one of a plurality of information systems via a high data rate telecommunication network in response to a request from one of plural subscriber stations, said method comprising the steps of:
    initiating a two-way transmission from subscriber computer means of said one of said plural subscriber stations to one of said in formation systems via said telecommunication network,
    outputting on output means of said one of said plural subscriber stations data related to plural information stored at one of said information systems,
    selecting at said one of said plural subscriber stations at least one of said information by means of input means of said one of said plural subscriber stations and transmit- ting a signal identifying said at least one selected information from said subscriber computer means to a selected information system via said telecommunication network,
    receiving at said one of said plural subscriber stations from said selected information system digital signals via said telecom- munication network, expanding by expansion means said transmitted signals, converting said expanded digital signals into analog signals and delivering said analog signals to transducer means.

This claim and others (including some that added a "controller" limitation) were rejected over four prior art references:

• Arif Ghafoor et al., A Distributed Multimedia Database System, Dep't of Elec. & Comp. Eng'g, Syracuse Univer sity (1988 IEEE).

• Stavros Christodoulakis & Theodora Velissaropoulos, Issues in the Design of a Distributed Testbed for Multimedia Information Systmems (MINOS), Journal of Mgmt. Inf. Sys., Vol. 4, No. 2 (1987).

• H.K. Huang et al., Picture Archiving and Communications Systems (PACS) for Radiological Images: State of the Art, CRC Critical Reviews in Diagnostic Imaging, Vol. 28, Issue 4 (1988).
• Barrett, U.S. Patent 4,918,588 (granted April 17, 1990).

In an opinion by Judge Lourie, joined by Chief Judge Rader and Judge Bryson, the Federal Circuit affirmed the PTO determination that the claims were either anticipated or obvious. In arriving at this conclusion, the Court addressed Antor's argument that the Board erred when it considered the prior art printed publications to be presumptively enabled. The Court set out the following reasoning for its disagreement with this argument.

The opinion cites Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003), for the proposition that "both claimed and unclaimed materials disclosed in a patent are presumptively enabling," noting that during prosecution "the examiner is entitled to reject application claims as anticipated by a prior art patent without conducting an inquiry into whether or not that patent is enabled or whether or not it is the claimed material (as opposed to the unclaimed disclosures) in that patent that are at issue," citing In re Sasse, 629 F.2d 675, 681, 207 USPQ 107, 111 (C.C.P.A. 1980). This is not determinative, however, because the applicant can then rebut the presumption by submitting evidence that the reference is not enabled.

The panel recognizes, however, that the Amgen case "did not decide whether a prior art printed publication, as distinguished from a patent, is presumptively enabling during patent prosecution," although in so going the Amgen Court did suggest that such a presumption was likely, saying that "[w]e note that by logical extension, our reasoning here might also apply to prior art printed publications as well, but as Sugimoto is a patent we need not and do not so decide today."

Accordingly, the opinion makes express that "logical extension": "the issue regarding non-patent publications [being] squarely before the court [], we now hold that a prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee." In coming to this conclusion, the panel rejected Antor's argument that printed publications should be treated differently than patents because of the statutory presumption of validity that attaches to a patent. 35 U.S.C. § 282. The basis here was the same basis the panel used in Amgen: § 282 is not the source of the presumption; rather, the panel here notes that the precedent cited in the Amgen case applied the logic that "it is procedurally convenient to place the burden on an applicant who is in a better position to show, by experiment or argument, why the disclosure in question is not enabling or operative" and thus that prior art patents can be presumed enabling for both claimed and unclaimed subject matter. Finally, closing the logical loop this panel explained that the undisclosed subject matter in a patent is not examined at all and thus in no different a posture than what is contained in a non-patent prior art publication. (The same could also be said, but it was not mentioned in the opinion, for prior art published applications.)

The consequence of this decision, according to the panel, changes nothing for patentees or applicants, because in any case the examiner "is governed by 35 U.S.C. § 132, which requires notification to an applicant of the reasons for a rejection with 'such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.'" Provided that an examiner has included in an Office Action "the theory of the rejection, the prior art basis for the rejection, and where each limitation of the rejected claims is shown in the prior art reference" she has met her burden under the statute. As a practical matter, the Court is aware that the examiner, having "no access to experts or laboratories, is not in a position to test each piece of prior art for enablement in citing it, and requiring him to do so would be onerous, if not impossible." Thus:

Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.

This decision has important implications for practitioners attempting to provide patent protection for biotechnology-based inventions. A great deal of biotechnology research and inventions have derived from university inventors, and even for those inventions that do not their inventiveness is assessed in view of prior art produced by university researchers. It is a feature of some of this art that portions therein are reserved for what can most kindly be called discussions of possible future implications and applications of a scientific result (unkindly, these can be nothing less than unsupported flights of fancy). However, the presence of such language in scientific references such as journal articles not expressly provides a much more robust source of prior art, insofar as anything said in a prior art printed publication now falls expressly within the presumption that it is enabled. While in many cases this will not pose an insurmountable challenge, it can be expected at the very least to increase the difficulties and cost of obtaining patents, and to open up a host of new prior art for use in invalidity defenses (the panel here noted that in Amgen "that presumption applies in the district court as well as the PTO, placing the burden on the patentee to show that unclaimed disclosures in a prior art patent are not enabling"). And while the heightened burden of "clear and convincing" evidence may serve to ameliorate this change in the district courts, the situation is very different during patent prosecution or reexamination, due to the "substantial evidence" standard of review used by the Federal Circuit for factual determinations by the Office. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). These consequences are even more significant in view of the expanded potential for post-grant review occasioned by enactment of the Leahy-Smith America Invents Act.

One hypothetical example may suffice. (NOTE to the literal minded: what follows is generally not patentable or patent eligible; it is just an example in extremis to make the point). As noted previously, perhaps the most beautiful sentence in scientific literature is this one:

It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.

James Watson & Francis Crick, "Molecular Structure of Nucleic Acids; A Structure for Deoxyribose Nucleic Acid," Nature 171: 737-38 (April 25, 1953). Now let's assume that patent protection was being sought for any of the practical applications of specific basepair hybridization (solution reassociation, various "blotting" techniques, even recombinant DNA production requiring proper hybridization of DNA fragments asymetrically cut with different restriction enzymes) and ask, what would the effect of this sentence be on such claims, keeping in mind that when Watson and Crick wrote this sentence they had no experimental evidence (of their own) and that the accuracy of their insight on the structure of DNA would take years to conclusively establish.

In re Antor Media Corp. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Lourie and Bryson
Opinion by Circuit Judge Lourie
Court Report

August 19, 2012

By Sherri Oslick —

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.

Bayer Intellectual Property GmbH et al. v. Warner Chilcott Company LLC et al.
1:12-cv-01032; filed August 13, 2012 in the District Court of Delaware

• Plaintiffs: Bayer Intellectual Property GmbH; Bayer Pharma AG
• Defendants: Warner Chilcott Co. LLC; Warner Chilcott (US) LLC; Warner Chilcott PLC

Infringement of U.S. Patent No. 5,980,940 ("Pharmaceutical Combination Preparation for Hormonal Contraception," issued November 9, 1999) based on Warner Chilcott's manufacture and sale of its Lo Loestrin product (norethindrone acetate and ethinyl estradiol tablets, used for oral contraception). View the complaint here.

Luitpold Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC et al.
3:12-cv-05064; filed August 10, 2012 in the District Court of New Jersey

• Plaintiff: Luitpold Pharmaceuticals, Inc.
• Defendants: Amneal Pharmaceuticals, LLC; Amneal Holdings, LLC; Amneal Pharmaceuticals Holding Co., LLC; Amneal Pharmaceuticals of New York, LLC.; Amneal Pharmaceuticals Co. India Private Ltd.; Recordati Ireland Ltd.

Infringement of U.S. Patent No. 6,333,044 ("Therapeutic compositions for intranasal administration which include KETOROLAC®," issued December 25, 2001) following a Paragraph IV certification as part of Amneal's filing of an ANDA to manufacture a generic version of Luitpold's Sprix® (ketorolac tromethamine nasal spray, used for the management of moderate to moderately severe pain that requires analgesia at the opioid level). View the complaint here.

Janssen Pharmaceuticals, Inc. v. Glenmark Generics Ltd. et al.
2:12-cv-05009; filed August 9, 2012 in the District Court of New Jersey

• Plaintiff: Janssen Pharmaceuticals, Inc.
• Defendants: Glenmark Generics Ltd.; Glenmark Generics Inc., USA

Infringement of U.S. Patent No. 6,214,815 ("Triphasic Oral Contraceptive," issued April 10, 2001) following a Paragraph IV certification as part of Glenmark's filing of an ANDA to manufacture a generic version of Janssen's Ortho Tri-Cyclen® Lo (norgestimate and ethinyl estradiol, used for oral contraception). View the complaint here.

Ariad Pharmaceuticals, Inc. v. Kappos
1:12-cv-00886; filed August 9, 2012 in the Eastern District of Virginia

Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 8,114,174 ("Substituted Acetylenic Imidazo[1,2-B] Pyridazine Compounds as Kinase Inhibitors," issued February 14, 2012). View the complaint here.
Conference & CLE Calendar

August 19, 2012

August 21, 2012 – Mayo v. Prometheus: The Supreme Court's New Methodology for Analyzing Patent Eligibility (American Bar Association) – 1:00 – 2:30 pm (EDT)

August 22, 2012 – The Final USPTO AIA Rules: What You Need to Know (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern)

August 24, 2012 – The America Invents Act: The Boundaries of Prior Art (American Bar Association) – 1:00 – 2:30 pm (EDT)

August 27, 2012 – AIA Post-Grant Implementation Begins – Is Your Business Strategy Aligned? (Foley & Lardner) – 3:00 pm (Eastern)

August 30, 2012 – The Written Description Requirement: Are Antibodies Chemicals, Proteins, or Exceptions? (American Bar Association) – 1:00 – 2:30 pm (Eastern)

September 6, 2012 – A Review of the Impact of Recent Supreme Court and Federal Circuit Decisions on Patent Strategy (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 – 11:15 am (CT)

September 9-11, 2012 – IPO Annual Meeting (Intellectual Property Owners Association) – San Antonio, TX

September 10-12, 2012 – Business of Biosimilars & Generic Drugs (Institute for International Research) – Boston, MA

September 19, 2012 – New Post Grant Proceeding Rules: Adjusting to the New Reality (Technology Transfer Tactics) – 1:00 – 2:15 pm (Eastern)

September 20-21, 2012 – FDA Boot Camp*** (American Conference Institute) – Boston, MA

September 24-25, 2012 – Biosimilars and Biobetters*** (SMi) – London, UK

September 25-26, 2012 – EU Pharma Regulatory Law*** (C5) – Brussels, Belgium

September 28, 2012 – Focus on Biologics and Biosimilars (Catalyzing Collaboration Between Industry and Academia in the Life Sciences) – Hospira, Inc., Lake Forest, IL

October 10-11, 2012 – Maximizing Pharmaceutical Patent Lifecycles*** (ACI) – New York, NY

October 10-11, 2012 – Biotech & Pharmaceutical Patenting*** (C5) – London, UK

October 22-23, 2012 – Tech Transfer Summit North America*** (Tech Transfer Summit Ltd.) – John Hopkins University, Montgomery County, MD

October 24-25, 2012 – FDA Boot Camp Devices Edition*** (American Conference Institute) – Chicago, IL

***Patent Docs is a media partner of this conference or CLE
ABA Journal Accepting Nominations for 6th Annual Blawg 100

August 19, 2012

The ABA Journal has begun work on its 6th annual list of the 100 best legal blogs (or blawgs) and has announced that it is seeking the advice of its readers, via the ABAJournal.com website, on which blawgs and practice areas to include on this year's Blawg 100. Readers interested in nominating a particular blog or practice area should use the blawg 100 amici form provided on the ABA Journal website. Additional information about the Blawg 100 can also be found on the blawg 100 amici form. The form requires that anyone making a nomination provide a name, employer or law school, city, and e-mail address. The ABA Journal requires this information in order to discourage:

• Blawggers who nominate their own blawgs or nominate blawgs to which they have previously contributed posts.
• Wives and husbands who nominate their spouses' blawgs.
• Employees of law firms who nominate blawgs written by their co-workers.
• Public relations professionals in the employ of lawyers or law firms who nominate their clients' blawgs.
• Pairs of blawggers who have clearly entered into a gentlemen's agreement to nominate each other.

The ABA Journal, however, welcomes comments from readers who do not fall into the above categories.

Nominations must be submitted no later than Friday, September 7.
ACI FDA Boot Camp Devices Edition

August 17, 2012

American Conference Institute (ACI) will be holding its FDA Boot Camp Devices Edition conference on October 24-25, 2012 in Chicago, IL. ACI faculty will help attendees:

• Master the basics of the application and approval processes, including 510(k) clearance and PMAs;
• Navigate the complexities of device regulations;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDRH;
• Develop a practical working knowledge of clinical trials and IDEs;
• Learn how devices are classified, monitored, and regulated;
• Recognize the pivotal role of labeling and learn how to avoid misbranding and off label promotion;
• See the importance of cGMPs and QSRs to the post-approval regulatory process; and
• Navigate the protocols of adverse events monitoring, product withdrawals, and recalls.

In particular, ACI's faculty will offer presentations on the following topics:

• The basics: Understanding and working with the FDA — jurisdiction, functions, organization, and operations;
• Overview of device regulation;
• Understanding clinical trials and the investigational device exemption (IDE);
• Comprehending the 510(k) clearance process;
• Navigating the premarket approval process (PMA);
• Complying with general post-market controls;
• Understanding FDA enforcement tools, policies, practices, and trends;
• Labeling and promotion;
• Medical device reporting;
• Guidance for navigating recalls and withdrawals; and
• Quality system regulation.

A pre-conference primer on the "Fundamentals of FDA Device Regulatory Law," will be offered on October 23, 2012 from 1:00 – 4:00 pm. The workshop will provide a basic overview of FDA regulations and will prepare attendees for the in-depth discussions that will take place throughout the conference.

A post-conference master class on "Unique Regulatory Schemes for Specialized Devices: In Vitro Diagnostics and Software Classified as Devices" will be offered from 2:00 – 5:15 pm on October 25, 2012. The master class will provide attendees with enhanced information specific to in vitro diagnostics and software that is classified as a medical device and will help attendees thoroughly comprehend the complexities and nuances of these areas of regulatory law.

An agenda for the conference can be found here, and more information regarding the pre-conference primer and master class can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $2,295 (conference alone), $2,895 (conference and pre-conference primer or master class), or $3,495 (conference, pre-conference primer, and master class). Those registering by August 24, 2012 will receive a $300 discount and those registering by September 21, 2012 will receive a $200 discount. Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, by faxing a registration form to 1-877-927-1563, or by e-mailing CustomerService@AmericanConference.com.

Patent Docs is a media partner of ACI's FDA Boot Camp Devices Edition conference.

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