(Informal 1-2 line summaries, which certainly should not be relied upon for legal or other research purposes)
-
- In this precedential decision, CAFC affirms JMOL lack of enablement invalidity for the claim (offending language highlighted):
"1. A method for treating gefitinib and/or erlotinib
resistant non-small cell lung cancer in a patient in
need thereof, comprising administering daily to the
patient having gefitinib and/or erlotinib resistant
non-small cell lung cancer a pharmaceutical composition comprising a unit dosage of an irreversible
epidermal growth factor receptor (EGFR) inhibitor
that covalently binds to cysteine 773 residue in the
ligand-binding pocket of EGFR or cysteine 805 residue in the ligand-binding pocket of erb-B2." (emphasis added)
Below, the DCT "emphasized that (1) the specification disclosed no workingexamples of unit dosages administered to patients, and
(2) AstraZeneca presented unrebutted evidence that some
disclosed dosage levels would be toxic, including doses required to achieve a therapeutic effect in patients."
After agreeing on the claim construction, CAFC turns to enablement:
"Wyeth argues that the
district court erred in granting JMOL because, viewing the
evidence in the light most favorable to Wyeth, a reasonable
jury could have concluded that AstraZeneca failed to prove
by clear and convincing evidence that the asserted claims
require undue experimentation to determine a non-toxic or
non-fatal unit dosage for daily administration to a patient. "
CAFC disagrees. Indeed, the specification says "[t]he
skilled artisan is aware of the effective dose for each patient." Ahem.
"[T]he specification leaves the determination of the claimed “unit dosage” entirely to the knowledge
of the skilled artisan . . .While the knowledge of one of ordinary skill may
play an important role in enablement, it may not provide
the only means to enable these specific claim limitations . . . That is what a specification
of a patent must provide." (emphasis added)
In sum:
"We recognize that it is accepted practice in patent law
for one to be able to claim a method of treatment disclosing
a range of doses to be administered, without showing actual clinical data, and leaving it to the FDA to ensure that
approved products are safe and effective . . . The problem with these patents
is that, perhaps because of close prior art, their claims are
limited to dosage forms to be administered to patients, yet
they disclosed only a broad range of doses some of which
were shown to be toxic, and they disclosed no actual dosages for any compound within the scope of the claims,
thereby leaving it to a practitioner of the claims to perform
undue experimentation." (emphasis added)
Thus, as the only disclosed ranges "are not compatible for use in patients because they far exceed the maximum tolerated dose in humans" CAFC affirms.
-
- CAFC affirms 101 ineligiblity on claims overbroadly focusing upon a "deep learning device" which "is a machine
learning device that, through training, can analyze images
and recognize patterns within the images." E.g., Claim 1 recites:
"1. A method for assessing the shape of an
orthodontic aligner, said method comprising the
following steps:
a) more than 1 week after the start of the
treatment with the aligner, acquisition of
at least one image at least partially
representing the aligner in a service
position in which it is worn by a patient,
called “analysis image”, the analysis image
being a photograph, or an image extracted
from a film;
b) analysis of the analysis image by means
of a deep learning device, trained by means
of a learning base, so as to determine a
value
for at least one tooth attribute of an
“analysis tooth zone” representing, at least
partially, a tooth on said analysis image,
the tooth attribute relating to a separation
between the tooth represented by the
analysis tooth zone, and the aligner
represented on the analysis image,
in the step a), a cellphone is used to acquire
the analysis image." (emphasis added)
The DCT found that "independent claim
1 was directed to the abstract idea of acquiring and
analyzing an image, then presenting the image in a
message to guide the user to take a new image."
Here, CAFC is similarly unimpressed by the "learning base" limitation:
"Furthermore, while claim 14 of the ’248 patent and
claim 7 of the ’409 patent require that the “deep learning
device” be trained in a specific manner ––i.e., on a “learning
base” comprising more than a thousand images of dental
arches, see ’248 pat., col. 34 ll. 21–33; ’409 pat., col. 33 ll.
12–17––that does not mean they provide a specific technological solution that would render the claims patent-eligible. That a “deep learning device” be trained on a specific
subset of data is “incident to the very nature of machine
learning,” and thus is not a “technological improvement”
rendering the claims eligible under § 101."
Similarly, CAFC is unwilling to read in technical character:
"[N]othing in claim 14 requires a specific quantitative assessment beyond the ability of an orthodontist . . . At most, the claimed
methods may perform such determination of the amplitude
of separation with greater efficiency or speed due to the
nature of the generic “deep learning device.” But that does
not render the claims patent-eligible . . . The showdown claims fare no better at step two, as
there is no “inventive concept” sufficient to transform the
ineligible abstract idea into patent-eligible subject matter.
As stated previously, the “deep learning device” from each
claim is conventional; the patents themselves explain that
the device can be chosen from a list of well-known and
available neural networks . . . Dental Monitoring next argues that using “deep
learning devices” to guide orthodontic treatment was not
“conventional” at the time the patent issued . . . But that misses the mark because “the relevant
inquiry is not whether the claimed invention as a whole is
unconventional or non-routine” . . . Rather, we look for an “inventive concept” that “transforms
the claims into something ‘significantly more’” than the
abstract idea . . . To the extent that
Dental Monitoring considers the “deep learning device” to
be “something significantly more” so as to render the
claims patent-eligible, that argument is unavailing given
that the patents themselves confirm that the “deep
learning device” is generic."
Ergo, affirmed.
-
- In an interesting case, similar to Aqua Marine, commenting on timing, plaintiff apparently expected CAFC to hear an appeal on the DCT's 101 invalidity determination, despite licensing the patent to defendant in the interim.
"Linfo and Trustpilot’s Agreement triggers a jurisdictional inquiry for this court because, if the Agreement
ended the controversy between the parties, we must dismiss this case as moot . . . Section 2.1 of the Agreement grants Trustpilot a
“worldwide and irrevocable license” to “make . . . use, offer
for sale, [and] sell” products or services covered by the ’428
patent “[s]ubject to [Trustpilot’s] payment of the Settlement Fee” . . . The Agreement also notes that if
the Southern District of New York lawsuit “resumes in any
manner, or the Federal Circuit . . . remands [this] case to
the District Court, [Linfo] . . . shall file a Stipulated Dismissal with Prejudice . . . Altogether, the Agreement demonstrates that Trustpilot no longer has a stake in the outcome of this litigation"
While it's true that "in some circumstances the opposing party’s lack of interest will not bar adjudication on
the merits, the outcome is different when the appellant is
responsible for the opposing party’s lack of continued interest, for example, as here by a settlement."
Ergo, dismissed.
-
- In this precedential 112f decision, CAFC clarifies the analysis for finding whether the following terms invoke means-plus-function:
. . . wherein said mobile computing device software comprises executable program code
configured to facilitate annotation of a portion of said synchronization index responsive to user input received by the mobile computing device . . .
. . . said mobile
computing device software comprises executable program code configured to synchronously play said associated multimedia with
said synchronization index other than as part
of a web page."
Defendant took the Aristocrat approach below, arguing 112f and then lack of specification structure. The DCT agreed on both counts, and here CAFC reconsiders the analysis of the first.
"Whether the non-function term (here, “executable program code”) identifies sufficient structure has two aspects
that are of particular importance for the present case.
First: We have often asked whether the non-function term
would be understood by relevant artisans to name something identified by structural (not just functional) properties at all (a necessary predicate to being a structure that suffices for the claimed function(s)) . . . Second: Not just extra-patent usage in the field on its
own, but, consistent with the importance of context to claim
construction generally, the claim language may suffice to
make clear whether certain claim words name sufficient
structure in the understanding of the relevant artisan." . . .
. . . The function-operation distinction warrants particular
attention in the software context, which is at issue here,
because a non-functional term referring to code “is partly
defined by its function . . .
. . . On remand, the focus of the § 112(f) analysis should be
on whether the disputed limitations, read in full and in context, recite enough structure to perform the claimed functions . . .
. . . The claim language that here requires the annotation, synchronous-play, and other
functions to be carried out by the same “software” communicates that the code referred to must be capable of being implemented with code that performs the other claimed
functions . . . The parties’ arguments to date have not been focused
on whether the claims reveal structure for those precise
functions . . .
. . . more attention must be paid to whether
the “executable program code” limitations, for the functions
stated above, were generally known in the art at the time
of the invention as names for known code.
”
Ergo, vacated and remanded to apply the more specific analysis.
-
- CAFC precedentially affirms the DCT's claim construction and the consequent preliminary injunction:
"Based principally on the guidance provided by the specification, we find Otsuka’s proposed claim construction
more persuasive than the construction offered by Hetero.
We construe the terms “dextromethorphan” and “quinidine” in the ’282 patent, including their use in the weightto-weight ratio of claim 1, to refer to the form in which
those compounds are administered. Applying that construction, we hold that the district court did not err in finding that Otsuka was likely to succeed in proving that
Hetero infringed the ’282 patent."
Basically, the claim recited that "the weight to weight
ratio of dextromethorphan to quinidine is 1:0.5 or less." the DCT elected the interpretation that dextromethorphan and quinidine could be the "free base" or "salt" form, rather than just the former.
"While at first blush it is appealing to construe the
terms “dextromethorphan” and “quinidine” to refer only to
the free base forms of those compounds, a close analysis of
the claims and specification of the ’282 patent leads us to
construe those terms as referring to the compounds
whether in free base or salt form."
Per Philips, CAFC first considers the intrinsic evidence: "To begin with, the claims as a whole indicate that the
terms “dextromethorphan” and “quinidine” refer not only
to the free base forms of dextromethorphan and quinidine,
but to the salt forms as well. Claim 7, which depends from
claim 1, requires that the dextromethorphan or quinidine
“is in a form of a pharmaceutically acceptable salt” . . . Because the dependent
claims include administration of those compounds in salt
form, the references to “dextromethorphan” and “quinidine” in the independent claim from which those claims depend must also be understood to include the salt forms of
the two compounds."
Similarly the specification includes "xpress language indicating that the references to dextromethorphan
and quinidine include the salt forms of those compounds,
but it specifically defines the active ingredients as including not only the free base forms of dextromethorphan and
quinidine, but also their salt forms."
Judge Dyk dissents:
"The majority’s construction, which calculates the weight-to-weight ratio either using the weight of the active moiety (when
administered in the pure “free base” form) or the total
weight of a salt compound (when administered in the salt
form), is inconsistent with the objective of the invention
and is unsupported by the specification and prosecution
history . . . The purpose of the invention claimed in the ’282 patent
is thus to decrease the blood level of quinidine while maintaining a therapeutically effective blood level of dextromethorphan in a patient that is receiving this treatment . . . Nothing in the intrinsic record indicates that administering quinidine or dextromethorphan in the form of a salt
(as opposed to the free base form) has any therapeutic effect related to the efficacy of the combination or that it affects the blood levels of dextromethorphan and quinidine . . . Because, under the correct claim construction, Hetero
has raised a substantial question of noninfringement, I
would reverse the preliminary injunction."
As they say . . . or maybe just me . . . "context is king."
James Skelley is a solo practitioner based in Mountain View, California since 2015, focusing primarily upon technology transactions and intellectual property procurement. James' practice also serves as an "incubator" for new legal service technologies / methodologies and a "living example" of their application. To this end, James regularly partners with larger law firms and with his clients so as to improve the practice of intellectual property law.
- Utility / Design / PCT Patent Prosecution
- Open Source Diligence
- Technology Transactions (typically as a team)
- Litigation / Inter Partes Review Support (typically as a team)
- James tends NOT to handle low-volume trademark work (though referrals are available)
- USPTO - #59458 - 10/16/2006
- California - #257829 - 12/01/2008
- District Columbia - #1014986 - 08/05/2013
- James is available by email, 8x8 hangout, and in-person meetups in the Valley.
- Email is typically the best way to reach James.
- Machine Learning / Robotics
- Cryptograpy / Cryptocurrency / Smart Contracts
- Medical Device
- Computational Biology (primarily modeling and proteomics)
- Signal Processing (primarily wireless and compression)
- Quantum Physics (primarily semiconductor) / Electromagnetics (antennae, waveguides, etc.)
- Manufacturing / 3D Printing
- James tends NOT to handle pure chemistry applications (though referrals are available), however James HAS handled matters involving computational proteomics, cellular modeling, and diagnostic lab protocols
LawMux Bites are (very) short, one-page summaries of various legal concepts, cases, and technologies. As informal summaries, you certainly shouldn't rely upon them as legal advice / for business use, but they can help orient you if you're new to the subject matter.