(Informal 1-2 line summaries, which certainly should not be relied upon for legal or other research purposes)
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- 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."
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- CAFC precedentially affirms anticipation based upon a public disclosure on claims directed to "compounds and methods of inhibiting coronavirus replication activity" denying priority that would have overcome the reference, because the alleged typographical error.
"The district court granted Pfizer’s motion, concluding
that the “C2” in —NHC(O)—C2-C12-alkyl of the ’048 provisional was not an obvious typographical error that it had
the power to correct, and therefore the change from —
NHC(O)—C2-C12-alkyl in the ’048 provisional to —
NHC(O)—C1-C12-alkyl in the ’953 patent impermissibly
broadened the scope of the patent such that the ’953 patent
was not entitled to priority from the ’048 provisional . . . Here . . . the
dispute is whether there is adequate written description
support in the ’048 provisional’s disclosure of —NHC(O)—
C2-C12-alkyl for the ’953 patent’s disclosure of —NHC(O)—
C1-alkyl. That is, whether “2” provides adequate written
description support for “1” . . .
We conclude that the ’048 provisional does not convey
to a skilled artisan that the inventors possessed —
NHC(O)—C1-alkyl at the time of the ’048 provisional’s filing date. The ’048 provisional and the ’953 patent recite
two different ranges of chemical moieties. The former recites —NHC(O)—C2-C12-alkyl and the latter recites —
NHC(O)—C1-C12-alkyl. C2 is simply different from C1, and
the ’048 provisional’s disclosure of a range of C2 to C12 provides no support for the ’953 patent’s disclosure of C1 because the ’048 application explicitly includes an alkyl group
with two to twelve carbon atoms (i.e., —NHC(O)—C2-C12-
alkyl), and notably does not include an alkyl group with one
carbon atom (i.e., —NHC(O)—C1-alkyl) . . . , “[e]ntitlement to a filing date . . .
extends only to that which is disclosed,” Lockwood,
107 F.3d at 1571–72, and —NHC(O)—C1-alkyl was simply
not disclosed in the ’048 provisional."
Ergo, affirmed.
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- In this precedential IPR estoppel decision, CAFC reverses and remands, disagreeing with the DCT that defendant was "estopped under 35 U.S.C. § 315(e)(2) from asserting two invalidity grounds." Previously, CAFC had heard the case and ruled that defendant wasn't necessarily bound by the diligence analysis of a peer ("We . . . criticized [the DCT's] use of CMG’s petition as proof against Valve . . . If, after all, CMG “employed ‘scorched earth’ tactics to find the references making up the [CMG] Grounds, then its experience may be irrelevant to a determination of what would have
been discovered by an ordinarily skilled searcher acting
with merely reasonable diligence.”"). Here, CAFC is clarifying the standard for such diligence, particularly clarifying what kind of searches do / do not effect estoppel:
"[T]here are two open disputes regarding the standard. First, we have not fully addressed whether the skilled
searcher inquiry poses a question of law, reviewable de
novo, or a question of fact, reviewable for clear error. We do
not opine on this issue here because we conclude that the
district court’s error regarding the Landon IP evidence is
apparent under either standard of review.
Separately, we have not yet had the opportunity to take
a conclusive stance on what “discover[y]” within the skilled
searcher inquiry entails . . . The district court purported to
rely on classification searches based on the Board’s application of § 315(e)(1) estoppel in the ’136 IPR, which primarily looked to classification searches in identifying the
reasonable discoverability of Wörn. The district court also
found that classification searching satisfied the standard
of reasonableness set forth in certain district court cases to
consider the issue of IPR estoppel . . . The district court’s conclusion regarding Kotkin was
error. First, as noted above, the Board in the ’136 IPR did
not consider mere classification searches, without more, to
be the endpoint of its analysis; rather, it went on to consider that these classifications would be manually
searched, or that keyword searching could have been used
to narrow the classification search results down further to
an amount capable of manual review. Similarly, we conclude that the Clearlamp standard relied upon by the district court does not go far enough when an unreviewably
large number of references are returned by a skilled
searcher’s diligent search. We do not hold that manual review of search results will in all instances be necessary to
establish discovery. We also do not go so far as to endorse Valve’s vision of the discoverability standard, though we
note the normative force of Valve’s argument that thousands of sources, not further narrowed in any way, likely
cannot be considered discovered for estoppel purposes under § 315(e)(2). We hold only that something more is required for estoppel when a classification search alone
returns an unreviewable number of search results—a demand not met here.." (emphasis added)
Thus, after finding subsequent declarations to be a matter of hindsight and therefore unaffecting the expert searcher standard, and a brief concurrence by Judge Stark, CAFC reverses / remands.
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- CAFC affirms denial of a preliminary injunction (potent doth remain that mighty specter of eBay!) for patent med device inducement, particularly a spinal nerve ablation tool, the claim reciting, in part:
"inserting an introducer through a pedicle of the
vertebral body such that an opening at a distal tip
of the introducer reaches a cancellous portion of the
vertebral body"
BSC sought a PI on the theory . . .
". . . that the OptaBlate BVN’s “access cannula” corresponded to the claimed “introducer.” Stryker argued that it did not induce
infringement of that limitation because Stryker did not instruct physicians to place the access cannula so that it
“reaches” the cancellous portion of the bone . . . The district court concluded that the
“reaches” limitation required that the distal tip of the introducer “touch[] or extend[] to” the cancellous portion of
the vertebral body and that the evidence did not sufficiently demonstrate that Stryker instructed physicians using its device to extend the access cannula to reach the
cancellous bone."
Here, CAFC acknowledges that the "contested limitation is facially ambiguous as to
whether the plain and ordinary meaning of “reaches”
means touches or also includes arriving in the proximity of" and agrees with the DCT for now. As for the likelihood of infringemnet, CAFC agrees that hte curent evidence is too nebulous:
"[A] slide show presented internally to sales personnel instructs “to enter just inside
the vertebral body past posterior wall,” but it is again unclear whether this is referring to the access cannula or the
tip of the stylet . . . The expert declarations supplied by the parties present conflicting views as to
how to interpret these documents. The district court reasonably considered evidence that Stryker instructed that
the “stylet tip should barely—if at all—enter the vertebral
body,” i.e., the cancellous bone, J.A. 17 (emphasis omitted),
and concluded that the slides’ reference to “[f]inal position
should be just inside the vertebral body” could be referring
to the final position of the stylet tip rather than the tip of
the access cannula . . . Boston Scientific appears to contend
that by instructing a physician to place the access cannula
inside the wall of the vertebral body, Stryker instructs
placing the tip of the access cannula through the wall and
inside the vertebral body rather than literally inside the
wall itself, which is made of cortical bone. As the district
court reasonably concluded, this could be read as instructing physicians to place the access cannula such that it
reaches the cortical wall rather than the cancellous portion . . . Boston Scientific relies on an internal Stryker
document that describes the access cannula as being
“placed within the cancellous bone of the spine” . . .
While this may well support Boston Scientific’s
position, it cannot carry Boston Scientific’s burden to show
no substantial question of infringement exists, as it is an
internal document, there is no contention that it was given
to users of the OptaBlate BVN, and Boston Scientific has
not proven what (if any) impact this or other internal materials have on what Stryker conveys to others."
Ergo, affirmed.
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- CAFC affirms obviousness IPR invalidity for "an arrangement for mixing and discharging fluids."
"Medmix presents two main arguments on appeal. The
principal argument is that the Board improperly construed
the term “at least two ramps” to not require an “inclined
plane” . . . Separately, medmix asserts that the Board’s motivation-to-combine findings were not supported by substantial evidence."
Regarding the construction, "the disputed limitation does not specify that the recited
ramps must be a particular shape, let alone an inclined
plane . . . The specification supports that understanding . . . No specific shape is mentioned for the
“guide groove.”" Owner points to ramp variations in the spec, but CAFC doesn't see why they should be read in, and so, after likewise finding no limitation in the prosecution history, CAFC affirms.
As for the motivation, "[t]he Board found that a skilled artisan would have been
motivated to incorporate Yu’s coarse thread design into
both Keller ’574 and Heusser because doing so provides
“mechanical advantage[s]” . . . medmix argued that a skilled artisan would
have been dissuaded from making the proposed combinations because each combination would have resulted in a
design where the backpressure generated during dispensing would cause the coarse-thread connection between the
mixer and cartridge to separate, leading to undesirable
fluid leakage."
CAFC is unmoved ("[H]ere, the Board explicitly found that a skilled artisan would have “easily” mitigated any back-pressure and
leakage concerns by using “tangs” and “flanges,” small projections on each of the mixer and cartridge which attach to
one another, to reinforce the connection between the mixer
and cartridge").
Ergo affirmed en toto.
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.