Source: http://ipbiz.blogspot.com/2019/03/
Timestamp: 2019-06-26 03:59:45
Document Index: 426097438

Matched Legal Cases: ['§ 112', '§ 112', '§ 112', '§ 101', '§ 101', '§ 101', '§ 101', '§ 1295', '§ 41', '§ 706']

IPBiz: March 2019
The outcome was vacating/reversal of ND Cal:
Following a jury trial finding Sealant Systems International
and ITW Global Tire Repair (collectively, “SSI”)
liable to TEK Corporation and TEK Global, S.R.L. (collectively,
“TEK”) for infringement of U.S. Patent No.
7,789,110 (“the ’110 patent”), SSI appeals several pre- and
post-judgment orders from the United States District
Court for the Northern District of California. Specifically,
SSI appeals the district court’s claim construction order
and its orders denying SSI’s motions for a new trial and
judgment as a matter of law (“JMOL”) on invalidity, noninfringement,
and damages. SSI also challenges the district
court’s permanent injunction.
Because the district court improperly restricted SSI’s
efforts to present the jury with relevant evidence of invalidity,
we vacate the court’s final judgment as to validity
and reverse its denial of SSI’s motion for partial new trial
on validity. In the interest of judicial economy, we also
reach the remaining issues on appeal. We affirm on those
issues in the event the ’110 patent is found not invalid following
The district court apparently interpreted SSI II to foreclose
all obviousness theories based on Eriksen in view of
Bridgestone. But taken in context, SSI II does not go so
far. In SSI II, SSI raised only one obviousness theory.
That theory was based on the contention that the air tube
54 in the Bridgestone reference met the “additional hose”
limitation in claim 26 of the ’110 patent. SSI II, 616
F. App’x at 995. It was the only obviousness theory that
SSI II foreclosed, and the district court should not have
barred SSI from presenting to the jury other preserved obviousness
theories based on the combination of Eriksen
and Bridgestone that were not before this court in SSI II.
To that end, we agree with SSI that a partial new trial on
validity is appropriate here.
While we decline to reverse the district court’s denial
of JMOL of invalidity, we reverse the district court’s denial
of SSI’s motion for a partial new trial on validity. The district
court is therefore directed to grant SSI a new trial limited
to determining the issue of validity on an appropriate
evidentiary record. In view of this decision, we do not reach
SSI’s remaining arguments related to invalidity.1
Of 112 P6:
Paragraph 6 does not apply when “the words of the
claim are understood by persons of ordinary skill in the art
to have a sufficiently definite meaning as the name for
structure.” See Diebold Nixdorf, Inc. v. ITC, 899 F.3d 1291,
1297 (Fed. Cir. 2018). As a procedural matter, to determine
whether § 112, ¶ 6 applies to a claim limitation, we
first look to whether the limitation uses the word “means.”
Id. at 1297–98. If not, which is the case here, “there is a
rebuttable presumption that [§ 112, ¶ 6] does not apply.”
Id. at 1298. The presumption, however, can be overcome
“if the challenger demonstrates that the claim term fails to
‘recite sufficiently definite structure.’” Id. (quoting Williamson,
792 F.3d at 1349). For example, in Williamson,
we said that “[g]eneric terms such as ‘mechanism,’ ‘element,’
‘device,’ and other nonce words that reflect nothing
more than verbal constructs may be used in a claim in a
manner that is tantamount to using the word ‘means’ because
they ‘typically do not connote sufficiently definite
structure’ and therefore may invoke § 112, para. 6.” 792
F.3d at 1350 (quoting Mass. Inst. of Tech. v. Abacus Software,
462 F.3d 1344, 1354 (Fed. Cir. 2006)).
To determine whether the claim limitation at issue
connotes sufficiently definite structure to a person of ordinary
skill in the art, we look first to intrinsic evidence, and
then, if necessary, to the extrinsic evidence. See Phillips v.
AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).
Endo Pharmaceuticals Inc. appeals the district court’s
decision holding the claims of U.S. Patent No. 8,808,737
ineligible under 35 U.S.C. § 101. See Endo Pharms. Inc. v.
Actavis Inc., No. 14-cv-1381-RGA, 2015 WL 7253674
(D. Del. Nov. 17, 2015) (“District Court Op.”), adopting report and
recommendation, 2015 WL 5580488 (D. Del.
Sept. 23, 2015) (“Magistrate Op.”). Because the district
court incorrectly concluded that the claims at issue are directed to a natural law, we reverse
As to 12(b)(6)
“We apply regional circuit law to the review of motions
to dismiss for failure to state a claim under Rule 12(b)(6),”
In re TLI Commc’ns Patent Litig., 823 F.3d 607, 610
(Fed. Cir. 2016), here, the Third Circuit. The Third Circuit
“review[s] de novo a district court’s grant of a motion to dismiss
for failure to state a claim under Federal Rule of Civil
Procedure 12(b)(6).” Ballentine v. United States, 486 F.3d
806, 808 (3d Cir. 2007). To survive a motion to dismiss for
failure to state a claim, a complaint must allege “enough
facts to state a claim to relief that is plausible on its face.”
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007). “We
review issues unique to patent law, including patent eligibility under § 101,
consistent with our circuit’s precedent.”
Smart Sys. Innovations, LLC v. Chi. Transit Auth.,
873 F.3d 1364, 1367 (Fed. Cir. 2017)
Applying this law, we conclude that the asserted claims
are not directed to patent-ineligible subject matter.3 On
the contrary, the claims are directed to a patent-eligible
method of using oxymorphone or a pharmaceutically acceptable salt
thereof to treat pain in a renally impaired patient.4 Our conclusion is supported by the claim language
itself and confirmed by the specification. The claims recite
“[a] method of treating pain in a renally impaired patient.”
’737 patent col. 48 ll. 7–9. Claim 1 also requires specific
steps: (a) providing a pharmaceutical (5–80 mg of oral controlled-release
oxymorphone or one of its pharmaceutically
acceptable salts), (b) testing the patient for a disease state
(reduced kidney function based on creatinine clearance
rate), and then (c) administering the pharmaceutical (a
lower dose of oxymorphone) based on the creatinine clearance rate to achieve
an average AUC of oxymorphone over
a 12-hour period of less than 21 ng·hr/mL. Consistent with
the claims, the abstract, patent title, and summary of the
invention all describe the invention as a “method of treating pain” in patients
with renal impairment. Id. at Abstract, col. 1 ll. 1–5; see id. at col. 2 ll. 35–43. The
specification predominantly describes the invention as a
method that treats renally impaired pain patients with less
oxymorphone while still treating their pain. Indeed, the
specification explains that the method “avoid[s] possible issues in dosing” and allows for treatment with “the lowest
available dose” for patients with renal impairment. Id.
at col. 10 ll. 26–27, 40–41.
We held similar claims patent-eligible in Vanda Pharmaceuticals Inc. v.
West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018).
issue in Vanda related to a method of treating schizophrenia patients with a drug (iloperidone),
where the administered dose is adjusted based on whether or not the patient
is a “CYP2D6 poor metabolizer.” 887 F.3d at 1121.
The claims at issue here are legally indistinguishable
from the representative claim in Vanda. Both claims recite
a method for treating a patient. The Vanda patent claims
recite the steps of carrying out a dosage regimen based on
the results of genetic testing. Id. at 1135. Here, the claims
similarly recite the steps of carrying out a dosage regimen,
though the steps are based on the results of kidney function
testing. Additionally, the claims in both cases require specific treatment steps.
Also like the claims in Vanda, the claims here differ
from those in Mayo in material respects. Although the representative claim in Mayo recited administering a thiopurine drug to a patient, the claim as a whole was not directed
to the application of a drug to treat a particular disease.
See Mayo, 566 U.S. at 74, 87; Vanda, 887 F.3d at 1134.
Furthermore, the administering step in Mayo is distinguishable from the administering step in the ’737 patent
because the administering step in Mayo is the first step in
the method that simply describes giving the drug to a patient with a certain disorder. By contrast, the administering step in the ’737 patent is the step that describes giving
a specific dose of the drug based on the results of kidney
function testing. The Supreme Court in Mayo underscored
the distinction between such method of treatment claims
and those in Mayo, noting that “[u]nlike, say, a typical patent on a new drug or a new way of using an existing drug,
the patent claims do not confine their reach to particular
applications of those laws.” Mayo, 566 U.S. at 87; Vanda,
887 F.3d at 1135. In Vanda, the inventors recognized the
relationship between iloperidone dosage and the patient’s
CYP2D6 poor metabolizer genotype, but that was not what
From eu-startups on IPlytics:
link: https://www.eu-startups.com/2019/03/berlin-based-market-intelligence-platform-iplytics-raises-millions-to-disrupt-patent-analytics/
Complexities in intellectual property for individual inventors: DeVona v Zeitels
At jury trial, the inventorship issue went one way; the contract issue the other way:
The parties went to trial on the patent inventorship
claim and partnership claims. The jury found against Mr.
DeVona on patent inventorship, rejecting his theory that
he meaningfully contributed to the glottiscope design embodied by U.S. Patent No. 6,955,645.
Thus, Dr. Zeitels remains the only inventor listed on the patent. However, the
jury found in Mr. DeVona’s favor on the partnership
claims. For breach of fiduciary duty, the jury awarded
$395,907. For breach of the partnership agreement, the
jury awarded Mr. DeVona $352,007
But JNOV went against DeVona, and the CAFC affirmed.
The outcome was mixed, with patent validity sustained (good for patentee SRI), but damages issues in need of review:
We affirm the district court’s denial of summary judgment of ineligibility,
adopt its construction of “network
traffic data,” and affirm its summary judgment of no anticipation.
We vacate and remand the district court’s denial
of judgment as a matter of law of no willful infringement,
and therefore vacate the district court’s enhancement of
damages. We also vacate the district court’s award of attorneys’ fees and remand for recalculation.
Finally, we affirm the district court’s award of ongoing royalties on postverdict
sales of products that were actually found to infringe or are not colorably different.
Accordingly, we affirm-in-part, vacate-in-part, and remand for further proceedings consistent with this opinion.
The Berkheimer case is cited:
We review de novo whether a claim is drawn to patenteligible subject matter.
Berkheimer v. HP Inc., 881 F.3d
1360, 1365 (Fed. Cir. 2018) (citing Intellectual Ventures I
LLC v. Capital One Fin. Corp., 850 F.3d 1332, 1338
(Fed. Cir. 2017)). Section 101 defines patent-eligible subject matter
as “any new and useful process, machine, manufacture, or composition of matter, or any new and useful
improvement thereof.” 35 U.S.C. § 101. Laws of nature,
natural phenomena, and abstract ideas, however, are not
patentable. See Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 70–71 (2012) (citing Diamond v.
Diehr, 450 U.S. 175, 185 (1981)).
To determine whether a patent claims ineligible subject matter, the Supreme Court has established a two-step
framework. First, we must determine whether the claims
at issue are directed to a patent-ineligible concept such as
an abstract idea. Alice Corp. v. CLS Bank Int’l, 573 U.S.
208, 217 (2014). Second, if the claims are directed to an
abstract idea, we must “consider the elements of each claim
both individually and ‘as an ordered combination’ to determine whether
the additional elements ‘transform the nature of the claim’ into a patent-eligible application.” Id.
(quoting Mayo, 566 U.S. at 79). To transform an abstract
idea into a patent-eligible application, the claims must do
“more than simply stat[e] the abstract idea while adding
the words ‘apply it.’” Id. at 221 (quoting Mayo, 566 U.S.
at 72 (internal alterations omitted)).
We resolve the eligibility issue at Alice step one and
conclude that claim 1 is not directed to an abstract idea.
See Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1337
(Fed. Cir. 2016). The district court concluded that the
claims are more complex than merely reciting the performance of a
known business practice on the Internet and are
better understood as being necessarily rooted in computer
technology in order to solve a specific problem in the realm
Contrary to Cisco’s assertion, the claims are not directed to just analyzing data
from multiple sources to detect suspicious activity. Instead, the claims are directed to
an improvement in computer network technology. Indeed,
representative claim 1 recites using network monitors to
detect suspicious network activity based on analysis of network traffic data,
generating reports of that suspicious activity, and integrating those reports using hierarchical
monitors. ’615 patent col. 15 ll. 2–21. The “focus of the
claims is on the specific asserted improvement in computer
capabilities”—that is, providing a network defense system
that monitors network traffic in real-time to automatically
detect large-scale attacks. Enfish, 822 F.3d at 1335–36.
We also hold that the district court did not err in granting summary judgment
that the asserted claims are not anticipated by SRI’s own EMERALD 1997 reference. We
review the district court’s summary judgment of no anticipation under regional circuit law.
See MAG Aerospace Indus., Inc. v. B/E Aerospace, Inc., 816 F.3d 1374, 1376
(Fed. Cir. 2016). The Third Circuit reviews a grant of summary judgment de novo, applying the same standard as the
district court. See Gonzalez v. Sec’y of Dep’t of Homeland
Sec., 678 F.3d 254, 257 (3d Cir. 2012). Summary judgment
is appropriate when, drawing all justifiable inferences in
the nonmovant’s favor, there exists no genuine issue of material fact and the movant
is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a); see also Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 255 (1986). Anticipation requires that a single prior art reference disclose each and
every limitation of the claimed invention, either expressly
or inherently. See Verdegaal Bros. v. Union Oil Co. of Cal.,
814 F.2d 628, 631 (Fed. Cir. 1987).
Here, Cisco was treading upon the ground of PREVIOUS arguments
EMERALD 1997 discloses a tool for tracking malicious
activity across large networks. The question before us is
whether the district court erred in concluding on summary
judgment that EMERALD 1997 does not disclose detection
of any of the network traffic data categories listed in
claim 1 of the ’203 and ’615 patents. The Patent Office
considered EMERALD 1997 during the original examination of the ’615 patent,
and the patentability of the claims
over the reference was confirmed in multiple reexamination and litigation proceedings.
Indeed, during reexamination, the Patent Office accepted SRI’s argument that the
claim limitation requires detecting suspicious activity
based on “direct examination” of network packets to distinguish EMERALD 1997.
J.A. 26402 (“[T]he closest prior art
of record, Emerald 1997, fails to teach direct examination
of packet data.”); J.A. 27101 (same).
AND Cisco's experts did not help:
On this record, we conclude that summary judgment
was appropriate. EMERALD 1997 does not expressly disclose directly
examining network packets as required by
the claims—especially not to obtain data about network
connection requests. Nor does Cisco’s expert testimony create a genuine issue of fact on this issue.
Rather, we agree
with the district court that Cisco’s expert’s testimony is
both inconsistent and “based on [] multiple layers of supposition.” Summary Judgment Op., 179 F. Supp. 3d at 358.
Because the evidence does not support express or inherent
disclosure of direct examination of packet data, we conclude that the district court did not err in holding that
there was no genuine issue of fact regarding whether
EMERALD 1997 disclosed analyzing the specific enumerated types of network traffic data recited in the claims.
Cisco did win on willful infringement
Cisco also appeals the district court’s denial of JMOL
that it did not willfully infringe the asserted patents because
the jury’s willfulness finding is not supported by substantial evidence.
We agree that the jury’s finding that
Cisco willfully infringed the patents-in-suit prior to receiving notice
thereof is not supported by substantial evidence
and therefore vacate and remand.
No need for engineers to read patents??
Even accepting this evidence as true and weighing all
inferences in SRI’s favor, we conclude that the record is insufficient
to establish that Cisco’s conduct rose to the level
of wanton, malicious, and bad-faith behavior required for
willful infringement. First, it is undisputed that the Cisco
employees who did not read the patents-in-suit until their
depositions were engineers without legal training. Given
Cisco’s size and resources, it was unremarkable that the
engineers—as opposed to Cisco’s in-house or outside counsel—
did not analyze the patents-in-suit themselves. The
other rationale offered by the district court—that Cisco designed
the products and services in an infringing manner
and that Cisco instructed its customers to use the products
and services in an infringing manner—is nothing more
than proof that Cisco directly infringed and induced others
to infringe the patents-in-suit.
Note footnote 6:
We recognize that, ideally, it should not fall to the
district court to determine when, if ever, willful infringement
began through the mechanism of JMOL. Rather, the
question of when willful infringement began is a fact issue
that would have been best presented to the jury in a special
verdict form with appropriate jury instructions. Better yet,
perhaps SRI could have recognized the shortcomings in its
case and presented a more limited case of willful infringement from 2012 onwards.
Or perhaps Cisco could have
filed a motion for summary judgment of no willful infringement prior to May 8, 2012.
Judge Lourie dissented on the 101 issue
I respectfully dissent from the majority’s decision upholding the eligibility of the claims. In my view, they are
clearly abstract. In fact, they differ very little from the
claims in Electric Power Group, LLC v. Alstom S.A., 830
F.3d 1350, 1355 (Fed. Cir. 2016), where we found the
claims to be abstract.
Thus, I would find the claims to be directed to an abstract idea at Alice step one, without an inventive concept
at step two, and reverse the district court’s finding of eligibility. Because I would find the claims at issue to be ineligible, I would not reach the remaining issues in the case.
CBS Sunday Morning on St. Patrick's Day 2019: why do something if it already exists?
From the story Hudson Yards' Vessel: Like a park, but vertical on CBS Sunday Morning on 17 March 2019:
Almanac did Nat King Cole and Nature did cardinals in Loganville, PA (in York County and home to Browns Orchards & Farm Market).
Natural Alternatives wins 101 appeal at CAFC: We live in the natural world, and all inventions are constrained by the laws of nature.
Natural Alternatives International, Inc., appeals a decision
of the U.S. District Court for the Southern District
of California granting Creative Compounds, LLC’s motion
for judgment on the pleadings that the asserted claims of
U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376,
8,993,610, 8,470,865, and RE45,947 are not patent eligible.
Because Creative Compounds has failed to demonstrate
under Natural Alternatives’ proposed claim constructions
that the claims are not patent eligible, we reverse and remand.
This was an appeal of a dismissal under FRCP 12(c):
The district court held that the claims at issue are not
patent eligible and dismissed. We review a district court’s
Rule 12(c) dismissal for judgment on the pleadings under
the law of the regional circuit. Amdocs (Isr.) Ltd. v. Openet
Telecom, Inc., 841 F.3d 1288, 1293 (Fed. Cir. 2016). The
Ninth Circuit reviews a court’s grant of judgment on the
pleadings de novo. Newton v. Parker Drilling Mgmt.
Servs., Ltd., 881 F.3d 1078, 1083 (9th Cir. 2018). T
his analysis is “functionally identical” to the standard for deciding
a motion to dismiss. Cafasso v. Gen. Dynamics C4 Sys.,
Inc., 637 F.3d 1047, 1055 n.4 (9th Cir. 2011) (quoting
Dworkin v. Hustler Magazine Inc., 867 F.2d 1188, 1192 (9th
Cir. 1989)). In doing so, the court “inquire[s] whether the
complaint’s factual allegations, together with all reasonable inferences,
state a plausible claim for relief.” Id. at
1055. In the Ninth Circuit, a court deciding a motion under
Rule 12 may consider “material which is properly submitted as part of the complaint,”
including documents that are
not physically attached to the complaint, if their authenticity is not contested
and the complaint necessarily relies on
them, and it may take judicial notice of matters of public
record. See Lee v. City of L.A., 250 F.3d 668, 688–89 (9th
As to method claims:
The Method Claims at issue are treatment claims.
They cover using a natural product in unnatural quantities
to alter a patient’s natural state, to treat a patient with
specific dosages outlined in the patents. We hold, therefore,
that the Method Claims are not directed to ineligible
Under Natural Alternatives’ proposed claim constructions,
the Method Claims are not directed to an exception
to § 101 under the first step of the Alice test. Therefore,
judgment on the pleadings was inappropriate.
Moreover, at step two, factual impediments exist to resolving the case at this stage.
Claim 1 of the ’865 patent
requires “the amino acid is provided through a dietary supplement,”
with the dietary supplement limitation construed as “an addition to the human diet, which is not a
natural or conventional food.” J.A. 581 (emphasis added).
Creative Compounds argues that the “inventors admitted
in the ’865 patent, and all of the patents-on-appeal, that
placing a natural substance into a dietary supplement for
administration to a human, in order to increase the function of tissues is a conventional,
well-known activity.” Appellee Br. 37 (citing ’865 patent 1:41–44). The language it
cites, however, does not stand for that proposition. Instead,
the patent states “[n]atural food supplements are
typically designed to compensate for reduced levels of nutrients in the modern human
and animal diet. In particular, useful supplements increase the function of tissues
when consumed.” ’865 patent 1:41–44. At most, this language shows that the prior art
contained food supplements
containing natural products, and typically those were used
to compensate for reduced levels of nutrients. It does not
establish that the dietary supplement in the claims, which
Note the "Big Mac" standard in footnote 3:
Indeed, the record contains an expert declaration
stating that “one 3.2 gram daily supplement of beta-alanine
is the equivalent to eating at least 109 Big Macs per
Of a procedural point:
Although Natural Alternatives argued that claim 34 is eligible as
it is a treatment claim with a very specific dosing
regimen contained within the claim itself, at oral argument
Natural Alternatives acknowledged that this patent was
not asserted against Creative Compounds. Oral Arg. 0:52–
1:20. Though rendered ineligible in the same district court
opinion as the other patents at issue in this appeal, the ’947
patent was not asserted against Creative Compounds.4
Claims not asserted in this litigation against this appellee,
Creative Compounds, are not properly before this court in
this appeal. This does not prejudice the patentee’s ability
to defend the eligibility of the ’947 patent in future proceedings.
Of the product claims, Chakrabarty is cited:
Although beta-alanine is a natural product, the Product Claims are
not directed to beta-alanine. A claim to a
manufacture or composition of matter made from a natural
product is not directed to the natural product where it has
different characteristics and “the potential for significant
utility.” See Diamond v. Chakrabarty, 447 U.S. 303, 310
(1980). Just as the Method Claims are directed to specific
methods of treatment that employ a natural law, the Product Claims
are directed to specific treatment formulations
that incorporate natural products, but they have different
characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.
Funk Brothers is mentioned:
Moreover, even though claim 6 contains a combination
of glycine and beta-alanine, both of which are natural products,
that is not necessarily sufficient to establish that the
claimed combination is “directed to” ineligible subject matter.
The Court’s decision in Funk Brothers does not stand
for the proposition that any combination of ineligible subject matter is itself ineligible.
In Funk Brothers, the Court
held that claims to a mixture of two naturally occurring
bacteria were not patent eligible where each bacteria species in the
claimed combination “ha[d] the same effect it
always had,” and the “combination of species produce[d] . . .
no enlargement of the range of their utility.” 333 U.S. at
131. The combination of the bacteria into the same package did
“not improve in any way their natural function.”
Id. Here, as Creative Compounds’ counsel acknowledged
at oral argument, the record indicates that the claimed
combination of glycine and beta-alanine could have synergistic
effects allowing for outcomes that the individual components could not have.
Given that this is the pleading stage, we would have to accept this statement as true even if it were just an allegation
in the pleadings. Instead, what we have goes far beyond
that, including a statement in an article attached to an expert report explaining that “one of insulin’s effects is to increase amino acid (such as beta-alanine) into our cells,”
J.A. 1063, a statement in the specification that “[i]t may be
that glycine enhances insulin sensitivity,” ’376 patent at
6:3–5, and an expert declaration explaining that direct supplementation of a different amino acid had no effect unless
“co-supplemented with glucose or other compounds increasing the concentration of insulin in circulation,”
J.A. 1132. All of these suggest that when combined the
beta-alanine and glycine have effects that are greater than
the sum of the parts. At a minimum, there are sufficient
factual allegations to render judgment on the pleadings inappropriate. Accordingly, given the factual allegations,
these claims would still survive a motion for judgment on
the pleadings at the first step of the Alice test
Finally, even if the Product Claims were directed to ineligible subject matter,
judgment on the pleadings would
still be inappropriate under step two. Like claim 1 of the
’865 patent, the Product Claims contain a dietary supplement limitation,
with the same proposed construction. See
J.A. 572, 574. As we explained with regard to the Method
Claims, the specification does not contain language supporting the idea that this limitation was well-understood,
routine, and conventional. The language in the specification does not support this proposition, and patentee’s claim
construction contradicts Creative Compounds’ position, so
such a determination may not be made on a motion for
The claims at issue are not directed to ineligible subject
matter under step one of the Alice test. We live in the natural world,
and all inventions are constrained by the laws
of nature. As the Supreme Court has warned, we must be
careful not to overly abstract claims when performing the
Alice analysis. For the foregoing reasons, we reverse the
district court’s decision that the claims are directed to ineligible subject matter,
and we remand for further proceedings consistent with this opinion.
link: https://www.the-scientist.com/news-opinion/the-lancet-retracts-cardiac-stem-cell-clinical-trial-paper-65598
CAFC vacates validity ruling of D. Del./Robinson in Forest case on "motivation to combine" issue
Following a bench trial, the district court held Appellants had not established
claims 1–2, 4–6, and 9–10 to be
invalid and held Forest had not established infringement
of claims 4, 9, and 10 as to Alembic and Breckenridge. Appellants appeal the
district court’s construction of claim 1
and its determination that the claims have not been established to be invalid. Forest cross-appeals,
arguing the district court’s finding that Breckenridge and Alembic do not
infringe claim 4 was clearly erroneous. We have jurisdiction under 28 U.S.C. § 1295(a)(1).
We vacate and remand
the district court’s validity determination, and we vacate
and remand for it to reconsider infringement under a corrected claim construction.
Of interest as to clinical trials
Appellants object to this reasoning, arguing that the
only reason the cardiotoxicity issue was not publicly known
was because Organon concealed and misrepresented the
events suffered by patients in clinical studies when it reported the
results of those studies. While the actions alleged may raise a variety of concerns, we do not see how
they affect the district court’s obviousness analysis.
Ultimately, we see no clear error in the district court’s consideration
of the unknown nature of the problem solved by the
inventors and the factors that would teach away from their
Here, the district court found it was “surprising and
unexpected” that the claimed “sublingual route of administration successfully resolved the serious cardiotoxic event
reported in the ’476 patent.” J.A. 74. However, as the district court found, there was nothing in the prior art that
indicated cardiotoxic problems existed with other routes of
administration. J.A. 68. We explained in Soni that the
reason why unexpected results support a conclusion of nonobviousness is simple:
“that which would have been surprising to a person of ordinary skill in a particular art
would not have been obvious.” 54 F.3d at 750. At the time
of the claimed invention, a person of ordinary skill could
not have been surprised that the sublingual route of administration did not result in cardiotoxic effects because
the person of ordinary skill would not have been aware that
other routes of administration do result in cardiotoxic effects. The district court, therefore, erred in its analysis of
We vacate the district court’s judgment that Claims 1
and 4 are not invalid and remand for it to consider the limited question of whether compliance concerns with patients
who have trouble swallowing would provide a motivation
to combine and its impact on the obviousness analysis.
The case IN RE: QAPSULE TECHNOLOGIES, INC. gives an interesting walk-through of case law, including a citation to
Yale Lock Mfg. Co. v. Greenleaf, 117 U.S. 554, 559 (1886)
(“The scope of letters patent must be limited to the invention covered by the
claim, and while the claim may be illustrated it cannot be
enlarged by language used in other parts of the specification.”).
Faced with the new ground of rejection, Qapsule had
the option of reopening prosecution before the examiner, or
requesting rehearing. See 37 C.F.R. § 41.50(B)(2). Qapsule
chose the rehearing route. Treating claim 1 as representative,
Qapsule argued that “Claim 1 includes a limitation
that the shell proteins are recombinant” whereas the shell
proteins identified by the Board in Perez “are not recombinant.”
’773 Application, Request for Rehearing, filed Jan.
22, 2018, at 3 (J.A.64). Qapsule stated in its request for
rehearing that Ye disclosed recombinant shell proteins, but
not in combination with recombinant proteins as claimed.
See id. But Qapsule acknowledged that the Board’s new
ground of rejection was for anticipation by Perez and not
Ye. See id. Accordingly, Qapsule argued that Perez did not
anticipate the rejected claims.
This led to invocation of
In re Dilnot, 300 F.2d 945, 950 (CCPA 1962), “addition of a
method step in a product claim, which product is not
patentably distinguishable from the prior art, cannot impart
patentability to the old product.”6 The Board concluded
that “whether the shell proteins were produced in a ‘recombinant’ eukaryotic
expression system in MDCK cells or produced as taught by Perez by virus infection in the MDCK
cells, the final constructs including the shell proteins would
be expected to be structurally identical because they would
share the same amino acid sequence, same glycosylation
patterns (if any), as they were produced by the same cell.”
Id. And the Board remarked that Qapsule had failed to
provide any evidence rebutting the inherency ruling. See
“[A]nticipation is a question of fact, including whether
an element is inherent in the prior art.” In re Gleave, 560
F.3d 1331, 1334–35 (Fed. Cir. 2009). Thus we review the
Board’s factual finding of inherent anticipation for support
by substantial evidence. 5 U.S.C. § 706(2)(E); Dickinson v.
Zurko, 527 U.S. 150, 152 (1999); In re Gartside, 203 F.3d
1305, 1316 (Fed. Cir. 2000). “Substantial evidence is something less
than the weight of the evidence but more than a
mere scintilla of evidence,” In re Kotzab, 217 F.3d 1365,
1369 (Fed. Cir. 2000), and “means such relevant evidence
as a reasonable mind might accept as adequate to support
a conclusion,” Consol. Edison Co. of New York v. NLRB, 305
U.S. 197, 229 (1938).
Yes, In re Best arises:
Qapsule further argues that the Board misapplied the
requirement of structural identity for inherent anticipation
under In re Best. 562 F.2d 1252, 1256 (CCPA 1977)
(“Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by
identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do
not necessarily or inherently possess the characteristics of
his claimed product.”). We find that the Board properly applied
the concept of inherency on an element-by-element
basis in order to establish that the M1 protein, viral RNA,
and PB1 protein would meet the claimed “shell protein,”
“bifunctional polynucleotide,” and “cargo protein” limitations, respectively.
If the anticipating reference has the elements following a "comprising" transition,
that is enough for a prima facie case:
On appeal, Qapsule points to the presence of additional
elements in Perez, such as a lipid envelope and other proteins, as evidencing
a structural difference between Perez’s
influenza A disclosure and the recited limitations of representative claim 1.
See Appellant Br. at 9–12. Qapsule contends that these structural differences negate anticipation.
That is incorrect, as applied herein, for as discussed supra,
Qapsule’s claims are not limited to the three recited components. The Board correctly found that the Examiner met
his burden of establishing structural identity of the
claimed synthetic capsule construct in view of the scope of
representative claim 1, and that this prima facie case has
not been rebutted by the Applicant. See In re Jung, 637
F.3d 1356, 1362 (Fed. Cir. 2011) (explaining the burdenshifting framework during prosecution); In re Mousa, 479
F. App’x 348, 352 (applying the same specifically to inherency).
There is also discussion of the distinction between comprising and having:
Similarly, the word “having,” in the clause “a bifunctional
polynucleotide having . . . a second aptameric activity for
retaining said bifunctional polynucleotide within said enclosure by assembly with the interior surface of said shell
protein” does not exclude additional, unrecited elements
from participating in capsule assembly. See id.:
The transition “having” can also make a claim
open. However, the term “having” does not convey
the open-ended meaning as strongly as “comprising.” “Having,”
for instance, does not create a presumption that the body of the claim is open.
Therefore, this court examines the claim in its full
context to determine whether [Applicant’s] use of
“having” limits claim 1 to its recited elements.
CAFC in Personal Web: "substantial evidence" meets the brick wall of inevitable inherency
The decision of the Board was found not to pass the substantial evidence threshold:
We conclude that the Board’s inherency finding derived
from column 17 of Woodhill for teaching the “compared to
a plurality of values” limitation lacks substantial evidence.
While it is possible that Woodhill’s system utilizes an unstated Binary Object
Identifier lookup table to locate binary objects of a previous version of a file that is going to
be restored (column 17 of Woodhill), mere possibility is not
enough. “Inherency . . . may not be established by probabilities or possibilities.”
PAR Pharm., Inc. v. TWI Pharm.,
Inc., 773 F.3d 1186, 1195 (Fed. Cir. 2014). “The mere fact
that a certain thing may result from a given set of circumstances is not sufficient.”
Id. (emphasis added). Rather, a
party must “show that the natural result flowing from the
operation as taught would result in the performance of the
questioned function.” Id. (emphasis in original).
As PersonalWeb suggests, an equally plausible, if not
more plausible, understanding of Woodhill is that
Woodhill’s system uses conventional file names and locations
to locate files and the Binary Object Offset field to
locate a given binary object within a file.
Because we find that the proposed, theoretical Binary
Object Identifier look-up table that Apple and the Board
rely on does not necessarily exist in Woodhill, the Board’s
reliance on inherency for that element in its obviousness
analysis was improper
New Jersey's 45J: regulating acceptance of compensation to prescribers by drug companies
The purpose of New Jersey's administrative rule 45J:
The rules in this chapter regulate the receipt and acceptance by prescribers of anything
of value from pharmaceutical manufacturers to ensure that such relationships do not
interfere with prescribers' independent professional judgment.
"Prescriber" means a physician, podiatrist, physician assistant, advanced practice
nurse, dentist, or optometrist licensed pursuant to Title 45 of the Revised Statutes.
"Prescriber" does not include a licensee who is an employee, as defined in N.J.A.C.
18:35-7.1, of a pharmaceutical manufacturer who does not provide patient care.
"Promotional activity" means any unaccredited activity, meeting, or program organized
or sponsored by a pharmaceutical manufacturer, or the manufacturer's agent, that is
directed at prescribers to promote the prescription, recommendation, supply,
administration, use, or consumption of the manufacturer's products through any media
or medium. “Promotional activity” does not include an education event or services
provided in connection with research activities.” [bolding added]
"Education event" means an education event, third-party scientific or educational
conference, professional meeting or workshop, seminar, U.S. Food and Drug
Administration required education and training, or any other gathering, held in a venue
that is appropriate and conducive to informational communication and training about
healthcare information, where:
1. The gathering is primarily dedicated, in both time and effort, to promoting
objective scientific and educational activities and discourse (one or more
educational presentation(s) should be the highlight of the gathering); and
2. The main purpose for bringing attendees together is to further their knowledge
on the topic(s) being presented.
13:45J-1.6 Bona fide services cap
A prescriber shall not accept more than $ 10,000 in the aggregate from all
pharmaceutical manufacturers in any calendar year for the bona fide services of
presentations as speakers at promotional activities, participation on advisory boards,
and consulting arrangements. Payments for speaking at education events are not
subject to this cap, but must be for fair market value and set forth in a written
agreement. Payments for research activities and, consistent with NJ.A.C. 13:45J1.4(a)10,
payments for royalties and licensing fees are not subject to this cap.
Text on NJ radio's 101.5 website states:
On the same day Chris Christie ends his rein as the Governor of New Jersey,
the state welcomes new rules — crafted by his administration — that aim to put a dent
in what's considered one of the leading causes of the deadly opioid crisis.
Proposed in August, the rules that take effect Tuesday impose limits on payments
and other compensation that licensed prescribers in New Jersey may accept from pharmaceutical companies.
Licensed physicians, physician assistants, dentists and other prescribers may not accept
more than $10,000 per year (total from all manufacturers) for services such as speaking engagements,
participation on advisory boards and consulting arrangements. Contracts entered before Tuesday do not apply.
The new cap does not apply to payments related to research and education events.
Meals provided by manufacturers to prescribers may not exceed a value of $15. The original proposal imposed
a cap on the number of meals at four per year, per manufacturer, but that was removed following public comment.
Prescribers are prohibited from accepting gifts such as cash, gift cards, entertainment and items
with a manufacturer's logo — anything that would benefit the prescriber or staff.
According to Christie's office, New Jersey doctors collected $69 million from drug companies
and device manufactures in 2016. Two-thirds of the cash was received by just 300 physicians,
with nearly 40 bringing in at least $200,000.
The rules hold the prescribers accountable for staying within the limits, not the pharmaceutical companies,
making New Jersey unique when compared to other states with caps in place.
"I think that anything that eliminates the appearance of a conflict, or the appearance that doctors are prescribing
opioids for the wrong reason, is certainly a step in the right direction," Angelo Valente, executive director
of the Partnership for a Drug-Free New Jersey, told New Jersey 101.5.
link: https://nj1015.com/new-rules-cap-payments-from-drug-makers-to-doctors/
A 2007 article in the New York Times brought out an issue in compensating doctors for giving
talks TO third parties:
Those delivering the talks get training that involves learning drug makers’ most important marketing messages.
And they receive anywhere from $500 to $5,000 for each talk they give, with some doctors earning more than $100,000 annually.
“This is the companies’ way of thanking high prescribers,” said David J. Rothman,
president of the Institute on Medicine as a Profession at Columbia University.
“Drug companies don’t really care who’s in the audience.”
When asked whether drug makers’ motivation for hiring doctors to educate secretaries
may be to influence them instead of the secretaries, many doctors said they had never thought of that.
“That’s a good question,” answered Dr. Kent G. Brockmann, a psychiatrist from the Twin Cities,
who earned more than $16,000 from 2003 to 2005 doing educational talks for drug makers.
“Maybe they’re trying to keep me loyal to those drugs.”
link: https://www.nytimes.com/2007/10/12/us/12gift.html
From meetingsnet.com:
The unintended consequences ROI-NJ.com reported on are not a surprise. As an initial response,
many of our clients have avoided placing programs in New Jersey or with New Jersey prescribers
until their legal and compliance teams have finalized their internal policies explaining how to
follow the new law. Whether these organizations end up mirroring their own protocols in Vermont and Minnesota,
or take a more nuanced approach, will become evident as the industry works quickly to adapt to the new law.
In the meantime, the law, which has had some disruptive elements, does deserve industry attention; and with
collaboration, communication, and attention to detail, compliance is achievable.
One notes that the details of 45J are in the form of a regulation, not as a statute passed through
the legislature. Note text from policymed.com:
State Sen. Joseph Vitale, D-Middlesex, said the proposal was a step in the right direction, but said $10,000 was still too high. “$10,000 is still a lot of money,” Vitale said. “Why not limit it to $100 or $200?”
Link: https://www.policymed.com/2017/09/christie-introduces-regulation-to-cap-physician-pharma-relationships.html
**There has been some discussion of the impact of 45J on patient educational programs in the area
of multiple sclerosis (MS).
"60 Minutes" on 10 March 2019 with Jerome Powell; and was Ben Bernanke right about what Lincoln said??
Within the "60 Minutes" interview with Jerome Powell on 10 March 2019, there was a quote of Lincoln by Ben Bernanke, described by CBS in the following way:
The "60 Minutes" interview also reunited Powell with his predecessors at the Fed,
former chairs Janet Yellen and Ben Bernanke. Both withstood withering criticism
during their stints at the helm of the nation's central bank.
Asked by Pelley for their advice for Powell, Yellen said, "To be inclusive in decision-making,
to bring many voices to the table, to listen carefully."
Bernanke cited a quotation on his desk from Abraham Lincoln: "To the effect that,
'If you're right, it won't matter what they say. If you're wrong, it won't matter what they say.'
So the best thing to do is to make what you believe is the right call."
[Link: https://www.cbsnews.com/news/jerome-powell-60-minutes-interview-we-dont-feel-any-hurry-to-raise-interest-rates-this-year/ ]
The quote mentioned by Bernanke is closer to words of Richard Nixon speaking on the war in Vietnam on November 3, 1969:
“If it does succeed, what the critics say now won’t matter If it does not succeed, anything I say then won’t matter.”
Public Papers of the Presidents of the United States: Richard Nixon, 1969, p. 909.
The relevant text of Lincoln
I do the very best I know how—the very best I can; and I mean to keep doing so until the end.
President ABRAHAM LINCOLN.—Francis Carpenter, Six Months at the White House, pp. 258–59 (1867).
Neither Lincoln nor Nixon said that if he were wrong, what the critics said would not matter, as
asserted by Bernanke [If you're wrong, it won't matter what they say.] Both Lincoln and Nixon were
speaking of the inadequacy of defenses to a wrong decision.
The interview of Powell was of interest. There had been a "teaser" ad by Pelley of what kept Powell up
at night. No, it turned out "not" to be Trump. From the interview:
PELLEY: How concerned are you about either criminals or more importantly hostile nations attacking
our banking system through the computer system?
POWELL: So cyber risk is a major focus. Perhaps the major focus in terms of big risks.
I think the kinds of risks that happened to us in the financial crisis, we've worked hard
to build up resilience against those. Cyber risk is a constantly evolving risk.
We devote very large amounts of time and resources to protect the Fed, but also
to protect financial institutions and the financial markets. And private corporations do the same thing.
The banks we supervise are required to have plans in place and state of the art, you know, technology and the like.
I would say for cyber risk though I've never felt a time when I think we're doing enough.
We just have to keep running hard to keep up with the risk.
The matter of labor participation/discouraged workers arose:
POWELL: But we have longer run issues. And it would be important for us as a nation to address these issues.
In particular, you're not counted as unemployed if you haven't looked for a job in the last four weeks.
And we have an unusually large number of people in their prime working years who are not in the labor force.
The United States has a lower labor force participation rate than almost every other advanced country.
That is not our self-image as a country. It's very important that we bring people back into the labor force
so that they can contribute to our shared prosperity and reap the benefits of doing so.
The economy will be stronger and the country will be stronger if we can do that.
Not all of the tools to accomplish that are the Fed's. Many of them are in the hands of Congress.
POWELL: They went a lot of places. Many of them are discouraged from finding work.
There are a range of causes, really. And part of it is evolving technology.
So as technology evolves, it requires rising skills on the part of the people.
U.S. educational attainment has not moved up as rapidly as it has in other countries.
Globalization's also a factor. For many advanced economies, manufacturing, to some extent,
has moved into developing countries. And so the manufacturing employment and the manufacturing base is smaller than it was.
So for whatever reason, and the opioid crisis is related to, I think,
to those other factors. There are just are quite a few people who are out of the labor force,
particularly young males, who would be better off in the labor force, and the country would be better off for it as well.
Powell brought up training:
POWELL: That no one is talking about? I would point to our longer-run challenges.
So, the U.S. economy right now is in a pretty good place. Unemployment is at a 50-year low.
Inflation is close to its target. We are growing at a reasonable rate. But we face longer-run challenges.
And I would like to see a stronger national focus on, for example, labor force participation.
There are plenty of prime-aged people who are not in the labor force and who would be better off in the labor force.
And I'd like to see us find policies that can support and reward work, provide training and education, and generally try to raise U.S. labor force participation so that we're no longer at the bottom of the league table among advanced economies. I think that's a win-win. That gives us faster growth. It gives us more widespread prosperity. These people can contribute to our shared prosperity, and they can also benefit from doing so.
HOWEVER, there are plenty of trained U.S. workers who are displaced by "trained" foreign workers who
See 2012 post on IPBiz Startup Act 2.0: are you turning up your nose at $150K/year jobs?
IAM on IBM's Kappos, not touching the political or patent pulse? including
A NBC Nightly News story on 3 April 09 discussed how an IBM Fishkill employee [Frederic (Rick) Clark]
was offered the opportunity to keep his job, in India at the prevailing salary in India [20 to 25% of US].
60 Minutes Powell transcript
https://www.cbsnews.com/news/full-transcript-60-minutes-interview-with-fed-chair-jerome-powell/
This "complete" transcript does NOT include the Bernanke text.
CAFC discusses nexus in XACTWARE SOLUTIONS, INC. v. EAGLE VIEW TECHNOLOGIES
Of interest in the decision,
The parties spent most of their briefing in these appeals debating
the evidentiary showing required for a patent owner to be given the presumption of nexus as to
evidence it offers to show secondary considerations of nonobviousness.
We do not reach that issue for two reasons.
First, this was not clearly at issue in the parties’ briefing
before the Board. In its Patent Owner Response, Eagle
View Technologies, Inc. (“Eagle View”) argued that a nexus
existed between its secondary considerations evidence and
the patent claims because the relevant products “are the
invention disclosed.” E.g., J.A. 1162. In its Reply,
Xactware merely challenged the credibility of Eagle View’s
expert and argued that the expert’s testimony failed to
demonstrate that the products actually practiced the
claimed inventions. E.g., J.A. 1786–88. The evidentiary
showing necessary to earn the presumption of nexus was
simply not at issue before the Board. Second, substantial
evidence supports the Board’s finding of nexus based on the
limited evidentiary record on this issue.
Appellant raises a few other arguments apart from the
challenge to the Board’s nexus finding. With respect to the
ʼ770 patent, we hold that substantial evidence supports the
Board’s finding that the “moving” and “movement” limitations are not disclosed
in Yair Avrahami, et al., Extraction
of 3D Spatial Polygons Based on the Overlapping Criterion
for Roof Extraction from Aerial Images, International Archives of
Photogrammetry, Remote Sensing and Spatial Information Sciences, August 29–30, 2005 (“Avrahami”). We
also see no error in the Board’s decision not to consider
Xactware’s untimely-raised argument that Avrahami discloses the “moving” and “movement” limitations by the
placement of subsequent seed points after placement of a
first seed point, as well as the addition of segmentations
around each seed point. As to Appellant’s arguments regarding the ʼ152 patent, we see no reversible error in the
Board’s treatment of claims 10, 15, and 25.
simply not at issue before the Board.
Although the CAFC acknowledged that the parties
disputed facts relating to nexus, the CAFC seems to require a discussion
of the legal requirements for nexus to entertain the appeal [?]
The CAFC affirm D. Mass. in BRIGHAM AND WOMEN'S HOSPITAL v. PERRIGO COMPANY.
Footnote 1 mentions Cardinal Chemical:
Under Cardinal Chemical Co. v. Morton Int’l, Inc.,
508 U.S. 83 (1993), a judgment of noninfringement does not
moot a counterclaim of invalidity. However, “we retain the
discretion to limit the grounds upon which appeals are decided.”
Meds. Co. v. Mylan, Inc., 853 F.3d 1296, 1302 n.1
(Fed. Cir. 2017) (affirming judgment of noninfringement
and not reaching issues of validity). Given the facts here,
we decline to reach the issues of validity. Perrigo agrees
that affirming noninfringement would make it unnecessary to review
the patent’s validity. Reply Br. 3. And while
we recognize the “strong public interest” in resolving questions of
patent validity, Cardinal Chem., 508 U.S. at 100,
that interest here is minimal because the ’137 patent has
expired and cannot be asserted against others, there are no
pending suits involving the patent, and there are no related
patents in examination at the U.S. Patent and Trademark
We agree with Perrigo that the district court’s JMOL
of noninfringement was proper. The parties’ dispute centers
on whether the evidence at trial was sufficient to show
that Pepcid Complete®, and by implication Perrigo’s generic product,
provides “immediate . . . relief from pain,
discomfort and/or symptoms associated with episodic
heartburn.” ’137 patent col. 7 ll. 23–25. The district court’s
construction of this term is undisputed: immediate relief
means “relief obtained from pain, discomfort and/or symptoms associated
with episodic heartburn which starts
within about 5–10 minutes following ingestion of the active
ingredients.” J.A. 1380–82; Decision, 280 F. Supp. 3d at
200. As we discuss, Brigham’s evidence was insufficient to
show immediate relief as claimed, and no reasonable jury
could have found otherwise.
CBS Sunday Morning on 3 March 2019: the difference between truth and objectivity
Jane Pauley led off the "news" portion of Sunday Morning with items related to President Trump, including
"Trump unscripted," request for documents, and the security clearance for Jared Kushner. Then, the outcome
of the police shooting in Sacramento, and the unmanned SpaceX probe.
There was a bit of trivia, with a note that January became the first month of the calendar year in 450 BCI.
The cover story, by David Pogue, concerned documentary films, and included a comment that there was a difference
between truth and objectivity.
Almanac commemerated the birth of Charles Ponzi on March 3, 1882 (he died January 18, 1949, many years after his scam of 1919-20)
Of interest was a "human interest" story, by Martha Teichner, on cheese making (and judging) in Wisconsin. Later, on March 3, NBC
did a more downbeat story, noting that 15% of Wisconsin's dairy farmers ceased business in 2018.
Moment of nature did the Grand Canyon, celebrating its 100th anniversary as a national park.
[On February 26, 1919, Grand Canyon became a National Park.]