Wednesday, March 20, 2019

Note US Patent 10,152,988: Selecting speech features for building models for detecting medical conditions


From the Background section of the '988 patent:



Early diagnosis of medical conditions, such as Alzheimer's disease or concussions, may allow for improved treatment and improved quality of life for the person with the medical condition. One method that may be used for detecting medical conditions is to process the speech of a person because the sound of a person's voice or the words used by a person may provide useful information for making a medical diagnosis.

To detect a medical condition from a person's speech, features may be extracted from the speech, and the features may be processed with a mathematical model. The type and number of features extracted from the speech may impact the performance of the model, especially where the amount of training data for training the model is limited. Accordingly, appropriate selection of features may improve the performance of the model.




First issued claim:


A system for training a mathematical model for detecting a medical condition, the system comprising at least one computer configured to: obtain a training corpus comprising speech data items, wherein each speech data item is labelled with a diagnosis value; obtain speech recognition results for each speech data item using automatic speech recognition, wherein the speech recognition results for a speech data item comprise a transcription of the speech data item; compute a plurality of acoustic features for each speech data item in the training corpus, wherein the plurality of acoustic features is computed from the speech data item and wherein computation of the plurality of acoustic features does not use the speech recognition results of the speech data item; compute a plurality of language features for each speech data item in the training corpus by processing the speech recognition results; compute a feature selection score for each feature of the plurality of acoustic features and each feature of the plurality of language features, wherein: the feature selection score for a feature indicates a usefulness of the feature for detecting the medical condition, and the feature selection score is computed using, for each speech data item, a value of the feature and the diagnosis value corresponding to the speech data item; select a plurality of features from the plurality of acoustic features and the plurality of language features using the feature selection scores; train the mathematical model for detecting the medical condition using the selected plurality of features for each speech data item of the training corpus; deploy a computer program product or computer service for detecting the medical condition using the mathematical model; present, by the computer program product or computer service, a prompt to a person; receive, by the computer program product or computer service, a speech data item corresponding to speech of a person in response to the prompt; compute a medical diagnosis score by processing the received speech data item using the mathematical model; and display, by the computer program product or computer service, one or more of the medical diagnosis score or a medical diagnosis based on the medical diagnosis score.


Will IPlytics disrupt patent analytics?



From eu-startups on IPlytics:


It’s important for companies in every industry to be informed at an early stage about relevant or even dangerous patents. Not just to monitor competition, but also to understand who is investing in the next technology trend that will change or even disrupt future markets. While most patent information is freely available online, it has become impossible to systematically analyse and understand more than 500,000 new patent applications every month, over 400,000 new research articles, or over 40,000 newly founded startups.

“We do not want to replace the patent attorney, but intelligently support the often manual analysis,” continued Pohlmann. “Our customers have domain knowledge and understand the content of a patent, but the number of patent applications has become too large to read everything. The learning algorithm of the IPlytics Platform uses users’ input to evaluate patents, cluster them, and link them to other documents such as research articles, technology standards or company profiles.”

Increased connectivity will result in more and more patented solutions being used in smartphones, computers, cars, machines, meters or even medical devices, as strategically placed patents can block entire industries. And recent patent disputes such as Broadcom’s billion-dollar lawsuit against Volkswagen demonstrate the sums involved.

“With its agnostic analysis approach, IPlytics has been able to link patent data to a variety of other data sources and automatically generate valuable new insights,” said Hannes Schill, Partner at eCAPITAL. “In particular, for so-called standard essential patents, which serve as the basis for new standards such as e.g. 5G or WiFi, IPlytics has become the most used software in the market.”




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.

SRI patents survive Cisco challenge at the CAFC, but damages, attorneys' fees issues remain


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
of computer networks.

(...)

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.



As to anticipation


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.

Sunday, March 17, 2019

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:


"It's really important to be scared all the time of becoming your own cliché," Heatherwick said.

"Similarity is your enemy?" Mason asked.

"Well, why do something if it already exists?"



Almanac did Nat King Cole and Nature did cardinals in Loganville, PA (in York County and home to Browns Orchards & Farm Market).

Friday, March 15, 2019

Natural Alternatives wins 101 appeal at CAFC: We live in the natural world, and all inventions are constrained by the laws of nature.

The outcome


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
Cir. 2001).




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
subject matter

(...)

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.



Separately


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
day.”



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




AND



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
judgment on the pleadings.


The Conclusion



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.

The Scientist discusses retraction by the Lancet of a Harvard paper on stem cells


from The Scientist:



Update (March 15): The Lancet sent The Scientist the retraction notice, which states that the data from Harvard “cannot be held to be reliable.” The editors note that they believe the clinical work conducted in Louisville was done “in good faith.”

Since 2014, a paper in The Lancet describing the results of a clinical trial using supposed cardiac stem cells has sat with an editors’ expression of concern looming over it. Now, the journal has retracted the paper—the 16th retraction for Piero Anversa, formerly of Harvard Medical School and Brigham and Women’s Hospital.

The Scientist could not locate a retraction notice, and the press office at The Lancet did not immediately respond to a request for information. (We sent the message after business hours in the UK, and will update this post once we hear back.)

In October, Harvard Medical School and Brigham and Women’s Hospital determined that 31 papers from the Anversa lab ought to be retracted. By Retraction Watch’s reporting, it’s not clear whether the 2011 paper in The Lancet was among the 31, but the expression of concern came about because the institutions gave the journal a heads up that they were investigating the “integrity of certain data” in the paper, the editors wrote at the time.

The cardiac stem cells given to patients in the clinical trial have been the subject of intense scrutiny by outside investigators, who have found that these “c-kit positive” cells don’t have regenerative capabilities in adult rodent hearts. Clinical trials continue to use c-kit cardiac stem cells.





link: https://www.the-scientist.com/news-opinion/the-lancet-retracts-cardiac-stem-cell-clinical-trial-paper-65598

Thursday, March 14, 2019

CAFC vacates validity ruling of D. Del./Robinson in Forest case on "motivation to combine" issue


The outcome


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
solution.


(...)

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
unexpected results.

(...)

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.

Tuesday, March 12, 2019

A new twist in fraud in college athletics: the fake profile making non-athletes into athletes; Yale women's soccer coach implicated in massive college admissions fraud


NPR quotes D. Mass. U.S. Attorney Andrew Lelling as indicating


33 parents "paid enormous sums" to ensure their children got into schools such as Yale, sending money to a man named William Singer for faking records and obtaining false scores on important tests such as the SAT and ACT.

"Singer's clients paid him anywhere between $200,000 and $6.5 million for this service."

In most cases, he added, the parents paid between $250,000 and $450,000 per student.

"These parents are a catalog of wealth and privilege," Lelling said. "They include, for example, CEOs of private and public companies, successful securities and real estate investors, two well-known actresses, a famous fashion designer, and the co-chairman of a global law firm."

(...)

Lelling cited one case in which the Yale women's soccer coach took hundreds of thousands of dollars to put a student on the team, despite knowing the student did not play the sport.



link: https://www.npr.org/2019/03/12/702539140/u-s-accuses-actresses-others-of-fraud-in-wide-college-admissions-scandal

The NPR link includes the names of the mail fraud defendants.


ABC News wrote:


"Beginning in or about 2011, and continuing through the present, the defendants -- principally individuals whose high-school age children were applying to college -- conspired with others to use bribery and other forms of fraud to facilitate their children's admission to colleges and universities in the District of Massachusetts and elsewhere, including Yale University, Stanford University, the University of Texas, the University of Southern California, and the University of Southern California -- Los Angeles," the indictment said.



link: https://abcnews.go.com/US/hollywood-actors-ceos-charged-nationwide-college-admissions-cheating/story?id=61627873

CNN wrote


The purpose of the alleged scam was to help student athletes get into college as recruited athletes,
regardless of their athletic ability, according to the indictment.

It alleges that a third party took the ACT and SAT college entrance exams in place of students.
The documents also allege that some defendants created fake athletic profiles for students to make them appear to be successful athletes and get them into college.

Athletic coaches from Yale, Stanford, USC, Wake Forest and Georgetown, among others, are implicated as well as parents and exam administrators, federal prosecutors said.




link: https://www.cnn.com/2019/03/12/us/college-admission-cheating-scheme/index.html

The New Haven Register reported:



Another defendant named in the case was Gordon Caplan, of Greenwich, and an attorney of an international law firm in New York City.

In late 2018, Caplan participated in the college entrance exam cheating scandal by making a charitable $75,000 donation to Key Worldwide Foundation, in exchange to have the coaches obtain his daughter’s exam and correct the answers after completing it.

Singer was a resident, variously, of Sacramento and Newport Beach, Califomia, the indictment says. Singer owned the Edge College & Career Network, LLC, also known as “The Key,” a for-profit college counseling and preparation business that he founded in or about 2007 and incorporated in the State of Califonia in or about 2012.



link: https://www.nhregister.com/news/article/Yale-soccer-coach-implicated-in-college-admission-13682117.php



****
Separately
Current Policy, Past Investigations Offer Window Into Harvard’s Next Steps In Abramson Plagiarism Case

Monday, March 11, 2019

Judge Newman goes through inherency in QAPSULE


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.”).



Of procedure,


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
id.


Of substantial evidence:


“[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.
(internal citation omitted)




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.



Some relevant definitions:



"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.

Among the highlights:

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?”

However, Vitale noted that he would like to see the proposal pass through the legislature for debate – something that many in Christie’s political party harped on about the Obama Administration’s implementation of the Affordable Care Act. As we have seen time and time again, many politicians can argue either side of the coin, depending on who is in charge.

Public Hearing

The new regulation which was submitted last week to the Office of Administrative law and will be published on October 2, 2017, in the New Jersey Register must undergo a public hearing before it is implemented, but that doesn’t necessarily mean that changes will be made. The public hearing is expected to be held on October 19, 2017, in the Monmouth Room at the Division of Consumer Affairs in Newark.



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).

Sunday, March 10, 2019

Sherrod Brown giving lemmings a bad name?


Sherrod Brown on Meet the Press on 10 March 2019:


SEN. SHERROD BROWN:

Well, I, I, I hear these stories that are — that’s the story of the day, about Democrats moving to the left.
I think the more-important story is how Republicans continue to move to the right. How President Trump extols
— betrays workers and utters racist, anti-Semitic rhetoric. And nobody in their party calls him out.
They don’t have divisions. They’ve all followed his racist actions and betrayal of workers.
They’ve followed it like lemmings off the cliff. That’s the story, not some degrees of differences
between and among Democrats. That’s the real story.



link: https://www.politicususa.com/2019/03/10/sherrod-brown-gop-lemmings.html

The myth of irrational lemming behavior arose from the 1958 Disney movie "White Wilderness." Of the staged
lemming suicide scenes, Snopes wrote:


None of what was shown in the film was realistic lemming behavior, however. Disney’s White Wilderness was filmed the Canadian province of Alberta, which is not a native habitat for lemmings and is landlocked with no outlet to the sea. The filmmakers had to import lemmings to Alberta for use in the documentary (reportedly by purchasing them from Inuit children who had caught them in other provinces); through the use of carefully controlled camera angles and tight editing, the filmmakers made no more than a few dozen lemmings look like a much larger number, placing them on turntables to create a frenzied migration effect and then herding them off a cliff and into the water (which was actually the Bow River, not an Arctic sea).
(...)
Lemmings do not periodically hurl themselves off cliffs and into the sea. Cyclical explosions in population do occasionally induce lemmings to attempt to migrate to areas of lesser population density, and when such migrations occur, some lemmings do die by falling over cliffs or drowning in lakes or rivers. These deaths are neither acts of “suicide” nor the result of compulsive unreasoning behavior, however; they’re accidental deaths resulting from lemmings’ venturing into unfamiliar territories and being crowded and pushed over dangerous ledges or venturing into the water in a quest to reach new territory.
(...)
And, quoting from the Alaska Department of Fish and Game :

Jarrell said when people learn that he works with lemmings, the mass suicide issue often comes up.

“It’s a frequent question,” he said “‘Do they really kill themselves?’ No. The answer is unequivocal, no they don’t.”


link: https://www.snopes.com/fact-check/white-wilderness/

Apart from Brown's attempt to give lemmings a bad name, one notes that Ohio Republican John Kasich has been criticizing President Trump.
See for example John Kasich issued a fiery response to Trump's Oval Office address that mostly criticized the president's leadership

***As a separate matter, the interchange between Cheney and Todd:


CHUCK TODD:

Well, there's actually anti-Semitism that has crept into our discourse.
Look at George Soros, okay? The Republican and conservative attacks on George Soros over the years.
In fact, Kevin McCarthy had to pull one tweet that implied that he was essentially trying to buy this or buy that.
That's gotten mainstreamed in ways for years to the point where George Soros had a -- had some guy that was trying to pipe bomb him. This whataboutism, can I just tell you--

REP. LIZ CHENEY:

No, no, no, no.

CHUCK TODD:

Congresswoman, this whataboutism --

REP. LIZ CHENEY:

Yeah, no. I -- Whataboutism -- I’m not going to --

CHUCK TODD:

--that everybody tries to point to the other side--

REP. LIZ CHENEY:

Chuck, Chuck --

CHUCK TODD:

-- and it’s getting a little old.



One might question whether charges against an individual (Soros) are analogous to charges
against an entire religion.

Finally, Todd ended the show with the line "That's all I have for today."


"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.
If the end brings me out all right, what is said against me won’t amount to anything.
If the end brings me out wrong, ten angels swearing I was right would make no difference.


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.

PELLEY: I have the sense that I just hit on the thing that keeps you up at night.

POWELL: I would say of the risks that we face, that certainly is the largest one.



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.

PELLEY: Where did these people go who are no longer looking for work?

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
will work for less money.

See 2012 post on IPBiz Startup Act 2.0: are you turning up your nose at $150K/year jobs?

AND


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.