Patent Office Guidelines on Myriad and Prometheus

The Patent Office has issued a new set of Guidelines for examiners of genetic-type patent applications in light of the Myriad and Prometheus cases.  I am just now trying to absorb them.  Here's a handy chart published in the Guidelines.  I will report more on this later.

Consumer Watchdog v WARF Update

Below is a summary of the Consumer Watchdog v WARF case (Human embryonic stem cells):
Bottom line:  We are waiting for a decision by the CAFC.

Court of Appeals Docket #: 13-1377 Docketed: 05/03/2013 Consumer Watchdog v. Wisconsin Alumni Research Appeal From: United States Patent and Trademark Office Fee Status: fee paid

Case Type Information:      1) Agency      2) Patent Trial and Appeal Board      3) -

Originating Court Information:      District: PATO-1 : 95/000,154      Date Rec'd COA:      03/22/2013

01/22/2014  46  6 paper copies of the amicus Brief [45] received from Amici Curiae US and PATO. [131074] 01/27/2014  47  Letter from Appellee Wisconsin Alumni Research Foundation regarding Response to United States' Amicus Curiae Brief. Service: 01/27/2014 by email. [131817] 01/27/2014  48  TENDERED from Appellant Consumer Watchdog. Title: COURT ORDERED SUPPLEMENTAL BRIEF/APPENDIX. Service: 01/27/2014 by email. [131818] 01/27/2014  49  BRIEF FILED (SUPPLEMENTAL) for Consumer Watchdog [48]. Title: Brief of appellant in response to United States., [Non-Confidential version only]. Number of Pages: 19. Service: 01/27/2014 by email.. Pursuant to ECF-10, filer is directed to file six copies of the brief in paper format. The paper copies of the brief should be received by the court on or before 02/03/2014. [132104] 01/29/2014  50  6 paper copies of the supplemental Brief [49] received from Appellant Consumer Watchdog. [132707] 02/18/2014  51  NOTICE OF CALENDARING. Panel: 1403N. Case scheduled Mar 13, 2014 2:00 p.m. at the United States Court of Appeals for the Federal Circuit (Howard T. Markey National Courts Building, 717 Madison Place, N.W. Washington, DC 20439), Courtroom 201. Response to oral argument order due: 02/24/2014. Counsel should check-in 30 minutes prior to the opening of the session. Please review the Oral Argument Order. [136334] 02/19/2014  52  Response to oral argument order from the Appellant Consumer Watchdog designating Sabrina Hassan as arguing attorney. Service: 02/19/2014 by email Designated time for argument: undecided minutes. Designated time for rebuttal: undecided minutes. [136519] 02/20/2014  53  Response to oral argument order from the Amici Curiae US and PATO designating Mark R Freeman as arguing attorney. Service: 02/20/2014 by email Designated time for argument: undecided minutes. Designated time for rebuttal: undecided minutes. [136808] 02/21/2014  54  Response to oral argument order from the Appellee Wisconsin Alumni Research Foundation designating Kara F. Stoll as arguing attorney. Service: 02/21/2014 by email Designated time for argument: undecided minutes. Designated time for rebuttal: undecided minutes. [137168] 03/13/2014  55  Submitted after ORAL ARGUMENT by Mr. Mark R. Freeman for US and USPTO, Sabrina Yasmin Hassan, Esq. for Consumer Watchdog and Kara F. Stoll for Wisconsin Alumni Research Foundation. Panel: Judge: Rader , Judge: Prost , Judge: Hughes. [141534]

Petition to The President

Petition to the President

Whereas, The Wisconsin Alumni Research Foundation (WARF) has obtained a patent on Human Embryonic Stem Cells, USPN 7,029,913, and the validity of the patent is opposed by the Consumer Watchdog

Whereas, the controversy is before the Court of Appeals For The Federal Circuit, and

Whereas the US government has filed a brief supporting dismissal of the case on grounds that Consumer Watchdog lacks standing.

Whereas, we feel that the public has a right to question the validity of the patent under the newly enacted America Invents Act,

Therefore we the undersigned request the President to instruct the US Department of Justice to withdraw its brief and submit a new brief supporting Consumer Watchdog.

Update on CW v Warf (The stem cell cae)

CW v WARF Update

Interesting "New Yorker" Article

The January 6, 2014 "New Yorker" had an article. "The Gene Factory," by Michael Specter.  It profiles Beijing Genomics Institute (BGI) a Chinese powerhouse in the biotech field.  The website of BGI proudly announces:

"-- World’s largest genome center to purchase 50 Ion Proton™ Sequencers from Life Technologies--

CARLSBAD, Calif., and Shenzhen, China, October 21, 2013 -- Life Technologies Corporation (NASDAQ: LIFE) and BGI, the world’s largest genomics center and service provider, jointly announced that BGI has purchased 38 Ion Proton™ Sequencers and plans to add at least a dozen more by the end of the year, strengthening the organization’s leadership position in the genomics industry. BGI also signed a supply and licensing agreement with Life Technologies, further enhancing BGI’s ability to perform basic, agricultural and clinical research."  

Reading further in the press release:

"Life Technologies Corporation (NASDAQ: LIFE) is a global biotechnology company...[w]ith a presence in more than 180 countries, the company's portfolio of 50,000 end-to-end solutions is secured by more than 5,000 patents and licenses that span the entire biological spectrum—scientific exploration, molecular diagnostics, 21st century forensics, regenerative medicine and agricultural research. Life Technologies has approximately 10,000 employees and had sales of $3.8 billion in 2012."

That's right, 5,000 patents and licenses.

Patent on Human Embryonic Stem Cells

The Wisconsin Alumni Research Foundation (WARF) has obtained a patent on Human Embryonic Stem Cells, USPN 7,029,913.  The validity of the patent is opposed by the Consumer Watchdog (formerly known as the Foundation for Taxpayer and Consumer Rights), a non-profit located in California with an office in D.C.  

The alleged inventor claims:

"I claim:

1. A replicating in vitro cell culture of human embryonic stem cells comprising cells which (i) are capable of proliferation in in vitro culture for over one year without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer.

2. The preparation of claim 1, wherein the stem cells will spontaneously differentiate to trophoblast and produce chorionic gonadotropin when cultured to high density.

3. The preparation of claim 1 wherein the cells are negative for the SSEA-1 marker, positive for the SSEA-4 marker, and express alkaline phosphatase."


I will report more on this later.

Background Information on Seqenom

March 28, 2012

From Clinical Sequencing News

"Sequenom could also face heightened skepticism because of its past problems. The company was preparing to introduce another prenatal Down syndrome test in 2009 when it abruptly announced that the data it had promoted to investors could no longer be trusted.

It turned out that a top research official had known which samples were positive and negative and had told subordinates to adjust the parameters of the test to improve its accuracy.

Five executives, including the chief executive and the research official, were fired. The research official, Elizabeth A. Dragon, pleaded guilty to conspiracy to commit securities fraud. (She died this February, before sentencing.)

Sequenom’s stock, which had been over $25 early in 2009, collapsed after the scandal. On Monday it rose 24 cents to close at $5.56.

The Sequenom test correctly identified 209 of the 212 Down syndrome samples, a rate of 98.6 percent. It incorrectly characterized three of 1,471 negative samples as showing Down syndrome. The test could not determine any answer for 13 pregnancies, or about 0.8 percent of cases.

...

The test counts small fragments of DNA in the mother’s blood. While most of this DNA is from the mother, some is from the fetus. Sequenom uses high-speed gene sequencers to determine the sequence of millions of the fragments. Using knowledge of the human genome, it determines which chromosome each fragment comes from. If the fetus has three copies of chromosome 21, there will be more than the expected number of fragments coming from chromosome 21.

One of the first papers on this approach was published in 2008 by Stephen Quake, a professor of bioengineering and applied physics at Stanford. Verinata has the rights to his discoveries, setting up a potential patent battle with Sequenom.

Professor Quake said that by increasing the number of fragments counted, it would be possible to prenatally diagnose abnormalities that do not involve entire extra chromosomes, even single mutations that cause diseases likecystic fibrosis."