SUPREMES HOLD FRCPs OUTPLAYS SECTION 145

SUPREME COURT OF THE UNITED STATES DECIDES KAPPOS v. HYATT 

[April 18, 2012]
JUSTICE THOMAS delivered the opinion of the Court.

Under the Patent Act of 1952, if a Patent and Trade Office (PTO) examiner denies a patent application, 35 U. S. C. §131, the applicant may file an administrative appeal with the PTO’s Board of Patent Appeals and Interferences, §134. If the Board also denies the application, the applicant may appeal directly to the Court of Appeals for the Federal Circuit under §141. Alternatively, the applicant may file a civil action against the PTO Director under , which permits the applicant to present evidence that was not presented to the PTO.

 

Respondent Hyatt filed a patent application covering multiple claims. The patent examiner denied all of the claims for lack of an adequate written description. Hyatt appealed to the Board, which approved some claims but denied others. Pursuant to §145, Hyatt filed a civil action against the Director, but the District Court declined to consider Hyatt’s newly proffered written declaration in support of the adequacy of his description, thus limiting its review to the administrative record. Applying the deferential “substantial evidence” standard of the Administrative Procedure Act (APA) to thePTO’s factual findings, the court granted summary judgment to the Director. On appeal, the Federal Circuit vacated the judgment, holding that patent applicants can introduce new evidence in §145 proceedings, subject only to the limitations in the Federal Rules of Evidence and the Federal Rules of Civil Procedure. It also reaffirmed its precedent that when new, conflicting evidence is introduced, the district court must make de novo findings to take such evidence into account.

Raw Scraped Ground Tuna Product Identified as Source of Salmonella bareilly Multistate Outbreak

Salmonella bareilly gram negative rod source of raw scraped ground yellowfin tuna.

FDA reports:

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product

“Nakaochi Scrape” associated with a multistate outbreak of Salmonella Bareilly infections

  • April 17, 2012 UPDATE:Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif., is voluntarily recalling all frozen raw yellowfin tuna product from India, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product.
  • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores.
  • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots.
  • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to the ongoing outbreak of SalmonellaBareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date.
  • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.”
  • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it.
  • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Center for Disease Control (CDC) reports:

  • A total of 116 persons infected with the outbreak strain of SalmonellaBareilly have been reported from 20 states and the District of Columbia.
    • The number of ill persons identified in each state is as follows: Alabama (2), Arkansas (1), Connecticut (5), District of Columbia (2), Florida (1), Georgia (5), Illinois (10), Louisiana (2), Maryland (11), Massachusetts (8), Mississippi (1), Missouri (2), New Jersey (7), New York (24), North Carolina (2), Pennsylvania (5), Rhode Island (5), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (12).
    • 12 ill persons have been hospitalized, and no deaths have been reported.
  • Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak of Salmonella Bareilly infections. Nakaochi Scrape is tuna backmeat that is scraped from the bones of tuna and may be used in sushi, sashimi, ceviche, and similar dishes.  The product looks like raw ground tuna.
  • Consumers should not eat the recalled product, and retailers should not serve the recalled raw Nakaochi Scrape tuna product from Moon Marine USA Corporation.
  • This investigation is ongoing. CDC and state and local public health partners are continuing surveillance to identify new cases.
Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak of Salmonella Bareilly infections. Nakaochi Scrape is tuna backmeat that is scraped from the bones of tuna and may be used in sushi, sashimi, ceviche, and similar dishes. The product looks like raw ground tuna.   Hypothesis-generating interviews of ill persons conducted by local and state health departments in March and April, 2012 suggested consumption of sushi made with raw tuna as a source for these infections. To date, among 53 ill persons who have been asked questions about eating sushi and other seafood in the week before illness, 43 (81%) reported eating sushi. This proportion is significantly higher when compared with results of healthy persons in which 5% reported eating “sushi, sashimi, or ceviche made with raw fish or shellfish” in the 7 days before they were interviewed. Of the 43 ill persons reporting eating sushi, 39 (91%) reported eating a sushi item containing tuna, and 36 (84%) reported eating a sushi item containing “spicy tuna.”

To date, a total of 7 clusters at restaurants or grocery stores have been identified where 2 or more unrelated ill persons reported eating in the week before illness.  In each cluster, at least one ill person reported eating sushi purchased at the restaurant or grocery store.  These clusters are located in 5 states: Connecticut, Maryland, Rhode Island, Texas, and Wisconsin.

Several methods were used to evaluate the association between tuna and illness in this outbreak. To estimate the frequency of consumption of tuna and “spicy tuna” among all sushi eaters, investigators assembled a comparison group from 1) diners who ate at one of the cluster restaurants or grocery stores or 2) a restaurant where a single ill person, who was judged to have a reliable memory, recalled consuming sushi only once in the week before illness. Records were collected on sushi orders that were placed at the same time of day (lunch or dinner) and as close to the date when the ill person ate at the restaurant.

This study is ongoing. Thus far, information has been collected from 4 clusters at restaurants or grocery stores. The proportion of sushi orders that contained tuna as an ingredient averaged 61% (ranging from 43% to 71%). The proportion of sushi orders that contained “spicy tuna” as an ingredient averaged 37% (ranging from 29% to 53%). These data suggest there is an association between illness and consumption of sushi made with tuna, and specifically “spicy tuna.”

Public health and regulatory officials also are visiting restaurants and grocery stores associated with ill persons and collecting information about the ingredients used in “spicy tuna” recipes.  Based on available information from 5 of the 7 restaurant or grocery store clusters about ingredients used to make “spicy tuna”, raw tuna was found to be a common ingredient among all 5 clusters.

State and local public health and regulatory officials are working with the U.S. Food and Drug Administration (FDA) to conduct a traceback of tuna.  FDA has selected 4 of the clusters, which are located in Connecticut, Rhode Island, Texas, and Wisconsin, as the focus of the initial investigation. Information to date indicates that all 4 received the same imported frozen raw Nakaochi Scrape tuna product from a single tuna processing facility in India.

This investigation is ongoing. CDC and state and local public health partners are continuing surveillance to identify new cases. Further investigation is ongoing to identify possible sources of contamination and whether any other tuna products are linked with illness. CDC will update the public on the progress of this investigation as information becomes available.

 

Tim Sallinger WGN News6:18 a.m. CDT, April 14, 2012
The FDA has located the source of a nationwide salmonella outbreak that has affected more than 100 nationwide, and 10 people in Illinois.
It’s a product found in raw fish dishes such as sushi or sashimi, called “raw yellow-fin tuna scrape,” produced by one California fish processor.

Moon Marine USA Inc. voluntarily recalled more than 58 thousand pounds of scrape, which is raw meat literally scraped from the spine of tuna.
The FDA urged consumers to avoid sushi unless they are sure that it does not come from the affected processor.
“When in doubt, don’t eat it,” said FDA spokesperson Curtis Allen.

Contact Elizabeth Reilly, Attorney

If you or a family member became ill with a Salmonella infection after consuming contaminated sushi please call your physician or go to your nearest hospital emergency room. Thereafter, if you are interested in pursuing a legal claim, contact Elizabeth Reilly for a free confidential claim evaluation.  As a former Medical Technologist, I have isolated many varieties of Salmonella species, other food borne or water borne bacteria, and parasites which cause injury. Kindly, contact me at:

253-330-6420 or patentpendinglaw@gmail.com

 

Sushi, Sashimi, or Similar Foods Suspected in Salmonella bareilly Outbreak In 19 States

Center for Disease Control (CDC)

Salmonella bareilly was isolated for the first time in 1928 (Bridges & Scott, 1931). Although identified in India for many years (Ganguli, 1958) its importance as a human pathogen causing both gastroenterities (Raichowdhuri et al. 1983; Agarwal et al. 1983) and nosocomial infections (Panhorta & Agarwal, 1982) has only been recently recognized.

A total of 100 individuals infected with the outbreak strain of Salmonella bareilly have been reported from 19 states and the District of Columbia. The 7 new cases are from Connecticut (1), Illinois (1), Maryland (2), New Jersey (1), Pennsylvania (1), and Wisconsin (1).

Among 100 persons for whom information is available, illness onset dates range from January 28 to March 25, 2012. Ill persons range in age from 4 to 78 years, with a median age of 31. Forty-seven percent of patients are female. Among 51 persons with available information, 10 (20%) reported being hospitalized. No deaths have been reported.

Illnesses that occurred after March 8, 2012, might not be reported yet due to the time it takes between when a person becomes ill and when the illness is reported.  Salmonellosis is an infection with bacteria called Salmonella. Most persons infected with Salmonella develop diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts 4 to 7 days, and most persons recover without treatment. However, in some persons, the diarrhea may be so severe that the patient needs to be hospitalized.

Initial Announcement

CDC is collaborating with public health officials in many states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella serotype bareilly infections. Salmonella Bareilly is an unusual serotype of Salmonella. Public health investigators used DNA “fingerprints” of Salmonella bacteria obtained through diagnostic testing with pulsed-field gel electrophoresis, or PFGE, to identify cases of illness that may be part of this outbreak. They used data from Pulse Net, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections.

A total of 93 individuals infected with the outbreak strain of Salmonella bareilly have been reported from 19 states and the District of Columbia. The number of ill people identified in each state with the outbreak strain is as follows: Alabama (2), Arkansas (1), Connecticut (4), District of Columbia (2), Georgia (4), Illinois (8), Louisiana (2), Maryland (8), Massachusetts (4), Mississippi (1), Missouri (1), New Jersey (6), New York (23), North Carolina (2), Pennsylvania (2), Rhode Island (4), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (8).

Among 93 persons for whom information is available, illness onset dates range from January 28 to March 23, 2012.  Ill persons range in age from 4 to 78 years, with a median age of 31. Forty-six percent of patients are female. Among 51 persons with available information, 10 (20%) reported being hospitalized. No deaths have been reported.

Illnesses that occurred after March 4, 2012, might not be reported yet due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 3 weeks.

 

Investigation of the Outbreak

State public health officials are interviewing ill persons to obtain information regarding foods they might have eaten and other exposures in the week prior to illness. On initial interviews, many of the ill persons reported consuming sushi, sashimi, or similar foods in a variety of locations in the week before becoming ill. Among 51 ill persons for whom information is available, 35 (69%) reported consuming sushi, sashimi, or similar foods in the week before illness onset. This percentage is higher than expected compared with results from a survey of healthy persons in which 5% of persons reported consuming sushi, sashimi, or ceviche made with raw fish or shellfish in the 7 days before they were interviewed. The investigation into specific types of sushi is ongoing.

The investigation has not conclusively identified a food source.  Investigation is ongoing into individual food items and their sources. CDC, FDA, and state and local public health partners are continuing surveillance to identify and interview other ill persons about the foods they ate. CDC will update the public on the progress of this investigation as information becomes available.

AP Video: Center for Food Safety

 

USPTO Patent Law School Clinic

USPTO Expands Patent Law School Clinic Certification Pilot Program.  The United States Patent and Trademark Office (USPTO) today announced that it will open the current Patent Law School Clinic Certification Pilot Program to admit 10 additional schools for the upcoming fall 2012 academic year. This pilot program allows law students to practice patent law before the agency under the guidance of a law school faculty clinic supervisor.  Submissions from interested law schools will be accepted through Friday, June 1, 2012.

Participating Law Schools

University of Akron School of Law American University, Washington College of Law
University of Connecticut School of Law The George Washington University School of Law
Howard University School of Law The John Marshall School of Law
University of Maine School of Law University of Maryland School of Law
University of New Hampshire School of Law North Carolina Central University School of Law
University of Puerto Rico School of Law University of Richmond – Richmond School of Law
Rutgers Law School – Newark Vanderbilt College of Law
West Virginia University School of Law William Mitchell College of Law