Patent Application Prosecution

November 7, 2011

Eli Lilly & Co. Loses Appeal in British Supreme Court Over Patent Dispute Over Gene Sequence

London, U.K. – The Supreme Court of the United Kingdom has ruled against Indianapolis-based Eli Lilly & Company in a patent dispute. Lilly had challenged the validity of the patent of Human Genome Sciences, Inc., of Rockville, Maryland that covers the gene sequence of a protein called Neutrokine-α. Lilly had challenged the patent based on the fact that there is no known use of the protein. Thus, Lilly argued, the gene sequence was not patentable due to a lack of industrial application.

According to the Indianapolis Business Journal, Lilly continues to maintain the patent is invalid. The IBJ quoted a Lilly statement as stating “Human Genome Sciences seek to foreclose a whole area of research in a way that is not only harmful to the industry, but would ultimately and unjustifiably hinder the future development of new medicines.”

Practice Tip: The Court’s decision was based upon the European Patent Convention and United Kingdom patent doctrine requiring a patentable invention be susceptible to industrial application, which is similar to the U.S. patent doctrine of utility. The Court’s decision here holds that the U.S. doctrine of utility creates a higher bar to patentability that the E.U. and U.K. doctrine. The opinion explicitly rejected U.S. cases on the doctrine, including Brenner v Manson, 383 U.S. 519 (1966) and in re Fisher, 421 F.3d 1365 (2005).

October 31, 2011

Preview of U.S. Supreme Court Patent Infringement Case Mayo Collaborative Services v. Prometheus Labs

By Overhauser Law Offices, LLC

Washington, D.C. – The United States Supreme Court will hear an important patent infringement case this term that will determine the scope of patent rights in certain medical methods. Patent lawyers for Prometheus Laboratories, Inc. of San Diego, California filed a patent infringement suit against Mayo Collaborative Services, doing business as Mayo Medical Laboratories of Rochester, Minnesota, alleging that Mayo infringed patent no. 6,355,623, Method of treating IBD/Crohn’s disease and related conditions wherein drug metabolite levels in host blood cells determine subsequent dosage and patent no. 6,680,302, Methods of optimizing drug therapeutic efficacy for treatment of immune-mediated gastrointestinal disorders which have been issued by the US Patent Office.

The patents at issue involve claims over an observed correlation between certain blood tests and patient health, specifically the correlation between the level of certain drug metabolites in the patient’s blood and the patient’s symptoms of gastrointestinal disease. As characterized by Mayo in its brief to the Supreme Court, the inventors did not “invent” these correlations; rather, they simply observed the correlations in a patient population. Based on the patents, Prometheus brought a blood test product called Pro-Predict to the market. The level of metabolite in the patient’s blood can give the treating physician information relevant to adjusting the patient’s dose of certain medications. Mayo improved upon Prometheus’s blood test product and later released its own competing product. Patent attorneys for Prometheus then initiated this lawsuit, alleging that Mayo had infringed its patents. Mayo has attempted to defend the suit by arguing that Prometheus’s patent claims were not patent-eligible under 35 U.S.C. § 101. The Court of Appeals for the Federal Circuit has twice ruled in Prometheus’s favor.

The oral argument is scheduled for December 7, 2011 at the United States Supreme Court. The briefs can be found on the American Bar Association’s preview page for the case. A number of amicus curiae briefs have been filed as well. Notably, the American Medical Association filed an amicus brief in support of Mayo.

October 4, 2011

U.S. Supreme Court Declines to Consider Several Intellectual Property Cases

By Overhauser Law Offices, LLC

Washington, DC – On Monday, October 3, 2011, the U.S. Supreme Court opened its session and refused to review several appellate decisions in patent, trademark and copyright cases. These included the following cases:

Lockwood v. Sheppard, Mullin, Richter, & Hampton, LLP., U.S., No. 10-1339.

The Federal Circuit summarily affirmed a district court dismissal of a patent owner’s malicious prosecution suite against the patent attorney that requested the USPTO to reexamine his patents. The patent owner had alleged, among other things, that the law firm filed a sham reexamination request with misrepresentations of the prior art. The district court held that the state law claims were essentially allegations of fraud and bad faith before the USPTO, preempted by federal law under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). The district court also found the claims over the 2003 reexamination request barred by the two-year statute of limitations.

September 9, 2011

Southern District of Indiana Issues Markman Ruling in Cook Inc. v. Endologix Patent Infringement Case Over Aortic Stent

By Overhauser Law Offices, LLC

Indianapolis, IN – The Southern District of Indiana has issued a claim construction order in a patent infringement lawsuit. Cook Incorporated, of Bloomington, Indiana, had filed a patent infringement lawsuit in the Southern District of Indiana against Endologix, Inc., of Irvine, California. The patents at issue are owned by Cook and are patent nos. 5,035,706, PERCUTANEOUS STENT AND METHOD FOR RETRIEVAL THEREOF and 5,755,777, EXPANDABLE TRANSLUMINAL GRAFT PROSTHESIS FOR REPAIR OF ANEURYSM, which have been issued by the US Patent Office.

The patents at issue are medical devices that are used to treat abdominal aortic aneurysms, which are caused by the weakening of the aorta. The patented technologies are stents that strengthen the walls of the aorta and delivery systems. Cook alleges that Endologix’s Powerlink product infringes its patents. On April 15, 2011, the court held a Markman hearing to determine whether the patents cover the alleged infringer’s product. The parties disputed whether certain features of Endologix product were covered by Cook’s patents and the meaning of specific terms in the patent’s claims. Judge Pratt’s order set out the meaning of over thirty the disputed claim terms.

According to Yahoo Finance, Endologix has interpreted the rulings to be favorable.

Practice Tip: As the court described in its opinion, “[i]n order to win a patent infringement suit, a plaintiff must establish that the patent claim “covers the alleged infringer’s product or process.” Markman, 517 U.S. at 374 (citation and internal quotations omitted). Consequently, the first step in an infringement analysis involves determining the meaning and the scope of the words of the patent’s claims.” While resolution of disputed claim terms, such as what occurred in this opinion, does not resolve the controversy entirely, it is a significant step.

June 6, 2011

Federal Circuit Applies Analogous Art Test to Exclude Prior Art References from Obviousness Analysis

By Overhauser Law Offices, LLC

Washington, DC – In a decision that may impact both patent prosecutors and litigators, the United States Court of Appeals for the Federal Circuit applied the analogous-art test to exclude certain prior art references from the consideration of whether a claimed invention was obvious in light of the prior art.In this case, patent applicant Arnold Klein appealed the rejection of certain claims in U.S. Patent Application No. 10/200,747 as obvious under 35 U.S.C. § 103. The relatively simple technology at issue is “a mixing device for use in preparation of sugar-water nectar for certain bird and butterfly feeders,” with sugar and water compartments separated by a removable divider. The placement of the divider can vary, depending on the species of bird to be fed. The device maintains a proper nectar ratio so long as water and sugar are at the same “line of sight” level.Citing prior art patents, the examiner at the USPTO made five rejections, each based on the notion that Mr. Klein’s invention would be obvious to one of ordinary skill in the art, and these rejections were each affirmed by the Board of Patent Appeals and Interferences (“the Board”).

Noting that a reference qualifies as prior art for an obviousness determination under § 103 only when it is “analogous” to the claimed invention, the Federal Circuit initially focused on the particular problem being solved by Mr. Klein and narrowly stated it as: “making a nectar feeder with a movable divider to prepare different ratios of sugar and water for different animals.” The court found that the three cited prior art references (respectively disclosing a type of drawer, a particular tray, and an “apparatus for keeping accounts”) which feature solid item separators are not pertinent to this problem “since none of these three references shows a partitioned container that is adapted to receive water or contain it long enough to be able to prepare different ratios in the different compartments.”

As for the two remaining prior art references (disclosing a type of “blood plasma bottle” and a certain fluid container), they are directed at dividing liquids which are mixed later; the Federal Circuit concluded that neither of these references are pertinent to Mr. Klein’s invention “because they do not address multiple ratios or have a ‘movable divider’.” Because none of the cited references were completely analogous to the stated problem, no grounds remained to support the obviousness rejections, and the Board’s decision was reversed.

May 16, 2011

U.S. Patent Office Pre-Examination Interview Program Expanded

By Overhauser Law Offices, LLC

Alexandria, VA – The United States Patent and Trademark Office (USPTO) recently announced its First Full Action Interview Pilot Program, which, unlike a previous test program, applies to all areas of technology.

Under this program, if an eligible utility patent applicant electronically files a request prior to the first Office action on the merits, he or she must be granted an interview with the patent examiner assigned to the case. Traditionally, the grant of such a preliminary interview was with the discretion of the examiner.

To be eligible, the subject patent application must not have more than three independent claims and twenty or fewer total claims that are directed to a single invention.