Why state the obvious

Moreover, the patent did not identify the supplier of the PLGA used for the described experiments, whereas it was evident from the prior art that the use of PLGA polymers from different suppliers resulted in microspheres with different release characteristics.

The results reported in the patent further concerned microspheres as described in document D6 using a PLGA polymer with a relatively high molecular weight, whilst document D12 additionally disclosed microspheres with single PLGA polymers having a relatively low molecular weight.

The problem to be solved in view of document D12 could therefore only concern the provision of an alternative composition. As solution to this problem it would have been obvious to the skilled person that a blend of PLGA polymers, which were already known from document D12 to be individually suitable for achieving zero-order release of risperidone, would also be suitable to achieve such desirable risperidone release profile.

The claimed subject-matter differed from the teaching in document D1 in the feature of the defined high lactide to glycolide ratio of the high molecular weight PLGA polymer of the blend and the feature of the defined uncapped state of both the PLGA polymers in the blend.

No particular effect had been shown to result from these differences and the problem to be solved in view of document D1 was therefore to be seen in the provision of an alternative composition. The influence of the capped state of the PLGA polymer on the risperidone release depended on the supplier of the polymer and was in case of the heavy weight polymer actually used in the blend of document D1 only marginal. Document D12 further indicated that uncapped PLGA polymers with a high lactide to glycolide ratio as defined in the patent showed suitable risperidone release characteristics.

As document D1 showed that the risperidone release characteristics of blends could be predicted from the properties of the individual polymers the claimed subject-matter was obvious to the skilled person as solution to the stated problem.

The arguments of the respondent relevant to the present decision can be summerized as follows:. Documents D17 and D18 addressed the problem of in vitro - in vivo correlations and were relevant to the appeal in which the appellant relied on in vitro data from the prior art, whereas the patent presented in vivo results.

The appellant's arguments relying on microspheres with a single low molecular weight polymer as closest prior art and the arguments referring to different properties of PLGA polymers depending on the supplier of the polymers were first presented in the the letter of 13 October and should not be admitted in to the appeal proceedings for being late filed. Document D1 described microsphere compositions for sustained release of risperidone comprising a blend of PLGA polymers with distinct molecular weights, which differed from the blend defined in the claims of the patent by the capped state and the lower lactide to glycolide ratio of the PLGA with the higher molecular weight.

Having regard to the experimental results reported in the patent the problem solved by the claimed subject-matter starting from document D1 concerned the provision of a "working" alternative formulation of microspheres for sustained release comprising risperidone and a blend of PLGA polymers that is characterized by stability, a satisfactory release profile without lag phase and initial burst and in vivo release.

The prior art provided the skilled person with no suggestion that the high molecular weight PLGA polymer in the blend of document D1 could be replaced by an uncapped PLGA polymer with the defined higher lactide to glycolide ratio in order to solve the stated problem.

Document D1 itself indicated that the release properties of PLGA based microspheres could be affected by a multitude of factors, including the capped state of the PlGA polymer.

The teaching of document D12 was of no relevance as it only concerned the optimization of the risperidone release profile of microspheres comprising a single PLGA polymer in stead of a blend. The teaching of document D12 was more remote from the claimed invention than the teaching of document D1. Document D12 could therefore not qualify as closest prior art. Moreover, as demonstrated by the results reported in the experimental section of the patent the claimed microsphere composition comprising the defined blend of PLGA polymers allowed, in contrast to comparative compositions comprising a single type of PLGA polymer, up-scaling of production without formation of drug crystals, 6-month storage without affecting in vivo drug release and avoidance of a lag phase also in case of low drug-loading.

With respect to document D12 the problem solved concerned the provision of improved microsphere compositions. The prior art provided no suggestion towards the claimed compositions comprising the defined blend of PLGA polymers as solution to that problem.

The appellant requested that the decision under appeal be set aside and that the patent be revoked. The appellant further requested that the appeal fee be reimbursed and that documents D17 and D18 and auxiliary requests 1 to 4 not be admitted into the proceedings.

The respondent requested that the appeal be dismissed. Subsidiarily, it requested to maintain the patent on the basis of one of auxiliary requests 1 to 4, filed with the response to the grounds of appeal.

The respondent further requested that the appellant's objections against the admission of documents D17 and D18 not be admitted and that the appellant's new arguments in the submission of 13 October be disregarded. In view of the respondent's explanation regarding the relevance of documents D17 and D18 the Board finds no grounds for not admitting these documents filed with the respondent's reply to the appeal Article 12 4 RPBA The Board therefore rejects the appellant's request not to admit these documents, which leaves the respondent's request not to admit the appellant's request without consequence.

The Board further considers the submissions in the appellant's letter of 13 October to represent a mere development of the arguments already presented in the statement of grounds of appeal, which did not confront the respondent with a fresh case to answer. Accordingly, the Board does not recognize any ground for disregarding these submissions Articles 12 3 and 13 2 RPBA Improved formulations described in document D6 increased the drug-loading rate and resolved drug release lag phase and burst-release problems, but suffered from crystal formation upon up-scaling the production process and changes of in vivo release upon long-term storage.

In paragraph [] the patent mentions the need for the provision of a risperidone microsphere formulation which is stable in quality and suitable for large scale production. The patent indicates in paragraph [] that the claimed microspheres provide the advantages of sustained drug-release without a lag phase in case of high as well as low drug-loading, production in a scaled-up process without precipitation of drug crystals during production and high stability such that the in vivo release profile does not change after long-term storage.

The Board recalls in this context that, in line with the jurisprudence as summerized in sections I. Definition and synonyms of obvious from the online English dictionary from Macmillan Education. This is the British English definition of obvious. View American English definition of obvious. Change your default dictionary to American English.

View the pronunciation for obvious. Open Dictionary. Collocations and examples. Adverbs frequently used with obvious. Synonyms and related words. When kilograms of cocaine are seized in New York, Chicago, Seattle, or right here in Dallas, we can frequently link those bricks to known drug lords and their laboratories through the logos they display.

Lastly, but not least, wire intercepts and cooperating witnesses frequently explicitly discuss the intended destination of the drugs. Under the laws of the high seas, as codified in Title 46, a sovereign nation has jurisdiction over any vessel on the high seas that is either stateless meaning it is not flying the flag of any country ; or where the flag country consents in the case of a vessel that is flying a flag. The Eastern District of Texas coordinates closely with the United States Coast Guard—who have been incredible partners—in order to prosecute many cases involving of these types of seizures.

In fact, just last month, we accepted two of these type of seizures for prosecution in our district, one with 1. Allow me to provide an example from an already resolved case. A few years ago, a group of Colombian drug traffickers that were targeted by EDTX had arranged to transfer over one ton of cocaine to a vessel which was floating several hundred miles off of the west coast of the Galapagos Islands.

When the United States Coast Guard approached the ship, they discovered that it was a Chinese fishing vessel. The Chinese government, in the first known case of its kind, consented to the United States taking jurisdiction over the vessel and its crew. The crew members were subsequently prosecuted in the Sherman Division of the Eastern District and all defendants were convicted. The Eastern District has aggressively utilized both prosecutorial tools — importation statutes and maritime jurisdiction — doing so with great success.

EDTX also led the nation in the number of defendants in opioid and fentanyl prosecutions, as well the number of these organizational defendants involved in financial crimes. And the Eastern District was number two in the country for the number of indictments against leadership-level defendants in these organizational cases.

In discussing these cases, and practice generally, one question inevitably comes up: Why the Eastern District of Texas?

Cauble was larger-than-life. He owned a chain of western wear stores, a fleet of shrimp boats, ranches, and even a bank. He was known, too, as an anti-drug crusader who recorded his own anti-drug commercials. The Eastern District prosecuted him and his entire organization, making national headlines. This case and other cases led to the establishment of long and lasting relationships with agents and officials in Colombia and throughout Central and South America. These relationships, in turn, led to joint efforts over the decades to prosecute the highest-level drug traffickers in the courts of the Eastern District.

Which leads me to my second point. In East Texas, we have great judges who are both fair-minded and serious about enforcing the law. I honestly cannot sing their praises high enough. They are thorough, prepared, and well-versed in the law. Furthermore, we have fair but tough juries who are no-nonsense when they evaluate these cases.

Moreover, years of positive experiences and great case results have shown our federal law enforcement partners, as well as our allies in Colombia and other countries, that EDTX can be counted upon to be aggressive and engaged, and to share the same passion for stomping out the drug trade that they do. Let me now speak a little bit about the mechanics of how we get defendants here.

The short answer is through the herculean efforts of the United States Marshals Service. The work that U. Marshal John Garrison and his team do to get extradited defendants to the United States is nothing short of extraordinary.

The longer answer, however, is that extradition is a matter of sovereign discretion. Both treaties and actual practices can differ widely among countries. The required paperwork to extradite defendants from another country may vary from 40 or 50 pages—to literally volumes, or even boxes, of papers.

Similarly, extradition proceedings in the foreign country can take anywhere from a few months to a few years, depending on the provisions of the respective treaty. Most countries afford a hearing in a judicial setting, but again, the specifics of the hearing will vary from country to country. Additionally, most countries afford a defendant at least one level of judicial review, as well as a final decision by one or more executive authorities.

Obviously, these proceedings will extend the length of the extradition process. The bulk of our cases come from Colombia and Guatemala. This reflects the reality that Colombia is a major source country for cocaine and heroin, and that Guatemala is the critical waypoint, for reasons of geography, that nearly all loads of narcotics have to pass through on the way to the United States.

Mexico is, of course, also a major transit point but it is much more difficult to accomplish extraditions from Mexico, often taking several years, sometimes even up to a decade. Since , the Eastern District has extradited a total of 92 individuals from Colombia, 11 from Guatemala, and ten from Mexico. There are many more suspects pending arrest in those countries, and even more than that, if one were to include requests to extradite that are currently pending before the State Department.

By all accounts, the demand for extradition is only increasing, and EDTX, as part of its commitment to its practice and partnerships, is scaling up in staffing and resources to meet the need.

So, once we have properly investigated the case and our grand jury has handed up an indictment there are four key steps to the process of getting the defendant to the United States. First, we work with our foreign partners to locate the fugitive.