Process claim, patents

In the PCT examination process, national patent applications may be filed at the end of Chapter I (18 months from the home appHcation filing date), or at the end of Chapter II (30 months from the home appHcation filing date). If the examination of the U.S. home appHcation ends successfully before completion of the examination of the counterpart appHcation in PCT Chapter I, the PCT AppHcant may file national appHcations including the claims examined and allowed by the U.S. PTO without proceeding to PCT Chapter II processing. A brief timeline of patent appHcation examination under the PCT is provided in Table I. 

In 1875, a paper by Winkler awakened interest in the contact process, first patented in 1831. Winkler claimed that successfiil conversion of SO2 to SO could only be achieved with stoichiometric, undiluted ratios of SO2 and O2. Although erroneous, this beUef was widely accepted for more than 20 years and was employed by a number of firms. Meanwhile, other German firms expended a tremendous amount of time and money on research. This culminated in 1901 with Knietsch s lecture before the German Chemical Society (3) revealing some of the investigations carried out by the Badische Anilin-iind-Soda-Fahrik. This revealed the abandonment of Winkler s theory and further described principles necessary for successfiil appHcation of the contact process. 

Electrochemical Process. Several patents claim that ethylene oxide is produced ia good yields ia addition to faradic quantities of substantially pure hydrogen when water and ethylene react ia an electrochemical cell to form ethylene oxide and hydrogen (206—208). The only raw materials that are utilized ia the ethylene oxide formation are ethylene, water, and electrical energy. The electrolyte is regenerated in situ ie, within the electrolytic cell. The addition of oxygen to the ethylene is activated by a catalyst such as elemental silver or its compounds at the anode or its vicinity (206). The common electrolytes used are water-soluble alkah metal phosphates, borates, sulfates, or chromates at ca 22—25°C (207). The process can be either batch or continuous (see Electrochemicalprocessing). 

An examination of two listed product-by-process patents illustrates this latter point. Patent Nos. 6,063,927 (the 927 patent) and 6,172,233 ( 233) both claim paroxetine hydrochloride made according to specified processes. In each case, the patent itself acknowledges that paroxetine hydrochloride was well known at the time the brand-name company applied for the patents. The brand-name company represented to the Patent Office in the patent document that the recited process was new and made the claims patentable. Therefore, if valid, these patents cover only those products (paroxetine hydrochloride) made according to the specified process, just as process patents cover products made according to the specified process. In contrast, product patents, such as listable drug substance and formulation patents, cover a product regardless of the process by which it is made. Thus, product-by-... 

A process claim covers performance of the process steps, but it also provides patent coverage to products made according to the recited process. 35 U.S.C. 271(g) ( Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a patented process in the United States shall be liable as an infringer. . . . ). 

Search and examination of an application are necessary in most countries before a patent can be granted. The purpose of the search is to identify documents (whether earlier patent applications or journal articles) which are relevant in assessing whether the invention claimed in the patent application is new or non-obvious the purpose of the examination is for a patent office examiner to assess whether the claimed invention meets all the requirements of patentability and other requirements of patent law. The examination process is an interactive procedure between the patent examiner and patent applicant (or more usually his professional representative) in which the patent applicant may have to put forward arguments and evidence to rebut objections that the patent examiner may have to the patent application. During this process the patent applicant may have to amend (i.e. redefine) the claims to his invention. 

The liquefaction train is the novel mixed fluid cascade process (MFCP) patented by Statoil/Linde. It is the first LNG base-load plant ever to employ electric drive for the compressors. Today the Oman plant (Shell) is claimed to be world s most efficient LNG plant as it consumes only 8% of the gas for its operation. When Snohvit goes on stream (2006) it is expected to become even more efficient as it will consume only 5% of the feed gas for the liquefaction. This means that Snohvit will constitute the most efficient LNG plant ever. The high efficiency is attainable much owing to the low temperature of the ambient air and the cooling water in the artic region. 

Each claim in an issued U.S. patent application will be numbered, and each claim is exactly one sentence long.8 The structure of a typical claim contains three parts, which are, in the order of their usual appearance, the preamble, the transition, and the claim body (Figure 5.4 identifies the three parts of the composition claim 1 and the process claim 2). 

All three solutions showed the presence (NMR) of the same boron intermediates. In light of this evidence, it was clear that Johnson et al. could not obtain a grant in Europe of valid patent claims to boron intermediates that would be an impediment to us. (Incidentally, for the same reason, Schering could not obtain such intermediate claims.) On the other hand, the Johnson et al. methyl tropate reduction process was patentable over the disclosed Choi diethyl phenylmalonate reduction process and Schering s formyl phenylacetate process was patentable over both the disclosed Choi and Johnson et al. processes. Both were novel and both had a basis for showing nonobviousness. 

There are basically three types of patent claims (i) product or compound claims (ii) process or method claims and (iii) product-by-process claims (see Table 3). The name of each type of claim is self-defining. Product claims cover devices such as robotics [2] which are used in combinatorial chemistry. In addition, these claims can cover a particular compound, group of compounds or even an entire library of compounds [3], Note that... 

In addition to claiming libraries via a standard product claim, the 684 patent includes a product-by-process claim as follows. 

The value of library claims such as those described above in the 684 patent is understood when one considers the split resin methodology [11] which was developed after the reaction rate constant method described above (see Process claims ). Using the split resin... 

Further, the court held the process claims invalid because they were too broad and indefinite and hence did not comply with the then Section 33 of the patent statutes this is none other than our old friend, Rule 75, which states that the applicant shall particularly point out and distinctly claim the part, improvement, or combination which he claims as his invention or discovery. In considering these last two grounds, we may recall that it has been frequently held that a patentee is not to be charged with a knowledge of the correct theory or even understanding of his invention (21). Yet we see that, as a practical matter, a misunderstanding of the theory was one reason which caused the court to strike down the method claims. 

The difficulty with process claim protection is twofold The first is the location in which the process is being carried out, and the second is who is carrying out the process. If an inventor has a patent on a process for making an old compound and that process is practiced in one country and the product itself imported into a different country, different laws apply in different countries. The International Association for the Protection of Industrial Property recommends that the patentee should have the same rights on the imported product which is accorded him by the domestic law in the country of importation had the processes been practiced there. As a practical matter prosecution against a source outside of a country is more complicated and more costly than against a domestic infringer of a process patent. The Tariff Act offers some aid 52). 

The second difficulty with process claims for new uses of an old chemical is Who should be sued That is How can the patent be enforced If a patent issues on a method of treatment involving the administration of an old substance as a medicine, is the actual infringer the physician or the patient Is the answer different if the patient is an adult, a baby, or an animal If the use is of an insecticide, the infringer is the farmer. If the patentee must file a separate suit for each patient or farmer, he may have a perfectly valid cause of action but it is illusory protection as it is difficult to catch each separate infringer and if he does, the recovery from each could be mockingly small. 

It is sufficient to apply Section 100(b), above quoted, which, in effect, has abrogated the principle laid down in a series of cases to the effect that a new use of an old process or an old device is not patentable on that ground alone. What we are confronted with in the two process claims is not a new process, as such, but the application of a previously known chemical to an entirely new and different use, and making it a participant in the process. There do not seem to have been very many decisions construing the new provision to which reference has been made, but there are two cases decided by the Court of Customs and Patent Appeals in regard to the matter that appear to be pertinent. ... 

The court reversed the Patent Office and allowed process claims. Claim 21 reads ... 

In summary, patents, creations of statutes, are subject to human frailties in preparation, prosecution, and interpretation. Some cases cannot be reconciled and some, which while once good law, are out of date. For the chemist who has developed a new use for an old compound, the first step should be to ascertain if there is some change in form, purity, carrier, or other feature which can distinguish the product from that which was old. In other words, if the two products were put in two bottles, side by side, would there be a difference, and is that difference important If not, protection may be obtainable by process claims under 35 USC 100 (SI) and direct or contributory infringement under 35 USC 271 (54). 

Process patents contain methods to prepare substances. Possible examples in the context of biomedicines are, e.g. isolation or purification methods, cell culture techniques, attenuation schemes and other more directed genetic manipulations of microorganisms, cloning techniques, and expression techniques for recombinant polypeptides. Since process patents are usually admitted in countries where certain products cannot be patented (see Table 9), process claims are a possibility to protect inventions in these countries. 

If a conventional vaccine for a certain disease exists, a new process/ product patent would, for example, claim a process for the manufacture of a recombinant vaccine and the resulting new vaccine itself. Patent claims for the vaccine could be deduced from a higher purity, an improved efficacy or a reduced risk of adventitious agents. Of course, these advantages should be substantiated by experimental data or by conclusive evidence from the literature. 

The above generalization may fortunately be going out of style, in that more and more chemical patents cany specific titles and have claims that are informative even to amateur patent attorneys. An excellent example is the patent on streptomycin and process of preparation, which was assigned to the nonprofit Rutgers Research and Endowment Foundation (14). The specification scarcely differs from a scientific paper and the process claims constitute easily understandable summaries of essential steps in the manufacturing procedure. Claim 13, a product claim, cannot be surpassed for conciseness T3. Streptomycin. ... 

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