By Mark Chael --
As Patent Docs has previously reported (here and here), the USPTO recently held a customer partnership meeting for the biotech, chemical, and pharmaceutical art groups. Of the many interesting and informative presentations and discussions from the meeting, those of us that prosecute patent applications directed to oligonucleotide, protein, and antibody inventions should find Mr. Bruce Campell's discussion of restriction practice for product and process inventions in TC1600 particularly helpful. Mr. Campell is a SPE in Art Group 1648. A revised copy of Mr. Campell's presentation is available here.
In addition to a fine introduction to restriction practice generally, Mr. Campell presented ten examples of restriction practice specific to the biotech, chemical, and pharma arts, especially nucleotide, protein, and antibody inventions.
By way of introduction, Mr. Campell mentioned that, restriction is not an option when the inventions as claimed are not independent or distinct or where "the claims define the same essential characteristics of a single disclosed embodiment of an invention."
For process inventions, one should compare the preambles, the active steps, and the specification. If the claimed preambles are different, but the active steps are the same, restriction would be improper as long as the specification indicated that the objectives of the methods recited in the preambles could all be accomplished using the same active step. On the other hand, restriction may be proper in claims with different preambles and identical active steps, if the objectives recited in the preambles were specific to different types of materials and resulted in different outcomes.
There are two criteria for a restriction requirement: 1) the claimed inventions must be independent and distinct, and 2) there would be a "serious burden" on the examiner if restriction were not required. A "serious burden" results where the "search and examination for one of the claimed inventions is not required for another of the claimed inventions." Prima facie serious burden results if one or more of the following reasons apply: separate classifications and/or status in the art, different fields of search, prior art for one invention not likely applicable to the other invention, and different non-prior art issues under § 101 and § 112. A "serious burden" may also be shown based on different fields and types of searching required, for example, different class/subclass classifications (which are apparently infrequently used by examiners) as well as different electronic resources and search queries. Mr. Campell mentioned that the identification of different electronic resources and search queries as supporting a "serious burden" on examiners would be finding its way into the latest revision of the MPEP due out some time soon.
Regarding the independence of biotech product and process inventions, Mr. Campell presented a particularly helpful slide during his presentation that correlated DNA, protein, and antibody product claims with related claims drawn to methods of making/using the DNA, protein, and antibody. Regarding the distinctness of product and process inventions, one should look to whether they are obvious variants, whether they are materially different, and/or whether they are mutually exclusive. A number of biotech-specific examples were presented that attempted to highlight the nuances in these concepts of distinctness as applied to restriction practice.
Lastly, in addition to touching on the subject of rejoinder, Mr. Campell presented a practical tip regarding the distinction between products and processes of screening or detecting. A screening or detection method claim seeks to produce information, e.g., information about an unknown product that has a certain effect or information about whether a known candidate product does or does not have a certain activity. Such methods typically do not lead to the production or isolation of the product and such methods typically do not require the presence of the product at all. Thus, method claims that are drawn to screening for or detecting a particular product are usually not methods of making or using a particular product with the activity in question.
During the course of the presentation, it was suggested that if applicants and practitioners desire to traverse a given restriction requirement for a group of related nucleic acids or proteins, they should provide an alignment of the sequences using any of the available programs/algorithms to support their argument that the sequences are in fact related and there would be no "serious burden" on the examiner to search and examine the related group of sequences, rather than restricting the claims to the individual sequences that make up the group.
A recording of Mr. Campell's presentation can be downloaded here. To play .wrf files, you will need to install the WebEx Player available here.
Note to Readers: This is the second in a series of articles regarding selected presentations from the June 13, 2007 quarterly biotechnology/chemical/pharmaceuticals customer partnership meeting. The first article in the series is entitled "Biotechnology Art Group Discusses Enablement of Antibody Claims."
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