Continuations can be submitted to the PTO after the original application is filed, and allow the applicant to supplement the original disclosure, and to pursue aspects of the invention that were described but not claimed in the original application. This could be, for example, from additional data from ongoing research that were not known at the time of the original application. Continuation practice allows applicants to retain the original application date. By restricting the number of continuations allowed to two, the new rules may hurt the pharmaceutical and biotech sector more than other industries. In the drug discovery industry, it is often common practice to file multiple continuations and build the patent portfolio up over a long-term period. Patent applications are normally filed at an early stage in a compound's life cycle but the final drug will not be on the market until many years later, and patent protection is used until expiry. By contrast, information technology and software patents are most valuable at the beginning of the patent life cycle, as the product is often quickly eclipsed by newer technology.
Additionally, the PTO rules now only allow one request for continued examination. When an applicant first applies for a patent, the PTO often rejects claims for being unclear, too broad or obvious. The applicant can then modify the patent and again present it to the PTO, who then issues a final office action saying whether the invention is patentable. If the PTO response is negative, the applicant files a request for continued examination to further assess patentability. Another significant change includes limiting the maximum number of claims in a patent to 25, of which 5 at most can be independent. Beyond these thresholds, the PTO will only permit additional continuations, claims and requests for continued examination when an applicant provides evidence as to why they are necessary.
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