September 26, 2018

3 Areas of Renewed Interest for Biotechnology, Chemical and Pharmaceutical Patents

The United States Patent & Trademark Office (USPTO) has renewed its interest in obviousness, functional claiming and requests for information, especially for biotechnology, chemical and pharmaceutical patents. The USPTO outlined its renewed interest in these areas while hosting a Biotechnology, Chemical and Pharmaceutical (BCP) Customer Partnership meeting on September 24, 2018. The BCP Customer Partnership fosters collaboration between USPTO staff, patent attorneys, and patent applicants in BCP industries.

Below are key takeaways from the meeting.

Obviousness

For years, the USPTO has recognized seven exemplary rationales to support obviousness rejections, all of which require some aspect of predictability. Thus, the USPTO emphasized the importance of unpredictability when rebutting obviousness rejections. The USPTO also indicated that BCP industries are being viewed with more predictability as research and knowledge grows, making obviousness rejections increasingly difficult to rebut. In one example from the meeting, the USPTO suggested that a list of 10 billion possible solutions could be deemed sufficiently finite and predictable under the obviousness analysis.

Functional Claiming

For decades, the USPTO has interpreted “means plus function” claims as “the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act” (pre-AIA 35 U.S.C. 112, sixth paragraph and post-AIA 35 U.S.C. 112(f)). The USPTO is now training examiners to think broadly about functional claims. The claim need not recite “means” to invoke the functional analysis – even words like “mechanism,” “device,” “unit,” “module” and “system” have been deemed non-structural. Also, the claim need not recite “for” to invoke the functional analysis — even phrases like “configured to” and “capable of” have been linked to functions. In one example from the meeting, the phrase “cleaning adjunct” was said to invoke the functional analysis.

Requests for Information

For years, the USPTO has been permitted to request information “reasonably necessary to properly examine or treat” patent matters (37 CFR 1.105). Such information includes prior art, commercial data and competitive data. The USPTO is now training examiners to consider making such requests. Special care should be taken when responding to such requests, especially when the requested information is proprietary, because there is a risk of the information becoming public if relied upon by the examiner for patentability.

Patent applicants would be well advised to consult with patent lawyers to address issues of obviousness, functional claiming and requests for information as the USPTO renews its interest in these areas.

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