Written by Mark Terry 

As a Florida Patent Attorney with a sizable patent prosecution docket, I frequently deal with rejections from the U.S. Patent and Trademark Office (USPTO). A common form of rejection is an anticipation rejection under 35 U.S.C. sec. 102. This type of rejection is used in cases where the Patent Examiner believes that a single prior art reference (usually an existing U.S. Patent) anticipates or discloses every element of your patent claim. How do you respond to these types of rejections and succeed? The answer to this question is illustrated in today’s decision by the Board of Patent Appeals and Interferences (BPAI) in a case involving Dow Chemical Company.

Today, the BPAI issued a decision affirming a Patent Examiner’s 35 U.S.C. sec. 102 rejection of Dow Chemical Company’s patent application for a crystalline drug particle invention that increases bioavailability and dissolution rates of a pharmaceutical product. High bioavailability and dissolution rates are desirable attributes of a pharmaceutical end product. Bioavailability is a term meaning the degree to which a pharmaceutical product, or drug, becomes available to the target tissue after being administered to the body. Poor bioavailability is a significant problem encountered in the development of pharmaceutical compositions, particularly those containing an active ingredient that is poorly soluble in water. Poorly water soluble drugs tend to be eliminated from the gastrointestinal tract before being absorbed into the circulation. Dow Chemical Company’s patent application claimed a new process that increases bioavailability and dissolution rates of drugs. Thus, this is a patent application of interest to the chemical and drug industries.

The Patent Examiner rejected certain Dow claims under 35 U.S.C. sec. 102 for being anticipated by a U.S. Patent to Kipp. In the rejection, the Patent Examiner made a prima facie case of anticipation by providing a detailed explanation of where each and every element of the pertinent claims were found in the Kipp patent. Once a prima facie case of anticipation has been established, the burden shifts to the Appellant, i.e., Dow, to prove that the prior art does not necessarily or inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). This is where Dow’s counsel made a big mistake.

In responding to the Patent Examiner’s rejection, Dow stated only the following “Kipp does not teach or suggest particles having crystalline domains, and more specifically, Kipp does not teach or suggest particles having crystalline domains of less than about 400 Angstroms.” Dow did not provide an adequate explanation as to why Kipp did not disclose the elements of the claims, Dow did not proffer any evidence to support its conclusions and Dow did not provide any scientific reference in line with its argument. The BPAI responded: “This argument misplaces the burden. The Examiner has provided significant evidence which supports [his] conclusion … Consequently, under Best, the burden of proving that the particles of Kipp do not inherently satisfy the claims is placed on Appellants .. Appellants have proffered no evidence that the particles of Kipp differ from those claimed.”

The lesson to be learned in this case is that once a Patent Examiner makes a prima facie case of anticipation under 35 U.S.C. sec. 102, the Applicant must respond with arguments as to why the prior does NOT disclose his invention AND the Applicant must come up with substantial evidence that supports his conclusion. An Applicant can’t simply respond with a blanket “I disagree.” The Applicant must do his research and come up with hard evidence, such as scientific literature, that supports his argument. Without good, hard evidence that supports his conclusion, an Applicant will not be able to rebut an Examiner’s prima facie case of anticipation under 35 U.S.C. sec. 102.