Florida Patent Lawyer Blog

Today, the Board of Patent Appeals and Interferences (BPAI) of the U.S. Patent and Trademark Office reversed a Patent Examiner's rejection of a key Guidant patent application for a heart stent used to treat arteriosclerosis. As a Florida Patent Lawyer with a daily patent prosecution docket, I follow cases such as these for practice pointers. This case illustrates an important point pertaining to rejections based upon 35 U.S.C. sec. 102(b) as being anticipated by a prior art patent.

Today's decision of the BPAI revolves around a rejection by the Patent Examiner wherein he asserted that two (2) elements of the claimed invention were disclosed by the presence of one (1) element in the prior art patent he cited. It is common for a Patent Examiner to claim that the two widgets of a patent claim are disclosed by a prior art patent that discloses only one widget. The BPAI disagreed with the Patent Examiner, citing See e.g. Lantech, Inc. v. Keip Machine Co., 32 F.3d 542 (Fed. Cir. 1994)(in infringement context, a single conveyor held to not meet claim element requiring at least two conveyors); In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)(claim requiring three separate means not anticipated by structure containing two means where one of the two means was argued to meet two of the three claimed means).

The practice pointer I learned from this BPAI decision is that 35 U.S.C. sec. 102(b) rejections by a Patent Examiner should be examined closely to ensure that, in fact, each element of the rejected claim is disclosed by a separate element in the prior art being cited against the claim. For a 35 U.S.C. sec. 102(b) rejection, it is not sufficient for a Patent Examiner to find only one instance of a claimed element in a prior art patent, when in fact two instances of the element are claimed. The patent attorney that prosecuted this Guidant patent application was astute in catching this Examiner flaw, thereby resulting in this key Guidant invention moving towards an issued patent. The financial incentives in this case are quite high, seeing as stent sales are estimated at $3 billion per year.

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 pharmaceautical 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.