In its only decision of yesterday’s Snowmaggedon, the BPAI affirmed a Patent Examiner’s anticipation rejection, citing the Applicant’s attempt to claim a new benefit of an old process. Ex parte Satoshi Matsubara, et al. is a brief but attention-grabbing case illustrating the law surrounding the concept of inherency and claiming a new use or benefit of a prior art process.

At issue were claims involving a therapeutic method for improving bone density of a human or animal having decreased bone density by administering fermented soy milk.  Representative independent claim 17 recited the following two steps:

17. A therapeutic method for improving bone metabolism in a human or animal subject comprising:

selecting a human or animal having a tendency toward a decrease in bone density, and

therapeutically administering to said human or animal subject fermented soy milk which is obtained by fermenting soy milk with one or more microorganisms selected from the group consisting of Lactobacillus casei, Lactobacillus mali, and Bifidobacterium breve.

The Patent Examiner rejected representative independent claim 17 under 35 U.S.C. §102(b) as being anticipated by an academic paper by Kikuchi-Hayakawa. The Examiner found that Kikuchi-Hayakawa disclosed administering fermented soy milk to rats with removed ovaries. Since ovariectomized rats have decreased bone densities, and soy milk increases bone density in rats, the Examiner concluded that Kikuchi-Hayakawa disclosed administering fermented soy milk to rats to improve their decreased bone densities. The Appellants, however, argued the rats of Kikuchi-Hayakawa were not selected for their decreased bone densities but for other reasons (to determine the effects of soy milk on lipid metabolism), and therefore Kikuchi-Hayakawa did not disclose every element of claim 17.

In their findings of fact, the BPAI found that, in fact, Kikuchi-Hayakawa disclosed administering fermented soy milk to ovariectomized rats to determine the effects of soy milk on lipid metabolism. The BPAI also found that another reference showed ovariectomized rats experienced bone loss and that administering fermented soy beans prevented this bone loss.

In their analysis, the BPAI held that Appellants’ argument – Kikuchi-Hayakawa’s rats were not selected for their decreased bone densities but for other reasons – was not persuasive. Specifically, the BPAI stated: “Appellants have not identified any manipulative difference between Kikuchi-Hayakawa’s method and the claimed method … the claimed method ‘is inherent and in the public domain if it is the ‘natural result flowing from’ the explicit disclosure of the prior art regardless of whether the inherent result is recognized.” Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005). And because a 35 U.S.C. §102(b) prior art reference may disclose a limitation inherently, claim 17 was anticipated by Kikuchi-Hayakawa. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). “To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently.” Thus, the BPAI affirmed the Examiner’s 35 U.S.C. §102(b) rejection of claim 17.

What I found particularly interesting about Ex parte Satoshi Matsubara, et al. was the BPAI’s apparent disregard for the claim element “selecting a human or animal having a tendency toward a decrease in bone density.” Sure, the prior art disclosed selecting ovariectomized rats, which happened to have decreased bone densities. But the prior art didn’t disclose selecting rats because they had decreased bone densities. The decreased bone densities of the rats in the prior art were a serendipitous (for the Patent Examiner) byproduct of the actual reason they were selected – because they were ovariectomized.

If we follow the BPAI’s logic on this one, any selecting step of this type (which is standard in pharmaceutical research-type patents) acts like a disclosure of selecting based on any related attribute held by the test subject. Thus, if the prior art discloses selecting test subjects based on high blood pressure, then the same prior art discloses selecting test subjects on any other attributes they might have, which are correlated to high blood pressure, such as angina, anxiety or high cholesterol. This logic seems strained and overreaching to me.

Another interesting aspect of the Ex parte Satoshi Matsubara, et al. case was the BPAI’s seemingly misplaced use of the “new use, old process” standard. As the BPAI Stated, “it is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). But in this case, the process was not old or prior art. As stated above, the Appellants’ process involved a novel element: selecting rats because they had decreased bone densities. It is not clear to me that Appellants’ process was old, and therefore it is not clear to me that the new benefit (increased bone densities of the test subjects) is inherent in the prior art.

For patent practitioners, the educational aspect of this case rests in the classification of a claimed invention as novel, as opposed to an old process. Beware of an Examiner’s determination that your claimed process is old or well-known. Further, be wary of an Examiner’s finding that your claimed new benefit naturally flows from the allegedly old process. These findings, if not properly rebutted, will hurt your chances of a reversal on appeal.

Read the full decision here:  Ex parte Satoshi Matsubara (pdf)

Today’s post is by Guest Barista Mark Terry of Florida Patent Lawyer Blog, a practicing patent attorney based in Miami, Florida.

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