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Biomedino, LLC v. Waters Technologies, Corp.

Patent claims prosecution has a convenient short-cut known as "means plus function."   Under 35 U.S.C. § 112, ¶ 6, a patent applicant may state a claim limitation as a means (or step) for executing a specified function within the invention without the need to claim the structure that actually performs the function.   In order to do so, however, the applicant must make clear in the specification which structure does the appointed task-it's the quid pro quo for using § 112, ¶ 6. 

Recently, the Federal Circuit addressed the question of just how specific the description of a § 112, ¶ 6 structure needs to be.

The answer? Pretty darn specific-at least according to the decision in Biomedino, LLC v. Waters Technologies, Corp.  Biomedino involved a device for binding and separating certain chemicals out of fluid at a molecular level. The patent included claims for a "control means" intended to address the operation of certain valves within the system.  The only references in the specification to those "control means" were a "black box" in a schematic labeled "Control," and a statement that part of the invention "may be controlled automatically by known differential pressure, valving and control equipment."  

The Federal Circuit held this description lacked the requisite level of specificity necessary to utilize the means plus function shortcut offered by § 112, ¶ 6.  Without that quotient of detail, the patent failed to satisfy the 35 U.S.C. § 112, ¶ 2 requirement that "the specification distinctly claim the subject matter which the applicant regards as his invention" and the patent was invalidated on grounds of indefiniteness. Key to court's analysis was its determination that § 112, ¶ 6  is satisfied only by a specific description of the methods/equipment that will perform the claimed function-a recitation that the function "can be" performed by the methods or equipment won't do-even if said methods are known to those skilled in the art.  

While the court couched its decision in terms of long-standing precedent, we expect that those challenging patents will argue that Biomedino heightens the standard for evaluating means plus functions claims. The Biomedino court was willing to invalidate the patent even though all parties agreed that one of ordinary skill in the art would know how to implement the control functionality-such functionality was contained in two prior art references relied upon by the defendants and was supported by the defendants' expert testimony.  Still, the court held fast to the requirement that the specification clearly state the structure which performs the claimed function.  Turning away from the "ordinary skill" debate to a more formalistic analysis of the specifications, the Federal Circuit seems (again) to favor strict compliance with the letter of the law in its handling of the claims before it.

We see the possibility that Biomedino will turn future means plus functions disputes into grammatical disquisitions: Would the court have been satisfied had the patent at issue stated that the referenced technology is used, as opposed to merely that it "may be" or "could be" used?  Careful parsing aside, Biomedino seems to exact a new, higher degree of precision and detail--perhaps in order to better focus future inquiries regarding claim construction, the range of equivalents, and the scope of related art.

Biomedino's four corners limitations may be at odds with the Supreme Court's recent decision in KSR. KSR emphasized looking outside the references in the patent to combinations derived from the "ordinary creativity" that motivates so-called routineers. Does this mean that only those challenging a patent's validity have the right to discuss what is inherently or contextually understood, while the patent holder is limited to express disclosures?   Only time, and the results of future litigation, will tell.

In any event Biomedino and other recent § 112, ¶ 6 decisions make clear the Federal Circuit wants every jot and tittle in place when it comes to means plus function claims.  Additionally, because these § 112, ¶ 6 cases have focused so specifically upon expert construction of general statements within the specification, expert testimony will figure ever more prominently in future means plus function litigation.

Given the risks, we think patent holders may want to skip the § 112, ¶ 6 short-cut and take the long way around in order to assure themselves that they've done all they can to adequately assert their patent claims and protect their inventions.

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