Executive Intellectual Property Bulletin

The Potential Effect of the Recent Amendment to Section 287 on Computer and Software Related Patents

Recently, Congress amended 35 U.S.C. § 287 to deprive patentees of remedies for patents on surgical or medical procedures that do not involve drugs or devices against medical practitioners. Specifically, the reform creates a new subsection (c) of 35 U.S.C. § 287, which is the patent law's provision on the limitations of damages. The subsection provides that:

(c)(1) With respect to a medical practitioner's performance, of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284 and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.

35 U.S.C. § 287(c)(1) (emphasis added). The subsection further includes definitions of terms found within the subsection, to aid in its interpretation. These definitions inter alia provide that:

(c)(2)(A) the term "medical activity" means the performance of a medical or surgical procedure on a body, but shall not include (I) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent.

35 U.S.C. § 287(c)(2)(A).

Issues for Software and Computer Patent Practitioners

Although section 287(c) is directed towards providing doctors and other medical practitioners with immunity in the practice of medical procedures, patent practitioners in the software and computer arts are understandably concerned about its effect on their clients' patent acquisition efforts. It remains to be seen how the federal courts, including the Federal Circuit, will interpret section 287(c) in the realm of computer and software-related patents. However, examination of the section itself yields a few preliminary conclusions on this matter.

On first impression, a patent claim directed towards a software or computerized system that is medically related (e.g., for a diagnostics or medical imaging software invention) escapes application under section 287(c). Section 287(c) specifically defines medical activity as "the performance of a medical or surgical procedure on a body." Insofar as such a system is not an "activity" -- that is, such a system is not a "medical or surgical procedure" but rather is a software or computerized system -- section 287(c) should not cover claims specifically directed to the system.

Therefore, the patent practitioner is probably safe in continuing to draft claims for software inventions that are cast as system, device, or apparatus claims, without expending considerable attention to the vagaries of section 287(c). Such claims are easily identified by their preambles, and include claims beginning with "A computerized system for diagnosing heart disease"; "A computer having software running thereon to inform a medical diagnosis related to cancer"; "A medical imaging device"; etc. Section 287(c) is specifically directed to medical or surgical procedures, not devices or systems.

However, considerably murkier is the question of whether 287(c) applies to computer or software inventions as protected by method claims. Such claims frequently recite a "medical or surgical procedure on a body" that may be within the auspices of section 287(c). The archetypical medical software method claim recites the steps of acquiring medical data from a patient, converting and inputting the data to a computer, conducting various analyses on that data by the computer, and outputting a diagnosis or other suggested course of action for performance on the patient. The question is, then, do such claims recite "medical activity" as defined by section 287(c)?

The answer is not necessarily clear. In the first instance, if a method claim directed to a medical software invention includes one or more steps for the performance of a course of action as suggested by the computerized analysis of previously acquired patient data, then section 287(c) may in fact encompass the claim. Such performance of a course of action appears to be a "medical or surgical procedure on a body," in that the claim directs a medical practitioner as to what to do -- viz., how to proceed -- by including a step to perform a course of action. Applicability of section 287(c) means that the patentee could not successfully seek damages against a medical practitioner utilizing the patented claim.

In the second instance, however, a method claim consciously drafted to avoid inclusion of a step for performing a course of action as suggested by a computerized analysis appears to avoid section 287(c). That is, rather than drafting a method claim having a step to "perform a diagnosis as suggested by the computerized analysis," by instead drafting a claim having a step to "provide a diagnosis as suggested by the computerized analysis" the practitioner may provide his or her client a great service in any later enforcement of the patent including such a claim. Performing a diagnosis on a patient may be a medical procedure on a body within 287(c), while providing a diagnosis for later or possible performance on a patient is probably not.

In other words, not knowing whether federal courts will interpret 287(c) to encompass method claims for software or computer-related inventions, the prudent patent practitioner should carefully couch such method claims with language that does not recite a medical procedure on a body. Rather than including a step to perform a diagnosis on a patient, a method should only include a step that provides the diagnosis. In practical effect, the method reciting a step to only provide a diagnosis as opposed to a step to also perform the diagnosis should still snag all misappropriators of the invention. By not including the performance of the diagnosis in the method claim, however, the patent practitioner steers clear of section 287(c).

Analysis of Sample Claims Under Section 287(c)

This distinction in claiming style to avoid section 287(c) is best seen in some sample claims. A hypothetical medical software invention analyzes the blood pressure waveform of a patient, along with other variables of the patient, to yield a risk factor for the potential that the patient may experience heart disease in the near future. Because 287(c) is directed to only "medical activity" defined as "the performance of a medical . . . procedure on a body," a system or apparatus claim covering the invention should not fall within the boundaries of 287(c), as has already been discussed.

However, the drafting of a method claim for the invention is a more tricky issue. Two claims, both valid and good claims except for their difference in the triggering of section 287(c), are presented. The first claim reads:

1. A method for determining a risk factor for the potential that a patient may experience heart disease, comprising the steps of:

• measuring over time a blood pressure of the patient to provide a blood pressure waveform, the blood pressure waveform containing heart beat signals;
• digitizing the blood pressure waveform and storing it in a storage device;
• classifying a type of the blood pressure waveform in accordance with a Fourier transform of the blood pressure waveform;
• measuring one or more physical attributes of the patient other than the blood pressure of the patient; and,
• determining the risk factor in accordance with analysis of the physical attributes of the patient as compared to the type of blood pressure waveform.

As drafted, claim 1 covers a novel method in which a blood pressure waveform of a patient is Fourier transformed so that a type of the waveform is determined. The risk factor for the potential that the patient may experience heart disease is then determined by analyzing the physical attributes of the patient (e.g., height, weight, etc.) as compared to the type of blood pressure waveform determined of the patient.

Claim 1 may fall within the auspices of section 287(c). The two "measuring" steps may sufficiently characterize the entire claim as a medical activity. That is, as interpreted against 287(c), the two "measuring steps" may render the claim a medical procedure on a body, performance of which by medical practitioners is immune from infringement liability under the section. Interesting, however, is that the claim does not necessarily require these steps.

For example, consider a second claim that reads:

2. A method for determining a risk factor for the potential that a patient may experience heart disease, comprising the steps of:

• digitizing a blood pressure waveform based on a blood pressure of the patient;
• classifying a type of the blood pressure waveform in accordance with a Fourier transform of the blood pressure waveform; and,
• determining the risk factor in accordance with analysis of one or more physical attributes of the patient other than the blood pressure of the patient as compared to the type of blood pressure waveform.

Claim 2 is essentially identical to claim 1, but does not recite specific steps of measuring a blood pressure or one or more physical attributes of the patient. Rather, these qualities are passively recited in the other claim steps as being "givens." That is, instead of measuring one or more physical attributes of the patient, which is a specific step of the method of claim 1, the method of claim 2 includes the step of "determining the risk factor in accordance with analysis of one or more physical attributes," without reciting the manner in which the attributes are obtained.

Therefore, claim 2 probably does not lie within the boundaries of section 287(c). There is no step of the method of claim 2 that is performed "on the body" as required by the section. Although the data subject to the steps of the method of claim 2 relates to the body of a patient, the body itself is not subject to the steps. Furthermore, the patentee likely does not "lose" any coverage by having a claim drafted as in claim 2 as opposed to as in claim 1. The claims are largely coextensive from a scope standpoint.

Conclusion

Section 287(c), which bars patentees from successfully seeking damages for the performance of medical or surgical procedures, raises issues for the patent practitioner who also practices in the medical software and computer arts. Although section 287(c) probably does not apply to system, device, and apparatus claims directed to medical software and computer inventions, it may apply to method claims directed to such inventions. Therefore, the prudent patent practitioner should carefully draft method claims to ensure that they do not carry out "medical or surgical procedures on a body," such that they may trigger application of 287(c). For more information on this topic or any other topic, please contact Brad Forrest or any of the attorneys at Schwegman, Lundberg & Woessner, P.A. at 612-339-0331 or by facsimile at 612-339-3061 or via this website.