On 28 March 2011, The U.S. Court of Appeals for the Federal Circuit (CAFC) issued an opinion explaining how examiners are allowed to reject claims submitted in patent applications. In re Jung (Opinion 2010-1019). This opinion also teaches how to properly respond to rejections by examiners at the U.S. Patent & Trademark Office (USPTO).

The examiner, in a first and second rejection, equated a “well-charge-level controller” of claim 1 of U.S. Patent Application No. 10/770,072 (“’072 application”) with a “controller 340” of U.S. Patent No. 6,380,571 (“Kalnitsky”). Office Action of Apr. 18, 2006, at 10-12 (“Final Office Action”). Jung appealed. The examiner’s rejection of claim 1 is exemplary:

“Regarding Claim 1, Kalnitsky et al. teach (see Fig. 2, 3, 6) a system comprising a photo-detector array (array of pixel cells (200)-see Col. 2, lines 55-61) having a first charge well (214) (see Col. 5, lines 5-15), a first charge pump (320) (see Col. 5, lines 28-33, 37-39) operably coupled with the first charge well, and a first charge counter (330) (see Col. 6, lines 56-67) op-erably coupled with said first charge pump (through controller (340)) (see Col. 5, lines 28-33, 37-39 and Col. 6, lines 38-44, 64-66). . . .”

In response to the office actions, Jung argued that “Kalnitsky does not teach” the controller. For the first time on appeal (and sounds like Jung made a mistake – he should have argued to the examiner before appealing), Jung explained why his “controller” was not equivalent to the one described in Kalnitsky. In re Jung, at 6-7. As the court explained, it “was not until he arrived at the Board that Jung explained . . . difference[s] more thoroughly, implying that his claims should be read as limited to a preferred embodiment.” Op. at 15.

The CAFC found that the examiner provided sufficient information to “put Jung on notice that the examiner considered Jung’s . . . [controller] to read on Kalnitsky’s” controller, by citing to specific columns and lines in the reference, Kalnitsky. Op. at 10. As expressed here, one may say that an inventor’s proposed claims in a patent application “read on” a description of something similar. When this happens, an Examiner is justified on rejecting the claims as proposed.

Jung argued on appeal that the examiner failed to make a “prima facie case” of anticipation and that the burden had not shifted to Jung to rebut the rejection. The expression “prima facie” is a legal expression that explains who has the initial burden of proof to present sufficient evidence to make their case. Thus, Jung argued that he was not obligated to explain in detail on the record at the USPTO why Jung did not believe the examiner failed to sufficiently reject the claims.

The court explained that the USPTO “satisfies its initial burden of production [of evidence] by ‘adequately explain[ing] the shortcomings it perceives so that the applicant is properly notified and able to respond.’” Hyatt v. Dudas, 492 F.3d 1365, 1369-70 (Fed. Cir. 2007) (citing In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). The USPTO carries its procedural burden of establishing a prima facie case when its rejection satisfies 35 U.S.C. § 132, in “notify[ing] the applicant . . . [by] stating the reasons for [its] rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of [the patent] application.” 35 U.S.C. § 132. As stated by the court (at p. 9 of the opinion), Section 132 “is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection.” Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir. 1990).

The court stated that there is “no reason to impose a heightened burden on examiners beyond the notice requirement of [35 U.S.C.] § 132.” Op. at 11. The court explained that section 132 does not “mandate that in order to establish prima facie anticipation, the PTO must explicitly preempt every possible response to a section 102 rejection,” and that section 132 “merely ensures that an applicant at least be informed of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.” Chester, 906 F.2d at 1578 (internal citation omitted).

As section 132 instructs, the examiner must “notify the applicant,” “stating the reasons for such rejection,” “together with such information and references as may be useful in judging the propriety of continuing prosecution of his application.” 35 U.S.C. § 132.

The court explained that, “the examiner’s discussion of the theory of invalidity . . . ["anticipation" under 35 U.S.C. § 102], the prior art basis for the rejection (Kalnitsky), and the identification of where each limitation of the rejected claims is shown in the prior art reference by specific column and line number was more than sufficient to meet this burden.” Op. at 12 (emphasis added).

From my experience, the vast majority of office actions from USPTO examiners meet this legal burden. However, I wish the minimum quality for a legally acceptable office action was a little higher. It is sometimes unclear as to what elements in the text of cited references map to the elements of the claims that I am presenting. Sometimes an examiner finds the exact words that are in my claims, but that upon careful reading, do not teach the same technology as I am attempting to claim. In these cases, I can just imagine an examiner performing an exact word search from the words in my claims! One lesson from this case (In re Jung) is that examiners have a fairly low burden to rejection claims presented to the USPTO.

Based on the language of precedent and as hinted at in this opinion, there is a particular style of arguing and submitting evidence to the record at the USPTO – a style that is distinct from presentation of evidence in traditional state and federal court cases. Experience in drafting responses to office actions from USPTO is essential to getting the right balance of presenting a strong case for allowance to the examiner without placing restrictions on claims – restrictions from the “history” of the case, and not from the explicit language in the final version of issued patent claims.

Toward the end of the Jung opinion, the court explained the true issue in this case was “whether the examiner ‘reasonably construe[d] the claims’”. Op. at 13. This issue is substantive and is proper grounds for appeal (and will be an issue to address in another blog post). Thus, as the court explained, this decision can and should be decided by evaluating the language of the claims in view of the language of Kalnitsky. The court found that the examiner and the board of appeals (“Board”) properly did that and rejected the claims as presented based on Kalnitsky. The court recognized that the Board “further explained the examiner’s rejection, . . . [and noted] that nothing in the claims limited the controller to this embodiment.” The lesson is that the language in the claims – as presented – is critical when making arguments to overcome references cited by an examiner to reject patent claims.

On any appeal, the court reminded patent practitioners that an applicant must show “reversible error” to the Board and show “what the examiner did wrong,” in order to win an appeal of a rejection by an examiner. The court explained that Board reviews the examiner de novo, and the examiner retains the burden to show invalidity. Op. at 16.

On 20 March 2012, the U.S. Supreme Court unanimously ruled that the claims of U.S. Patent Nos. 6,355,623 and 6,680,302 failed to satisfy the prohibition of claiming laws of nature. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012), the Court reasons that “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Slip Op. 2.

Exemplary claim 1 of the ’623 Patent reads as follows:

“A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
“(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointesti­nal disorder; and
“(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointesti­nal disorder,
“wherein the level of 6-thioguanine less than about 230 pmol per 8×10^8 red blood cells indicates a need to increase the amount of said drug subsequently admin­ istered to said subject and
“wherein the level of 6-thioguanine greater than about 400 pmol per 8×10^8 red blood cells indicates a need to decrease the amount of said drug subsequently ad­ ministered to said subject.”

After the Supreme Court decided Bilski, it remanded this case back to the Federal Circuit to further consider the case where the machine or transformation test “is not a definitive test of patent eligibility, but only an important and useful clue.’” Bilski 561 U.S. ___, (slip op., at 7-8). On remand, the Federal Circuit reasoned that the steps of “(1) administering a . . . drug,” and “(2) determining the [resulting metabolite] level,” were important non-natural steps that brought the claims within the purview of allowable subject matter of 35 U.S.C. 101. With this language, the Federal Circuit tried to shoehorn the claim language into the language of its own Bilski decision that announced the “machine or transformation test.” The steps of the claims allegedly involved the “transformation of the human body or of blood taken from the body,” and thus the claims were patent eligible under 101, so the Federal Circuit reasoned. Hence, this case ends up back at the U.S. Supreme Court.

At Slip Op. 8, the question before the Court is, “whether the claims do significantly more than simply describe . . . [the] natural relations” of measuring the metabolism of a specific thiopurine compound by the human body.

At Slip Op. 13, the Court summarizes that the claim “simply tells doctors to: (1) measure . . . [by any means] the current level of the relevant metabolite, (2) use [a] particular . . . [law] of nature . . . to calculate . . . limits, and (3) reconsider the drug dosage.” These steps are those “that must be taken in order to apply the laws in question.” At slip op. 14, the Court tells us that “appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those . . . patentable.”

The Court reminds us that there is a “prohibition against patenting abstract ideas” and that the prohibition “‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.’” Bilski at ___ (slip op., at 14) (quoting Diehr 450 U.S., at 191-192). The Court reminds us that “well-understood, routine, conventional activity” related to pre-solution and post-solution activities “is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law.”

The Court reviewed in detail Diehr and Flook. The Diehr process of curing rubber by continuously re-calculating using an equation to determine when to open a rubber curing press (machine) was found to be patentable. The Diehr claims did not foreclose others from using the Arrhenius Equation in other applications. Diehr reminds us that a “new combination of steps in a process may be patentable even tough all the constituents of the combination were well known and in common use before the combination was made.” Diehr at 188.

The process in Flook, which was held not patentable, provided a method for adjusting “alarm limits” in a catalytic conversion of hydrocarbons. Unlike the process in Diehr, the Flook claims did not “explain how the variables used in the formula were to be selected, nor did the [claim] contain any disclosure relating to chemical processes at work or the means of setting off an alarm or adjusting the alarm limit.” Diehr at 192, n. 4; Flook, 437 U.S., at 586.

The process in Benson was held unpatentable because “simply implanting a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle.” The claims in Benson were directed to a process for converting binary-coded decimal numbers into pure binary numbers on a general purpose computer. The claims were “purported to cover any use of the claimed method” to a computer of any type. It did not differ from merely claiming “apply the algorithm.” The Court in Benson stated that the claims were “so abstract and sweeping as to cover both known and unknown uses of the [mathematical formula]“. 409 U.S., at 67-68.

Turning to the claims at issue, the Court deftly states that the “determining” step is all encompassing and “is set forth in highly general language covering all processes that make use of the correlations after measuring metabolites, including later discovered processes that measure metabolite levels in new ways.” Slip Op. at 18. The presence of “the basic underlying concern that these patents tie up too much future use of [the particular] laws of nature” simply yields an invalidation of the claims under 35 U.S.C. 101.  “[E]ven a narrow law of nature . . . can inhibit future research” and thus can be found invalid. Slip Op. at 20.

It is here (Slip Op. at 20, et seq.) that the Court’s opinion deviates from my view of patent law. The Court reasons that the 101 should be substantial barrier to patentability and should be the only screening factor against patenting laws of nature. I disagree that (1) 35 U.S.C. 101 should be considered first or in isolation before all other statutes (as the Court appears to do here), and (2) sections 102, 103 and 112 cannot also invalidate over-reaching claims to laws of nature and mathematical formulas. I disagree that if the Court upholds these claims the Court would “shift the patent-eligibility inquiry entirely to these later sections” of the patent statute. However, I can agree that the claims at issue were not appealed based on rejection under 35 U.S.C. 102, 103 and 112.  Based upon the factual record, it appears to me that these claims would also fail under 35 U.S.C. 102, 103 and possibly 112. My view is more closely aligned with and argued by the Government (see Brief for United States as Amicus Curiae 27). In the end, I agree with the Court that the claims at issue “effectively claim the underlying laws of nature themselves,” and preempt future discoveries. See Slip Op. 24.