Updated subject matter eligibility guidance from the USPTO

On the same day that the Supreme Court’s opinion was handed down in Assoc. for Mol. Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), the U.S. Patent Office issued a “memorandum… to provide preliminary guidance” (“memorandum”) for Examiners to use in light of the Myriad holding. This memorandum indicated that further guidelines would be coming in the future, and on 4 March 2014 they finally arrived (“guidelines”). These guidelines apply most particularly to inventions that might fall into the “product of nature” and “law of nature” exceptions to subject matter eligibility; the guidelines are careful to make clear (pg. 1) that “[t]here is no change to examination of claims reciting an abstract idea, which should continue to be analyzed for subject matter eligibility using the existing guidance in MPEP § 2106(II),” (emphasis in original). The guidelines supersede the previous memorandum, and answer important questions that the memorandum left unaddressed. The following points are worth noting:

(1)  Although the holding of Myriad only specifically addressed “naturally occurring DNA,” (Id. at 2111), the logic by which the Court arrived at this conclusion would appear to apply with equal force to other naturally occurring substances, such as proteins, lipids, viruses, etc. The initial post-Myriad memorandum was careful to confine itself only to the subject of nucleic acids (pg. 1, “Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof…” emphasis in original). Indeed, the PTO evidently still believes that Myriad’s holding applies only to nucleic acids (guidelines, pg. 1 “the holding in Myriad was limited to nucleic acids…”).

      Nevertheless, the new guidelines make clear that they apply beyond just nucleic acids (pg. 3, “If the claim recites or involves… something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself,” bold/italic in original, underlining added).

(2) The new guidelines provide a flow chart for determining subject matter eligibility, which ends with a multi-factor balancing test that the guidelines liken to the Wands factors for enablement determination. The guidelines strongly favor use of these Wands-like factors (pg. 3, “If there is any doubt as to whether the claim recites a judicial exception… the claim requires further analysis under Question 3. For example, if the claimed product is a protein or a mineral, then the analysis must proceed to Question 3…” emphasis in original).

This is true even when the analysis arguably could stop at Question 2. For example, page 5 of the new guidelines give the example of a claim “A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.” It is at least possible that such a Pseudomonas exists in nature, but the guidelines are careful to make clear (pg. 6) that this possibility is not enough to sustain a §101 rejection. In this respect, the guidelines are following Myriad, where the court indicated in dictum that the mere theoretical possibility that something exists in nature is not enough to bring a claim into the “product of nature” exception. Myriad, 133 S. Ct. at 2119 n.8.

The multi-factor balancing test gives a number of points to consider, no one of which is supposed to be determinative. The points include:
Factors that weigh toward eligibility:

a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.
b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).
c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).
d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).
e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application. (See MPEP 2106(II)(B)(1) for an explanation of the machine or transformation factors).
f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.

AND

Factors that weigh against eligibility:

g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.
h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered
i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).
j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field.
k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s).
l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.

As with most multi-factor tests, some factors appear in practice to matter more than others. For composition claims, all the work is done by factors (a) and (g) in the examples. For method claims, factors (b), (c), (h), and (i) appear to do most of the work. In the examples given, factor (e) appears somewhat superfluous (see, e.g. Example E, claim 2, pg. 13 and Example F, claim 1, pg. 14).

(3) Perhaps most significantly, the PTO has reaffirmed that the subject matter eligibility analysis must be conducted on the claim as a whole (guidelines pg. 3, “Question 3”). This is important, because some District Courts read Mayo Serv. v. Prometheus Labs, 132 S. Ct. 1289 (2012) to hold that claims should be broken up into “routine” and “novel” elements, with the “routine” elements playing no role in the §101 determination. See, e.g., Ariosa Diagnostics v. Sequenom, Inc., No. C11-06391, 2013 U.S. Dist. LEXIS 156554, at *27–30 (C.D. Cal. Oct. 30, 2013).

(4) Finally, it is worth considering two examples that the guidelines provide of claims that the PTO considers subject-matter eligible, even in view of Mayo. On pages 7 and 15 the following exemplary claims are provided:

A method of treating colon cancer, comprising:
administering a daily dose of purified amazonic acid to a patient suffering from colon cancer for a period of time from 10 days to 20 days,
wherein said daily dose comprises about 0.75 to about 1.25 teaspoons of amazonic acid.

A method for treating a mood disorder in a human patient, the mood disorder associated with neuronal activity in the patient’s brain, comprising:
providing a light source that emits white light;
filtering the ultra-violet (UV) rays from the white light; and
positioning the patient adjacent to the light source at a distance between 30–60 cm for a predetermined period ranging from 30–60 minutes to expose photosensitive regions of the patient’s brain to the filtered white light, wherein the exposure to the filtered white light alters the neuronal activity in the patient’s brain and mitigates the mood disorder.

The guidelines provide that both of these claims are patent eligible, despite the fact that at their inner-most core, the claims involve a law of nature (viz., the ability of amazonic acid to combat cancer in the first example, the ability of light exposure to treat a mood-disorder in the second). The guidelines explain that the additional limitations, in particular “10 days to 20 days,” “0.75 to about 1.25 teaspoons,” and “colon cancer” (as distinct from “cancer” more generally) (pg. 8) in the first example and “distance between 30–60 cm” and “filtering the ultra-violet (UV) rays” (pg. 17) in the second example create a significant difference between the claim and the bare recitation of the law of nature.

Therefore, when facing a subject matter eligibility rejection predicated on a law of nature exception, it seems worthwhile to add details such as dosage and disease to the independent claim (provided, of course, that there is written description support for the limitation). Ideally, one could create a series of independent claims that would dominate the entire field, even though each single independent claim would be restricted enough to be subject matter eligible. That is to say, instead of claiming a “method of treating cancer,” one can write the application to disclose every known cancer individually, and then claim different cancers in different claims.

In Lighting Ballast Control LLC, v. Philips Electronics North America Corporation, [2012-1014] (February 21, 2014), the Federal Circuit en banc held that claim construction is a matter of law that is subject to de novo review on appeal, confirming the continued validity of its en banc decision in Cybor Corp. v. FAS Technologies, Inc., 138 F.3d 1448 (Fed. Cir. 1998).

In an opinion by Judge Newman, the Court relied upon principles of stare decisis, finding that “[a]fter fifteen years of experience with Cybor, we conclude that the court should retain plenary review of claim construction, thereby providing national uniformity, consistency, and finality to the meaning and scope of patent claims.”  The Court said that experience has confirmed that Cybor is an effective implementation of Markman II, and that the criteria for departure from stare decisis are not met.

In Ring & Pinion Service Inc. v. ARB Corporation LTD., [2013-1238] (February 19, 2013), the Federal Circuit held that foreseeable equivalents could be infringing equivalents.  Through stipulations, the parties set up the question perfectly, agreeing that if a foreseeable equivlent at the time of filng could infringe, the patent was infringed, but if a foreseeable equivalent at the time of infringe could not infringe, the patent was not infringed.  The Federal Circuit affirmed the district court, stating: “There is not, nor has there ever been, a foreseeability limitation on the application of the doctrine of equivalents.”

The Federal Circuit noted that it has long been clear that known interchangeability weighs in favor of finding infringement under the doctrine of equivalents, citing Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 36 (1997); Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609 (1950); Abraxis Bioscience, Inc. v. Mayne Pharma (USA) Inc., 467 F.3d 1370, 1382 (Fed. Cir. 2006); Interactive Pictures Corp. v. Infinite Pictures, Inc., 274 F.3d 1371, 1383 (Fed. Cir. 2001); and Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1261 (Fed. Cir. 1989), and concluding that “[e]xcluding equivalents that were foreseeable at the time of patenting would directly conflict with these holdings that “known interchangeability” supports infringement under the doctrine of equivalents.

COMMENT: The defendant may have been confused by the foreseeability test of Festo Corp. v. Skoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), which determines the scope of prosecution history estoppel created by a narrowing claim amendment, and thus indirectly the scope of infringing equivlents.  Patent prosecutors can breath easier, but should still strive to write claims broad enough to literally cover foreseeable equivalents.

Novartis v. Lee and Exelixis v. Lee (2013-1160, 2013-1179, 2013-1175, Fed. Cir. 2014)

Summary: For a patent application issuing after 3 years, an RCE filed at any time during prosecution will reduce patent term adjustment (PTA) of the patent (i.e., the component of PTA referred to as “B Delay”).  The amount of reduction in PTA is the period from the day the RCE was filed to the day a Notice of Allowance was sent (not to the day the patent issued).

Practice Note:  It may be necessary to request PTA adjustments for recently issued patents and allowed applications that benefit from these decisions, as the USPTO will not automatically increase PTA of a patent that has already issued. At the latest, requests for reconsideration of PTA must be filed with the USPTO within 2 months of patent issuance.[i] Civil action challenges to PTA must be filed within 180 days from patent issuance.[ii] Unless successfully appealed to the Supreme Court, these decisions remove the basis that many Patentees had recently used for requesting additional PTA based on the lower courts’ decisions. For previous timely filed requests for reconsideration of PTA (challenging the PTO calculations based on the district court Exelixis and Novartis decisions), the USPTO held these in abeyance awaiting the Federal Circuit decisions.  As of January 20, 2014, the USPTO had not yet issued guidelines on how these pending requests will be handled in view of the January 15, 2014 Federal Circuit decisions.

Discussion: The terms of many recently issued and future patents will be impacted by the companion Federal Circuit decisions in Novartis and Exelixis.  Patent term adjustment (PTA) compensates a Patentee for certain delays caused by the USPTO during patent prosecution (by adding more term to a patent according to 35 U.S.C. 154).[iii]  However, the USPTO delays may be offset by certain delays attributed to the Patentee.  The USPTO determines PTA for each patent it issues based on its interpretation of the statute (35 U.S.C. 154(b)). Unfortunately, the statute is ambiguous and the USPTO’s interpretations have been subject to various challenges, including in the companion Exelixis and Novartis cases.

In each of Exelixis and Novartis, the Patentee disputed the USPTO’s calculation of PTA.  The USPTO found that the Patentee’s filing of a request for continued examination (RCE) negated certain delays caused by the USPTO.  Those familiar with prosecution before the USPTO are aware that RCEs are filed regularly.  Thus, these companion decisions will likely impact the adjustment of terms of many patents in the future.

The statute divides the USPTO’s potential delays into “A Delay,” “B Delay,” and “C Delay.” B Delay was at issue here, which is a “[g]uarantee of no more than 3-year application pendency.” 35 U.S.C. 154(b)(1)(B).[iv]  If the USPTO fails to issue a patent within 3 years after the application filing date, the patent term will be extended by one day for each day beyond the 3-year deadline.  However, the statute also provides that certain Patentee delays offset the USPTO delay.  These Patentee delays include, among others, “any time consumed by continued examination of the application requested by applicant.”

The Exelixis and Novartis decisions depend on statutory interpretation of the language “not including — any time consumed by continued examination.”  It was undisputed that filing an RCE before the USPTO’s 3 year deadline would reduce the PTO B Delay after the 3-year deadline.  However, whether filing an RCE after the 3-year period had passed would also reduce the USPTO B Delay (who already had not met the 3-year deadline) was at issue.  If the USPTO’s interpretation was incorrect as the lower courts held, the filing of an RCE after the 3-year deadline did not count towards reducing the USPTO B Delay.  Many patents, including those here, would have significant amounts of term added.  However, the Federal Circuit endorsed the USPTO’s interpretation that the filing of an RCE by an applicant at any time during prosecution (regardless of whether before or after the 3 year mark) is considered to be Patentee delay that will offset the USPTO B Delay (for not meeting the 3 year deadline).

Another issue was how much time should be attributed to Patentee’s RCE delay.  Did the delay extend from filing the RCE to (1) notice of allowance or (2) actual issuance (as the USPTO calculated)? The Federal Circuit sided with the Patentees finding the USPTO was incorrectly calculating the amount of this delay.  The delay attributable to a Patentee for filing an RCE only extends until the notice of allowance is sent, not until issuance of the patent. Thus, in the future, the USPTO will now have to adjust its PTA calculations to include its delays between the notice of allowance and issuance for PTA (assuming that this time is past the 3-year deadline).  Presumably, this holding also applies to any 35 U.S.C. 154(b)(1)(i)-(iii) delays, including filing of appeals and appellate review.  Accordingly, promulgation of new regulations (37 C.F.R. 1.703(b)) by the USPTO should also be forthcoming.

Example: To illustrate how this case will apply to PTA calculation, a simplified example is below (focusing on B Delays).

The application was filed on 3/1/2006.

The 3-year pendency period ended on 3/1/2009.

The RCE was filed on 9/1/2011.

A notice of allowance was issued on 7/1/2013.

The patent issued on 12/1/2013.