USPTO Issues Guidelines for Assessing Enablement in Utility Applications and Patents In view of the SCOTUS decision in Amgen Inc. et al. v. Sanofi et al.

In view of the recent, unanimous decision from the Supreme Court of the United States (SCOTUS) in Amgen Inc. et al. v. Sanofi et al., the United States Patent and Trademark Office (USPTO) has now provided “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in ” (hereinafter “the Guidelines”) to patent personnel.

In a United States Patent, the claims define the scope of legal protection offered to the invention and the specification provides context as to how the claims can be implemented or used in practice. The specification is required to enable someone having ordinary skill in the art to make or use the invention. 35 U.S.C. §112.

In Amgen Inc. et al. v. Sanofi et al., a case about cholesterol antibody drugs, SCOTUS held that the enablement standard is tougher when patent claims cover more subject matter. “[T]he more a party claims, the broader the monopoly it demands, the more it must enable.”  Id. at 1256. In affirming the invalidity of Amgen’s claims over an entire Genus of antibodies, SCOTUS felt that the specification did not provide guidance over how to enable the full scope of embodiments. The specification provided only a “trial and error method” to enable the specific examples, or species, covered within its claims. While a reasonable amount of experimentation would have been acceptable, Amgen failed to enable its broad Genus claims by failing to enable the many covered Species. Thus, Amgen’s claims were determined to be invalid. Id.

As set forth in the Guidelines, the USPTO’s position is that the SCOTUS decision in Amgen Inc. et al. v. Sanofi et al. (hereinafter “the Amgen decision”) applies to all technologies, not just the antibody technology at issue in the Amgen decision. The USPTO’s guidelines reiterate that patent examiners are to continue to use the Wands factors discussed in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)), as they had previously when examining patent specifications for enablement (see MPEP 2164.01 Test of Enablement).

While the Guidelines will eventually be added to the USPTO’s Manual for Patent Examination Procedure (MPEP), the USPTO will continue to use the Wands factors to determine whether patent application claims are enabled by their specification. The Guidelines appear to be indistinguishable from the Supreme Court’s consideration regarding the determination that only a “reasonable” amount of experimentation is required to practice the complete scope of the patent claims. This analysis seems similar to the scope used within the Wands factors, which are based on an “undue amount of experimentation.” Therefore, it appears at first blush that the Amgen decision does not change much, but there are a couple of issues to note.

The Guidelines assert that their standards for enablement applies to all technology areas, not just the antibodies discussed in Amgen Inc. et al. v. Sanofi et al. Additionally, the Guidelines state that the USPTO may increase its assertion of the enablement doctrine against patent claim limitations that include functional language/limitations that may be directed to a plethora of embodiments. This analysis is different from the Amgen’s decision that all Species of a Genus must be enabled. Means Plus Functional limitations in claims has its own procedural rules and standards, but one can see how the projection from Genus/Species analysis to Functional limitations covering all implementations would appear reasonable in theory. Time will tell how this theoretical projection will work in practice.

The Guidelines provide a summary of the history regarding the Amgen case, which states that the Federal Circuit decision (affirmed by SCOTUS) applied the Wands factors to assess enablement of patent claims. The Guidelines recognize that SCOTUS did not explicitly address the Wands factors in the Amgen decision, but asserted that SCOTUS emphasized that the patent application specification may call for a reasonable amount of experimentation to make and use the full scope of the claimed invention.

The USPTO’s view in the Guidelines asserts that “[t]he Wands factors are probative of the essential inquiry in determining whether one must engage in more than a reasonable amount of experimentation.”

The Guidelines summarize the Wands factors, which are (for details, see MPEP  2064.01(a)):
(A) The breadth of the claims;

(B) The nature of the invention;

(C) The state of the prior art;

(D) The level of one of ordinary skill;

(E) The level of predictability in the art;

(F) The amount of direction provided by the inventor;

(G) The existence of working examples; and

(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

The Guidelines discuss the Amgen decision and three later Federal Circuit decisions for examples to be used by their personnel regarding how the Wands factors can be applied for determining whether the experimentation required to practice a claimed invention is reasonable or not.

The Amgen decision did not explicitly reference Federal Circuit decisions that provide enablement standards. It should be noted that the Amgen decision does not even mention the Wands factors that are relied upon by patent examiners (and litigants) to assess if a person having ordinary skill in the art needs to conduct an unreasonable amount of experimentation in order to make and use the claimed invention.

While there are questions as to whether the Amgen decision will impact how patent claims are analyzed regarding enablement under 35 USC § 112, the Guidelines maintain that patent personnel are to use the Wands factors over all technologies during patent application examination, and also when reviewing granted patents. While there appears to be a shift between “undue” to “unreasonable” experimentation (semantics), it appears the Amgen decision has increased the likelihood of raising enablement issues, which increases the likelihood that patent claims including functional language will be a focus under 35 USC § 112.

Sherman IP’s attorneys are specialists in drafting and prosecuting patent applications at the United States Patent and Trademark Office. Specifications must be drafted to both maximize the claimed subject matter and fully enable the claimed invention to provide for strong, enforceable patents. Sherman IP would be happy to consult with you to discuss how best to protect your ideas.