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[Federal Register Volume 89, Number 7 (Wednesday, January 10, 2024)]
[Notices]
[Pages 1563-1566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00259]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2023-0013]

Guidelines for Assessing Enablement in Utility Applications and 
Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. 
Sanofi et al.

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice.

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SUMMARY: The United States Patent and Trademark Office (USPTO) is 
publishing guidelines for USPTO employees to use, regardless of the 
technology, for ascertaining compliance with the enablement requirement 
of the patent laws during the examination of utility patent 
applications and the review of utility patents in light of the recent 
U.S. Supreme Court decision in Amgen Inc. et al. v. Sanofi et al. These 
guidelines, which also inform the public of the USPTO's practices, 
provide that when considering whether claims in a utility patent 
application or patent are enabled, USPTO personnel will continue to use 
the In re Wands factors to ascertain whether the amount of 
experimentation required to enable the full scope of the claimed 
invention is reasonable. Publishing these guidelines will promote 
consistent analysis of the enablement requirement of the patent laws by 
USPTO employees and will result in clearer USPTO communications to 
applicants, patentees, and relevant third parties concerning any 
deficiencies in enablement compliance. These guidelines will also 
promote the consistent treatment of enablement, both by the patent 
examining corps in patent applications and reexamination proceedings 
and by the Patent Trial and Appeal Board (PTAB) in ex parte appeals and 
post-patent issuance proceedings.

DATES: These guidelines are effective January 10, 2024.

FOR FURTHER INFORMATION CONTACT: Mary C. Till, Senior Legal Advisor, 
Office of Patent Legal Administration, at [email protected] or 571-
272-7755; or Andrea S. Grossman, Legal Advisor, Office of Patent Legal 
Administration, at [email protected] or 571-270-3314.

SUPPLEMENTARY INFORMATION: These guidelines are intended to inform 
USPTO personnel and the public on the USPTO's implementation of the 
Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. 
Ct. 1243 (2023) (hereafter Amgen). These

[[Page 1564]]

guidelines will assist USPTO personnel in assessing enablement under 35 
U.S.C. 112(a) and, where a lack of enablement has been found, they will 
assist in providing appropriate supporting rationale in view of the 
Amgen decision. These guidelines are based on the USPTO's current 
understanding of the law, and are believed to be fully consistent with 
the binding precedent of the Federal Circuit and the Supreme Court.
    These guidelines do not constitute substantive rulemaking and 
therefore do not have the force and effect of law. They have been 
developed as a matter of internal USPTO management and are not intended 
to create any right or benefit, substantive or procedural, enforceable 
by any party against the USPTO. Rejections will continue to be based on 
the substantive law, and it is the rejections that are appealable. 
Consequently, any failure by USPTO personnel to follow the guidelines, 
by itself, does not create a new ground to appeal or petition.
    These guidelines are not intended to announce any major changes to 
USPTO practice or procedure, and are incorporating guidance from the 
Amgen decision and several post-Amgen enablement court decisions that 
are consistent with current USPTO policy. If earlier guidance from the 
USPTO, including certain sections of the current Manual of Patent 
Examining Procedure (9th ed., Rev. 07.2022, February 2023) (MPEP), is 
inconsistent with the guidance set forth in this notice, USPTO 
personnel are to follow these guidelines. The Amgen decision and the 
guidance in these guidelines will be incorporated into the MPEP in due 
course.

Enablement Requirement

    The enablement requirement refers to the requirement of 35 U.S.C. 
112(a) that the specification must describe the invention in such terms 
that one skilled in the art can make and use the claimed invention. As 
discussed in section 2164.01 of the MPEP, any analysis of whether a 
particular claim is supported by the disclosure in an application 
requires a determination of whether that disclosure, when filed, 
contained sufficient information regarding the subject matter of the 
claim so as to enable one skilled in the pertinent art to make and use 
the claimed invention. In Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 
1080 (Fed. Cir. 2021) (hereafter Sanofi-Aventisub), the Federal Circuit 
applied the factors from In re Wands, 858 F.2d 731, 737 (Fed. Cir. 
1988) (hereafter Wands), to assess whether the specification of Amgen's 
patent provided sufficient enablement, for purposes of 35 U.S.C. 
112(a), to make and use the full scope of the claimed invention. The 
Wands factors include, but are not limited to: (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 and use the invention based on the 
content of the disclosure. MPEP 2164.01(a).
    In Amgen, the Supreme Court, in a unanimous decision, affirmed 
Sanofi-Aventisub and held that claims drawn to a genus of monoclonal 
antibodies, which were functionally claimed, were invalid due to a lack 
of enablement. The patents at issue (U.S. Patent Nos. 8,829,165 and 
8,859,741) concerned a genus of monoclonal antibodies that bind to 
specific amino acid residues on the PCSK9 protein and block the binding 
of PCSK9 to a particular cholesterol receptor, LDLR. The claims at 
issue were functional in that they defined the genus by its function 
(the ability to bind to specific residues of PCSK9) as opposed to 
reciting a specific structure (the amino acid sequence of the 
antibodies in the genus). In affirming the Federal Circuit's decision, 
the Supreme Court concluded that the patents at issue failed to 
adequately enable the full scope of the genus of antibodies that 
performed the function of binding to specific amino acid residues on 
PCSK9 and blocking the binding of PCSK9 to the LDLR cholesterol 
receptor.
    In Sanofi-Aventisub, the Federal Circuit relied on its prior 
precedential opinions when determining whether the full scope of a 
genus was enabled. These decisions included McRO, Inc. v. Bandai Namco 
Games Am. Inc., 959 F.3d 1091 (Fed. Cir. 2020) (hereafter McRO); Wyeth 
& Cordis Corp. v. Abbott Laboratories, 720 F.3d 1380 (Fed. Cir. 2013) 
(hereafter Wyeth); Enzo Life Sciences, Inc. v. Roche Molecular Systems, 
Inc., 928 F.3d 1340 (Fed. Cir. 2019) (hereafter Enzo); and Idenix 
Pharmaceuticals LLC v. Gilead Sciences Inc., 941 F.3d 1149 (Fed. Cir. 
2019) (hereafter Idenix).
    The Federal Circuit, citing McRO, provided guidance on the 
application of enablement to genus claims, holding that ``[a]lthough a 
specification does not need to describe how to make and use every 
possible variant of the claimed invention, when a range is claimed, 
there must be reasonable enablement of the scope of the range.'' 
Sanofi-Aventisub, 987 F.3d at 1085 (internal quotations omitted). 
Additionally, the Federal Circuit characterized Wyeth as holding ``that 
due to the large number of possible candidates within the scope of the 
claims and the specification's corresponding lack of structural 
guidance, it would have required undue experimentation to synthesize 
and screen each candidate to determine which compounds in the claimed 
class exhibited the claimed functionality.'' Id. at 1086. Similarly, 
the Federal Circuit characterized Enzo as holding ``that the 
specification failed to teach one of skill in the art whether the many 
embodiments of the broad claims would exhibit that required 
functionality.'' Id. Finally, the Federal Circuit characterized Idenix 
as affirming ``the district court's determination that the claims had 
both structural and functional limitations, and that undue 
experimentation would have been required to synthesize and screen the 
billions of possible compounds because, given a lack of guidance across 
that full scope, finding functional compounds would be akin to finding 
a `needle in a haystack.' '' Id.
    Turning to the claims at issue in Sanofi-Aventisub, the Federal 
Circuit analyzed the Wands factors and found that there was a lack of 
enablement for the broad functional genus claims. See Sanofi-Aventisub, 
987 F.3d at 1087-1088. The court relied on evidence showing that the 
scope of the claims encompassed millions of antibodies and that it was 
necessary to screen each candidate antibody in order to determine 
whether it met the functional limitations of the claim. Id. at 1088. 
Consequently, the Federal Circuit concluded that there was a lack of 
enablement.
    Thus, the Federal Circuit decision in Sanofi-Aventisub positioned 
the Supreme Court to answer the question of what is required to satisfy 
the enablement requirement for a patent claim directed to a functional 
genus. The Supreme Court held that ``[i]f a patent claims an entire 
class of processes, machines, manufactures, or compositions of matter, 
the patent's specification must enable a person skilled in the art to 
make and use the entire class. . . . The more one claims, the more one 
must enable.'' Amgen, 143 S. Ct. at 1254. While the specification in 
Amgen identified 26 exemplary antibodies that performed the claimed 
function by their amino acid sequences, the claims at issue were 
directed to a class that included ``a `vast' number of additional 
antibodies'' that Amgen had not described by their amino acid 
sequences. Id. at 1256. The Supreme Court found that Amgen sought to 
monopolize an entire class of antibodies

[[Page 1565]]

by their function, which was much broader than the 26 exemplary 
antibodies disclosed by their amino acid structure.
    The Supreme Court clarified that the specification does not always 
need to ``describe with particularity how to make and use every single 
embodiment within a claimed class.'' Id. at 1254. Rather, the 
specification may require a reasonable amount of experimentation to 
make and use the invention, and what is reasonable will depend on the 
nature of the invention and the underlying art. For example, ``it may 
suffice to give an example (or a few examples) if the specification 
also discloses some general quality . . . running through the class 
that gives it a peculiar fitness for the particular purpose,'' and 
``disclosing that general quality may reliably enable a person skilled 
in the art to make and use all of what is claimed, not merely a 
subset.'' Id. at 1254-1255 (internal quotations omitted). However, the 
Supreme Court found that Amgen failed to enable all that it claimed, 
even if allowing for a reasonable degree of experimentation.
    The Supreme Court's conclusion rested on the examination of the 
particular claims in light of the Court's precedent, including O'Reilly 
v. Morse, 56 U.S. 62 (1854) (hereafter Morse); The Incandescent Lamp 
Patent, 159 U.S. 465 (1895) (hereafter Incandescent Lamp); and Holland 
Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928) (hereafter 
Holland Furniture). While each of these decisions involved different 
technologies than Amgen, the Supreme Court stated that ``these 
decisions are no less instructive for it.'' Amgen, 143 S. Ct. at 1252. 
The Supreme Court compared the claims in Amgen to the claims of Morse, 
Incandescent Lamp, and Holland Furniture. The Court found that ``Amgen 
seeks to claim `sovereignty over [an] entire kingdom' of antibodies,'' 
just as ``Morse sought to claim all telegraphic forms of communication, 
Sawyer and Man sought to claim all fibrous and textile materials for 
incandescence, and Perkins sought to claim all starch glues that work 
as well as animal glue for wood veneering.'' Id. at 1256. The Supreme 
Court further stated that ``if our cases teach anything, it is that the 
more a party claims, the broader the monopoly it demands, the more it 
must enable. That holds true whether the case involves telegraphs 
devised in the 19th century, glues invented in the 20th, or antibody 
treatments developed in the 21st.'' Id. The Supreme Court emphasized 
that while Amgen involved a new technology, antibodies, the Court has 
applied the same legal principle for over 150 years for many different 
technologies. Thus, since the Supreme Court relied on precedent from a 
wide variety of technologies, there is no reason to treat the decision 
as limited to antibodies or biotechnology; the principles set forth in 
this decision regarding the enablement requirement apply to all fields 
of technology.
    In reviewing the Federal Circuit's enablement determination, the 
Supreme Court stated that the specification is not necessarily 
inadequate just because it leaves the skilled artisan to perform some 
measure of adaptation or testing. The Supreme Court, citing Wood v. 
Underhill, 46 U.S. 1 (1846), and Minerals Separation, Ltd. v. Hyde, 242 
U.S. 261 (1916) (hereafter Minerals Separation), stated that the 
specification may call for a reasonable amount of experimentation to 
make and use the claimed invention. Amgen, 143 S. Ct. at 1246. The 
Court in Amgen, citing to Minerals Separation, opined that ``[w]hat is 
reasonable in any case will depend on the nature of the invention and 
the underlying art.'' Id. That reasonableness standard is still the one 
to be applied following the Supreme Court decision in Amgen.

Determining ``Reasonableness of Experimentation''

    To assess the amount of experimentation required by the 
specification so as to determine compliance with the enablement prong 
of 35 U.S.C. 112(a), the Federal Circuit developed a framework of 
factors in Wands, 858 F.2d at 737, referred to as the Wands factors. 
The Supreme Court did not explicitly address the Wands factors in 
Amgen; however, the Court emphasized that the specification may call 
for a reasonable amount of experimentation to make and use the full 
scope of the claimed invention. The Wands factors are probative of the 
essential inquiry in determining whether one must engage in more than a 
reasonable amount of experimentation and were applied or at least 
discussed by the Federal Circuit in several post-Amgen enablement 
decisions. See Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. 
LEXIS 24863 (Fed. Cir. 2023) (hereafter Baxalta); Medytox, Inc. v. 
Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023) (hereafter Medytox); and 
In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential) 
(hereafter Starrett). Therefore, consistent with the Federal Circuit in 
Sanofi-Aventisub and in post-Amgen enablement decisions, the Wands 
factors, which were used by the USPTO prior to Amgen, will continue to 
be used to assess whether the experimentation required by the 
specification to make and use the entire scope of the claimed invention 
is reasonable. See MPEP 2164.01(a). Federal Circuit precedent applying 
the Wands factors prior to Amgen is still informative as to how the 
Wands factors should be analyzed in different situations.
    For more recent guidance on how to determine whether 
experimentation is reasonable, it is instructive to look at the Sanofi-
Aventisub decision, which the Supreme Court affirmed, and the Federal 
Circuit's post-Amgen enablement decisions. In Amgen, 143 S. Ct. at 
1256, the Supreme Court agreed with the Federal Circuit's 
determination, which the Federal Circuit rendered utilizing the Wands 
factors, that Amgen failed ``to enable all that it has claimed, even 
allowing for a reasonable degree of experimentation.'' While both Wands 
and Sanofi-Aventisub are antibody cases, the Federal Circuit 
distinguished Wands based on the facts and evidence and stated in 
Sanofi-Aventisub that its decision was not inconsistent with Wands. 987 
F.3d at 1088. The court weighed the Wands factors and found that the 
scope of the claims was far broader in functional diversity than the 
disclosed examples, that the invention was in an unpredictable field of 
science with respect to satisfying the full scope of the functional 
limitations, and that there was not adequate guidance in the 
specification. Id. at 1087-1088. While the Federal Circuit did not hold 
``that the effort required to exhaust [i.e., make and use the full 
scope of] a genus is dispositive,'' the court relied on the evidence 
that showed that the scope of the claims encompassed millions of 
antibodies and that it was necessary to first generate and then screen 
each candidate to determine whether it met the functional limitations. 
Id. at 1088. The Federal Circuit concluded that there was a lack of 
enablement, which was affirmed by the Supreme Court in Amgen.
    In Baxalta, a post-Amgen enablement decision, the Federal Circuit 
affirmed a district court's grant of summary judgment that the claims 
of a patent directed to a functionally defined genus of antibodies were 
not enabled. Baxalta, 2023 U.S. App. LEXIS 24863 at *1. The court found 
that the ``facts of this case are materially indistinguishable from 
those in Amgen.'' Id. at *9. Although the scope of the claims 
potentially encompassed millions of antibodies, the patent only 
disclosed 11 antibodies and a method of producing and screening 
antibodies to determine whether they met the claimed functional 
limitations. Id. at *10. The court found that, just like

[[Page 1566]]

in Amgen, the method ``simply directs skilled artisans to engage in the 
same iterative, trial-and-error process the inventors followed to 
discover the eleven antibodies they elected to disclose'' and that 
``[u]nder Amgen, such random trial-and-error discovery, without more, 
constitutes unreasonable experimentation that falls outside the bounds 
required by Sec.  112(a).'' Id. at *8, *10. In response to an argument 
that the district court's enablement determination was inconsistent 
with Wands, the Federal Circuit stated, ``[w]e do not interpret Amgen 
to have disturbed our prior enablement case law, including Wands and 
its factors,'' and ``[w]e see no meaningful difference between Wands' 
`undue experimentation' and Amgen's `[un]reasonable experimentation' 
standards.'' Id. at *10.
    In Medytox, another post-Amgen enablement decision, the Federal 
Circuit affirmed a PTAB decision in a post-grant review proceeding 
using the Wands factors and found that the full scope of a substitute 
claim was not enabled. Medytox, 71 F.4th at 998-999. The substitute 
claim was directed to a method of using an animal protein-free 
botulinum toxin composition that exhibited a longer-lasting effect in 
the patient than an animal protein-containing botulinum toxin 
composition, and included a responder rate limitation of 50% or 
greater. Id. at 993. The Federal Circuit interpreted the responder rate 
limitation as having an upper limit of 100%. Id. at 997. The 
specification contained, at most, three examples of responder rates 
above 50%. Id. at 998. Employing the Wands factors, the PTAB found that 
a skilled artisan, reading the specification, would not have been able 
to achieve higher than 62% for the responder rate limitation without 
undue experimentation. Id. at 998-99. Citing Amgen, the Federal Circuit 
stated that ``[t]he more one claims, the more one must enable'' and 
that although the specification does not need to always ``describe with 
particularity how to make and use every single embodiment within a 
claimed class, it must nevertheless enable the full scope of the 
invention as defined by its claims, for example by disclosing [a] 
general quality of the class that may reliably enable a person skilled 
in the art to make and use all of what is claimed.'' Id. at 998 
(internal quotations omitted). The Federal Circuit found that the PTAB 
provided an adequate explanation and reasoning for its enablement 
finding, which utilized the Wands factors, and found no error in the 
PTAB's determination of a lack of enablement. Id. at 999.
    Finally, in Starrett, another post-Amgen enablement decision, the 
Federal Circuit affirmed a PTAB decision in an ex parte appeal 
upholding an examiner's rejection for a lack of enablement of a claim 
to a non-transitory computer readable medium for maintaining augmented 
telepathic data for telepathic communication. Starrett, 2023 WL 3881360 
at 1. While reviewing the examiner's enablement rejection, the PTAB 
treated the claim as a genus claim because it contained 47 ``or'' 
clauses and potentially covered over 140 trillion embodiments. Id. at 
2. The PTAB affirmed the examiner's determination of a lack of 
enablement and found that the examiner properly analyzed all the 
relevant Wands factors when making the determination that the claim 
lacked enablement. Id. The Federal Circuit once again cited Amgen for 
the proposition that ``the specification must enable the full scope of 
the invention as defined by its claims,'' and the ``more one claims, 
the more one must enable.'' Id. at 4. The Federal Circuit found that, 
as in Amgen, ``[h]ere, much is claimed, and little is enabled.'' Id. In 
reliance on Amgen, the Federal Circuit stated that ``[a]lthough a 
finding of enablement is not precluded by a skilled artisan's need[ ] 
to engage in some measure of experimentation, the extent of that 
experimentation must be reasonable.'' Id. The Federal Circuit endorsed 
using the Wands factors to determine whether the amount of 
experimentation required in Starrett was reasonable when it stated that 
``[t]he determination as to whether the extent of experimentation is 
undue or reasonable is informed by the eight Wands factors.'' Id. In 
concluding that the claim lacked enablement, the Federal Circuit found 
that nothing in the specification or claims undermined the PTAB's 
reliance on the examiner's Wands factor analysis and that the 
examiner's discussion of the Wands factors ``properly faulted the 
specification for failing to describe how the claim elements 
function,'' thereby indicating that the Wands factors should be used to 
determine whether the experimentation was reasonable. Id. at 4-5 
(emphasis in original).

Conclusion

    Therefore, consistent with Amgen and the Federal Circuit's post-
Amgen decisions of Baxalta, Medytox, and Starrett, when assessing 
whether the claims in a utility patent application or patent are 
enabled, regardless of the technology, USPTO personnel will continue to 
use the Wands factors to ascertain whether the experimentation required 
to enable the full scope of the claimed invention is reasonable. The 
explanation in an enablement rejection or in a PTAB determination that 
a claim is not enabled should focus on those factors and the reasons 
and evidence that led the examiner or decision-maker to arrive at their 
conclusion. See MPEP 2164.04. The Wands analysis should provide 
adequate explanation and reasoning for a lack of enablement finding in 
order to facilitate the USPTO's clarity of the record goals, as well as 
the USPTO's goals of providing consistency between examination and 
post-grant challenges.

Katherine Kelly Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2024-00259 Filed 1-9-24; 8:45 am]
BILLING CODE 3510-16-P
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