Federal Register / Vol. 89, No. 7 / Wednesday, January 10, 2024 / Notices 1563 

TABLE 3—DRAWING COSTS TO PRIVATE SECTOR RESPONDENTS

Item No. Item 

Estimated 

annual 

responses 

Estimated 

drawing 

costs amount 

($) 

Drawing cost 

totals 

(a) (b) (a) × (b) = (c) 

1 .............. Utility Application Drawings ..................................................................................................................... 230,520 $1,250 $288,150,000 

2 .............. Plant Application Drawings (Photographs) ............................................................................................. 1,005 750 753,750 

3 .............. Design Applications Drawings ................................................................................................................ 48,850 2,000 97,700,000 

11 ............ Provisional Application Drawings ............................................................................................................ 84,800 1,150 97,520,000 

Total Drawing Costs ............................................................................................................................ ........................ 365,175 484,123,750 

Postage 

Although the USPTO prefers that the 

items in this information collection be 

submitted electronically, the items may 

be submitted by mail through the 

United States Postal Service (USPS). 

The USPTO estimates the following: 

• If an applicant decides to file a 

patent application covered under this 

information collection by mail, the 

USPTO recommends that the patent 

application be filed by Priority Mail 

Express® in accordance with 37 CFR 

1.10 to establish the date of deposit with 

the USPS as the filing date (otherwise 

the filing date of the application will be 

the date that it is received at the 

USPTO). The USPTO estimates that 

about 1.5% of patent applicants (lines 

1–10) will be filed by mail resulting in 

6,245 mailed applications. Using the 

Priority Mail Express® flat rate cost for 

mailing envelopes, the USPTO estimates 

that the average cost for sending a 

patent application by Priority Mail 

Express® will be $28.95; resulting in a 

cost of $180,793. 

• If an applicant decides to file a 

petition or a paper filed under 37 CFR 

1.41(c), 1.41(a)(2) (pre-AIA), 1.48(d), 

1.53(c)(2), 1.53(c)(2) (pre-PLT (AIA)), 

1.55(c), or 1.78(b) by mail, the USPTO 

estimates that the petition or paper will 

be sent by Priority Mail. The USPTO 

estimates that about 1.5% of these 

petitions (lines 14 and 15) will be filed 

by mail resulting in 117 mailed items. 

Using the Priority Mail USPTO further 

estimates that the average cost for a 

Priority Mail legal flat rate envelope 

shipped via USPS is $9.95; resulting in 

an cost of $1,164. 

Therefore, the total estimated postage 

cost for this collection is $181,957. 

IV. Request for Comments 

The USPTO is soliciting public 

comments to: 

(a) Evaluate whether the collection of 

information is necessary for the proper 

performance of the functions of the 

Agency, including whether the 

information will have practical utility; 

(b) Evaluate the accuracy of the 

Agency’s estimate of the burden of the 

collection of information, including the 

validity of the methodology and 

assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

All comments submitted in response 

to this notice are a matter of public 

record. USPTO will include or 

summarize each comment in the request 

to OMB to approve this information 

collection. Before including an address, 

phone number, email address, or other 

personally identifiable information (PII) 

in a comment, be aware that the entire 

comment—including PII—may be made 

publicly available at any time. While 

you may ask in your comment to 

withhold PII from public view, USPTO 

cannot guarantee that it will be able to 

do so. 

Justin Isaac, 

Information Collections Officer, Office of the 

Chief Administrative Officer, United States 

Patent and Trademark Office. 

[FR Doc. 2024–00268 Filed 1–9–24; 8:45 am] 

BILLING CODE 3510–16–P 

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. 

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 

Mary.Till@uspto.gov or 571–272–7755; 

or Andrea S. Grossman, Legal Advisor, 

Office of Patent Legal Administration, at 

Andrea.Grossman@uspto.gov 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 


lotter on DSK11XQN23PROD with NOTICES1
1564 Federal Register / Vol. 89, No. 7 / Wednesday, January 10, 2024 / Notices 

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 SanofiAventisub 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.’’ SanofiAventisub, 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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 7 / Wednesday, January 10, 2024 / Notices 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 postAmgen 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 SanofiAventisub 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 


lotter on DSK11XQN23PROD with NOTICES1
1566 Federal Register / Vol. 89, No. 7 / Wednesday, January 10, 2024 / Notices 

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 § 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 postgrant 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 proteincontaining 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 postAmgen 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 nontransitory 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 

DEPARTMENT OF DEFENSE 

Department of the Army 

Army Education Advisory Committee 

Meeting Notice 

AGENCY: Department of the Army, DoD. 

ACTION: Notice of open committee 

meeting. 

SUMMARY: The Department of the Army 

is publishing this notice to announce 

the following Federal advisory 

committee meeting of the Army 

Education Advisory Committee (AEAC). 

This meeting is open to the public. 

DATES: The Army Education Advisory 

Committee will meet from 8 a.m. to 5 

p.m. on both January 24–25, 2024. 

ADDRESSES: Army Education Advisory 

Committee, 950 Jefferson Avenue, 

Building 950, U.S. Training and 

Doctrine Command (TRADOC) 

Headquarters, Conference Room 2047, 

Ft. Eustis, VA 23604. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Justin M. Green, the Designated Federal 

Officer for the committee, in writing at 

ATTN: ATTG–TRI–G, TRADOC, 950 

Jefferson Ave, Fort Eustis, VA 23604, by 

email at justin.m.green12.civ@army.mil, 

or by telephone at (757) 501–9935. 

SUPPLEMENTARY INFORMATION: Due to 

circumstances beyond the control of the 

Designated Federal Officer, the Army 

Education Advisory Committee was 

unable to provide public notification 

required by 41 CFR 102–3.150(a) 

concerning its January 24–25, 2024 

meeting. Accordingly, the Advisory 

Committee Management Officer for the 

Department of Defense, pursuant to 41 


lotter on DSK11XQN23PROD with NOTICES1