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
Federal Register / Vol. 89, No. 7 / Wednesday, January 10, 2024 / Notices 1567 

CFR 102–3.150(b), waives the 15- 

calendar day notification requirement. 

The committee meeting is being held 

under the provisions of the Federal 

Advisory Committee Act (FACA; 5 

U.S.C. 10), the Government in the 

Sunshine Act of 1976 (5 U.S.C. 552b, as 

amended), and 41 CFR 102–3.150. 

Purpose of the Meeting: The purpose 

of the meeting is to review TRADOC 

Priorities, the AEAC Charter, and to 

conduct mandatory annual ethics 

training. The Committee will also 

receive an overview of the Fiscal Year 

2024 AEAC Study which will focus on 

the modernization of the Special 

Operations School of Excellence 

(SOCoE). 

Agenda: January 24 and 25: The 

committee is chartered to provide 

independent advice and 

recommendations to the Secretary of the 

Army on the educational, doctrinal, and 

research policies and activities of U.S. 

Army educational programs. The 

committee will complete all FACA 

annual requirements, will begin 

discussions related to the modernization 

of the Special Operations School of 

Excellence (SOCoE), and discuss and 

deliberate provisional findings and 

recommendations submitted by its 

subcommittees. 

Public Accessibility to the Meeting: 

Pursuant to 5 U.S.C. 552b, as amended, 

and 41 CFR 102–3.140 through 102– 

3.165, and subject to the availability of 

space, this meeting is open to the 

public. Seating is on a first to arrive 

basis. Attendees are requested to submit 

their name, affiliation, and daytime 

phone number seven business days 

prior to the meeting to Dr. Green, via 

electronic mail, the preferred mode of 

submission, at the address listed in the 

FOR FURTHER INFORMATION CONTACT

section. 

Because the meeting of the committee 

will be held in a Federal Government 

facility on a military base, security 

screening is required. A photo ID is 

required to enter base. Please note that 

security and gate guards have the right 

to inspect vehicles and persons seeking 

to enter and exit the installation. 

TRADOC Headquarters is fully 

handicap accessible. Wheelchair access 

is available in front at the main entrance 

of the building. For additional 

information about public access 

procedures, contact Dr. Green, the 

committee’s Designated Federal Officer, 

at the email address or telephone 

number listed in the FOR FURTHER

INFORMATION CONTACT section. 

Written Comments or Statements: 

Pursuant to 41 CFR 102–3.105(j) and 

102–3.140 and section 10(a)(3) of the 

Federal Advisory Committee Act, the 

public or interested organizations may 

submit written comments or statements 

to the committee in response to the 

stated agenda of the open meeting or in 

regard to the committee’s mission in 

general. Written comments or 

statements should be submitted to Dr. 

Green, the committee Designated 

Federal Officer, via electronic mail, the 

preferred mode of submission, at the 

address listed in the FOR FURTHER

INFORMATION CONTACT section. Each page 

of the comment or statement must 

include the author’s name, title or 

affiliation, address, and daytime phone 

number. The Designated Federal Official 

will review all submitted written 

comments or statements and provide 

them to members of the committee for 

their consideration. Written comments 

or statements being submitted in 

response to the agenda set forth in this 

notice must be received by the 

Designated Federal Official at least 

seven business days prior to the meeting 

to be considered by the committee. 

Written comments or statements 

received after this date may not be 

provided to the committee until its next 

meeting. 

Pursuant to 41 CFR 102–3.140d, the 

Committee is not obligated to allow a 

member of the public to speak or 

otherwise address the Committee during 

the meeting. Members of the public will 

be permitted to make verbal comments 

during the Committee meeting only at 

the time and in the manner described 

below. If a member of the public is 

interested in making a verbal comment 

at the open meeting, that individual 

must submit a request, with a brief 

statement of the subject matter to be 

addressed by the comment, at least 

seven business days in advance to the 

committee’s Designated Federal Official, 

via electronic mail, the preferred mode 

of submission, at the address listed in 

the FOR FURTHER INFORMATION CONTACT

section. The Designated Federal Official 

will log each request, in the order 

received, and in consultation with the 

committee Chair, determine whether the 

subject matter of each comment is 

relevant to the committee’s mission 

and/or the topics to be addressed in this 

public meeting. A 15-minute period 

near the end of the meeting will be 

available for verbal public comments. 

Members of the public who have 

requested to make a verbal comment 

and whose comments have been 

deemed relevant under the process 

described above, will be allotted no 

more than three minutes during the 

period, and will be invited to speak in 

the order in which their requests were 

received by Designated Federal Official. 

James W. Satterwhite Jr., 

Army Federal Register Liaison Officer. 

[FR Doc. 2024–00308 Filed 1–9–24; 8:45 am] 

BILLING CODE 3710–02–P 

DEPARTMENT OF ENERGY 

Federal Energy Regulatory 

Commission 

[Project No. 2544–000] 

Hydro Technology Systems; Notice of 

Authorization for Continued Project 

Operation 

The license for the Meyers Falls 

Hydroelectric Project No. 2544 was 

issued for a period ending December 31, 

2023. 

Section 15(a)(1) of the FPA, 16 U.S.C. 

808(a)(1), requires the Commission, at 

the expiration of a license term, to issue 

from year-to-year an annual license to 

the then licensee(s) under the terms and 

conditions of the prior license until a 

new license is issued, or the project is 

otherwise disposed of as provided in 

section 15 or any other applicable 

section of the FPA. If the project’s prior 

license waived the applicability of 

section 15 of the FPA, then, based on 

section 9(b) of the Administrative 

Procedure Act, 5 U.S.C. 558(c), and as 

set forth at 18 CFR 16.21(a), if the 

licensee of such project has filed an 

application for a subsequent license, the 

licensee may continue to operate the 

project in accordance with the terms 

and conditions of the license after the 

minor or minor part license expires, 

until the Commission acts on its 

application. If the licensee of such a 

project has not filed an application for 

a subsequent license, then it may be 

required, pursuant to 18 CFR 16.21(b), 

to continue project operations until the 

Commission issues someone else a 

license for the project or otherwise 

orders disposition of the project. 

If the project is subject to section 15 

of the FPA, notice is hereby given that 

an annual license for Project No. 2544 

is issued to Hydro Technology Systems 

for a period effective January 1, 2024, 

through December 31, 2024, or until the 

issuance of a new license for the project 

or other disposition under the FPA, 

whichever comes first. If issuance of a 

new license (or other disposition) does 

not take place on or before December 31, 

2024, notice is hereby given that, 

pursuant to 18 CFR 16.18(c), an annual 

license under section 15(a)(1) of the 

FPA is renewed automatically without 

further order or notice by the 


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