51570 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 

risk of cardiovascular diseases; for use 

in diabetes management; for identifying 

or inferring the identity of a 

microorganism directly from clinical 

material; for detection of antibodies to 

microorganisms other than 

immunoglobulin G (IgG) and IgG assays 

when the results are not qualitative, or 

are used to determine immunity, or the 

assay is intended for use in matrices 

other than serum or plasma; for 

noninvasive testing; or for near-patient 

testing (point of care). 

Exemption from the requirement of 

premarket notification does not exempt 

a device from other applicable 

regulatory controls under the FD&C Act, 

including the applicable general and 

special controls. Indeed, FDA’s decision 

to grant 510(k) exemption for these 

devices is based, in part, on the special 

controls, in combination with general 

controls, providing sufficiently rigorous 

mitigations for the risks identified for 

this generic type. 

This exemption from 510(k), subject 

to the limitations described above, is 

immediately in effect for autosomal 

recessive carrier screening gene 

mutation detection systems. This 

exemption will decrease regulatory 

burdens on the medical device industry 

and will eliminate private costs and 

expenditures required to comply with 

Federal regulation. Specifically, 

regulated industry will no longer have 

to invest time and resources in 

premarket notifications, including 

preparation of documents and data for 

submission to FDA, payment of user 

fees associated with 510(k) submissions, 

and responding to questions and 

requests for additional information from 

FDA during 510(k) review for devices in 

this exempted type. 

VII. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.34(b) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Paperwork Reduction Act of 1995 

This notice refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 807, subpart, E have been 

approved under OMB control number 

0910–0120 and the collections of 

information in 21 CFR parts 801 and 

809 have been approved under OMB 

control number 0910–0485. 

IX. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA Guidance, ‘‘Procedures for Class II 

Device Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff,’’ February 19, 1998, 

available at https://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM080199.pdf. 

2. FDA Guidance for Industry and FDA Staff 

‘‘Class II Special Controls Guidance 

Document: CFTR Gene Mutation 

Detection Systems,’’ October 26, 2005, 

available at: https://www.fda.gov/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm071104.pdf. 

List of Subjects in 21 CFR Part 866 

Biologics, Laboratories, Medical 

devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 866 is 

amended as follows: 

PART 866—IMMUNOLOGY AND 

MICROBIOLOGY DEVICES 

■ 1. The authority citation for part 866 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. In § 866.5940, revise paragraph (b) 

introductory text to read as follows: 

§ 866.5940 Autosomal recessive carrier 

screening gene mutation detection system. 

* * * * * 

(b) Classification. Class II (special 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 866.9, 

except § 866.9(c)(2). Autosomal 

recessive carrier screening gene 

mutation detection system must comply 

with the following special controls: 

* * * * * 

Dated: November 1, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24162 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF COMMERCE 

United States Patent and Trademark 

Office 

37 CFR Part 42 

[Docket No. PTO–P–2016–0029] 

RIN 0651–AD10 

Rule on Attorney-Client Privilege for 

Trials Before the Patent Trial and 

Appeal Board 

AGENCY: Patent Trial and Appeal Board, 

United States Patent and Trademark 

Office, U.S. Department of Commerce. 

ACTION: Final rule. 

SUMMARY: This final rule on attorneyclient privilege amends the existing 

rules relating to the United States Patent 

and Trademark Office (Office or 

USPTO) trial practice for inter partes 

review, post-grant review, the 

transitional program for covered 

business method patents, and derivation 

proceedings that implemented 

provisions of the Leahy-Smith America 

Invents Act (‘‘AIA’’) providing for trials 

before the Office. 

DATES: This rule is effective on 

December 7, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Edward Elliott, Attorney Advisor, by 

telephone at (571) 272–7024 or by email 

at edward.elliott@uspto.gov. 

SUPPLEMENTARY INFORMATION: 

Executive Summary: Purpose: This 

final rule clarifies situations where 

privilege is recognized for 

communications between clients and 

their domestic or foreign patent 

attorneys and patent agents. 

Background 

In February 2015, the USPTO held a 

roundtable and solicited comments on 

attorney-client privilege issues. See 

Notice of Roundtable and Request for 

Comments on Domestic and 

International Issues Related to 

Privileged Communications Between 

Patent Practitioners and Their Clients, 

80 FR 3953 (Jan. 26, 2015). As part of 

that process, the USPTO requested 

comments on whether communications 

between patent applicants or owners 

with their U.S. patent agents or foreign 

patent practitioners should be 

recognized as privileged to the same 


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extent as communications with U.S. 

patent attorneys. Respondents 

unanimously supported a rule 

recognizing such privilege in courts. See 

USPTO, Summary of Roundtable and 

Written Comments, available at http://

www.uspto.gov/sites/default/files/

documents/Summary%20of%

20Privileged%20Communication%20

Roundtable.pdf (‘‘Privilege Report’’). 

Some roundtable participants noted 

that rules regarding privilege for U.S. 

patent agents and foreign practitioners 

in PTAB discovery proceedings were 

difficult to discern, as there has been no 

explicit rule on privilege. When the 

issue arises before PTAB, 

Administrative Law Judges make legal 

determinations as to which 

communications may be protected from 

disclosure on a case-by-case basis, based 

on the Federal Rules of Evidence and 

common law. See 37 CFR 42.62(a); see 

also GEA Process Engineering, Inc. v. 

Steuben Foods, Inc., IPR2014–00041, 

Paper 117 (PTAB 2014). U.S. courts 

have devised several different 

approaches to determine under what 

circumstances communications with 

these practitioners are privileged. As the 

Privilege Report notes, the common law 

on privilege for domestic and foreign 

patent practitioners varies across 

jurisdictions. Different approaches are 

taken, and results sometimes conflict. 

This may lead to administrative 

inefficiencies and inconsistencies in 

outcomes, as PTAB must select which 

set of common law rules to follow. 

Administrative Law Judges in other 

agencies have treated certain 

confidential communications with a 

patent agent as privileged. See, e.g., 

USITC Inv. No. 337–TA–339, slip op. at 

2, 1992 WL 811804 (ITC 1992) (finding 

that confidential communications 

between a U.S. patent agent and his 

client in connection with a patent 

prosecution are privileged). In 2016, the 

Federal Circuit recognized that attorneyclient privilege applies to U.S. patent 

agents acting within the scope of their 

authorized practice. See In re Queen’s 

University at Kingston, 820 F.3d 1287 

(Fed. Cir. 2016). 

To address the aforementioned issues 

with privilege rules, the USPTO put 

forth a proposed PTAB rule for public 

comment in October 2016. See Rule 

Recognizing Privileged Communications 

Between Clients and Patent 

Practitioners at the Patent Trial and 

Appeal Board, 81 FR 71653 (Oct. 18, 

2016). The Office received eighteen 

comments from bar associations, trade 

groups, law firms, and individuals. The 

Office expresses its gratitude for the 

thoughtful and comprehensive 

comments provided by the public, 

which are available online at https://

www.regulations.gov/docket?D=PTO-P2016-0029. 

The vast majority of commenters 

expressed support for this rule, echoing 

the need for clarity and certainty in this 

area. The policy arguments they raised 

in favor are already covered extensively 

in the Privilege Report. Several 

commenters raised additional issues 

about specific language in the proposed 

rule, which are addressed herein. A few 

commenters opposed the rule based on 

misunderstandings of the scope and 

purpose of the rule, which are clarified 

herein as well. Based on the feedback, 

the Office presents the following final 

rule on recognizing privilege for patent 

attorneys and agents. 

Responses to Comments 

Nature of Privilege 

Comments: Some comments 

expressed concern over the scope and 

interpretation of the proposed rule. One 

commenter objected to expanding those 

eligible to practice before PTAB to 

include agents. Others characterized the 

rule as primarily to protect 

communications between clients and 

counsel involved in PTAB proceedings. 

Response: Attorney-client privilege 

exists to protect clients. It allows them 

to have full and frank discussions with 

attorneys when seeking legal advice, 

without fear that those discussions will 

be used against them in legal 

proceedings. The privilege vests with 

the client, not the attorney, and does not 

confer authorization to practice law, but 

rather flows from those already having 

such authorization. Because of this, 

recognizing privilege for patent agents 

does not determine what types of work 

they are authorized to perform. The 

authorized functions of patents agents, 

including representing clients before 

PTAB, are established in 37 CFR 11.5(b). 

Likewise, privilege does not confer 

additional power to patent agents 

because it vests in the client, not the 

agent or attorney. Applying the privilege 

to agents simply recognizes that they 

perform legal services and that clients 

deserve the same protections regardless 

of which type of authorized legal 

provider they choose. Further, some 

foreign jurisdictions rely entirely or 

almost entirely on non-attorney patent 

agents. In such jurisdictions, hiring an 

attorney to handle patent matters can be 

difficult or impossible. See the Privilege 

Report for further discussion of the 

policy considerations supporting 

privilege for patent agents. 

More fundamentally, this rule is not 

intended primarily to protect 

communications between clients and 

their counsel for purposes of PTAB 

proceedings. Rather, it is primarily 

intended to protect communications 

made when seeking patents at the 

USPTO or foreign IP offices, such as 

when prosecuting applications or 

contemplating whether to file. The 

counsel on those communications may 

not be involved in any PTAB 

proceedings. Communications about 

prosecution are much more commonly 

implicated in PTAB discovery 

proceedings than communications about 

the PTAB proceeding itself. Perhaps this 

reflects the inherent asymmetry of 

privilege protections: Both parties are 

affected if their communications seeking 

legal advice about the PTAB proceeding 

are discoverable, whereas only the 

patent holder is affected by discovery of 

communications from prosecution. 

Regardless, the purpose of the rule is to 

protect any communications with 

authorized counsel from discovery in 

PTAB, not just communications about 

the instant proceeding. 

Similarly, this privilege rule does not 

affect an attorney, agent, or applicant’s 

duty to disclose material information to 

the USPTO at any time, as the duty of 

disclosure under 37 CFR 1.56 continues 

to be controlling. This duty is not at 

odds with privilege protections; the 

duty of disclosure governs all 

information known by a party and 

establishes whether information must be 

provided to the USPTO, while privilege 

governs material available to third party 

adversaries in adjudicated proceedings 

under part 42. For instance, the 

privilege rule does not apply in the 

filing and prosecution of a patent 

application. Further, the privilege only 

protects information exchanged for 

purposes of obtaining legal opinions or 

services, not underlying facts or 

business documents. The precise metes 

and bounds of what types of 

communications are protected by 

privilege are determined according to 

Federal law. Finally, this rule does not 

nullify privilege for others who are not 

covered by the rule, such as attorneys 

not admitted to practice before the 

USPTO or a foreign patent office. Other 

sources of privilege under Federal law 

remain unaffected. 

Scope of Activities 

Comments: Some commenters 

requested clarity on the scope of 

covered activities. One commenter 

asked the USPTO to clarify whether a 

communication with a registered patent 

agent about claim interpretation of an 

issued patent would qualify as 

privileged. Others asked for general 

clarification of what activities by patent 

agents would be covered, with one 


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requesting examples of activities that 

would qualify for the privilege. One 

commenter noted that 37 CFR 11.5(b)(1) 

may not provide an exhaustive list of 

authorized activities. 

Response: We understand the 

commenters’ desire for clarity on these 

issues. The USPTO has described the 

functions agents are authorized to 

perform before the Office in 37 CFR 

11.5(b)(1). Whether a particular scenario 

falls within the bounds of an agent’s 

authorization is subject to determination 

by an appropriate authority. 

More precisely defining what types of 

work patent agents are and are not 

authorized to perform is a much larger 

issue that goes far beyond privilege 

considerations. This rulemaking is not 

the proper forum to address that issue. 

If the public feels that the general 

definition of authorized functions put 

forth by the USPTO in § 11.5(b)(1) 

should be updated, they should contact 

the USPTO to express interest in a more 

comprehensive process to consider that 

issue, which accounts for the numerous 

equities involved. We also note that 

regardless of any clarifications made to 

the scope of authorized duties for U.S. 

patent agents, the USPTO cannot alter 

or clarify the authorized functions of 

foreign patent agents in their home 

jurisdiction, which are established by 

foreign laws and regulations. 

Federal Privilege 

Comments: One comment suggested 

clarifying that the ‘‘same protections of 

privilege’’ refers to Federal privilege, 

since state courts have their own 

separate sources of privilege. 

Response: We concur and have 

adjusted the rule to specify ‘‘privilege 

under Federal law’’ in paragraph (a). 

Direct Communications 

Comments: One comment suggested 

that the rule as written may only cover 

communications directly between a 

client and a foreign practitioner, and not 

communications made by the client’s 

U.S. attorney with the foreign 

practitioner. According to the comment, 

communications made between a 

client’s representatives in the absence of 

the client could be inadvertently 

excluded by the current phrasing of the 

rule. 

Response: Under U.S. Federal law, 

attorney-client privilege generally 

encompasses communications with an 

attorney made by the client’s 

representatives as well as the client. 

Similarly, privilege generally 

encompasses communications made 

with an attorney’s employee or 

assistant, as well as communications 

between multiple attorneys working for 

a client. That is not to say such 

communications are necessarily 

privileged; they must still meet the 

other requirements for privilege, such as 

appropriate subject matter. However, 

these parties are generally regarded as 

parties that fall within the scope of 

privilege, rather than as third parties 

who break privilege. 

Under the new rule, communications 

with such parties should similarly be 

entitled to privilege under the same 

circumstances as when the practitioner 

is an attorney. However, we recognize 

that there is potential for a narrower 

reading of the proposed rule that does 

not cover communications with such 

parties and therefore affords lesser 

protection to non-attorney practitioners. 

We have added paragraph (c) to the rule 

to clarify that the scope of coverage will 

be the same for practitioners as for 

attorneys under these types of scenarios 

and any other situations. For instance, 

privilege will extend to communications 

with the aforementioned parties under 

appropriate circumstances, not just to 

communications directly between the 

practitioner and the client. 

Limitations and Exceptions 

Comments: One comment suggested 

explicitly defining which ‘‘limitations 

and exceptions’’ should apply to the 

privilege. 

Response: Exceptions to attorneyclient privilege such as crime/fraud are 

based on longstanding common law, 

which continues to evolve. Our purpose 

here is not to redefine those exceptions. 

This may lead to growing discrepancies 

as the common law changes, which 

could lead to disparate treatment of 

privilege for patent attorneys and agents 

compared with other attorneys. Rather, 

this rule codifies who is eligible for the 

privilege, while leaving questions about 

exceptions and limitations for general 

jurisprudence to address in a broader 

manner. 

Practitioners With Limited Recognition 

Comments: A couple of commenters 

noted that the rule does not extend to 

all categories of practitioners, namely, 

those granted limited recognition under 

37 CFR 11.9. 

Response: The rule has been amended 

to cover USPTO practitioners meeting 

the registration requirements of 37 CFR 

11.7. This includes practitioners under 

both §§ 11.6 and 11.9(b), who have 

demonstrated the requisite legal, 

scientific, and technical qualifications 

and moral character. Foreign 

practitioners practicing at the USPTO 

under § 11.9(c) can qualify for privilege 

under paragraph (b) of the new rule 

through their admittance to practice in 

a foreign jurisdiction. Students in the 

USPTO law school clinic program 

practicing under § 11.16 can qualify for 

privilege under paragraph (c) of the new 

rule since they work under the 

supervision of a registered practitioner. 

At this time, we are not convinced an 

extension to other categories of 

practitioners is necessary or 

appropriate. It is not clear that 

recognizing privilege for these 

individuals furthers any of the policy 

reasons for applying privilege to patent 

agents, or that these individuals play a 

significant role in providing legal 

services for applicants. 

Relation to In re Queen’s 

Comments: A few commenters noted 

the parallels between this rule and the 

Federal Circuit’s decision in In re 

Queen’s University, wondering if a 

USPTO rule is still necessary and 

whether there would be any distinction 

between our rule and the Federal 

Circuit’s. One commenter mentioned a 

supposed difference in coverage for 

third-party patent validity opinions by 

agents. 

Response: The USPTO supports the 

Federal Circuit’s finding of privilege for 

patent agents as a matter of public 

policy. The Privilege Report catalogs the 

many reasons that privilege for patent 

agents is warranted. A USPTO rule on 

privilege is still needed, for at least 

several reasons. The Queen’s decision 

was a 2–1 panel result, which may be 

revisited in future cases either en banc 

at the Federal Circuit or at the Supreme 

Court. There are clarity benefits to 

having a rule explicitly codified rather 

than only in common law. 

Also, the Federal Circuit decision 

only addresses domestic patent agents, 

not foreign attorneys and agents. 

Without comparable protections in U.S. 

tribunals for foreign practitioners, 

privileged communications with U.S. 

patent attorneys may effectively lose 

that protection through parallel 

communications with foreign 

practitioners prosecuting corresponding 

foreign applications, which often raise 

very similar legal issues. Having a U.S. 

attorney supervise communications 

with foreign practitioners is not only an 

undesirable policy, but may not be 

enough to preserve privilege in all 

circumstances. Because the U.S. 

attorney is generally not authorized to 

practice law in foreign jurisdictions, the 

foreign attorney might not be considered 

as working ‘‘under the supervision’’ of 

the U.S. attorney in all instances. 

Further, some jurisdictions use nonattorney patent agents exclusively or 

predominantly, so it may not be 

possible for applicants to rely on 


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privilege afforded by U.S. courts to 

foreign attorneys. The new privilege 

rule protects eligible communications 

with qualified foreign attorneys and 

agents from discovery at PTAB, 

preventing such back door exposure. 

The rule does not have extraterritorial 

effects; how communications with U.S. 

and foreign practitioners are treated by 

foreign courts is entirely up to the 

foreign jurisdiction. 

Another reason for the USPTO’s rule 

is administrative economy and judicial 

efficiency, as explained by commenter 

John Cross of the University of 

Louisville. The typical approach to 

privilege for foreign practitioners 

examines whether the foreign 

jurisdiction affords something like 

privilege for attorneys and agents. 

However, this inquiry can be intensive, 

difficult, and lead to inconsistent 

results, because many jurisdictions do 

not need a comparable protection when 

their constrained discovery system 

prevents communications with patent 

practitioners from even being 

discoverable. Similarly, U.S. courts that 

use a ‘‘touch base’’ standard often make 

complex inquiries into a foreign 

communication’s nexus with the United 

States, which can lead to uncertain and 

inconsistent results. The USPTO rule 

simplifies such inquiries by instead 

considering whether the foreign 

practitioner was authorized to practice 

within their home jurisdiction by 

satisfying their jurisdiction’s 

professional requirements, and whether 

the communications fall within their 

authorized scope of practice in that 

jurisdiction. These criteria are simpler 

to adjudicate and lead to more 

predictable and consistent results, 

helping applicants understand where 

privilege applies long before they 

appear at a tribunal. 

Also, the USPTO rule applies 

regardless of the source of privilege for 

agents. Whether there is a separate 

agent-client privilege or agents are 

afforded attorney-client privilege on the 

basis of practicing patent law does not 

matter for purposes of this rule. The rule 

simply recognizes that privilege issues 

will be treated the same for agents as for 

attorneys within their scope of 

authorized practice. 

Practice of Law 

Comments: Two commenters 

suggested that the rule would promote 

the ‘‘unauthorized practice of law’’ by 

U.S. patent agents. It was suggested that 

participation by patent agents in PTAB 

proceedings would constitute 

unauthorized practice, and that agents 

participating in PTAB proceedings held 

concurrently with patent litigation on 

the same patents would constitute 

unauthorized litigation practice by those 

agents. One of these commenters also 

said that state bar rules may conflict 

with this PTAB rule. 

Response: As previously mentioned, 

the rule does not grant additional 

powers to patent agents. Privilege is a 

protection that vests with the client, not 

the practitioner. Agents are already 

authorized to practice before PTAB in 

any USPTO proceedings. Practice before 

PTAB cannot be unauthorized practice 

of law because U.S. patent agents are 

authorized to do so. 

The second objection suggests that 

practicing before PTAB is tantamount to 

practicing before Federal courts when 

there is concurrent litigation on the 

same patents. Because they are separate 

venues with separate practices and 

practitioners, this argument is not 

persuasive. Agents are authorized to 

advise and represent clients in PTAB 

proceedings because the issues are 

restricted to patent law matters they are 

authorized to perform. Federal courts 

have different jurisdiction than PTAB 

and consider a range of non-patent 

issues. The fact that certain patent 

issues, such as validity, may arise before 

both tribunals does not equate practice 

before both venues. Just because a 

practitioner is authorized to address the 

issue in one forum does not mean they 

are authorized to address it in other 

forums. This is true regardless of 

whether the practitioner is an agent or 

an attorney and whether the two forums 

are, for instance, PTAB and a Federal 

court, or a Federal court and a foreign 

court. 

Finally, state bar rules generally are 

not germane to USPTO rules. The 

USPTO may properly regulate the 

conduct of practitioners before the 

Office, including PTAB proceedings, as 

authorized by Congress. Similarly, states 

can properly regulate the practice of law 

within their borders, subject to 

federalism principles and rules 

established by the Supreme Court. The 

USPTO and states have separate 

jurisdiction. States may of course 

consider the policy issues the USPTO 

has documented when deciding 

privilege matters within their own 

courts for domestic and foreign patent 

agents and attorneys. 

Changes From the Proposed Rule 

In response to comments received 

from the public, the USPTO makes the 

following changes from the proposed 

rule. The terms for types of practitioners 

(domestic and foreign) were adjusted 

slightly for uniformity with other rules. 

The application of Federal law was 

clarified. The USPTO registration 

requirement now points to 37 CFR 11.7 

for more precision. Paragraph (c) was 

added to clarify that non-attorney 

practitioners are afforded privilege in all 

the same situations as attorneys, not just 

for direct communications between 

practitioner and client. 

Rulemaking Considerations 

A. Administrative Procedure Act 

(APA): This final rule revises the rules 

relating to Office trial practice for inter 

partes review, post-grant review, the 

transitional program for covered 

business method patents, and derivation 

proceedings. The changes being adopted 

in this notice do not change the 

substantive criteria of patentability. 

These changes involve rules of agency 

practice. See, e.g., 35 U.S.C. 316(a)(5), as 

amended. These rules are procedural 

and/or interpretive rules. See Bachow 

Commc’ns Inc. v. F.C.C., 237 F.3d 683, 

690 (D.C. Cir. 2001) (Rules governing an 

application process are procedural 

under the Administrative Procedure 

Act.); Inova Alexandria Hosp. v. 

Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (Rules for handling appeals were 

procedural where they did not change 

the substantive requirements for 

reviewing claims.); Nat’l Org. of 

Veterans’ Advocates v. Sec’y of Veterans 

Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 

2001) (Rule that clarifies interpretation 

of a statute is interpretive.); JEM Broad. 

Co. v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. 

1994) (Rules are not legislative because 

they do not ‘‘foreclose effective 

opportunity to make one’s case on the 

merits.’’). 

Accordingly, prior notice and 

opportunity for public comment are not 

required pursuant to 5 U.S.C. 553(b) or 

(c) (or any other law). See Cooper Techs. 

Co. v. Dudas, 536 F.3d 1330, 1336–37 

(Fed. Cir. 2008) (stating that 5 U.S.C. 

553, and thus 35 U.S.C. 2(b)(2)(B), do 

not require notice and comment 

rulemaking for ‘‘interpretative rules, 

general statements of policy, or rules of 

agency organization, procedure, or 

practice’’ (quoting 5 U.S.C. 553(b)(A))). 

However, the Office chose to seek 

public comment before implementing 

the rule to benefit from the public’s 

input. 

B. Regulatory Flexibility Act: As prior 

notice and an opportunity for public 

comment are not required pursuant to 5 

U.S.C. 553 or any other law, neither a 

regulatory flexibility analysis nor a 

certification under the Regulatory 

Flexibility Act (5 U.S.C. 601–612) is 

required. See 5 U.S.C. 603. Nonetheless, 

for the reasons set forth herein, the 

Senior Counsel for Regulatory and 

Legislative Affairs in the Office of 

General Law of the USPTO has certified 


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51574 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 

to the Chief Counsel for Advocacy of the 

Small Business Administration that this 

rule will not have a significant 

economic impact on a substantial 

number of small entities. See 5 U.S.C. 

605(b). This rule revises the rules of 

practice before PTAB to explicitly 

recognize that communications between 

non-attorney or foreign patent 

practitioners and their clients that 

pertain to authorized practice before the 

USPTO or foreign patent offices are 

privileged, and to define those persons 

who may avail themselves of this 

privilege. These changes are expected to 

create no additional burden to those 

practicing before the Board as this rule 

merely clarifies rights and protections 

for the practitioner and client and does 

not impose a change in practice or 

requirements. In fact, this rule may 

produce a small benefit from a 

reduction in uncertainty and mitigation 

of discovery costs. For the above 

reasons, the changes in this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

Office has complied with Executive 

Order 13563. Specifically, the Office 

has, to the extent feasible and 

applicable: (1) Made a reasoned 

determination that the benefits justify 

the costs of the rule; (2) tailored the rule 

to impose the least burden on society 

consistent with obtaining the regulatory 

objectives; (3) selected a regulatory 

approach that maximizes net benefits; 

(4) specified performance objectives; (5) 

identified and assessed available 

alternatives; (6) involved the public in 

an open exchange of information and 

perspectives among experts in relevant 

disciplines, affected stakeholders in the 

private sector, and the public as a 

whole, and provided on-line access to 

the rulemaking docket; (7) attempted to 

promote coordination, simplification, 

and harmonization across government 

agencies and identified goals designed 

to promote innovation; (8) considered 

approaches that reduce burdens and 

maintain flexibility and freedom of 

choice for the public; and (9) ensured 

the objectivity of scientific and 

technological information and 

processes. 

E. Executive Order 13771 (Reducing 

Regulation and Controlling Regulatory 

Costs): This rule is not an Executive 

Order 13771 regulatory action because 

this rule is not significant under 

Executive Order 12866. 

F. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

G. Executive Order 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) Have substantial direct effects on one 

or more Indian tribes; (2) impose 

substantial direct compliance costs on 

Indian tribal governments; or (3) 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

H. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

I. Executive Order 12988 (Civil Justice 

Reform): This rulemaking meets 

applicable standards to minimize 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

J. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

K. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not affect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

L. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule, the United States 

Patent and Trademark Office will 

submit a report containing the rule and 

other required information to the United 

States Senate, the United States House 

of Representatives, and the Comptroller 

General of the Government 

Accountability Office. The changes in 

this final rule are not expected to result 

in an annual effect on the economy of 

100 million dollars or more, a major 

increase in costs or prices, or significant 

adverse effects on competition, 

employment, investment, productivity, 

innovation, or the ability of United 

States-based enterprises to compete 

with foreign-based enterprises in 

domestic and export markets. Therefore, 

this final rule is not a ‘‘major rule’’ as 

defined in 5 U.S.C. 804(2). 

M. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

rulemaking do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

of 100 million dollars (as adjusted) or 

more in any one year, or a Federal 

private sector mandate that will result 

in the expenditure by the private sector 

of 100 million dollars (as adjusted) or 

more in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions are 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995. See 2 U.S.C. 1501 et seq. 

N. National Environmental Policy 

Act: This rulemaking will not have any 

effect on the quality of the environment 

and is thus categorically excluded from 

review under the National 

Environmental Policy Act of 1969. See 

42 U.S.C. 4321 et seq. 

O. National Technology Transfer and 

Advancement Act: The requirements of 

section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) are not 

applicable because this rulemaking does 

not contain provisions which involve 

the use of technical standards. 

P. Paperwork Reduction Act: The 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3549) requires that the 

Office consider the impact of paperwork 

and other information collection 

burdens imposed on the public. This 

final rule involves information 

collection requirements which are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3549). This rulemaking 

does not add any additional information 

requirements or fees for parties before 

the Board. Therefore, the Office is not 

resubmitting information collection 

packages to OMB for its review and 

approval because the revisions in this 

rulemaking do not materially change the 

information collections approved under 

OMB control number 0651–0069. 

Notwithstanding any other provision 

of law, no person is required to respond 

to, nor shall any person be subject to, a 

penalty for failure to comply with a 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information displays a currently valid 

OMB control number. 

List of Subjects in 37 CFR Part 42 

Administrative practice and 

procedure, Inventions and patents. 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 51575 

For the reasons set forth in the 

preamble, 37 CFR part 42 is amended as 

follows. 

PART 42—TRIAL PRACTICE BEFORE 

THE PATENT TRIAL AND APPEAL 

BOARD 

■ 1. The authority citation for 37 CFR 

part 42 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), 6, 21, 23, 41, 

135, 311, 312, 316, 321–326; Public Law 112– 

29, 125 Stat. 284; and Pub. L. 112–274, 126 

Stat. 2456. 

■ 2. Add § 42.57 to read as follows: 

§ 42.57 Privilege for patent practitioners. 

(a) Privileged communications. A 

communication between a client and a 

USPTO patent practitioner or a foreign 

jurisdiction patent practitioner that is 

reasonably necessary and incident to the 

scope of the practitioner’s authority 

shall receive the same protections of 

privilege under Federal law as if that 

communication were between a client 

and an attorney authorized to practice 

in the United States, including all 

limitations and exceptions. 

(b) Definitions. The term ‘‘USPTO 

patent practitioner’’ means a person 

who has fulfilled the requirements to 

practice patent matters before the 

United States Patent and Trademark 

Office under § 11.7 of this chapter. 

‘‘Foreign jurisdiction patent 

practitioner’’ means a person who is 

authorized to provide legal advice on 

patent matters in a foreign jurisdiction, 

provided that the jurisdiction 

establishes professional qualifications 

and the practitioner satisfies them. For 

foreign jurisdiction practitioners, this 

rule applies regardless of whether that 

jurisdiction provides privilege or an 

equivalent under its laws. 

(c) Scope of coverage. USPTO patent 

practitioners and foreign jurisdiction 

patent practitioners shall receive the 

same treatment as attorneys on all issues 

affecting privilege or waiver, such as 

communications with employees or 

assistants of the practitioner and 

communications between multiple 

practitioners. 

Joseph Matal, 

Associate Solicitor, performing the functions 

and duties of the Under Secretary of 

Commerce for Intellectual Property and 

Director of the United States Patent and 

Trademark Office. 

[FR Doc. 2017–24190 Filed 11–6–17; 8:45 am] 

BILLING CODE 3510–16–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2017–0280; FRL–9969–89– 

Region 5] 

Air Plan Approval; Wisconsin; 2017 

Revisions to NR 400 and 406 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking direct final 

action to approve a revision to the 

Wisconsin State Implementation Plan 

(SIP) submitted by the Wisconsin 

Department of Natural Resources 

(WDNR) to EPA on May 16, 2017. The 

revision replaces the definition of 

‘‘emergency electric generator’’ with a 

broader definition of ‘‘restricted internal 

combustion engine’’. In addition, the 

revision makes amendments to 

procedures for revoking construction 

permits as well as language changes and 

other administrative updates. Lastly, 

WDNR is removing from the SIP two 

Wisconsin Administrative Code 

provisions that affect eligibility of 

coverage under general and construction 

permits. 

DATES: This direct final rule will be 

effective January 8, 2018, unless EPA 

receives adverse comments by 

December 7, 2017. If adverse comments 

are received, EPA will publish a timely 

withdrawal of the direct final rule in the 

Federal Register informing the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2017–0280 at http://

www.regulations.gov or via email to 

damico.genevieve@epa.gov. For 

comments submitted at Regulations.gov, 

follow the online instructions for 

submitting comments. Once submitted, 

comments cannot be edited or removed 

from Regulations.gov. For either manner 

of submission, EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. EPA will generally not consider 

comments or comment contents located 

outside of the official comment (i.e. on 

the web, cloud, or other file sharing 

system). For additional submission 

methods, please contact the person 

identified in the FOR FURTHER

INFORMATION CONTACT section. For the 

full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Radhica Kanniganti, Environmental 

Engineer, Air Permits Section, Air 

Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–8097, 

kanniganti.radhica@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. Review of State Submittals 

II. What action is EPA taking? 

III. Incorporation by Reference 

IV. Statutory and Executive Order Reviews 

I. Review of State Submittals 

This final rulemaking addresses the 

May 16, 2017, WDNR submittal for SIP 

revision, revising the rules in the 

Wisconsin SIP to align them with 

Federal requirements. WDNR’s 

submittal includes changes to the term 

‘‘electric generator’’, replacing it with 

‘‘restricted internal combustion engine’’ 

as well as other minor language and 

administrative changes. Specifically, NR 

400.02(136m) replaces the existing 

definition of emergency ‘‘electric 

generator’’ with a broader definition of 

‘‘restricted internal combustion engine’’ 

and NR 406.04(1)(w) amends the 

exemption language for ‘‘emergency 

electric generators’’, replacing it with 

exemption for ‘‘restricted use 

reciprocating internal combustion 

engines’’. NR 406.08(1) and NR 406.10 

involve minor changes to language, and 

NR 406.11(1) amends procedures for 

revoking construction permits. These 

changes serve the purpose of aligning 

the state and Federal regulations and are 

consistent with the Federal program. 

WDNR is also requesting the removal of 

two provisions from the SIP. NR 

406.16(2)(d) and NR 406.17(3)(e) affect 

the eligibility of coverage under general 

and registration construction permits 

based on whether the project 

constituted a Type 2 action under the 

previous ch. NR 150. However, the 

current ch. NR 150 was amended and no 

longer defines or sets requirements for 

Type 2 actions. Removing these 

provisions from Wisconsin’s SIP 

ensures consistency with Wisconsin 

Environmental Protection Act (WEPA) 


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