Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Rules and Regulations 51567 

range of age and educational levels and 

have no prior experience with the test 

or its manufacturer. These factors shall 

be well defined in the inclusion and 

exclusion criteria. 

(ii) All sources of bias must be 

predefined and accounted for in the 

study results with regard to both 

responders and non-responders. 

(iii) The testing must follow a format 

where users have limited time to 

complete the studies (such as an onsite 

survey format and a one-time visit with 

a cap on the maximum amount of time 

that a participant has to complete the 

tests). 

(iv) Users must be randomly assigned 

to study arms. Test reports in the user 

comprehension study given to users 

must define the target condition being 

tested and related symptoms, explain 

the intended use and limitations of the 

test, explain the relevant ethnicities in 

regard to the variant tested, explain 

genetic health risks and relevance to the 

user’s ethnicity, and assess participants’ 

ability to understand the following 

comprehension concepts: The test’s 

limitations, purpose, appropriate action, 

test results, and other factors that may 

have an impact on the test results. 

(v) Study participants must be 

untrained, be naı ̈ve to the test subject of 

the study, and be provided the labeling 

prior to the start of the user 

comprehension study. 

(vi) The user comprehension study 

must meet the predefined primary 

endpoint criteria, including a minimum 

of a 90 percent or greater overall 

comprehension rate (i.e., selection of the 

correct answer) for each comprehension 

concept. Other acceptance criteria may 

be acceptable depending on the concept 

being tested. Meeting or exceeding this 

overall comprehension rate 

demonstrates that the materials 

presented to the user are adequate for 

over-the-counter use. 

(vii) The analysis of the user 

comprehension results must include 

results regarding reports that are 

provided for each gene/variant/ethnicity 

tested, statistical methods used to 

analyze all data sets, and completion 

rate, non-responder rate, and reasons for 

nonresponse/data exclusion. A 

summary table of comprehension rates 

regarding comprehension concepts (e.g., 

purpose of test, test results, test 

limitations, ethnicity relevance for the 

test results, etc.) for each study report 

must be included. 

(4) The intended use of the device 

must not include the following 

indications for use: 

(i) Prenatal testing; 

(ii) Determining predisposition for 

cancer where the result of the test may 

lead to prophylactic screening, 

confirmatory procedures, or treatments 

that may incur morbidity or mortality to 

the patient; 

(iii) Assessing the presence of genetic 

variants that impact the metabolism, 

exposure, response, risk of adverse 

events, dosing, or mechanisms of 

prescription or over-the-counter 

medications; or 

(iv) Assessing the presence of 

deterministic autosomal dominant 

variants. 

Dated: November 1, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24159 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2015–N–3455] 

Medical Devices; Exemption From 

Premarket Notification; Class II 

Devices; Autosomal Recessive Carrier 

Screening Gene Mutation Detection 

System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

publishing an order to exempt 

autosomal recessive carrier screening 

gene mutation detection systems from 

the premarket notification requirements, 

subject to certain limitations. This 

exemption from 510(k), subject to 

certain limitations, 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 certain Federal 

regulations. FDA is also amending the 

codified language for the autosomal 

recessive carrier screening gene 

mutation detection system devices 

classification regulation to reflect this 

final determination. 

DATES: This order is effective November 

7, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866. 

SUPPLEMENTARY INFORMATION: 

I. Statutory Background 

Section 510(k) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360(k)) and the implementing 

regulations, 21 CFR part 807 subpart E, 

require persons who intend to market a 

device to submit and obtain FDA 

clearance of a premarket notification 

(510(k)) containing information that 

allows FDA to determine whether the 

new device is ‘‘substantially equivalent’’ 

within the meaning of section 513(i) of 

the FD&C Act (21 U.S.C. 360c(i)) to a 

legally marketed device that does not 

require premarket approval. 

On December 13, 2016, the 21st 

Century Cures Act (Pub. L. 114–255) 

(Cures Act) was signed into law. Section 

3054 of the Cures Act amended section 

510(m) of the FD&C Act. As amended, 

section 510(m)(2) provides that, 1 

calendar day after the date of 

publication of the final list under 

paragraph (1)(B), FDA may exempt a 

class II device from the requirement to 

submit a report under section 510(k) of 

the FD&C Act, upon its own initiative or 

a petition of an interested person, if 

FDA determines that a 510(k) is not 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. This section requires FDA 

to publish in the Federal Register a 

notice of intent to exempt a device, or 

of the petition, and to provide a 60- 

calendar-day comment period. Within 

120 days of publication of such notice, 

FDA must publish an order in the 

Federal Register that sets forth its final 

determination regarding the exemption 

of the device that was the subject of the 

notice. If FDA fails to respond to a 

petition under this section within 180 

days of receiving it, the petition shall be 

deemed granted. 

II. Criteria for Exemption 

There are a number of factors FDA 

may consider to determine whether a 

510(k) is necessary to provide 

reasonable assurance of the safety and 

effectiveness of a class II device. These 

factors are discussed in the January 21, 

1998, Federal Register notice (63 FR 

3142) and subsequently in the guidance 

the Agency issued on February 19, 1998, 

entitled ‘‘Procedures for Class II Device 

Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff’’ (referred to herein as the 

Class II 510(k) Exemption Guidance) 

(Ref. 1). 

III. Device Description 

On February 19, 2015, FDA 

completed its review of a De Novo 

request for classification of the 23andMe 


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Personal Genome Service (PGS) Carrier 

Screening Test for Bloom syndrome. 

FDA classified the 23andMe PGS Carrier 

Screening Test for Bloom syndrome, 

and substantially equivalent devices of 

this generic type, into class II (special 

controls) under the generic name 

‘‘Autosomal recessive carrier screening 

gene mutation detection system.’’ This 

type of device is a qualitative in vitro 

molecular diagnostic system used for 

genotyping of clinically relevant 

variants in genomic DNA isolated from 

human specimens intended for 

prescription use or over-the-counter 

(OTC) use. The device is intended for 

autosomal recessive disease carrier 

screening in adults of reproductive age. 

The device is not intended for copy 

number variation, cytogenetic, or 

biochemical testing. 

FDA believes that De Novo 

classification will enhance patients’ 

access to beneficial innovation, in part 

by reducing regulatory burdens. When 

FDA classifies a device into class I or II 

via the De Novo process, the device can 

serve as a predicate for determining 

substantial equivalence for future 

devices within that type (see 21 U.S.C. 

360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or a premarket 

approval application in order to market 

a substantially equivalent device (see 21 

U.S.C. 360c(i), defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

In the Federal Register of October 27, 

2015 (80 FR 65774), FDA published a 

notice (‘‘October 2015 notice’’) 

announcing its intent to exempt 

autosomal recessive carrier screening 

gene mutation detection system devices 

from premarket notification 

requirements, subject to certain 

limitations, and provided opportunity 

for interested persons to submit 

comments by November 27, 2015. After 

reviewing comments received 

(summarized in section IV), FDA is now 

providing its final determination for 

autosomal recessive carrier screening 

gene mutation detection system devices 

by exempting this type of device from 

premarket notification requirements, 

subject to certain limitations as 

identified in this notice. FDA is also 

amending the codified language for the 

autosomal recessive carrier screening 

gene mutation detection system devices 

classification regulation to reflect this 

final determination. Persons with 

pending 510(k) submissions for devices 

that are now exempt from premarket 

notification, subject to the limitations, 

should withdraw their submissions. 

IV. Comments on the Proposed 

Exemption and FDA Response 

In response to the October 2015 notice 

announcing FDA’s intent to exempt 

autosomal recessive carrier screening 

gene mutation detection system devices 

from premarket notification 

requirements, FDA received 

submissions from three commenters—a 

device industry manufacturer, a 

professional organization, and a health 

care organization—supporting an 

exemption from premarket notification 

for this type of device. 

To make it easier to identify 

comments and our responses, the word 

‘‘Comment’’ and a comment number 

appear in parentheses before each 

comment’s description, and the word 

‘‘Response’’ in parentheses precedes 

each response. Similar comments are 

grouped together under the same 

number. Specific issues raised by the 

comments and the Agency’s responses 

follow. 

(Comment 1) Two commenters 

requested that FDA clarify that the list 

of autosomal recessive carrier diseases 

included in the October 2015 notice is 

not exhaustive or expand the list of 

diseases and conditions covered by the 

exemption to include all diseases and 

conditions described in the scientific 

literature as inherited in an autosomal 

recessive manner. One commenter 

further requested that FDA clarify that 

the determination of the applicability of 

§ 866.5940 (21 CFR 866.5940) should be 

based upon scientific and clinical 

literature as to the autosomal recessive 

nature of the disease or condition. 

(Response) The diseases and 

conditions listed in table 1 of the 

October 2015 notice were based upon a 

limited review of the scientific and 

clinical literature at that time. After 

consideration of the public comments, 

FDA agrees that the autosomal recessive 

diseases and conditions listed in that 

table should be treated as illustrative, 

and not an exhaustive list. Based on 

FDA’s review of current scientific and 

clinical literature, FDA would not 

consider screening for autosomal 

recessive carrier status by detection of 

clinically relevant gene mutations 

associated with a large variety of 

diseases and conditions, in addition to 

those listed in table 1 of the October 

2015 notice, to constitute a different 

intended use from that of a legally 

marketed device in the generic type 

under § 866.5940 for purposes of § 866.9 

(21 CFR 866.9). Because FDA agrees that 

the list of diseases and conditions 

provided in the October 2015 notice is 

not comprehensive, and that 

applicability of § 866.5940 should be 

based upon scientific and clinical 

literature as to the autosomal recessive 

nature of a particular disease or 

condition, we are not providing a 

revised list in this final order. 

(Comment 2) One commenter 

requested clarification that § 866.5940 

applies to OTC carrier detection devices 

for the determination of carrier status by 

detection of clinically relevant gene 

mutations associated with cystic 

fibrosis. 

(Response) In the October 2015 

notice, FDA stated ‘‘[a] gene mutation 

detection system indicated for the 

determination of carrier status by 

detection of clinically relevant gene 

mutations associated with Cystic 

Fibrosis is not 510(k)-exempt since it is 

a class II device subject to premarket 

notification and special controls under 

21 CFR 866.5900—Cystic fibrosis 

transmembrane conductance regulator 

(CFTR) gene mutation detection 

system.’’ Similarly, in the final order 

announcing the classification of an 

autosomal recessive carrier screening 

gene mutation detection system into 

class II (80 FR 65626, October 27, 2015), 

FDA stated ‘‘A gene mutation detection 

system indicated for the determination 

of carrier status by detection of 

clinically relevant gene mutations 

associated with cystic fibrosis is 

separately classified under 21 CFR 

866.5900—Cystic fibrosis 

transmembrane conductance regulator 

(CFTR) gene mutation detection system 

(class II, special controls), and is thus 

not included in the de novo 

classification.’’ 

However, after considering the 

comments regarding this exemption 

action, and after reviewing the devices 

that are classified as CTFR gene 

mutation detection systems under 

§ 866.5900 (21 CFR 866.5900), FDA is 

now clarifying that an OTC gene 

mutation detection system indicated for 

the determination of autosomal 

recessive carrier status by detection of 

clinically relevant gene mutations 

associated with cystic fibrosis (‘‘OTC 

Cystic Fibrosis carrier screening test’’) is 

included within the scope of the 

classification regulation for an 

autosomal recessive carrier screening 

gene mutation detection system 

(§ 866.5940) and this exemption action. 

At the time FDA classified a CFTR 

gene mutation detection system under 

§ 866.5900, we were not aware of any 

OTC Cystic Fibrosis carrier screening 

tests, and it was not our intent at the 

time to classify this test for OTC use. We 

also note that, to date, the only Cystic 

Fibrosis carrier screening tests that have 

been cleared by FDA under § 866.5900 

are for prescription use only. Finally, 


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FDA does not believe that the special 

controls under § 866.5900(b) would 

reasonably assure the safety and 

effectiveness of OTC Cystic Fibrosis 

carrier screening tests, as such special 

controls were developed to be 

applicable to prescription use only tests. 

For example, when classifying a CFTR 

gene mutation detection system into 

class II, FDA determined that the special 

controls under § 866.5900(b), in 

conjunction with general controls, 

provided a reasonable assurance of the 

safety and effectiveness of the device. 

One risk to health that FDA identified 

was that ‘‘errors in interpretation of 

results may lead to improper clinical 

recommendations and medical patient 

management.’’ The special controls 

concerning generation of test results, 

interpretation of test results, and 

precautions for interpretation of the test 

results were developed only for 

prescription use only tests with health 

care providers in mind (see Section 6— 

Device Description; Test Results/ 

Reporting, Section 10—Labeling; 

Interpretation of Results, and Section 

10—Labeling; Precautions for 

interpretations of the ‘‘Class II Special 

Controls Guidance Document: CFTR 

Gene Mutation Detection Systems’’ 

(October 26, 2005) (Ref. 2). 

Therefore, FDA is clarifying that with 

regard to gene mutation detection 

systems indicated for the determination 

of carrier status by detection of 

clinically relevant gene mutations 

associated with cystic fibrosis, the 

classification regulation § 866.5900 is 

only applicable to prescription use only 

tests. FDA is further clarifying that we 

would not consider a gene mutation 

detection system indicated for use as an 

OTC device for the determination of 

carrier status by detection of clinically 

relevant gene mutations associated with 

cystic fibrosis to constitute a different 

intended use from that of a legally 

marketed device in the generic type 

§ 866.5940 for purposes of § 866.9(a). As 

such, OTC Cystic Fibrosis carrier 

screening tests are within the scope of 

the classification regulation for an 

autosomal recessive carrier screening 

gene mutation detection system 

(§ 866.5940) and are included within the 

scope of this action. 

(Comment 3) One commenter 

requested that the exemption be 

expanded to include carrier screening 

for X-linked conditions. The commenter 

further requested that the exemption be 

expanded to allow for the reporting of 

diagnostic results. 

(Response) The October 2015 notice 

and this final order concern the 

exemption from premarket notification 

of autosomal recessive carrier screening 

gene mutation detection systems in the 

generic type § 866.5940. Devices within 

the scope of the § 866.5940 regulation 

for autosomal recessive carrier screening 

gene mutation detection systems are 

intended for autosomal recessive carrier 

screening in adults of reproductive age. 

The requested indications for carrier 

screening for X-linked conditions and 

for reporting of diagnostic results are 

outside the scope of the § 866.5940 

regulation. As this final order concerns 

only exemption of devices within the 

§ 866.5940 regulation, the request to 

expand the exemption to include carrier 

screening for X-linked conditions or for 

the reporting of diagnostic results is 

outside the scope of this action. 

(Comment 4) The three commenters 

were generally supportive of the 

regulation and special controls 

established for the device type, 

including for the special controls that 

relate to genetic counseling (e.g., 

§ 866.5940(b)(1) and (b)(4)(iii)(A)). Two 

commenters requested FDA provide 

additional recommendations that relate 

to the special control requirements 

related to genetic counseling. 

(Response) FDA appreciates the 

comments supporting the regulation and 

special controls established for the 

device type. FDA believes that the class 

II special controls established for the 

device type, along with the applicable 

general controls, provides reasonable 

assurance of the safety and effectiveness 

of the device type. FDA notes that while 

the comments received did not propose 

specific amendments to the special 

control requirements, such discussion is 

outside the scope of the October 2015 

notice and this final order, which 

concerns the exemption from premarket 

notification of autosomal recessive 

carrier screening gene mutation 

detection systems in the generic type 

§ 866.5940. 

V. Exemption for Autosomal Recessive 

Carrier Screening Gene Mutation 

Detection System Devices 

FDA has assessed the need for 510(k) 

clearance for this type of device by 

considering the factors discussed in the 

January 21, 1998, Federal Register 

notice (63 FR 3142) and subsequently in 

the Class II 510(k) Exemption Guidance, 

as previously discussed in the October 

2015 notice, and has determined they 

weigh in favor of 510(k) exemption, 

subject to certain limitations discussed 

later in this order. Therefore, for the 

reasons set forth in the Federal Register 

of October 27, 2015, and as informed by 

the comments received and FDA’s 

understanding and experience with 

autosomal recessive carrier screening 

gene detection systems, FDA has 

determined that premarket notification 

is not necessary to assure the safety and 

effectiveness of autosomal recessive 

carrier screening gene detection 

systems, so long as the limitations on 

exemption described later in this 

document are not met. 

VI. Limitations on Exemption 

This exemption from 510(k) for an 

autosomal recessive carrier screening 

gene mutation detection system applies 

only to those devices that have existing 

or reasonably foreseeable characteristics 

of commercially distributed devices 

within that generic type, or, in the case 

of in vitro diagnostic devices, for which 

a misdiagnosis, as a result of using the 

device, would not be associated with 

high morbidity or mortality. Therefore, 

a manufacturer of an autosomal 

recessive carrier screening gene 

mutation detection system would still 

be required to submit a premarket 

notification to FDA before introducing a 

device or delivering it for introduction 

into commercial distribution when the 

device meets any of the conditions 

described in § 866.9, except § 866.9(c)(2) 

to the extent it may include an 

autosomal recessive carrier screening 

gene mutation detection system, for the 

reasons explained in the October 2015 

notice. 

Specifically, an autosomal recessive 

carrier screening gene mutation 

detection system is not exempt from the 

premarket notification requirement if 

such device: (1) Has an intended use 

that is different from the intended use 

of a legally marketed device in that 

generic type; e.g., the device is intended 

for a different medical purpose, or the 

device is intended for lay use where the 

former intended use was by health care 

professionals only; or (2) operates using 

a different fundamental scientific 

technology than that used by a legally 

marketed device in that generic type; 

e.g., a surgical instrument cuts tissue 

with a laser beam rather than with a 

sharpened metal blade, or an in vitro 

diagnostic device detects or identifies 

infectious agents by using a DNA probe 

or nucleic acid hybridization or 

amplification technology rather than 

culture or immunoassay technology; or 

(3) is an in vitro device that is intended: 

for use in the diagnosis, monitoring or 

screening of neoplastic diseases with 

the exception of immunohistochemical 

devices; for measuring an analyte which 

serves as a surrogate marker for 

screening, diagnosis, or monitoring of 

life threatening diseases, such as 

acquired immune deficiency syndrome 

(AIDS), chronic or active hepatitis, 

tuberculosis, or myocardial infarction, 

or to monitor therapy; for assessing the 


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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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