Aids to Compliance With Duty of Disclosure

While it is not appropriate to attempt to set forth procedures by which

attorneys, agents, and other individuals may ensure compliance with the duty of disclosure,

the items listed below are offered as examples of possible procedures which could help

avoid problems with the duty of disclosure. Though compliance with these procedures may not

be required, they are presented as helpful suggestions or best practices to avoid duty of

disclosure problems.

1. Many attorneys, both corporate and private, are using letters and

questionnaires for applicants and others involved with the filing and prosecution of the

application and checklists for themselves and applicants to ensure compliance with the duty

of disclosure. The letter generally explains the duty of disclosure and what it means to

the inventor and assignee. The questionnaire asks the inventor and assignee questions

about:

__

the origin of the invention and its point of departure from

what was previously known and in the prior art,

__

possible public uses and sales (See

GS Cleantech

Corp. v. Adkins Energy LLC

, 951 F.3d 1310, 2020 USPQ2d 10092 (Fed. Cir.

2020)),

__

prior publication, knowledge, patents, foreign patents,

etc.

The checklist is used by the attorney to ensure that the applicant has

been informed of the duty of disclosure and that the attorney has inquired of and cited

material prior art.

The use of these types of aids would appear to be most helpful, though not

required, in identifying prior art and may well help the attorney and the client avoid or

more easily explain a potentially embarrassing and harmful “fraud” allegation.

2. It is desirable to ask questions about inventorship. Who is the proper

inventor? Are there disputes or possible disputes about inventorship? If there are

questions, call them to the attention of the U.S. Patent and Trademark Office.

3. It is desirable to ask questions of the inventor about the disclosure

of the best mode. Make sure that the best mode is described. See

MPEP §§ 2165

-

2165.04

.

4

2. It is desirable to ask questions about inventorship. Who is the proper

inventor? Are there disputes or possible disputes about inventorship? If there are

questions, call them to the attention of the U.S. Patent and Trademark Office.

3. It is desirable to ask questions of the inventor about the disclosure

of the best mode. Make sure that the best mode is described. See

MPEP §§ 2165

-

2165.04

.

4. It is desirable for an attorney or agent to make certain that the

inventor, especially a foreign inventor, recognizes his or her responsibilities in signing

the oath or declaration. See

37 CFR 1.69(a)

.

37 CFR 1.69  Foreign language oaths and declarations.

(a) Whenever an individual making an oath or declaration cannot

understand English, the oath or declaration must be in a language that such

individual can understand and shall state that such individual understands the

content of any documents to which the oath or declaration relates.

*****

Note

MPEP § 602.06

for a more detailed

discussion.

5. It is desirable for an attorney or agent to carefully evaluate and

explain to the applicant and others involved the scope of the claims, particularly the

broadest claims. Ask specific questions about possible prior art which might be material in

reference to the broadest claim or claims. There is some tendency to mistakenly evaluate

prior art in the light of the gist of what is regarded as the invention or narrower

interpretations of the claims, rather than measuring the art against the broadest claim

with all of its reasonable interpretations. It is desirable to pick out the broadest claim

or claims and measure the materiality of prior art against a reasonably broad

interpretation of these claims.

6. It may be useful to evaluate the materiality of prior art or other

information from the viewpoint of whether it is the closest prior art or other information.

This will tend to put the prior art or other information in better perspective. See

Semiconductor Energy Laboratory Co. v

claim

or claims and measure the materiality of prior art against a reasonably broad

interpretation of these claims.

6. It may be useful to evaluate the materiality of prior art or other

information from the viewpoint of whether it is the closest prior art or other information.

This will tend to put the prior art or other information in better perspective. See

Semiconductor Energy Laboratory Co. v. Samsung Electronics Co.,

204

F.3d 1368, 1374, 54 USPQ2d 1001, 1005 (Fed. Cir. 2000) (“A withheld reference may be highly

material when it discloses a more complete combination of relevant features, even if those

features are before the patent examiner in other references.” (citations omitted)).

However,

37 CFR

1.56

may still require the submission of prior art or other

information which is not as close as that of record.

7. Care should be taken to see that prior art or other information cited

in a specification or in an information disclosure statement is properly described and that

the information is not incorrectly or incompletely characterized. See

Apotex v.

UCB, Inc.,

763 F.3d 1354, 1361-62, 112 USPQ2d 1081, 1087-88 (Fed. Cir.

2014)(finding that the patent specification omitted material information was among the

facts that supported a conclusion that the patent is unenforceable due to inequitable

conduct). It is particularly important for an attorney or agent to review, before filing,

an application which was prepared by someone else, e.g., a foreign applicant or

practitioner. It is also important that an attorney or agent make sure that foreign

clients, including foreign applicants, attorneys, and agents understand the requirements of

the duty of disclosure, and that the U.S. attorney or agent review any information

disclosure statements or citations to ensure that compliance with

37 CFR 1.56

is

present. See

Semiconductor Energy Laboratory Co. v. Samsung Electronics

Co.,

204 F.3d 1368, 54 USPQ2d 1001 (Fed. Cir. 2000)

ke sure that foreign

clients, including foreign applicants, attorneys, and agents understand the requirements of

the duty of disclosure, and that the U.S. attorney or agent review any information

disclosure statements or citations to ensure that compliance with

37 CFR 1.56

is

present. See

Semiconductor Energy Laboratory Co. v. Samsung Electronics

Co.,

204 F.3d 1368, 54 USPQ2d 1001 (Fed. Cir. 2000). In this case, during

prosecution the patentee submitted an untranslated 29-page Japanese reference as well as a

concise explanation of its relevance and an existing one-page partial English translation,

both of which were directed to less material portions of the reference. The untranslated

portions of the Japanese reference “contained a more complete combination of the elements

claimed [in the patent] than anything else before the PTO.” 204 F.3d at 1374, 54 USPQ2d at

1005. The patentee, whose native language was Japanese, was held to have understood the

materiality of the reference. “The duty of candor does not require that the applicant

translate every foreign reference, but only that the applicant refrain from submitting

partial translations and concise explanations that it knows will misdirect the examiner’s

attention from the reference’s relevant teaching.” 204 F.3d at 1378, 54 USPQ2d at 1008. See

also

Gemveto Jewelry Co. v. Lambert Bros., Inc

., 542 F. Supp. 933, 216

USPQ 976 (S.D.N.Y. 1982) wherein a patent was held invalid or unenforceable because

patentee’s foreign counsel did not disclose to patentee’s United States counsel or to the

Office prior art cited by the Dutch Patent Office in connection with the patentee’s

corresponding Dutch application. The court stated, 542 F. Supp. at 943, 216 USPQ at

985:

Foreign patent attorneys representing applicants for U.S

Q 976 (S.D.N.Y. 1982) wherein a patent was held invalid or unenforceable because

patentee’s foreign counsel did not disclose to patentee’s United States counsel or to the

Office prior art cited by the Dutch Patent Office in connection with the patentee’s

corresponding Dutch application. The court stated, 542 F. Supp. at 943, 216 USPQ at

985:

Foreign patent attorneys representing applicants for U.S. patents

through local correspondent firms surely must be held to the same standards of conduct

which apply to their American counterparts; a double standard of accountability would

allow foreign attorneys and their clients to escape responsibility for fraud or

inequitable conduct merely by withholding from the local correspondent information

unfavorable to patentability and claiming ignorance of United States disclosure

requirements.

8. Care should be taken to see that inaccurate statements, inaccurate

evidence or inaccurate experiments are not introduced into the record, either inadvertently

or intentionally. For example, stating that an experiment “was run” or “was conducted”

when, in fact, the experiment was not run or conducted is a misrepresentation of the facts.

See

Apotex v. UCB, Inc.,

763 F.3d 1359, 112 USPQ2d 1085 (Fed. Cir.

2014). No results should be represented as actual results unless they have actually been

achieved. Paper or prophetic examples should not be described using the past tense.

Hoffman-La Roche, Inc. v. Promega Corp.,

323 F.3d 1354, 1367, 66

USPQ2d 1385, 1394 (Fed. Cir. 2003); see also

MPEP § 608.01(p), subsection II

and

§

707.07(l)

. Also, misrepresentations can occur when experiments

which were run or conducted are inaccurately reported in the specification, e.g., an

experiment is changed by leaving out one or more ingredients. See

Steierman v.

Connelly,

192 USPQ 433 (Bd. Pat. Int. 1975); 192 USPQ 446 (Bd. Pat. Int.

1976). Misrepresentations can also occur in declarations submitted to the Office. See

Intellect Wireless v. HTC Corp.,

732 F. 3d 1339, 1342, 108 USPQ2d

1563, 1565 (Fed. Cir

e run or conducted are inaccurately reported in the specification, e.g., an

experiment is changed by leaving out one or more ingredients. See

Steierman v.

Connelly,

192 USPQ 433 (Bd. Pat. Int. 1975); 192 USPQ 446 (Bd. Pat. Int.

1976). Misrepresentations can also occur in declarations submitted to the Office. See

Intellect Wireless v. HTC Corp.,

732 F. 3d 1339, 1342, 108 USPQ2d

1563, 1565 (Fed. Cir. 2013) wherein applicants submitted a declaration under

37 CFR

1.131

containing false statements regarding reduction to practice of

the claimed invention.

When drafting a patent application, it is a best practice to

take care to ensure the proper tense is employed to describe experiments and test results

so readers can readily distinguish between actual results and predicted results. Any

ambiguities should be resolved so a person having ordinary skill in the art reading the

disclosure, including those who may not have the level of skill of the inventor, can rely

on the disclosure as an accurate description of experiments that support the patent claim

coverage. It is a best practice to label examples as prophetic or otherwise separate them

from working examples to avoid ambiguities. Such presentation will help a reader easily

distinguish prophetic examples from working examples with actual experimental results and

will enhance the public’s ability to rely on the patent disclosure. See

Properly

Presenting Prophetic and Working Examples in a Patent Application

, 86 Fed.

Reg. 35074, 5 (July 1, 2021).

9. Do not rely on the examiner of a particular application to be aware of

other applications belonging to the same applicant or assignee. It is desirable to call

such applications to the attention of the examiner even if there is only a question that

they might be “material to patentability” of the application the examiner is considering.

See

Dayco Prod., Inc. v. Total Containment, Inc.

, 329 F.3d 1358,

1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir

plication to be aware of

other applications belonging to the same applicant or assignee. It is desirable to call

such applications to the attention of the examiner even if there is only a question that

they might be “material to patentability” of the application the examiner is considering.

See

Dayco Prod., Inc. v. Total Containment, Inc.

, 329 F.3d 1358,

1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003) (contrary decision of another examiner

reviewing substantially similar claims is ‘material’; copending application may be

‘material’ even though it cannot result in a shorter patent term, when it could affect the

rights of the patentee to assign the issued patents). It is desirable to be particularly

careful that prior art or other information in one application is cited to the examiner in

other applications to which it would be material. Do not assume that an examiner will

necessarily remember, when examining a particular application, other applications which the

examiner is examining, or has examined. A “lapse on the part of the examiner does not

excuse the applicant.”

KangaROOS U.S.A., Inc. v. Caldor, Inc.

, 778 F.2d

1571, 1576, 228 USPQ 32, 35 (Fed. Cir. 1985); see also

MPEP § 2001.06(b).

10. When in doubt, it is desirable and safest to submit information. Even

though the attorney, agent, or applicant does not consider it necessarily material, someone

else may see it differently and embarrassing questions can be avoided. The court in

U.S. Industries v. Norton Co.

, 210 USPQ 94, 107 (N.D. N.Y. 1980)

stated “[i]n short, the question of relevancy in close cases, should be left to the

examiner and not the applicant.” See also

LaBounty Mfg., Inc. v. U.S. Int’l Trade

Comm’n

, 958 F.2d 1066, 22 USPQ2d 1025 (Fed. Cir. 1992).

11. It is desirable to submit material information about prior uses and

sales even if it appears that they may have been experimental, not involve the specifically

claimed invention, or not encompass a completed invention. See

TransWeb v.

3M

, 812 F.3d 1295, 1300, 117 USPQ2d 1617, 1619-20 (Fed

See also

LaBounty Mfg., Inc. v. U.S. Int’l Trade

Comm’n

, 958 F.2d 1066, 22 USPQ2d 1025 (Fed. Cir. 1992).

11. It is desirable to submit material information about prior uses and

sales even if it appears that they may have been experimental, not involve the specifically

claimed invention, or not encompass a completed invention. See

TransWeb v.

3M

, 812 F.3d 1295, 1300, 117 USPQ2d 1617, 1619-20 (Fed. Cir. 2016). See also

Hycor Corp. v. The Schlueter Co.,

740 F.2d 1529, 1534-37, 222 USPQ

553, 557-59 (Fed. Cir. 1984),

LaBounty Mfg., Inc. v. U.S. Int’l Trade

Comm’n

, 958 F.2d 1066, 22 USPQ2d 1025 (Fed. Cir. 1992), and

GS

Cleantech Corp. v. Adkins Energy LLC

, 951 F.3d 1310, 2020 USPQ2d 10092 (Fed.

Cir. 2020).

12. Submit information promptly. An applicant, attorney, or agent who is

aware of prior art or other information and its significance should submit the same early

in prosecution, e.g., before the first action by the examiner, and not wait until after

allowance. Potentially material information discovered late in the prosecution should be

immediately submitted. That the issue fee has been paid is no reason or excuse for failing

to submit information. See

Elmwood Liquid Products, Inc.

v. Singleton Packing Corp

., 328 F. Supp. 974, 170 USPQ 398 (M.D. Fla.

1971).

13. It is desirable to avoid the submission of long lists of documents if

it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative

information. If a long list is submitted, highlight those documents which have been

specifically brought to applicant’s attention and/or are known to be of most significance.

See

Penn Yan Boats, Inc. v. Sea Lark Boats, Inc

., 359 F. Supp. 948, 175

USPQ 260 (S.D. Fla. 1972),

aff’d,

479 F.2d 1338, 178 USPQ 577 (5th Cir.

1973),

cert. denied,

414 U.S. 874 (1974). But cf.

Molins PLC

v.

Textron Inc.

, 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).

14

ght those documents which have been

specifically brought to applicant’s attention and/or are known to be of most significance.

See

Penn Yan Boats, Inc. v. Sea Lark Boats, Inc

., 359 F. Supp. 948, 175

USPQ 260 (S.D. Fla. 1972),

aff’d,

479 F.2d 1338, 178 USPQ 577 (5th Cir.

1973),

cert. denied,

414 U.S. 874 (1974). But cf.

Molins PLC

v.

Textron Inc.

, 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).

14. Watch out for continuation-in-part (CIP) applications where

intervening material information or documents may exist; particularly watch out for foreign

patents and publications related to the parent application and dated more than 1 year

before the filing date of the CIP. These and other intervening documents may be material

information. See

In re Ruscetta

, 255 F.2d 687, 690-91, 118 USPQ 101, 104

(CCPA 1958);

In re van Langenhoven

, 458 F.2d 132, 173 USPQ 426 (CCPA

1972);

Chromalloy American Corp. v. Alloy Surfaces Co.

, 339 F. Supp.

859, 173 USPQ 295 (D. Del. 1972).

15. Watch out for information that might be deemed to be prior art under

pre-AIA 35 U.S.C.

102(f)

and (g).

Prior art under

pre-AIA 35 U.S.C. 102(f)

may be

available under

pre-AIA

35 U.S.C. 103

. See

OddzOn Products, Inc. v. Just

Toys

,

Inc.,

122 F.3d 1396, 1401, 43 USPQ2d 1641, 1644 (Fed.

Cir. 1997)(35 U.S.C. “102(f) is a prior art provision for purposes of § 103”);

Dale Electronics v. R.C.L. Electronics

, 488 F.2d 382, 386, 180 USPQ

225, 227 (1st. Cir. 1973); and

Ex parte Andresen

, 212 USPQ 100, 102 (Bd.

App. 1981).

Note also that evidence of prior invention under

pre-AIA 35 U.S.C.

102(g)

may be available under

pre-AIA 35 U.S.C. 103

, such as in

In re Bass

, 474 F.2d 1276, 177 USPQ 178 (CCPA 1973). In addition, the

AIA provides that the provisions of

pre-AIA 35 U.S.C. 102(g)

apply to each

claim of an AIA application for patent if the patent application: (1) contains or contained

at any time a claim to a claimed invention having an effective filing date as defined in

35 U.S.C

102(g)

may be available under

pre-AIA 35 U.S.C. 103

, such as in

In re Bass

, 474 F.2d 1276, 177 USPQ 178 (CCPA 1973). In addition, the

AIA provides that the provisions of

pre-AIA 35 U.S.C. 102(g)

apply to each

claim of an AIA application for patent if the patent application: (1) contains or contained

at any time a claim to a claimed invention having an effective filing date as defined in

35 U.S.C.

100(i)

that occurs before March 16, 2013; or (2) is ever designated

as a continuation, divisional, or continuation-in-part of an application that contains or

contained at any time a claim to a claimed invention that has an effective filing date

before March 16, 2013.

Note

pre-AIA 35 U.S.C. 103(c)

disqualifies

pre-AIA 35 U.S.C.

102(f)

/

103

or

102(g)

/

103

prior art which was, at the time

the second invention was made, owned by or subject to an obligation of assignment to, the

person who owned the first invention. Further note that

pre-AIA 35 U.S.C. 103(c)

disqualifies

pre-AIA 35 U.S.C.

102(e)/103

prior art for applications filed on or after November 29,

1999. See

MPEP §§

2146

-

2146.02

.

16. Watch out for information picked up or disclosed by the inventors and

others at conventions, plant visits, in-house reviews, etc. See, for example,

Dale

Electronics v. R.C.L. Electronics

, 488 F.2d 382, 386-87, 180 USPQ 225, 228

(1st Cir. 1973).

17. Make sure that all of the individuals who are subject to the duty of

disclosure, such as spelled out in

37 CFR 1.56

, are informed of and

fulfill their duty.

18. If information was specifically considered and discarded as not

material, this fact might be recorded in an attorney’s file or applicant’s file, including

the reason for discarding it. If judgment might have been bad or something might have been

overlooked inadvertently, a note made at the time of evaluation might be an invaluable aid

in explaining that the mistake was honest and excusable

ty.

18. If information was specifically considered and discarded as not

material, this fact might be recorded in an attorney’s file or applicant’s file, including

the reason for discarding it. If judgment might have been bad or something might have been

overlooked inadvertently, a note made at the time of evaluation might be an invaluable aid

in explaining that the mistake was honest and excusable. Though such records are not

required, they could be helpful in recalling and explaining actions in the event of a

question of “fraud” or “inequitable conduct” raised at a later time.

19. Finally, where relevant documentation is submitted to a

regulatory review body, such as the Food & Drug Administration (FDA), and is material

to a pending patent application, such documentation should be submitted for examiner

review. While the considerations made by the FDA for approving clinical trials are

different from those made by the USPTO in determining whether a claim is patentable,

submissions, particularly opposing arguments, may be material to ongoing patent

prosecution.

Belcher Pharmaceuticals, LLC v. Hospira, Inc.

, 11 F.4th

1345, 1353-54, 2021 USPQ2d 909 (Fed. Cir. 2021).

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