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Chapter 10 Information Disclosure Statement § 10:1 Introduction § 10:2 What Information Must Be Disclosed § 10:2.1 The Current Materiality Standard § 10:2.2 The Pre-1992 Standard § 10:2.3 The Current Patent Office Standard § 10:2.4 Ethical Considerations § 10:2.5 Recommendations [A] Checklist of Material Information § 10:3 When Should the Information Disclosure Statement Be Filed? § 10:4 Content of Information Disclosure Statement § 10:5 Submission of Listed Documents § 10:6 Electronic Filing of an Information Disclosure Statement § 10:7 Example Exhibit 10-1 Sample Information Disclosure Statement § 10:1 Introduction It is a very rare patent application that is not accompanied by an information disclosure statement. This is because the Patent Office and the courts impose upon inventors and their attorneys and agents a duty of candor and good faith toward the Patent Office. That duty requires the attorney and agent to disclose to the Patent Office any information known to them that is material to the patentability of the application. 1 The duty also extends to any other individual who is 1. 37 C.F.R. § 1.56. 10 1

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© Practising Law Institute

Chapter 10

Information DisclosureStatement

§ 10:1 Introduction§ 10:2 What Information Must Be Disclosed

§ 10:2.1 The Current Materiality Standard§ 10:2.2 The Pre-1992 Standard§ 10:2.3 The Current Patent Office Standard§ 10:2.4 Ethical Considerations§ 10:2.5 Recommendations

[A] Checklist of Material Information§ 10:3 When Should the Information Disclosure Statement Be Filed?§ 10:4 Content of Information Disclosure Statement§ 10:5 Submission of Listed Documents§ 10:6 Electronic Filing of an Information Disclosure Statement§ 10:7 ExampleExhibit 10-1 Sample Information Disclosure Statement

§ 10:1 Introduction

It is a very rare patent application that is not accompanied by aninformation disclosure statement. This is because the Patent Officeand the courts impose upon inventors and their attorneys and agents aduty of candor and good faith toward the Patent Office. That dutyrequires the attorney and agent to disclose to the Patent Office anyinformation known to them that is material to the patentability of theapplication.1 The duty also extends to any other individual who is

1. 37 C.F.R. § 1.56.

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involved in the substantive preparation or in the prosecution of theapplication.2

Even if the Patent Office did not explicitly require disclosure ofmaterial information, a good practitioner should voluntarily disclosethat information. It is usually in the best interest of any inventor tohave the most relevant art before the Patent Office when the examinerexamines the application. This is because any resulting patent is muchstronger and much less vulnerable to collateral attack if the PatentOffice considered all material prior art and still allowed the patent toissue. In any subsequent patent infringement action, the accusedinfringer will have a difficult time at trial trying to persuade the trialjudge or jury that the Patent Office made a mistake in issuing thepatent when the infringer can find no art more pertinent than thatalready considered by the examiner.

The consequences of failing to comply with this duty to disclosematerial information can be substantial. For example, it becomesmuch easier for an accused infringer to overcome the presumptionof validity of the patent at trial by producing documents that are morematerial to the patentability of an invention than those cited by thepatent holder than it is without such documents. Moreover, inten-tional withholding of material prior art can result in a finding ofinequitable conduct, even if at least some of the claims of the patentwould have issued the patent had the prior art been disclosed to thePatent Office.3 A finding of inequitable conduct can have the followingdisastrous consequences:

1. Unenforceability of the entire patent, even if the inequitableconduct occurred in relation to fewer than all the claims in thepatent.4 Moreover, inequitable conduct can render relatedpatents unenforceable.5

2. Awarding of attorneys’ fees: a finding of inequitable conductcan result in the case’s being considered exceptional, resultingin an award of attorneys’ fees under 35 U.S.C. § 285.6

2. Id.3. Merck & Co. v. Danbury Pharmacal, Inc., 873 F.2d 1418, 1421, 10

U.S.P.Q.2d 1682 (Fed. Cir. 1989).4. Kingsdown Med. Consultants, Ltd. v. Hollister, 863 F.2d 867, 9 U.S.P.Q.2d

1384, 1392 (Fed. Cir. 1988).5. Consol. Aluminum Corp. v. Foseco Int’l Ltd., 910 F.2d 804 (Fed. Cir. 1990)

(concealment of best mode rendered related patents unenforceable).6. J.P. Stevens & Co. v. Lex Tex, Ltd., 822 F.2d 1047, 233 U.S.P.Q. 1089

(Fed. Cir. 1987).

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3. Antitrust liability if the inequitable conduct amounts tofraudulent procurement of a patent.7

4. Suspension, disbarment, or both suspension and disbarmentof the attorney or patent agent responsible for the inequitableconduct under 35 U.S.C. § 32.

At a minimum, even if the patentee ultimately prevails in persuad-ing the court that the uncited prior art need not have been brought tothe attention of the Patent Office, substantial sums will have beenspent litigating the issue.

§ 10:2 What Information Must Be Disclosed

§ 10:2.1 The Current Materiality Standard

A recent decision by the Federal Circuit has most likely changed themateriality standard applied by the Patent Office with regard tosubmitting information disclosure statements. In Therasense, Inc. v.Becton, Dickinson & Co.,8 the Federal Circuit held that the materialityrequired for establishing inequitable conduct is a but-for materialitystandard. In other words, when an applicant fails to disclose prior art tothe Patent Office, that prior art is material if the Patent Office would nothave allowed a claim but for a lack of awareness of the undisclosed priorart, applying a preponderance of evidence standard and giving the claimstheir broadest reasonable construction.

The Patent Office has proposed rules to conform the Code ofFederal Regulations to the Therasense decision. However, until thoserules become final, it makes sense to discuss the prior Patent Officemateriality standards, which is done in the following sections.

The Patent Office’s proposed rules also provide another basis formateriality in conformance with the Therasense decision, namely, ifthe applicant engages in affirmative egregious misconduct before thePatent Office as to information.9

§ 10:2.2 The Pre-1992 Standard

According to 37 C.F.R. § 1.56, all information that is material tothe examination of the application must be disclosed. According to 37

7. Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172,147 U.S.P.Q. 404.

8. Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 99U.S.P.Q.2d 1065 (Fed. Cir. 2011) (en banc).

9. Revision of the Materiality to Patentability Standard for the Duty toDisclose Information in Patent Applications, 76 Fed. Reg. 43,631 (July 21,2011).

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C.F.R. § 1.56, as it existed prior to March 16, 1992, information ismaterial “where there is substantial likelihood that a reasonableexaminer would consider it in deciding whether to allow the applica-tion to issue as a patent.” This is not a “but for” test. Under a “but for”test, information would need to be disclosed to the Patent Office onlyif the Patent Office would not have issued the patent, as it issued, hadthe Patent Office been aware of the withheld information. As discussedabove, even if the patent would have issued had the uncited informa-tion been disclosed to the Patent Office, there may be a violation of 37C.F.R. § 1.56 if the nondisclosed information is found to be material.

§ 10:2.3 The Current Patent Office Standard

By a notice published in the Federal Register on January 17, 1992,37 C.F.R. § 1.56 and related rules were changed. These changesincluded a change in the standard of materiality. The new rules areeffective with respect to all applications and re-examination pro-cedures pending or filed after March 16, 1992. Under the newstandards, the test for materiality is much closer to a “but for” test.Under this standard, information is material if:

1. the information establishes by itself or in combination withother information a prima facie case of unpatentability of aclaim; or

2. the information refutes, or is inconsistent with, a position theapplicant takes in either,

(a) opposing an argument of unpatentability relied on by thePatent Office; or

(b) asserting an argument of patentability.

The new rule also includes a definition of “prima facie case ofunpatentability.” A prima facie case of unpatentability “is establishedwhen the information compels a conclusion that a claim is unpatent-able under the preponderance of evidence, burden-of-proof standard.”This standard is applied by “giving each term in the claim its broadestreasonable construction consistent with the specification, and beforeany consideration is given to evidence which may be submitted in anattempt to establish a contrary conclusion of patentability.”10

Information is not material when the information is cumulativewith respect to information already of record or being made of recordin the application.

10. 37 C.F.R. § 1.56.

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It is not necessary that the information be material to the broadestclaims in the application. Information material only to a dependentclaim is still considered material and should be cited in an informationdisclosure statement.11

§ 10:2.4 Ethical ConsiderationsWhat is a patent attorney to do when Rule 56 requires disclosure of

client confidential information and the client refuses permission todisclose that information? The problem could arise because ABAModel Rule 1.6 requires attorneys to keep client information confi-dential except in specific circumstances. The Patent Office adopts thesame basic requirement in its corresponding ethics rule, section11.106. However, subsection C of that rule states that client con-fidentiality must be breached when necessary to comply with theagency ’s disclosure requirements, which mandate compliance with37 C.F.R. § 1.56.

Arguably, that information can be cited to the Patent Office withoutviolating the client confidentiality rule, because both the Patent Officerules and ABA Model Rule 1.6(b) allow an attorney to reveal informa-tion to prevent a client from committing a crime or fraud that wouldresult in substantial injury to the financial interest of another party.However, this does not protect an attorney prosecuting patent applica-tions for a first client who discovers information obtained from adifferent client that is material.

Probably the safest thing to do is withdraw from representation.This is less of a problem for patent agents, because they are not

subject to the state bar ethical rules governing attorney conduct.

§ 10:2.5 RecommendationsThe author recommends that everyone who can conceivably be

considered to have a duty to disclose material information to thePatent Office be interviewed. This includes all individuals associatedwith the filing or prosecution of the patent application, and not onlythe inventors. “Substantively involved” under 37 C.F.R. § 1.56(c)(3)means any involvement related to the content of the applicationand decisions related thereto, where that involvement is not whollyadministrative or secretarial in nature. Thus, a noninventor presidentof a closely held company was held to have a duty of disclosure.12

The author also recommends that a “rule of doubt” be followedwhen deciding whether certain information should be disclosed to

11. Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010).12. Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir.

2010).

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the Patent Office. Even if there is doubt as to whether particularinformation is “material” under either old or new Rule 56, it shouldnevertheless be cited to the Patent Office. It is better to cite a referencethan incur the risk of a finding of inequitable conduct.

The Federal Circuit decision in Therasense is unlikely to have alarge effect on what information is cited to the Patent Office for tworeasons.

First, the time and cost associated with determining whether eachpossible piece of prior art is but-for material is something most clientsare not willing to incur. It is easier and simpler to cite whateverinformation is available to the Patent Office.

Second, the Patent Office endorses this rule of doubt:

When in doubt, it is desirable and safest to submit information.Even though the attorney, agent, or applicant does not consider itnecessarily material, someone else may see it differently andembarrassing questions can be avoided. . . . “In short, the ques-tions of relevancy in close cases, should be left to the examinerand not the applicant.”13

Another reason to use a rule of doubt is that the filing of aninformation disclosure statement is not construed as an admissionthat the information cited in the statement is, or is considered to be,material to the patentability of the invention.14

This “rule of doubt” means that in most situations, even when thepractitioner preparing or prosecuting an application believes that theinformation does not affect the patentability of a particular invention,the practitioner should let the Patent Office make the decision.Exemplary of situations that can arise are the following:

1. Nonanalogous art: The examiner should be given the oppor-tunity to determine whether a particular reference is analo-gous or nonanalogous.

2. “Prior” art or nonprior art: Even if the publication date of areference is after the filing date of a parent or foreign applica-tion from which priority is claimed, the reference should becited to the Patent Office.15 That allows the examiner to

13. M.P.E.P. § 2004(10) (quoting U.S. Indus. v. Norton Co., 210 U.S.P.Q. 94,107 (N.D.N.Y. 1980)).

14. Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir.2010).

15. This does not apply in the situation of divisional and continuationapplications, since the specifications of the parent and subsequent applica-tion are supposed to be identical.

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independently determine whether the applicant is entitled tothe benefit of the filing date of the parent application or foreignpriority application. Similarly, even if the applicant can swearbehind the filing date of a U.S. patent or publication date of areference with a declaration under 37 C.F.R. § 1.131, thePatent Office should determine that the showing complieswith the requirements of 37 C.F.R. § 1.131.

3. On sale, publicly known, or experimental uses: Sufficientrelevant facts and documents should be presented to thePatent Office to let the examiner reach his or her own conclu-sion regarding whether a particular activity amounts to an “onsale” or “public use,” or whether the experimental use excep-tion applies.16 A sale for “on sale” purposes can occur when acontract supplier offers a product to the inventor or theinventor ’s assignee.17 The Patent Office’s position on thisissue is very much in favor of disclosure. The Patent Officebelieves it is desirable to submit information about prioruses and sales even if it appears that they may have beenexperimental, did not specifically involve the claimed inven-tion, or did not encompass a complete invention.18

4. Inventorship: Because facts relating to inventorship issues canbe material, even if inventorship is correct,19 consider present-ing facts relating to inventorship to the PTO. This is particu-larly true where there may be a motive for misjoinder of aninventor or nonjoinder of an inventor, such as where apotential inventor has no obligation to assign the inventionto the client.20

If information is specifically considered and discarded as not beingmaterial, that should be noted in the attorney ’s or applicant’s file,along with the reasons for discarding it. An honest and excusablemistake can help prevent a finding of fraud or inequitable conduct.21

16. Avid Identification Sys., Inc. v. Crystal Imp. Corp., 603 F.3d 967 (Fed. Cir.2010).

17. Hamilton Beach Brands, Inc. v. Sunbeam Prods., Inc., 726 F.3d 1370 (Fed.Cir. 2013).

18. M.P.E.P. § 2004(11).19. Perspective Biosystems, Inc. v. Pharmacia Biotech, Inc., 225 F.3d 1315

(Fed. Cir. 2000).20. Advanced Magnetic Closures, Inc. v. Rome Fastener Corp., 607 F.3d 817

(Fed. Cir. 2010).21. M.P.E.P. § 2004(18).

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[A] Checklist of Material Information

A good practitioner expends extra effort in identifying informationthat should be brought to the attention of the Patent Office. Not onlywill this ensure that the practitioner complies with the duty of goodfaith and candor under 37 C.F.R. § 1.56, but it also allows forpreparation of a better patent application. It is much easier to writea strong patent application knowing all the prior art. The followingchecklist is useful for identifying material information.

q Publications and patents that belong to the inventor(s). It isvery difficult for an inventor charged with inequitable conductto deny knowledge of his or her own publications or patents.

q Other documents known to the inventor, such as postersshown at a conference.22

q Information obtained by the inventors and others at conven-tions, plant visits, in-house reviews, etc.

q Any references developed by any search in the technology,including prior art, novelty, state-of-the-art, infringement, andpatentability searches.

q References cited in related U.S. applications, including parentand sister applications. According to the Patent Office, priorart references from one application must be made of recordin another, subsequent application.23

q References cited in related foreign applications.24 The PatentOffice believes there is a strong inference that prior art orother information is material when it has been usedin rejecting the same or similar claims in a related foreignapplication or is the only prior art cited in a related foreignapplication.25 It is recommended that any search report issuedby a foreign patent office be included with the documents cited.

q Published related foreign applications.

q Related U.S. applications or patents, including parent andsister applications and patents. These applications andpatents can raise double-patenting issues, and a parentpatent can be the closest prior art for claims not supportedby the parent patent. Practitioners cannot assume that theexaminer of a particular application is necessarily aware of

22. Monsanto Co. v. Bayer Bioscience N.B., 514 F.3d 1229 (Fed. Cir. 2008).23. M.P.E.P. § 2001.06(b).24. 37 C.F.R. § 1.56(a)(1).25. M.P.E.P. § 2001.06(a).

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other applications that may be material. This situation canarise when a particular inventor has different applicationspending with patentably indistinct claims present.26 More-over, failure to disclose the rejection of claims in a copendingapplication before a different examiner that are substantiallysimilar to the claims present can constitute inequitableconduct.27

q Any commercial activity relating to the invention. This canresult in an “on sale” or “publicly known” bar under 35 U.S.C.§ 102. Once an attorney is on notice that a possibly materialevent, such as a sale, public use, publication, or issuance of apatent occurred about one year before the filing date of theapplication, there is a duty to investigate that event.28 TheAmerica Invents Act (AIA) has changed what qualifies as priorart. A grace period is provided for an inventor ’s own disclo-sure, but the exact scope of that grace period is not clear.Accordingly, any disclosure of an invention that is not on aconfidential basis, even if it is less than one year before thefiling date, should be submitted to the Patent Office. It isunclear whether such a disclosure would be prior art as toclaims that include limitations not present in that disclosure.Also confusing the issue as to what needs to be disclosed is theposition of the Patent Office that “on sale” or “publiclyknown” under the AIA requires that the invention be availableto the public. (See section 8:2.2.) It is unknown if the courtswill follow that interpretation of 35 U.S.C. § 102. Until thereis a definite interpretation, it is recommended that even if it isbelieved that the claimed invention was not available to thepublic, “on sale” or “publicly known” information, applyingthe pre-AIA standard, should be cited to the Patent Office.

q Clinical studies, because without sufficient confidentiality,they can amount to public use.29

q Information from related litigation,30 such as art cited by theopposing party, motions filed by the opposing party, and any

26. Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 66 U.S.P.Q.2d1801 (Fed. Cir. 2003); M.P.E.P. § 2001.06(b).

27. Dayco Prods., Inc., 329 F.3d at 1358; see also Larson Mfg. Co. v. AluminartProds. Ltd., 559 F.3d 1317 (Fed. Cir. 2009).

28. Brasseler, U.S.A. I, LP v. Stryker Sales Corp., 267 F.3d 888 (Fed. Cir. 2001);Dippin’ Dots, Inc. v. Mosey, 476 F.3d 1337 (Fed. Cir. 2007).

29. Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351 (Fed. Cir. 2013).30. M.P.E.P. § 2001.06(c); Outside the Box Innovations, LLC v. Travel Caddy,

Inc., 695 F.3d 1285 (Fed. Cir. 2012).

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claim construction by the court. This applies to relatedpatents, such as a parent patent.31

q Information relating to claims copied from a patent. Whenclaims are copied or are substantially the same as claims froma patent, 37 C.F.R. § 1.607(c) requires the applicant to identifythe patent and the numbers of the patent claims.32 However,this may apply only in the context of an interference.33

q Information relating to a potential priority conflict, even if theinformation is not prior art. It can be dangerous to unilaterallydetermine that such information is not prior art.34

q Information that is relevant to enablement, even if it is notprior art.35

q Any translation available for foreign prior art submitted.Partial translations can be troublesome. It is best to get afull translation, because an opponent in litigation can allegethat the partial translation was deceptive.36

q Information relating to the claimed invention submitted togovernment agencies such as the FDA, and particularly priorart so identified.37

q Information about a related application, such as issuance of anotice of allowance, because it may raise double patentingissues. Citation of the related application is insufficient.38

q Office actions from related applications, which can providebases for rejections. Citation of the related application isinsufficient.39

31. Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed.Cir. 2010).

32. M.P.E.P. § 2001.06(d).33. Leviton Mfg. Co. v. Universal Sec. Instruments, Inc., 606 F.3d 1353 (Fed.

Cir. 2010).34. GFI Inc. v.FranklinCorp.,265F.3d1268,60U.S.P.Q.2d1141 (Fed.Cir.2001).35. Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc., 326 F.3d 1226, 66

U.S.P.Q.2d 1481 (Fed. Cir. 2003) (non-prior-art article by the inventorsreporting unsuccessful use of compounds specifically taught in the patentas being successful was material as to enablement).

36. Semiconductor Energy Lab. Co. v. Samsung Elec. Co., 204 F.3d 1368 (Fed.Cir. 2000).

37. Bruno Indep. Living Aids, Inc. v. Acorn Mobility Servs. Ltd., 394 F.3d 1348(Fed. Cir. 2005) (failure to cite to the PTO prior art submitted to the FDAresulted in a finding of inequitable conduct and exceptional case).

38. McKesson Info. Sols., Inc. v. Bridge Med., Inc., 487 F.3d 897 (Fed. Cir.2007).

39. Id.

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q During prosecution of a foreign application, the remarksregarding a reference, where those remarks are inconsistentwith a statement made during prosecution of a related U.S.patent application.40

q Even if it is unclear whether certain information has asufficiently early date to qualify as prior art, it should be citedto the Patent Office to give the examiner an opportunity todetermine whether or not it is prior art.41

§ 10:3 When Should the Information Disclosure StatementBe Filed?

Whenever possible, the information disclosure statement should befiled with the patent application. This makes certain that the informa-tion is brought to the attention of the examiner at the time theapplication is originally examined. Moreover, the prior art is fresh inthe mind of the practitioner when the application is filed. Thepractitioner of course had to consider the prior art when draftingthe claims in the application, and it is much easier to discuss therelevance of the references, as is required under 37 C.F.R. § 1.56, whenthe references are fresh in mind.

Whether or not an information disclosure statement is timelydepends on when it is filed. A filing is timely if the statement is filedwithin three months of the filing date of the application or before themailing date of a first office action on the merits, whichever eventoccurs last. The three-month period does not apply to continuedprosecution applications because of their expedited examination.42

Thus, it is still possible to make a timely filing when it is not possibleto file the information disclosure statement with the application, suchas when copies of references are not available or when the filing is doneon short notice to avoid a statutory bar date.

A late filed information disclosure statement will be considered bythe Patent Office if certain requirements are met. For the Patent Officeto consider an information disclosure statement that is not timelyfiled but that is filed before a final action or a notice of allowance, theapplicant must pay an extension fee as set forth in 37 C.F.R. § 1.17(b),or provide a statement as to why the information disclosure statementwas not filed in time.43

40. Therasense, Inc. v. Becton, Dickinson & Co., 593 F.3d 1325 (Fed. Cir.2010).

41. Golden Hour Data Sys., Inc. v. emsCharts, Inc., 614 F.3d 1367 (Fed. Cir.2010).

42. 37 C.F.R. § 1.97(b).43. 37 C.F.R. § 1.97(c).

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Late filing of an information disclosure statement can reduce thepatent term. Lateness of an information disclosure statement canbe considered to be failure to engage in a reasonable effort to concludeprosecution under 37 C.F.R. § 1.704(c)(8).44

The statement must state that the information was cited in acommunication from a foreign patent office in a counterpart foreignpatent application within the past three months, or that the informa-tion was not known to any individual associated with the filing orprosecution of the patent application within the three months prior tofiling the information disclosure statement.45 These individuals in-clude the inventor(s), the attorney or agent who prepares or prosecutesthe application, and “every other person who is substantively involvedin the preparation or prosecution of the application, and who isassociated with the inventor, with the assignee or with anyone towhom there is an obligation to assign the application.”46

It is best to cite the art cited in a corresponding foreign applicationor corresponding U.S. application, even after issuance of a notice ofallowance, within thirty days. This is to avoid any reduction of thepatent term that can occur if more than thirty days is taken.47

No extensions of time for filing an information disclosure statementare permitted under section 1.136. If a bona fide attempt is made tocomply with section 1.98, but part of the required content is inadver-tently omitted, additional time may be given to enable full compliance.48

It is very difficult to get the Patent Office to consider informationafter the issuance of a final action or a notice of allowance. To have theinformation disclosure statement considered, it is necessary to

(1) provide the statement regarding lateness discussed above,

(2) provide the fee specified, and

(3) file the statement before the issue fee is paid.49

It is strongly recommended that before submitting any nontimelyinformation disclosure statement, a telephone call be placed to theexaminer to let the examiner know that additional information isbeing transmitted. It is very frustrating for an examiner to examine anapplication or amendment and issue an office action that crosses inthe mail with the submission of information more material than whatthe examiner had before him. It is not in the best interest of a

44. Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015).45. 37 C.F.R. § 1.97(e).46. 37 C.F.R. § 1.56(c).47. 37 C.F.R. § 1.704(d).48. 37 C.F.R. § 1.97(f).49. 37 C.F.R. § 1.97(d).

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practitioner or inventor to have a frustrated examiner. If the identity ofthe examiner is not known, the secretary or clerk of the groupidentified on the filing receipt can be contacted. The secretary canthen identify the examiner assigned to an application.

§ 10:4 Content of Information Disclosure Statement

The information disclosure statement itself is composed of two parts:(1) a list of patents, publications, or other information, and (2) a conciseexplanation of the relevance of each listed item that is not in the Englishlanguage.50 It is recommended that the listing of the informationbe provided on Form PTO-1449 or a form substantially in thesame format. A form is provided as part of Exhibit 10-1.51 The formhas been modified by providing a coded designation, that is, AA, AB, AC,and so on, for each document. This provides an easy way to refer to eachlisted reference. The code letters can also be written on each documentsubmitted to the Patent Office to help the examiner coordinate thedocuments with the information. Alternatively, the Patent Office has anonline information disclosure statement form that can be used.

Nothing submitted to the PTO, including the form listing thedisclosed information and the accompanying statement, should referto the information as being “prior art.” This avoids the informationbecoming prior art by admission.52 There can be information that issubmitted that does not qualify as prior art, and it is important toretain the ability to prove that. For example, it may be possible toswear behind an issued patent, or the information submitted maybe partly the work of the named inventor. Identification of a referencein an Information Disclosure Statement is not an admission that thereference constitutes prior art.53

Whether or not the PTO form is used, all U.S. patents should beidentified by their patent number, patent date, and inventor.Each foreign published application or patent should be cited byidentifying the country or office that issued it, the document number,and the publication date indicated in the document. Printed publica-tions should be identified by author (if any), title of the publication,relevant pages, publisher, and the date and place of publication.54

50. 37 C.F.R. § 1.98.51. PTO-1449 is provided by the Patent Office in M.P.E.P. § 609.52. Riverwood Int’l Corp. v. R.A. Jones & Co., 324 F.3d 1346, 66 U.S.P.Q.2d

1331 (Fed. Cir. 2003) (discusses the law regarding prior art by admissionand holds that an inventor ’s own work, even though labeled prior art, isnot prior art by admission); Abbott Labs. v. Baxter Pharm. Prods., Inc., 334F.3d 1274, 67 U.S.P.Q.2d 1191 (Fed. Cir. 2003).

53. ResQNet.com, Inc. v. Lansa, Inc., 594 F.3d 860 (Fed. Cir. 2010).54. 37 C.F.R. § 1.98(b).

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There is no longer a requirement to write a discussion of therelevance of the references in English. Therefore, beyond whatis required on Form PTO-1449, nothing should be stated aboutEnglish-language references, unless the statement would help achieveallowability of the application. When the reference is a non-English-language reference, either an accurate translation should be provided,or its relevance has to be discussed. If a translation is provided, itneeds to be accurate, or else a reference can be deemed not to havebeen considered by the examiner.55

As little as possible should be stated about the references. More-over, the references should not be interpreted, because whatever isstated could come back to haunt the applicant in litigation. State-ments made in the information disclosure statement can be a basisfor interpreting the scope of the claims and can create an estoppelthat precludes a finding of infringement under the doctrine ofequivalents.56 Thus, say as little as possible about prior art referencesin an information disclosure statement. For example, when discuss-ing the relevance of the document, it is best to quote language fromthe document, such as the Abstract or the Summary portion of apatent. If a search report discusses the reference (and is accurate),then quote the search report.

The explanation of the relevance of each listed item need not beelaborate. It can consist of nothing more than identification of aparticular figure or paragraph of the patent or publication that hassome relation to the claimed invention. It might be a simple statementpointing out the similarities between the item of information and theclaimed invention. Even a statement that an item is listed because itwas cited during the prosecution of a counterpart foreign applicationand is not considered material to the examination of the U.S.application is considered to satisfy the concise explanation require-ment.57 If there is a portion of a reference that is particularly relevant,the examiner can be referred to that portion by column and linenumber or by page and paragraph number.

Certainly any statement regarding the teachings of the prior artneeds to be accurate. Misrepresenting material facts regarding theprior art can lead to a finding of inequitable conduct.58

55. Taltech Ltd. v. Esquel Enters. Ltd., 604 F.3d 1324 (Fed. Cir. 2010).56. Ekchian v. Home Depot, Inc., 104 F.3d 1299, 41 U.S.P.Q.2d 1364

(Fed. Cir. 1997).57. M.P.E.P. § 609.58. Apotex Inc. v. UCB, Inc., 2014 WL 3973498, 763 F.3d 1354 (Fed. Cir.

2014).

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The disclosure of the prior art must be complete, and include thematerial portions. An incomplete disclosure can result in a finding ofinequitable conduct.59

Arguments about the patentability of the invention over the citedinformation should not be included in the information disclosurestatement. By arguing and distinguishing a reference, the practitionercan create a prosecution history estoppel situation. Why do thatprematurely? Arguments should wait until the examiner actuallyrelies on the reference. Often the examiner may not consider areference as material as does the practitioner who prepared theapplication and will not apply the reference against the claims.

When there are a large number of references, in excess of aboutfifteen, it is best to identify to the examiner those documents that arebelieved to be the most significant.60 Failure to do that could result in acharge by an accused infringer that the inventor “buried” the mostrelevant art by citing a large number of obscure references.

It is recommended that an explicit reference be made to the filehistory of any related U.S. patent or pending application in the informa-tion disclosure statement. “Related” applications are applications fromwhich the present application claims priority, and applications thatclaim priority from the same application from which the presentapplication claims priority. As noted above in section 10:2.5, relatedpatents and applications can raise double-patenting issues. Also, rejec-tion of similar claims in a co-pending application, not disclosed to thePatent Office, can give rise to a charge of inequitable conduct. Theauthor has also noted that in litigation there can be charges of inequi-table conduct for not disclosing the Patent Office’s reason for allowancein a related application. There can also be a charge of inequitableconduct for not disclosing an objection in a related application. To avoidthese types of charges, it is prudent not to rely solely on disclosure of therelated application or patent, but also, in a separate line, to makereference to the file history of that related application or patent.

It is recommended that if papers from litigation are submitted tothe Patent Office, and there is a claim construction order, and theapplicant disagrees with the claim construction, that be explicitlystated. In one case, the Federal Circuit held that submission of astipulated construction for a term in a patent claim constituted a dis-claimer with regard to the scope of the claim.61

59. Am. Calcar, Inc. v. Am. Honda Motor Co., 768 F.3d 1185 (Fed. Cir. 2014).60. M.P.E.P. § 2004(13).61. Golden Bridge Tech., Inc. v. Apple, Inc., 758 F.3d 1362 (Fed. Cir. 2014).

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§ 10:5 Submission of Listed Documents

The information disclosure statement must be accompanied by acopy of each patent or publication or other item or information listed,or at least the portions that are considered to be pertinent.62 There arethree exceptions to this rule. The first exception is that issued U.S.patents and published U.S. patent applications need not be submitted.The second exception applies when two or more patents or publica-tions are substantially cumulative, and that is stated; in this situation,only a representative document has to be provided.63 The thirdexception applies when copies are in the file of the applicant’s priorapplication, provided the earlier application is identified in theinformation disclosure statement and is relied on for an earliereffective filing date under 35 U.S.C. § 120. Reference to the submis-sion in the prior application is sufficient for the continuingapplication.64

A translation of the pertinent portions of foreign-language patentsor publications is to be transmitted if an existing translation is readilyavailable to the applicant.65

Whenever possible, provide clean copies of the references, that is,copies not having any markings on them. Markings can unduly attractan examiner ’s attention to portions of a document. It can be particu-larly troublesome if the marked or highlighted portions are the less-pertinent portions of the references. An accused infringer can arguethat the examiner ’s attention was distracted from the more significantportions of the references.

Submission of nonpatent literature may create a copyright infringe-ment issue if the material submitted is copyrighted, such as a journalarticle. It is the position of the PTO that such a submission is fair use.66

However, that does not answer the copyright infringement questionregarding electronic copies or hard copies maintained by the practi-tioner. It is recommended that any potential liability for copyrightinfringement be passed on to the client by way of an attorney-client agreement or an express provision when the client submitsnonpatent literature to the practitioner. Alternatively, as is the casewith many journal articles, it is possible to purchase a copy.

62. 37 C.F.R. § 1.98(a)(2).63. 37 C.F.R. § 1.98(c).64. 37 C.F.R. § 1.98(d); M.P.E.P. § 609(2).65. 37 C.F.R. § 1.98(c).66. U.S. Patent & Trademark Office, Office of the General Counsel, Memo-

randum: USPTO Position on Fair Use of Copies of NPL Made in PatentExamination (Jan. 19, 2012).

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§ 10:6 Electronic Filing of an Information DisclosureStatement

It is possible to file an information disclosure statement (IDS)electronically. This is effective for up to fifty references, and thereferences are limited to U.S. patents and U.S. published applications.For other references, it is necessary to file a paper IDS. If there aremore than fifty references, it is necessary to file multiple IDSs.

The software for filing an electronic IDS is obtainable at the PTOwebsite.67 It can be filed when the filing receipt is received, or byobtaining the application confirmation number using the PAIRsystem.68

An advantage of electronic filing is that it avoids the delaysassociated with the PTO mailroom.

§ 10:7 Example

A sample information disclosure statement is provided asExhibit 10-1.

It is recommended that the explanation of relevance of English-language references not be included in information disclosure state-ments submitted under the current rules. Anything that is said aboutthe references can provide an opening during litigation for an oppo-nent to argue noninfringement, invalidity, or inequitable conduct. Theonly exception to this recommendation occurs when a large number ofreferences are provided. Under these circumstances, the examinershould be advised as to the most pertinent references. This would behelpful to the examiner and would avoid an argument during litigationthat the most pertinent references were “buried.”

67. The PTO website is www.uspto.gov.68. Carl Oppedahl, Electronic Filing of Information Disclosure Statements,

INTELL. PROP. TODAY, Oct. 2002, at 10.

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§ 10:7Information Disclosure Statement

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Exhibit 10-1

Sample InformationDisclosure Statement

10EX–1

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