608.01(p) Completeness of Specification [R-07.2022]

Newly filed applications obviously failing to disclose an invention with the clarity required are discussed in MPEP § 702.01.

The contents of an application, to be complete, must include a specification containing a written description of the invention using such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date. See 35 U.S.C. 112. At least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims.

For the written description requirement, an applicant’s specification must reasonably convey to those skilled in the art that the applicant was in possession of the claimed invention as of the date of invention. See MPEP § 2163et seq. for further guidance with respect to the evaluation of a patent application for compliance with the written description requirement.

An applicant’s specification must enable a person skilled in the art to make and use the claimed invention without undue experimentation. The fact that experimentation is complex, however, will not make it undue if a person of skill in the art typically engages in such complex experimentation. See MPEP § 2164et seq. for detailed guidance with regard to the enablement requirement of 35 U.S.C. 112.

See also MPEP § 2161.01 regarding computer programming and 35 U.S.C. 112; and MPEP § 2181 and § 2185 regarding 35 U.S.C. 112 in the context of functional claims.

The specification should include a statement which identifies a specific and substantial credible utility for the claimed invention. This usually presents no problem in mechanical or electrical cases. Questions regarding compliance with the utility requirement arise more often in biotechnological or chemical cases.

For “Guidelines For Examination Of Applications For Compliance With The Utility Requirement of 35 U.S.C. 101,” see MPEP § 2107.

For “General Principles Governing Utility Rejections,” see MPEP § 2107.01.

For a discussion of the utility requirement under 35 U.S.C. 111(a) in drug cases, see MPEP § 2107.03 and § 2164.06(a).

For “Procedural Considerations Related to Rejections for Lack of Utility,” see MPEP § 2107.02.

For “Special Considerations for Asserted Therapeutic or Pharmacological Utilities,” see MPEP § 2107.03.

I. INCORPORATION BY REFERENCE

The Director has considerable discretion in determining what may or may not be incorporated by reference in a patent application. General Electric Co. v. Brenner, 407 F.2d 1258, 159 USPQ 335 (D.C. Cir. 1968). In 2004, the Office codified in 37 CFR 1.57(b) – (g) existing practice with respect to explicit incorporations by reference with a few changes to reflect the eighteen-month publication of applications. In addition, in 2004, 37 CFR 1.57(a) was added to provide a safeguard for applicants when a page(s) of the specification, or a portion thereof, or a sheet(s) of the drawing(s), or a portion thereof, is inadvertently omitted from an application, such as through a clerical error. In 2013, the Office moved the provisions of former 37 CFR 1.57(a) to 37 CFR 1.57(b) in order to provide for reference filing in 37 CFR 1.57(a), which is a new procedure provided by the implementation of section 201(a) of the Patent Law Treaties Implementation Act of 2012 (PLTIA) (Public Law 112-211). 37 CFR 1.57(b) permits inadvertently omitted material to be added to the application by way of a later filed amendment if the inadvertently omitted portion of the specification or drawing(s) is completely contained in a prior-filed application (for which priority/benefit is claimed) even though there is no explicit incorporation by reference of the prior-filed application. See MPEP § 217 for discussion regarding 37 CFR 1.57(b).

As mentioned above, 37 CFR 1.57 was revised, effective December 18, 2013, to implement the reference filing provisions in title II of the PLTIA, which amended the patent laws in accordance with the Patent Law Treaty. As provided in 35 U.S.C. 111(c), as amended by the PLTIA, a nonprovisional application filed under 35 U.S.C. 111(a) on or after December 18, 2013, may be filed by a reference to a previously filed application (foreign, international, provisional, or nonprovisional) indicating that the specification and any drawings of the application are replaced by the reference to the previously filed application. See MPEP § 601.01(a), subsection III, for information on the conditions, including the payment of a surcharge, under which a reference made upon the filing of an application under 35 U.S.C. 111(a) to a previously filed application shall constitute the specification and any drawings of the subsequent application for purposes of a filing date.

The incorporation by reference practice with respect to applications which issue as U.S. patents provides the public with a patent disclosure which minimizes the public’s burden to search for and obtain copies of documents incorporated by reference which may not be readily available. Through the Office’s incorporation by reference policy, the Office ensures that reasonably complete disclosures are published as U.S. patents. The following is the manner in which the Director has elected to exercise that discretion. Section A provides the guidance for incorporation by reference in applications which are to issue as U.S. patents. Section B provides guidance for incorporation by reference in benefit applications; i.e., those domestic (35 U.S.C. 120) or foreign (35 U.S.C. 119(a)) applications relied on to establish an earlier effective filing date. See MPEP § 2181 for the impact of incorporation by reference on the determination of whether applicant has complied with the requirements of 35 U.S.C. 112(b) when 35 U.S.C. 112(f) is invoked.

A.Review of Applications Which Are To Issue as Patents

An application as filed must be complete in itself in order to comply with 35 U.S.C. 112. Material nevertheless may be incorporated by reference. An application for a patent when filed may incorporate “essential material” by reference to (1) a U.S. patent, or (2) a U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. See 37 CFR 1.57(d).

“Essential material” is defined in 37 CFR 1.57(d) as that which is necessary to (1) provide a written description of the claimed invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a); (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or (3) describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). In any application that is to issue as a U.S. patent, essential material may only be incorporated by reference to a U.S. patent or patent application publication.

Other material (“nonessential subject matter”) may be incorporated by reference to (1) patents or applications published by the United States or foreign countries or regional patent offices, (2) prior and concurrently filed, commonly owned U.S. applications, or (3) non-patent publications. Nonessential subject matter is subject matter referred to for purposes of indicating the background of the invention or illustrating the state of the art. See 37 CFR 1.57(e).

An incorporation by reference by hyperlink or other form of browser executable code is not permitted. See 37 CFR 1.57(e) and MPEP § 608.01.

Mere reference to another application, patent, or publication is not an incorporation of anything therein into the application containing such reference for the purpose of the disclosure required by 35 U.S.C. 112. In re de Seversky, 474 F.2d 671, 177 USPQ 144 (CCPA 1973). 37 CFR 1.57(c)(1) limits a proper incorporation by reference (except as provided in 37 CFR 1.57(b)) to instances only where the perfecting words “incorporated by reference” or the root of the words “incorporate” (e.g., incorporating, incorporated) and “reference” (e.g., referencing) appear. The requirement for specific root words will bring greater clarity to the record and provide a bright line test as to where something is being referred to is an incorporation by reference. The Office intends to treat references to documents that do not meet this “bright line” test as noncompliant incorporations by reference and may require correction pursuant to 37 CFR 1.57(h). If a reference to a document does not clearly indicate an intended incorporation by reference, examination will proceed as if no incorporation by reference statement has been made and the Office will not expend resources trying to determine if an incorporation by reference was intended. In addition to other requirements for an application, the referencing application must include an identification of the referenced patent, application, or publication. See 37 CFR 1.57(c)(2). Particular attention should be directed to specific portions of the referenced document where the subject matter being incorporated may be found. Guidelines for situations where applicant is permitted to fill in a number for Application No. __________ left blank in the application as filed can be found in In re Fouche, 439 F.2d 1237, 169 USPQ 429 (CCPA 1971) (Abandoned applications less than 20 years old can be incorporated by reference to the same extent as copending applications; both types are open to the public upon the referencing application issuing as a patent.). See 37 CFR 1.14(a)(i), (iv), and (vi), and MPEP § 103.

1. Complete Disclosure Filed

If an application is filed with a complete disclosure, essential material may be canceled by amendment and may be substituted by reference to a U.S. patent or a U.S. patent application publication. The amendment must be accompanied by a statement signed by the applicant, or a practitioner representing the applicant, stating that the material canceled from the application is the same material that has been incorporated by reference and no new matter has been included (see 37 CFR 1.57(g)). The same procedure is available for nonessential material.

If an application as filed incorporates material by reference, a copy of the incorporated by reference material may be required to be submitted to the Office even if the material is properly incorporated by reference. The examiner may require a copy of the incorporated material to review and to understand what is being incorporated or to put the description of the material in its proper context. Another instance where a copy of the incorporated material may be required is where the material is being inserted by amendment into the body of the application to replace an improper incorporation by reference statement so that the Office can determine that the material being added by amendment in lieu of the incorporation is the same material as was attempted to be incorporated. If the Office requires the applicant to supply a copy of the material incorporated by reference, the material must be accompanied by a statement that the copy supplied consists of the same material incorporated by reference in the referencing application. See 37 CFR 1.57(f).

2. Improper Incorporation

37 CFR 1.57(g) addresses corrections of incorporation by reference by inserting the material previously incorporated by reference. A noncompliant incorporation by reference statement may be corrected by an amendment. 37 CFR 1.57(g). However, the amendment must not include new matter. Incorporating by reference material that was not incorporated by reference on filing of an application may introduce new matter. An incorporation by reference of essential material to an unpublished U.S. patent application, a foreign application or patent, or to a publication is improper under 37 CFR 1.57(d). The improper incorporation by reference is not effective to incorporate the material unless corrected by the applicant (37 CFR 1.57(h)). Any underlying objection or rejection (e.g., under 35 U.S.C. 112) should be made by the examiner until applicant corrects the improper incorporation by reference by submitting an amendment to amend the specification or drawings to include the material incorporated by reference. A statement that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter is also required. 37 CFR 1.57(g). See also In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973). Improper incorporation by reference statements and late corrections thereof require expenditure of unnecessary examination resources and slow the prosecution process. Applicants know (or should know) whether they want material incorporated by reference, and must timely correct any incorporation by reference errors. Correction must be done within the time period set forth in 37 CFR 1.57(h).

An incorporation by reference that does not comply with 37 CFR 1.57(c), (d), or (e) is not effective to incorporate such material unless corrected within any time period set by the Office (should the noncompliant incorporation by reference be first noticed by the Office and applicant informed thereof), but in no case later than the close of prosecution as defined by 37 CFR 1.114(b) (should applicant be the first to notice the noncompliant incorporation by reference and the Office informed thereof), or abandonment of the application, whichever occurs earlier. The phrase “or abandonment of the application” is included in 37 CFR 1.57(h) to address the situations where an application is abandoned prior to the close of prosecution, e.g., the situation where an application is abandoned after a non-final Office action.

37 CFR 1.57(h)(1) authorizes the correction of noncompliant incorporation by reference statements that do not use the root of the words “incorporate” and “reference” in the incorporation by reference statement when the application as filed clearly conveys an intent to incorporate the material by reference. This correction can usually be made, for example, when an originally filed claim of an application identifies an amino acid or nucleotide sequence by database accession number. In making the determination of clear intent the examiner should consider the language used in referencing the sequence, the context in which it is disclosed, and any additional arguments or evidence presented by applicants.

37 CFR 1.57(h)(2) states that a citation of a document can be corrected where the document is sufficiently described to uniquely identify the document. Correction of a citation for a document that cannot be identified as the incorporated document may be new matter and is not authorized by 37 CFR 1.57(h)(2). An example would be where applicant intended to incorporate a particular journal article but supplied the citation information for a completely unrelated book by a different author, and there is no other information to identify the correct journal article. Since it cannot be determined from the citation originally supplied what article was intended to be incorporated, it would be improper (e.g., new matter) to replace the original incorporation by reference with the intended incorporation by reference. A citation of a patent application by attorney docket number, inventor name, filing date and title of invention may sufficiently describe the document, but even then correction should be made to specify the application number.

A petition under 37 CFR 1.183 to suspend the time period requirement set forth in 37 CFR 1.57(h) will not be appropriate. After the application has been abandoned, applicant must file a petition to revive under 37 CFR 1.137 for the purpose of correcting the incorporation by reference. After the application has issued as a patent, applicant may correct the patent by filing a reissue application. Correcting an improper incorporation by reference with a certificate of correction is not an appropriate means of correction because it may alter the scope of the claims. The scope of the claims may be altered because 37 CFR 1.57(h) provides that an incorporation by reference that does not comply with paragraph (c), (d), or (e) is not an effective incorporation. For example, an equivalent means omitted from a patent disclosure by an ineffective incorporation by reference would be outside the scope of the patented claims. Hence, a correction of an incorporation by reference pursuant to 37 CFR 1.57 may alter the scope of the claims by adding the omitted equivalent means. Changes involving the scope of the claims should be done via the reissue process. Additionally, the availability of the reissue process for corrections would make a successful showing required under 37 CFR 1.183 unlikely. The following examples show when an improper incorporation by reference is required to be corrected:

The filing date of any application wherein essential material is improperly incorporated by reference will not be affected by applicant’s correction where (A) there is a clear intent to incorporate by reference the intended material and the correction is to add the root words of “incorporate” and “reference,” (B) the incorporated document can be uniquely identified and the correction is to clarify the document’s identification, and (C) where the correction is to insert the material from the reference where incorporation is to an unpublished U.S. patent application, foreign application or patent, or to a publication.

Reliance on a commonly assigned, prior filed or concurrently filed copending application by a different inventor may ordinarily be made for the purpose of completing the disclosure provided the incorporated material is directed to nonessential material. See 37 CFR 1.57(e). See In re Fried, 329 F.2d 323, 141 USPQ 27 (CCPA 1964), and General Electric Co. v. Brenner, 407 F.2d 1258, 159 USPQ 335 (D.C. Cir. 1968).

Since a disclosure must be complete as of the filing date, subsequent publications or subsequently filed applications cannot be relied on to establish a constructive reduction to practice or an enabling disclosure as of the filing date. White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 218 USPQ 961 (Fed. Cir. 1983); In re Scarbrough, 500 F.2d 560, 182 USPQ 298 (CCPA 1974); In re Glass, 492 F.2d 1228, 181 USPQ 31 (CCPA 1974).

B.Review of Applications Which Are Relied on To Establish an Earlier Effective Filing Date

The limitations on the material which may be incorporated by reference in U.S. patent applications which are to issue as U.S. patents do not apply to applications relied on only to establish an earlier effective filing date under 35 U.S.C. 119 or 35 U.S.C. 120. Neither 35 U.S.C. 119(a) nor 35 U.S.C. 120 places any restrictions or limitations as to how the claimed invention must be disclosed in the earlier application to comply with 35 U.S.C. 112(a). Accordingly, an application is entitled to rely upon the filing date of an earlier application, even if the earlier application itself incorporates essential material by reference to another document. See Ex parte Maziere, 27 USPQ2d 1705, 1706-07 (Bd. Pat. App. & Inter. 1993).

The reason for incorporation by reference practice with respect to applications which are to issue as U.S. patents is to provide the public with a patent disclosure which minimizes the public’s burden to search for and obtain copies of documents incorporated by reference which may not be readily available. Through the Office’s incorporation by reference policy, the Office ensures that reasonably complete disclosures are published as U.S. patents. The same policy concern does not apply where the sole purpose for which an applicant relies on an earlier U.S. or foreign application is to establish an earlier filing date. Incorporation by reference in the earlier application of (1) patents or applications published by foreign countries or regional patent offices, (2) nonpatent publications, (3) a U.S. patent or application which itself incorporates “essential material” by reference, or (4) a foreign application, is not critical in the case of a “benefit” application.

When an applicant, or a patent owner in a reexamination or interference, claims the benefit of the filing date of an earlier application which incorporates material by reference, the applicant or patent owner may be required to supply copies of the material incorporated by reference. For example, an applicant may claim the benefit of the filing date of a foreign application which itself incorporates by reference another earlier filed foreign application. If necessary, due to an intervening reference, applicant should be required to supply a copy of the earlier filed foreign application, along with an English language translation. A review can then be made of the foreign application and all material incorporated by reference to determine whether the foreign application discloses the invention sought to be patented in the manner required by 35 U.S.C. 112(a) so that benefit may be accorded. In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).

As a safeguard against the omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, applicant may include a statement at the time of filing of the later application incorporating by reference the prior application. See MPEP § 201.06(c) and 211et seq. where domestic benefit is claimed. See MPEP §§ 213 – 216 where foreign priority is claimed. See MPEP § 217 regarding 37 CFR 1.57(b). The inclusion of such an incorporation by reference statement in the later-filed application will permit applicant to include subject matter from the prior application into the later-filed application without the subject matter being considered as new matter. For the incorporation by reference to be effective as a proper safeguard, the incorporation by reference statement must be filed at the time of filing of the later-filed application. An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)). Although, as discussed above, an incorporation by reference statement can be used as a safeguard against an omission of a portion of a prior application for which priority is claimed under 35 U.S.C. 119(a)-(d) or (f), or for which benefit is claimed under 35 U.S.C. 119(e) or 120, it should be noted that an incorporation by reference statement will not satisfy the specific reference requirement of 35 U.S.C. 119(e) or 120 or 37 CFR 1.78. See Droplets, Inc. v. E*TRADE Bank, 887 F.3d 1309, 126 USPQ2d 317 (Fed. Cir. 2018).

II. SIMULATED OR PREDICTED TEST RESULTS OR PROPHETIC EXAMPLES

Simulated or predicted test results and prophetical examples (paper examples) are permitted in patent applications. Working examples correspond to work actually performed and may describe tests which have actually been conducted and results that were achieved. Paper examples describe the manner and process of making an embodiment of the invention which has not actually been conducted. Paper examples should not be represented as work actually done. No results should be represented as actual results unless they have actually been achieved. Paper 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). For further guidance, see “Properly Presenting Prophetic and Working Examples in a Patent Application”, 86 FR 35074 (July 1, 2021).

For problems arising from the designation of materials by trademarks and trade names, see MPEP § 608.01(v).