608.01(p) Completeness of Specification
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| 608.01(p) |
The contents of an application 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.
- At least one specific operative embodiment or example of the invention must be set forth.
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.
I. INCORPORATION BY REFERENCE
[Editor Note: Paragraph (a) below is only applicable to patent applications filed under 35 U.S.C. 111(a) on or after December 18, 2013.]
(a) Subject to the conditions and requirements of this paragraph, a reference made in the English language in an application data sheet in accordance with § 1.76 upon the filing of an application under 35 U.S.C. 111(a) to a previously filed application, indicating that the specification and any drawings of the application under 35 U.S.C. 111(a) are replaced by the reference to the previously filed application, and specifying the previously filed application by application number, filing date, and the intellectual property authority or country in which the previously filed application was filed, shall constitute the specification and any drawings of the application under 35 U.S.C. 111(a) for purposes of a filing date under § 1.53(b).
(1) If the applicant has provided a correspondence address (§ 1.33(a)), the applicant will be notified and given a period of time within which to file a copy of the specification and drawings from the previously filed application, an English language translation of the previously filed application, and the fee required by § 1.17(i) if it is in a language other than English, and pay the surcharge required by § 1.16(f), to avoid abandonment. Such a notice may be combined with a notice under § 1.53(f).
(2) If the applicant has not provided a correspondence address (§ 1.33(a)), the applicant has three months from the filing date of the application to file a copy of the specification and drawings from the previously filed application, an English language translation of the previously filed application, and the fee required by § 1.17(i) if it is in a language other than English, and pay the surcharge required by § 1.16(f), to avoid abandonment.
(3) An application abandoned under paragraph (a)(1) or (a)(2) of this section shall be treated as having never been filed, unless:(i) The application is revived under § 1.137; and
(ii) A copy of the specification and any drawings of the previously filed application are filed in the Office.(4) A certified copy of the previously filed application must be filed in the Office, unless the previously filed application is an application filed under 35 U.S.C. 111 or 363, or the previously filed application is a foreign priority application and the conditions set forth in § 1.55(i) are satisfied with respect to such foreign priority application. The certified copy of the previously filed application, if required by this paragraph, must be filed within the later of four months from the filing date of the application or sixteen months from the filing date of the previously filed application, or be accompanied by a petition including a showing of good and sufficient cause for the delay and the petition fee set forth in § 1.17(g).
(b) Subject to the conditions and requirements of this paragraph, if all or a portion of the specification or drawing(s) is inadvertently omitted from an application, but the application contains a claim under § 1.55 for priority of a prior-filed foreign application, or a claim under § 1.78 for the benefit of a prior-filed provisional, nonprovisional, international application, or international design application, that was present on the filing date of the application, and the inadvertently omitted portion of the specification or drawing(s) is completely contained in the prior-filed application, the claim under § 1.55 or 1.78 shall also be considered an incorporation by reference of the prior-filed application as to the inadvertently omitted portion of the specification or drawing(s).
(1) The application must be amended to include the inadvertently omitted portion of the specification or drawing(s) within any time period set by the Office, but in no case later than the close of prosecution as defined by § 1.114(b), or abandonment of the application, whichever occurs earlier. The applicant is also required to:
(i) Supply a copy of the prior-filed application, except where the prior-filed application is an application filed under 35 U.S.C. 111;
(ii) Supply an English language translation of any prior-filed application that is in a language other than English; and
(iii) Identify where the inadvertently omitted portion of the specification or drawings can be found in the prior-filed application.(2) Any amendment to an international application pursuant to paragraph (b)(1) of this section shall be effective only as to the United States, and shall have no effect on the international filing date of the application. In addition, no request under this section to add the inadvertently omitted portion of the specification or drawings in an international application designating the United States will be acted upon by the Office prior to the entry and commencement of the national stage (§ 1.491) or the filing of an application under 35 U.S.C. 111(a) which claims benefit of the international application. Any omitted portion of the international application which applicant desires to be effective as to all designated States, subject to PCT Rule 20.8(b), must be submitted in accordance with PCT Rule 20.
(3) If an application is not otherwise entitled to a filing date under § 1.53(b), the amendment must be by way of a petition pursuant to § 1.53(e) accompanied by the fee set forth in § 1.17(f).
(4) Any amendment to an international design application pursuant to paragraph (b)(1) of this section shall be effective only as to the United States and shall have no effect on the filing date of the application. In addition, no request under this section to add the inadvertently omitted portion of the specification or drawings in an international design application will be acted upon by the Office prior to the international design application becoming a nonprovisional application.
(c) Except as provided in paragraphs (a) or (b) of this section, an incorporation by reference must be set forth in the specification and must:
(1) Express a clear intent to incorporate by reference by using the root words “incorporat(e)” and “reference” (e.g. , “incorporate by reference”); and
(2) Clearly identify the referenced patent, application, or publication.
(d) “Essential material” may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. “Essential material” is material that 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).
(e) Other material (“Nonessential material”) may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.
(f) The examiner may require the applicant to supply a copy of the material incorporated by reference. If the Office requires the applicant to supply a copy of 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.
(g) Any insertion of material incorporated by reference into the specification or drawings of an application must be by way of an amendment to the specification or drawings. Such an amendment must be accompanied by a statement that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter.
(h) An incorporation of material by reference that does not comply with paragraphs (c), (d), or (e) of this section is not effective to incorporate such material unless corrected within any time period set by the Office, but in no case later than the close of prosecution as defined by § 1.114(b), or abandonment of the application, whichever occurs earlier. In addition:
(1) A correction to comply with paragraph (c)(1) of this section is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.
(2) A correction to comply with paragraph (c)(2) of this section is only permitted for material that was sufficiently described to uniquely identify the document. (i) An application transmittal letter limited to the transmittal of a copy of the specification and drawings from a previously filed application submitted under paragraph (a) or (b) of this section may be signed by a juristic applicant or patent owner.
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.
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.
A. Review of Applications Which Are To Issue as Patents.
An application for a patent when filed may incorporate “essential material” by reference to:
- a U.S. patent, or
- a U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference.
“Essential material” is defined as that which is necessary to:
- 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;
- describe the claimed invention in terms that particularly point out and distinctly claim the invention; or
- describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function. 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:
- patents or applications published by the United States or foreign countries or regional patent offices,
- prior and concurrently filed, commonly owned U.S. applications, or
- 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.
An incorporation by reference by hyperlink or other form of browser executable code is not permitted.
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.
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.
- 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.
2. Improper Incorporation
A noncompliant incorporation by reference statement may be corrected by an amendment.
- However, the amendment must not include 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.
- The improper incorporation by reference is not effective to incorporate the material unless corrected by the applicant.
Improper incorporation by reference statements and late corrections thereof require expenditure of unnecessary examination resources and slow the prosecution process.
An incorporation by reference that does not comply with 37 CFR 1.57(b), (c), or (d) 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 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(g)(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(g)(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(g)(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(g) 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(g) provides that an incorporation by reference that does not comply with paragraph (b), (c), or (d) 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:
Upon review of the specification, the examiner noticed that the specification included an incorporation by reference statement incorporating essential material disclosed in a foreign patent. In a non-final Office action, the examiner required the applicant to amend the specification to include the essential material.
In reply to the non-final Office action, applicant must correct the improper incorporation by reference by filing an amendment to add the essential material disclosed in the foreign patent and a statement in compliance with 37 CFR 1.57(f) within the time period for reply set forth in the non-final Office action.
Upon review of the specification, the examiner determined that the subject matter incorporated by reference from a foreign patent was “nonessential material” and therefore, did not object to the incorporation by reference. In reply to a non-final Office action, applicant filed an amendment to the claims to add a new limitation that was supported only by the foreign patent. The amendment filed by the applicant caused the examiner to re-determine that the incorporated subject matter was “essential material” under 37 CFR 1.57(c). The examiner rejected the claims that include the new limitation under 35 U.S.C. 112(a) in a final Office action.
Since the rejection under 35 U.S.C. 112(a) was necessitated by the applicant’s amendment, the finality of the Office action is proper. If the applicant wishes to overcome the rejection under 35 U.S.C. 112(a) by filing an amendment under 37 CFR 1.57(f) to add the subject material disclosed in the foreign patent into the specification, applicant may file the amendment as an after final amendment in compliance with 37 CFR 1.116. Alternatively, applicant may file an RCE under 37 CFR 1.114 accompanied by the appropriate fee, and an amendment per 37 CFR 1.57(f) within the time period for reply set forth in the final Office action.
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 places any restrictions or limitations as to how the claimed invention must be disclosed in the earlier application.
- 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.
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.
608.01(q) Substitute or Rewritten Specification
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(a) If the number or nature of the amendments or the legibility of the application papers renders it difficult to consider the application, or to arrange the papers for printing or copying, the Office may require the entire specification, including the claims, or any part thereof, be rewritten.
(b) Subject to § 1.312, a substitute specification, excluding the claims, may be filed at any point up to payment of the issue fee if it is accompanied by a statement that the substitute specification includes no new matter.
(c) A substitute specification submitted under this section must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown pursuant to this paragraph.
(d) A substitute specification under this section is not permitted in a reissue application or in a reexamination proceeding.
The specification is sometimes in such faulty English that a new specification is necessary; in such instances, a new specification should be required.
A substitute specification, excluding claims, may be voluntarily filed by the applicant at any point up to the payment of the issue fee provided it is accompanied by a statement that the substitute specification includes no new matter.
- A substitute specification must be submitted in clean form without markings.
- A marked-up copy of the substitute specification showing all the changes relative to the immediate prior version of the specification of record must also be submitted.
The text of any added subject matter must be shown by underlining the added text.
The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five of fewer consecutive characters.
- The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived.
The paragraphs of any substitute specification, other than the claims, should be individually numbered in Arabic numerals (for example [0001]) so that any amendment to the specification may be made by replacement paragraph
A substitute specification must be accompanied by a statement indicating that no new matter was included.
608.01(s) Restoration of Canceled Matter
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608.01(t) Use in Subsequent Application
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608.01(v) Marks Used in Commerce and Trade Names
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The expressions “trademarks” and “trade names” as used below have the following meanings:
- Trademark: a word, letter, symbol, or device adopted by one manufacturer or merchant and used to identify and distinguish his or her product from those of others. It is a proprietary word, letter, symbol, or device pointing distinctly to the product of one producer.
- Trade Names: a nonproprietary name by which an article or product is known and called among traders or workers in the art, although it may not be so known by the public, generally. Trade names do not point to the product of one producer, but they identify a single article or product irrespective of producer.
I. PERMISSIBLE USE IN PATENT APPLICATIONS
A trademark or trade name may be used in a patent application to identify an article or product if:
- its meaning is established by an accompanying definition in the specification which is sufficiently descriptive, enabling, precise and definite such that a claim including the trademark or trade name complies with the requirements of 35 U.S.C. 112, or
- its meaning is well-known to one skilled in the relevant art and is satisfactorily defined in the literature.
II. PROPRIETARY NATURE OF TRADEMARKS
Although the use of trademarks having definite meanings is permissible in patent applications, the proprietary nature of the marks should be respected.
