MPEP § 1845.01 — Preparing the Written Opinion of the International Searching Authority (Form PCT/ISA/237) (Annotated Rules)

§1845.01 Preparing the Written Opinion of the International Searching Authority (Form PCT/ISA/237)

USPTO MPEP version: BlueIron's Update: 2025-12-31

This page consolidates and annotates all enforceable requirements under MPEP § 1845.01, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Preparing the Written Opinion of the International Searching Authority (Form PCT/ISA/237)

This section addresses Preparing the Written Opinion of the International Searching Authority (Form PCT/ISA/237). Primary authority: 37 CFR 1845.01. Contains: 8 requirements, 1 prohibition, 10 guidance statements, 3 permissions, and 2 other statements.

Key Rules

Topic

International Searching Authority (ISA)

16 rules
StatutoryInformativeAlways
[mpep-1845-01-457f152dfbd35cc805f36fd3]
Written Opinion Requirement for PCT Applications
Note:
The rule requires the preparation of a written opinion by the International Searching Authority (ISA) for international applications filed after July 1, 2022.

[Editor Note: This section discusses the July 2022 version of PCT/ISA/237. For international applications having an international filing date before July 1, 2022, information regarding form PCT/ISA/237 (revised January 2019) may be found in §1845.01 of the 10.2019 revision of the Ninth Edition of the MPEP published June 2020 at: www.uspto.gov/web/offices/pac/mpep/old/ mpep_E9R10.htm.]

Jump to MPEP Source · 37 CFR 1845.01International Searching Authority (ISA)International SearchPatent Cooperation Treaty
StatutoryRequiredAlways
[mpep-1845-01-852a6e9fd234ab69dca81892]
Indicate Language Basis for Opinion
Note:
Examiners must indicate whether the opinion is based on the international application in its original language or a translation provided during the search process.

When completing Box No. I, item 1, of Form PCT/ISA/237, the examiner must indicate whether or not the opinion has been established on the basis of the international application in the language in which it was filed. If a translation was furnished for the purpose of the search, this must be indicated.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISARequest Content and Form
StatutoryRequiredAlways
[mpep-1845-01-d35a43467d0d6780dc93e585]
Translation for Search Must Be Noted
Note:
If a translation was provided for the search, it must be indicated on Form PCT/ISA/237.

When completing Box No. I, item 1, of Form PCT/ISA/237, the examiner must indicate whether or not the opinion has been established on the basis of the international application in the language in which it was filed. If a translation was furnished for the purpose of the search, this must be indicated.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISAInternational Search
StatutoryInformativeAlways
[mpep-1845-01-948b4d8768d416fed35572e1]
Mark Item 2 When Rectifying Obvious Mistake in PCT
Note:
Mark Box No. I, item 2 of Form PCT/ISA/237 when the opinion is based on rectifying an obvious mistake under PCT Rule 91.

Box No. I, item 2 of Form PCT/ISA/237 is to be marked when the opinion is established taking into account the rectification of an obvious mistake under PCT Rule 91.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISACompetent Authority for Rectification
StatutoryInformativeAlways
[mpep-1845-01-f9fbc1b7d113dd2285ed5aad]
Notification of Priority Request Status Required
Note:
Box No. II of Form PCT/ISA/237 must inform the applicant about the status of their priority request, especially when international search report citations are published after the earliest priority date.

Box No. II of Form PCT/ISA/237 is to inform applicant of the status of a request for priority. Where one or more citations of the international search report were published after the earliest priority date, the validity of that earliest priority date requires checking. Where the priority document is one which is in the records of the ISA, it should be obtained from those records. If a copy of the priority document is not available before preparation of the written opinion of the ISA because it has not yet been provided by the applicant, and if that earlier application was not filed with that Authority in its capacity as a national Office or the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, the written opinion of the ISA may be established as if the priority had been validly claimed.

Jump to MPEP SourceInternational Searching Authority (ISA)Priority Claim in PCTRequest Content and Form
StatutoryInformativeAlways
[mpep-1845-01-add5f50c1502050a79914343]
Check Validity of Earliest Priority Date When Citations Published After It
Note:
When citations from the international search report are published after the earliest priority date, the validity of that date must be verified.

Box No. II of Form PCT/ISA/237 is to inform applicant of the status of a request for priority. Where one or more citations of the international search report were published after the earliest priority date, the validity of that earliest priority date requires checking. Where the priority document is one which is in the records of the ISA, it should be obtained from those records. If a copy of the priority document is not available before preparation of the written opinion of the ISA because it has not yet been provided by the applicant, and if that earlier application was not filed with that Authority in its capacity as a national Office or the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, the written opinion of the ISA may be established as if the priority had been validly claimed.

Jump to MPEP SourceInternational Searching Authority (ISA)International Search ReportPriority Claim in PCT
StatutoryRecommendedAlways
[mpep-1845-01-1b0e16717ca6b43b18788c8f]
Priority Document from ISA Records Required
Note:
If the priority document is in ISA records, it must be obtained from those records for checking the validity of the earliest priority date.

Box No. II of Form PCT/ISA/237 is to inform applicant of the status of a request for priority. Where one or more citations of the international search report were published after the earliest priority date, the validity of that earliest priority date requires checking. Where the priority document is one which is in the records of the ISA, it should be obtained from those records. If a copy of the priority document is not available before preparation of the written opinion of the ISA because it has not yet been provided by the applicant, and if that earlier application was not filed with that Authority in its capacity as a national Office or the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, the written opinion of the ISA may be established as if the priority had been validly claimed.

Jump to MPEP SourceInternational Searching Authority (ISA)Priority Claim in PCTInternational Search
StatutoryPermittedAlways
[mpep-1845-01-bfd750d8c45203b2ac9921b8]
Written Opinion May Be Issued Without Priority Document
Note:
If the priority document is not available before preparing the ISA written opinion, the opinion can still be issued as if the priority claim was valid.

Box No. II of Form PCT/ISA/237 is to inform applicant of the status of a request for priority. Where one or more citations of the international search report were published after the earliest priority date, the validity of that earliest priority date requires checking. Where the priority document is one which is in the records of the ISA, it should be obtained from those records. If a copy of the priority document is not available before preparation of the written opinion of the ISA because it has not yet been provided by the applicant, and if that earlier application was not filed with that Authority in its capacity as a national Office or the priority document is not available to that Authority from a digital library in accordance with the Administrative Instructions, the written opinion of the ISA may be established as if the priority had been validly claimed.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISAPriority Claim in PCT
StatutoryRecommendedAlways
[mpep-1845-01-59e688746929076cfe75124d]
ISA Must Not Delay Written Opinion Await Priority Document Response
Note:
The International Searching Authority must prepare the written opinion without waiting for a response to an invitation for a priority document, even if it is not yet provided.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISASignatory Authority Review
StatutoryRecommendedAlways
[mpep-1845-01-466cd41f0d9637f00c03f762]
Examiner Must Notify Applicant of Lack of Unity Using Form PCT/ISA/237
Note:
The examiner must use Box No. IV of Form PCT/ISA/237 to inform the applicant that lack of unity has been found and specify one of four reasons under item 1.

Box No. IV of Form PCT/ISA/237 should be used by the examiner to notify applicant that lack of unity has been found by checking item 1, and one of the four boxes under item 1.

Jump to MPEP SourceInternational Searching Authority (ISA)Request Content and FormSignature Requirements
StatutoryRecommendedAlways
[mpep-1845-01-e096835841dcb5891ad7354f]
Check Fourth Box for First Invention Search Report
Note:
Examiner must check the fourth box under item 1 if the search report is based on the first mentioned invention and no additional search fees were paid.

If the search report is based on the first mentioned invention (no additional search fees were paid), the examiner should check the fourth box under item 1.

Jump to MPEP SourceInternational Searching Authority (ISA)International Search ReportRequest Content and Form
StatutoryPermittedAlways
[mpep-1845-01-686f17f7e0c800fb99baba79]
Reason for Lack of Unity from International Search Report
Note:
If a lack of unity exists, the examiner should state that the reason is set forth in the international search report rather than marking the second box under item 3.

If a lack of unity exists, the examiner would mark the second box under item 3. However, since the reasons for the lack of unity have already been set forth on the simultaneously issued international search report, the examiner can simply state that the reason the requirement of unity of invention is not complied with is set forth in the international search report. The first box under item 3 would never be marked.

Jump to MPEP SourceInternational Searching Authority (ISA)International Search ReportRequest Content and Form
StatutoryInformativeAlways
[mpep-1845-01-5fbfc7ad3f4cd5e8b1c6d5ab]
Claims Must List N, IS, IA Criteria
Note:
The examiner must summarize claims regarding novelty, inventive step, and industrial applicability in Box No. V of Form PCT/ISA/237.

In Box No. V of Form PCT/ISA/237, the examiner must list in summary form all claims with regard to the criteria of novelty (N), inventive step (IS), and industrial applicability (IA). For definitions of novelty, inventive step, and industrial applicability see MPEP §§ 1878.01(a)(1), 1878.01(a)(2), and 1878.01(a)(3), respectively.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISAInternational Search
StatutoryPermittedAlways
[mpep-1845-01-5afbe2b53dc7e5a5a7f1d968]
Objections Must Be Substantive Not Technical
Note:
Form paragraphs in Box No. VIII require noting objections that are substantive rather than merely technical.

The following form paragraphs may be used in Box No. VIII, “Certain observations on the international application,” of Form PCT/ISA/237 for noting objections which are substantive rather than merely technical in nature.

Jump to MPEP SourceInternational Searching Authority (ISA)Request Content and FormInternational Search
StatutoryRequiredAlways
[mpep-1845-01-31b64eb3140854d1f6b4e3fd]
Written Opinion Must Include Authorized Officer Name
Note:
The written opinion of the International Searching Authority must include the name of the officer responsible for preparing it.

Pursuant to PCT Rules 43bis.1 and 70.14, the written opinion of the International Searching Authority must indicate the name of the officer of the International Searching Authority responsible for the written opinion, i.e., the “authorized officer.” An “authorized officer” is the person who actually performed the search work and prepared the search report and the written opinion, or another person who was responsible for supervising the search and the establishment of the written opinion. See PCT Administrative Instructions Section 514. Thus, an examiner need not have signatory authority in order to be named as an authorized officer on the written opinion. However, the “file copy” of the written opinion must be signed by an examiner having at least partial signatory authority.

Jump to MPEP SourceInternational Searching Authority (ISA)Written Opinion of ISASignatory Authority Review
StatutoryInformativeAlways
[mpep-1845-01-2dcc2fcf6ec58b8cf5d9d96a]
Authorized Officer for Written Opinion Required
Note:
The person who performed the search work and prepared the written opinion must be identified as the authorized officer.

Pursuant to PCT Rules 43bis.1 and 70.14, the written opinion of the International Searching Authority must indicate the name of the officer of the International Searching Authority responsible for the written opinion, i.e., the “authorized officer.” An “authorized officer” is the person who actually performed the search work and prepared the search report and the written opinion, or another person who was responsible for supervising the search and the establishment of the written opinion. See PCT Administrative Instructions Section 514. Thus, an examiner need not have signatory authority in order to be named as an authorized officer on the written opinion. However, the “file copy” of the written opinion must be signed by an examiner having at least partial signatory authority.

Jump to MPEP SourceInternational Searching Authority (ISA)International Search ReportWritten Opinion of ISA
Topic

Article 19 Amendment Scope

13 rules
StatutoryPermittedAlways
[mpep-1845-01-6b036805ed483bc7566bcc49]
Examiner May Request Priority Document from Applicant
Note:
The examiner can request a copy of the foreign priority document from the applicant if the International Bureau has not yet received it.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourceArticle 19 Amendment ScopeInterviews in National StagePriority Claim in PCT
StatutoryInformativeAlways
[mpep-1845-01-0b7f2ea212030b34f6ee527a]
Invalid Priority Claim Must Be Noted
Note:
When the claim for priority is found invalid, note it in Box II and provide reasons under Additional Observations.

When the claim for priority has been found invalid (e.g., the notification under PCT Rule 26bis.2(b) has been provided or all claims are directed to inventions which were not described and enabled by the earlier application), check item 2 in Box II and indicate why the claim for priority has been found invalid following item 3 “Additional observations.”

Jump to MPEP SourceArticle 19 Amendment ScopePCT Claims FormatPriority Claim in PCT
StatutoryProhibitedAlways
[mpep-1845-01-0a5cc51ca89b99b0dbe22af3]
Claims Must Be Clear and Supported
Note:
The rule requires that claims in an international application must be clear and adequately supported by the description to allow for consideration of novelty, inventive step, and industrial applicability.

Box No. III of Form PCT/ISA/237 is intended to cover situations where some or all claims of an application are so unclear or inadequately supported by the description that the question of novelty, inventive step (nonobviousness), and industrial applicability cannot be considered, or where the international application or claims thereof relate to subject matter for which it is not required to establish a written opinion concerning novelty, inventive step and industrial applicability, or where no international search report has been established for the claims.

Jump to MPEP SourceArticle 19 Amendment ScopeArticle 19 Amendment TimingPCT Description Requirements
StatutoryRequiredAlways
[mpep-1845-01-0b47289e93d0b91dabd94da4]
Requirement for Claims Not Requiring Written Opinion
Note:
Indicate which claims do not require a written opinion on novelty, inventive step and industrial applicability and specify the reasons.

If some or all of the claims of an application relate to subject matter for which it is not required to establish a written opinion concerning novelty, inventive step and industrial applicability, check the appropriate box, indicate which claims relate to that subject matter and specify the reasons e.g., improper multiple dependent claims that fail to comply with PCT Rule 6.4.

Jump to MPEP SourceArticle 19 Amendment ScopePCT Claims FormatWritten Opinion of ISA
StatutoryInformativeAlways
[mpep-1845-01-01cc726cb8ca27d7f7bf549c]
Second Box for Lack of Unity Identified Claims
Note:
Check the second box and identify relevant claims when unity of invention is lacking.

Item 4 is used by the examiner to indicate which parts of the application form the basis of the opinion after the lack of unity of invention has been explained. The first box should be checked when the opinion is established for all parts. Otherwise, the second box is checked and the relevant claims identified.

Jump to MPEP SourceArticle 19 Amendment ScopeRequest Content and FormPCT Article 19 Amendments
StatutoryRequiredAlways
[mpep-1845-01-1991fbfb2608e6cca9e0a147]
Claims Must Summarize Novelty, Inventive Step, and Industrial Applicability
Note:
Examiners must list all claims in Form PCT/ISA/237 summarizing their compliance with novelty, inventive step, and industrial applicability criteria.

In Box No. V of Form PCT/ISA/237, the examiner must list in summary form all claims with regard to the criteria of novelty (N), inventive step (IS), and industrial applicability (IA). For definitions of novelty, inventive step, and industrial applicability see MPEP §§ 1878.01(a)(1), 1878.01(a)(2), and 1878.01(a)(3), respectively.

Jump to MPEP SourceArticle 19 Amendment ScopePCT Abstract RequirementsInternational Searching Authority (ISA)
StatutoryRecommendedAlways
[mpep-1845-01-ce9584a37db85cc36bed341c]
Claims Meeting Novelty and Nonobviousness Require Detailed Reasons for Allowance
Note:
If claims meet novelty, nonobviousness, and industrial applicability over prior art, a detailed reasons for allowance must be provided indicating how the claims satisfy these requirements.

Examiner statements in Box No. V can be positive or negative. If the claims define over the prior art and meet the test of novelty, inventive step (nonobviousness) and industrial applicability, a positive statement equivalent to detailed reasons for allowance in a corresponding U.S. national application should be provided, indicating how the claims meet the tests of novelty, inventive step and industrial applicability. Form paragraphs 18.04 and 18.04.01 may be used for this purpose.

Jump to MPEP SourceArticle 19 Amendment ScopeStatement Under Article 19International Search Report
StatutoryRecommendedAlways
[mpep-1845-01-2da8295283de20d80dbf741b]
Claims Meeting Industrial Applicability Follow Form 18.04.01
Note:
If claims satisfy the industrial applicability criteria in PCT Article 33(4), they must be followed by form paragraph 18.04.01.

3. If the claims also meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.04.01.

37 CFR 1.77Article 19 Amendment ScopeRequest Content and FormPCT Article 19 Amendments
StatutoryRecommendedAlways
[mpep-1845-01-f24eb77803d3e7e38e947798]
Claims Must Meet Industrial Applicability Criteria
Note:
If claims do not meet the industrial applicability criteria set out in PCT Article 33(4), form paragraph 18.03 must be followed.

4. If the claims do not meet the industrial applicability criteria set out in PCT Article 33(4), this form paragraph should be followed by form paragraph 18.03.

37 CFR 1.77Article 19 Amendment ScopeRequest Content and FormPCT Article 19 Amendments
StatutoryInformativeAlways
[mpep-1845-01-9e1715fbfdcb5491293c7597]
Positive Statements for Novelty and Inventive Step Required Before Form Paragraph 18.04
Note:
If claims meet PCT Article 33(2)-(4) requirements, provide positive statements for novelty and inventive step before form paragraph 18.04.

3. If the claims meet all of the requirements of PCT Article 33(2)-(4), use form paragraph 18.04 before this form paragraph to provide positive statements for novelty and inventive step under PCT Article 33(2)-(3).

37 CFR 1.77Article 19 Amendment ScopeRequest Content and FormPCT Article 19 Amendments
StatutoryPermittedAlways
[mpep-1845-01-b9baf09489f697aab0799803]
Claims Must Be Supported by Description
Note:
The claims must be adequately supported by the description to form a meaningful opinion on novelty, inventive step, and industrial applicability.

If the claims, the description, or the drawings are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the question of novelty, inventive step (nonobviousness) or industrial applicability, the applicant is so informed in Box No. III. See PCT Article 34(4)(a)(ii). Reasons for the examiner’s opinion that the claims, description and drawings, etc., lack clarity must also be provided.

Jump to MPEP SourceArticle 19 Amendment ScopePCT Description RequirementsRequest Content and Form
StatutoryRequiredAlways
[mpep-1845-01-f41e71bea7cfe3b9da22c257]
Examiner Must Provide Clarity Reasons
Note:
The examiner must provide reasons if the claims, description, or drawings lack clarity and prevent a meaningful opinion on novelty, inventive step, or industrial applicability.

If the claims, the description, or the drawings are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the question of novelty, inventive step (nonobviousness) or industrial applicability, the applicant is so informed in Box No. III. See PCT Article 34(4)(a)(ii). Reasons for the examiner’s opinion that the claims, description and drawings, etc., lack clarity must also be provided.

Jump to MPEP SourceArticle 19 Amendment ScopePCT Description RequirementsPCT Article 19 Amendments
StatutoryRequiredAlways
[mpep-1845-01-1a6e5c052d3a703bccd33ec3]
Article 34(4)(a)(ii) Applies to Certain Claims
Note:
If the specified situation is found in certain claims, those claims must comply with PCT Article 34(4)(a)(ii).

If the above situation is found to exist in certain claims only, the provisions of PCT Article 34(4)(a)(ii) shall apply to those claims only.

Jump to MPEP SourceArticle 19 Amendment ScopePCT Article 19 AmendmentsPatent Cooperation Treaty
Topic

Request Content and Form

5 rules
StatutoryRecommendedAlways
[mpep-1845-01-81b9763636a5f4150dd6315b]
Check First Box for Additional Inventions
Note:
Examiner must check the first box under item 1 if applicant has paid additional fees for extra inventions.

If applicant paid additional fees for additional inventions, the examiner should check the first box under item 1.

Jump to MPEP SourceRequest Content and FormSignature RequirementsPCT Request Form
StatutoryRecommendedAlways
[mpep-1845-01-da9070cde64a03acbae2b450]
Protest Box for Paid Additional Fees
Note:
Examiners must check the second box under item 1 if additional fees were paid under protest.

If the additional fees were paid under protest, the examiner should check the second box under item 1.

Jump to MPEP SourceRequest Content and FormExaminer Action on ProtestPCT Request Form
StatutoryInformativeAlways
[mpep-1845-01-7f3282b5f072ec6814bbc9df]
Requirement for Not Marking First Box Under Item 3
Note:
The examiner should not mark the first box under item 3 if there is no lack of unity, as the reason for non-compliance with unity of invention is already stated in the international search report.

If a lack of unity exists, the examiner would mark the second box under item 3. However, since the reasons for the lack of unity have already been set forth on the simultaneously issued international search report, the examiner can simply state that the reason the requirement of unity of invention is not complied with is set forth in the international search report. The first box under item 3 would never be marked.

Jump to MPEP SourceRequest Content and FormPCT Request FormInternational Searching Authority (ISA)
StatutoryPermittedAlways
[mpep-1845-01-f7ce4d235f266c1a98f5203e]
Examiner Statements Can Be Positive or Negative
Note:
Examiner statements in Box No. V must be either positive or negative, indicating whether claims meet the tests of novelty, inventive step, and industrial applicability.

Examiner statements in Box No. V can be positive or negative. If the claims define over the prior art and meet the test of novelty, inventive step (nonobviousness) and industrial applicability, a positive statement equivalent to detailed reasons for allowance in a corresponding U.S. national application should be provided, indicating how the claims meet the tests of novelty, inventive step and industrial applicability. Form paragraphs 18.04 and 18.04.01 may be used for this purpose.

Jump to MPEP SourceRequest Content and FormPCT Request FormInternational Searching Authority (ISA)
StatutoryPermittedAlways
[mpep-1845-01-be289231b81d7c51ee1ef260]
Requirement for Positive Examiner Statements on Novelty and Nonobviousness
Note:
Examiner statements must affirm that claims meet novelty, nonobviousness, and industrial applicability if the claims overcome prior art.

Examiner statements in Box No. V can be positive or negative. If the claims define over the prior art and meet the test of novelty, inventive step (nonobviousness) and industrial applicability, a positive statement equivalent to detailed reasons for allowance in a corresponding U.S. national application should be provided, indicating how the claims meet the tests of novelty, inventive step and industrial applicability. Form paragraphs 18.04 and 18.04.01 may be used for this purpose.

Jump to MPEP SourceRequest Content and FormPCT Request FormInternational Searching Authority (ISA)
Topic

Written Opinion of ISA

3 rules
StatutoryInformativeAlways
[mpep-1845-01-ba55bdbb5861f455954e195c]
Item 4 Indicates Opinion Basis After Lack of Unity
Note:
Item 4 is used by the examiner to specify which parts of the application support the opinion after lack of unity of invention has been explained.

Item 4 is used by the examiner to indicate which parts of the application form the basis of the opinion after the lack of unity of invention has been explained. The first box should be checked when the opinion is established for all parts. Otherwise, the second box is checked and the relevant claims identified.

Jump to MPEP SourceWritten Opinion of ISARequest Content and FormLack of Unity Finding
StatutoryRecommendedAlways
[mpep-1845-01-ab5d8e2ae09bad33efef2fad]
Opinion Established for All Parts Requirement
Note:
The first box must be checked if the opinion is established for all parts of the application; otherwise, the second box and relevant claims should be identified.

Item 4 is used by the examiner to indicate which parts of the application form the basis of the opinion after the lack of unity of invention has been explained. The first box should be checked when the opinion is established for all parts. Otherwise, the second box is checked and the relevant claims identified.

Jump to MPEP SourceWritten Opinion of ISARequest Content and FormPCT Request Form
StatutoryRequiredAlways
[mpep-1845-01-0dd7980fd1ce8117664b0539]
Examiner Not Required to Have Signatory Authority
Note:
An examiner can be named as an authorized officer on the written opinion without needing signatory authority, but the file copy must be signed by an examiner with partial signatory authority.

Pursuant to PCT Rules 43bis.1 and 70.14, the written opinion of the International Searching Authority must indicate the name of the officer of the International Searching Authority responsible for the written opinion, i.e., the “authorized officer.” An “authorized officer” is the person who actually performed the search work and prepared the search report and the written opinion, or another person who was responsible for supervising the search and the establishment of the written opinion. See PCT Administrative Instructions Section 514. Thus, an examiner need not have signatory authority in order to be named as an authorized officer on the written opinion. However, the “file copy” of the written opinion must be signed by an examiner having at least partial signatory authority.

Jump to MPEP SourceWritten Opinion of ISASignatory Authority ReviewAllowance Quality Review
Topic

35 U.S.C. 102 – Novelty / Prior Art

3 rules
StatutoryRequiredAlways
[mpep-1845-01-bad93cecfd75bd729039a6d0]
Claims Must Be Clear for Written Opinion Consideration
Note:
If claims are clear enough to form a meaningful opinion, the examiner must consider them and render an opinion on novelty, inventive step, and industrial applicability.

If the lack of clarity of the claims, the description, or the drawings is of such a nature that it is possible to form a meaningful opinion on the claimed subject matter, then it is required that the examiner consider the claims and render a written opinion on novelty, inventive step, and industrial applicability in Box No. V.

Jump to MPEP SourceNovelty / Prior Art
MPEP GuidanceInformativeAlways
[mpep-1845-01-8a3a5b0ba8580c7b5815eadb]
Claims Must Have Industrial Applicability but Lack Novelty and Inventive Step
Note:
If claims are industrially applicable but lack novelty and inventive step, use form paragraph 4 and additionally use form paragraph 18.01.

4. If the claims have industrial applicability but lack novelty and inventive step, use this form paragraph and additionally use form paragraph 18.01.

MPEP § 1845.01Novelty / Prior Art
MPEP GuidanceRequiredAlways
[mpep-1845-01-6de004e5581ab051107e35ac]
Reasons for Lack of Novelty, Inventive Step, or Industrial Applicability Must Be Given
Note:
If an examiner determines that claims lack novelty, inventive step, or industrial applicability, specific reasons similar to those used in U.S. national applications must be provided.

If, on the other hand, it is the opinion of the examiner that some or all claims lack novelty, inventive step, or industrial applicability, specific reasons must be given similar to those used in U.S. national applications.

Jump to MPEP SourceNovelty / Prior Art
Topic

International Filing Date

2 rules
StatutoryPermittedAlways
[mpep-1845-01-e6ef61bdb41f2e215edfb063]
Written Opinion Requirement for Pre-July 2022 Filings
Note:
Provides guidance on using the January 2019 version of PCT/ISA/237 for international applications filed before July 1, 2022.

[Editor Note: This section discusses the July 2022 version of PCT/ISA/237. For international applications having an international filing date before July 1, 2022, information regarding form PCT/ISA/237 (revised January 2019) may be found in §1845.01 of the 10.2019 revision of the Ninth Edition of the MPEP published June 2020 at: www.uspto.gov/web/offices/pac/mpep/old/ mpep_E9R10.htm.]

Jump to MPEP Source · 37 CFR 1845.01International Filing DateInternational Searching Authority (ISA)Request Content and Form
StatutoryRequiredAlways
[mpep-1845-01-b98c91efad7258bf268b05af]
Sequence Listing Must Be Filed Before International Filing Date
Note:
The examiner must indicate if the sequence listing was filed with the international application or after, and whether it includes a statement that it does not exceed the initial filing.

With respect to Box No. I, item 3 of Form PCT/ISA/237, if the opinion has been based on a nucleotide and/or amino acid sequence disclosed and necessary to the claimed invention, the examiner must indicate whether the sequence listing was filed as part of the international application or subsequent to the international filing date for the purpose of international search, and whether it was accompanied by the required statement to the effect that the sequence listing does not go beyond the disclosure in the international application as filed, if filed subsequent to the international filing date.

Jump to MPEP SourceInternational Filing DateEffect of International FilingInternational Searching Authority (ISA)
Topic

Patent Cooperation Treaty

2 rules
StatutoryInformativeAlways
[mpep-1845-01-9d8acd8ca1cb810483238c6c]
Examiner May Request Priority Document Copy From IB
Note:
The examiner can request a copy of the foreign priority document from the International Bureau unless it has not yet received the document. If the document is not in English, the applicant must provide a translation within two months.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourcePatent Cooperation TreatyRequest Content and FormPCT Request Form
StatutoryInformativeAlways
[mpep-1845-01-220713721abb9f3153396707]
Claims Must Be Clearly Described
Note:
The claims must be supported by a clear description to ensure that the novelty, inventive step, and industrial applicability can be assessed.

If the claims, the description, or the drawings are so unclear, or the claims are so inadequately supported by the description, that no meaningful opinion can be formed on the question of novelty, inventive step (nonobviousness) or industrial applicability, the applicant is so informed in Box No. III. See PCT Article 34(4)(a)(ii). Reasons for the examiner’s opinion that the claims, description and drawings, etc., lack clarity must also be provided.

Jump to MPEP SourcePatent Cooperation TreatyArticle 19 Amendment ScopePCT Description Requirements
Topic

Interviews in National Stage

1 rules
StatutoryPermittedAlways
[mpep-1845-01-66ca4aea8188faeab3291b0d]
Examiner Can Consult QA Specialist for Priority Document Copy
Note:
The examiner may seek assistance from the Technology Center Quality Assurance Specialist or PCT Special Program Examiner when requesting a copy of a foreign priority document from the International Bureau.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourceInterviews in National StagePriority Claim in PCTQuality Assurance Specialist Review
Topic

Article 19 Amendment Timing

1 rules
StatutoryPermittedAlways
[mpep-1845-01-17e7bfca2d6e40c3f313bc87]
Priority Document Translation Required Within Two Months
Note:
If the priority document is not in English, the examiner may invite the applicant to provide a translation within two months.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourceArticle 19 Amendment TimingInterviews in National StagePriority Claim in PCT
Topic

Priority Claim in PCT

1 rules
StatutoryPermittedAlways
[mpep-1845-01-219a87228e84c5ba137414b1]
Invitation for Priority Document and Translation
Note:
Examiner may invite applicant to provide a copy of the priority document and/or its translation if not in English within two months.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourcePriority Claim in PCTRequest Content and FormSignature Requirements
Topic

Article 34 Amendments

1 rules
StatutoryPermittedAlways
[mpep-1845-01-565966c98182c8eca11948c6]
Priority Claim Valid Even Without Copy or Translation
Note:
The written opinion will be based on the valid priority claim even if the document and/or translation have not been provided, but failure to provide them in time may invalidate further opinions.

If the examiner needs a copy of a foreign priority document, the copy will be supplied on request to the International Bureau (IB) unless the IB has not yet received the priority document, in which case the examiner may invite the applicant to furnish such a copy. See PCT Rule 66.7(a). The examiner may consult with the Technology Center Quality Assurance Specialist or PCT Special Program Examiner regarding requesting a copy of the priority document from the IB. If the priority document is not in English, the examiner may invite the applicant to furnish a translation of the priority document within two months of the invitation. See PCT Rule 66.7(b). Box No. II, item 3, “Additional Observations” may be used to invite applicant to supply a copy of the priority document and/or translation. Preparation of the written opinion by the International Searching Authority should not be delayed to await a response to the invitation. The written opinion of the ISA will ordinarily be established as if the priority claim had been validly claimed even though the copy and/or translation has not been furnished. However, failure to timely furnish a copy of the priority document and/or translation may result in any further written opinion or international preliminary examination report of the International Preliminary Examining Authority being established as if the priority had not been claimed.

Jump to MPEP SourceArticle 34 AmendmentsInternational Preliminary Examining Authority (IPEA)International Searching Authority (ISA)
Topic

Sequence Listing in PCT

1 rules
StatutoryRequiredAlways
[mpep-1845-01-15393b2152682d969563e1f6]
Requirement for Sequence Listing Compliance
Note:
The examiner must indicate if the sequence listing does not comply with WIPO Standard ST.26 or if the late furnishing fee was not paid.

If a meaningful opinion could not be formed without the nucleotide and/or amino acid sequence listing because it does not comply with WIPO Standard ST.26, and/or the applicant did not pay the late furnishing fee, if required, the examiner must indicate the reason for the non-compliance.

Jump to MPEP SourceSequence Listing in PCTWritten Opinion of ISARequest Content and Form

Examiner Form Paragraphs

Examiner form paragraphs are standard language that you might see in an Office Action or communication from the USPTO. Examiners have latitude to change the form paragraphs, but you will often see this exact language.

¶ 18.02 ¶ 18.02 Lacks Inventive Step – One Reference
¶ 18.03 ¶ 18.03 Lacks Industrial Applicability
¶ 18.08 ¶ 18.08 Drawing – Defect in Form or Contents Thereof

The drawings contain the following defect(s) in the form or content thereof: [1]

Examiner Note

In bracket 1, insert identification of defects in drawings.

¶ 18.09 ¶ 18.09 Description – Defect in Form or Contents Thereof

The description contains the following defect(s) in the form or contents thereof: [1]

Examiner Note

In bracket 1, insert the technical problem, e.g., misspelled word.

¶ 18.10 ¶ 18.10 Claims – Defect in Form or Contents Thereof

Claim [1] contain(s) the following defect(s) in the form or contents thereof: [2]

Citations

Primary topicCitation
International Filing Date
International Searching Authority (ISA)
37 CFR § 1845.01
Article 19 Amendment Scope
International Searching Authority (ISA)
MPEP § 1878.01(a)(1)
35 U.S.C. 102 – Novelty / Prior ArtForm Paragraph § 18.01
Article 19 Amendment ScopeForm Paragraph § 18.03
Article 19 Amendment ScopeForm Paragraph § 18.04
Article 19 Amendment ScopeForm Paragraph § 18.04.01
Article 19 Amendment ScopePCT Rule 26bis.2(b)
Article 19 Amendment ScopePCT Article 33(2)
Article 19 Amendment Scope
Patent Cooperation Treaty
PCT Article 34(4)(a)(ii)
International Searching Authority (ISA)
Written Opinion of ISA
PCT Rules 43bis.1
International Searching Authority (ISA)
Written Opinion of ISA
PCT Administrative Instructions Section 514
Article 19 Amendment ScopePCT Rule 6.4
Article 19 Amendment Scope
Article 19 Amendment Timing
Article 34 Amendments
International Searching Authority (ISA)
Interviews in National Stage
Patent Cooperation Treaty
Priority Claim in PCT
PCT Rule 66.7(b)
International Searching Authority (ISA)PCT Rule 91

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2025-12-31