1893.03 Prosecution of U.S. National Stage Applications Before the Examiner [R-07.2015]
37 C.F.R. 1.496 Examination of international applications in the national stage.
National stage applications having paid therein the search fee as set forth in § 1.492(b)(1) and examination fee as set forth in § 1.492(c)(1) may be amended subsequent to the date of commencement of national stage processing only to the extent necessary to eliminate objections as to form or to cancel rejected claims. Such national stage applications will be advanced out of turn for examination.
An international application which enters the national stage will be forwarded to the appropriate Technology Center (TC) for examination in turn based on the date of entry into the national stage. See MPEP § 1893.01(a). This is commonly referred to as the "35 U.S.C. 371(c)" date of the application.
If an international preliminary examination report (IPER) prepared by the United States International Preliminary Examining Authority or a written opinion on the international application prepared by the United States International Searching Authority states that the criteria of novelty, inventive step (non-obviousness), and industrial applicability, as defined in PCT Article 33(1) - (4) have been satisfied for all of the claims presented in the application entering the national stage, the national stage search fee is reduced and the national stage examination fee is reduced. See 37 CFR 1.492(b)(1) and 37 CFR 1.492(c)(1). Such applications may be amended only to the extent necessary to eliminate objections as to form or cancel rejected claims, and they will be advanced out of turn for examination. See MPEP § 708 for a discussion of the order of examination of applications by examiners.
Once the national stage application has been taken up by the examiner, prosecution proceeds in the same manner as for a domestic application with the exceptions that:
- (A) the international filing date (or, if appropriate, the priority date) is the date to keep in mind when searching the prior art; and
- (B) unity of invention proceeds as under 37 CFR 1.475.
1893.03(a) How To Identify That an Application Is a U.S. National Stage Application [R-08.2017]
Applicant’s initial submission under 35 U.S.C. 371 must be identified as a submission to enter the national stage under 35 U.S.C. 371. See 37 CFR 1.495(g). If the initial submission does not include any indication that the submission is made under 35 U.S.C. 371, the application will be treated as an application filed under 35 U.S.C. 111(a) (unless the submission is clearly identified as a submission pursuant to 35 U.S.C. 154(d)(4) for the purpose of obtaining provisional rights). See 37 CFR 1.417. Thus, if applicant wishes the application to be treated as a filing under 35 U.S.C. 111(a), the originally filed application papers need indicate simply that the papers are for a new U.S. patent application. If, however, applicant is submitting papers for entry into the national stage of a PCT application, or to establish an effective date for provisional rights resulting from the filing of a PCT application under 35 U.S.C. 154(d), applicant must so state.
When filing an application via EFS-Web, the EFS-Web screen prompts applicant for the type of filing being made, e.g., "nonprovisional application under 35 U.S.C. 111(a) " or "U.S. National Stage Under 35 U.S.C. 371." Identifying the type of filing as a national stage submission under 35 U.S.C. 371 on this screen will serve to identify the submission as a national stage submission under 35 U.S.C. 371. Applicants seeking to enter the national stage are also advised to use transmittal Form PTO-1390, as this form clearly indicates that the submission is under 35 U.S.C. 371. The inclusion with the initial application submission of an inventor’s oath or declaration identifying the international application by international application number as the application to which the oath or declaration is directed is considered an indication that the application was submitted under 35 U.S.C. 371. However, claiming priority of an international application in an oath or declaration will not serve to indicate a submission under 35 U.S.C. 371.
Examination of the original application papers occurs in the Office of Patent Application Processing (OPAP) where it is determined whether applicant has asked that the papers be treated as a submission to enter the national stage under 35 U.S.C. 371. If the application is accepted for entry into the national stage, the image file wrapper will contain a "Notification of Acceptance of Application Under 35 U.S.C. 371 and 37 CFR 1.495" (Form PCT/DO/EO/903) indicating acceptance of the application as a national stage submission under 35 U.S.C. 371. PALM records will indicate that the application is a national stage entry of the PCT application (e.g., under "Continuity Data"). Initially, the examiner should check the application file for the presence of Form PCT/DO/EO/903 and review the PALM Bib-data sheet for an indication that the application is a national stage entry (371) of the PCT application. If neither of these indications are present, in the absence of evidence to the contrary (i.e., an indication in the originally filed application papers that processing as a national stage is desired), the application may be treated as a filing under 35 U.S.C. 111(a). If both indications are present, the application should be treated as a submission under 35 U.S.C. 371.
The examiner is advised to consult the International Patent Legal Administration if he or she has any question as to whether the application should be treated under 35 U.S.C. 111(a) or 371.
Where applicant’s initial submission under 35 U.S.C. 371 contains conflicting instructions as to whether the filing is under 35 U.S.C. 111(a) or 35 U.S.C. 371, the application will be treated in accordance with 37 CFR 1.495(g). Note that 37 CFR 1.495(g) in effect prior to September 16, 2012, provided that an application submission containing conflicting instructions as to treatment under 35 U.S.C. 371 or 111(a) was to be treated under 35 U.S.C. 111(a). However, 37 CFR 1.495(g) was amended with effect on September 16, 2012 to provide that conflicting indications will result in the application being treated as a national stage submission under 35 U.S.C. 371.
A conflicting instruction will be present, for example, where applicant, in the initial submission under 35 U.S.C. 371, selects "Nonprovisional Application under 35 U.S.C. 111(a) " as the utility application type when submitting the application in EFS-Web, includes a "Utility Patent Application Transmittal" (Form PTO/AIA/15 or PTO/SB/05), or includes a benefit claim under 35 U.S.C. 120 to the international application. As additional examples, a conflicting instruction will be present where applicant includes in an initial filing under 35 U.S.C. 111(a) a "Transmittal Letter To The United States Designated/Elected Office (DO/EO/US) Concerning A Submission Under 35 U.S.C. 371 " (Form PTO-1390) or an indication (for example, on the application data sheet) that the application is the national stage (or 371) of an international application.
The examiner is advised to contact the International Patent Legal Administration if he or she has any question as to whether an application has been properly treated, or should have been treated, as a national stage application under 35 U.S.C. 371.
1893.03(b) The Filing Date of a U.S. National Stage Application [R-07.2015]
An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Specifically, 35 U.S.C. 363 provides that
An international application designating the United States shall have the effect, from its international filing date under Article 11 of the treaty, of a national application for patent regularly filed in the Patent and Trademark Office.
Similarly, PCT Article 11(3) provides that
...an international filing date shall have the effect of a regular national application in each designated State as of the international filing date, which date shall be considered to be the actual filing date in each designated State.
National stage applications are ordinarily taken up for action based on the date of entry into the national phase. See MPEP § 1893.01 regarding entry into the national stage. Because the date of entry is dependent upon receipt of certain items required under 35 U.S.C. 371(c), this date is also referred to as the "371(c) date." The 371(c) date, not the international filing date, is the date that appears in the "Filing or 371(c) Date" box on the filing receipt and the application data sections of PALM and PAIR.
The NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495 (Form PCT/DO/EO/903) indicates the 371(c) date of the national stage application. Because of changes implemented pursuant to the America Invents Act (AIA), and in particular, the ability to postpone the submission of the oath or declaration required under 35 U.S.C. 371(c)(4) under certain conditions, the requirements for entry into the national stage, and thus the determination of the 371(c) date, are different based on the international filing date of the national stage application. See MPEP § 1893.03. Form PTO/DO/EO/903 in a national stage application having an international filing date prior to September 16, 2012 identifies the 371(c) date as the date of receipt of the 35 U.S.C. 371(c)(1), (c)(2), and (c)(4) requirements, while Form PTO/DO/EO/903 in a national stage application having an international filing date on or after September 16, 2012 identifies the 371(c) date as the date of receipt of the 371(c)(1) and (c)(2) requirements. Filing receipts are mailed concurrently with the mailing of the Form PCT/DO/EO/903.
The "Date of Completion of all 35 U.S.C. 371 Requirements" included on the NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495 (Form PCT/DO/EO/903) in pre-AIA national stage applications is relevant for purposes of patent term adjustment under former 35 U.S.C. 154(b)(1)(A)(i)(II) when the Office has failed to mail at least one of a notification under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 151 not later than fourteen months after the date on which the requirements under 35 U.S.C. 371 were fulfilled. This date is the latest of:
- (A) the date of submission of the basic national fee;
- (B) the date of submission or communication of the copy of the international application;
- (C) the date of submission of the translation of the international application if the international application is not in the English language;
- (D) the date of submission of an oath or declaration of the inventor in compliance with 35 U.S.C. 371(c)(4);
- (E) the earlier of 30 months from the priority date or the date of request for early processing under 35 U.S.C. 371(f) if requested prior to 30 months from the priority date (Form PCT/DO/EO/903 will indicate the date early processing was requested);
- (F) if a request for early processing has not been requested prior to 30 months from the priority date, the date of submission of any translation of the annexes to the international preliminary examination report if the translation of the annexes are filed within the time period set in a Notification of Missing Requirements (Form PCT/DO/EO/905) requiring either an English translation of the international application or an oath or declaration; and
- (G) the date of submission of any surcharge for submitting the oath or declaration later than 30 months from the priority date.
The AIA Technical Corrections Act, enacted on January 14, 2013, amended 35 U.S.C. 154(b)(1)(A)(i)(II) to change "the date on which an international application fulfilled the requirements of section 371" to "the date of commencement of the national stage under section 371 in an international application." See Public Law 112-274, 126 Stat. 2456 (2013). Thus, under the AIA Technical Corrections Act, the fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i) for a national stage application is measured from the date of commencement of the national stage under 35 U.S.C. 371 in an international application.
1893.03(c) The Priority Date, Priority Claim, and Priority Papers for a U.S. National Stage Application [R-10.2019]
A U.S. national stage application may be entitled to: (A) a right of priority under 35 U.S.C. 119(a) and 365(b) based on a prior foreign application or international application designating at least one country other than the United States; and (B) the benefit of an earlier filed U.S. national application or international application designating the United States pursuant to 35 U.S.C. 119(e) or 35 U.S.C. 120 and 365(c).
Pursuant to 35 U.S.C. 365(b) a U.S. national stage application shall be entitled to a right of priority based on a prior foreign application or international application designating at least one country other than the United States in accordance with the conditions and requirements of 35 U.S.C. 119(a) and the treaty and the PCT regulations. See in particular PCT Article 8 and PCT Rules 4.10 and 26bis. To obtain priority in the U.S. national stage application to such applications, the priority must have been timely claimed in the international stage of the international application. See 37 CFR 1.55(d)(2). In the event that a claim of foreign priority is not timely made in the international stage, the priority claim may be made in the U.S. national stage application upon petition under 37 CFR 1.55(e), if the entire delay between the date the priority claim was due under PCT Rule 26bis and the date the claim is filed is unintentional.
Note that in U.S. national stage applications it is permissible, but not required, to present the claim for priority in an application data sheet. A proper claim for priority will be acknowledged (subject to the paragraph below) and the national stage application file will then be checked to see if the file contains a copy of the certified copy of the priority document submitted to the International Bureau. See subsection II below for further information concerning the certified copy of the priority document.
International applications filed on or after April 1, 2007 are subject to amended PCT Rules permitting restoration of a right of priority. See MPEP § 1828.01. Consequently, international applications filed on or after April 1, 2007 may claim priority to a foreign application filed more than 12 months before the filing date of the international application. Such a priority claim will be effective in the U.S. national stage if the right of priority has been restored under PCT Rule 26bis.3 during the international stage. See 37 CFR 1.55(c).
Furthermore, the right of priority may be restored in a U.S. national stage application upon petition under 37 CFR 1.55(c). Restoration of the right of priority upon petition under 37 CFR 1.55(c) is not limited to applications having an international filing date of April 1, 2007 or later. It should be noted that where a petition under 37 CFR 1.55(c) is necessary to restore the right of priority in a U.S. national stage application, a petition under 37 CFR 1.55(e) to add a delayed priority claim will also be required where the priority claim was not properly made within the time limit set forth in the PCT and the Regulations under the PCT. 37 CFR 1.55(d)(2).
For a comparison with 35 U.S.C. 119(a) - (d) priority claims in a national application filed under 35 U.S.C. 111(a), see MPEP § 1895.01.
The requirement in PCT Rule 17 for a certified copy of the foreign priority application is normally fulfilled by applicant providing a certified copy to the receiving Office or to the International Bureau, or by applicant requesting the receiving Office to prepare and transmit the priority document to the International Bureau if the receiving Office issued the priority document, or by applicant requesting the International Bureau to obtain the priority document from a digital library. Pursuant to PCT Rule 17.1(a), (b) or (b-bis), applicant must submit the certified copy, request the receiving Office to prepare and transmit the certified copy or request the International Bureau to obtain the priority document from a digital library, within 16 months from the priority date. Where applicant has complied with PCT Rule 17, the International Bureau will forward a copy of the certified priority document to each Designated Office that has requested such document with an indication that the priority document was submitted in compliance with the rule and the date the document was received by the International Bureau. This indication may be in the form of either a cover sheet attached to the copy of the priority document or a WIPO stamp on the face of the certified copy. The U.S. Patent and Trademark Office, as a Designated Office, will normally request the International Bureau to furnish the copy of the certified priority document upon receipt of applicant’s submission under 35 U.S.C. 371 to enter the U.S. national phase. The copy from the International Bureau is placed in the U.S. national stage file. The copy of the priority document received from the International Bureau with either of the indications above is acceptable to establish that applicant has filed a certified copy of the priority document in compliance with 37 CFR 1.55(f). The examiner should acknowledge in the next Office action that the copy of the certified copy of the foreign priority document has been received in the national stage application from the International Bureau.
On the following pages, note the examples of acceptable indications in the form of:
- (A) a cover sheet indicating receipt by the International Bureau on 12 April 2018 (12.04.2018) and compliance with PCT Rule 17.1(a), (b) or (b-bis) in the "Remark" section; and
- (B) the stamp (box) in the upper right hand section indicating receipt by the International Bureau (WIPO) on 30 December 2002 and the stamped indication "PRIORITY DOCUMENT SUBMITTED OR TRANSMITTED IN COMPLIANCE WITH RULE 17.1(a) OR (b)."


If the International Bureau is unable to forward a copy of the certified priority document to the U.S. Patent and Trademark Office, then applicant must provide a certified copy of the priority document during the national stage, unless the requirements of 37 CFR 1.55(h) or 37 CFR 1.55(i) have been met. For international applications in which the U.S. national stage commenced under 35 U.S.C. 371 on or after December 18, 2013, applicant must submit the certified copy within the later of four months from the date of entry into the U.S. national stage as set forth in 37 CFR 1.491 or sixteen months from the filing date of the prior-filed foreign application. See 37 CFR 1.55(f)(2). A delay in filing the certified copy under 37 CFR 1.55(f)(2) may be excused upon petition under 37 CFR 1.55(f)(3). The International Bureau may not forward a copy of the priority document because the certified priority document was not furnished in compliance with PCT Rule 17.1(a), (b) or (b-bis) or applicant requested examination to begin pursuant to 35 U.S.C. 371(f) prior to availability of the priority document from the International Bureau. If the priority claim was not in accordance with PCT Rule 4.10 or the priority document was not provided in accordance with PCT Rule 17.1(a), (b) or (b-bis), the copy of the priority document will not have been provided by the International Bureau. If a copy of the foreign priority document is not in the national stage application file but applicant asserts that a certified copy of the priority document was timely furnished under PCT Rule 17 in the international phase, then the examiner should consult with a Quality Assurance Specialist in his or her Technology Center or a PCT Special Program Examiner.
A national stage application may include a benefit claim under 35 U.S.C. 119(e), or 120 and 365(c) to a prior U.S. national application or under 35 U.S.C. 120 and 365(c) to a prior international application designating the U.S. The conditions for according benefit under 35 U.S.C. 120 are as described in MPEP §§ 201.07, 201.08, and 211 et seq. and are similar regardless of whether the U.S. national application is a national stage application submitted under 35 U.S.C. 371 or a national application filed under 35 U.S.C. 111(a).
The conditions for according benefit of a provisional application under 35 U.S.C. 119(e) are also similar for national stage applications and applications filed under 35 U.S.C. 111(a), and the conditions are described in MPEP § 211.01(a).
In order for a national stage application (of international application "X") to obtain benefit under 35 U.S.C. 119(e) of a prior U.S. provisional application, the national stage application must comply with the requirements set forth in 37 CFR 1.78(a). 37 CFR 1.78(a)(2) requires that the prior provisional application must be entitled to a filing date as set forth in 37 CFR 1.53(c), and the basic filing fee set forth in 37 CFR 1.16(d) must be paid on the provisional application within the time period set forth in 37 CFR 1.53(g). Additionally, the provisional application must name as an inventor at least one inventor named in the later filed international application "X" and disclose the named inventor’s invention claimed in at least one claim of the national stage application in the manner provided by the first paragraph of 35 U.S.C. 112. The national stage application must contain a reference to the provisional application identifying it as a provisional application, and including the provisional application number (series code and serial number). If the national stage application has an international filing date prior to September 16, 2012, then the reference must be in either an application data sheet (37 CFR 1.76 ) or in the first sentence(s) of the specification. See pre-AIA 37 CFR 1.78(a)(5)(iii). If the national stage application has an international filing date that is on or after September 16, 2012, then the reference must be in an application data sheet (37 CFR 1.76 ). See 37 CFR 1.78(a)(3). However, the requirement for inclusion of the benefit claim in an application data sheet will be satisfied in a U.S. national stage application by the presentation of such benefit claim in the PCT request form contained in the international application or the presence of such benefit claim on the front page of the published international application. See 37 CFR 1.76(g). The required reference to the earlier provisional application must be submitted within the time period provided by 37 CFR 1.78(a)(4). This time period is not extendable. However, if the entire delay, between the date the claim was due under 37 CFR 1.78(a)(4) and the date the claim was filed, was unintentional, a petition under 37 CFR 1.78(c) may be filed to accept the delayed claim. If the provisional application was filed in a language other than English, an English-language translation of the non-English language provisional application and a statement that the translation is accurate will be required. See MPEP § 211.01(a). If the translation and statement that the translation is accurate were not filed in the provisional application or in the later-filed national stage application before November 25, 2005, applicant will be notified and given a period of time within which to file an English-language translation and a statement that the translation is accurate in the provisional application, and a reply in the national stage application that the translation and statement were filed in the provisional application. Failure to timely reply to such a notice will result in abandonment of the national stage application. See 37 CFR 1.78(a)(5).
Public Law 106-113 amended 35 U.S.C. 119(e) to eliminate the copendency requirement for a nonprovisional application claiming benefit of a provisional application. 35 U.S.C. 119(e)(2) as amended became effective on November 29, 1999 and applies to provisional applications filed on or after June 8, 1995. An international application claiming benefit under 35 U.S.C. 365(c) and 35 U.S.C. 119(e) to a prior filed provisional application must be filed within twelve months of the filing date of the provisional application. The Director may extend the twelve month statutory period by an additional two months in situations where the failure to file the international application under 35 U.S.C. 363 was unintentional. See 35 U.S.C. 119(e).
International applications filed on or after April 1, 2007 are subject to amended PCT Rules permitting restoration of a right of priority. See MPEP § 1828.01. Consequently, international applications filed on or after April 1, 2007 may claim the benefit of a provisional application filed more than 12 months before the filing date of the international application. Such a benefit claim will be effective in the U.S. national stage if the benefit of the provisional application has been restored under PCT Rule 26bis.3 during the international stage. See 37 CFR 1.78(b).
Furthermore, the benefit of a provisional application may be restored in a U.S. national stage application upon petition under 37 CFR 1.78(b). Restoration of the benefit of a provisional application upon petition under 37 CFR 1.78(b) is not limited to applications having an international filing date of April 1, 2007 or later. It should be noted that where a petition under 37 CFR 1.78(b) is necessary to restore the benefit of a provisional application in a U.S. national stage application, a petition under 37 CFR 1.78(c) to add a delayed benefit claim will also be required, unless the benefit claim was timely made under 37 CFR 1.78(a)(4) (which includes, inter alia, making the benefit claim during the international stage).
In order for a national stage application (of international application "X") to obtain benefit under 35 U.S.C. 120 and 365(c) of a prior filed copending nonprovisional application or prior filed copending international application designating the United States of America, the national stage application must comply with the requirements set forth in 37 CFR 1.78(d). The prior nonprovisional application or international application must name as an inventor at least one inventor named in the later filed international application "X" and disclose the named inventor’s invention claimed in at least one claim of the national stage application in the manner provided by the first paragraph of 35 U.S.C. 112. The national stage application must contain a reference to the prior nonprovisional or international application identifying it by application number (series code and serial number) or international application number and international filing date and indicating the relationship of the applications. If the national stage application has an international filing date prior to September 16, 2012, then the reference must be in either an application data sheet (37 CFR 1.76 ) or in the first sentence(s) of the specification. See pre-AIA 37 CFR 1.78(a)(2)(iii). If national stage application has an international filing date that is on or after September 16, 2012, then the reference must be in an application data sheet (37 CFR 1.76 ). See 37 CFR 1.78(d)(2). However, the requirement for inclusion of the benefit claim in an application data sheet will be satisfied in a U.S. national stage application by the presentation of such benefit claim in the PCT Request form contained in the international application or the presence of such benefit claim on the front page of the published international application. See 37 CFR 1.76(g). The required reference to the earlier filed application must be submitted within the time period set forth in 37 CFR 1.78(d)(3). This time period is not extendable and failure to timely submit the required reference to the earlier application will be considered a waiver of any benefit under 35 U.S.C. 120, 121, or 365(c) to such prior-filed application. See 37 CFR 1.78(d)(3). However, if the entire delay, between the date the claim was due under 37 CFR 1.78(d)(3) and the date the claim was filed, was unintentional, a petition under 37 CFR 1.78(e) may be filed to accept the delayed claim.
A prior filed nonprovisional application is copending with the national stage application if the prior U.S. national application was pending on the international filing date of the national stage application.
A prior-filed international application designating the United States of America is copending with the national stage application if the prior international application was not abandoned or withdrawn, either generally or as to the United States, on the international filing date of the national stage application.
Note: a national stage application submitted under 35 U.S.C. 371 may not claim benefit of the filing date of the international application of which it is the national stage since its filing date is the international filing date of the international application. See also MPEP § 1893.03(b). Stated differently, since the international application is not an earlier application (it has the same filing date as the national stage), a benefit claim under 35 U.S.C. 120 in the national stage to the international application is inappropriate.
For a comparison with 35 U.S.C. 120 benefit claims in a national application filed under 35 U.S.C. 111(a), see MPEP § 1895.
1893.03(d) Unity of Invention [R-08.2017]
37 C.F.R. 1.499 Unity of invention during the national stage
If the examiner finds that a national stage application lacks unity of invention under § 1.475, the examiner may in an Office action require the applicant in the response to that action to elect the invention to which the claims shall be restricted. Such requirement may be made before any action on the merits but may be made at any time before the final action at the discretion of the examiner. Review of any such requirement is provided under §§ 1.143 and 1.144.
PCT Rule 13 was amended effective July 1, 1992. 37 CFR 1.475 was amended effective May 1, 1993 to correspond to PCT Rule 13.
Examiners are reminded that unity of invention (not restriction practice pursuant to 37 CFR 1.141 - 1.146 ) is applicable in international applications (both Chapter I and II) and in national stage applications submitted under 35 U.S.C. 371. Restriction practice in accordance with 37 CFR 1.141 -1.146 continues to apply to U.S. national applications filed under 35 U.S.C. 111(a), even if the application filed under 35 U.S.C. 111(a) claims benefit under 35 U.S.C. 120 and 365(c) to an earlier international application designating the United States or to an earlier U.S. national stage application submitted under 35 U.S.C. 371.
The sections of the MPEP relating to double patenting rejections (MPEP § 804), election and reply by applicant (MPEP § 818), and rejoinder of nonelected inventions (MPEP § 821.04) generally also apply to national stage applications submitted under 35 U.S.C. 371. See MPEP § 823.
When making a unity of invention requirement, the examiner must (1) list the different groups of claims and (2) explain why each group lacks unity with each other group (i.e., why there is no single general inventive concept) specifically describing the unique special technical feature in each group.
The principles of unity of invention are used to determine the types of claimed subject matter and the combinations of claims to different categories of invention that are permitted to be included in a single international or national stage patent application. See MPEP § 1850 for a detailed discussion of Unity of Invention. The basic principle is that an application should relate to only one invention or, if there is more than one invention, that applicant would have a right to include in a single application only those inventions which are so linked as to form a single general inventive concept.
A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art. For example, a corresponding technical feature is exemplified by a key defined by certain claimed structural characteristics which correspond to the claimed features of a lock to be used with the claimed key. Note also the examples contained in Chapter 10 of the International Search and Preliminary Examination Guidelines which can be obtained from the Patent Examiner’s Toolkit or WIPO’s website (www.wipo.int/pct/en/texts/gdlines.html ).
A process is "specially adapted" for the manufacture of a product if the claimed process inherently produces the claimed product with the technical relationship being present between the claimed process and the claimed product. The expression "specially adapted" does not imply that the product could not also be manufactured by a different process.
An apparatus or means is specifically designed for carrying out the process when the apparatus or means is suitable for carrying out the process with the technical relationship being present between the claimed apparatus or means and the claimed process. The expression specifically designed does not imply that the apparatus or means could not be used for carrying out another process, nor does it imply that the process could not be carried out using an alternative apparatus or means.
Note: the determination regarding unity of invention is made without regard to whether a group of inventions is claimed in separate claims or as alternatives within a single claim. The basic criteria for unity of invention are the same, regardless of the manner in which applicant chooses to draft a claim or claims.
If an examiner (1) determines that the claims do not meet the unity of invention requirement and (2) requires election of a single invention, when all of the claims drawn to the elected invention are allowable (i.e., meet the requirements of 35 U.S.C. 101, 102, 103 and 112 ), the nonelected invention(s) should be considered for rejoinder. Any nonelected product claim that requires all the limitations of an allowable product claim, and any nonelected process claim that requires all the limitations of an allowable process claim, should be rejoined. See MPEP § 821.04. Any nonelected processes of making and/or using an allowable product should be considered for rejoinder. The examiner should notify applicants of potential rejoinder of non-elected process claims by placing form paragraph 8.21.04 at the end of any lack of unity determination made between a product and a process of making the product or between a product and a process of using the product.
¶ 18.18 Heading for Lack of Unity Action in National Stage Applications Submitted Under 35 U.S.C. 371 (Including Species)
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475( a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept ("requirement of unity of invention"). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
- (1) A product and a process specially adapted for the manufacture of said product; or
- (2) A product and a process of use of said product; or
- (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
- (4) A process and an apparatus or means specifically designed for carrying out the said process; or
- (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
Examiner Note:
1. Begin all Lack of Unity actions in national stage applications submitted under 35 U.S.C. 371 (including species) with this heading.
2. Follow with form paragraph 18.19 or 18.20, as appropriate.
3. For lack of unity during the international phase, use form paragraph 18.05 instead of this form paragraph.
¶ 18.19 Restriction Requirement in National Stage Applications Submitted Under 35 U.S.C. 371 
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Examiner Note:
1. This form paragraph is to be used when making a restriction requirement in a national stage application submitted under 35 U.S.C. 371.
2. This form paragraph is to be followed by form paragraphs 18.06 - 18.06.02, as appropriate, and by form paragraphs 18.07 - 18.07.02, as appropriate.
3. All restriction requirements between a product/apparatus and a process of making the product/apparatus or between a product and a process of using the product should be followed by form paragraph 8.21.04 to notify the applicant that if all product/apparatus claims are found allowable, process claims that require all the limitations of the patentable product/apparatus should be considered for rejoinder.
4. When all of the claims directed to the elected invention are in condition for allowance, the propriety of the restriction requirement should be reconsidered to verify that the non-elected claims do not share a same or corresponding technical feature with the allowable claims.
¶ 8.21.04 Notice of Potential Rejoinder of Process Claims
The examiner has required restriction between product and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Examiner Note:
This form paragraph should appear at the end of any requirement for restriction between a process and a product/apparatus for practicing the process (see form paragraph 8.17), a product/apparatus and a process of making the product/apparatus (see form paragraph 8.18) or between a product/apparatus and a process of using the product/apparatus (see form paragraph 8.20). See MPEP § 821.04 for rejoinder practice.
¶ 18.20 Election of Species in National Stage Applications Submitted Under 35 U.S.C. 371 
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: [2].
Examiner Note:
1. This form paragraph is to be used when making an election of species requirement in a national stage application submitted under 35 U.S.C. 371.
2. In bracket 1, identify the species from which an election is to be made.
3. In bracket 2, identify each generic claim by number or insert the word --NONE--.
4. This form paragraph is to be followed by form paragraphs 18.07 - 18.07.03, as appropriate.
¶ 18.21 Election by Original Presentation in National Stage Applications Submitted Under 35 U.S.C. 371 
Newly submitted claim [1] directed to an invention that lacks unity with the invention originally claimed for the following reasons: [2]
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim [3] withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
¶ 18.22 Requirement for Election and Means for Traversal in National Stage Applications Submitted Under 35 U.S.C. 371
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143 ) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a) ), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Examiner Note:
1. This form paragraph should be used when requiring restriction (including an election of species) in an application that entered the national stage under 35 U.S.C. 371.
2. This form paragraph should follow form paragraph 8.23.01 when a telephone call was made that did not result in an election being made.
1893.03(e) Documents Received from the International Bureau and Placed in a U.S. National Stage Application File [R-10.2019]
The national stage application includes documents communicated by the International Bureau and submissions from applicant. Some of the documents from the International Bureau are identified in this section with a brief note as to their importance to the national stage application. The examiner should review each such document and the important aspect indicated.
The publication of the international application includes
- (A) a cover page with the applicant/inventor data, the application data (application number, filing date, etc.) and the Abstract (and, if appropriate, a figure of drawing),
- (B) the description, claims and drawing parts of the international application, and
- (C) the search report (Form PCT/ISA/210), if available.
The publication may also include other items as set forth in PCT Rule 48.
The cover page is important as a source of the correct application data, most importantly the filing date and priority date accorded to the international application. If the international application is published in English, the Office will use the description, claims, abstract and drawings as published in the pamphlet for the U.S. national stage application under 35 U.S.C. 371. The description, claims and drawing parts of the international application reflect the application subject matter on the international filing date and are important for comparison with any amendments to check for new matter. The search report reflects the International Searching Authority’s opinion regarding the prior art.
The abstract is reproduced on the cover page of the publication, even though it appears on a separate sheet of the international application in accordance with PCT Rule 11.4(a). The requirement of 37 CFR 1.52(b) that the abstract "commence on a separate physical sheet or electronic page" does not apply to the copy of the published international application communicated to the designated Offices by the International Bureau under PCT Article 20. Accordingly, it is improper for the examiner of the U.S. national stage application to require the applicant to provide an abstract commencing on a separate sheet if the abstract does not appear on a separate sheet in the publication of the international application. Unless the abstract is properly amended under the U.S. rules during national stage processing, the abstract that appears on the cover page of the published international application will be the abstract published by the USPTO under 35 U.S.C. 122(b) and in any U.S. patent issuing from the application.
II. THE INTERNATIONAL PRELIMINARY EXAMINATION REPORT AND THE INTERNATIONAL PRELIMINARY REPORT ON PATENTABILITY (CHAPTER I AND II) 
When an international preliminary examination is performed by an International Preliminary Examining Authority (IPEA), an international preliminary examination report (IPER) is prepared on Form PCT/IPEA/409 by the IPEA and sent to the elected Offices. This report reflects the IPEA’s non-binding opinion regarding novelty, inventive step and industrial applicability. The IPER bears the title "International Preliminary Report on Patentability (Chapter II of the Patent Cooperation Treaty)".
If the applicant did not timely file a demand for international preliminary examination with the IPEA, then an "International Preliminary Report on Patentability (Chapter I of the Patent Cooperation Treaty)" reflecting the International Searching Authority’s (ISA’s) non-binding opinion regarding novelty, inventive step and industrial applicability is sent to the designated Offices.
The examiner may adopt any portion or all of the report on patentability of the IPEA or ISA upon consideration in the national stage so long as it is consistent with U.S. practice. The first Office action on the merits should indicate the report on patentability of the IPEA or ISA has been considered by the examiner. The indication may be a mere acknowledgement.
The IPER may include annexes, i.e., amendments to the international application that were made during the international phase. See MPEP § 1893.01(a)(3). These annexes will be placed in the U.S. national stage application file. Consequently, if the international application has been extensively amended during the international stage, there may be a number of different copies of the description, claims and drawings present in the national stage application file. The IPER may be consulted in Box No. I "Basis of the report" to determine what pages the report was based upon. Using the IPER as a roadmap of what happened during Chapter II examination will help determine which version should be examined.
Original sheets, substitute sheets, rectified sheets, and sheets that were incorporated by reference and included as part of the application examined under Chapter II are listed in the IPER as "originally filed/furnished." Replacement sheets showing amendments made under PCT Article 19 or 34 and considered during Chapter II are also listed. See MPEP § 1879. If the IPER was established in a language other than English, the International Bureau will translate the IPER into English. However, the International Bureau will not translate the annexes to the IPER into English. Unless proper and timely translations are furnished by the applicant, foreign language annexes will be considered canceled. See MPEP § 1893.01(a)(3). All replacement sheets in the international application are marked with the international application number and the date of receipt in the upper right-hand corner. Replacement sheets that contain changes in format only and are accepted by the receiving Office are marked as "SUBSTITUTE SHEET" at the bottom of the page. Replacement sheets that contain a rectification of an obvious error or mistake and are accepted by either the ISA or the IPEA are marked as "RECTIFIED SHEET (RULE 91)" at the bottom of the page. Sheets that were incorporated by reference and accepted by the receiving Office are marked as "INCORPORATED BY REFERENCE (RULE 20.6)." Additionally, replacement sheets to the claims submitted to the International Bureau as Article 19 Amendments will be marked as "AMENDED SHEET (Article 19)" at the bottom of the page. Furthermore, replacement sheets to the description, claims and drawings submitted to the IPEA as Article 34 Amendments will be marked as "AMENDED SHEET" at the bottom of the page. The IPER will indicate in "Box No. I Basis of the Report" that claim numbers submitted under either PCT Article 19 or 34 have been considered and will indicate the date they were received and the replacement sheets will be annexed to the IPER. The NOTIFICATION OF ACCEPTANCE OF APPLICATION UNDER 35 U.S.C. 371 AND 37 CFR 1.495 (Form PCT/DO/EO/903) should also be consulted, as it will indicate if the annexes or their translation have not been entered.
See the discussion in MPEP § 1893.03(c).
If the national stage application papers include an indication that the international application or US designation has been withdrawn, then the application should be brought to the attention of the International Patent Legal Administration to determine whether the withdrawal occurred prior to completion of the requirements under 35 U.S.C. 371(c). If the withdrawal occurred prior to completion of the requirements under 35 U.S.C. 371(c), then entry into the U.S. national stage is prohibited. See 35 U.S.C. 366. The indication of withdrawal may appear on a Notification of Withdrawal (PCT/IB/307 or PCT/RO/136), a Notification that International Application Considered to Be Withdrawn (Form PCT/RO/117), or other notification.
1893.03(e)(1) Title of the Invention [R-08.2012]
In the absence of an application data sheet (37 CFR 1.76 ) or preliminary amendment changing the title, the Office will use the title of the invention that appears on the first page of the description of the published international application (if published under PCT Article 21 in English) or the title that appears on the first page of the description of the English translation of the international application (if not published under PCT Article 21 in English) in preparing the official filing receipt. If the title does not appear on the first page of the description, and an application data sheet or preliminary amendment changing the title has not been furnished, then the title will be taken from the cover page of the published international application. If applicant furnishes an application data sheet or preliminary amendment changing the title, the Office will use the title as indicated in such document in preparing the official filing receipt. If applicant submits both an application data sheet and a preliminary amendment, the later filed document will govern. See 37 CFR 1.76(d)(1). An application data sheet will govern over a concurrently filed preliminary amendment. See 37 CFR 1.76(d)(2).
1893.03(f) Drawings and PCT Rule 11 [R-08.2012]
The drawings for the national stage application must comply with PCT Rule 11. The USPTO may not impose requirements beyond those imposed by the Patent Cooperation Treaty (e.g., PCT Rule 11 ). However, the examiner does have the authority to require new drawings if the drawings were published without meeting all requirements under the PCT for drawings.
1893.03(g) Information Disclosure Statement in a National Stage Application [R-07.2015]
An extensive discussion of Information Disclosure Statement practice is to be found in MPEP § 609. Although not specifically stated therein, the duty to disclose information material to patentability as defined in 37 CFR 1.56 is placed on individuals associated with the filing and prosecution of a national stage application in the same manner as for a domestic national application. The averment with respect to the duty under 37 CFR 1.56 required under 37 CFR 1.63(b)(3) in an oath or declaration is applicable to oaths and declarations filed in U.S. national stage applications. See 37 CFR 1.497(c).
When an international application is filed under the Patent Cooperation Treaty (PCT), prior art documents may be cited by the examiner in the international search report and/or the international preliminary examination report. It is desirable for the U.S. examiner to consider the documents cited in the international application when examining the U.S. national stage application or when examining an application filed under 35 U.S.C. 111(a) which claims the benefit of the international application under 35 U.S.C. 365(a) or (c).
When all the requirements for a national stage application have been completed, applicant is notified (Form PCT/DO/EO/903) of the acceptance of the application under 35 U.S.C. 371, including an itemized list of the items received. The itemized list includes an indication of whether a copy of the international search report and copies of the references cited therein are present in the national stage file. The examiner will consider the documents cited in the international search report and any supplementary international search report under PCT Rule 45bis , without any further action by applicant under 37 CFR 1.97 and 1.98, when both the international search report (or supplementary international search report under PCT Rule 45bis ) and copies of the documents are indicated to be present in the national stage file. The examiner will note the consideration in the first Office action. There is no requirement that the examiners list the documents on a PTO-892 form. See form paragraphs 6.53, 6.54, and 6.55 (reproduced in MPEP § 609.03). Otherwise, applicant must follow the procedure set forth in 37 CFR 1.97 and 1.98 in order to ensure that the examiner considers the documents cited in the international search report.
This practice applies only to documents cited in the international search report relative to a national stage application filed under 35 U.S.C. 371. It does not apply to documents cited in an international preliminary examination report that are not cited in the search report. It does not apply to applications filed under 35 U.S.C. 111(a) claiming the benefit of an international application filing date.