On August 21, the US Patent and Trademark Office (USPTO) published a Final Rule in the Federal Register [72 FR 161, 46716-46843]. The Final Rule becomes effective November 1. 2007. It also is provided that for applications filed before November 1, applicants are to comply with the provisions of 37 C.F.R. 1.78(f)(1)/ (f)(2) within the applicable time periods specified in the rules or by February 1, 2008, which ever is later. The effect of these changes will be felt immediately notwithstanding the date the rules become effective.

The Final Rule includes provisions that:

  • limit the number of continuation (CON) or continuation-in-part (CIP) applications and request for continued examination (RCE) that can be filed as of right from an initial or divisional application; and require an applicant to justify the filing of any further CON/CIP applications and RCE to maintain the benefit of the earlier priority date;
  • require submission of an examination support document when an application or a group of related applications with patentably indistinct claims exceed a threshold limit of 5 independent and 25 total claims (the so-called 5/25 Rule);
  • require an applicant to identify to the USPTO all applications that are related to one another;
  • changes practice for continuation-in-part applications; and
  • re-defines divisional applications.

I. LIMITATIONS ON CON/CIP APPLICATIONS

(i) Filings permitted as a matter of right:

For applications filed on or after November 1, an applicant can file two CON/CIP applications in an initial application family and in each divisional application family as a matter of right. In addition, for an application being filed on or after November 1, 2007, an applicant can file one RCE in an initial application family and in each divisional application family as a matter of right. As used in the rules, the term “application family” means the initial/divisional application and the related CON or CIP applications.

For US non-provisional or reissue applications that were filed before August 21, 2007 and for PCT national stage applications that entered the national stage in the US before August 21, 2007, an applicant may file “one more” CON/ CIP application after November 1, 2007 without a petition and showing provided that no CON/CIP application(s) was filed between August 21, 2007 and November 1, 2007. This would be the case, even if the so-called “one more” continuing application would be the third or subsequent CON/CIP application being filed for the application family.

(ii) Additional filings available upon petition:

Applicant can file a third or subsequent CON or CIP application or a second or subsequent RCE; however, in most instances1 the applicant also must file:

(i) A petition in compliance with §1.78(d)(1)(vi) or 1.114(g);

(ii) The petition fee set forth in §1.17(f);

(iii)An amendment, argument, or evidence; and

(iv) A showing that the amendment, argument, or evidence sought to be entered could not have been submitted during the prosecution of the prior-filed application, or prior to the close of prosecution in the application. An amendment, argument, or evidence does include any new claims in a CON/CIP application, but does not include an IDS.

(iii) Consideration of petitions for additional filing:

If the showing under the petition is found to be insufficient, then the USPTO will refuse to enter the benefit claim as being improper. The USPTO also will refuse the benefit of the filing date of the prior-filed application, and as a result, the third or subsequent CON/CIP application or second or subsequent RCE will be treated as being entitled only to the actual filing date and therefore, will be subject to prior art based on the actual filing date of the application. For example, if the prior-filed application is published more than 1 year prior to the actual filing date of the third or subsequent CON/ CIP application or second or subsequent RCE, the publication of the prior-filed application can be used as prior art under 35 U.S.C. §102(b).

The petition for the third or subsequent CON/ CIP application or second or subsequent RCE will be decided on a case-by-case basis as to whether the showing is sufficient. The USPTO may review the prosecution history of the priorfiled application(s) or require additional information and also may consider the following factors in arriving at its decision.

(a) Whether applicant should have filed an appeal or a petition under §1.181 rather than a continuing application or an RCE. If the showing under §1.78(d)(1)(vi) or §1.114(g) relates to an issue that should be petitioned or appealed, the USPTO indicated that it will likely not grant the petition for an additional continuing application or request for continued examination.

(b) The number of applications filed in parallel or series with substantially identical disclosures. For example, the higher the number of applications with identical or substantially identical disclosures or the higher the number of applications in the chain of prior-filed co-pending applications, the more opportunities applicant had to present the amendment, argument or evidence earlier.

(c) Whether the amendment, argument, or evidence was submitted with reasonable diligence. According to the USPTO, this will take into account the condition of the application at the time of examination (e.g., was the initial application in proper form for examination by the time of the first Office Action (OA) in the initial application or was it was necessary for the first OA to containing rejections under §112 or objections to have the application placed in proper form for examination); the consistency of the Office’s position during prosecution (e.g., did applicant receive wholly new prior art rejections versus prior art rejections slightly modified to address the amendments); and the earnestness of applicant’s efforts to overcome outstanding rejections (e.g., did replies fully address all grounds of rejection or objection in the Office Action(s), or were amendments or evidence submitted only when arguments failed to persuade the examiner).

II. CON/CIP APPLICATIONS FILED BETWEEN AUGUST 21 AND NOVEMBER 1

The limitations on CON/CIP applications and RCE filings do not apply to a CON/CIP application or RCE that is filed between the publication date of the final rule (August 21, 2007) and the date on which the Final Rules become effective (November 1, 2007). Thus, an Applicant can file any number of CON/CIP applications in connection with an application or a second or subsequent RCE in connection with an application during this time period as is presently allowed by the present rules. If such action is taken, however, then an Applicant cannot file the “one more” CON/CIP application after November 1, 2007 without a petition and showing as provided above for US non-provisional or reissue applications that were filed before August 21, 2007 and for PCT national stage applications that entered the national stage in the US before August 21, 2007.

Thus, consideration should be given to filing one or more CON/CIP applications before the Final Rule becomes effective (November 1, 2007). In this regard, consideration should be given to filing the additional CON/CIP application so as to include claims that are directed to more than one patentably distinct invention so that a restriction or election of species requirement will result. In this way, the subsequently filed application is a divisional application not another continuation.

Also, as the filing of a continuing application to continue prosecution of rejected claims so that allowed claims in a present application can pass to issue is not considered by the USPTO as a sufficient reason to file a continuing application, in any such cases, consideration should be given to filing a CON/CIP application during this time period, particularly were there are more than two CON/CIP applications.

Also, if a final office action is pending in connection with a previously filed RCE, it would be preferable to respond to the final office action by filing another RCE during this time period with the after final response or amendment instead of filing the response or amendment. In this way, an applicant is not relying upon the Examiner acting before November 1, 2007 so that the second or subsequent RCE is filed without requiring a petition and showing.

USPTO responses to comments regarding CON/CIP Rules

In the Final Rule package, the USPTO included over 300 hundred responses to comments made regarding the proposed rules. The following includes some examples of the USPTO responses to comments concerning the petition and showing requirements of the new rules.

  • The USPTO indicated that it will likely not grant a petition for an additional continuing application based on the mere showing that an examiner indicated in an advisory action that the entry of an after-final amendment would require a new search, or that the evidence or amendment sought to be entered will overcome a final rejection. Because numerous opportunities are given to submit any desired amendment, argument, or evidence, the mere fact that an amendment, argument, or evidence is refused entry because prosecution in the prior-filed application is closed will not, by itself, be a sufficient reason to warrant the grant of a petition under § 1.78(d)(1)(vi) or 1.114(g).
  • The USPTO indicated that it is not likely to grant a petition under § 1.78(d)(1)(vi) for an additional continuing application if some of the claims in the prior application are rejected and other claims are allowed, and applicant wishes to appeal the rejected claims and obtain a patent on the allowed claims, in the absence of special circumstances. An applicant is expected to use the two CON/CIP applications permitted as of right for this purpose.
  • The USPTO indicated that the mere fact that an examiner made a new ground of rejection in a final Office Action (e.g., a new ground of rejection using a new prior art reference, a reference already of record but not previously applied, a new basis for the rejection for example changing a rejection under §102 to a rejection under §103, or a different reasoning, for example the supporting arguments have changed or the rejection refers to a new portion of the applied art), probably would not constitute a sufficient showing. The USPTO will focus on whether the new ground of rejection in the final Office action could have been anticipated by the applicant.
  • The USPTO indicted that it was not likely to grant a petition when an applicant needs an additional CON/CIP application to partition the claims in the prior-filed application, such that a terminal disclaimer applies only to some but not all claims in the prior-filed application, the sole purpose of partitioning the claims being to avoid a terminal disclaimer.
  • In regards to additional CIP applications, the USPTO indicated that the mere fact that the subject matter was not present at the time of filing the prior-filed application would not be a sufficient showing under §1.78(d)(1)(vi). For example, if the new subject matter is not being claimed in the continuation-in-part application, but merely being added to circumvent the rule, the USPTO will not grant the petition.

III. 5/25 RULE

Under amended Rule 37 C.F.R. §1.75(b), a patent application may not have more than five independent claims or twenty-five total claims (hereinafter referred to as the “5/25 Rule”) unless an Examination Support Document is provided by an applicant.

The new limits on claims in the final rule apply in four situations:

(1) new applications filed on or after November 1;

(2) new PCT national stage applications that enter the national stage under §371 on or after November 1;

(3) previously filed applications in which a first Office Action (OA) on the merits was not mailed by November 1;2 and

(4) reissue applications seeking to change claims.

Appended to this Advisory is a schematic of operation of the 5/25 Rule (see last page).

Complying with the 5/25 Rule

(i) Restriction

If an application governed by the new rules exceeds the 5/25 Rule, the application may be brought into compliance through restriction of one or more claims. An applicant may file a Suggested Requirement for Restriction (SRR) before mailing of the first OA on the merits or a restriction requirement issued by the USPTO. If the SRR is accepted, the Examiner will notify the applicant in a subsequently mailed OA.

(ii) Responding to USPTO Non-Compliance Notice

If the claims are not reduced through restriction so as to comply with the 5/25 Rule, the applicant will receive notification from the USPTO that the application does not comply with Rule 1.75(b). At this point, the applicant has two options: (i) cancel claims or (ii) file an Examination Support Document (ESD). Canceling claims is the simplest. Cancellation of claims avoids the expense and potential risks of filing an ESD and thus may be generally preferable. Such a USPTO Notice of Non-Compliance could be included with a Restriction Requirement.

(iii) Grouping of multiple applications for 5/25 determination

If a plurality of applications have been filed including the application under consideration and these applications including the one under consideration contain claims that are patentably indistinct, the 5/25 Rule is applied to all of the patentable indistinct claims and actions are required to be taken so the plurality of applications are brought into compliance.

(iv) Examination Support Document (ESD)

Filing an ESD is generally not recommended because of the associated expense and risks. The applicant must conduct a patentability search and state what the field of search was (including the classes and subclasses searched). The search must cover U.S. patent and pre-grant publications, foreign patent documents, and non-patent literature unless the applicant can justify otherwise. For each of the most closely related references, the ESD must identify each limitation disclosed. An explanation must then demonstrate how each independent claim is patentable over the most closely related references.

The ESD must also identify where support for each claim is located in the specification. For applications claiming priority (i.e. continuations, continuations-in-part, applications claiming priority from provisional applications, applications claiming priority from foreign applications under § 119, and national stage filings under § 371), the location of support in the priority document must be identified. Additionally, a Supplemental ESD must be filed if claims are amended beyond the scope of the previously filed ESD and after filing of an IDS unless the references in the IDS are less closely related to the claims than those references listed in the previously filed ESD. From the above, one can see that an applicant submitting an ESD essentially undertakes a large portion of an Examiner’s job.

Perhaps more importantly, filing an ESD exposes the applicant to greater risks in litigation. Under the usual flow of patent prosecution, all parties associated with filing and prosecution are subject to a duty of candor and good faith in dealing with the USPTO (37 C.F.R. § 1.56). This duty requires parties to disclose all known information material to patentability, but does not require an applicant to conduct a prior art search. See, e.g., Allen Eng’g Corp. v. Bartell Indus., Inc., 56 F. Supp. 2d 867 (E.D. Ark. 1999) (“Defendant’s argument places the total responsibility of locating prior art on the applicant. The Court concludes that Defendants have pointed to nothing that would justify reliance on counsel’s candor as a substitute for a patent examiner’s duty to examine the claims.”), aff’d, 299 F.3d 1336 (Fed. Cir. 2002). As the Courts have not had to deal with cases involving an ESD, it could be arguable in litigation that the applicant is held to a higher standard.

IV. COMMONLY-OWNED “RELATED” APPLICATIONS

(i) Identification of commonly-owned “related” applications required

New rule 37 CFR §1.78(f) requires an applicant to identify to the USPTO other commonly-owned pending or patented applications within a specified period of time after filing an present application. Under 37 CFR 1.78(f)(1), the present application must not have been allowed.

(a) Applications that must be identified:

The conditions for which a commonly-owned application must be identified are:

(1) Has a filing date that is the same as or within 2 months of the filing date of one or more other pending or patented provisional applications, taking into account any filing date for which a benefit is sought under title 35, United States Code (for purposes of this rule an allowed application that is not withdrawn is not considered a pending application);

(2) Names at least one inventor in common with the one or more application; and

(3) Is owned by the same person, or subject to an obligation of assignment to the same person, as the one or more other applications.

(b) Due date for identification to USPTO:

This identification is to be submitted by the later of:

(i) four months from the actual filing date in a nonprovisional application filed under 35 U.S.C.§111(a); or

(ii) four months from the date on which the national stage commenced under 35 U.S.C. §371(b) or (f) in a nonprovisional application entering the national stage from an international application under 35 U.S.C.§371, or

(iii) two months from the mailing date of the initial filing receipt in such other nonprovisional application.

(c) Rebuttable presumption of patentably indistinct claims:

If at least one such other application is identified, a rebuttable presumption, that the present application contains at least one claim that is not patentably distinct from at least one of the claims of the other application, arises if each of the following four conditions exits (37 CFR 1.78(f )(2)):

(1) Has the same filing date as the filing date of one or more other pending or patented nonprovisional applications, taking into account any filing date for which a benefit is sought under title 35, United States Code (the “filing date” includes any priority date claimed);

(2) Names at least one inventor in common with the one or more other applications;

(3) Is owned by the same person, or subject to an obligation of assignment to the same person, as the one or more other application; and

(4) Contains substantial overlapping disclosure as the one or more other pending or patent applications.

(ii) Terminal disclaimers and rebuttal statements

If the above conditions are met, applicant must file either:

(1) a terminal disclaimer (with explanation, if required) or

(2) a statement (“rebuttal statement”) explaining how the present application contains only claims which are patentably distinct from the claims in the one or more identified applications. The explanation accompanying the terminal disclaimer is required if the one or more identified applications are still pending (must explain why there are two or more pending nonprovisional applications which contain patentably indistinct claims).

The terminal disclaimer or rebuttal statement or the terminal disclaimer is to be submitted by the later of:

(i) four months from the actual filing date in a nonprovisional application filed under 35 U.S.C. §111(a);

(ii) four months from the date on which the national stage commenced under 35 U.S.C. §371(b) or (f) in a nonprovisional application entering the national stage from a PCT international application;

(iii) the date on which a claim that is patentably indistinct from at least one of the claims in the one or more other pending or patented nonprovisional application is presented; or

(iv) two months from the mailing date of the initial filing receipt in the one or more other pending or patented nonprovisional applications.

If the explanation provided by an applicant to rebut the presumption is deemed unpersuasive, then the at least one claim in the other application(s) is considered patentably indistinct from the claims in the present application. The USPTO will require an explanation as to why there are two or more pending applications that contain patentably indistinct claims. Furthermore, a rejection based upon double patenting (including an obviousness-type double patenting rejection) will be made in any subsequent Office Action, unless a terminal disclaimer has been filed by applicant.

(iii) Failure to properly identify commonlyowned “related” applications

A specific penalty is not provided in the rules for failure to timely identify commonly-owned applications. If an applicant inadvertently fails to identify the other commonly owned applications or patents in a timely manner, however, Edwards Angell Palmer & Dodge LLP Client Advisory then applicant should submit the identification as soon as practical. If such late submission necessitates a new rejection based upon double patenting (including an obviousness-type double patenting rejection) in a second or subsequent Office Action on the merits, the Examiner can make such an action Final assuming that the conditions for making a second or subsequent action Final are otherwise met.

Identification of commonly-owned patent applications will, in practice, be difficult. In the case where the owner or assignee of the patent rights uses multiple law firms to prosecute patent applications, the owner or assignee should be vigilant for these types of situations and should advise their U.S. patent attorney or agent of any such commonly owned applications that should be identified, preferably when an application is to be filed.

V. ADDITIONAL REQUIREMENTS FOR CIP APPLICATIONS

Rule 37 C.F.R. §1.78(d)(3) requires that when the application being filed is a continuation-inpart (“CIP”), an applicant must also identify the claims in the CIP application that are supported by the prior-filed application. Any claims that are not identified by applicant will be subject to prior art based on the actual filing date of the CIP application. If a new ground of rejection is necessitated by a late submission of such an identification, this will not preclude a second or subsequent action from being made final.

VI. DIVISIONAL APPLICATION REDEFINED

The USPTO re-defined (i.e., narrowed) the term “divisional application” as a continuing application that discloses and claims only an invention(s) that was disclosed and claimed in a prior-filed application, and which also, (i) was subject to a requirement for restriction in the prior-filed application, and (ii) was not elected for examination and was not examined in any prior-filed application.

In view of this, and in contrast to past practice; if the application being filed includes claims to a non-elected invention and, for example, claims that were not subject to the a restriction requirement, then the application is not a divisional application but rather a continuation application. Also, the USPTO has advised that an applicant cannot rely upon (continued on next page) the restriction requirement being maintained after a divisional application is filed, such as for example when an applicant traverses the restriction requirement or the restriction requirement is provisional (e.g., an election of species requirement where there is a generic claim. If the restriction requirement is later withdrawn, the filed application may not be considered as a proper divisional application.

The proposed rule changes that had proposed limiting when a divisional application should be filed are not present in the final rule. Thus, a divisional application still can be filed at any time, in series or in parallel, as long as the co-pendency requirement is met.