By Kevin E. Noonan —

In an earlier post, Patent Docs provided a synopsis of that portion of the U.S. Patent and Trademark Office’s August 23, 2007 webcast regarding the portion of the recently-published revised rules of practice regarding continuation applications.  This article concerns the other major change in patent prosecution caused by the rules, involving restrictions on total claim numbers permitted without imposing a requirement that an applicant file an Examination Support Document.

In the past, the Office has limited its attempts to restrict the number of claims in an application using purely economic coercion, by increasing the cost of filing independent claims in excess of three and total claims in excess of twenty (and providing a surcharge for multiply-dependent claims).  Indeed, a few years ago these efforts led to a proposal that was so burdensome (where applications having fewer than 100 claims could incur fees in excess of ten thousand dollars) that the fee schedule was never implemented.  Like the new rules regarding continuation applications, there is nothing in the statute (35 U.S.C. § 112, ¶ 2) that provides for any limitations in the total number of claims that an applicant can file (and in fairness, the new rules provide no such absolute limits in contravention of the statute).

The incentive this time is a requirement that an applicant wishing to file more than five independent claims or more than 25 total claims (the Office uses the term "5/25") will be required to file an Examination Support Document (ESD; 37 C.F.R. § 1.265).  An ESD must contain:

• A preexamination search statement;
• Listing of references deemed most closely related to the subject matter of each claim;
• Identification of claim limitations disclosed by each reference;
• Detailed explanation of patentability; and
• Showing of support under 35 U.S.C. § 112, ¶ 1.

The preexamination search statement must contain:

• A statement that a preexamination search in compliance with 37 C.F.R. § 1.265(b) was conducted.
• An identification of:
  • The field of search by U.S. class and subclass, the date of the search; and
  • For database searches, the search logic or chemical structure or sequence used as a query, the name of the file(s) searched and the database service, and the date of the search (in the manner set forth in M.P.E.P. § 719.05).

Like current practice in submitting Information Disclosure Statements, the ESD is required to provide U.S. patents and patent application publications; foreign patent documents; and non-patent (e.g., scientific) literature.  Unlike current IDS practice, the references must be discussed with particularity, especially with regard to the relevance of each reference to the claimed invention.  "The ESD must include a detailed explanation that particularly points out how each of the independent claims is patentable over the references cited in the listing of references," as well as explaining why the claims are novel and non-obvious with regard to the references, as well as evidence of support in the specification in compliance with 35 U.S.C. § 112, ¶ 1.

For purposes of calculating the total number of claims directed towards an invention disclosed in the specification, the Office does not take into account withdrawn claims, or patented claims, but will consider all the claims of any co-pending application containing even one claim that is not patentably distinct from a claim in a different application.  And as we previously reported, an applicant is under an affirmative obligation to disclose any related U.S. applications filed within two months of any application being considered prior to examination.  The existence of such a related application raises a rebuttable presumption that there are no patentably distinct inventions between two commonly-owned applications under circumstances where the applications share the same filing date or priority date and there is overlap between the two disclosures.  If the presumption is not rebutted, the Office will count all of the claims of both applications (patentably distinct or not) in computing that the 5/25 status has been violated and an ESD is required.  The 5/25 rule also applies to reissue applications, but not if the patentee does not seek to change the claims either by direct amendment or amendment to the specification that changes the scope of a claim term.

The Office hastens to point our that, when combined with the continuation rules, there is the potential for filing a total of 15 independent and 75 total claims in any original application and two permitted continuations or continuations-in-part; this assumes that each application is granted with substantially all the claims present at filing.  The Office will also not "count" any claims withdrawn from consideration, for example, for filing in a divisional application, and provides suggestions for filing a Suggested Restriction Requirement (SRR) prior to the first Office Action (accompanied by an election of claims to be examined complying with the 5/25 rule) to allow the applicant to obtain a restriction requirement prior to any actions on the merits.  An applicant cannot file an SRR after a restriction requirement has been issued by the Office, but in either event, the claims must be amended to comply with the 5/25 rule.  The Office will not refund excess claim fees paid on the application as filed in which the new provisions require cancellation of excess claims.  The Office is also increasing the stringency with which they will review the status of a claim as being "independent" or "dependent"; for example, a claim reciting a method using a composition from another claim, even though explicitly reciting "the composition of claim X" will be counted as an independent claim.  Also, multiply dependent claims, and claims dependent on them, will each be counted for each claim recited in the pendency terms of the claim.

If the Office neither accepts the applicants’ SRR or issues a restriction requirement on its own, then the applicant will have to either file an ESD or cancel claims to comply with the 5/25 rules.  Despite promises made during town hall meetings in the spring of 2006, the Office has not proposed any revisions to the scope of the duty of candor (37 C.F.R. § 1.56) to accommodate the requirements of the examination support document.  Since this document requires an applicant to make a series of affirmative representations that are likely to have a direct bearing on whether an examiner is convinced claims are patentable, the resulting potential for a practitioner being accused of inequitable conduct is immense and should act to change applicant behavior in order to avoid the necessity of filing an ESD.

If an ESD is required by the Office, it must be filed prior to the first Office Action, or the applicant will be required to cancel or amend claims to bring the claims into compliance with the 5/25 limitation in order to avoid the need to file an ESD.  If the applicant has not complied with either provision, the Office will send a notification having a non-extendable, two-month deadline for applications filed (or that entered the national stage) on or after November 1, 2007, requiring that the applicant amend the claims.

Like the continuation rules, these rules will be effective for any application filed on or after November 1, 2007, or that is a national stage application filed on or before November 1, 2007 (without regard to the International Filing Date).  For pending applications, the rules will apply unless there has been a first action on the merits prior to November 1, 2007; this rule was adopted no doubt to prevent applicants from filing additional applications prior to November 1, 2007, as many applicants did when the rules changes relating to adoption of the GATT provisions (the change in U.S. patent term from 17 years from issue to 20 years from earliest filing date) in 1995 or those changes caused by the American Inventors Protection Act (AIPA) in 2000 (providing for U.S. patent applications to be published, and more importantly, for the prosecution file histories to be publicly available after publication) were implemented.

Patent Docs plans to provide additional
information and commentary on the new continuation and claims rules in future articles.  We also
anticipate posts relating to the consequences of the new rules (and ways to
avoid them where possible) given sufficient time to review the rules and
contemplate their implications.  For
additional information on this and other related topics, please see:

• "The ‘Word’ on the New Continuation Rules (from the USPTO Webcast) – Part I," August 23, 2007
• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

    By Kevin E. Noonan —

The Patent and Trademark Office appears to recognize that
the recently-published revised rules of practice regarding continuation
applications and restrictions on total claim numbers are producing as much
confusion as they are anger and concern among inventors, patent holders, and
patent practitioners.  (The rules have
already provoked a legal challenge filed in the Federal District Court in
Virginia, as reported by Patently-O) In an effort to explain the rules (which is likely to be an easier task
than justifying them), the Office hosted a webcast today starting at 1 p.m.
Eastern time.  Patent Docs will present a
series of summaries of the webcast (the PowerPoint presentation for the webcast can be obtained here),
and of course reference to the slides supersedes these synopses.  We will also provide some initial
recommendations, surely to be subject to refinement and further development as the
rules are implemented starting November 1, 2007.

With regard to the "starting" date for applying
the rules, the Office has made one controversial decision already: it will permit applications filed prior to
August 21, 2007 (the day the rules were published) to have the benefit of one
additional continuation application without requiring a showing that the claims
in such a continuation could not have been earlier presented.  This move is clearly a way to avoid what many
have predicted:  a rush to file additional applications prior to the "effective"
date of the rule.  Once again, the Patent
Office appears to have violated the spirit if not the letter of the
Administrative Procedures Act by making this retroactive application of the
rule prior to its effective date.  Anyone
who was practicing (or inventing) when the rules changes relating to adoption
of the GATT provisions (the change in U.S. patent term from 17 years from issue
to 20 years from earliest filing date) in 1995 or those changes caused by the
American Inventors Protection Act (AIPA) in 2000 (providing for U.S. patent
applications to be published, and more importantly, for the prosecution file
histories to be publicly available after publication) will understand the
Patent Office’s reasoning, regardless of its legality.  Notably, these provisions will also apply to
U.S. national phase applications filed after November 1, 2007, and
retroactively to any national phase applications filed after August 20, 2007,
regardless of the filing date of the International Application from which they
derive.

Turning to the most well-publicized of the new rules
changes, applicants will be permitted to file two continuation or
continuation-in-part applications and one Request for Continued Examination
(RCE) for each application "family" (thus limiting RCE practice by
requiring a showing, as discussed below, for any "additional" RCE in
any related continuation or CIP once a first RCE has been filed in the parent
or continuation/CIP application).  The
effective date of the RCE practice is November 1, 2007; however, for pending applications having filed at least
one RCE prior to that date, filing a subsequent RCE will require a petition and
showing (i.e., RCEs needed for consideration of newly-discovered art, etc.
should be filed prior to November 1, 2007).  Continuation/CIP applications can be filed "in series," claiming priority sequentially from an
originally-filed application, or
"in parallel," with each continuation claiming priority to a pending, originally-filed
application.

The Office will refuse to acknowledge any priory claim
that is inconsistent with the new rules (i.e., if a "third"
continuation application is filed without the required petition and showing),
and the application’s priority date will be the application’s filing date.  Since applications in a series of continuing
applications frequently depend on a priority claim to avoid anticipation by an
earlier-granted patent or U.S. application under 35 U.S.C. § 102(b), failure to
recognize the priority claim could be fatal to patentability of such a
continuation.

The Office has emphasized that additional RCEs,
continuation, or continuation-in-part applications will be available if an
applicant can make the appropriate showing.  The procedure includes:

• A petition in compliance with § 1.78(d)(1)(vi) or
  1.114(g);
• The petition fee set forth in § 1.17(f);
• An amendment, argument, or evidence; and
• 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.

Unfortunately, "evidence" does not include
newly-uncovered prior art to be submitted in an Information Disclosure
Statement.  Besides a requirement for
"reasonable diligence" the Office has provided little guidance on
what will be sufficient to make a sufficient showing, and has further
compounded this uncertainty by stating that each petition will be decided on a
"case-by-case" basis (suggesting that the decisions will be
subjective and that whatever standard is developed will be applied
inconsistently).

The Office has anticipated that patent applicants would
be tempted to increase the likelihood that they would retain (albeit
transiently) the potential to pursue all of the claims they are entitled to by
statute through the expedient of filing multiple parallel applications
containing substantially the same disclosure prior to the November 1, 2007
"effective date." To forestall
these efforts, the Office is imposing a requirement (37 C.F.R. § 1.78(f)) that
an applicant identify all commonly-owned applications (or patents) having at
least one inventor in common and a filing date or priority date within two
months of an application’s filing date.  The Office must be notified of any such "related" applications
or patents within four months of the application’s filing date or two months
of the receiving a filing receipt for the related application.  The Office will exercise a rebuttable
presumption that any such related applications contain at least one
patentably indistinct claim (and are thus subject to mandatory joinder as
explained elsewhere) if, in addition to having at least one common inventor and
being filed/asserting a priority claim within two months of each other, the
applications contain "substantial overlapping disclosure" (defined as
disclosure that would support at least one claim in the related
application).  An applicant can either
rebut the presumption (by supplying, for example, the type of reasoning found
in a restriction requirement), or submit a terminal disclaimer.

In the "miscellaneous provisions" category, the
Office will not "count" an earlier-filed divisional against an
applicant if the application was abandoned at the pre-examination stage (the
Office used abandonment for failure to comply with a formalities requirement).

Patent Docs plans to provide additional
information and commentary on the new continuation and claims rules in future articles.  We also
anticipate posts relating to the consequences of the new rules (and ways to
avoid them where possible) given sufficient time to review the rules and
contemplate their implications.

    By Kevin E. Noonan —

The recently-published revised rules of practice promulgated by the U.S. Patent and Trademark Office differ in significant ways from the proposed rules published for comment on January 3, 2006.  Some of these differences relate to the rules for filing divisional applications; these are a form of "continuing" application filed in response to a Patent Office determination that the claims of an application encompass more than one patentably-distinct invention (pursuant to the provisions of 35 U.S.C. § 121).

As originally proposed, the rules would have required all divisional applications to be filed during the pendency of the originally-filed application (the claims of which would be subject to the restriction requirement).  Additional divisional applications could be filed thereafter, but would not be entitled to the original filing date.  Instead, the proposed rules would have limited a priority claim for these "later-filed" divisionals to be the filing date of any pending divisional application.  Since a divisional application by definition contains claims that were originally filed in the earliest-filed application, and the specification is also identical, these proposed rules would have forced applicants to file all divisional applications prior to patent grant (or application abandonment) of the originally-filed application.  The earlier practice, of filing divisional applications sequentially, although not explicitly prohibited, would be disfavored based on publication of most U.S. patent applications plus the statutory bar provisions (publication) of 35 U.S.C. § 102(b).

This result would have exercised a great financial burden on universities and small entities by forcing them to incur all divisional filing fees substantially at the same time.  It also would have precluded applicants, especially biotechnology applicants, from evaluating the commercial development of their technology and making patenting decisions based on their commercial and investment realities.

Fortunately, the final rules have eliminated the proposed requirement that all divisional applications be filed during the pendency of the originally-filed application (as long as the copendency requirement of 35 U.S.C. § 120 is met).  Moreover, each divisional application is entitled to two continuation or continuation-in-part applications (to be discussed in future Patent Docs posts).  However, as with other "continuing"
applications, divisional applications will be limited to only one request for
continuing examination for each divisional "family" (which the rules
indicate encompass all divisional applications stemming from an originally-filed
application).  Although the definition of
"family" in this regard seems confusing as written, the PowerPoint
presentation materials supplied in connection with the Patent and Trademark
Office webcast on the new rules (see "New Continuation and Claims Rules Published") appear to
indicate that an RCE filing will be available for each divisional filed
(provided, of course, that the divisional resulted from a Patent Office-imposed
restriction requirement).  Also initially unclear, the new rules permit two
continuation applications, but not two continuations-in-part, from each
divisional application.  These provisions are as of right; additional continuation applications or requests for continuing examination are available for divisional applications, like all other applications, upon petition and a showing of good cause for the additional application/request.

The right to file a divisional application is limited to "claims to a non-elected invention that has not been examined if the application was subject to a requirement for restriction."  So-called "voluntary" divisional applications (where the claims have been examined and are not subject to a restriction requirement) are to be treated as a continuation application.  The divisional application provisions are also abrogated in instances where the Office rejoins restricted claims (for example, where the applicant elects to pursue composition of matter claims and withdraws method of making or use claims).  Rejoinder would vitiate the basis for filing a divisional in such circumstances; this rule suggests that divisional application filings in this instance may best be delayed until the possibility of rejoinder has been exercised or withheld.  Any "divisional" applications that have been filed before this determination would thus be "continuation" applications, subject to the other provisions of the final rules.  The Office also recommends that prosecution of generic claims be pursued to completion in the originally-filed application and that divisional applications relating to species be forestalled until the patentability status of the generic claims has been determined.

With regard to limitations on the number of claims that will be examined, applicants can prosecute divisional applications "in parallel" (i.e., at the same time) "without the claims in the divisional application being taken into account in determining whether the initial application or its continuation or continuation-in-part applications exceed the five independent claim or twenty-five total claim threshold for invoking the examination support document requirement."  These provisions do not apply to instances where claims subject to restriction are subsequently rejoined, suggesting that in these instances claims be crafted with these provisions in mind.

Revised Section 37 C.F.R. § 1.78(a)(2) defines a "divisional application” as a continuing application that discloses and claims only an invention or inventions that were disclosed and claimed in a prior-filed application, but were subject to a requirement to comply with the requirement of unity of invention under PCT Rule 13 or a requirement for restriction under 35 U.S.C. § 121 in the prior-filed application, and were not elected for examination and were not examined in any prior-filed application.

Patent Docs plans to provide additional
commentary regarding the new continuation and claims rules and their
impact on
biotech/pharma patent prosecution in the coming days and weeks.  For
additional information on this and other related topics, please see:

• "New Continuation and Claims Rules Published," August 22, 2007
• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006

    By Donald Zuhn —

Yesterday, the U.S. Patent and Trademark Office published its long-awaited rules changes for continuation application and
claims practice.  The 129-page notice,
entitled "Changes To Practice for Continued Examination Filings, Patent
Applications Containing Patentably Indistinct Claims, and Examination of Claims
in Patent Applications; Final Rule," can be obtained here.  In addition, the USPTO has created a webpage
dedicated to the new continuation and claims rules, where the Office provides documents highlighting the rules changes, listing the differences between the final and proposed
rule, and containing a section-by-section summary of the rules changes.  In addition, the USPTO webpage contains a PowerPoint
presentation and FAQ concerning the rules changes.

Patent Docs plans to provide additional
commentary regarding the new continuation and claims rules and their impact on
biotech/pharma patent prosecution in the coming days and weeks.  For additional information on this and other related topics, please see:

• "More on M.P.E.P. § 710.06," August 20, 2007
• "Patent Office to Hold Webcast on New Claim and Continuation Rules on August 23, 2007," August 20, 2007
• "Patent Office Announces that New Continuation and Claims Rules Will Be Published . . . Tomorrow," August 20, 2007
• "Procuring Patent Protection from the Present USPTO," August 15, 2007
• "New Continuation and Claims Rules to Be Published in Late Summer," July 25, 2007
• "They Just Don’t Get It – ‘Patent Reform’ at the USPTO," April 11, 2007
• "Patent Applicants Beware: The Rules Are Changing (Again)" Part 1 and Part 2, November 6, 2006