An Analysis of the New Rules: 37 C.F.R. § 1.265: Examination Support Document

    By Kevin E. Noonan --

On August 21, 2007, the U.S. Patent and Trademark Office published new rules concerning continuation and claims practice that will undoubtedly have a profound effect on the way patent attorneys and agents prosecute applications before the Patent Office.  In view of the 128-page Federal Register notice regarding the new rules, the Patent Office's nearly two hour webcast on August 23, 2007 (and the webcast's accompanying 109-page presentation), and the Office's 45-page list of Frequently Asked Questions, Patent Docs believes it may be helpful to examine the rules piece-by-piece in an attempt to identify areas where patent attorneys and agents will need to modify their patent prosecution practice.

37 C.F.R. § 1.265:

One of the more controversial (and problematic) of the new rules promulgated by the U.S. Patent and Trademark Office on August 21, 2007 is the requirement that an applicant submit an examination support document (ESD) for any application having more than 5 independent claims or 25 total claims (see 5/25 Limit on Claims).  This rule is part of a broader effort to shift the examination burden from the Patent Office to applicants, which is a key motivation for the new rules (the other motivation, of course, being to reduce the number of applications pending in the Office, regardless of the effect on protecting innovation).  Although Office representatives indicated during "town hall" meetings that new rules regarding the Rule 56 duty of candor would be developed to address the enormous increase in the risk of inequitable conduct accusations occasioned by filing an ESD, no revisions to Rule 56 are forthcoming.  This severely limits the usefulness of the ESD practice, which may be in line with the Office's purpose for creating the requirement in the first place.

The ESD portion of the new rules (37 C.F.R. § 1.265) has a number of specific provisions in addition to providing the Office with prior art known to the applicant (which has been the burden imposed by Rule 56 before now).  These include the following:

1.  An applicant is required to perform (or have performed on her behalf) a preexamination search and to submit an affirmative statement that a search has been performed.  Included in the statement must be the field of search as defined by the PTO's class and subclass definitions, as well as the date of the search.  For chemical and biotechnology applications, an applicant must also submit the chemical structure or sequence searched, as well as identifying the database searched (such as Chemical Abstracts or GenBank).  Copies of all references (except U.S. patents and applications) must be submitted.

The rules require a search of U.S. and foreign patents and applications, as well as any other prior art source such as the scientific literature.  Failure to cite any references in these categories must be accompanied by a statement justifying with "reasonable certainty" that no more pertinent reference would be found in the eliminated prior art source than have been found elsewhere.  Unresolved by the rule is whether an Examiner will be required to duplicate the search (which would reduce the benefits to the Office resulting from the rule) or rely upon it; such reliance would only bolster any inequitable conduct allegations made against any claims granted as the result, and raises questions on the legitimacy of the search fees charged by the Office as part of the filing fee for a new application.

2.  The results of the search must be provided as a list of references.  Unlike current Information Disclosure Statement (IDS) practice, however, an applicant must identify the references deemed (by the applicant) as being "most closely related" to the subject matter of each of the claims.  This list must contain substantially the same bibliographic information on each reference (title, author/inventor, publication date, priority date, etc.) as is now required for an IDS.

Unlike an IDS, the new rule requires an applicant to go on the record with particularity by characterizing the significance of each reference to each claim.  No doubt there will be instances where this is clear and unambiguous; however, the frequency with which charges of inequitable conduct are raised under the less specific disclosure rules in place prior to these new rules suggests that any information provided according to this portion of the rule will expose patent practitioners to a much greater risk of these allegations.  Filing an ESD will also give patent infringement defendants a much greater opportunity to elicit information at deposition from the prosecuting attorney.

3.  Not satisfied with requiring specific identification of the "most closely related" references, the new rules also require an applicant to identify all of the limitations in each of the claims that are contained in or disclosed by the reference.

The purpose of this requirement is clearly to improve Examiner efficiency, but at the risk of serious second-guessing during litigation, particularly in instance where additional limitations are added during prosecution.

(This portion of the new rules do not apply to small entities as defined by the rule.  These include businesses not having more than 500 employees, not-for-profit enterprises not "dominant in its field," and government entities from populations of 50,000 or less.)

4.  Not satisfied with the above requirements, the rules also require an applicant to provide a "detailed explanation" of why each of the independent claims is patentable over the cited art.

This provision completes the burden-shifting from the Office to the applicant, and raises the question of whether the rule is in compliance with the provisions of 35 U.S.C. § 102 which state that an applicant is entitled to a patent unless there is novelty-destroying prior art in one of the seven subcategories of the statute.

5.  Finally, an applicant is required to provide a showing of support in the specification under 35 U.S.C. § 112, first paragraph, for "each limitation in each of the claims."  Where there is a priority claim made, this showing must be provided for each of the priority applications.

With this provision of the rule, the Office has abandoned any pretense that Examiners are required to read the applications under examination, something known to be a pretense for anyone who has experienced a rejection under 35 U.S.C. § 112 based on the absence of a term definition or explicit support where the specification clearly contains the required disclosure.

6.  The filing of an Information Disclosure Statement does not satisfy the rule.  In addition, should the Office determine that an ESD is insufficient, an applicant will be notified and given a non-extendable, two-month period to file a corrected or supplemental ESD.  Alternatively, the claims can be amended to fall within the 5/25 rule, thereby removing the ESD requirement.

It is unlikely that the alternative is truly a viable one; having submitted an ESD in the first place, an applicant is exposed to the increased likelihood of an inequitable conduct charge since the ESD is part of the prosecution history.  Moreover, any defect in the ESD resulting in a determination that it is "insufficient" will not be cured by amending the claims to remove the ESD requirement.

In view of the liability that will predictably attach by filing an ESD, it would be folly for any applicant to comply with this rule except in cases where there is objectively no prior art to be cited.  Although such instances may exist (for example, where an International Search Report provides only "A" references), they can be expected to be both unlikely and rare.  The potential for a later determination that a patent is unenforceable for inequitable conduct in any other circumstance should severely limit the instances where ESDs are filed, further influencing applicant behavior to conform to the 5/25 rule.  The Office's failure to address the Rule 56 changes needed to enable applicants to comply with the rule suggests that the purpose of the rule is merely to provide a sufficient incentive for applicants to restrict their claims to 5 independent claims and 25 total claims.  The Office's use of the ESD rules to force compliance with the 5/25 limitation is yet another reason for practitioners to question the Office's honesty and good faith in promulgating these rules.

For additional articles in this series, please see:

• "An Analysis of the New Rules: Revisions to First Action and Second Action Final Practice," September 11, 2007
• "An Analysis of the New Rules: 37 C.F.R. §§ 1.78(d)(1) and 1.114: Streamlined Examination," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.117: Refund Due to Cancellation of Claims," September 10, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.142: Suggested Restriction Requirements," September 6, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.114: RCE Practice," September 5, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.75(b): 5/25 Limit on Claims," September 4, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(d)(1): Claims for Benefit of Prior-Filed Applications," September 3, 2007
• "An Analysis of the New Rules: 37 C.F.R. § 1.78(f): Commonly Owned Applications and Patents," August 27, 2007

For additional information on this and other related topics, please see:

• "Inventor Sues PTO to Prevent New Continuation Rules from Taking Effect," August 30, 2007
• "Patent Office Provides Recorded Web-Based Discussion of New Rules," August 30, 2007
• "New PTO Continuation Rules: Unfair to Biotech?" August 29, 2007
• "Proposed Agenda for September 12, 2007 Biotechnology/ Chemical/Pharmaceutical Art Group Meeting," August 24, 2007
• "The 'Word' on the New Continuation Rules (from the USPTO Webcast) - Part II," August 24, 2007
• "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

Changes to Rules 265:

(a) An examination support document as used in this part means a document that includes the following:

(1) A statement that a preexamination search in compliance with paragraph (b) of this section was conducted, including an identification of the field of search by United States class and subclass and the date of the search, where applicable, and, for database searches, the search logic or chemical structure or sequence used as a query, the name of the file or files searched and the database service, and the date of the search;
(2) A listing of the reference or references deemed most closely related to the subject matter of each of the claims (whether in independent or dependent form) in compliance with paragraph (c) of this section;
(3) For each reference cited, an identification of all of the limitations of each of the claims (whether in independent or dependent form) that are disclosed by the reference;
(4) A detailed explanation particularly pointing out how each of the independent claims is patentable over the cited references; and
(5) A showing of where each limitation of each of the claims (whether in independent or dependent form) finds support under the first paragraph of 35 U.S.C. 112 in the written description of the specification. If the application claims the benefit of one or more applications under title 35, United States Code, the showing must also include where each limitation of each of the claims finds support under the first paragraph of 35 U.S.C. 112 in each such priority or benefit application in which such support exists.

(b) The preexamination search referred to in paragraph (a)(1) of this section must involve U.S. patents and patent application publications, foreign patent documents, and non-patent literature, unless the applicant justifies with reasonable certainty that no references more pertinent than those already identified are likely to be found in the eliminated source and includes such a justification with the statement required by paragraph (a)(1) of this section. The preexamination search referred to in paragraph (a)(1) of this section must be directed to the claimed invention and encompass all of the limitations of each of the claims (whether in independent or dependent form), giving the claims the broadest reasonable interpretation.
(c) The listing of references required under paragraph (a)(2) of this section as part of an examination support document must include a list identifying each of the cited references in compliance with paragraphs (c)(1) and (c)(2) of this section, a copy of each reference if required by paragraph (c)(3) of this section, and each English language translation if required by paragraph (c)(4) of this section.

(1) The list of cited references must itemize U.S. patents and U.S. patent application publications (including international applications designating the U.S.) in a section separate from the list of other references. Each page of the list of the cited references must include:
(i) The application number, if known, of the application in which the examination support document is being filed;
(ii) A column that provides a space next to each cited reference for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is part of an examination support document listing of references.
(2) The list of cited references must identify each cited reference as follows:

(i) Each U.S. patent must be identified by first named patentee, patent number, and issue date.
(ii) Each U.S. patent application publication must be identified by applicant, patent application publication number, and publication date.
(iii) Each U.S. application must be identified by the applicant, application number, and filing date.
(iv) Each foreign patent or published foreign patent application must be identified by the country or patent office which issued the patent or published the application, an appropriate document number, and the publication date indicated on the patent or published application.
(v) Each publication must be identified by publisher (e.g., name of journal), author (if any), title, relevant pages of the publication, date, and place of publication.

(3) The listing of references required under paragraph (a)(2) of this section must also be accompanied by a legible copy of each cited reference, except for references that are U.S. patents or U.S. patent application publications.
(4) If a non-English language document is being cited in the listing of references required under paragraph (a)(2) of this section as part of an examination support document, any existing English language translation of the non-English language document must also be submitted if the translation is within the possession, custody, or control of, or is readily available to any individual identified in § 1.56(c).

(d) If an information disclosure statement is filed in an application in which an examination support document is required and has been filed, the applicant must also file a supplemental examination support document addressing the reference or references in the manner required under paragraphs (a)(3) and (a)(4) of this section unless the information disclosure statement cites only references that are less closely related to the subject matter of one or more claims (whether in independent or dependent form) than the references cited in the examination support document listing of references under paragraph (a)(2) of this section.
(e) If an examination support document is required, but the examination support document or preexamination search is deemed to be insufficient, or the claims have been amended such that the examination support document no longer covers each of the claims, applicant will be notified and given a two-month time period that is not extendable under § 1.136(a) within which, to avoid abandonment of the application, the applicant must:

(1) File a corrected or supplemental examination support document in compliance with this section that covers each of the claims (whether in independent or dependent form); or
(2) Amend the application such that it contains no more than five independent claims and no more than twenty-five total claims.

(f) An examination support document, or a corrected or supplemental examination support document, is not required to comply with the requirements set forth in paragraph (a)(3) of this section if the examination support document is accompanied by a certification that any rights in the application have not been assigned, granted, conveyed, or licensed, and there is no obligation under contract or law to assign, grant, convey, or license any rights in the application, other than a security interest that has not been defaulted upon, to any entity other than:

(1) A business or other concern:

(i) Whose number of employees, including affiliates, does not exceed 500 persons; and
(ii) Which has not assigned, granted, conveyed, or licensed (and is under no obligation to do so) any rights in the invention to any person who made it and could not be classified as an independent inventor, or to any concern which would not qualify as a non-profit organization or a small business concern under paragraph (f)(1)(i) of this section.

(2) A not-for-profit enterprise which is independently owned and operated and is not dominant in its field; or
(3) A government of a city, county, town, township, village, school district, or special district, with a population of less than fifty thousand.

Comments

[BabelBoy]

Kevin
You state:

"The new rules do not apply to small entities as defined by the rule. These include businesses not having more than 500 employees, not-for-profit enterprises not "dominant in its field," and government entities from populations of 50,000 or less."

Please check that. I believe the only break small entities get from 265(f)is that they don't have to comply with the pin-point citations required by 265(a)(3). They still have to comply with the other onerous provisions of the statute.

If I've missed broader breaks for SE's, please correct this post.

Babel Boy

[Donald Zuhn]

Babel Boy:

Kevin's post has been corrected. Thank you for your comment.

Donald Zuhn

[Kevin E. Noonan]

Dear Babel Boy:

Good catch. Thanks for the comment.