By Donald Zuhn —

Last August, the U.S. Patent and Trademark Office published a notice of proposed rule making entitled "Examination of Patent Applications That Include Claims Containing Alternative Language" (sometimes referred to as the Markush rules).  The Office’s proposed rule making would require each claim in an application to be limited to a single invention.  According to the Office’s notice of proposed rule making, when alternative language is used to define multiple species in a single claim, such claims would be considered to be limited to a single invention only when at least one of two conditions is met:

1.  "All of the species encompassed by the claim share a substantial feature essential for a common utility."
2.  "[A]ll of the species are prima facie obvious over each other."
The notice defines a substantial feature essential for common utility as being "a common structure, material, or act necessary for at least one shared specific, substantial, and credible utility."

In March, the Patent Office published a supplementary notice concerning its proposed alternative claiming rules.  Despite asserting that the proposed rules "involve rules of agency practice and procedure for which prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 (or any other law), and thus neither a regulatory flexibility analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) is required under 5 U.S.C. 603," the Office nevertheless decided to "subject the proposed rules to a regulatory flexibility analysis to provide a further opportunity for comment on the small business impact of the proposed rules."  The Office set April 9, 2008 as the deadline to submit comments on the Office’s supplementary notice.

The Patent Office has now posted all of the comments it received regarding the August notice of proposed rule making or the Office’s supplementary notice.  Among the organizations, corporations and individuals submitting comments to either (or in some instances both) notices were the American Intellectual Property Law Association (AIPLA), the Intellectual Property Owners Association (IPO), the National Association of Patent Practitioners (NAPP), the National Institutes of Health (NIH), Eli Lilly and Company, BIOCOM, the Biotechnology Industry Organization (BIO), Genentech, Inc., GlaxoSmithKline, IBM Corporation, the Pharmaceutical Research and Manufacturers of America (PhRMA), E. I. du Pont de Nemours and Company, Curis, Inc., Wyeth, ZymoGenetics, Inc., David Boundy of Cantor Fitzgerald L.P., Thomas Dodd and Hal Woodrow of Johnson & Johnson, and Harold Wegner of Foley & Lardner LLP.  Earlier this month, we reported on the comments Mr. Boundy submitted regarding the economic impact of the proposed alternative claiming rules (see "Cantor Fitzgerald VP Comments on Markush Rules").  In his submission, Mr. Boundy estimated that Office’s alternative claiming rules would impose upon applicants an economic burden of $16 billion per year.

While we plan to review and report on a number of the other comments posted on the PTO’s website, we begin today with GlaxoSmithKline’s comments (in part because GSK kindly provided us with a copy of its comments prior to today’s posting).  In its initial set of comments submitted in October of 2007, GSK argued (as it did in Tafas/GSK v. Dudas) that although the proposed alternative claiming rules were "styled as procedural, the changes to practice mandated by the new rules are in fact substantive."  While recognizing that the Office had a right to exercise control over administrative matters, GSK asserted that "it is not the prerogative of the Office to diminish the patentee’s substantive rights for the convenience of its examination policy."

Moreover, GSK criticized the Office for failing to provide any data justifying the proposed rules:

There is no data indicating how many applications are affected by the rules; no data to indicate the scope of the perceived problem; no data to justify limiting "nested" Markush groups to one.  There is also no data to indicate the amount of search and examination time that will be saved by the proposed rules; no data to indicate how many divisional applications will be necessitated by the increased restriction requirements that will likely result from implementation of the rules; and no data to indicate the increased burden upon applicants as they attempt to comply.

GSK also recommended that the USPTO "adopt the unity of invention standard applied by the PCT to evaluate patent applications, and adhere to claiming practices that have found common application throughout the world’s patent system," as opposed to creating "yet another system of rules and standards that would be unique to the U.S. and at variance with other major examining authorities."

With regard to specific changes to the rules, GSK contended that the requirement of proposed Rule 75(j)(1) that the number and presentation of alternatives not make the claim "difficult to construe" would create "a new and subjective standard for objecting to a claim."  Predicting that "[d]ifferent examiners are bound to perceive claims with differing degrees of difficulty," GSK argued that:

If a claim particularly points out and distinctly claims the subject matter in accordance with § 112, ¶2, that is sufficient under the law for clarity.  If it does not, then it should be rejected under § 112.  No new criteria are needed.

With respect to the prohibition against the nesting of Markush groups under proposed Rule 75(j)(2), GSK noted that such a limitation "would appear to render many common terms, such as halogen and alkyl, as inappropriate terms within a Markush group — because each is itself a group of alternatives."  To comply with the proposed rule, an applicant would have to forgo the shorthand for a much longer recitation.  To illustrate its point, GSK noted that the phrase "wherein R is OH, OCH3, C1-6alkyl, or halogen" in the following example:

would have to be expanded to:

wherein R = OH, OCH3, methyl; ethyl, n-propyl, i-propyl; n-butyl, s-butyl, i-butyl, t-butyl; 1-pentyl, 2-pentyl, 3-pentyl, 1-butyl-2-methyl, 1-butyl-3-methyl, 2-butyl-2-methyl, 1-propyl-3,3-dimethyl; 1-hexyl, 2-hexyl, 3-hexyl, 1-pentyl-2-methyl, 1-pentyl-3-methyl, 1-pentyl-4-methyl, 2-pentyl-2-methyl, 2-pentyl-3-methyl, 2-pentyl-4-methyl, 3-pentyl-2-methyl, 3-pentyl-3-methyl, 1-butyl-1,1-dimethyl, 1-butyl-2,2-dimethyl, 1-butyl-3,3-dimethyl, 1-butyl-2,3-dimethyl, 1-butyl-2-ethyl, fluoro, chloro, bromo, and iodo.

Therefore, far from making the examination of such claims less burdensome, Rule 75(j)(2) would actually make the process more burdensome.

GSK also took issue with provisions of the proposed rules that would require an applicant to petition an unfavorable ruling under the proposed rules.  Instead, GSK argued that "the refusal to examine a claim that is clear and distinct should be appealable to the Board of Patent Appeals," noting that "[t]he very due process that was accorded to Weber, Haas, and Harnisch [in cases cited in the proposed rule making], has now been obviated by rulemaking."

In addressing the supplementary notice, GSK again argued "that these proposed rules exceed the boundaries of the PTO’s rulemaking authority and, if made final, would be contrary to law."  In contrast with its earlier submission, however, GSK was able to use its recent victory in Tafas/GSK v. Dudas to support its argument (see "No April Fool’s Joke — Tafas and GSK Win on Summary Judgment").  Thus, because the proposed rules will "force an applicant to divide his heretofore permissible claim into multiple claims in an effort to try to obtain the full scope of patent coverage for his invention," the proposed rules will affect an applicant’s rights and obligations.  Because the proposed rules affect an applicant’s rights and obligations, they are substantive.  And because the proposed rules are substantive, they exceed the Patent Office’s authority under 35 U.S.C. § 2.

For additional information concerning this topic, please see:
• "Cantor Fitzgerald VP Comments on Markush Rules," April 10, 2008
• "You Can’t Fight the USPTO — or Can You?" March 11, 2008
• "Patent Office Publishes Notice Regarding Impact of Proposed Markush Claims Rules on Small Entities," March 10, 2008
• "Federal Register Notice Regarding Markush Claims to Publish on Monday March 10, 2008," March 7, 2008
• "USPTO’s Bruce Kisliuk Addresses ACI Conference," March 3, 2008
• "IPO Releases Comments on New Markush Rules," October 30, 2007
• "Patent Office Proposes New Rules for Alternative Claiming," August 12, 2007

    By Christopher P. Singer —

In an April 14, 2008 pre-O.G. notice the U.S. Patent and Trademark Office made a request for voluntary submission of electronic Complex Work Unit (CWU) files as part of its Pilot Program.  This program became effective on April 14, 2008 and is intended to alleviate the publication burden of applications that contain various CWUs such as structural data for chemical and biological molecules, mathematical formulas, and large data tables.  Importantly, the USPTO considers submissions of a CWU in this program as a supplement (not replacement) to a paper copy submitted by mail or a PDF copy submitted by EFS-Web, of the corresponding CWU (e.g., a protein structure represented in a Figure, supplemented by the supporting structural data).  In particular, chemical structure data can be submitted in IUPAC International Chemical Identifier (InChI) formatted files, protein crystal structure data can be submitted in Protein Data Bank (PDB) compliant format, and mathematical equations can be submitted using Mathematical Markup Language (MathML) format.  Each of these particular formats consists of ASCII text strings that can be effectively submitted as a text file using EFS-Web, in light of the recent upgrade to EFS-Web 1.1.

Alternatively, the voluntary participants in this pilot program can submit the InChI, PDB, and MathML files on CD as a supplement, not a replacement (important to note) to the paper or PDF-based submission of the CWU either by mail or EFS-Web, respectively.  For CDs submitted for the purposes of this pilot program, the PTO is waiving the format requirements of 37 C.F.R. § 1.52(e).  Excluded items from this CWU pilot program are computer program listings, sequence listings, and tables in ASCII format, which must be submitted on CDs in compliance with 37 C.F.R. § 1.52(e), or by EFS-Web in accordance with the legal framework.

The PTO notes that in order to participate in this program, the following requirements must be met:

1.  The patent application submitted on paper or as a PDF file by EFS-Web must include therein at least one CWU (a table, chemical structure, 3-D protein crystal structure, or mathematical formula).

2.  Any CD or text file submitted in accordance with this program must be accompanied by a statement that the CWU file submitted in electronic form is the same as the file used to create the image of the CWU submitted as part of the paper (or PDF format) patent application.  If a discrepancy between the paper or PDF and electronic version of a CWU, the paper or PDF version will be treated as the true version.

3.  Each CD submitted must be labeled "CWU Pilot" and only one copy of each CD is required.  The files on CD must be labeled according to the instructions found here.  The provisions of 37 C.F.R. § 1.52(e) are waived to the extent that they are inconsistent with the CWU pilot program requirements.

This pilot program is expected to last six months, at which time the PTO will determine whether to extend the program, or to enact procedural changes in light of the program’s success.  More information, including FAQs, about the CWU pilot program can be found here.

    By Christopher P. Singer —

In a recent notice, the U.S. Patent and Trademark Office announced that it has launched the "Financial Profile" (FP) system which allows users to access payment history through a secure (and fast) website.  Users of the FP are able to view detailed information for all fees paid to the USPTO.  According to the USPTO’s announcement, other options of the FP system include the ability to:

• Create and maintain your unique FP account using a self-registration process;
• Include transactions for multiple payment types (e.g., credit card, USPTO deposit accounts, and USPTO EFT accounts);
• View and print detailed information regarding any particular transaction (e.g., patent/application number, attorney docket number, payment amount, fee code, and fee code description);
• View, print, and download (PDF and CSV files) monthly statements for each registered payment type;
• Search transactions by attorney docket number (i.e., client matter number), application number, transaction type (e.g., sale or refund), and/or payment amount; and
• Transfer funds between existing USPTO deposit accounts, replenish deposit accounts via EFT, and/or select an option to stop receiving paper deposit account statements by mail.

The PTO has created an FP Helpdesk to handle questions and concerns relating to the FP system:  FinancialProfile@uspto.gov.  You can login to (or sign up for) the FP system at this link.