BPAI Seeks Further Briefing on Claim Encompassing "400 Billion Oligomers"

By Donald Zuhn --

Last week, in Ex parte DeGrado, an appeal before the Board of Patent Appeals and Interferences concerning U.S. Application No. 10/801,951 (U.S. Patent Application Publication No. US 2006/0041023), the Board issued an order calling for further briefing on two issues related to a claim that the Board "conservatively estimate[s] . . . encompasses in excess of 400 billion oligomers."  In particular, the Board is requiring Applicants to brief the following questions:

1.  Whether Applicants may be required to restrict their claims to a single invention under the provisions of 35 U.S.C. § 121.

2.  Whether Claim 16 is a proper "Markush Claim."

Aside from the issues for which the Board seeks further briefing, the appeal is notable in that the panel consists of the Commissioner of Patents.

In its order, the Board notes that claim 16 relates to a method for treating microbial infections by administering a compositions including at least one amphiphilic oligomer, and that the amphiphilic oligomers falling within the scope of the claims are defined by the formula R¹-[-x-A₁-x-y-A₂-y-]m-R² (wherein the definitions of R¹, R², x, y, A₁, A₂, and m take up three pages of the 12-page order).  Reviewing the prosecution history, the Board stated that the application as originally filed contained seven independent claims, five directed to methods of treating microbial infections by administering oligomers and two directed to groups of oligomers.  None of the originally filed claims required that the oligomers be amphiphilic.

The Examiner opened prosecution by issuing a restriction requirement that identified fifteen inventions and required Applicants to select one of the inventions as well as a single species of oligomer from the elected group.  Following Applicants' selection of the invention of Group III and a specific oligomer, the Examiner issued an additional restriction requirement for the invention of Group III that identified 28 classes of oligomers within Group III and required Applicants to select one of the classes as well as a single species of oligomer from the elected class.  Applicants responded by amending claim 16 to require that the oligomers be amphiphilic, and traversing the restriction and election requirement, in part, on the ground that it ignored the amphiphilicity feature of the invention, which Applicants explained gave the oligomers their anti-microbial property.  Applicants also argued that they could not elect one of the 28 classes of oligomers because none of the classes "permit the property of amphiphilicity, which is the central feature of Applicants' invention."  Applicants further argued that requiring a restriction between independent inventions present in a single claim is improper under In re Weber, 580 F.2d 455 (C.C.P.A. 1978) and In re Haas, 580 F.2d 461 (C.C.P.A. 1978), and that M.P.E.P. § 803.02 requires the Office to examine all claims exactly as presented by Applicants unless the claims lack "unity of invention."  Applicants contended that the recited amphiphilic oligomers demonstrated unity of invention because they share the common utility of antimicrobial activity and the structural feature of amphiphilicity.  Following Applicants' amendment of claim 16, the Examiner withdrew the earlier restriction requirements and issued a new restriction requirement that identified 21 inventions.  Applicants selected the same group of claims (16-48) and oligomer as selected in response to the initial restriction requirement, and again argued that the property of amphiphilicity common to all the claimed compounds and their effectiveness for treating microbial infections precluded restriction.  Applicants also argued the impropriety of restricting between multiple inventions in a single claim, noting that 35 U.S.C. § 121 "does not grant the PTO the authority to refuse to examine a single claimed invention."

The Board notes in its order that in Weber:

The Court held that in requiring that "[t]he specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention," 35 U.S.C. § 112, 2nd paragraph, allows the inventor to claim the invention in the way he chooses (subject to the other requirements of law), including claiming multiple independent and distinct inventions in a single claim.

However, the order "require[s] that Applicants brief the apparent conflict between the plain language of § 121 [which appears to empower the Director to require any "application to be restricted to one of the inventions"] and the Weber and Haas opinions.

Citing In re Harnisch, 631 F.2d 716, 722 (C.C.P.A. 1980), and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984), the Board states that "[a] Markush claim is improper if the inventions (1) do not share a common use; or (2) do not share a 'single structural similarity,' that is, a substantial structural feature disclosed as being essential to the common utility."  Noting that the Examiner restricted claims 16-48 into 21 inventions on the basis of "the markedly different chemical structures between the oligomers in the different groups," the Board also requires additional briefing from Applicants on whether claims 16-48 are proper Markush Claims.  In particular, the Board states that:

Applicants are required to brief whether the recitation of a broad general formula covering a very large group of compounds, the recitation of a general chemical property (amphiphilicity) that may be possessed by those compounds, and the recitation of the single broad step of "administering an effective amount" is per se sufficient to create "unity of invention" as that concept was used by the Harnisch court.

Applicants must submit their brief by June 6.

Comments

[moondog]

How does the number of species in these claims (400,000,000,000) compare with a typical chemical case, assuming ~10 variable substituents? And if the Board (or CAFC) were to rule that these claims were sufficiently definite to pass muster under Sec. 112, 2nd para., what about written description or enablement?

[ANon]

There is no question that the claims are definite if all the variables are clearly defined.

Further, I don't think there have been any recent cases holding a Markush group to be "improper" nor would there be any basis for such a holding in 112. Courts have already rejected 121 as a basis for such a rejection.