Ex parte Sims

• Decision Date: 30 April 2001
• Docket Number: 893,Application 08/441,Appeal 1999-1430
• Parties: Ex parte JOHN E. SIMS, DAVID J. COSMAN, STEPHEN D. LUPTON, BRUCE A. MOSLEY, and STEVEN K. DOWER
• Court: United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board

Ex parte JOHN E. SIMS, DAVID J. COSMAN, STEPHEN D. LUPTON, BRUCE A. MOSLEY, and STEVEN K. DOWER

Appeal No. 1999-1430

Application No. 08/441, 893

United States Patent and Trademark Office, Patent Trial and Appeal Board

April 30, 2001

This Opinion is Not binding Precedent of the Board.

ON BRIEF

Before, WILLIAM F. SMITH, ADAMS, and MILLS Administrative Patent Judges.

DECISION ON APPEAL

ADAMS Administrative Patent Judge.

This is a decision on the appeal under 35 U.S.C. § 134 from the examiner's final rejection of claims 16 and 23-25, which are all the claims pending in the application.

Claim 16^[1] is illustrative of the subject matter on appeal and is reproduced below:

16. An isolated and purified Type II IL-1 receptor (Type II IL-1R) that binds IL-1, and is encoded by a DNA that hybridizes under moderately stringent conditions with a DNA selected from the group consisting of:

(a) a DNA encoding a Type II IL-1R having an amino acid sequence as set forth in SEQ ID NO.:2, having an amino terminus at amino acid 1, and a carboxy terminus selected from the group consisting of an amino acid between amino acids 330 and 385, inclusive, of SEQ ID NO.:2;

(b) a DNA encoding a Type II IL-1R having an amino acid sequene as set forth in SEQ ID NO.:13, having an amino terminus at amino acid 1, and a carboxy terminus selected from the group consisting of an amino acid between amino acids 342 and 397, inclusive, of SEQ ID NO.:13; and

(c) a DNA encoding a fragment of the polypeptide of (a) or (b), which fragment binds IL-1.

References relied upon by the examiner^[2].

Sims et al. (Sims)

5, 464, 937

Nov. 7, 1995

GROUNDS OF REJECTION^[3]

Claims 16 and 23-25 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 and 2 of Sims.

Claims 16, and 23-25 are rejected under 35 U.S.C. § 112, first paragraph, as based on a non-enabling disclosure.

We affirm the rejection under the judicially created doctrine of obviousness-type double patenting. We vacate^[4] the rejection under 35 U.S.C. § 112, first paragraph.

DISCUSSION

Obviousness-type double patenting:

In response to this rejection appellants state (Brief^[5], page 13):

Appellants filed a terminal disclaimer on January 7, 1997. The fee set forth in 37 C.F.R. § 1.20(d) was not paid at the time the [sic]. A copy of the terminal disclaimer and the appropriate fee will be filed upon notice that the Board has reversed the [e]xaminer's rejection of the pending claims under 35 U.S.C. § 112, first paragraph.

Appellants provide no further comment with regard to this rejection. Accordingly, we affirm the examiner's rejection of claims 16 and 23-25 under the judicially created doctrine of obviousness-type double patenting.

35 U.S.C. § 112, first paragraph:

According to the examiner (Answer^[6], page 4) "the disclosure is enabling only for claims limited to proteins which correspond in scope to those protein[s] which are encoded by the nucleic acid of the allowed claims from U.S. Patent Application Number 08/242, 211, now Patent Number 5, 464, 937." The examiner finds (Answer, page 4) that "the presence of the hybridization limitation of the instant claims has the effect of encompassing any mutant of the disclosed type II IL-1R which retains the ability to bind IL-1.

The examiner reasons (Answer, pages 5-6) that:

The instant specification does not provide a single working example of an IL-2 [sic] receptor whose amino acid sequence deviates from a natural amino acid sequence and yet the claims encompass potentially thousands of embodiments which do. Further, the instant specification does not identify those amino acid residues in the amino acid sequence of either of the two disclosed type II IL-1 receptors which are essential for their biological activity and structural integrity and those residues which are either expendable or substitutable. In the absence of this information a practitioner would have to resort to a substantial amount of undue experimentation in the form of insertional, deletional and substitutional mutation analysis of over three hundred amino acid residues before they could even begin to rationally design a functional IL-1 receptor having other than a natural amino acid sequence. The disclosure of two DNAs encoding two IL-1 receptors, each having it's natural amino acid sequence, is clearly insufficient support under the first paragraph of 35 U.S.C. § 112 for claims which encompass any and all type II IL-1 receptor proteins including mutants thereof, which are encoded by a DNA which hybridizes to any DNA encoding one of the disclosed proteins under moderate or even high stringency conditions.

In response appellants argue (Brief, page 7):

With respect to the breadth of the claims, contrary to the [e]xaminer's position, the claims do not encompass ANY and all mutants, variants, or derivatives of SEQ ID NO:2 and SEQ ID NO:13. Similarly, the claims do not encompass potentially thousands of embodiments that deviate from the natural amino acid sequences. The claims encompass polypeptides that bind IL-1 and which are encoded by DNA that hybridizes under specified conditions to the DNA that encodes SEQ ID NO:2 or SEQ ID NO:13. [Emphasis removed].

With regard to the quantity of experimentation appellants argue (Brief, page 8) that:

[T]he [e]xaminer has erroneously maintained that "a practitioner would have to resort to a substantial amount of undue experimentation in the form of insertional, deletional and substitutional mutation analysis …" The CAFC has consistently held that the test is not merely quantitative, because a considerable amount of experimentation is permissible, if it is merely routine. … It is further the law that the disclosure of a large number of embodiments does not render a claim broader than the enabled scope as long as undue experimentation is not involved in determining the embodiments.

There is simply no room to conclude that the quantity of experimentation required to practice this invention is excessive in view of the above discussion of the claim breadth. One need only to prepare variants using routine and often automated procedures, determine whether the degree of homology of the encoding DNA is sufficient for it to hybridize to DNA that encodes the specified regions of SEQ ID NO:2 or SEQ ID NO:13 under the recited conditions, and determine its IL-1 binding characteristics using known binding methodologies or those described in Example 5 of the present specification. All methodologies for performing such tasks are routine and well known in the art and/or disclosed in the present specification and require no inventive effort or thought.

Appellants further argue (Brief, page 10) that "the [e]xaminer [has not] backed up his own assertions with acceptable evidence and reasoning that refutes [a]ppellants showing that methods for preparing variant DNA and polypeptides and methods for testing the variant molecules are within the ordinary skill of those in this art." We agree. It is the examiner who bears the initial burden of providing reasons why a supporting disclosure does not enable a claim. In re Marzocchi, 439 F.2d 220, 223, 169 U.S.P.Q. 367, 369 (CCPA 1971). In this case, the rejection under 35 U.S.C §112, first paragraph, is more of a series of conclusions by the examiner than a fact-based, reasoned explanation as to why a person skilled in the art would not be able to make and use the claimed invention throughout its scope without undue experimentation.

Here the examiner did not perform the fact-finding needed in order to reach a proper conclusion that it would require undue experimentation, to practice the full scope of appellants' claimed invention. The enablement requirement of 35 U.S.C. or § 112, first paragraph, requires that the patent specification enable "those skilled in the art to make and use the full scope of the claimed invention without 'undue experimentation.'" Genentech, Inc. v. Novo Nordisk. A/S, 108 F.3d 1361, 1365, 42 U.S.P.Q.2d 1001, 1004 (Fed. Cir. 1997)(quoting In re Wright, 999 F.2d 1557, 1561, 27 U.S.P.Q.2d 1510, 1513 (Fed. Cir. 1993)). Whether making or using the invention would have required undue experimentation, and thus whether the disclosure is enabling, is a legal conclusion based on several underlying factual inquiries. See In re Wands, 858 F.2d 731, 735, 736-37, 8 U.S.P.Q.2d 1400, 1402, 1404 (Fed. Cir. 1988). As set forth in Wands, the factors to be considered in determining whether a claimed invention is enabled throughout its scope without undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of...