Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE * * * ET AL.
Appeal No. 92-1168
January 29, 1993
Application for Patent filed * * * Serial No. * * *; a Continuation of Serial No. * * * filed * * *, Abandoned. DNA Sequence Containing the DNA Sequence Coding for Human Tissue Plasminogen Activator Originating from Human Normal Cells, Recombinant DNA Incorporating the DNA Sequence, Host Cells Transformed with the Recombinant DNA, and Process for Producing Human Tissue Plasminogen Activator by Use of the Host Cells.
Supervisory Primary Examiner--Richard A. Schwartz
This is an appeal from the examiner's decision finally rejecting claims 1 through 5, all the claims in the application.
The subject matter on appeal involves a DNA sequence coding for human tissue plasminogen activator (t-PA) produced by human normal cells (claim 1). The invention also includes the specific DNA nucleotide sequence coding for said t-PA (claim 2), a vector capable of self replication and containing the DNA sequence of claim 1 (claim 3), a microbial or mammalian cell transformed with the recombinant DNA of claim 3 (claim 4) and a process for culturing the mammalian cell of claim 4 to produce human t-PA (claim 5). To exemplify the claims on appeal, claim 1, the only independent claim, is reproduced as follows:
1. A DNA sequence containing the DNA sequence coding for human tissue plasminogen activator produced by human normal cells.
Goeddel et al. (Goeddel) 4,766,075 Aug. 23, 1988
All the claims stand rejected for being anticipated [35 U.S.C. 102(e) ] by Goeddel. The examiner points out that the reference at Fig. 5C discloses the DNA sequence claimed by appellants herein in claim 1. Additionally, we are told, the claimed sequence in claim 2 corresponds to that encoding amino acids - 3 through 527 of the reference. The examiner further specifies the particular portions of the patent disclosing the features to which appellants' other claims are directed.
Contrariwise, appellants, beginning at page 3 of their brief, contend that Goeddel is not effective as a reference as of its filing date for the information upon which the examiner relies because the originally disclosed t-PA DNA base sequence, included in the application as filed, differs from that claimed in the issued patent. At page 4 of the brief, appellants present the following argument:
The Court of Customs and [sic] Appeals, predecessor to the Court of Appeals for the Federal Circuit, has held that only actual matter contained in an issued patent or fairly referenced and incorporated in an issued U.S. Patent, is citable as prior art as of either the filing date of the patent or one of its earlier, parent applications. The relevant case is In re Lund, [376 F.2d 982] 153 USPQ 625 (CCPA  ).
*2 After giving due consideration to the arguments presented by appellants, as well as the opposing arguments advanced by the examiner, we are unpersuaded of reversible error in the rejection before us, which will be sustained. Since we are in substantial agreement with the examiner's reasoning, we incorporate by reference the explanation presented in the answer. We add the following comments to amplify the examiner's rationale.
In passing, we note that claims 1 and 2 contain no indication that the DNA sequence is either isolated or purified. Therefore, it appears that the DNA sequence to which these claims are directed does not distinguish from the naturally occurring substance. In this connection, compare the claim in the Goeddel patent of record. In the event of any further prosecution involving the present subject matter in this or a continuing application, care should be taken by appellants and the examiner to insure that the claims are limited to the specific subject matter appellants regard as their invention.
Returning to the rejection at hand, we observe that appellants, at page 8 of the brief, identify three changes in the DNA sequence that Goeddel is alleged to have made in the application corresponding to the patent cited by the examiner. Appellants state that at positions 722 and 761, G (Guanine) has been changed to A (Adenine) and at position 713, A has been changed to G. Appellants discuss sequences that were disclosed subsequent to the filing date of the Goeddel application and tabulate all the variations in the encoded sequences in Table I accompanying the brief.
Conversely, the examiner, at page 5 of the answer, contends there is only one difference between the coding sequence disclosed in the Goeddel application, as filed, and the final published patent. In this connection, the examiner invites attention to column 15 of said Table I. We are told that said difference consists of a change in base position 726 from A to C (Cytosine) in the issued patent. The examiner further explains that:
This difference leads to no change in the amino acid sequence. Although there are additional differences between the sequence disclosed in the Goeddel application as filed and the final published patent in the 5' and 3' non-coding regions, these regions are not present in the sequence claimed by the applicants, and have no effect on the operability of the sequence encoding human t-PA. The DNA sequence claimed by appellants (see claim 2, page 19 of the appeal brief) corresponds to that which codes for amino acids -3 to 527 of the t-PA protein, i.e. coding sequence only.
As is evident from the foregoing, appellants and the examiner agree that some change was made to the disclosure in the Goeddel application as filed. However, a change, per se, in an application disclosure does not constitute proscribed new matter. The question that first must be answered is whether the initial application provided by the patentee adequately enabled a person skilled in the subject art to practice the invention as claimed. On the record before us, we are convinced that Goeddel represents an effective reference under 35 U.S.C. 102(e).
*3 Goeddel is a domestic patent and, therefore, is imbued with a legal presumption of correctness under 35 U.S.C. 282. See In re Lamberti, 545 F.2d 747, 192 USPQ 278 (CCPA1976); In re Weber, 405 F.2d 1403, 160 USPQ 549 (CCPA1969); and In re Jacobs, 318 F.2d 743, 137 USPQ 888 (CCPA1963). Consequently, the examiner's citation and reliance upon the Goeddel patent shifted the burden of going forward to appellants, who, to overcome the rejection, were required to rebut the presumption of operability of the cited patent by a preponderance of the evidence. Compare In re Sasse, 629 F.2d 675, 207 USPQ 107 (CCPA1980). This, appellants have not done.
While the cited decisions refer to chemical compounds, rather than sequenced DNA, we stress that a gene is a chemical compound, albeit a complex one. See Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.Cir.1991), at 18 USPQ2d 1021. Thus, it is manifest that the prior decisions involving chemical compounds are equally applicable to claims directed to the present subject matter.
Addressing the question of alleged new matter in the Goeddel application, we invite attention to the decision in In re Nathan, 328 F.2d 1005, 140 USPQ 601 (CCPA1964), wherein the court, in the third paragraph from the end of its decision, holds as follows:
A subsequent clarification of or a change in an original disclosure does not necessarily make that original disclosure fatally defective. This court in Reister v. Kendall, 34 CCPA 859, 159 F.2d 732, 72 USPQ 481, dealt with an interference in which a count was directed to certain dyestuffs. Appellee relied on a British provisional specification for constructive reduction to practice although the structural formulae given for the identification of the respective products of the reaction in appellee's British specification differed from the corrected formulae for the same products recited in his U.S. application. The board nevertheless, in finding for appellee, held that his British specification disclosed the dyestuffs and the means for identifying them irrespective of the wrong formulae and thus was a sufficient disclosure of the patentable subject matter. This court found no error in the board's decision. (140 USPQ 603-604)
Appellants have not apprised us of any objective evidence tending to establish that the Goeddel disclosure, as filed, was non-enabling, i.e., that the patent specification was insufficient to enable one of ordinary skill in the art to make and use the claimed invention without undue experimentation. See Amgen Inc. v. Chugai Pharmaceutical Co., supra, and In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed.Cir.1988). In particular, see the Wands decision at 8 USPQ2d 1404, wherein the court explains:
*4 Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. "the key word is 'undue,' not 'experimentation.' "
The determination of what constitutes undue experimentation in a given case requires the application of a standard of reasonableness, having due regard for the nature of the invention and the state of the art ... The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed * * *.
The court cited and relied upon the discussion in Ex parte Jackson, 217 USPQ 804 (Bd.App.1982), at 217 USPQ 807.
Parallel to the holding in the Wands decision, there was a high level of skill in this art at the time the application was filed and all the methods needed to practice the invention were well-known. Compare In re O'Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed.Cir.1988). Since "routine experimentation" may involve rather extensive studies without straying from "undue" experimentation, and since appellants have provided no countervailing evidence to persuade us otherwise, we are satisfied that the changes in the application of the Goeddel patent were of the type condoned by the decisions in In re Magerlian, supra, and In re Nathan, supra.
Insofar as we can ascertain, for legal precedent, appellants rely only upon the decision in In re Lund, 376 F.2d 982, 153 USPQ 625 (CCPA1967). This decision is inapposite to the facts at hand. In the Lund decision, the court held that a "continuation-in-part" of a prior application is entitled to the filing date of the parent application as to all subject matter carried over into it from the parent application, whether for purposes of obtaining a patent or subsequently utilizing the patent disclosure as evidence to defeat another's right to a patent. The court further held that the mere characterization of the application as a continuation-in-part of a prior application subsequently abandoned, was not sufficient in and of itself to render Example 2 of the abandoned application part of the patent disclosure as if fully set out therein. Thus, the indicated example was not tacitly described in the patent within the meaning of Section 102(e).
Additionally, the court considered the question of whether the example in the abandoned application showed that the invention was known or used by others in this country before the invention thereof by the applicant for patent. The court pointed out that "knowledge" required by that provision of the statute to defeat another's patent rights has long been interpreted to mean public knowledge. Therefore, the example in the abandoned application was not the type of knowledge contemplated by the statute. Neither of the foregoing situations is germane to the facts of the present appeal. Rather, see Kennecott Corp. v. Kyocera International Inc., 835 F.2d 1419, 5 USPQ 1194 (Fed.Cir.1987) and In re Oda, 443 F.2d 1200, 170 USPQ 268 (CCPA1971), both of which follow the reasoning in the Nathan and Magerlein opinions.
*5 Revisiting the question of "new matter", we turn to the decision in Ex parte Marsili, 214 USPQ 904 (Bd.App.1979), cited in the answer. In addition to the relevant decisions cited in the Marsili case, we stress the logic in the concluding paragraph of the Board's holding, regarding the basis for the policy permitting the change in Goeddel's application. Thus, as observed in the noted opinion:
To refuse correction of the structural formula of Appellants' claimed compounds, which have been found patentable by the Examiner, would lead to the absurdity of issuing a patent which teaches the public in its specification the wrong scientific formula for the new products. (214 USPQ 906-907)
The relevance of the above to the circumstances in the Goeddel patent are inescapable.
In view of our foregoing remarks, taken with the specific facts of the present appeal, we find that the examiner has a meritorious position. Since appellants have not informed us of any technical information or current patent jurisprudence inconsistent with the examiner's position, the rejection before us logically must be sustained.
For the reasons expressed in the answer and those discussed above, the examiner's decision rejecting claims 1 through 5 is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
William F. Smith