Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE AURORA F. DECASTRO, SURENDRA K. GUPTA AND ARUN K. AGARWAL
Appeal No. 92-3899
March 23, 1993
Application for Patent filed February 12, 1988, Serial No. 07/155,498. Enzymatic Determination Of Theophylline.
Anne M. Kornbau et al. for appellants
Primary Examiner--Esther M. Kepplinger
Before Pellman, Goolkasian and W. Smith
This is an appeal from the final rejection of claims 1 through 70, all the claims in the application.
Claims 1, 33, and 57 are illustrative of the subject matter on appeal and read as follows:
1. A method for determining theophylline in a sample which comprises contracting the sample with a theophylline utilizing enzyme which provides a measurable signal in the presence of theophylline, determining the amount of signal produced and correlating this amount to the concentration of theophylline in the sample.
33. A test composition for the determination of theophylline in a sample comprising a theophylline utilizing enzyme capable of producing a measurable signal in the presence of theophylline and a means for measuring and correlating the signal to the quantity of theophylline present in the sample.
57. A test device for the determination of theophylline in a sample comprising a solid matrix incorporated with the residue of a composition consisting essentially of a theophylline utilizing enzyme capable of producing a measurable signal in the presence of theophylline.
The examiner has not relied upon prior art in rejecting the claims on appeal. Rather, the sole ground of rejection of claims 1 through 70 is under 35 U.S.C. § 112, first paragraph, as being nonenabled. In setting forth this rejection, the examiner has set forth a first ground which is applicable to claims 1 through 70 and a second separate reason which is relevant to claims 5, 6, 10 through 12, 36, 37, 41, 42, and 65.
As apparent from the claims reproduced above, the present invention is directed to a method of determining theophylline in a sample which uses a theophylline utilizing enzyme. Appellants set forth in the Background portion of the specification that theophylline is a bronchodilator and respiratory stimulant used, inter alia, in treating persons with asthmatic and allergic conditions. The concentration of theophylline in the blood of a patient must be monitored to ensure a therapeutic and nontoxic level is maintained. The background portion of the present specification also includes a review of test systems previously used to measure theophylline levels. After noting that previous test systems did not use enzymes which utilized or changed theophylline, appellants state in the paragraph bridging pages 4-5 of the present specification that:
[r]ecently three theophylline utilizing or recognizing enzymes have become available from GDS Technology Inc., P.O. Box 473, Elkhart, Indiana 46515. These enzymes were identified as 1. Enzyme T-090, 2. Enzyme T-060 and 3. Enzyme T-040.
*2 GDS Technology, Inc., is the present assignee.
The claimed invention involves the use of the three above identified theophylline utilizing enzymes in an enzymatic test for the determination of theophylline in samples including body fluids, food extracts, and medicinal compounds. The present specification does not describe the three above referenced enzymes by any physical characteristic such as molecular weight, nor does it set forth the microbial source of these enzymes. The only manner in which the three enzymes are described in the specification is by listing certain properties they possess such as oxidizing, dehydrating or demethylating theophylline.
The examiner's consideration of the original disclosure of this application led her to conclude that (1) theophylline utilizing enzymes are critical to practice the claimed invention and (2) the three enzymes disclosed to be commercially available by the present assignee under the T-designation were not described or enabled such that one could practice the invention as claimed. The examiner noted appellants acknowledge that no theophylline utilizing enzymes were known in the prior art prior to the present invention and that appellants had not characterized the three T-enzymes by physical characteristics or their microbial source. The examiner recognized that under appropriate circumstances an applicant may describe a material used in a claimed invention by referencing materials sold under a particular trade name or trademark, In re Metcalfe, 410 F.2d 1378, 161 USPQ 789 (CCPA 1969), but determined under the circumstances of this application, further disclosure regarding the theophylline utilizing enzymes of the present invention was needed.
Appellants' position is two-fold. First, appellants argue the three T-designated theophylline utilizing enzymes were commercially available through the present assignee prior to the filing date of this application. Co-appellant Surendra K. Gupta, who is also president of the present assignee, states in a declaration under 37 C.F.R. § 1.132 (Paper No. 14, April 1, 1991) that the theophylline utilizing enzymes T-040, T-060, and T-090 will be available for sale to the public without any restriction, during the enforceable life of any patent which may issue upon the present application. The second approach taken by appellants includes their deposit of microorganisms from which the T-040, T-060, and T-090 enzymes are stated to have been isolated. Dr. Gupta states in his declaration that the deposits were made on August 10, 1990, which is subsequent to the present effective filing date. Dr. Gupta goes on to state in his declaration that the public would have access to the three T- theophylline utilizing enzymes disclosed in the present specification by obtaining samples of the deposited microorganisms and isolating the enzymes using what Dr. Gupta considers to be well-known and routine techniques.
*3 The examiner has concluded that the deposit of these microorganisms is not an effective rebuttal under the circumstances of this application. The examiner notes that appellants did not disclose or describe the microorganisms in any manner in the original disclosure of this application. The examiner has also determined that appellants have not properly established on this record that the public would, in fact, be able to isolate the needed theophylline utilizing enzymes from the deposited microorganisms.
We agree with the examiner that the present specification does not enable one skilled in the art to practice the claimed invention. This conclusion is consistent with the decision in White Consolidated Industries Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 218 USPQ 961 (Fed.Cir.1983). In that case, a language translator known by the acronym SPLIT was needed in order to practice the claimed subject matter of that patent. As reported, SPLIT was a trade secret of the assignee of that patent at the time the application was filed and was available only by purchase from assignee, the same circumstances found in the present case in that at the time this application as filed, the only known theophylline utilizing enzymes were available only through purchase from the present assignee.
As set forth by the court in White Consolidated, [218 USPQ at 963]:
White's assertion that SPLIT was itself widely available, albeit only upon purchase from Sundstrand, misses the mark. The sine qua non of a valid patent is a full, clear, enabling description of the invention. Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480, 181 USPQ 673, 678 (1974). Though the "language translator" by itself is not the claimed invention, it is an integral part of the disclosure necessary to enable those skilled in the art to "make and use the same." Were Sundstrand (now White) to maintain SPLIT as a trade secret, it could, as Judge Cohn noted, theoretically extend its exclusionary rights beyond the 17 year life of the patent by controlling access to SPLIT, a result inconsistent with the objectives of the patent system. Sundstrand was therefore obliged to disclose the details of SPLIT or some other language translator, unless suitable substitutes were known and available to those skilled in the art or unless a suitable substitute could be obtained without undue experimentation. [emphases in original]
We find appellants' reliance upon In re Metcalfe, supra, to be misplaced. As set forth in Metcalfe, there were several factors concerning the trademarked materials in issue therein which militated in favor of those appellants. The court noted the resins employed in that application were not identified only by trademark and manufacturer. Rather, the resins were further identified by their chemical nature. The court concluded that should the trademarked products become unavailable, the information of record would be of assistance to a worker in the art seeking to prepare equivalent resins.
*4 Here, the only information set forth in the original disclosure of this application which would aid the public in finding other equivalent enzymes is the limited statement of certain properties the three disclosed enzymes have, e.g., enzyme T-060 oxidizes theophylline and converts theophylline to 1,3- dimethyl uric acid. However, what is missing from the disclosure of this application is any information as to the microbial source of such enzymes. Such information is among the minimum needed by workers in this art in order to obtain the needed enzymes. See Ex parte Jackson, 217 USPQ 804 (Bd.App.1982). Thus, as filed, the specification was nonenabling.
Under the circumstances of this case, we agree with the examiner that appellants' subsequent deposit of microorganisms stated to produce the three theophylline utilizing enzymes disclosed in the specification of this application does not rectify this problem. The examiner has correctly pointed out that the original disclosure of this application does not describe any microorganism which produces the needed theophylline utilizing enzymes. This fact distinguishes the present situation from the facts in In re Lundak, 723 F.2d 1216, 227 USPQ 90 (Fed.Cir.1985), where a subsequent deposit of biological material described in the original application was determined to be sufficient to comply with the enablement requirement of 35 U.S.C. § 112, first paragraph.
We also agree with the examiner that appellants have not established on this record that one skilled in this art would be able to isolate the needed enzymes from the deposited material. Dr. Gupta states in his declaration that one need only use routine procedures in order to isolate the needed enzymes. However, the so-called conventional procedures are disclosed only in the broadest terms and it can not be determined from this record whether the use of these broad procedures to recover the specific enzymes needed to practice the claimed invention would require undue experimentation. Again, we point out that the original disclosure of this application does not describe the enzymes by their physical characteristics, e.g., molecular weight.
Claims 5, 6, 10 through 12, 36, 37, 41, 42, and 65 are directed to that aspect of the present invention where the measurable signal is the result of a "change" in the enzyme upon contact with theophylline. The examiner has separately rejected these claims explaining that the specification does not enable measuring the concentration of theophylline based on a "change" in the enzyme upon contact with theophylline. The examiner concludes that it would require an undue amount of experimentation to determine whether the enzyme "changed" as a result of its interaction with theophylline and questions how one would measure such a "change" without further disclosure in the specification.
*5 Appellants argue in the Appeal Brief that Example 3 of the present specification discloses such a "change" in the enzyme. Example 3 sets forth an experiment which shows that the presence of theophylline causes an increase in the absorbance spectrum of the enzyme T-090 at 417.5 and 550 nm wavelength. Appellants argue this increase in absorbance is an example of the so-called "change" in the enzyme required by these claims.
The examiner has pointed out that Example 3 does not contain sufficient detail to allow one to reach a proper conclusion that the observed increase in absorbance was in fact due to a "change" in the enzyme. For example, Example 3 does not show that a concentration of theophylline could be measured. A control experiment where only theophylline is provided to demonstrate the absorbance value of theophylline by itself was not provided. Absent such information, it can not be concluded that the enzyme did "change" or that such a "change" is useful in determining the amount of theophylline present in a sample. We agree that the present disclosure does not enable this portion of the claimed subject matter in that the specification does not adequately describe how the enzyme changes.
While appellants argue in the Reply Brief that the binding of a substrate by an enzyme can result in a conformational change in the enzyme, the examiner correctly points out there is no evidence in the present record to support the conclusion that such a conformational change occurs in the present invention.
Appellants also argue that the copy of a printout attached to the Reply Brief of an online search of a database shows that other workers in the field have used theophylline-utilizing enzymes for analytical techniques. However, the references relied upon were published after the present filing date. Appellants have not established that such later published references may be properly relied upon under the present circumstances since it can not be determined whether these documents reflect the state of the art at the time this application was filed or are based upon knowledge subsequently obtained. In re Glass, 492 F.2d 1228, 181 USPQ 31 (CCPA 1974).
For the reasons set forth above and those in the Examiner's Answers, the decision of the examiner is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 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
John T. Goolkasian
William F. Smith