Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE HEINZ HILDEBRAND, WERNER ZITZMANN, DIETER ARLT AND HEINZ KOLBL
Appeal No. 88-1505
HEARD: January 10,1990
Application for Patent filed May 6, 1985, Serial No. 06/731,234. Preparation Of Cyclopropanecarboxylic Acids.
Richard S. Barth et al. for appellants
Primary Examiner - Esther M. Kepplinger
Before Goldstein, Pellman, Lovell, Meros and W. Smith
This is an appeal from the final rejection of claims 1 through 6, 8 through 10, 12 and 13. Subsequent to the final rejection, appellants cancelled claims 10, 12 and 13 and added claims 14 through 16. Claims 1 through 6, 8, 9, and 14 have been allowed by the examiner. Thus, claims 15 and 16 are the only claims remaining in the application which are rejected. Allowed claim 1 and rejected claims 15 and 16 are illustrative of the subject matter on appeal and read as follows:
Claims 15 and 16 are not rejected over prior art. Rather, the sole rejection of these claims is under 35 USC §112, first paragraph, as being based upon a nonenabled specification. We affirm.
In relevant part, 35 USC §112, first paragraph, requires the specification of a patent application to contain a written description of the invention so as to enable any person skilled in the art to which it pertains to make and use the claimed invention. In most patent cases, written words are adequate to satisfy this requirement. However, in patent cases where biological material plays an integral, necessary role in the claimed subject matter, written words may not suffice to provide an enabled description of the invention. In these cases, a practice has evolved in which the enablement requirement of 35 USC §112, first paragraph, may be complied with by applicant depositing a viable sample of the biological material involved in the claimed invention in a recognized depository. In this manner, the public will be in a position to make and use that invention when a patent is granted as required by this section of the statute upon obtention of a viable sample of deposited material from the depository. In re Argoudelis, 58 CCPA 769, 434 F.2d 1390, 168 USPQ 99 (1970).
This issue arises in regard to claims 15 and 16 in this application in view of their recitation of specific strains of microorganisms. The examiner has determined upon the facts of record in this application that claims 15 and 16 are enabled under 35 USC §112, first paragraph only if appellants make an appropriate deposit of the claimed microorganism strains. Appellants have not contested the examiner's determination that deposits of these strains must be made in order for these claims to be considered enabled. Nor have appellants argued that the deposit of the microorganism strains specified in these claims need not be made under the conditions set forth in MPEP 608.01(p) C. Deposit of microorganisms or biological material. Rather, the sole issue in this application is whether appellants have complied with one of the requirements set forth in this section of the manual, i.e., that "all restrictions on the availability to the public of the cultures so deposited will be irrevocably removed upon the granting of the patent." See page 2 of the Supplemental Brief for Appellants filed May 22, 1987 ("there appears to be one narrow issue remaining, namely, the issue of restriction of availability"). [FN1]
*2 Appellants' position on this narrow issue is set forth in the paragraph bridging pages 2 and 3 of the Supplemental Brief. In essence, appellants argue that the specific microorganism strains set forth in claims 15 and 16 were deposited in a depository under the terms of the Budapest Treaty [FN2] and that "the treaty provides that there are no such restrictions on issued patents." In support of this argument, appellants rely upon Rule 11.3b) of the Treaty which reads as follows:
b) In respect of patents granted and published by any industrial property office, such office may from time to time communicate to any international depositary authority lists of the accession numbers given by that authority to the deposits of the micro-organisms referred to in the said patents. The international depositary authority shall, on the request of any authority, natural person or legal entity (hereinafter referred to as "the requesting party"), furnish to it a sample of any micro-organism where the accession number has been so communicated. In respect to deposited micro-organisms whose accession numbers have been so communicated, the said office shall not be required to provide the certification referred to in Rule 11.3(a).
Appellants conclude on page 3 of the Supplemental Brief that any restriction which may have existed on the availability of the deposits when they were deposited will automatically be removed under the provisions of the Budapest Treaty upon issuance of a patent.
Appellants continue this line of argument in the Reply Brief filed November 23, 1987 arguing on page 2 thereof that "it is the crux and essence of the Budapest Treaty that the depositor, once he deposits his microorganism, loses all control on the deposited organism. The depositor cannot limit, restrict or influence the release of the deposit in any way and cannot even cancel or withdrawn the deposit." Appellants have not referred to any portion of the treaty or rules promulgated thereunder in support of this argument.
In announcing the coming into force of the Budapest Treaty with respect to the United States, the then Commissioner of Patents and Trademarks, Sidney A. Diamond, stated (Commissioner's Notice, 999 O.G. 2):
This Treaty authorizes each State for which the Treaty is in effect to designate a depository on its territory to serve as an international depository authority. More than one depository may be designated. Each such depository will be authorized to receive and store deposits, and dispense samples thereof, in compliance with the Treaty and the patent laws of each State adhering thereto. The Treaty is open for adherence by any member State of the Paris Union for the Protection of Industrial Property.
As seen from Mr. Diamond's remarks, an individual patent application in which a deposit issue arises must still comply with the national patent laws. See In re Lundak, 723 F.2d 1216, 227 USPQ 90, n.2, (Fed. Cir. 1985). The Commissioner's Notice also reproduced a memorandum from the World Intellectual Property Organization, Geneva, Switzerland, and the Secretariat for the Paris Union which explains the role and obligations of international depositary authorities established under the Budapest Treaty. Among the listed requirements is:
*3 [C]omplying with respect to the microorganisms deposited under the Treaty with the requirement of secrecy which means giving no information to anyone on the question whether a microorganism has been thus deposited and giving no information to anyone (except to a person which is entitled to a sample)...
This requirement is based upon Rule 9.2 of the Treaty which reads as follows:
No international depositary authority shall give information to anyone whether a micro-organism has been deposited with it under the Treaty. Furthermore, it shall not give any information to anyone concerning any micro-organism deposited with it under the Treaty except to an authority, natural person or legal entity which is entitled to obtain a sample of the said micro-organism under Rule 11 and subject to the same conditions as provided in that Rule.
From this rule, it is apparent that appellants' underlying position, i.e., appellants have not placed any restrictions on the availability of the deposited strains by filing under the Budapest Treaty, is incorrect since by the rules of the Budapest Treaty appellants' deposits are held in secrecy. There is no evidence of record that appellants have waived their right to secrecy under Rule 9.2 of the Treaty. Thus, as the record now stands, if a patent were to issue without appellants making the required statement that all restrictions on access to the deposit be irrevocably removed upon issuance of the patent, there are no assurances that upon granting of a patent that the public will have access to the deposited strains.
Appellants' reliance upon Rule 11.3b) of the Treaty as authorizing the international depositary authority to provide samples of the present deposits once a patent is issued is misplaced. This rule comes into operation only after a patent has been granted. It has no bearing on the present issue where a patent application is pending before the United States Patent and Trademark Office (PTO) with a pending rejection of claims under 35 USC §112, first paragraph, for lack of enablement. [FN3]
Turning to the dissent, we conclude that our affirmance of the examiner's rejection does not amount to a new ground of rejection. As set forth in In re Kronig, 539 F.2d 1300, 190 USPQ 425 (CCPA 1976), the question to be resolved is "whether appellants have had fair opportunity to react to the thrust of the rejection." As set forth above, appellants are well aware of the specific rejection made against the claims on appeal. Again, counsel represented at oral argument that he was well aware of the precise rejection made by the examiner and how to overcome it. Our reliance upon Rule 9.2 of the Budapest Treaty is in response to appellants' assertion that no restrictions have been placed upon the deposits in question merely by the act of filing under the Budapest Treaty. Our pointing out an inconsistency in appellants' arguments does not, in our opinion, amount to a new ground of rejection.
*4 The remainder of the dissent is based upon an erroneous premise, i.e., that Rule 11.3b) of the Budapest Treaty creates an obligatory duty on the PTO. However, Rule 11.3b) only states that an Industrial Property Office, e.g., the PTO, may from time to time communicate to an international depository authority in the manner provided by the rule. The use of the permissive word "may" in this rule does not create an obligation on the PTO as envisioned by the dissent.
We point out again, that appellants have not argued that under the circumstances of this application they need not meet all of the requirements set forth in MPEP 608.01(p) C. which were approved in Argoudelis, supra, including that all restrictions regarding access to the deposited strains be removed upon granting of the patent, in order to comply with the enablement requirement of 35 USC §112, first paragraph. Appellants have only argued that this requirement was satisfied by depositing the claimed strains of microorganisms under the terms of the Budapest Treaty. However, as set forth above, appellants' premise is incorrect since by the rules of the Budapest Treaty the deposited strains are held in secrecy.
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 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
Irving R. Pellman
Charles N. Lovell
William F. Smith
FN1. Counsel reiterated at oral argument that this was the single issue in this appeal and indicated that he knew how to satisfy this requirement according to this established procedure pending the outcome of this appeal.
FN2. The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure which entered into force with respect to the United States on August 19, 1980. See the Commissioner's Notice 997 O.G. 10.
FN3. We note that rules pertaining to the issue of deposits of biological material have recently come into force for all applications filed in the PTO on or after January 1, 1990. See 37 CFR 1.801-1.809. These rules provide an orderly procedure for these issues to be raised and resolved. See especially 37 CFR 1.809.
Edward J. Meros
It is to be first noted that the majority states that "the sole issue" in this appeal is "whether appellants have complied with one of the requirements" set forth in MPEP 608.01(p)C notwithstanding the fact that MPEP 608.01(p) C was not mentioned, let alone relied on, by the examiner in her Answer. Also, in an apparent attempt to reinforce its own approach to the rejection, the majority states that "appellants have not argued that under the circumstances of this application they need not meet all of the requirements set forth in MPEP 608.01(p)C". [FN1] Moreover, Rule 9.2 of the Budapest Treaty relied on by the majority to support its decision was not relied on or, indeed, even mentioned by the examiner. Further, the majority bases its decision, at least in part, on some unknown "required statement that all restrictions on access to the deposit be irrevocably removed upon issuance of the patent" (emphasis added) which finds no basis in the Examiner's Answer. Thus, the decision of the majority is obviously based on reasons or a rationale not set forth in the Examiner's Answer and, therefore, should have been labeled a new ground of rejection pursuant to 37 CFR 1.196(b) in order to safeguard appellant's procedural rights under said rule.
*5 In any case, the deciding issue as to the examiner's rejection of claims 15 and 16 is whether appellants have provided reasonable assurance that the microorganisms recited in said claims would be available to the general public upon issuance of the present application as a U.S. patent by depositing them in an International Depository Authority (IDA) under the terms of the Budapest Treaty of which the United States is a signatory country. I agree with appellants that the terms of the Budapest Treaty provide such assurance. Rule 11.3(b) of the Treaty, pointed out by appellants, reads as follows:
b) In respect of patents granted and published by any industrial property office, such office may from time to time communicate to any international depositary authority lists of the accession numbers given by that authority to the deposits of the micro-organisms referred to in the said patents. The international depositary authority shall, on the request of any authority, natural person or legal entity (hereinafter referred to as "the requesting party"), furnish to it a sample of any micro-organism, where the accession number has been so communicated. In respect of deposited micro-organisms whose accession numbers have been so communicated, the said office shall not be required to provide the certification referred to in Rule 11.3(a). (emphasis added)
On its face, the effect of said Rule 11.3(b) is that the IDA will furnish samples of the deposited microorganisms to anyone upon request when the industrial property office (here the PTO) exercises its obligatory duty as a party to the treaty of communicating to the IDA the accession number(s) of the microorganism(s) set forth in the issued patent.
Notwithstanding the clear intent and effect of Rule 11.3(b) of the Treaty pointed out above, the majority still takes the position that Rule 9.2 of the Treaty would somehow place a restriction (which is unclear from the decision) on the availability of samples of appellants' deposited microorganisms to the general public upon issuance of this application as a patent which is not obviated by the provisions of Rule 11.3(b). After taking this position the majority states as follows:
There is no evidence of record that appellants have waived their right to secrecy under Rule 9.2 of the Treaty. Thus, as the record now stands, if a patent were to issue without appellants making the required statement that all restrictions on access to the deposit be irrevocably removed upon issuance of the patent, there are no assurances that upon granting of a patent that the public will have access to the deposited strains.
Insofar as it is understandable, I see little logic in the reasoning of the majority. First, the secrecy provision of Rule 9.2 of the Treaty would obviously be overridden and nullified by Rule 11.3(b) upon issuance of this application as a U.S. patent. In fact, this is specifically indicated by the last statement of Rule 9.2. Secondly, I fail to see the logic in the position of the majority that appellants must waive "their right to secrecy under Rule 9.2 of the Treaty", especially when appellants would still retain their right of secrecy under 35 USC 122 and 37 CFR 1.14, if, indeed, such a waiver is possible under the terms of the Budapest Treaty. [FN2] Also, the majority has not provided basis for "the required statement that all restrictions on access to the deposit be irrevocably removed upon issuance of the patent" mentioned in its decision.
*6 The majority asserts that appellants' reliance upon Rule 11.3(b) of the Budapest Treaty is "misplaced" because "(i)t has no bearing on the present issue where a patent application is pending with a pending rejection of claims under 35 USC §112, first paragraph, for lack of enablement" (emphasis in original). I see little merit in the above position taken by the majority since the deciding issue as to the examiner's rejection certainly does not involve the availability of appellants' deposited microorganisms to the general public during the pendency of this application but, rather, involves only the availability of said microorganisms to the general public upon issuance of this application as a U.S. patent. As pointed out by the court in In re Argoudelis, 58 CCPA 769, 434 F.2d 1390, 168 USPQ 99, 102, (1970) "(i)t is not necessary that the general public have access to the culture prior to issuance of the patent". Moreover, only assurance that the general public will have access to the deposited microorganisms upon issuance of the patent is required under the enablement provision of the first paragraph of 35 USC 112. As explained hereinabove, Rule 11.3(b) of the Budapest Treaty provides that assurance in the present case.
FN1. While the majority's decision would lead one to believe that appellants have agreed that MPEP 608.01(p)C constitutes a proper basis for the rejection in issue, this is simply not true. This is clearly evidenced, for example, by the following statement on page 7 of appellants' Brief:
In her fist [sic, first] Office Action, the examiner cited MPEP 608.01(p) (pages 600-36) under "C. Deposit of Microorganisms". The Manual of Patent Examining Procedure, however, is not the patent statute or the rules, but only guidelines from [sic, for] the Examiners.
The examiner's response thereto was to refrain from mentioning MPEP 608.01(p)C in her Answer.
FN2. Neither the Examiner nor the majority has refutted appellants' contention that "it is the crux and essence of the Budapest Treaty that the depositor once he deposits his microorganisms loses all control on the deposited organism(s)" (page 2 of Reply Brief).