Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE STANDISH K. ALLEN JONATHAN A. CHAITON AND SANDRA L. DOWNING
Appeal No. 86-1790
April 3, 1987
Application for Patent filed September 6, 1984, Serial No. 647,963. Inducing Polyploidy in Oysters.
Jeffrey J. Miller et al. for appellants
Primary Examiner--Hugh R. Chamblee
Before Serota
Chairman
Calvert
Spencer, R. Smith and McCandlish
Examiners-in-Chief
R. Smith
Examiner-in-Chief
ON BRIEF
This is an appeal from the rejection of claims 8, 12, 13 and 14. Claims 1 through 7 and 9 through 11 have been allowed. Claims 15 and 16, proposed by appellants in their amendment pursuant to Rule 116 (Paper No. 16), were refused entry by the examiner (Paper No. 17).
The subject matter on appeal relates to polyploid oysters. The four rejected claims are product-by-process claims. They read as follows:
8. Polyploid Pacific oysters produced by the method of claim 1.
12. Polyploid Pacific oysters produced by the method of claim 9.
13. The Pacific oysters of claim 8 belonging to the species Crassostrea gigas.
14. The Pacific oysters of claim 12 belonging to the species Crassostrea gigas.
The rejected claims are dependent on allowed claims drawn to a method of inducing polyploidy in oysters utilizing hydrostatic pressure which read as follows:
1. A method of inducing polyploidy in oysters, comprising:
separating oysters from one another such that male oysters are isolated from female oysters;
inducing said oysters to spawn;
controlling the temperature of eggs from said oysters;
fertilizing said eggs with sperm to form zygotes;
applying hydrostatic pressure to said zygotes at a predetermined intensity for a predetermined duration after a predetermined time following formation of said zygotes to induce polyploidy; and
cultivating said polyploid zygotes.
9. A method of inducing polyploidy in oysters, comprising:
separating oysters from one another such that male oysters are isolated from female oysters;
inducing said oysters to spawn;
controlling the temperature of eggs from said oysters at approximately 25C;
fertilizing said eggs with sperm to form zygotes;
applying hydrostatic pressure of approximately 6000 to 10,000 psi for a predetermined duration approximately 15 minutes after fertilization to said zygotes to induce polyploidy; and
cultivating said polyploid zygotes.
The reference of record relied on by the examiner is:
Stanley et al., 'Growth of American Oysters Increased by Polyploidy Induced by Blocking Meiosis I But Not Meiosis II,' Aquaculture, 37 (1984), pages 147- 155.
Claims 8 and 12 through 14 are rejected for obviousness under 35 USC 103 in view of Stanley et al. and are also rejected under 35 USC 101 on the ground that the claimed invention is directed to nonstatutory subject matter.
*2 In support of his rejection under 35 USC 101, the examiner states that polyploid oysters are held to be living entities and do not fall within the statutory subject matter of 35 USC 101. The examiner adds that the animal produced by the method claimed is 'controlled by laws of nature and not a manufacture by man that is patentable.' The examiner also relies on In re Merat, 519 F.2d 1390, 186 USPQ 471 (CCPA 1975) and In re Bergy, 563 F.2d 1031, 195 USPQ 344 (CCPA 1977) in support of his position. In its 1975 decision in Merat the Court affirmed a rejection under 35 USC 112 and did not reach the 35 USC 101 rejection made by the examiner and affirmed by the Board of Appeals. Although the Court reversed a 35 USC 101 rejection in Bergy and held that living microorganisms were within the terms 'manufacture' and 'composition of matter' in § 101, the examiner notes that the Court in its opinion categorized the claimed microorganisms as 'more akin to inanimate chemical compositions such as reactants, reagents, and catalysts than they are to horses and honeybees or raspberries and roses.'
We shall not sustain this rejection. As we have previously noted in our decision in Ex parte Hibberd, 227 USPQ 443 (BPAI 1985), the Supreme Court has interpreted the scope of 35 USC 101 [FN1] in the recent case of Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980). The Court noted that the use of the expansive terms 'manufacture' and 'composition of matter' modified by the comprehensive 'any' indicated that Congress 'plainly contemplated that the patent laws would be given wide scope.' The Supreme Court also noted that the legislative history of Section 101 supports a broad construction and concluded from the Committee Reports accompanying the 1952 Act that Congress intended statutory subject matter to 'include anything under the sun that is made by man.' Thus, the Court held at 447 U.S. 309, 206 USPQ 197, that the involved microorganism plainly qualified as patentable subject matter.
The examiner's position that the claimed polyploid oysters are 'held to be living entities' is not controlling on the question of whether the claims are drawn to patentable subject matter under 35 USC 101 because the Supreme Court made it clear in its decision in Diamond v. Chakrabarty, supra, that Section 101 includes man-made life forms. The issue, in our view, in determining whether the claimed subject matter is patentable under Section 101 is simply whether that subject matter is made by man. If the claimed subject matter occurs naturally, it is not patentable subject matter under Section 101. The fact, as urged by the examiner, that the oysters produced by the claimed method are 'controlled by the laws of nature' does not address the issue of whether the subject matter is a non-naturally occurring manufacture or composition of matter. The examiner has presented no evidence that the claimed polyploid oysters occur naturally without the intervention of man, nor has the examiner urged that polyploid oysters occur naturally. The record before us leads to no conclusion other than that the claimed polyploid oysters are non-naturally occurring manufactures or compositions of matter within the confines of patentable subject matter under 35 USC 101. Accordingly, the rejection under Section 101 must be reversed.
*3 The examiner's reliance on the 35 USC 101 rejection affirmed by the Board of Appeals, which the Court did not address in In re Merat, supra, is misplaced because Merat was decided before the decision by the Supreme Court in Chakrabarty. The Board in Merat did not have the benefit of the Supreme Court's analysis of the scope of Section 101 as set forth in Chakrabarty. The Board of Patent Appeals and Interferences is now obliged to interpret Section 101 in accordance with Chakrabarty.
Nor does the examiner's position find any support in the Bergy decision. The holding in Bergy that the fact that the claimed culture was alive did not remove it from the categories of invention enumerated in § 101 is consistent with Chakrabarty. The Court in Bergy made clear that it was only deciding the case before it and was not 'deciding whether living things in general, or, at most, whether any living things other than microorganisms, are within § 101.' Moreover, the decision by the Supreme Court in Chakrabarty is controlling authority that Congress intended statutory subject matter to 'include anything under the sun that is made by man.'
With respect to the rejection under 35 USC 103 we have carefully considered the respective positions of the examiner and the appellants and the declaration of co-inventor Allen, who is also a co-author of the Stanley et al. reference relied on by the examiner in support of the rejection. We have decided that we will affirm this rejection.
Stanley et al. disclose a method of inducing polyploidy in oysters involving the use of cytochalasin B. Stanley et al. report that they successfully induced polyploidy in the American oyster, Crassostrea virginica, by treating the fertilized eggs with cytochalasin B. The treatment resulted in polyploidy of over half the individuals. Stanley et al. recommend the induction of polyploidy in oysters as a way to increase growth as follows:
We have shown a clear growth advantage in triploid American oysters produced by blocking the first meiosis division. We recommend induction of polyploidy as a way to increase growth in cultured oysters.
We agree with the examiner that in view of the express recommendation by Stanley et al., experts in the art who have successfully induced polyploidy in one species of oysters, it would have been obvious to one of ordinary skill in the art to induce polyploidy in Pacific Crassostrea gigas oysters. Moreover, one of ordinary skill in the art would have a reasonable expectation that the Stanley et al. method would be successful in inducing polyploidy in Crassostrea gigas oysters based on the success by Stanley et al. with Crassostrea virginica oysters and the recommendation by Stanley et al. to utilize the method with cultured oysters. Although appellants utilize a different process than Stanley et al. to induce polyploidy in oysters, involving the use of hydrostatic pressure rather than chemical treatment, the patentability of a product does not depend on its method of production. If the product in a product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). Thus, the examiner has correctly adduced a prima facie case of obviousness for the claimed polyploid oysters, and the burden shifted to appellants to rebut the prima facie obviousness. In our view appellants have not done so.
*4 In an attempt to rebut the examiner's prima facie case of obviousness, appellants rely on the declaration of co-inventor Allen. Allen declares in paragraph 6. of his declaration that:
. . . there are distinctive phenotypic differences between c. gigas and c. virginica, and that it would not have been obvious to apply the prior art techniques to c. gigas, because the techniques disclosed by Stanley et al. do not work on c. gigas.
Appellants argue that, based on the Allen declaration, the claimed Pacific c. gigas oysters would not have been obvious from the disclosure of Stanley et al. because the Stanley et al. techniques do not work on c. gigas oysters. Allen urges further that a modification of a prior art process which renders the process inoperable cannot serve as a basis for a § 103 rejection.
We agree with the Examiner that the Allen declaration is not persuasive of nonobviousness. Preliminarily, we note that mere conclusory statements, such as the one quoted, supra, are entitled to little weight when the Patent and Trademark Office questions the efficacy of the statements. In re Lindner, 59 CCPA 920, 457 F.2d 506, 173 USPQ 356 (1972). Here, the examiner challenged the noted conclusion of inoperability, as do we, and pointed out that the declaration as a whole supports the examiner's position of obviousness. Thus, as noted by the examiner, the declaration indicates in paragraphs 12-15 that low yields are obtained and near total mortality is experienced when treating c. gigas oysters at the precise temperature and duration of chemical treatment utilized by Stanley et al. Such facts do not establish inoperability of the reference. Quite clearly, inoperativeness is not established merely by showing that the particular disclosed embodiment for carrying out the principles of the invention is lacking in perfection, Decca Ltd. v. United States, 544 F.2d 1070, 191 USPQ 439 (Ct. Cl. 1976). Cf. Bennett v. Halahan, 48 CCPA 782, 285 F.2d 807, 811, 128 USPQ 398, 401 (1961) where the Court said:
It is well settled that the apparatus disclosed in an application need not necessarily be operative in the exact form in which it is shown and described. It is sufficient if it can be rendered operative by adjustments and corrections which would naturally occur to a skilled worker in the art attempting to construct the apparatus on the basis of the application disclosure.
We agree with the examiner that it is well within the skill of the art to optimize the parameters such as temperature and time of chemical treatment when applying the Stanley et al. process to a different species of oyster in order to obtain the optimum yield of polyploid oysters. The fact that such optimization may be required when utilizing the Stanley et al. recommended method to induce polyploidy in c. gigas oysters does not in our view render polyploid c. gigas oysters unobvious. The Allen declaration indicates in paragraph 20. that an 'acceptable' treatment was developed for inducing polyploidy in c. gigas utilizing cytochalasin B as recommended by Stanley et al. as follows:
*5 20. That extensive experimentation was in fact done to develop an acceptable cytochalasin B treatment for induction of polyploidy in c. gigas, involving 3 years years sic of effort by trained scientists.
We attach no significance to the fact that appellants may have experimented for three years to develop an 'acceptable' treatment in the absence of any indication of what experimentation was undertaken and what constitutes an 'acceptable' treatment. The fact remains that Stanley et al. recommended the cytochalasin B treatment for the induction of polyploidy in cultured oysters generally, and that appellants followed that recommendation by using the cytochalasin B treatment to induce polyploidy in c. gigas oysters. After some modifications in process parameters, such as temperature and time of treatment, the process was 'acceptable.'
Appellants urge that the examiner misconstrued what the declarant was saying, and appellants explain in their supplemental reply brief (Paper No. 18) what the declarant intended. However, we find the examiner's construction of the declaration to be entirely consistent therewith. Nonobviousness cannot be based on lawyer's arguments in the brief, but rather must find clear, unequivocal support in the evidence relied on. We find it significant that, although appellants rely on the alleged inoperability of the Stanley et al. process, there is no clear indication in the declaration that the Stanley et al. process was carried out using the precise conditions utilized by Stanley et al. Rather, appellants rely on a conclusory statement by the declarant based on conditions other than those utilized by Stanley et al.
We disagree with appellants' characterization of the examiner's rejection as 'obvious to try.' In the circumstances here where experts in the art have successfully utilized the process with one species of oyster and have specifically recommended that the process be utilized with cultured oysters generally, we agree with the examiner that it would have been obvious to one skilled in the art to apply the process to Pacific c. gigas oysters, and that he would have had a reasonable expectation, indeed a strong expectation, of success in producing a polyploid oyster. In our view the successful utilization of the Stanley et al. process to produce an 'acceptable' cytochalasin B treatment for induction of polyploidy in c. gigas oysters, albeit with some optimization of process parameters, substantiates the reasonableness of the expectation of success.
Appellants' argument that the claimed polyploid c. gigas oysters are unobvious because they are sterile and do not devote significant portions of their body weight to reproduction, thereby remaining edible year around, is not persuasive. It was known in the area that polyploids exhibit sterility. See, e.g., Stanley et al. page 147. Thus, it is not unexpected that sterile, polyploid c. gigas oysters do not devote significant portions of their body weight to reproductive gamete formation.
*6 The decision of the examiner is affirmed.
AFFIRMED
BOARD OF PATENT APPEALS AND INTERFERENCES
Saul I. Serota
Chairman
Ian A. Calvert
Vice-Chairman
Richard A. Spencer, Jr
Examiner-in-Chief
Ronald H. Smith
Examiner-in-Chief
Harrison E. McCandlish
Examiner-in-Chief
FN1. The language of 35 USC 101 is as follows:
§ 101. Inventions patentable
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
<< Return to Board of Patent Appeals and Interferences Index