Trademark Trial and Appeal Board
Patent and Trademark Office (P.T.O.)
*1 EX PARTE STEVEN D. TANKSLEY AND ROBERT BERNATZKY
Appeal No. 93-2307
Application 07/205,223 [FN1]
November 16, 1994
Pursuant to the Board's Standard Operating Procedure No. 94-02, this opinion has been approved for publication. The opinion is binding precedent of the Board. This appeal was decided November 16, 1994.
Chief Administrative Patent Judge
WINTERS and WILLIAM F. SMITH
Administrative Patent Judges
Administrative Patent Judge
DECISION ON APPEAL
This appeal is from the examiner's decision refusing to allow claims 1 through 6, which are all of the claims remaining in the application.
Appellants' invention relates to a set of DNA marker clones, also called "probes," useful for distinguishing between tomato varieties and for linking with traits of interest to facilitate the process of plant breeding by fostering or eliminating such traits. According to appellants, these DNA marker clones are unique, individual compositions of matter isolated from a large number of random clones produced from mRNA and selected on the basis of their useful properties. Appellants assert that the specification describes these clones in terms of their most important utility, namely, hybridizing to tomato genomic DNA at specified map locations. Specifically, appellants assert that:
[w]hat appellants have given the art is a set of clones that are useful because they have been mapped to unique and specific locations on the tomato chromosome map. [Emphasis added].
See the main Brief before the Board, page 1, last paragraph.
Further by way of background, appellants point out that a set of unique cDNA probes, each identifying particular loci on the tomato genome, has been previously derived. These cDNA probes are listed in Table 1 of the specification and are named according to their original designation during the cloning process and according to their loci. A first library comprising 60 cDNA probes in plasmids was placed on deposit according to Budapest Treaty requirements at the In Vitro International Depository of 7885 Jackson Road, Ann Arbor, Michigan 48103, deposited March 19, 1986, entitled "Tomato Nuclear cDNA Clones," under Accession No. IVI-10107. See the specification, pages 11 and 12. A further set of unique cDNA probes, the subject of this patent application, was derived to expand the tomato chromosome map. The library of new probes, comprising 18 cDNA probes in plasmids, was placed on deposit according to Budapest Treaty requirements at In Vitro International Inc., 611P Hammonds Ferry Road, Linthicum, Maryland 21090, deposited March 16, 1987, entitled "Tomato Nuclear cDNA Clones," under Accession No. IVI-10131. See the specification, page 13. Figure 2 of this application illustrates the expanded tomato linkage map of appellants' invention, and a copy of Figure 2 is attached to this opinion as an appendix.
*2 Appealed claims 1 through 6 read as follows:
1. A cDNA library corresponding to tomato DNA comprising at least two clones selected from the group consisting of CD10, CD76, CD66, CD71, CD69, CD68, CD70, CD78, CD74, CD26, CD72, CD18, CD17, CD19, CD39, CD32 and CD2.
2. The cDNA library of claim 1 wherein said two clones are selected from the same chromosome.
3. The cDNA library of claim 1 containing all the clones listed in claim 1.
4. a cDNA clone selected from the group consisting of CD10, CD76, CD71, CD69, CD68, CD36, CD70, CD78, CD74, CD26, CD66, CD72, CD18, CD17, CD19, CD39 and CD2.
5. A plasmid containing a cDNA clone of claim 4.
6. The plasmid of claim 5 comprising pBR322 or pUC8.
In rejecting the appealed claims on non-prior art grounds, the examiner relies on these references:
Graham et al. (Graham), The Journal of Biological Chemistry, "Wound-induced Proteinase Inhibitors from Tomato Leaves," Vol. 260, No. 11, 1985, pages 6555-6560.
In rejecting the appealed claims on prior art grounds, the examiner relies on these references:
Helentjaris et al. (Helentjaris (I)), Plant Molecular Biology, "Restriction fragment polymorphisms as probes for plant diversity and their development as tools for applied plant breeding," Vol. 5, 1985, pages 109-118.
Helentjaris et al. (Helentjaris (II)), Theoretical and Applied Genetics, "Construction of genetic linkage maps in maize and tomato using restriction fragment length polymorphisms," Vol. 72, 1986, pages 761-769.
Alexander et al. (Alexander), Gene, "A simplified and efficient vector-primer cDNA cloning system," Vol. 31, 1984, pages 79-89.
Molecular Biologicals, Cohen, "Cloning Vectors," 1984, pages 55, 57 and 58.
The appealed claims stand rejected as follows:
(1) Claims 1 through 6 under 35 U.S.C. § 112, first paragraph, as based on a specification which does not provide an adequate, written description of the claimed invention and as based on a non-enabling disclosure;
(3) Claims 1 through 6 under 35 U.S.C. § 102 as anticipated by or, in the alternative, under 35 U.S.C. § 103 as unpatentable over Helentjaris (II);
(4) Claims 1 through 5 under 35 U.S.C. § 102 as anticipated by or, in the alternative, under 35 U.S.C. § 103 as unpatentable over Alexander; and
(5) Claim 6 under 35 U.S.C. § 103 as unpatentable over the combined disclosures of Alexander and the Molecular Biologicals reference.
*3 Our deliberations in this matter have included evaluation and review of the following materials:
(1) the instant specification, including Figures 1 and 2, and all of the claims on appeal;
(2) appellants' main Brief before the Board;
(3) the Examiner's Answer and the communication mailed by the examiner March 8, 1993;
(4) the references cited and relied on by the examiner;
(5) the declaration of David Clark, executed November 5, 1991;
(7) the previous opinion and decision of the Board in related Application Serial No. 841,594, Ex parte Tanksley, 26 USPQ2d 1384 (BPAI 1991).
As stated in the communication mailed by the examiner March 8, 1993, "[t]he reply brief filed October 2, 1992 has not been entered." Accordingly, in our deliberations, we have not considered appellants' Reply Brief before the Board.
Having carefully considered those materials, except for appellants' Reply Brief, we disagree with the examiner's prior art and non-prior art rejections. For the reasons discussed infra, we shall not sustain those rejections. Nevertheless, we enter a new ground of rejection of claims 1 through 6 under 35 U.S.C. § 112, first and second paragraphs.
THE EXAMINER'S REJECTIONS
Relying on the declaration of David Clark, executed November 5, 1991, appellants argue that both Helentjaris references are non-enabling. In the declaration, Clark states the following:
1. That on and prior to March 13, 1987, Native Plants, Inc. was the sole owner of the tomato cDNA libraries and clones made by Native Plants, Inc. and described in Helentjaris, T. et al. (1985) Plant Mol. Biol. 5:109-118; and Helentjaris, T. et al. (1986) Theor.Appl.Genet. 72:761-769.
a) A nonexclusive license was being offered for approximately one million dollars. Licensees were not permitted to sublicense or distribute the clones to third parties.
b) Public institutions could obtain clones upon request for research purposes only under a Letter of Confidentiality requiring that they not release the clones to third parties.
According to appellants, the declaration establishes that access to the Helentjaris libraries and clones was restricted to either (1) nonexclusive licensees, at a cost of approximately one million dollars; and (2) public institutions, for research purposes only, under a Letter of Confidentiality requiring that the institutions not release the clones to third parties. See appellants' main Brief before the Board, page 24. In view of that restricted access, appellants assert, the tomato cDNA libraries and clones described in the Helentjaris references were not publicly available on or before the filing date of their parent application. Appellants conclude that both Helentjaris references are non-enabling.
*4 Likewise, based on the declaration of Michael G. Murray, executed March 25, 1991, appellants argue that the Alexander reference is non-enabling. In the declaration, Murray states the following:
I further submit that the Alexander et al., Graham et al. and Helentjaris et al. references do not contain disclosures which would enable a skilled worker to reproduce their libraries. There is no mention in these references of the clones described being on deposit or publicly available, and it would be impossible to duplicate the clone libraries described following the procedures set forth in the articles. The libraries described in the articles are nowhere near large enough to be statistically representative, i.e., to have a good probability of representing all possible mRNAs. This may be illustrated by considering a simplified case as follows: Assuming that an organism contains only 1000 different messages named 1 through 1000 and all are of equal abundance. mRNA is isolated from the organism and because cDNA cloning is often inefficient, only two partial libraries of only 100 clones are obtained on two successive attempts. The probability that every clone in the first library is also present in the second is less than 10-136 (see Dayhoff, J.E. (1984) Bulletin of Mathematical Biology 46:529-543, attached hereto as Exhibit F). By analogy, the cited libraries cannot now be duplicated to determine whether or not any clones therein are the same as the clones claimed in the present application. [Emphasis added].
According to appellants, the Murray Declaration provides an adequate, evidentiary basis to support the conclusion that the Alexander reference is non-enabling.
In view of our disposition of this appeal, we find it unnecessary to reach or decide the question whether the Helentjaris and Alexander references are enabling. For the purposes of this appeal, we shall assume, arguendo, that each reference is enabling. Even making that assumption, however, we hold that neither of the Helentjaris references nor the Alexander reference constitutes sufficient evidence to support a conclusion of anticipation or obviousness of the subject matter sought to be patented in claims 1 through 6.
In the declaration of Michael G. Murray, executed March 25, 1991, Murray offers his expert opinion that "the likelihood of an identical clone to one of the clones from the Tanksley library having been present in the Alexander ... or Helentjaris libraries is so low as to be unworthy of serious consideration" and "[i]t is therefore virtually impossible for the Alexander et al .... or Helentjaris et al. libraries to contain exact duplicates of the Tanksley clones." See the declaration, page 2, first full paragraph and page 3, second full paragraph. That opinion is based on a detailed statistical analysis involving logic and sound scientific reasoning, replete with references to the literature. See the Murray Declaration, particularly pages 2 through 4. The declaration evidence is entitled to fair weight and, in our judgment, the examiner erred by (1) characterizing Murray's analysis as "merely hypothetical," and (2) summarily dismissing the declaration as containing "unsupported opinions." See the Examiner's Answer, page 19, last paragraph.
*5 Taking into account the analysis presented in the Murray Declaration, we hold that neither of the Helentjaris references nor the Alexander reference anticipates appellants' claims either under the doctrine of inherency or any other recognized legal doctrine. As stated by Murray, "[t]he likelihood of an identical clone to one of the clones from the Tanksley library having been present in the Alexander ... or Helentjaris libraries is so low as to be unworthy of serious consideration" and "[i]t is therefore virtually impossible for the Alexander et al .... or Helentjaris et al. libraries to contain exact duplicates of the Tanksley clones." Accordingly, we reverse each of the § 102 rejections set forth by the examiner.
With respect to the rejections under 35 U.S.C. § 103, we find that the cited prior art provides no suggestion which would have led a person having ordinary skill from "here to there," i.e., from the clones disclosed by Helentjaris or Alexander to the clones recited in appellants' claims. We have no doubt that the prior art could be modified in such manner to arrive at appellants' clones. The mere fact, however, that the prior art could be so modified would not have made the modification obvious unless the prior art suggests the desirability of the modification. In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed.Cir.1984) and cases cited therein. That is not the case here. Accordingly, we reverse each of the § 103 rejections set forth by the examiner. In so doing, we note that the Molecular Biologicals reference does not cure the above-noted deficiency of the Alexander reference, and does not, in combination with Alexander, establish the obviousness of claim 6.
Respecting the non-prior art rejection, the examiner rejects claims 1 through 6 under 35 U.S.C. § 112, first paragraph, as based on a specification which fails to provide an adequate, written description of the claimed invention and as based on a non-enabling disclosure. Like the situation presented in Ex parte Tanksley, 26 USPQ2d 1384 (BPAI 1991), however, the reasons set forth by the examiner are more germane to a rejection under 35 U.S.C. § 112, second paragraph, for claim indefiniteness. The examiner emphasizes that appellants' claimed subject matter relates to DNA fragments. According to the examiner, appellants are remiss in not providing sequence data for their DNA fragments or information pertaining to proteins encoded by or partially encoded by the claimed cDNAs. According to the examiner, sequence data "would better characterize the cDNA clones" and "facilitate a complete search of the prior art." See the Examiner's Answer, page 13. The examiner takes the position that appellants' specification and claims do not provide adequate information so that the examiner may readily search and examine the application. We disagree with this line of reasoning.
*6 The § 112 rejection amounts to a requirement, imposed by the examiner, that appellants amend their claims in a specified manner to "facilitate a complete search of the prior art." Again, see the Answer, page 13. We find no language in the statute or case law which would support that requirement. On the contrary, the second paragraph of § 112 states that the specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention, and our reviewing court has interpreted that provision as requiring that the claims do, in fact, set out and circumscribe a particular area with a reasonable degree of precision and particularity. See In re Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971). In our judgment, a patent applicant is entitled to a reasonable degree of latitude in complying with the second paragraph of 35 U.S.C. § 112 and the examiner may not dictate the literal terms of the claims for the stated purpose of facilitating a search of the prior art. Stated another way, a patent applicant must comply with 35 U.S.C. § 112, second paragraph, but just how the applicant does so, within reason, is within applicant's discretion.
We are mindful that the examiner relies on the above-cited Graham and Martin references in rejecting claims 1 through 6 on non-prior art grounds. We have carefully reviewed those references, but find no disclosure therein persuading us that the examiner's rationale supporting the § 112 rejection is correct.
For the reasons discussed infra, in the new ground of rejection, we find that claims 1 through 6 are indefinite within the meaning of 35 U.S.C. § 112, second paragraph, and based on a non-enabling disclosure within the meaning of 35 U.S.C. § 112, first paragraph. We do not, however, agree with the examiner's reasons in rejecting claims 1 through 6 on non-prior art grounds. Accordingly, we reverse the rejection of claims 1 through 6 under 35 U.S.C. § 112, first paragraph.
To the extent that the previous Board's holding in Ex parte Tanksley, 26 USPQ2d 1384 (BPAI 1991), may be considered in conflict with our holding with respect to the non-prior art rejection, we invite attention to Helentjaris (II) published in Theoretical and Applied Genetics, 72:761-769 (1986), entitled "Construction of genetic linkage maps in maize and tomato using restriction fragment length polymorphisms." That reference was not of record in the previous appeal, but it is of record here, and indicates the appropriate terminology, nomenclature, and usage familiar to persons having ordinary skill in this art. Note particularly Figure 3 in Helentjaris (II), i.e., the tomato genetic linkage map illustrated therein. Considering all the evidence in this record, we are of the firm conviction that the examiner's approach in rejecting claims 1 through 6 under 35 U.S.C. § 112, first paragraph, is incorrect.
NEW GROUND OF REJECTION
*7 Under the provisions of 37 CFR § 1.196(b), we enter the following new ground of rejection.
Claims 1 through 6 are rejected under 35 U.S.C. § 112, first and second paragraphs, as based on a non-enabling disclosure and as not particularly pointing out and distinctly claiming the subject matter which appellants regard as their invention. This rejection has three aspects.
scope of equivalents
On first reading, claims 1 through 6 appear to set out and circumscribe a particular area with a reasonable degree of precision and particularity. This is so because the claims recite a finite number of cDNA clones, analogous to the recitation of a finite number of integers along the number line. We point out, however, that claims which on first reading appear definite may upon a reading of the specification disclosure take on an unreasonable degree of uncertainty. See In re Moore, 439 F.2d 1232, 169 USPQ 236 (CCPA 1971).
Here, we have analyzed the definiteness of claims 1 through 6 not in a vacuum, but rather in light of the specification disclosure as the claim language would be interpreted by a person having ordinary skill in the art. Note particularly the following passage in appellants' specification, page 34, first paragraph:
As discussed above, the map distances given herein in Figures 1 and 2 are statistically derived. It should be understood that variations of 5 to 10 cM are not statistically significant, and clones within such distance of each other are within the scope of equivalents of this invention.
Apparently, in light of that disclosure, appellants would not restrict or limit coverage to the finite number of cDNA clones recited in claims 1 through 6. Rather, they would extend coverage to a "scope of equivalents" referred to at page 34 of the specification in conjunction with Figures 1 and 2 of this patent application. This would be analogous to extending coverage to other integers along the number line, not recited in the claims. The situation is exacerbated here because only Figure 2 shows the expanded tomato linkage map of this invention. Figure 1 shows a tomato linkage map based on cDNA and isozyme markers as disclosed in U.S.Patent Application No. 841,594, filed March 20, 1986. See appellants' specification, paragraph bridging pages 7 and 8.
In view of that latent ambiguity, we hold that the claims take on an unreasonable degree of uncertainty and are indefinite within the meaning of 35 U.S.C. § 112, second paragraph.
We emphasize, as a matter of claim interpretation, that it is incorrect to read unwritten limitations into pending claims contrary to the plain words of those claims. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed.Cir.1989). Even assuming arguendo, however, that we read the unwritten limitations from the specification into claims 1 through 6, the claims would still be indefinite. In our judgment, the full range or "scope of equivalents" referred to in the specification, page 34, first paragraph, is entirely unclear.
*8 Furthermore, to the extent that claims 1 through 6 embrace more than the finite number of cDNA clones expressly recited, the claims are based on a non-enabling disclosure. This is so because appellants have not established that they have placed on deposit, in an appropriate manner, any cDNA clones which are the subject of this patent application other than those referred to in the specification, page 13, first paragraph.
This aspect of the new ground of rejection may be overcome if appellants cancel the passage appearing at page 34, first paragraph, of the specification.
status as an international depository
As reflected by the prosecution history of this application, an appropriate deposit of appellants' cDNA library in a recognized depository is required to satisfy the enablement provision of 35 U.S.C. § 112, first paragraph. The examiner determined that appellants' deposit with In Vitro International Inc., referenced at page 13 of the specification, satisfies that requirement. Be that as it may, we note that In Vitro International Inc.'s status as an international depository was terminated effective September 25, 1991. See 1129 OG 51, "Notice of Termination of Status of International Depository Authority under Budapest Treaty," August 27, 1991, copy enclosed with this opinion. That termination of status raises the question whether appellants may continue to rely on the In Vitro International Inc. deposit to satisfy the enablement provision of 35 U.S.C. § 112, first paragraph. Clarification of the status of the deposit is required and, on the facts of this case, appellants carry the burden of supplementing the record with such clarification.
appropriate accession no.
Conspicuous by its absence from claims 1 through 6 is any reference to the appropriate Accession No. of a recognized, international depository authority. Manifestly, the claim language should tie in directly to the relevant Accession No. This follows because the CD numbers referred to in the claims, in and of themselves, are arbitrary and meaningless. Reference to the appropriate Accession No. in the appealed claims is necessary so that the claims set out and circumscribe a particular area with a reasonable degree of precision and particularity, and are based on an enabling disclosure.
This aspect of the new ground of rejection may be overcome if appellants amend the claims, in an appropriate manner, to insert reference to the relevant Accession No. of a recognized, international depository authority.
In conclusion, we do not sustain the examiner's prior art or non-prior art rejections. We enter a new ground of rejection of claims 1 through 6 under 35 U.S.C. § 112, first and second paragraphs. The examiner's decision is reversed.
*9 Any request for reconsideration or modification of this decision by the Board of Patent Appeals and Interferences based upon the same record must be filed within one month from the date of the decision (37 CFR § 1.197). Should appellants elect to have further prosecution before the examiner in response to the new rejection under 37 CFR § 1.196(b) by way of amendment or showing of facts, or both, not previously of record, a shortened statutory period for making such response is hereby set to expire two months from the date of this decision.
Effective August 20, 1989, 37 CFR § 1.196(b) has been amended to provide that a new ground of rejection pursuant to the rule is not considered final for the purpose of judicial review under 35 U.S.C. § 141 or § 145.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR § 1.136(a).
REVERSED--37 CFR § 1.196(b)