Court Opinion

ID: 9489157
Source: CourtListenerOpinion
Date Created: 2023-08-05 13:07:14.25922+00
Date Added: 2024-06-11T17:53:21.657001
License: Public Domain

PAULINE NEWMAN, Circuit Judge,
dissenting.
The issue at this threshold stage is not priority of invention: it is the right to contest priority. The only issue is whether the junior party Schendel made a prima facie case that he was in possession of the subject matter of the count, for the purpose of determining whether there should be an interference proceeding. As discussed in Kahl v. Scoville, 609 F.2d 991, 995, 203 USPQ 652, 656 (CCPA 1979), at this stage of the proceedings “[a]ppellants are only required to establish a prima facie ease; that is, it is assumed that the allegations in appellants’ affidavits are true.” The evidence supporting the allegations on behalf of Schendel was extensive, and was prima facie probative of conception and reduction to practice of the subject matter of the count. Thus I must, respectfully, dissent from the ruling of the panel majority that summary judgment was properly granted against Dr. Schendel.
The record evidence of conception, disclosure, synthesis, and assay meets the requirements of the prima facie case. The testimony and the documentary records are unambiguous and straightforward. The scientific sufficiency of this evidence has not been challenged by persons of skill in this field of science; indeed, both sides followed similar synthesis and assay procedures, to the same effect. The ruling of the majority of a three-member Board of Patent Appeals and Interferences1 that more laboratory work was needed implements an incorrect *1407standard at this stage of the proceedings. For this court to hold by summary judgment that the scientific record is insufficient, when the scientists themselves deemed it sufficient, is an improper judicial role.
The quality of the evidence on behalf of Schendel has not been seriously challenged by the party Curtis. The Board’s summary disposition under 37 C.F.R. § 1.617 was necessarily based on the premise that there is no genuine issue as to any material fact and the party Curtis is entitled to judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 106 S.Ct. 2505, 2514, 91 L.Ed.2d 202 (1986); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). The grant of summary judgment is reviewed de novo on appeal to the Federal Circuit, without deference to the Board’s conclusions of law, and “assum[ing] that the allegations in appellants’ affidavits are true.” Kahl, 609 F.2d at 995, 203 USPQ at 656.
The interference count is as follows:
1. A fusion protein of the formula IL-3/X or X/IL-3 substantially free from association with other proteinaceous materials, wherein X is a hematopoietin selected from the group consisting of G-CSF and GM-CSF, and wherein IL-3 and X are linked either directly or through a peptide linker.
The record shows that Dr. Schendel described the fusion protein of the count in written memoranda to Dr. Stephen C. Clark and also to Dr. Kamen, both research managers at Genetics Institute. The record contains a declaration by Dr. Clark describing discussions with Dr. Schendel of the products that Dr. Schendel proposed to make and the method of their preparation. Conception of the subject matter of the count was found by the Board, and is not at issue.
Dr. Schendel’s declarations describing the various procedures involved, and notebook records showing the experiments that he conducted, are in evidence, as are the declarations and notebook records of others who conducted various phases of the work. The procedures are unchallenged as established modes of carrying out the reactions described. Plasmids containing the known DNA sequences for IL-3 and G-CSF were cleaved at known restriction sites and combined with a peptide linker of known structure. The Board did not dispute the materials used and the reactions conducted, leaving me somewhat surprised that the majority of this panel holds that Dr. Schendel should have re-proved the basic structures, for example by DNA sequencing. As discussed in Berges v. Gottstein, 618 F.2d 771, 774, 205 USPQ 691, 694 (CCPA 1980), “a reasonable analysis of the evidence in toto” is required in determining whether there was a reduction to practice of the count, with reasonable inferences drawn from the scientific tests and data. Similarly, a reasonable an analysis of all the evidence is required in determining whether a prima fade case has been made.
Dr. Schendel, on a form entitled “Requisition for Synthetic Oligodeoxyribonucleo-tides,” ordered the synthesis of two oligonu-cleotides to be used as primers, in order to verify the junctions between the known linker sequence and the known protein-encoding genes. In evidence are the declaration and records of the person who performed the synthesis, Mr. Sookdeo, using an automated commercial nucleotide synthesizer for this routine procedure. Schendel tested the junctions by standard procedure, described in his declaration, and confirmed that the IL-3 vector and G-CSF gene fragment had been linked via the peptide linker. The resulting combination was transformed into a standard E. coli cell line which then expressed the molecule of the count, a fusion protein containing both IL-3 and G-CSF.
The tests and data well support the reasonable inference that these standard reactions proceeded in a standard way to produce the intended product. The IL-3 and G-CSF are known proteins, and the identity of the starting materials is not disputed. The DNA sequences encoding for these proteins are known, the plasmids were cleaved at known sites, and the fusion was conducted by a known procedure using a peptide linker of known structure. No scientific challenge to these procedures was raised. The junctions between the DNA sequences in the recombinant plasmid were verified by known techniques. This standard procedure for linking the expression plasmids for IL-3 and G-CSF *1408was followed by a standard procedure for transformation into a cell line. There is no evidence or suggestion, by Curtis or by the Board, that the procedures were unreliable or flawed. The panel majority criticizes the terseness of Dr. Schendel’s laboratory record that the transformation was successful, by showing data in graphical form and stating that “all cultures induce well.” However, the Board did not dispute that this procedure was routine to scientists skilled in this field, and there is no suggestion that a scientist of similar skill would have deemed these entries and observations unreasonable.
The product was analyzed using standard bioassay procedures. The tests were conducted by analysts experienced in these bioassays. Their declarations and notebook records are in evidence, and the scientific validity of their assays is unchallenged. Analyst JoAnn Giannotti tested for the G-CSF component by Murine Bone Marrow Assay, using the procedure that is described in her declaration. This is an established method of G-CSF analysis, and was not challenged by Curtis or the Board or the majority of this panel. Ms. Giannotti found G-CSF activity. She also recorded in her notebook that the same protein was found by Ms. Ciarletta, another analyst, to have IL-3 activity.
Agnes B. Ciarletta analyzed for the IL-3 component using the M07e Assay; an established technique for this analysis. Her declaration states the details of the procedure, and copies of her laboratory records are in evidence. Analyst Frances Bennett also analyzed for the G-CSF component, using the 32D Proliferation Assay and the DA2 assay, two additional established methods for such analysis. Her notebook pages, and details of the tests and how they were performed, are in the record.
The Board found that these were “positive tests.” The Board held, however, that they did not establish that these proteins “were either IL-3 or G-CSF.” The Board stated that “A sample exhibiting G-CSF activity would not have necessarily had the amino acid sequence of G-CSF.” I don’t know the absolute scientific correctness of this statement as applied to random samples of unknown provenance, but the undisputed facts make the statement extremely unlikely to be correct, or even reasonable, in this case. These scientists started with the known nucleotide sequences for G-CSF and IL-3; they followed standard procedures that do not disrupt the amino acid sequences of G-CSF or IL-3; and the bioassays established that G-CSF and IL-3 activities were present in the proteins that were expressed by standard procedures. It is surely more likely than not that the products were the G-CSF and IL-3 proteins and not some heretofore unknown mimics. Other than a general nay-saying, the Board offered no basis whatsoever for its finding, on summary judgment, that the known IL-3 and G-CSF nucleotide sequences could reasonably be expected to be transformed into something other than the IL-3 and G-CSF proteins.
The Board also held that “there is no evidence that the IL-3 and G-CSF of that sample are linked directly or through a peptide linker.” That is incorrect, and untenable on summary judgment. The evidence was that known starting materials were subjected to known chemical reactions by procedures that were standard, and that the analytical data confirmed that the expected linked product was obtained. Neither the Board, nor Curtis, nor the majority of this panel, has challenged the efficacy of the synthesis to produce the intended molecule. The starting materials contained the known IL-3 and G-CSF sequences and the assays were positive for both IL-3 and G-CSF. The Sookdeo declaration and records showed the synthesis of oligonucleotides of a known sequence, complementary to the IL-3/G-CSF recombinant plasmid linker sequences, and Dr. Schendel testified that these oligonucleotides verified the junctions between the linker and the IL-3 and G-CSF genes.
It is always possible to devise an additional experiment, as does the panel majority in its criticism of the absence of a direct molecular weight determination. However, even if such a test would be interesting to this court, it has not been shown to be critical. In addition, molecular weight was not ignored by Dr. Schendel, who made a more complex type of analysis in calculating specific activity on a molar basis. The specific activity calcu*1409lation when expressed as a ratio to molecular weight shows that the product had half the IL-3 specific activity of the IL-3 dimer, reinforcing the conclusion that the product was the IL-3/G-CSF linked protein:
When calculated on a molar basis, that is, when the raw data are expressed as a ratio of activity to molecular weight, the specific activity of the IL-3/G-CSF fusion protein was about one-half (46%) that of IL3. This is fully consistent with its purported structure (since roughly half the molecule was IL-3 and half was not). By contrast, the homodimer IL34 (with two units of IL3 fused together) was found to have approximately twice the activity as that of IL3 alone, again fully consistent with its purported structure (since both halves of the molecule were IL-3).
Appellant’s brief at 39-10 (footnote omitted.)
Determination of whether the evidence is sufficient to make a prima facie showing that Schendel produced what he said he produced must be based on objective scientific standards, from the viewpoint of the scientists in the field of the invention. It is thus relevant whether the fusion reaction was scientifically routine and reliable, or exotic and unreliable; whether the bioassays were scientifically routine and professionally performed, or whether they were unusual or performed by amateurs. All of the procedures and data together present a prima facie case that Dr. Schendel had produced the molecule of the count. There was no contrary evidence. Although our standard of review of the Board’s grant of summary judgment is plenary, at this stage of the proceedings neither the Board nor we can weigh evidence; to the contrary, reasonable factual inferences must be drawn in favor of the party Schendel. Kahl, 609 F.2d at 995, 203 USPQ at 656; see Anderson, 477 U.S. at 255, 106 S.Ct. at 2513-14.
It is not our appellate role to devise experiments that the inventor did not deem it necessary to conduct, and then to hold that the judges’ choice of experiments is disposi-tive of the issue. The criteria for the grant of summary judgment, a procedure expressly authorized in 37 C.F.R. § 1.617, are not isolated from the law governing summary dispositions. As the law requires, unsupported or conclusory averments are insufficient. Celotex v. Catrett, 477 U.S. at 322-23, 106 S.Ct. at 2552-53. Further, the truth of the factual evidence adduced is not determined in summary proceedings. Anderson v. Liberty Lobby, 477 U.S. at 255, 106 S.Ct. at 2513; Kahl, 609 F.2d at 995, 203 USPQ at 656.
The grant of summary judgment under 37 C.F.R. § 1.617 requires that the evidence is insufficient, on its face, to make a prima facie case of possession of the subject matter of the count before the critical date. Hahn v. Wong, 892 F.2d 1028, 1032, 13 USPQ2d 1313, 1317 (Fed.Cir.1989). The prima facie case, in turn, is based on whether it is more likely than not, on the evidence presented in the affidavits and documentary records, that the party was in possession of the invention of the count. Bosies v. Benedict, 27 F.3d 539, 542, 30 USPQ2d 1862, 1864 (Fed.Cir.1994). Schendel’s evidence showed conception, disclosure, synthesis, and testing of the subject matter of the count. This is not a matter of retrospective reconstruction of ambiguous experiments or vague theories. This is a case of hard evidence, straightforward testimony, and supporting documentation.2
The issue is the threshold question of the right to contest priority. When this right is denied summarily, the law requires that the procedure is fair, and fairly administered. This in turn requires that the rules of summary judgment be properly applied. Since on the evidence of record summary judgment was improperly granted, I respectfully dissent from the affirmance of the Board’s decision.

. The Board was constituted in a curious manner: first an administrative patent judge, in his role as examiner, made the decision; then it was reviewed by a three-member Board presided over by the same administrative patent judge, who wrote an opinion sustaining his action, quoting himself with approval. One member of the Board dissented, stating that the Board had applied an incorrect standard.

. The majority opinion states at n. 8 that "there were no analytical data," but simply "vague inference based on surrounding circumstances.” These conclusions, respectfully, are contrary to the extensive record that was filed in accordance with 37 C.F.R. § 1.608, including the declarations and documents of the analysts who obtained the data. Assuming that the majority is stating that it disbelieves the evidence that was provided, matters of truth and credibility and judicial determination of scientific significance contrary to the view of the scientists themselves, are not matters for summary adjudication.