Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 NASHEF ET AL.
Patent Interference No. 101,355
July 1, 1987
Final Hearing June 2, 1987
Method For Inhibiting Mineralization of Natural Tissue During Implantation
Application of Aws S. Nashef and Ahmed I. Ahmed filed November 12, 1982, Serial No. 441,023
Patent granted to Elisabeth M. Pollock on September 20, 1983, Patent No. 4,405,327, Serial No. 411,190, filed August 25, 1982.
Leonard P. Prusak, Robert L. Minier, Wayne R. Eberhardt, and Lawrence D. Schuler for Pollock. Oral argument by Wayne R. Eberhardt
Before R. Smith, Seidleck and Caroff
This interference [FN1] involves an application of Nashef et al (Nashef), apparently assigned to Baxter Travenol Laboratories, Inc. [FN2], and a patent granted to Pollock, assigned to Extracorporeal Medical Specialties, Inc.
The subject matter in issue concerns a method for treating fixed natural tissue with a particular type of quaternary ammonium salt in aqueous solution prior to implantation in a living body so that mineralization, i.e., calcification, of the tissue is inhibited after implantation. The subject matter in issue is particularly defined by the following count, which is the only count involved in this interference:
A method for inhibiting the mineralization of fixed natural tissue after implantation in a living body comprising contacting fixed natural tissue intended for implantation with an aqueous solution of a water soluble quaternary ammonium salt whose nitrogen atom has at least one alkyl group containing from 7 to 15 carbon atoms.
The claims of the parties which correspond to this count are:
Nashef: Claims 7, 19-30 and 43 [sic 37] [FN3]
Pollock: Claims 1-22
Both parties took testimony in an attempt to establish a date of invention prior to their respective filing dates. Additionally, Nashef relies upon a motion for judgment (Paper No. 40) on the ground of inequitable conduct, consideration of which was deferred to final hearing. Both parties filed briefs and appeared through counsel, at final hearing.
The following issues were raised in the parties' briefs and, therefore, are before us for adjudication:
2. Has Nashef, the junior party, established a date of invention [FN4] prior to Pollock's filing date?
3. If Nashef is found to have established a date of invention prior to Pollock's filing date, has Pollock established an even earlier date of invention?
The Charge of Inequitable Conduct
The Nashef motion is premised on the notion that certain allegedly unfavorable test results obtained by Pollock were material to the examination of her involved patent application and that the failure to disclose such information constituted inequitable conduct on the part of Pollock. The test results in question relate to the investigation by Pollock of so-called '16- carbon compounds', i.e., those quaternary ammonium salts containing an alkyl group having 16 carbon atoms (Cetyltrimethyl ammonium chloride and Cetyltrimethyl ammonium p-toluene sulfonate) [FN5], as calcification inhibitors. Nashef contends that, at the time, the test results were judged by Pollock herself as failing to show that a 16-carbon compound would inhibit calcification. We are thus asked to conclude that Pollock or her attorney should have known that the allegedly unsuccessful tests of 16-carbon compounds, which are just outside Pollock's claimed range of compounds, reflected upon predictability with regard to the effectiveness of the entire claimed range of compounds and, accordingly, that a reasonable examiner would have considered the tests important in deciding whether to allow the application to issue as a patent. To support these contentions, Nashef points to a number of statements and exhibits in Pollock's record, [FN6] e.g., RP-37, 99, 121; P-20 (Table I).
*2 In opposition, Pollock places emphasis on the test results themselves rather than on her contemporaneous interpretation of the data. According to Pollock, an independent examination of the test data reveals that in fact the 16-carbon compounds were effective in inhibiting calcification; in some instances even more so than the 12-carbon compound which was unequivocally considered to be an effective inhibitor. Specifically, the senior party refers to the test data reported in P-13, P-14, P-15 and P-20, and points out that Pollock elected not to include the 16-carbon compounds as part of her invention even though the experimental data allegedly would have easily supported a claim which included these compounds as calcification inhibitors. Thus, we are asked to conclude that if any error was made by Pollock, it was in claiming less than she had a right to claim; and that such error would not support a finding of inequitable conduct.
Opinion re: Inequitable Conduct
An allegation of inequitable conduct is a serious charge and should not be made lightly; one who makes the charge bears a heavy burden of proof. J.P. Stevens & Co. v. Lex Tex., Ltd., 747 F.2d 1553, 223 USPQ 1089 (Fed.Cir. 1984); cert. denied, ---- U.S. ----, 106 S.Ct. 73 (1985); Rohm and Haas Co. v. Crystal Chemical Co., 722 F.2d 1556, 220 USPQ 289 (Fed.Cir. 1983), cert. denied, 105 S.Ct. 172 (1984). The burden is on Nashef to establish inequitable conduct by clear and convincing evidence of the following elements: (1) materiality, i.e., a substantial likelihood that a reasonable examiner would have considered the omitted information important in deciding whether to allow the application to issue as a patent; and (2) scienter, i.e., actual intent to mislead the Patent and Trademark Office in the performance of its duties or such reckless abandon amounting to gross negligence. Once the thresholds of materiality and intent are established, they must be balanced to determine whether the scales tilt to a conclusion that inequitable conduct occurred. Thus, a greater showing of materiality will lower the threshold level of intent that must be present. American Hoist & Derrick Co. v. Sowa & Sons, Inc., 220 USPQ 763 (Fed.Cir. 1984).
In this case, we fail to find the requisite materiality and scienter. First of all, it is not at all clear that the omitted information would have been considered material by a reasonable examiner in the sense of casting doubt upon the effectiveness of the entire claimed range of compounds as anticalcifying agents. In this connection, we note that the 16-carbon compounds are not within the scope of Pollock's claims. Moreover, the record indicates that Pollock's characterization of these compounds as having 'not inhibited calcification' was not as totally negative as Nashef make it out to be, for Pollock apparently also felt that 16-carbon and longer compounds were worthy of further investigation. See P-23 (page 1, paragraph 3). More significantly, it is not at all clear from the record that a reasonable examiner would have concluded that the 16-carbon compounds are totally ineffective for the purpose of inhibiting calcification if the test data in question were brought to the attention of the Patent and Trademark Office for its independent evaluation. In this regard, we note that nowhere in the Pollock patent is it suggested that by 'inhibition' is meant the total and complete prevention of mineralization. For the reasons set forth in Pollock's brief, the omitted test data are certainly consistent with a conclusion that the 16-carbon compounds are effective, at least to some extent, as inhibitors relative to a control sample.
*3 For the sake of argument, even if the information not disclosed by Pollock could be viewed as somewhat material, the level of materiality could not be considered so great as to lower the threshold level of intent that must be proven. In our opinion, materiality, if any, is diminished by the fact that the tests in question involved compounds outside the scope of Pollock's claims, as distinguished from the situations addressed in cases [FN7] cited by Nashef where the unfavorable test data which were withheld related to the testing of materials embraced by the involved claims. The relationship of the information not disclosed to the claimed subject matter is a factor which must be considered in assessing degree of materiality.
As for scienter, a mistake may have been made in drafting the involved Pollock application. This mistake could have been mere error (the involved attorney claimed less than could have been claimed) or fraud (Pollock and her attorney may both have believed that 16-carbon or longer compounds were totally ineffective inhibitors and may have realized that this information could reflect adversely upon the operability of some of the lower carbon compounds within the claimed range). The party Nashef has not sustained its burden of proof to show, by clear and convincing evidence, that the mistake was other than simple error. In this connection, see Glaser v. Strickland, 220 USPQ 446, 454 (Bd.Pat.Int. 1983). Indeed, no testimony was taken of the attorney who drafted the involved Pollock application in an attempt to establish the necessary scienter. A party making charges of fraud or inequitable conduct would under normal circumstances be expected to have taken the testimony of the principals involved in an attempt to establish the necessary scienter. Cf. KangaRoos U.S.A., Inc. v. Caldor, Inc., 778 F.2d 1571, 228 USPQ 32 (Fed.Cir. 1985). Absent such proof, we must conclude that inequitable conduct has not been established.
Nashef's Case For Priority
Nashef, as the junior party, has the burden of proving priority by a preponderance of the evidence. Peeler v. Miller, 535 F.2d 647, 190 USPQ 117 (CCPA 1976). Nashef's case for priority is primarily based upon activities by or on behalf of the junior party which occurred prior to the senior party's filing date and which are said to constitute an actual reduction to practice of the invention defined by the count at issue.
We find Nashef's evidentiary record insufficient to establish an actual reduction to practice prior to the critical date of August 25, 1982. There is no question that Nashef first treated tissue by the subject method on or about June 10, 1982 (RN-92); implanted the treated tissue in test animals on or about June 21, 1982 (RN-98); and 'explanted' all samples by August 2, 1982 (N-8, page 56). Pollock admits as much on page 15 of her brief. However, the invention in issue involves the treatment of natural tissue to render it less susceptible to calcification after implantation, in essence a method of making a product. To establish an actual reduction to practice of such an invention, it is not enough to show that the method was performed. Such an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and this may require successful testing of the product. Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371 (CCPA 1948).
*4 The calcification-resistant tissue resulting from the process here in issue is clearly of such a nature that tests would be necessary to determine whether or not it was satisfactory. The resistance to calcification after implantation clearly could not be determined by inspection alone. In fact, it appears that for a complete evaluation of any particular prospective calcification inhibitor, Nashef considered it necessary to conduct a testing program including the collection of x-ray, histology and atomic absorption data and, in addition, the performance of a statistical analysis of all the data (RN 10-11, 27-28, 132-133).
Nashef's evidentiary record is insufficient to establish that all the requisite data was both collected and analyzed prior to the senior party's filing date. In this connection, it is noted that atomic absorption results were apparently not received from the testing laboratory until about September 8, 1982 (N-8, page 60) and there is no evidence whatsoever that the statistical analysis of the data (PX-5) was completed prior to the critical date (RN 69-71, 85-86). Also, although Nashef testified that certain quaternary ammonium surfactants were 'found to be satisfactory' (RN 75-76, 77-78), there is no indication as to exactly when they were found to be satisfactory.
Even assuming arguendo that the histology test results, the first set of data collected (RN-123), would alone have been considered sufficient to determine the effectiveness or not of a particular surfactant in mitigating calcification, the record is deficient with respect to establishing a specific date prior to the critical date on which this data was evaluated, statistically or otherwise (RN 132-133). Karen Philbrick Kosnosky was the chemist responsible for making the evaluation (RN 132). With regard to a specific date relating to the histology study, she merely testified that the test data were recorded 'maybe the 10th or so of August, 1982'. (RN-114) We find no testimony regarding the date on which such test data were evaluated and determined to be indicative of success (RN 132-133; N-8, page 62).
While Nashef also makes some attempt to establish priority by presenting evidence of conception coupled with diligence up to the alleged actual reduction to practice, the attempt must fail since we have found no actual reduction to practice and there is no evidence extending the period of diligence up to Nashef's filing date, the date on which Nashef is considered to have constructively reduced the invention in issue to practice. The party chargeable with diligence must account for the entire period during which diligence is required. Gould v. Schawlow, 363 F.2d 908, 150 USPQ 634 (CCPA 1966).
Moreover, the evidence of conception and diligence which Nashef has adduced is in and of itself deficient. With regard to the evidence of conception, Nashef relies upon entries on page 29 of co-inventor Ahmed's laboratory notebook 268 (N-2) and testimony relating thereto. However, we find no testimony corroborating the '3/29/82' date appearing at the top of the page. The witness, Karen Philbrick Kosnosky, testified only that she made some entries on the page on December 15, 1982 (RN-107), which is consistent with the date which appears next to her signature on the notebook page. Even if we view the admission on page 3 of the senior party's brief, to the effect that Nashef co-inventor Ahmed recorded an outline in 'Laboratory Notebook 268 (Exhibit N-2) dated March 29, 1982', as dispensing with the need for corroboration of conception, activities relied upon to prove diligence must be corroborated. Gould v. Schawlow, supra. With regard to the evidence of diligence, the junior party relies almost exclusively on the testimony of one of the co-inventors, Nashef, which we do not find to be adequately corroborated. Even were we to disregard the necessity for corroboration and thus accord Nashef's testimony the full weight to which properly corroborated testimony is entitled, we find the testimony in and of itself insufficient to adequately establish precisely when each activity relied upon, e.g., designing an experimental protocol, was begun and completed. Little attempt has been made to identify particular activity with particular periods of time. Testimony must be specific as to dates as well as facts, and not be of a general nature. Kendall v. Searles, 173 F.2d 986, 81 USPQ 363 (CCPA 1949); Gould v. Shawlow, supra. In our view, Nashef's testimony taken as a whole does not set forth an adequate correlation of activities with the time periods involved to support a finding of that continuity of activity which constitutes reasonable diligence.
*5 Nashef, the junior party, has failed to establish a date of invention prior to Pollock's filing date, or to substantiate the charge of inequitable conduct by clear and convincing evidence. Accordingly, a judgment as to the subject matter of the count is in order and shall be awarded to Pollock in due course. But, first, for the sake of completeness, Nashef's position with respect to Pollock's case for priority will be briefly considered.
Pollock's Case for Priority
Pollock alleges that she conceived the invention in issue on November 30, 1981 when she recorded a proposal in her notebook 1701 (P-8, page 175) to test certain quaternary ammonium salts and other compounds for their ability to inhibit calcification of implanted animal tissue. Hohman, a histopathologist, confirmed that he had signed the notebook page in question as a witness (RP 175-176). [FN8] Further, an actual reduction to practice is alleged to have occurred on or about May 26, 1982 when x-rays of explanted tissue samples were taken. However, in view of the fact that Pollock apparently considered it necessary to evaluate explanted tissue samples by three different methods (RP 17-18; P-20), and consistent with our finding relative to Nashef's case for priority that proof of a reduction to practice requires a showing that all requisite data was collected and evaluated, we conclude that the earliest date on which Pollock can be considered to have completed an actual reduction to practice is July 14, 1982, the earliest date by which it appears Pollock had collected and evaluated all relevant test results, i.e., x-ray, atomic absorption and histology data (P-20; RP 43-45).
Nashef argues that Pollock's alleged reduction to practice must fail for lack of corroboration of sample treatment by the method of the count. Specifically, it is argued that:
(1) There was apparently no witness to the sample treatment.
(2) Pollock merely testified that she made notebook entries (RP 19-20), not that she treated the tissue samples with the listed chemicals.
(3) There was no testimony that the treatment solutions used were aqueous.
(4) The evidence is insufficient to establish that the 18 jars sent for animal implantation on or about February 23, 1982 contained the same compounds as those listed on page 186 of Pollock's notebook no. 1701 (P-8) when similar jar numbers were used for other studies at about the same time (NX-1A, page 184; P-29A, page 89; RP 149-150).
In considering Pollock's case for priority in light of these arguments, we must recognize the realities of technical operations in modern day research laboratories. Breuer v. DeMarinis, 558 F.2d 22, 194 USPQ 308 (CCPA 1977). We also must apply the 'rule of reason' when considering the adequacy of corroboration, Berges v. Gottstein, 618 F.2d 771, 205 USPQ 691 (CCPA 1980), while at the same time examining the evidence as a whole with an eye toward its persuasiveness and continuity. Borror v. Herz, 666 F.2d 569, 213 USPQ 19 (CCPA 1981).
*6 Applying these principles, we must disagree with Nashef since, in our view, there is sufficient circumstantial evidence of an independent nature to corroborate Pollock's actual treatment of tissue samples by the method of the count, particularly with regard to treatment with dodecyltrimethyl ammonium chloride (treatment '4'). Hernandez, a senior research technician who reported to Dr. Pollock, testified that she prepared porcine tissue samples for animal implantation in connection with an anticalcification study and then transferred the samples in 18 jars to Dr. Pollock by February 5, 1982 for treatment with different types of surfactants prior to implantation (RP 129-132). Dr. Pollock testified that the treatments 'were set up' on February 9, 1982 and 'were carried [sic (carried out)]' at ambient temperature (RP-22). The notebook pages referred to by Dr. Pollock, which record the surfactants corresponding to each treatment number, support her testimony and are internally self-consistent (P-8, pages 186-187; RP-20). The treated samples were sent to Ethicon Research Foundation on or about February 23, 1982 (RP 29-30; P-12) and Fetter, the Director of Ethicon, verified that these samples were indeed implanted for the requested length of time and then explanted and returned (RP 171-173). Hernandez testified relative to testing of the explanted samples and collection of data (RP 137-146). The notion that each individual act necessary for an actual reduction to practice must be proved in detail by an unbroken chain of evidence has been rejected. Mann v. Werner, 347 F.2d 636, 146 USPQ 199 (CCPA 1965). Over-the-shoulder observation of every step is not necessary to satisfy the corroboration rule where there is independent circumstantial evidence of a reduction to practice. Knorr v. Pearson, 671 F.2d 1368, 213 USPQ 196 (CCPA 1982); Berges v. Gottstein, supra. This is especially true where, as here, the activities in question were apparently part of an organized program of research. Lacotte v. Thomas, 225 USPQ 633 (Fed.Cir. 1985).
Viewing the evidence as a whole, we find it reasonable to conclude that Dr. Pollock carried out the method of the count on February 9, 1982. Her testimony, supported by notebook records, indicates that the treatments in question 'were' set up or carried out (RP-22; P-8, pages 186-187). This is consistent with the related support activities undertaken by Hernandez and Fetter. Hernandez understood that Dr. Pollock was the one who treated the samples with different types of surfactants (RP-132).
With regard to the nature of the involved solutions, the fact that the surfactant solutions were described in terms of 'pH' and 'BE' (P-8, pages 186- 187), with 'BE' presumably referring to a balanced electrolyte (see P-20, page 2, para. 2), is indicative of an aqueous medium. No other reasonable explanation has been offered. Pollock need only establish that the existence of the contested fact, the use of an aqueous solution, is more probable than its nonexistence. Cf. Photis v. Lunkenheimer, 225 USPQ 948 (Bd.Pat.Int. 1984)
*7 As for the adequacy of the evidence regarding identification of the 18 sample jars used in the subject anticalcification study, there is no evidence that the workers involved were confused by the fact that other studies were taking place at about the same time which employed some of the same jar numbers. Indeed, Hernandez testified that jars from a previous study could be distinguished on the basis of a recorded date indicative of a particular processing stage and the range of jar numbers reported (RP-150).
Further, Nashef insists that even if Pollock's testing of one compound within the scope of the count, presumably the testing of dodecyltrimethyl ammonium chloride, is found to be sufficiently corroborated, the successful testing of one compound or specie is not sufficient to establish a reduction to practice of a range of compounds or genus especially where results may be found to be unpredictable. We cannot agree with Nashef on this point since such is not the law. On the contrary, it is axiomatic that an actual reduction to practice of a single species within the scope of a count constitutes a reduction to practice of the invention defined by the count for purposes of priority. Breuer v. DeMarinis, supra, footnote 5.
For the foregoing reasons, we conclude that Pollock has established an actual reduction to practice of the invention in issue on or about July 14, 1982 by a preponderance of the evidence.
Judgment as to the subject matter of the count in issue is awarded to Elisabeth M. Pollock, the senior party. Accordingly, Aws S. Nashef and Ahmed I. Ahmed are not entitled to a patent containing their claims 7, 19-30 and 43 which correspond to the count.
BOARD OF PATENT APPEALS AND INTERFERENCES
Ronald H. Smith
James A. Seidleck
Marc L. Caroff
FN2. See the 'Notice Under 37 CFR 1.602(c)' (Paper No. 50; filed September 26, 1986).
FN3. Nashef claims 2-4, 9-18 and 31-42 have been designated as not corresponding to the count (see Paper No. 16).
FN4. By 'date of invention' we of course mean the date on which the invention defined by the count was actually reduced to practice, or the date of conception if shown to have been coupled with diligence commencing just prior to an opponent's conception up to an actual or constructive reduction to practice.
FN5. Although Pollock asks us to disregard the results obtained from the sulfonate which was mentioned, for the first time, in Nashef's brief, we have nevertheless considered these results as being essentially cumulative and thus having no significant impact upon our ultimate determination of the issue at hand.
FN6. Consistent with the nomenclature used by both parties, reference to the Record for Nashef will be abbreviated 'RN-', and to the Record for Pollock, 'RP-'. Exhibits introduced during Nashef's direct examination are identified with the prefix 'N-'; those introduced during Pollock's direct examination with the prefix 'P-'; those introduced during Nashef's cross examination with the prefix 'NX-'; and those introduced during Pollock's cross examination with the prefix 'PX-'.
FN7. Mead Johnson & Co. v. Premo Pharmaceutical Labs, 207 USPQ 820 (D.N.J. 1980); Cosden Oil & Chemical Co. v. American Hoechst Corp., 214 USPQ 244 (D.Del. 1982).
FN8. Apparently, Nashef does not contest the fact that Pollock was the first to conceive the invention in issue. Therefore, it is noted that any case Nashef may have for priority based on an alleged conception date of March 29, 1982 must fail for the additional reason that Nashef was not the first to conceive.