Ernest I. Gifford and Avery N. Goldstein
8.6.4 Hess v. Advanced Cardiovascular Systems Inc
(Fed. Cir. 1997)
This case concerns inventive activities involving multiple collaborators, and reveals a problem in inventorship. The case involved two inventors, Dr. Simpson and Dr. Robert, who developed a balloon catheter. The inven- tors tried various materials (PVC and Teflon) for making the balloon, but these materials did not work, and balloon expansion could not be properly controlled. The inventors then consulted with Mr. Hess, an engineer at Raychem Corp. Mr. Hess suggested use of a heat-shrinkable irradiated polyolefin tubing, and a seal that did not require adhesives. Following this consultation, the two inventors worked alone (without Mr. Hess’ participa- tion). At one point, Mr. Hess stated that his suggestion was published in textbooks, and that the suggested process was generally known. Drs. Simp- son and Robert filed their patent application. Mr. Hess filed a lawsuit to be named as a coinventor. The court decided that Mr. Hess was only supplying generally known information, that he was only acting as a sales represen- tative, that he did not supply continuing input to the inventive process, and concluded that Mr. Hess was not a coinventor. (If the court had decided that Mr. Hess should have been named as a coinventor, the patent could have been invalidated, because of the failure to name him as an inventor.) The lesson is that consultants who supply only information that is generally known, will probably not be considered to be inventors.
8.6.5 Kimberly-Clark Corp. v. Proctor & Gamble (Fed. Cir. 1992)
This case concerns inventive activities where the issue was whether there were multiple inventors. The case describes an invention of a new diaper,
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where the diaper contained elasticized flaps to prevent runny leakage. The diaper flaps had been invented by Mr. Lawson at Procter & Gamble (P & G), and resulted in a patent application and eventually in a patent. Mr. Lawson worked alone and was totally unaware of earlier work (resulting in the same invention) by another employee (Mr. Buell) at P & G. After Mr. Lawson’s patent application was filed, P & G wished to add Mr. Buell as an inventor, because his inventive activities had occurred on an earlier date than Mr. Lawson’s. However, the court refused this request to allow Mr. Buell to be listed as an inventor. The reason was that even though Mr. Lawson and the other inventor worked for the same company, they did not collab- orate. The take-home lesson is that there is no requirement that joint inven- tors must physically work together, but there is a requirement for some form of collaboration (35 U.S.C. 116).
8.6.6 In re Mahurkar Patent Litigation (N.D. Ill. 1993); Mahurkar v. Impra (Fed. Cir. 1995)
This case concerns the on-sale bar. The on-sale bar has its basis in 35 U.S.C.
102(b). Mr. Mahurkar is the inventor in U.S. Patent No. 4,583,968. The inventor argued that there was no sale, and that the on-sale bar did not apply. Another party, accused of infringing this patent, argued that the on- sale bar did apply, and that the patent should therefore be invalidated under 35 U.S.C. 102(b). The inventor agreed that something resembling a sale occurred prior to 1 year before the filing of the patent application, but that it was really a ‘‘sham sale.’’ The court agreed that it was a ‘‘sham sale’’ and refused to invalidate U.S. Patent No. 4,583,968. The inventor provided the court with five reasons (see below), where these reasons succeeded in persuading the court that there was really no sale. Mr. Mahurkar had a licensing agreement with Wayne Quinton, owner of an instruments com- pany. Mr. Quinton cherished the licensing agreement and did not wish to give it up. The licensing agreement stated that there must be a sale by a specific date in order for the licensing agreement to remain in effect.
The invention (catheter) had been built, and all of the patentable features were in the catheter. However, the catheter was only a crude working model, and could not be commercially sold. So Mr. Quinton devised a ‘‘sham sale’’
in order to keep the licensing agreement alive, but at the same time, not activate the on-sale bar. During a subsequent lawsuit, the court was per- suaded that the ‘‘sale’’ was not enough of a sale to activate the on-sale bar, because:
1. The sales agreement, which involved Mr. Quinton and Northwest Kidney Center, stated that the catheter could not be used with human patients;
2. The catheter was not sent to the shipping department of the North- west Kidney Center, but stored in a little-known cabinet;
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3. Mr. Quinton purposefully included false instructions for using the catheter that, if followed, would immediately melt the catheter into a mass of useless plastic;
4. The Northwest Kidney Center never used or needed the type of catheter that was provided; and
5. The catheter contained all the patentable features, but was hand- made and contained rough edges that would cause hemolysis, and dead spots that would cause blood clots, and thus harm any human patient.
Bard, Inc. v. M3 Systems Inc(Fed. Cir. 1998) illustrates another case that concerned whether a ‘‘sale’’ was really a sale [84]. Here, it was held that where the inventor can argue that the ‘‘sale’’ was actually a cost defrayment between collaborators, there was really no sale, and the on- sale bar did not apply.
8.6.7 Microchemical, Inc. v. Great Plains Chemical Co, Inc.
(Fed. Cir. 1997)
This case concerns one of the two steps required to activate the on-sale bar, i.e., the step that the invention be ready for patenting at the time of the sale.
Readiness for patenting can be demonstrated by proof that, at the time of the sale, there had existed descriptions that were sufficient to allow one of ordinary skill in the art to make and use the invention. Readiness for patenting can also be shown by proof that a working model of the invention had been made at the time of the sale [85]. Microchemical v. Great Plains Chemicalconcerns one of the two steps required to activate the on-sale bar, i.e., the step that the invention be patentably complete, or described in enough detail to allow one of ordinary skill in the art to make and use the invention, at the time of the sale. Microchemical v. Great Plains focuses on the date that all of the elements of the invention, and not just one or two of these elements, were conceived and described. The case reveals an argu- ment that the on-sale bar did not apply based on the fact that at the time of the sale, all of the patentable features had not yet been invented. Mr. Pratt had invented a machine for weighing and adding small amounts of ingre- dients to poultry feed. The machine included bins, weighing hopper, weight frame, mixing vessel, and other components. Mr. Pratt offered to sell the machine to Mr. Isaac, manager of a feedlot located in Kansas, in December 1984. At that time, the machine did not work, because of vibrations that prevented accurate weighing. A month or so later, the inventor thought of ways to acquire accurate weighing (isolation mechanism, pads, stabilizers).
The inventor filed a patent application on February 26, 1986. The patent application was allowed, resulting in U.S. Patent No. 4,733,971. During a subsequent lawsuit, the court stated that the following decision tree applied:
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If the invention had been complete on the date of the offer to the feedlot manager (thus triggering the start of the 1-year grace period), then the on- sale bar would cause invalidation of the patent, but if the invention had not been complete on the date of offer to the bankers then there could not be an on-sale bar. The court decided that, at the time of the December 1984 offer to sell, the machine had not yet been completely invented, that at that time
‘‘there is not yet any invention which could be placed on sale,’’ and that therefore the December 1984 offer to sell did not start the clock ticking for the 1-year grace period. The court refused to apply 35 U.S.C. 102(b) to invalidate Mr. Pratt’s claims.
Robotic Vision v. View (Fed. Cir. 2001) also concerns the date that the invention was ready for patenting, but focuses on the requirement that the invention be described in enough detail to allow one of ordinary skill in the art to make and use the invention [86]. The invention was sold before 1 year prior to the date of filing the patent application. At the time of the sale, the invention was complete except that the machine did not contain some routine software. The software had not yet been designed.
The inventor argued that the invention had not been completed at the time of the sale, and that the 1-year clock, or grace period, had not started ticking. The court refused this argument because one of ordinary skill in the art (an ordinary programmer) could have made a working version of the machine, given the information that was available at the time of the sale.
It is gratifying to point out the following consistency in the published law case. The standard of completeness of the invention is the same when (1) applying the on-sale bar; and (2) filing a patent application for a paper patent (see below, In re Strahilevitz [C.C.P.A. 1982]). In both cases, the standard is that the invention should be described in enough detail to enable one of ordinary skill in the art to make and use the invention.
8.6.8 Monsanto Co. v. Mycogen Plant Science, Inc. (D. Del. 1999)
The inventor’s activities in maintaining a laboratory notebook, which can help in winning priority disputes, are revealed by this case.Table 8.1reveals the fact pattern that resulted in the court’s decision that the Monsanto patent was invalid. Both patents concerned the same invention. The invention was a plant that produced a bacterial protein, where the production was at high levels, rather than at low levels. The bacterial protein was from Bacillus thuringiensis. The gene coding for the bacterial protein was altered by scientists (at Monsanto and at Mycogen) so that its codons would be more compatible with the biochemical machinery in the plant cell. The two patent applications were filed several months apart. Monsanto filed its patent application before Mycogen. Upon examination of the laboratory notebooks from the inventors of both companies, it was determined that Mycogen (August 26) had conceived the invention before Monsanto (September 8).
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Hence, the court decided that Monsanto’s patent was invalid, while Myco- gen’s remained valid.
Where party A is the first to conceive the invention, this is not quite enough to convince the court that party A has priority over party B. Party A must also demonstrate that it had worked more or less continuously (with diligence) on the invention, from the date of conception to the date of making a working invention. More accurately, the party that is first to conceive the invention (party A) must demonstrate that it was diligent from just prior to party B’s date of conception to the date that party A made a working version of the invention. Mycogen succeeded in persuading the court that it showed diligence. Mycogen’s laboratory notebooks revealed continuous work (Table 8.2; note that ‘‘Bt’’ meansBacillus thuringiensis).
To conclude, the court awarded priority to Mycogen, and invalidated Monsanto’s patent. If Mycogen had not been able to show its priority date of August 26, 1987, it is likely that Mycogen’s patent would have been invali- dated. Furthermore, if Mycogen had not been able to reveal more or less
Table 8.1 Dates of conception, completion of the invention, and filing of Monsanto and Mycogen [4]
Monsanto Mycogen
Date of conception September 8, 1987 August 26, 1987 Date of completion the
working invention
August 10, 1988 August 11, 1988 (western blot test) Date of filing patent with patent office February 24, 1989 August 7, 1989 Patent that was eventually issued U.S. Patent U.S. Patent
No. 5,500,365 No. 5,380,831
Priority goes to Mycogen
Patent that was invalidated Monsanto’s patent
Table 8.2 Mycogen’s continuous laboratory work. Data used to reveal continuous work from just before September 8, 1987 until mid-August 1988 include the
following [4].
October 20, 1987 AMVBt2 construct made by Barton November 2, 1987 AMVBt3 construct made by Barton January 15, 1988 AMVBt4 construct made by Barton
Mid-January 1988 Transformation experiments conducted by Cannon May 23–26, 1988 Tobacco hornworm bioassays conducted by Cannon June 3, 1988 Cannon enters data in her laboratory notebook June and July 1988 Additional bioassays conducted by Cannon August 11, 1988 Western blot tests conducted by Miller
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continuous work on its invention from just prior to September 8, 1987 to August 11, 1988, it is likely that Mycogen’s patent would have been invali- dated. It has been pointed out that the date of conception is not the same thing as the date of ‘‘clearly articulating the problem.’’ The date of concep- tion is the date that a solution to the problem was provided [87]; the date of clearly articulating the problem has little or no relevance to the patent application process.
8.6.9 In re Oetiker (Fed. Cir. 1992)
This case reveals a technique that can be used to rebut 103-rejections.
Hans Oetiker invented a metal clamp, where the clamp contained a hook.
The hook maintains the preassembly condition of automobile axles. The examiner rejected Mr. Oetiker’s patent application. It was a 103-rejection.
The examiner stated that the invention would have been obvious to one viewing two previously existing patents — an earlier patent of Oetiker’s (U.S. Patent No. 4,492,004) and Lauro’s U.S. Patent No. 3,426,400. The earlier Oetiker patent was in the same field of technology as his present patent application, but did not describe the hook. Lauro’s patent was in a different field. It related to ladies’ garments, not to automobile axles. Oetiker argued that one of ordinary skill, seeking to solve the problem that was facing him or her, would not look to patents or publications in the field of ladies’
garments for a solution. Mr. Oetiker’s argument succeeded. The take- home lesson is that when an inventor is faced with a 103-rejection, and if the prior art cited by the examiner is in a different field of art than that of the inventor’s application, the inventor should try to utilize Mr. Oetiker’s argument.
8.6.10 Promega v. Novagen (D. W. Wisc. 1997)
This case shows the use of a Declaration to establish inoperability of the prior art. The examiner rejected a claim because a similar or identical invention had been described by the ‘‘Baranov reference.’’ Promega filed a Declaration revealing some of the work done to show that the Baranov procedure did not work. The Declaration used conventional scien- tific commentary to convince the examiner that the prior art was inopera- tive. The Declaration read in part, ‘‘The first experiment . . . utilized the incubation mixture alone as defined in Baranov Example 4. The second experiment . . . utilized the incubation mixture and buffer A as defined in Baranov Example 4. See Exhibit 1 attached . . . which shows the compon- ents, concentrations, and amount added for 0.5 ml batch Baranov incubation mixture.’’ The examiner allowed the patent application, and it became U.S. Patent No. 5,324,637. The take-home lesson, at this point, is that sometimes an examiner’s rejections can be overcome by a Declaration
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showing that the device or method in a prior art patent or publication does not work.
In a later-occurring lawsuit, there arose a problem with Promega’s Declaration. The court stated that the examiner’s understanding was only heresay, and thus unpersuasive to the court. The take-home lesson is that the inventor should request the examiner to document his or her under- standing on paper, and provide copies of this document to the inventor and to the inventor’s file in the Patent Office.
8.6.11 Refac v. Lotus (D.S.N.Y. 1995)
This case reveals use of a Declaration to convince the court that the speci- fication contained enough information to allow one of ordinary skill in the art to make and use the invention. U.S. Patent No. 4,398,249 concerns a method of converting software source code to object code. The inventors are Rene Pardo and Remy Landau. After the patent application was filed, the examiner rejected the application, stating that the specification was not sufficient to enable an ordinary programmer to make and use the invention.
To convince the examiner that the specification was sufficient, Pardo filed a Declaration (37 C.F.R. 132; Rule 132) stating that the specification was sufficient. The examiner was not persuaded. The examiner responded that declarations by the inventor (rather than by an impartial observer) are ‘‘self- serving’’ and have ‘‘very little probative value.’’ The take-home lesson from the case, so far, is that declarations attesting to the ability of the specification of a patent application should preferably be written by an impartial user.
The inventors then filed an additional Declaration from Peter Jones, a computer scientist. Mr. Jones’ Declaration stated that, ‘‘From the written disclosures and flowchart shown in the drawing of such patent applica- tion . . . ’’ one of ordinary skill in the art could make and use the invention.
The examiner was persuaded by this second Declaration, and allowed the patent to be issued.
However, it was later determined that Mr. Jones had previously been a coworker of Pardo in the software company, and concluded that he could not have been impartial when he wrote the Declaration. Furthermore, it was also determined that during Mr. Jones’ employment at the software com- pany, he had received instructions on how to use the invention. The court concluded that Mr. Jones was not impartial. The court concluded that Mr. Jones was not of ordinary skill in the art, since he had previously been given special training in the invention. The court held that even though the Declaration contained acts of omission, rather than acts of misrepresenta- tion, the inventors had intentionally misled the Patent Office. The court invalidated U.S. Patent No. 4,398,249. The take-home lesson is that declar- ations regarding the ability of the specification to enable the invention should be made by an observer who is impartial, i.e., one who has no
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financial interest in the invention, and should not take liberties with the level of skill of an ordinary practitioner of the relevant technology.
8.6.12 Schendel v. Curtis, Park, and Cosman (Fed. Cir. 1996)
This case illustrates an attempt to establish a date of building a working model. Genetics Institute filed a patent application on August 29, 1990.
Immunex filed a patent application on an earlier date, August 22, 1989.
The inventions from both companies concerned a fusion protein, i.e., an artificial protein consisting of two natural proteins linked together in one continuous polypeptide. The two natural proteins were interleukin and colony-stimulating factor. Genetics Institute wanted to convince the Patent Office that Immunex’s patent was invalid. To do so, a first step was to convince the examiner that Genetics Institute had made a working version of its fusion protein on a date prior to Immunex’s filing date (August 22, 1989). The inventor at Genetics Institute wrote a Declaration. The Declar- ation read, in effect, ‘‘I, Dr. Schendel, prepared DNA coding for the fusion protein before August 22, 1989. The protein consisted of interleukin linked to colony-stimulating factor. The fusion protein was tested for biological activity, and it had activity of interleukin and of colony-stimulating factor.’’
The court was not convinced. The court pointed out that the Declaration failed to provide evidence that the fusion protein existed, since the inventor at Genetics Institute failed to conduct a test to detect the fusion protein. One such test is to sequence the DNA coding for the fusion protein. Another test is to determine the molecular weight of the expressed fusion protein. All the inventor had done was to determine that both of the biological activities were present (the court pointed out that both activities could have been due to a mixture of the two proteins, but in a separate, unlinked state). The result is that Genetics Institute was not able to invalidate Immunex’s patent. The take-home lesson is that declarations should contain fact-based information, not just conclusory statements.
8.6.13 In re Strahilevitz (C.C.P.A. 1982)
This case reveals the concept of a ‘‘prophetic patent,’’ i.e., where the patent application described how to make and use all of the claimed features of the invention but where no working model had been built. The invention was a device for removing antigens from the blood of a living mammal. The patent described a solid matrix containing immobilized (bound) antibodies. (Anti- gens are molecules that bind to antibodies.) The method of the invention involved passing blood (containing the antigen) through a filter, and allow- ing the filtered blood to contact the matrix, where contact with the matrix would remove the antigen from the filtered blood. After processing on the
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