By Kevin E. Noonan --
In a case otherwise of little interest to the biotech/pharma community, the Federal Circuit last month increased the burden on proving patentability created by prior art references for patent applicants and patentees. This was accomplished by defining a presumption of enablement not only for prior patents and published patent applications but also for all prior printed publications, regardless of source of provenance.
The case involved an appeal from a U.S. Patent and Trademark Office rejection (in five ex parte reexaminations merged for consideration by the Office) of claims in U.S. Patent No. 5,734,961 directed to "to a method and apparatus for transmitting information recorded on digital disks from a central server to subscribers via a high data rate telecommunications network." For completeness, independent method claim 1 is set forth as follows:
1. Method of receiving information from one of a plurality of information systems via a high data rate telecommunication network in response to a request from one of plural subscriber stations, said method comprising the steps of:
initiating a two-way transmission from subscriber computer means of said one of said plural subscriber stations to one of said in formation systems via said telecommunication network,
outputting on output means of said one of said plural subscriber stations data related to plural information stored at one of said information systems,
selecting at said one of said plural subscriber stations at least one of said information by means of input means of said one of said plural subscriber stations and transmit- ting a signal identifying said at least one selected information from said subscriber computer means to a selected information system via said telecommunication network,
receiving at said one of said plural subscriber stations from said selected information system digital signals via said telecom- munication network, expanding by expansion means said transmitted signals, converting said expanded digital signals into analog signals and delivering said analog signals to transducer means.
This claim and others (including some that added a "controller" limitation) were rejected over four prior art references:
• Arif Ghafoor et al., A Distributed Multimedia Database System, Dep't of Elec. & Comp. Eng'g, Syracuse Univer sity (1988 IEEE).
• Stavros Christodoulakis & Theodora Velissaropoulos, Issues in the Design of a Distributed Testbed for Multimedia Information Systmems (MINOS), Journal of Mgmt. Inf. Sys., Vol. 4, No. 2 (1987).
• H.K. Huang et al., Picture Archiving and Communications Systems (PACS) for Radiological Images: State of the Art, CRC Critical Reviews in Diagnostic Imaging, Vol. 28, Issue 4 (1988).
• Barrett, U.S. Patent 4,918,588 (granted April 17, 1990).
In an opinion by Judge Lourie, joined by Chief Judge Rader and Judge Bryson, the Federal Circuit affirmed the PTO determination that the claims were either anticipated or obvious. In arriving at this conclusion, the Court addressed Antor's argument that the Board erred when it considered the prior art printed publications to be presumptively enabled. The Court set out the following reasoning for its disagreement with this argument.
The opinion cites Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1354 (Fed. Cir. 2003), for the proposition that "both claimed and unclaimed materials disclosed in a patent are presumptively enabling," noting that during prosecution "the examiner is entitled to reject application claims as anticipated by a prior art patent without conducting an inquiry into whether or not that patent is enabled or whether or not it is the claimed material (as opposed to the unclaimed disclosures) in that patent that are at issue," citing In re Sasse, 629 F.2d 675, 681, 207 USPQ 107, 111 (C.C.P.A. 1980). This is not determinative, however, because the applicant can then rebut the presumption by submitting evidence that the reference is not enabled.
The panel recognizes, however, that the Amgen case "did not decide whether a prior art printed publication, as distinguished from a patent, is presumptively enabling during patent prosecution," although in so going the Amgen Court did suggest that such a presumption was likely, saying that "[w]e note that by logical extension, our reasoning here might also apply to prior art printed publications as well, but as Sugimoto is a patent we need not and do not so decide today."
Accordingly, the opinion makes express that "logical extension": "the issue regarding non-patent publications [being] squarely before the court , we now hold that a prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant or patentee." In coming to this conclusion, the panel rejected Antor's argument that printed publications should be treated differently than patents because of the statutory presumption of validity that attaches to a patent. 35 U.S.C. § 282. The basis here was the same basis the panel used in Amgen: § 282 is not the source of the presumption; rather, the panel here notes that the precedent cited in the Amgen case applied the logic that "it is procedurally convenient to place the burden on an applicant who is in a better position to show, by experiment or argument, why the disclosure in question is not enabling or operative" and thus that prior art patents can be presumed enabling for both claimed and unclaimed subject matter. Finally, closing the logical loop this panel explained that the undisclosed subject matter in a patent is not examined at all and thus in no different a posture than what is contained in a non-patent prior art publication. (The same could also be said, but it was not mentioned in the opinion, for prior art published applications.)
The consequence of this decision, according to the panel, changes nothing for patentees or applicants, because in any case the examiner "is governed by 35 U.S.C. § 132, which requires notification to an applicant of the reasons for a rejection with 'such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.'" Provided that an examiner has included in an Office Action "the theory of the rejection, the prior art basis for the rejection, and where each limitation of the rejected claims is shown in the prior art reference" she has met her burden under the statute. As a practical matter, the Court is aware that the examiner, having "no access to experts or laboratories, is not in a position to test each piece of prior art for enablement in citing it, and requiring him to do so would be onerous, if not impossible." Thus:
Consistent with the statutory framework and our precedent, we therefore hold that, during patent prosecution, an examiner is entitled to reject claims as anticipated by a prior art publication or patent without conducting an inquiry into whether or not that prior art reference is enabling. As long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.
This decision has important implications for practitioners attempting to provide patent protection for biotechnology-based inventions. A great deal of biotechnology research and inventions have derived from university inventors, and even for those inventions that do not their inventiveness is assessed in view of prior art produced by university researchers. It is a feature of some of this art that portions therein are reserved for what can most kindly be called discussions of possible future implications and applications of a scientific result (unkindly, these can be nothing less than unsupported flights of fancy). However, the presence of such language in scientific references such as journal articles not expressly provides a much more robust source of prior art, insofar as anything said in a prior art printed publication now falls expressly within the presumption that it is enabled. While in many cases this will not pose an insurmountable challenge, it can be expected at the very least to increase the difficulties and cost of obtaining patents, and to open up a host of new prior art for use in invalidity defenses (the panel here noted that in Amgen "that presumption applies in the district court as well as the PTO, placing the burden on the patentee to show that unclaimed disclosures in a prior art patent are not enabling"). And while the heightened burden of "clear and convincing" evidence may serve to ameliorate this change in the district courts, the situation is very different during patent prosecution or reexamination, due to the "substantial evidence" standard of review used by the Federal Circuit for factual determinations by the Office. In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). These consequences are even more significant in view of the expanded potential for post-grant review occasioned by enactment of the Leahy-Smith America Invents Act.
One hypothetical example may suffice. (NOTE to the literal minded: what follows is generally not patentable or patent eligible; it is just an example in extremis to make the point). As noted previously, perhaps the most beautiful sentence in scientific literature is this one:
It has not escaped our notice that the specific pairing we have postulated immediately suggests a possible copying mechanism for the genetic material.
James Watson & Francis Crick, "Molecular Structure of Nucleic Acids; A Structure for Deoxyribose Nucleic Acid," Nature 171: 737-38 (April 25, 1953). Now let's assume that patent protection was being sought for any of the practical applications of specific basepair hybridization (solution reassociation, various "blotting" techniques, even recombinant DNA production requiring proper hybridization of DNA fragments asymetrically cut with different restriction enzymes) and ask, what would the effect of this sentence be on such claims, keeping in mind that when Watson and Crick wrote this sentence they had no experimental evidence (of their own) and that the accuracy of their insight on the structure of DNA would take years to conclusively establish.
In re Antor Media Corp. (Fed. Cir. 2012)
Panel: Chief Judge Rader and Circuit Judges Lourie and Bryson
Opinion by Circuit Judge Lourie