Opinion ID: 208706
Heading Depth: 1
Heading Rank: 3

Heading: precedent and practice

Text: The court's opinion does not mention the long-established precedent that it is overturning. This is not a simple conflict between isolated rulings of the Federal Circuit; it is a change of law and practice with roots in century-old decisions. I start with this precedent, for the expedient of what came to be called the rule of necessity originated in the recognition, by the courts and the Patent Office, that not all new products could be fully described by their structure, due to the state of scientific knowledge or available analytical techniques. It was also recognized, over a century ago, that sufficient distinction from prior art products could sometimes be achieved by reference to how the product was made. Thus the courts and patent administrators established the exception that permitted inclusion in a product claim of sufficient recitation of how the product was made, to aid in identifying the product and distinguishing it from the prior art. This claim form was loosely called a product-by-process form, although that term includes a variety of situations, see n. 1 supra, having diverse legal consequences. The only form here at issue is that in which the product is new and its structure is not fully or readily known, such that its definition as a product is aided by referring to how it was made. Since before 1891, this has been an accepted way to claim products as products, recognizing that this is an exception to the general rule that new products are claimed without reference to the process by which they are produced. This exception was discussed in 1891 in Ex parte Painter, the Commissioner of Patents explaining that when there is entitlement to a patent on a new article of manufacture, it can be claimed by reference to the process of producing it, when the inventor lacks other language to define and discriminate the invention: It requires no argument to establish the proposition that as a rule a claim for an article of manufacture should not be defined by the process of producing that article. On the other hand, when a man has made an invention his right to a patent for it, or his right to a claim properly defining it, is not to be determined by the limitations of the English language. When the case arises that an article of manufacture is a new thing, a useful thing, and embodies invention, and that article cannot be properly defined and discriminated from prior art otherwise than by reference to the process of producing it, a case is presented which constitutes an exception to the rule. 1891 C.D. 200, 200-01 (Comm'r Pat. 1891). The Commissioner cited, as an earlier example of this exception, the claim in Globe Nail Co. v. U.S. Horse Nail Co., 19 F. 819 (C.C.D.Mass.1884) (sustaining validity of claim directed to horse-shoe nail claimed by reference to its process of manufacture, and finding it infringed by the accused nail having only a trivial and unsubstantial variation from the claimed product). In contrast, where the patent application made clear that the product could be described by its structure, the Patent Office ruled that the exception did not apply. See, e.g., Ex parte Scheckner, 1903 C.D. 315, 315-16 (Comm'r Pat.1903) (sustaining rejection of claim directed to an etched printing-plate that specifies certain steps by means of which the etching is accomplished because other claims define the plate in terms of its structure). This expedient has been discussed in various judicial decisions. In all cases the issue has not been whether this expedient was available, for its availability was not challenged; the issue was simply its application to the particular facts. For example, at a time when it heard direct appeals from Patent Office rulings, the D.C. Circuit remarked on this only exception to the general rule of product claiming, stating: It is a well-settled rule of patent law that claims for a product which is defined by the process of producing it will not be allowed; and the only exception to this rule seems to be in cases where the product involves invention and cannot be defined except by the process used in its creation. In extreme cases of this character, the product may be allowed; but that is not this case, especially in view of the broad claims allowed appellant in his copending application.... In re Brown, 29 F.2d 873, 874 (D.C.Cir. 1928) (emphasis added). The Court of Customs and Patent Appeals discussed precedent involving claims for processes and products in various factual situations, and summarized that: Where it is possible to define a product by its characteristics, the practice is clearly settled that this should be done. Where, however, the product is novel and involves invention and cannot be defined except by the steps of the process involved in its creation, there are cases holding that such a claim may be allowed, and it has been sustained by a Court. In re Butler, 17 C.C.P.A. 810, 37 F.2d 623, 626 (1930) (emphasis added) (quoting Ex Parte Feisenmeier, 1922 C.D. 18 (Comm'r Pat.1922)). The CCPA then found this rule inapplicable to the facts of Butler's invention, explaining that the record at bar does not meet this requirement [that the product was new]. Id. In In re Lifton, 38 C.C.P.A. 1119, 189 F.2d 261 (1951), the CCPA again commented on this exception for product claims, stating that when proper article claims were possible they must be used, with the exception of when such claims are impossible: This court has uniformly held that a claim for an article must define the article by its structure and not by the process of making it. The one exception to this rule, where the invention is the article and it is impossible to otherwise define it, is clearly ruled out in the present case because appellant has demonstrated the possibility of proper article claims by including several devoid of process limitations. Id. at 263 (emphasis added, citations omitted). The court again recognized the one exception, holding once again that it does not apply when the product can be described independently of the process of making it. These inquiries into the facts warranting application of the exception demonstrate that the rule of necessity was seldom applied, but was nonetheless recognized both by the courts and the Patent Office. Decisions of the Patent Office Board of Appeals illustrate the practice. See, e.g., Ex parte Pfenning, 65 U.S.P.Q. 577 (Pat.Off. Bd.App.1945) (allowing claim directed to a product which results from the method of claim 9 in light of applicant's argument that it is impossible in the instant case to define the product adequately in terms of the elements which compose it or in terms of its physical characteristics); Ex parte Lessig, 57 U.S.P.Q. 129 (Pat.Off.Bd.App. 1943) (allowing claim for a product containing vulcanized rubber strongly adhered to fibers which has been prepared by the process of claim 4 because it is not possible to otherwise distinguish over the art of record). Commentators have explained that this claiming practice became of increasing importance as the complex sciences blossomed. See, e.g., Mark D. Passler, Product-by-Process Patent Claims: Majority of the Court of Appeals for the Federal Circuit Forgets Purpose of the Patent Act, 49 U. Miami L.Rev. 233, 233 n. 3 (1994) (Such claims are often used by companies to patent complex drug or chemical products whose structure is not completely understood and, therefore, can only be accurately described by the process through which it is made.). It is well known that the full structure of some chemical and biological products is not always known at the time the patent application is filed. Indeed, it is a tenet of the scientific method that explanation and theory tend to follow, not precede, the observation of a development in the science. The CCPA continued to recognize the use of process terms to aid in describing new productsthe form of claim sometimes called a pure product-by-process claim, see n. 1 supra  and repeatedly ruled that such claims are properly viewed as product, not process, claims. The court also disallowed such claims where the product itself was not novel and unobvious. The court confirmed that such a claim, when justified for a novel and unobvious product, is properly construed as encompassing the full scope of a product claim. For example, in In re Bridgeford, 53 C.C.P.A. 1182, 357 F.2d 679 (1966), the court again explained that a new product may be defined by the process of making it if there is no other way to describe the product, stressing that the invention so defined is a product and not a process, id. at 682. The Bridgeford court relied on this view of the scope of the product-by-process claims in a related patent, and held unpatentable for double patenting claims that defined the product per se. Id. at 680. The court explained that product-by-process claims are true product claims, and overruled the suggestion in In re Freeman, 35 C.C.P.A. 920, 166 F.2d 178, 181 (1948), that product-by-process claims are dependen[t] ... on process limitations and therefore coextensive with process claims. Bridgeford, 357 F.2d at 683 n. 6 (While there is some language in Freeman to support the contention that a product-by-process type claim differs only `in scope' from a process type claim and they therefore `are directed to a single invention,' (166 F.2d at 181) so far as this is inconsistent with our holding here it must be overruled.). My colleagues misstate the holding of Bridgeford, for Bridgeford directly contravenes today's holding. In Bridgeford the CCPA noted that some courts have construed claims with process steps as limited to the recited process, id. at 683 n. 5, apparently without inquiring whether the rule of necessity justified full product scope for the invention at issue. The CCPA's observation that patents are construed inconsistently in other courts cannot be taken, as apparently do my colleagues, as error by the CCPA. To the contrary, the inconsistency among courts led eventually to consolidation. [2] Again in In re Brown, 59 C.C.P.A. 1036, 459 F.2d 531 (1972), the CCPA explained that product-by-process claims are product claims, not process claims, and that the patentability of the product must be established independently of the process by which it is identified. See id. at 535 ([I]n spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established.). Other decisions discussing application of this expedient to claims directed to complex new products include In re Pilkington, 56 C.C.P.A. 1237, 411 F.2d 1345, 1349 (1969) (While we are satisfied that the references of record do not anticipate appellant's glass or demonstrate that it would be obvious, the differences between that glass and the glass of the prior art do not appear to us to be particularly susceptible to definition by the conventional recitation of properties or structure.), and In re Fessmann, 489 F.2d 742, 743 (CCPA 1974) (affirming obviousness rejection of product-by-process claim directed to a liquid smoke product, but observing that prior art compositions are complex mixtures of the chemical compounds which can be derived from wood which defy simple characterization and this fact presumably accounts for the use of product-by-process claims). The need for this expedient, and the proper scope afforded such claims, is summarized in the treatise Walker on Patents: [P]atent rights over a chemical product are typically independent of the process by which the product is made, and are particularly valuable because of this fact. This independence is normally accomplished by defining the product in terms of its structural features alone, with no reference in the claims to process steps whatsoever. The state of chemical technology, however, is sometimes too limited for a structural description of this type to be made. The structure of some chemicals, especially those including elaborate polymer chains, cannot be accurately determined. The same chemicals, however, may be both economically valuable and technologically reproducible, in the sense that they can be reliably made by subjecting a particular set of raw materials to a particular set of process steps.    The law reacted to these difficulties by making it easier to obtain traditional product protection over this special class of chemicals. The inventor was allowed to describe such a chemical in terms of how one gained possession of it, that is, by way of the process steps by which it was made. Once he did so, the law preserved to the inventor the fullest measure of product-only protection that it could; it treated the process recitations as proxies for the direct recitations of structure that could not be made. Such a claim was therefore equivalent to one stated in terms of structure only. It would broadly dominate all methods by which the chemical could be made or used. At the same time, it carried the same dangers of running afoul of the art: it would be anticipated if the chemical had been produced previously, even if by a method other than what the inventor disclosed. 1 Moy's Walker on Patents § 4:74 (4th ed.2008) (emphases added). The en banc court appears to misunderstand this precedent, for my colleagues now state that binding case law of the Court of Customs and Patent Appeals and the Court of Claims mandates a single rule for all claims that contain any process terms, whether the product is novel or known, citing In re Hughes, 496 F.2d 1216 (CCPA 1974), for this proposition. However, Hughes does not state this proposition; Hughes stands for the contrary proposition. In Hughes the question was the patentability of claims directed to shakes as are used in roofing, as follows: 12. Shakes manufactured from a shake bolt by the process of making a plurality of cuts into and across the shake bolt to an extent to establish predetermined tip lengths, and splitting the weather end portions of the shakes from the bolt by starting the splits at the inner ends of the cuts and continuing the splits to the end of the bolt. This claim had been rejected as an improper product-by-process claim, on the ground that the product could be described without including process steps. The Hughes court acknowledged the general rule against product-by-process claiming, but also explained the proper exception to the general rule as first set forth in Painter, as follows: [T]he Commissioner of Patents enunciated the general rule that a product should not be defined in terms of the process of making it. In Painter, a proper exception to the general rule was found on the ground that the product could not be properly defined and discriminated from the prior art otherwise than by reference to the process of producing it. This basic rule and the exception have been recognized and followed continuously by the Patent Office and the Courts. Hughes, 496 F.2d at 1218 (quoting approvingly the Solicitor's argument). The court reaffirmed that in spite of the fact that a product-by-process claim may recite only process limitations, `it is the product which is covered by the claim and not the recited process steps.' Id. Contrary to my colleagues' statement, Hughes did not eliminate this form of claim, or change its role as a product claim. Indeed, the Hughes court applied the exception and reversed the Board's rejection of a product-by-process claim, stating: We agree with appellant that the [general] rule should not be applied to the situation before us. We have been shown no true product claim which describes appellant's invention, in the words of the solicitor, in terms of structure or physical characteristics. When an applicant seeks to describe his invention by a product-by-process claim because he finds that his invention is incapable of description solely by structure or physical characteristics, it is incumbent upon the Patent Office to indicate where, or how, the applicant's invention is, or may be, so described. Id. at 1219. My colleagues could hardly have selected less apt support for their construction of product-by-process claims, for Hughes explicitly states that such claims are for the product, not the process. In addition to misstating precedent of the CCPA, the en banc court also mischaracterizes the decisions of our predecessor the Court of Claims, stating that the Court of Claims' decisions support today's ruling. The court cites Tri-Wall Containers v. United States, 187 Ct.Cl. 326, 408 F.2d 748 (1969), for this purpose. That citation, too, is mysterious, for in Tri-Wall Containers the court found that the claimed product was not new because it had been on sale for more than the permitted period, although the product that was on sale had been made by a different process than the process stated in the claim. The Court of Claims stated that the evidence showed that the prior art product and the claimed product are structurally identical, id. at 751, and explained that a known product cannot be patented by including process terms in the claim: It is well established that a product claimed as made by a new process is not patentable unless the product itself is new. The Wood-Paper Patent, 90 U.S. (23 Wall.) 566, 596, 23 L.Ed. 31 (1874), Cochrane v. Badische Anilin & Soda Fabrik [BASF], 111 U.S. 293, 311, 4 S.Ct. 455, 28 L.Ed. 433 (1984).... . . . . More recent cases point out that the addition of a method step in a product claim, which product is not patentably distinguishable from the prior art, cannot impart patentability to the old product. Jungersen v. Baden, 69 F.Supp. 922, 928 (S.D.N.Y.1947), aff'd, 166 F.2d 807 (2d Cir.1948), aff'd, 335 U.S. 560, 69 S.Ct. 269, 93 L.Ed. 235 (1949); In re Stephens, 345 F.2d 1020, 1023, 52 C.C.P.A. 1409 (1965). Tri-Wall Containers, 408 F.2d at 750-51. This case applied the standard rule that old products cannot be patentedit contains no statement limiting the scope of claims that include process aspects to aid in describing new products. The Supreme Court cases cited in Tri-Wall are all directed to new processes for making old productsthese are the same cases that the en banc court today incorrectly applies to new products, as I discuss post. Contrary to my colleagues' statement, CCPA and Court of Claims precedent do not support today's en banc thesis. Our predecessor courts understood the complexity of patenting, and the CCPA consistently implemented the expedient whereby process terms contributed to the description of complex new products of incompletely known structure. These courts recognized the independence of product claims for new products, and did not limit such claims to the specific process steps that were used to aid in describing the product. [3] With the advent of the Federal Circuit, this court continued to apply these principles. In In re Thorpe, 777 F.2d 695 (Fed. Cir.1985), the court explained that product-by-process claims are anticipated when the product existed in the prior art, even if the product was made by a different process. My colleagues are mistaken in stating that Thorpe held that all such claims are to be construed as process claims, even when the product is new and the rule of necessity justifies this mode of describing the invention. In Thorpe the product was not new; it was a known color developer for carbonless paper copy systems, and this court held that the PTO correctly rejected the claim to the product of the process of claim 1, explaining that since the product was old it could not be claimed as a product, whether or not process steps are recited in the claim. The facts of Thorpe did not concern the exception and expedient where process terms are invoked to describe a new product of complex structure. This exception is rarely invoked. The general rule requiring claims to have a process-free definition of the structure of a new product accommodates most inventions. Some recent exceptions are seen in emerging aspects of biotechnology. For example, in Amgen, Inc. v. Chugai Pharmaceutical Co., 706 F.Supp. 94 (D.Mass.1989), aff'd in relevant part, 927 F.2d 1200 (Fed.Cir. 1991), the district court considered the following claim: 4. A procaryotic or eucaryotic host cell transformed or transfected with a DNA sequence according to claim 1, 2 or 3 in a manner allowing the host cell to express erythropoietin. Id. at 108. The district court found claim 4 ambiguous, explaining that while it is directed to a new productthis host cell the words transformed or transfected appear to invoke a process. The district court recognized that [i]n the traditional patent framework, a product is wholly separate and distinct from a process. Id. at 107. The court observed that [a] product patent gives the patentee the right to restrict the use and sale of the product regardless of how and by whom it was manufactured, while [a] process patentee's power extends only to those products made by the patented process. Id. (quoting United States v. Studiengesellschaft Kohle, 670 F.2d 1122, 1127-28 (D.C.Cir. 1981)). The district court, affirmed by the Federal Circuit, found this claim to be valid and infringed as a product claim, and although many issues and arguments were present in this litigation, the applicability of the venerable rule of necessity was not at issue. In Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed.Cir.1991), the Federal Circuit addressed the interpretation and scope of claims exemplified by claim 13: 13. Highly purified and concentrated VIII:C prepared in accordance with the method of claim 1. Claim 1 set forth the method referred to in claim 13, as follows: 1. An improved method of preparing Factor VIII procoagulant activity protein [VIII:C] comprising the steps of (a) adsorbing a VIII:C/VIII:RP complex from a plasma or commercial concentrate source onto particles bound to a monoclonal antibody specific to VIII:RP, (b) eluting the VIII:C, (c) adsorbing the VIII:C obtained in step (b) in another adsorption to concentrate and further purify same, (d) eluting the adsorbed VIII:C, and (e) recovering highly purified and concentrated VIII:C. It was not disputed that the product was a new product, that the highly purified and concentrated blood clotting Factor VIII:C had not previously been obtained, and that a complete structural identification of Factor VIII:C was not available. The defendant Genentech had made its commercial Factor VIII:C not by the method set forth in claim 1, but by using a sample of the Scripps product to clone Factor VIII:C protein using recombinant DNA techniques. One question presented in the case was whether claims such as claim 13 were infringed by the same product produced by a different method, or whether such claims were infringed only if the accused infringer used the process of claim 1. Scripps stressed that its product was novel and enabled and was patentable as a product, although the full structure of Factor VIII:C was not available at that stage of the science. The court addressed whether claims exemplified by claim 13, properly construed, were product claims, or whether they were limited to the specific processes in the process claims to which they referred. This court held that the claims were product claims. The court held that since claims are construed the same way for infringement as for validity, the question was whether the Genentech product was the same as the claimed product, not whether they were produced by the same process. The court remanded to the district court for this factual determination. Scripps, 927 F.2d at 1584. After Scripps was decided, a panel of this court decided an appeal concerning plastic innersoles for shoes. In Atlantic Thermoplastics Co. v. Faytex Corp., 970 F.2d 834 (Fed.Cir.1992), the claims at issue were represented by: Claim 24. The product produced by the method of claim 1. In turn, claim 1 was as follows: 1. In a method of manufacturing a shock-absorbing, molded innersole for insertion in footwear, which method comprises: (a) introducing an expandable, polyurethane into a mold; and (b) recovering from the mold an innersole which comprises a contoured heel and arch section composed of a substantially open-celled polyurethane foam material, the improvement which comprises: (i) placing an elastomeric insert material into the mold, the insert material having greater shock-absorbing properties and being less resilient than the molded, open-celled polyurethane foam material, and the insert material having sufficient surface tack to remain in the placed position in the mold on the introduction of the expandable polyurethane material so as to permit the expandable polyurethane material to expand about the insert material without displacement of the insert material; and (ii) recovering a molded innersole with the insert material having a tacky surface forming a part of the exposed bottom surface of the recovered innersole. The panel held that a claim in the form of claim 24 always requires use of the referenced method, and that it is irrelevant whether the product was new or known. The court stated that the rule of necessity, as applied in Scripps, is contrary to Supreme Court rulings. The panel stated that the decision in Scripps is incorrect. A majority of the Federal Circuit declined to resolve the conflict en banc, resulting in several further opinions. E.g., Atlantic Thermoplastics Co. v. Faytex Corp., 974 F.2d 1279 (Fed.Cir.1992) (dissents of Chief Judge Nies and Judges Rich, Newman, and Lourie from denial of rehearing en banc ). Judge Rich wrote: [T]his whole excursion was unnecessary because the patentee admitted that claim 24, the product-by-process claim, was limited to the process. The claim read: The molded innersole produced by the method of claim 1. There was, therefore, no occasion to review the law to determine how the claim should be construed.... We are not here to provide restatements of the law. Such restatements should not be made without an opportunity for all affected parties to be heard from. The affected parties here are not the vendors of inner soles but largely the entire chemical industry, particularly the pharmaceutical manufacturers. Id. at 1280 (Rich, J., dissenting from denial of rehearing en banc ). Most trial courts continued to recognize the rule of necessity. For example, in Trustees of Columbia University v. Roche Diagnostics GmbH, 126 F.Supp.2d 16 (D.Mass.2000), the district court considered claims such as the following. 72. A eukaryotic cell into which foreign DNA I has been inserted in accordance with the process of claim 54. The court referred to the Scripps/Atlantic conflict, concluded that the earlier panel decision controlled under the Federal Circuit's rule, see Newell Companies, Inc. v. Kenney Manufacturing Co., 864 F.2d 757, 765 (Fed.Cir.1988) (This court has adopted the rule that prior decisions of a panel of the court are binding precedent on subsequent panels unless and until overturned in banc. ), and applied the Scripps ruling, holding that the new cell was not limited by the process by which it was made. The PTO also continued to apply the rule of necessity. In instructing examiners that products should whenever possible be described without reference to how they were made, the PTO continued to point out the exception that patentability as a product is not foreclosed when independent description is not available. The Manual of Patent Examining Procedure (MPEP) instructs the examiner to consider the structure implied by any process steps in the claim: The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. MPEP § 2113 (8th ed., July 2008 rev.). This has been the practice since at least Ex parte Painter in 1891. I am surprised at the en banc court's casual misstatement about the treatment of product-by-process claims throughout the years by the PTO, maj. op. at 1293, for the statement is directly contrary to the treatment of such claims throughout the years by the PTO. The en banc court's insistence that one universal rule should now be applied is contrary to the entire body of decisional law, including the Supreme Court cases cited by my colleagues. As I next discuss, in most of the cited cases the product was not a new product and thus was not patentable as a product, whether or not any process term was included in the claim. The Court consistently held that when the product was old and only the process was a patentable invention, a claim for the product of that process could not cover the old product made by a different process. That is, and has always been, the law. I comment briefly on the Court's cases that my colleagues misinterpret and misapply: