Board of Patent Appeals and Interferences
Patent and Trademark Office (P.T.O.)
*1 EX PARTE MICHIHIKO OCHIAI, TAIITI OKADA, OSAMI AKI, AKIRA MORIMOTO, KENJI
KAWAKITA AND YOSHIHIRO MATSUSHITA
Appeal No. 92-2372
July 8, 1992
HEARD: June 11, 1992
Application for Patent filed January 8, 1990, Serial No. 462,492; which is a continuation of application Serial No. 203,410, filed June 7, 1988, now U.S. Patent No. 4,973,684; which is a division of application Serial No. 674,364, filed November 26, 1984, now abandoned; which is a continuation of application Serial No. 191,934, filed September 29, 1980, now abandoned; which is a continuation-in-part of application Serial No. 071,032, filed August 28, 1979, now U.S. Patent No. 4,298,606; which is a division of application Serial No. 900,233, filed April 26, 1978, now abandoned; which is a continuation-in-part of application Serial No. 642,356, filed December 19, 1975, now U.S. Patent No. 4,098,888. Methods For The Manufacture Of Cephems.
Harold C. Wegner et al. for Appellants
Primary Examiner--Nicholas S. Rizzo
Before Goldstein, Goolkasian and Garris
This is an appeal from the examiner's final rejection of claims 6 through 10, all drawn to a process of making a cephalosporin type antibiotic. Claims 15 through 18 remain in the application but are directed to a different process of making the R@1 = nucleophilic residue version of the cephem compound using the R 4 = hydrogen version as a starting material. These claims stand withdrawn from consideration pursuant to the examiner's requirement for restriction.
Claims 6 and 8 are illustrative of the invention and read as follows:
6. A process for preparing a cephem compound of the formula:
wherein R@3 is hydrogen or methoxy, R@4 is hydrogen or a residue of a nucleophilic compound, R@5 is hydroxyl or a protected hydroxyl, and R@8 is hydrogen or a halogen, or a pharmaceutically acceptable salt or ester thereof, which comprises introducing an acyl group of the formula:
TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE
wherein R@5 and R@8 are as defined above into the amino group of the molecule of the formula:
TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE
wherein R@3 and R@4 are as defined above or a salt or ester thereof.
8. A process according to claim 6, wherein the introduction is performed by reacting a compound of the formula:
TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE
or a salt or ester thereof, with a compound of the formula:
TABULAR OR GRAPHIC MATERIAL SET FORTH AT THIS POINT IS NOT DISPLAYABLE
wherein R@1 is an amino group, or a salt or reactive derivative thereof.
Our reproduction of claims 6 and 8 is not exact. As can be seen in claim 6, the cephem compound being prepared is divided into two segments, a first "acyl" segment we have identified as [A], and a second "amino" segment we have identified as [B]. We shall hereinafter refer to the cephem compound as the compound AB.
The references relied on by the examiner are:
Hoover 3,167,549 Jan. 26, 1965
Takano et al. (Takano '897) 3,338,897 Aug. 29, 1967
Takano et al. (Takano '515) 3,360,515 Dec. 26, 1967
Cook et al. (Cook) 4,024,133 May 17, 1977
Gregson et al. (Gregson) 4,024,134 May 17, 1977
*2 Flynn, Cephalosporin and Penicillins, 1972, pages 83-91.
Appellants have not argued the separate patentability of claims 6 through 10 with any degree of specificity. Accordingly, all claims stand or fall together. In re Kroekel, 803 F.2d 705, 231 USPQ 640 (Fed.Cir.1986).
All of appellants' claims stand rejected under 35 U.S.C. § 103 over the combined teachings of six references all of which relate to cephem compounds having the general formula AB wherein the B portion of the molecule is the same as appellants and the A portion differs. The examiner notes that all six references suggest preparing the respective AB cephem compounds by reacting A with B using a standard acylation reaction between a carboxyl group (or reactive derivative thereof) on the A moiety and a specific amine group of the B moiety; the very same reaction claimed herein. It is the examiner's position that it would have been obvious for one skilled in the art to make appellants' compounds using the claimed process, i.e., "introducing" A into AB or "reacting" A with B. The examiner relies on In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed.Cir.1985) as legal precedent supporting his decision.
We have carefully considered each and every argument set forth in appellants' Brief but, nevertheless, are unpersuaded of error in the examiner's position and, accordingly, we affirm the examiner's rejection.
Appellants note that the starting material [A] was unknown and unobvious prior to appellants' invention thereof. It is the subject of appellants' U.S. Patent No. 4,203,899 issued May 20, 1980. The product AB is also novel and unobvious; claims to the product appear in appellants' U.S. Patent No. 4,298,606 issued November 3, 1981. Appellants urge that since neither the final product nor the method of introducing the particular [A] component were known, obvious or even remotely suggested in the prior art, this alone should be dispositive of the obviousness of the invention (Brief, page 4). Appellants also urge that because there are plural, distinct processes that could be used to make the products of the instant invention, the absence of a suggestion to utilize the particular process claimed demonstrates unobviousness. These arguments are not persuasive. We are not here concerned with the patentability of the starting materials, the final compounds or other processes of making the AB compounds. We are concerned only with the claimed process and the patentability thereof. Cases such as In re Larsen, 292 F.2d 531, 130 USPQ 209 (CCPA 1961); In re Albertson, 332 F.2d 379, 141 USPQ 730 (CCPA 1964) and, particularly, In re Durden, supra, all of which were directed to processes of making chemical compounds, are controlling herein.
We consider first that aspect of appellants' arguments directed to the selection of the particular process claimed, i.e., "reacting A with B," from "plural, patentably distinct processes." We are unpersuaded by this argument for several reasons. First, there is no evidence of record of other processes being used to make the R@4 = hydrogen cephem compounds of the claims. The reduction process of claims 15 through 18, which are the subject of the restriction requirement, makes a different compound, i.e., R@4 = nucleophilic residue, using the R@4 = hydrogen version of the compound AB of appellants' claims. Second, there is no evidence of record of whether the process claimed herein is superior to other processes alleged to exist. Third, the process claimed herein, reacting A with B, is suggested by the references as a preferred process.
*3 We consider next appellants' arguments regarding selection of the starting reactants for the process.
Though appellants urge that they neither explicitly nor implicitly place sole reliance on the patentability of the final product, they argue strongly that there is no suggestion in the art to combine the specific novel A starting material with the old B starting material to make the novel AB product. We are unpersuaded by this argument.
We are unable to distinguish the fundamental facts of this case from the fundamental facts before our reviewing courts in In re Larsen, supra; In re Albertson, supra; In re Ross, 305 F.2d 878, 134 USPQ 320 (CCPA 1962) and In re Durden, supra. In each case, the process claimed involved making a chemical compound by reacting two chemical compounds using a standard claimed reaction. In Larsen and Ross, the compounds made were novel but were prepared from precursors using processes which were standard in the art. [FN1] Albertson and Durden involve similar issues in which both the starting materials and the final product were patentable. In each case, a material A, either known or novel, was subjected to a standard process of reacting with a standard reactant, B, in order to produce the result expected from the reaction of A with B. Indeed in Albertson as in the instant case, the only manipulative step of the process is that which is embodied in the word "reacting."
Appellants urge that the position taken by the examiner does not consider the "invention as a whole" as required by the patent statutes. We cannot be persuaded by this argument which was before our reviewing courts each time the issue has been decided. In this regard we note the dissenting opinions in Larsen and Ross, Judge Rich's concurring opinion in Larsen, the appellants' arguments in In re Albertson to the effect that the specific reactants in a process "are a vital significant part of any process," and the minority opinion of the Board of Appeals in Ex parte Durden (unpublished decision). The latter urged that the starting materials and final products should not be considered as "givens" and that consideration of the invention as a whole was required.
Appellants also urge that the prior art teaches away from the claimed process because the B-imino-carboxylic acid of the claims has, immediately adjacent the carboxylic acid group, the group C = N - R@5 as opposed to a simple methylene bridge usually possessed by the prior art. Appellants appear to argue that this is a somewhat more complex starting material than previously used in the prior art, is not suggested by the prior art, and may present potential difficulties in attempting to react A with B. (See page 15 of the Brief wherein appellants state there is no suggestion that one "could introduce an imino group at the B-position to the carboxamido group.") We are unpersuaded by this argument.
As noted in In re Ross, when the examiner has cited prior art showing the general reaction to be old, the burden is on appellants to present " 'reason or authority for believing that the group ... would take part in or affect the basic ... reaction disclosed in the references.' " 305 F.2d at 881, 134 USPQ at 322. In this case appellants have presented no evidence that any difficulty is presented by the use of the C = N - R@5 moiety. We note also that the examiner has introduced the '134 Gregson patent and '133 Cook patent each of which describes similar AB cephem compounds wherein the A portion has a C = N - R@5 group quite similar in structure to that claimed by appellants.
We do not regard Durden as authority to reject as obvious every method claim reading on an old type of process, such as mixing, reacting, reducing, etc.
We are unpersuaded by this argument. We note that the Court's remarks in Dillon are dicta presented in the context of claims directed to a "method of using" a novel combustible fluid. The claims herein are directed to a "method of making" a particular compound.
At oral argument, when counsel was asked whether the claims were directed to a "method of making" or a "method of using," counsel indicated that the claims were to a method of making but appeared to dismiss the "method of making"/ "method of using" concept as being subsumed beneath the broader approach to patentability espoused in In re Dillon. We have recently had the opportunity to study our reviewing courts' past approach to this type of case and include the following comments thereon.
The chicken/egg conundrum discussed by appellants at pages 9 through 11 of the Brief presents a real world dilemma to a patent examiner trying to balance the "invention as a whole" concept with the rationale of the Larsen, Albertson and Durden line of cases. Faced with the use of a novel and unobvious material to make a novel and unobvious product, it is difficult to determine whether the invention is patentable as a "use" of the new starting material or unpatentable as a "method of making" the final product. Moreover, it is difficult to divorce from the patentability consideration the novelty and unobviousness of starting materials and final products when one is constantly advised to consider the invention as a whole when reaching the ultimate conclusion of patentability.
We have reviewed the Federal Circuit's decisions in In re Pleuddemann, 910 F.2d 823, 15 USPQ2d 1738 (Fed.Cir.1990) and Durden, supra, and the CCPA decisions in In re Mancy, 499 F.2d 1289, 182 USPQ 303 (CCPA 1974) and In re Kuehl, 475 F.2d 658, 177 USPQ 250 (CCPA 1973) for guidance. We note that prior to resolving the patentability question in each case, the court first reviewed all the facts of the case, including arguments of counsel, and determined whether the claims were directed to a "method of making" or a "method of using." When the process claimed was considered to be one of "using" a novel material, patentability of the process was linked to the patentability of the material used. However, when the process claimed was considered to be directed to a "method of making" a novel material, patentability of the process was determined based on the inventiveness of the process steps themselves. Selection of a novel starting material was not considered dispositive of patentability if, indeed, an element of the process.
*5 Linkage between product and use thereof is logical because the obviousness of a process of using a novel product must be ascertained without knowledge of the thing used and its properties. In chemical cases, a compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). Logic dictates that one can not use a novel material without prior knowledge of the specific material and its properties. See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed.Cir.1985).
While linkage of the starting material selected and patentability may seem equally logical, this is not the case. Our reviewing courts have ascertained a distinction between "methods of using" and "methods of making" and have iterated this distinction in a number of decisions.
In Kuehl, supra, the Court of Customs and Patent Appeals was presented with claims to a process of using anovel zeolite as a hydrocarbon cracking catalyst, a use to which prior art zeolites had been put. In reversing the examiner's rejection, the court drew a distinction between "method of making" and "method of using" cases and stated that each category of process claims (making or using) must be independently considered on its own merits. The court criticized In re Saunders, 154 F.2d 693, 69 USPQ 341 (CCPA 1946) in part because the Saunders court had applied "process of making" law to a "process of using" fact situation.
In In re Mancy, supra, the Court of Customs and Patent Appeals was presented with claims to a process "for the production" of an antibiotic by "cultivating" a novel and unobvious microorganism. The examiner had rejected the claim on the basis that the antibiotic had been produced previously by "cultivating" similar but different strains of the same genus of microorganism. It was argued by the Patent Office that earlier decisions, i.e., In re Kanter, 399 F.2d 249, 158 USPQ 331 (CCPA 1968) and In re Neugebauer, 330 F.2d 353, 141 USPQ 205 (CCPA 1964), had held that the performance of "an old process on a starting material ... not previously used in the process" was obvious (Kanter, 399 F.2d at 251, 158 USPQ at 333). In rejecting the Patent and Trademark Office's position, the Mancy court stated:
We think that there is a significant difference between a method of making a novel product and method of using a novel product. Cases such as Kanter, which involve the former are not controlling in the latter situation (499 F.2d at 1293, 182 USPQ at 306).
We note that the Court considered Mancy's process one of "using" notwithstanding the claim's preamble being couched in "making" terminology. Again, in Pleuddemann, the Federal Circuit stated:
*6 ... there is a real difference between a process of making and a process of using and the cases dealing with one involve different problems from the cases dealing with the other. (910 F.2d at 827, 15 USPQ2d at 1741).
We recognize that there may be many who consider the "method of making" and "method of using" distinction to be arbitrary and without basis in law or logic. [FN2] This may be because there are certain dicta in In re Larsen, 292 F.2d 531, 130 USPQ 209 (CCPA 1961) and In re Albertson, 332 F.2d 379, 141 USPQ 730 (CCPA 1964) which, when considered out of the "making" and "using" context of each case appear to be all encompassing. For example, it is stated in Larsen, "when the sole inventive concept resides in the product the claims should be limited to the product," (292 F.2d at 533, 130 USPQ at 211). It is similarly stated in Albertson:
We do not agree with appellant's proposition that the 'use of an unobvious starting material renders a process unobvious.' Were this true, every step, for example, dissolving or heating, when performed on a new compound would result in a patentable process. We reiterate that all of the evidence must be considered on the 'subject matter as a whole,' from the viewpoint of one skilled in the art, in the determination of obviousness, and not simply the patentability of one of the starting reactants in a process (332 F.2d at 382, 141 USPQ at 732).
Both Larsen and Albertson were "method of making" cases. The dictum in Larsen related to claims to a method of making novel chemical compounds by reacting admittedly old compounds by a standard chemical reaction. The dictum in Albertson related to claims to a method of making a novel compound from a novel compound utilizing a standard chemical reaction.
Some patent practitioners, often examiners, may prefer to extend the dicta of Larson and Albertson to "methods of using" novel products notwithstanding the "method of making" circumstances from which the dicta arose. This limits the categories of inventions capable of being supported and claimed by what is, in reality, a single inventive concept set forth in the patent application. Others, often patent solicitors, will espouse the dissenting opinions of Judge Smith in Larsen and Kanter and take the position that the product made or used cannot be considered a "given" from which the obviousness of the method of making or using is determined. This expands the categories of inventions which may be claimed.
These different viewpoints have been before our reviewing courts on several occasions. [FN3] In the latest case, In re Pleuddemann, supra, the Federal Circuit appears to have resolved the dilemma by studying the specification to ascertain the nature of the invention and how that invention was capable of being claimed. Upon considering the facts and arguments, [FN4] the Court concluded that Pleuddemann's invention concerned a novel silane coupling agent and the use of that novel silane coupling agent both as a bonding agent to impart superior moisture resistance to mineral-filled resins and as a primer for materials which are to be coated with resin. [FN5] Noting that bonding properties were "inherent" in the novel silane, the Court concluded that Pleuddemann's invention was capable of "being claimed both as new compounds or as a new method or process of bonding/priming" (910 F.2d at 827, 15 USPQ2d at 1741). Importantly, the Federal Circuit distinguished In re Durden, 763 F.2d at 1406, 226 USPQ 359 (Fed.Cir.1985) as "involving only the patentability of a process of making a novel insecticide" (910 F.2d at 827, 15 USPQ2d at 1741) notwithstanding the fact that there were novel and unobvious starting materials used and novel and unobvious products obtained.
*7 In the case before us, appellants have admitted the claims are directed to a process of making a desired AB product. The process steps, "introducing" A into AB or "reacting" A with B are standard processes used by practitioners in the prior art for reacting similar A moieties with the same B moiety. We are in agreement with the examiner that there is nothing unobvious in the particular process chosen and claimed by appellants.
The examiner's rejection of claims 6 through 10 under 35 U.S.C. § 103 is affirmed.
No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR 1.136(a). See the final rule notice, 54 F.R. 29548 (July 13, 1989), 1105 O.G. 5 (August 1, 1989).
BOARD OF PATENT APPEALS AND INTERFERENCES
John T. Goolkasian
Bradley R. Garrris
FN1. We note Judge Rich's concurring opinion in In re Larsen, 292 F.2d 531, 130 USPQ 209 (CCPA 1961) wherein it is stated:
While selecting A and selecting B to react with it may not be the only way to produce AB, it cannot be contended that it is not the obvious thing to do if AB is what you want to make.
FN2. Some have attempted to distinguish Mancy and Kuehl on the theory that the cases were directed, respectively, to biological and catalytic materials which are inherently unpredictable. This position was taken by both the PTO Board of Appeals majority in Ex parte Durden and the Board panel deciding Ex parte Pleuddemann (unpublished decisions). In its Pleuddemann decision the Federal Circuit expressly indicated that this reasoning was flawed insofar as the reasoning presumed appellant's new compounds were in the prior art. The court noted that in Kuehl, it had stated that the prior art did not include the new catalyst such that the obviousness of the process of using the catalyst had to be determined "without reference to knowledge of [the catalyst] ... and its properties." See also In re Way, 514 F.2d 1057, 185 USPQ 580 (CCPA 1975) wherein Kuehl's zeolite catalyst is described as finding "obvious use in the process."
FN3. In Ex parte Durden (unpublished decision), a seven member minority of this board urged the CCPA to overrule In re Albertson, 332 F.2d 379, 141 USPQ 730 (CCPA 1964) and reverse the majority decision because it treated both the novel, unobvious and patented starting material used to make the final product and the final product itself as "givens." The board minority's view was not persuasive at the Federal Circuit, which refused to overrule Albertson and considered it controlling. See In re Durden, supra.
FN4. Counsel for Pleuddemann had argued strongly that the claims at issue were directed to the use of the novel silane.
FN5. Pleuddemann's novel silane was used for the same purpose and in the same manner as the silanes of the prior art.