Ex Parte No Data

Board of Patent Appeals and Interferences

Jul 31, 2006

90004950 (B.P.A.I. Jul. 31, 2006)

The opinion in support of the decision being entered today 1
was not written for publication 2
and is not binding precedent of the Board. 3
4
5
6
UNITED STATES PATENT AND TRADEMARK OFFICE 7
____________ 8
9
BEFORE THE BOARD OF PATENT APPEALS 10
AND INTERFERENCES 11
____________ 12
13
Ex parte MICHIHIKO OCHIAI, TAIITI OKADA, 14
OSAMI AKI, AKIRA MORIMOTO, 15
KENJI KAWAKITA and YOSHIHIRO MATSUSHITA 16
____________ 17
18
Appeal 2006-1443 19
Reexamination 90/005,200 20
Patent 5,583,216 21
Technology Center 1600 22
____________ 23
24
Appeal 2006-1465 25
Reexamination Control 90/004,950 26
Patent 5,583,216 27
Technology Center 1600 28
____________ 29
30
Oral Argument: 26 June 2006 31
Decided: 31 July 2006 32
33
Before: McKELVEY, Senior Administrative Patent Judge, and HANLON and 34
DELMENDO, Administrative Patent Judges. 35
36
McKELVEY, Senior Administrative Patent Judge. 37
38
DECISION ON APPEAL UNDER 35 U.S.C. § 306 39
A. Introduction 40
The appeal is from a decision of the Examiner rejecting claims 1-5 41
of U.S. Patent 5,583,216 (Ochiai ‘216) in consolidated Reexamination 42
Proceedings 90/004,950 and 90/005,200. 43
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Claims 1-5 are the only claims in the patent. 1
The rejection is based on double patenting. 2
The real party in interest is Takeda Pharmaceutical Company Limited, which we 3
are told was formerly Takeda Chemical Industries, Ltd. 4
Reexamination was requested by E. Thomas Wheelock, Esq., of the firm of 5
Morrison & Foerster LLP (Palo Alto, CA). 6
Oral argument took place on 26 June 2006. 7
A transcript (Tr-) of oral argument has been made part of the record. 8
For reasons that follow, the decision of the Examiner rejecting claims 1-5 based 9
on double patenting is affirmed. 10
11
B. The “new evidence appendix” 12
Following docketing of the appeal, the board requested that Appellants file a new 13
evidence appendix comprising documents having exhibit numbers beginning with 14
Exhibit 1001. 15
The Board appreciates Appellants' compliance with the request. 16
We have considered the following record in resolving the appeal: 17
(1) The specification, including the claims, of the patent under 18
reexamination—Ochiai ‘216. 19
(2) The appeal brief filed 2 September 2005. 20
(3) The Examiner’s answer entered 16 November 2005. 21
(4) The new evidence appendix filed 20 June 2006, except as noted 22
below, but only to the extent that particular and specific portions of the documents have 23
been called to our attention in the appeal brief or a declaration. The mere fact that a 24
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document containing many pages has been “cited” does not mean that we have 1
considered the entire document. Rather, we consider only that portion of the document 2
called to our attention. DeSilva v. DiLeonardi, 181 F.3d 865, 866-67 (7th Cir. 1999) 3
(court will not play archaeologist with the record); Clintec Nutrition Co. v. Baxa Corp., 4
44 USPQ2d 1719, 1723 n.16 (N.D. Ill. 1977) (where party cites to a multi-page exhibit 5
without citing a specific portion or page, the court will not pour over the documents to 6
extract the relevant information). 7
We have not considered the following: 8
(1) The reply brief, which was refused entry by the Examiner. The 9
Chief Administrative Patent Judge invited Appellants to have the appeal remanded so that 10
the Director of Technology Center 1600 could entertain a petition to review the 11
Examiner’s refusal to enter the reply brief. Appellants declined the Chief Judge’s 12
invitation, electing instead to go forward with oral argument. 13
(2) Documents in the new evidence appendix which are not in English. 14
15
C. Findings of fact 16
The record supports the following findings of fact by at least a preponderance of 17
the evidence. 18
The patent under reexamination (Ochiai ‘216) 19
U.S. Patent 5,583,216 (Ochiai ‘216) under reexamination and now on appeal 20
issued on 10 December 1996. 21
Ochiai ‘216 is based on an application filed 8 January 1990, and claims benefit of 22
a series of applications, the first of which was filed on 19 December 1975 (Ochiai ‘888). 23
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The Ochiai ‘216 is based on a pre-GATT application and therefore enjoys a 1
17-year term. 2
The patent contains claims 1-5 that are reproduced in Appendix 1 of this opinion. 3
According to Appellants, “all claims stand or fall with *** claim 1” (Appeal 4
Brief, filed 2 September 2005, page 6). Accordingly, we select claim 1 as representative 5
of all of the appealed claims and confine our discussion to claim 1. 37 CFR 6
§ 41.37(c)(1)(vii) (2005). 7
As is apparent from Appendix 1, Ochiai ‘216 claim 1 is directed to a method for 8
preparing organic “cephem” compounds having particular chemical structures. 9
We note that one feature of the cephem compound to be made by the process of 10
Ochiai ‘216 is the presence of a —C(=NR5)— group. 11
According to claim 1, the sole step in the process involves “introducing” (1) an 12
acyl group having a first particular chemical formula “into” (2) the amino group of a 13
“Molecule” having a second particular chemical formula. 14
The acyl group has a structure that includes, e.g., (1) a —COOH group or 15
(2) a —COO-+salt (e.g., Na+) group. 16
The “Molecule” mentioned in claim 1 on appeal has an amino group, i.e., a 17
chemical group having a structure which includes —NH2. 18
It is known in the art that a compound with an acyl group can be made to react 19
with a molecule having an amino group to form an “amide”, e.g., the reaction: 20
R—COOH + H2N—R’ ——► R—CONH—R’ + H2O. 21
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The Examiner’s rejection 1
The Examiner rejected claims 1-5 as being unpatentable based on double 2
patenting. 3
We understand a “first” double patenting rejection to be bottomed on the claims 4
of each of 5
(1) Ochiai U.S. Patent 4,298,606 (‘606) (Ex. 1036) or 6
(2) Ochiai U.S. Patent 4,098,888 (‘888) (Ex. 1037) or 7
(3) Ochiai U.S. Patent 4,203,899 (‘899) (Ex. 1038) 8
“in view of ” 9
(a) Chauvette (Ex 1039), 10
(b) Gottstein (Ex. 1040), 11
(c) Cocker (Ex. 1041), 12
(d) Fieser (Ex. 1042) and 13
(e) Dolfini (Ex 1043). 14
Examiner’s Answer entered 16 November 2005, page 3. 15
A “second” double patenting rejection is bottomed on the claims of either 16
(1) Ochiai ‘888 (Ex. 1037) or 17
(2) Ochiai ‘606 (Ex. 1036). 18
Examiner’s Answer, page 16. 19
Ochiai ‘606 20
Ochiai ‘606 issued on 3 November 1981 and accordingly has expired. 21
Ochiai ‘606 is based on an application filed 28 August 1979 and claims benefit of 22
at least an application filed 19 December 1975 (Ochiai ‘888). 23
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Claim 1 of Ochiai ‘606 is directed, inter alia, to cephem compounds having a 1
particular formula (Ochiai, col. 38, line 67 through col. 39, line 24). See the (a) member 2
of the Markush group of claim 1. 3
The process of claim 1 on appeal can be used to make some of the cephems 4
covered by claim 1 of Ochiai ‘606, including cephems with a —C(=NR5)— group. 5
The method of claim 1 on appeal can be used to make the cephems of claim 1 of 6
Ochiai ‘606 at least when: 7
(1) R8 of Ochiai ‘216 claim 1 is hydrogen (—H); 8
(2) —CH(R2)— of Ochiai ‘606 is —C(═NR5)— and R5 is hydroxyl 9
(—OH); 10
(3) R3 of both claim 1 on appeal and Ochiai ‘606 is hydrogen or 11
methoxy (— OCH3); and 12
(4) R4 of both claim 1 on appeal and Ochiai ‘606 is hydrogen (—H) 13
or acetoxy. 14
15
Ochiai ‘606 claim 15 (1) is narrower than Ochiai ‘606 claim 1 and (2) is also 16
directed to cephem compounds which can be produced by the process of claim 1 on 17
appeal at least when: 18
(1) R9 of claim 15 of Ochiai ‘606 is amino (—NH2); 19
(2) R5 of claim 15 of Ochiai ‘606 and claim 1 on appeal are hydroxyl; 20
(3) R11 of claim 15 of Ochiai ‘606 and R3 of claim 1 on appeal are 21
hydrogen or methoxy; and 22
(4) R4 of claim 15 of Ochiai ‘606 and claim 1 on appeal are 23
hydrogen. 24
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A process described in Ochiai ‘606 for making the cephems of claims 1 and 15 of 1
Ochiai ‘606 is reacting compound VI (col. 1, line 36) with compound V (col. 1, line 46). 2
See also (1) col. 2, lines 26-29 and (2) col. 6, line 55 through col. 7, line 62. 3
Compound VI of Ochiai ‘606 is the “Molecule” with the amino group of claim 1 4
on appeal. 5
Compound V is the compound with the acyl group of claim 1 on appeal. 6
The process described in Ochiai ‘606 for making cephems is the process of 7
claim 1 on appeal. 8
Ochiai ‘888 9
In view of the rationale for our affirmance, we find it unnecessary to make 10
detailed findings with respect to what is claimed and described in Ochiai ‘888. 11
Ochiai ‘888 has expired. 12
Ochiai ‘899 13
In view of the rationale for our affirmance, we find it unnecessary to make 14
detailed findings with respect to what is claimed and described in Ochiai ‘899. 15
Ochiai ‘899 has expired. 16
Other prior art cited by the Examiner 17
The Examiner cited prior art in support of one of the double patent rejections on 18
appeal. 19
In view of the rationale for affirmance, we find it unnecessary to discuss the cited 20
prior art. 21
Wuest Declaration 22
Appellants rely on declaration testimony of Dr. James D. Wuest (Ex 1001). 23
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The Wuest declaration was filed on or about 2 September 2005. 1
Dr. Wuest has a Ph.D. in organic chemistry. 2
In Dr. Wuest’s opinion none of the prior art cited by the Examiner describes or 3
suggests introducing an acyl group into an amino group of a “Molecule” as called for by 4
claim 1 on appeal. 5
As noted earlier, we do not find it necessary to discuss or rely on the prior art 6
cited by the Examiner. 7
Accordingly, we have no occasion to assess the weight to be given Dr. Wuest’s 8
opinions with respect to that prior art. 9
Dr. Wuest seems to be of the opinion that, prior to considering the Ochiai 10
specifications, a person having ordinary skill in the art would not have had a reasonable 11
expectation that the process of Ochiai ‘216 claim 1 would be successful. 12
As explained in Paragraph 15 of his declaration, Dr. Wuest suggests that one 13
skilled in the art would have expected that “self-condensation” would occur. 14
What is “self-condensation”? 15
What Dr. Wuest suggests is that a person having ordinary skill in the art might at 16
first blush believe that the compound with acyl group of Ochiai ‘216 claim 1 would react 17
with itself and not the “Molecule” of claim 1. Why? Because (1) the compound has both 18
an acyl group (e.g., —COOH) and an amino group (e.g., —NH2) and, (2) as noted above 19
and known in the art, acyl groups react with amino groups to form amide groups, in this 20
case a group with the formula —CONH—. 21
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Dr. Wuest illustrates his concern in the chemical reaction set out in Paragraph 15 1
of his declaration where it is suggested that the Compound of Ochiai ‘216 might become 2
involved in self-condensation more or less according to the chemical equation: 3
n H2N—R—COOH ——► H2N—(R—CONH)n-1—R—COOH 4
5
Dr. Wuest does not satisfactorily explain why one skilled in the art would have 6
expected the “hindered” amine group attached to an aromatic-like group on the 7
compound also having the acyl would have been expected to be more reactive than the 8
primary amine group attached to the molecule. 9
Dr. Wuest expressed other reasons why, absent the Ochiai specifications, one 10
skilled in the art would not have expected the Ochiai ‘216 claim 1 process to be 11
successful. 12
However, Dr. Wuest acknowledges that one skilled in the art would have been 13
able to carry out the process of claim 1 of Ochiai ‘216 as described in the specification of 14
Ochiai ‘216. Wuest declaration, Paragraph 43. 15
In fact, Dr. Wuest goes on to tell us that based on “references” published between 16
1989 and 1997 one skilled in the art would have been able to carry out the process of 17
Ochiai ‘216 claim 1 as described by Ochiai ‘216 notwithstanding any concerns expressed 18
in the prior art. Wuest declaration, Paragraph 44. 19
Dr. Wuest testified that “there are various possible alternative pathways for 20
making the cephem compound of claim 1 of the ‘216 patent.” Wuest declaration, 21
Ex. 1001, Paragraph 50. 22
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Dr. Wuest starts his analysis by noting that “There Are Other Potential Routes for 1
Making the Final Product of Claim 1 Of the ‘216 Patent”. Wuest declaration, Ex. 1001, 2
page 22. 3
We take Dr. Wuest’s testimony to be that, as of the date he signed his declaration 4
in 1999, one skilled in the art would have understood that there “are various possible 5
alternative pathways for making the cephem compound of claim 1 of the ‘216 patent.” 6
Wuest declaration, Ex. 1001, Paragraph 50. 7
The Morin document contains numerous pages and is an example of a large 8
document submitted by Appellants where only a few pages are mentioned in the Wuest 9
declaration. Consistent with our previous observation, we have considered only the 10
pages mentioned. 11
With reference to page 21 of Morin et al., Chemistry and Biology of β-Lactam 12
Antibiotics (1982) (Ex. 1010), we think that Dr. Wuest is trying to tell us that compounds 13
similar to the starting materials in the process of Ochiai ‘216 claim 1 are shown as 14
Compounds 65 and 66. 15
According to Dr. Wuest, a displacement reaction is said to be shown on page 87 16
of Morin. Wuest declaration, Ex. 1001, page 23 and Ex. 1010, page 87. 17
Dr. Wuest goes on to testify that “[a]lthough the Morin reference does not 18
specifically disclose coupling of an amino-substitute thiazolyl compound to penicillin 19
sulfoxide, given the examples taught in the Ochiai specification, I would expect that this 20
reaction could be carried out.” Wuest declaration, Ex. 1001, page 23. 21
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The Examiner’s assessment of the Wuest declaration testimony 1
The Examiner was not impressed with Dr. Wuest’s declaration testimony and 2
declined to give the testimony much, if any, weight. 3
Among other things, the Examiner found that the testimony was “speculative” and 4
had never been performed. Examiner’s answer, page 8; Tr-8:16-18. The Examiner 5
further found that the process suggested by Dr. Wuest was not described by Ochiai. The 6
Examiner still further found that the process suggested by Dr. Wuest relies on a 7
compound not shown to have been known earlier than the 1982 date of Morin. 8
Usami declaration 9
Appellants also rely on a declaration of Mr. Hirofumi Usami filed on or about 10
2 September 2005. Ex. 1035. 11
Mr. Usami is employed in the intellectual property department of the real party in 12
interest--Takeda. Usami declaration, Paragraph 3. 13
Through Mr. Usami’s testimony, we are told about what appears to have been a 14
somewhat long and involved prosecution of the numerous Ochiai applications. 15
According to Mr. Usami, part of the reason for the long prosecution is that Takeda 16
was unable to promptly obtain claims to cover competitors’ later developed compounds 17
within the scope of Ochiai’s generic claims “because of the refusal of the Examiner to 18
allow generic claims and the long appeal pendency at the Board *** that was the norm in 19
the 1980’s ***.” Usami declaration, Paragraph 20. 20
Mr. Usami undertakes an explanation of why “process of making” claims like 21
those in claim 1 of Ochiai ‘216 were not presented early in the Ochiai patent application 22
filing strategy. Usami declaration, Paragraph 25. 23
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According to Mr. Usami, (1) process of making claims “were not valuable in 1
terms of protection of pharmaceutical compounds” and (2) “claims of this type were not 2
considered patentable under the case law of the United States ***.” Usami declaration, 3
Paragraph 25. 4
The “were not valuable” portion of Mr. Usami’s testimony is apparently based on 5
his view that the § 271(g) protection now available was not then available in the United 6
States as Mr. Usami believes it was in Europe. 7
Since 1989, § 271(g) protection has been available in the United States; a person 8
infringes a patented process if the product made by the process is made abroad and the 9
product is imported into the United States during the life of the process patent. 10
While he does not say so in so many words, we believe Mr. Usami’s “were not 11
considered patentable” portion of his testimony is based on cases like In re Larsen, 12
292 F.2d 531, 130 USPQ 209 (CCPA 1961) and its progeny. 13
Mr. Usami recognizes that a case decided shortly after Larsen left open the 14
possibility that appropriate evidence in a particular case might provide a means for 15
overcoming In re Larson rejections of method claims, but says that he has no recollection 16
of having seen the case. The case is In re Ross, 305 F.2d 878, 134 USPQ 320 (CCPA 17
1962). 18
We understand that Mr. Usami is telling us that post Larsen it was not worth 19
pursuing “method of making” claims until § 271(g) protection became available in 1989. 20
Accordingly, if we are to believe Mr. Usami, and if we correctly understand what 21
he is trying to tell us, it was not until 1990, when the application which matured into 22
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Ochiai ‘216 was filed, that it was worth Takeda’s time and effort to file “method of 1
making” claims for some of the cephem compounds of the claims of Ochiai ‘606. 2
Mr. Usami does not tell us why the cephems of method claims of Ochiai ‘216 are 3
not exactly co-extensive with the cephems of Ochiai ‘606 and we perceive no reason why 4
they could not have been exactly co-extensive. 5
Other findings as necessary appear in the Discussion portion of this opinion. 6
D. Discussion 7
1. 8
Double patenting is designed to prevent an unjustified extension of patent rights 9
beyond the term of a patent. Since double patenting seeks to avoid unjustly extending 10
patent rights at the expense of the public, the focus of any double patenting analysis is on 11
the claims of the patents involved in the analysis, in this case Ochiai ‘216 and Ochiai 12
‘606. As applied to the facts of this case, the appeal boils down to the following issue: 13
Having taken out a full-term cephem compound patent 14
(Ochiai ‘606), 15
are Appellants also entitled to take out yet another full-term patent 16
to a method of making some of those cephem compounds where 17
(1) the claimed method for making the cephem compounds is 18
described in the cephem compound patent and 19
(2) there is no credible alternative method for making the 20
cephems which does not involve an infringement of the method patent? 21
We think not. 22
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Our appellate reviewing court and the Patent and Trademark Office have 1
recognized at least two categories of double patenting. 2
A first form of double patenting is where a second patent claims the same 3
invention as a first patent. The second patent is said to be precluded based on double 4
patenting bottomed on the statutory language in 35 U.S.C. § 101 which states that “a 5
patent” may be issued for certain inventions. 6
A second form of double patenting is where a second patent claims a different 7
invention from a first patent, but the invention claimed in the second patent would have 8
been obvious based on the invention claimed in the first patent—with or without 9
considering additional relevant prior art. 10
We believe there may be a tendency to try to “pigeon hole” every double 11
patenting situation into one of these two recognized categories of double patenting. 12
However, we decline to hold that every double patenting must fit precisely into one of the 13
two categories. In our view, the focus should be on whether a second patent unjustly 14
extends the patent rights of a first patent. Each case, of course, must be decided on its 15
facts. 16
2. 17
As applied to the facts of this case, we think that a decision of the Supreme Court 18
provides support for the decision of the Examiner to reject claims 1-5 on appeal based on 19
double patenting. Mosler Safe & Lock Co. v. Mosler, Bahmann & Co., 127 U.S. 354, 20
8 S.Ct. 1148 (1888). 21
In Mosler, a patent was obtained for an article, viz., “[a]n angle-bar for safe 22
frames.” U.S. Patent 281,640 issued 17 July 1883 based on an application filed 23
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27 December 1881. A second patent was obtained for a “process of bending angle-1
irons.” U.S. Patent 283,136, issued 14 August 1883 based on an application filed 2
11 December 1882. As in the case, before us, the method patent was applied for after the 3
article patent was applied for. The Supreme Court recognized that the method claims and 4
the article claims “might have been all included in one application had the patentee 5
chosen to so present them.” 127 U.S. at 359, 8 S.Ct. at 1150. The Supreme Court found 6
that “the claim for the process in No. 283,136 is merely for the process or method *** 7
involved in making the article covered by claims 1 and 2 of No. 281,640. In other words, 8
claims 1 and 2 of No. 281,640 are each for an article produced by a described method or 9
process, and the claim of No. 283,136 is for such a method or process of producing such 10
article.” 127 U.S. at 361, 8 S.Ct. at 1151-52. The Supreme Court reasoned that “the 11
inventor cannot afterwards, on an independent application, secure a patent for the method 12
or process of cutting away the metal and then bending it so as to produce the identical 13
article covered by the previous patent, which article was described in that patent as 14
produced by the method or process sought to be covered by taking out the second patent.” 15
Ochiai ‘216 covers the method described in Ochiai ‘606 for making at least some 16
of the cephems claimed in Ochiai ‘606. Appellants have not shown that they presented 17
the method claims of Ochiai ‘216 in the application that matured into Ochiai ‘606. 18
Rather, Appellants waited until 15 years into the prosecution of the family of Ochiai 19
applications to first present the method claims on appeal. In this sense, Ochiai’s 20
experience is similar to Mosler’s experience, although the time difference between 21
presentation of article and method claims in Mosler’s case is considerably shorter. 22
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When Appellants received Ochiai ‘216, they acquired the right to prevent others 1
from making (1) the cephems falling within the scope of claims 1-5 of Ochiai ‘216 and 2
(2) some of the cephems claimed in Ochiai ‘606. 3
After 1989, and as a result of enactment and codification of 35 U.S.C. § 271(g), 4
Appellants also acquired the right to exclude others from making or using some of the 5
cephems of now expired Ochiai ‘606 if those cephems were made abroad using the 6
method claimed in Ochiai ‘216. 7
3. 8
Appellants bottom their argument for reversal on the proposition that the process 9
claimed in Ochiai ‘216 is an “independent and distinct” invention from the cephems of 10
Ochiai ‘606. 11
In what is generally recognized as a double patenting case, the Supreme Court in 12
Miller v. Eagle Mfg. Co., 151 U.S. 186, 199, 14 S.Ct. 310, 315 (1894) made the 13
following observation: 14
The result of the foregoing and other authorities is [1] that no 15
patent can issue for an invention actually covered by a former patent, 16
especially to the same patentee, although the terms of the claims differ; 17
[2] that the second patent, although containing a broader claim, more 18
generical [today we would say “generic”] in its character than the specific 19
claims, contained in the prior patent, is also void; but [3] that where the 20
second patent covers matter described in the prior patent, essentially 21
distinct and separate from the invention covered thereby, and claims made 22
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thereunder, its validity may be sustained.” (Emphasis and numbers in 1
brackets added). 2
One of the “foregoing and other authorities” referred to by the Miller court is 3
Mosler Safe & Lock Co. v. Mosler, Bahmann & Co., 127 U.S. 354, 8 S.Ct. 1148 (1888). 4
According to the Miller court, in Mosler “it was held that, a patent having issued for a 5
product as made by a certain process, a later patent could not be granted for the process 6
which results in the same product.” 151 U.S. at 197, 14 S.Ct. at 315. 7
4. 8
Appellants present two arguments, using the rubric “independent and distinct”, in 9
an attempt to fit their case for reversal into the “distinct and separate” category mentioned 10
in Miller. 11
Appellants’ first “independent and distinct” argument is based in part on a 12
restriction requirement made in a different Ochiai application by former Examiner 13
Nicholas Rizzo. At the same time, Appellants candidly acknowledge that “[n]o claim is 14
made for the statutory shield of 35 U.S.C. § 121 ***.” See the last three lines on page 12 15
of the Appeal Brief. 16
Appellants’ second “independent and distinct” argument is based in part on their 17
opinion that there are methods other than the method of Ochiai ‘216 for making the 18
cephems of expired Ochiai ‘606. 19
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5. 1
Appellants’ first argument is bottomed on a restriction requirement made by 2
former Examiner Nicholas Rizzo. 3
According to Appellants, Examiner Rizzo made a restriction requirement between 4
claims said to cover an acylation process and claims said to cover a displacement process. 5
We have found a document in the record discussing a restriction requirement between 6
acylation and displacement processes. See Exhibit 1046. However, Exhibit 1046 is 7
confusing to say the least. Exhibit 1046 consists of five pages. The first page discusses 8
claims 6-10 and 15-18, is dated 28 May 1991 and appears to be part of 9
application 07/462,492. The second page discusses claims 1-21, is dated 6 December 10
1976 and appears to be part of application 07/642,356. Page 3 discusses a restriction 11
requirement between different compounds and appears to be part of 12
application 07/642,356. The fourth page returns to application 07/462,492 and is the 13
page discussing a restriction between an acylation process and a displacement process. 14
The fifth page seems to be part of the file of application 07/462,492. In sum, it would 15
appear that the second and third pages should not have been included in the exhibit. 16
It appears that Examiner Rizzo made a restriction requirement between 17
claims 6-10 (Group A) calling for what is characterized as an acylation process and 18
claims 15-18 (Group B) calling for what is characterized as a displacement process. The 19
language of claims 6-10 and 15-18 has not been placed before us and therefore we are 20
unable to determine the precise metes and bounds of those claims or of the subject matter 21
involved in the Rizzo restriction. Our appellate reviewing court has observed that Ҥ 121 22
only applies to a restriction requirement that is documented by the PTO in enough clarity 23
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and detail to show consonance. The restriction requirement documentation must identify 1
the scope of the distinct inventions that the PTO has restricted ***.” Geneva 2
Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382, 68 USPQ2d 1865, 3
1872 (Fed. Cir. 2003). While we are not dealing with a § 121 situation here, Appellants 4
having expressly declined to place any reliance on § 121, we believe the Federal Circuit’s 5
Geneva observations are applicable here where Appellants in part bottom their case based 6
on what they characterize as a restriction requirement albeit a restriction requirement in a 7
related, but different, case. Having failed to favor us with a copy of the claims said to 8
have been restricted by Examiner Rizzo, we are unable to determine the precise nature of 9
that restriction requirement or the weight, if any, to be given to the Rizzo restriction 10
requirement. 11
In our view, the Rizzo restriction requirement does not give much aid and comfort 12
to Appellants. They have not sufficiently established what the restriction requirement 13
was actually about, and in particular what the displacement process was all about. In 14
short, Appellants’ restriction proofs are not bottomed on sufficient and credible evidence. 15
6. 16
Appellants have an alternate theory. According to Appellants, we should find that 17
there are two ‘independent and distinct” processes that can be used to make the cephems 18
of Ochiai ‘606. 19
Appellants’ theory is based on the declaration testimony of Dr. Wuest. As noted 20
earlier, the Examiner was not impressed with Dr. Wuest’s testimony. 21
According to Appellants, the Examiner has to believe Dr. Wuest’s testimony 22
because there is no opposing evidence. Wrong! The Examiner is entitled to assess 23
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20
testimony and there is no requirement of law that an examiner must have counter-1
testimony or evidence to discredit declaration testimony. See, e.g., Rohm and Haas Co. 2
v. Brotech Corp., 127 F.3d 1089, 1092, 44 USPQ2d 1459, 1462 (Fed. Cir. 1997) (fact-3
finder need not credit unsupported assertions of an expert witness). At oral argument, 4
Appellants acknowledge that one reason the Examiner declined to credit Dr. Wuest was 5
that the alternate process Dr. Wuest has suggested has not been shown to have been 6
"actually been carried out ***." Tr-8:16-18. Appellants go on to say "[b]ut the 7
[E]xaminer never provided any references to dispute the credibility of the expert opinion 8
of Dr. Wuest on this point." Tr-8:20-22. In point of fact, however, Appellants do not, 9
and cannot, deny the correctness of the Examiner's observation that the Wuest alternative 10
process has not been shown to have been carried out. 11
Dr. Wuest characterized the proposed “alternative pathways” as “Potential 12
Routes” and “possible” alternatives. As indicated earlier, Dr. Wuest does not indicate 13
that any scientist made any attempt to carry out his suggested alternative. While 14
Dr. Wuest refers to a Morin text, the most he can say is that “I would expect that this 15
reaction [meaning the Ochiai reaction] could be carried out.” Wuest declaration, 16
Ex. 1010, page 23. Why? Painting with a broad brush, Dr. Wuest refers to the examples 17
in Ochiai specifications, but does not refer to any particular example or why the content 18
of the examples provides a basis for his “I would expect” opinion. Moreover, as 19
developed during oral argument, counsel for Appellants conceded that Dr. Wuest made 20
no analysis of the advantages and disadvantages of his proposed reaction scheme vis-à-21
vis the reaction schemes actually described in the Ochiai specifications. Tr-24:13-22. 22
There is no discussion by Dr. Wuest as to why one skilled in the art would go out of the 23
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21
way to use his “potential” or “possible” reaction schemes when there is a detailed and 1
straightforward reaction scheme described in the Ochiai specifications. Appellants have 2
not shown us that the Wuest alternative processes may be described in the family of 3
Ochiai applications. On this record, it would appear that the Wuest alternative method is 4
a post-litigation afterthought, particularly given the 1982 date of Morin when compared 5
to the 1975 filing date of the first Ochiai application. We cannot say that the Examiner 6
did not have a sufficient basis for finding that the Wuest testimony was “speculative” and 7
we do not think it is our role in this case to second-guess the Examiner’s assessment of 8
the Wuest testimony. The Examiner works in the art area day to day; we do not. 9
When pressed at oral argument, counsel for Appellants maintained that 10
Ochiai ‘606 describes at least two methods for making the cephems of claim 1 of 11
Ochiai ‘606. Tr-6:18 et seq. A first method is reacting compound VI with compound V. 12
Ochiai ‘606, col. 2, lines 26-29 and col. 6, line 55 through col. 7, line 62. A second 13
method is reacting compound IX with a “nucleophilic” compound. Ochiai ‘606, col. 2, 14
lines 33-35 and col. 8, line 32 through col. 9, line 24. A third method, not discussed at 15
oral argument, may be reducing compound VII. Ochiai ‘606, col. 2, lines 30-32 and col. 16
7, line 63 through col. 8, line 31. 17
Each of the three methods described in Ochiai ‘606 involves the use of the 18
process of claim 1 of Ochiai ‘216. 19
The first method involves reacting an acyl containing compound with an amine 20
“Molecule” as described in our findings. 21
The second method involves using Ochiai ‘606 compound IX (top of col. 2). 22
R6 of compound IX can be various organic moieties, including acyloxy, such as 23
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acetyloxy. Ochiai ‘606, col. 8, lines 34-35. The process of claim 1 on appeal can be used 1
to make Compound IX when R4 of claim 1 on appeal is a residue of a nucleophilic 2
compound. For example, R4 can be —W—R where W is oxygen and R is acyl. One 3
example of an —W—R group is acyloxy, e.g., acetyloxy. Ochiai 216, col. 6, lines 30 4
and 39. The method of claim 1 of Ochiai ‘216 can be used to make some of the 5
compounds falling within the scope of Ochiai ‘606 compound IX. 6
The third method involves use of Ochiai ‘606 compound VII (col. 1, line 60). 7
Some of the compounds falling within the scope of Ochiai ‘606 compound VII are made 8
by reacting a compound having an acyl group with a “Molecule” in accordance with 9
claim 1 of Ochiai ‘216. 10
What surfaces from the discussion above is that regardless of whether one skilled 11
in the art practices the first, second or third method described in Ochiai ‘606, that person 12
uses the process of claim 1 of Ochiai ‘216 to make at least some of the Ochiai ‘606 13
compounds. The Ochiai ‘216 method is used to make compounds via the first method. 14
The process is also used to make starting materials for practicing the second or third 15
method. We have a case where all the described methods for making some of the ‘606 16
cephems in one fashion or another involve the use of the process of claim 1 of 17
Ochiai ‘216. Having rejected Dr. Wuest’s speculative method, no credible method for 18
making the cephems of Ochiai ‘606, other than those described in Ochiai ‘606, has been 19
placed before us. This is not a case where a credible alternative method for making the 20
Ochiai ‘606 compounds has been established. Appellants have not established that there 21
are credible separate “independent and distinct” methods for making some of the 22
cephems claimed in Ochiai ‘606. 23
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7. 1
At oral argument, Appellants indicated that “the final product of the [Ochiai] '216 2
process is substantially coextensive with the two final product patents that are the subject 3
of the double patenting rejection.” Tr-17:19 through 18:4. One of the "two final product 4
patents" is Ochiai '606. Nevertheless, we recognize that the process of Ochiai ‘216 5
cannot be used to make all of the cephems within the scope of claims 1 and 15 of Ochiai 6
‘606. In other words, the scope of the cephems that can be made using the process of 7
claims 1-5 of Ochiai ‘216 is narrower than the scope of the cephems covered by Ochiai 8
‘606, although the scope of the cephems made by claim 15 of Ochiai ‘606 is very close. 9
However, to the extent that the process of Ochiai ‘216 is used to make only some of the 10
cephems within the scope of the Ochiai ‘606 claims, Appellants ultimately conceded at 11
oral argument that the public is not entitled to use that process to make “some of the 12
cephems” of Ochiai ‘606. Tr-19:19 through 20:10. In effect, the claims of Ochiai ‘216 13
operate to extend the patent rights conferred by now expired Ochiai ‘606 at least to the 14
extent that the Ochiai ‘606 and Ochiai ‘216 claims are co-extensive. 15
Given the rationale upon which double patenting is based, we see no reason why a 16
process claim and the expired compound have to be co-extensive in scope to sustain a 17
rejection for double patenting. Just as one described species or several species may 18
anticipate a genus in an anticipation analysis under 35 U.S.C. § 102(b) even if other 19
described species do not anticipate, we see no reason why double patenting should not 20
apply, under the facts of this case, where a process claim operates to preclude making of 21
some compounds of an expired compound patent. It should suffice to justify double 22
patenting that some or all of the compound claims of an expired compound patent 23
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continue to be monopolized by virtue of patent rights in a narrow method patent. In 1
In re Vogel, 422 F.2d 438, 442, 164 USPQ 619, 622 (CCPA 1970), the former CCPA 2
noted that issuance of a second patent to a process of treating meat would extend the time 3
of monopoly as to a process of treating pork claimed in a first patent. Here, to the extent 4
the Ochiai ‘216 patent extends the monopoly as to the compounds which can be made by 5
that process which are the same as the compounds covered by claim 1 of Ochiai ‘606, the 6
monopoly of Ochiai ‘606 is also extended, particularly as to products made abroad by the 7
process and subsequently imported into the United States. Tr-20:11 through 21:1. 8
Double patenting should not turn on “creative” method claim drafting. Rather, 9
the focus should be on an analysis of whether all or some of a patentee’s patent rights are 10
being unjustly extended. For example, in this very case it is not apparent, and Mr. Usami 11
did not explain, why Ochiai ‘216 method claims were not drafted to include making all of 12
the cephems of Ochiai ‘606 claims 1 and 15. Appellants conceded at oral argument, as 13
they had to, that product and process claims could have been presented in a single 14
application. Tr-11:7-10. See also Tr-25:6 through 26:1. In our opinion, what might be 15
characterized as Appellants’ creative and conveniently timed claim drafting should not be 16
a back door “around” double patenting. 17
8. 18
Appellants presented the declaration testimony of Mr. Hirofumi Usami (Ex 1035) 19
to explain why the Ochiai ‘216 process claims were first presented in 1990 in the 20
application that matured into Ochiai ‘216. Ochiai ‘216 is based on several continuations, 21
continuations-in-part and divisions of an Ochiai application filed in 1975, viz., Ochiai 22
‘888. As noted in our findings, Mr. Usami states that process claims were not earlier 23
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presented because (1) process protection was said not to be valuable until 1989 when 1
§ 271(g) was enacted and (2) process claims were not patentable in the United States. 2
Appellants seem to be saying that because they could not have benefited from process 3
claims pre-1989, they were under no obligation to present process claims. 4
It may be fairly debatable whether any weight should be assigned to Mr. Usami’s 5
testimony. How relevant is it to any issue before us? To the extent that double patenting 6
ought to be based in whole or in part on equitable, as opposed to wholly legal, 7
considerations, we would find that Mr. Usami’s declaration amounts to an “excuse” but 8
not a “justification” for the delay in presenting the process claims on appeal. Appellants' 9
delay in seeking process protection has extended in part the 1998 expiration date of 10
Ochiai ‘606 until 2013, all because Takeda did not diligently pursuant its right to a 11
process patent. 12
It is true that § 271(g) made process claims more valuable. Tr-25:6-13. 13
However, Congress has long authorized inventors to apply for patents on processes. 14
35 U.S.C. § 101. Moreover, the law encourages individuals to diligently seek to protect 15
their “rights” and not delay to the prejudice of others. The "others" in this case is the 16
public. 17
It is also true that In re Larsen and some of its progeny could have been viewed as 18
discouraging inventors to seek certain process claims. Tr-10:2-5. Included among the 19
progeny is In re Durden, 763 F.2d 1406, 226 USPQ 359 (Fed. Cir. 1985). Tr-10:3. 20
Notwithstanding the 1985 Durden decision, Edwin P. Pleuddemann and his assignee 21
Dow Corning Corporation, applied for a process patent on 14 October 1986, as a division 22
of a product patent filed on 29 November 1985. Unlike Ochiai and Takeda, 23
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Plueddemann and Dow Corning Corporation successfully sought to vindicate what they 1
felt was their right to a process patent notwithstanding Larsen and Durden and did so 2
prior to enactment of § 271(g). In re Pleuddemann, 910 F.2d 823, 15 USPQ2d 1738 3
(Fed. Cir. 1990). Moreover, in this very case, we note that Appellants, like 4
Pleuddemann, successfully overcame a so-called Durden rejection. In re Ochiai, supra. 5
9. 6
Appellants cited and rely on In re Cady, 77 F.2d 106, 25 USPQ 345 (CCPA 7
1935). According to Appellants, the 1952 Patent Act and subsequent PTO 8
pronouncements codified the holdings of Cady. A first holding was that if a restriction 9
requirement is made, the PTO cannot use double patenting. The holding is codified in 10
35 U.S.C. § 121. Here there was no restriction. A second holding is said to be that if 11
there are two methods of a making a product, the methods might be regarded as 12
independent and distinct from each other and the product. The pre-271(g) Cady holding 13
and any PTO codification of that holding is not applicable to the facts of this case. 14
Appellants have failed to establish that there two “independent and distinct” methods for 15
making the cephems of Ochiai ‘606 which do not involve the use of the Ochiai ‘216 16
process. 17
10. 18
Appellants have discussed In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 19
1968). We are not at all sure what Schneller has to do with the issues on appeal. We 20
agree with Appellants that Schneller is not controlling. Accordingly, further discussion 21
concerning Schneller would not be productive. 22
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11. 1
Appellants make a point in the Appeal Brief, and at oral argument, that the 2
Examiner has “combined” several Ochiai patents to make the double patenting rejecting. 3
Tr-15:12-17. 4
We do not think the Examiner combined several Ochiai patents to make the 5
rejection. However, given the rationale upon which we have affirmed, we find it 6
unnecessary in this case to resolve any issue of whether two or more patents owned by a 7
patentee may be “combined” to support a double patenting rejection of another patent 8
owned by the patentee. We leave that issue for another day. 9
E. ORDER 10
Upon consideration of the record indicated above and for the reasons given, it is 11
ORDERED that the decision of the Examiner rejecting claims 1-5 is 12
affirmed. 13
FURTHER ORDERED that no time period for taking any subsequent 14
action in connection with this appeal may be extended under 37 CFR § 1.136(a) (2005). 15
AFFIRMED. 16
17
______________________________ ) 18
FRED E. McKELVEY, Senior ) 19
Administrative Patent Judge ) 20
) 21
) 22
______________________________ ) BOARD OF 23
ADRIENE LEPIANE HANLON ) PATENT 24
Administrative Patent Judge ) APPEALS AND 25
) INTERFERENCES 26
) 27
______________________________ ) 28
ROMULO H. DELMENDO ) 29
Administrative Patent Judge ) 30
31
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