Ex Parte Abe et al

Board of Patent Appeals and Interferences

Aug 3, 2011

10693315 (B.P.A.I. Aug. 3, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte TAKAO ABE, HIROSHI MATSUNAGA,
ADO MIHIRA, CHISATO SATO, HIDEKI USHIROGOCHI,
KOICHI SATO, TSUYOSHI TAKASAKI,
ARANAPAKAM MUDUMBAI VENKATESAN,
and TAREK SUHAYL MANSOUR
__________

Appeal 2010-010445
Application 10/693,315
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a process of
making chemical compounds. The Examiner entered a rejection for
obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

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STATEMENT OF THE CASE
Appellants‟ invention is directed to “a novel process for the
production of 6-alkylidene penem derivatives that can be important as broad
spectrum β-lactamase inhibitors and anti-bacterial agents” (Spec. 1).
Claims 9-11, 13-30, and 32-40 stand rejected and appealed (App. Br.
1).
1
Claim 9 illustrates the appealed subject matter, and recites “[a] process
for the preparation of compounds of the formula I

(App. Br. 5.)
Claim 9 specifies an extensive number of different substituents that
can be at positions A, B, and R5 (id. at 5-7), and further recites that
said process compris[es]:
(a) condensing an appropriately substituted aldehyde 17

wherein A' is defined as A or B whichever one of A or B is not
hydrogen, with 6-bromo-penem derivative of structure 16

1
Appeal Brief entered March 3, 2010.
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wherein R is p-nitrobenzyl in the presence of a Lewis acid and an
organic tertiary amine base, at a temperature of -10°C to -40°C to
form an intermediate aldol product 18

wherein A' and R are as defined above;
(b) reacting intermediate 18 with an acid chloride or anhydride, (R8)Cl
or (R8)2O, or with tetrahalomethane, C(X1)4, and triphenyl phosphine,
to form intermediate compound 19

wherein R8 is alkylSO2, arylSO2, alkylCO, or arylCO; X1 is Br, I, or
Cl; A' and R are as defined above; and R9 is X1 or OR8; and

(c) converting the intermediate compound 19 to the desired formula I
compound by a reductive elimination process, wherein the reductive
elimination process is carried out using activated zinc and a phosphate
buffer at a pH of about 6.5 to 8.0 and hydrogenating over a catalyst.

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The sole rejection before us for review is the Examiner‟s rejection of
claims 9-11, 13-30, and 32-40 “on the ground of nonstatutory obviousness-
type double patenting as being unpatentable over claims 1-20 of U.S. Patent
No. 7018997”
2
(Ans. 3-5).
DISCUSSION
ISSUE
In rejecting the appealed claims over claims 1-20 of the „997 patent,
the Examiner finds that, “[a]lthough the conflicting claims are not identical,
they are not patentably distinct from each other because there is no
patentable distinction between the compounds as claimed in the patent, and
the method of synthesis, as claimed here” (Final Rejection 3 (entered July
11, 2008) (citing Mosler Safe & Lock Co. v. Mosler, Bahmann & Co., 127
U.S. 354 (1888), and Ex parte MacAdams, 206 USPQ 445 (BPAI 1978)).
The Examiner also specifically notes that “no restriction was made in
the prosecution of 7018997 between these compounds and their method of
synthesis” (Final Rejection 4).
Appellants, in addition to taking issue with the Examiner‟s
interpretation of case law, urge that the Examiner has “erroneously used a
rote analysis, rather than applying the proper standard for obviousness type
double patenting. In a proper obviousness analysis, the Examiner should
consider the differences between the patent claims and the pending claims
and determine whether the differences are obvious from the patent claims”
(App. Br. 4).

2
Aranapakam Mudumbai Venkatesan et al., U.S. Patent No. 7,018,997 B2
(filed May 1, 2003).
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Thus, Appellants argue:
In this case, the process steps of the pending claims represent a
significant difference from the patent claims; the Examiner has
not provided any reasons to support his assertion that these
process steps are obvious from the patent claims. Appellants
claim a specific multi-step process. In view of the known
unpredictability of the chemical arts, it is certainly not obvious
from the mere knowledge of the end product.

(Id.)
The Examiner responds that, “[i]nitially, claims to a product, and
claims to methods of preparing or using, are not patentably distinct” (Ans. 3
(citing Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d
1373 (Fed. Cir. 2003), In re Boylan, 392 F.2d 1017 (CCPA 1968); In re
Byck, 48 F.2d 665 (CCPA 1931), and In re Freeman, 166 F.2d 178 (CCPA
1948))).
The Examiner reasons, therefore, that “to show that the compound and
process inventions are patentably distinct, applicants must demonstrate that
there is an alternative method” of making the patented compounds (Ans. 3-4
(citing Takeda Pharmaceutical Co., Ltd. v. Dudas, 511 F.Supp.2d 81
(D.D.C. 2007); Takeda Pharmaceutical Co., Ltd. v. Doll, 561 F.3d 1372
(Fed. Cir. 2009); Phillips Petroleum Co. v. U.S. Steel Corp., 604 F.Supp.
555 (D. Del. 1985), Ex parte Zoss, 114 USPQ 309 (BPAI 1956), In re Cady,
77 F.2d 106 (CCPA 1935), and MPEP § 806.05)).
The Examiner further reasons that, because Appellants have not
unequivocally stated and provided supporting evidence that the patented
compounds can be made by an alternative process to that recited in the
appealed claims, “the standard of specifically setting forth an alternative
process has not been met” and “therefore, the rejection is sound” (Ans. 4-5).
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The Examiner also concludes that Appellants‟ urged standard of
obviousness-type double patenting, requiring the Examiner to compare the
conflicting sets of claims and determine whether the claims at under
examination are obvious over the patented claims, “is not the correct
standard. Applicants present no case law in defense of their standard for
overcoming the nonstatutory obviousness-type double patenting rejection,
and the examiner is not aware of any” (id. at 5).
In view of the positions advanced by Appellants and the Examiner,
the issue here is whether a prima facie case of obviousness-type double
patenting necessarily exists when an applicant presents claims directed to a
process of making a patented product, the prima facie case being overcome
only by a showing that the patented product can be made by an alternative
process to that recited in the claims under examination, or whether, in
making a prima facie case of obviousness-type double patenting, the
Examiner bears the burden of explaining why an ordinary artisan would
have considered the process claims obvious in view of the patented product
claims.
FINDINGS OF FACT (“FF”)
1. It is undisputed that claims 1-20 of the „997 patent recite
compounds which are produced by the process recited in claims 9-
11, 13-30, and 32-40, on appeal herein.
2. It is undisputed that no restriction requirement was made between
the compound claims and claims directed to processes of making
the compounds during prosecution of the „997 patent.
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3. The Examiner finds, and Appellants do not dispute, that the
“claimed synthetic process here is in fact the same process as is in
the [„997] patent” (Ans. 5).
4. The Examiner does not advance any evidence to support the
finding that the patented product can be made only by the claimed
process.
5. Appellants do not advance any evidence to support a finding that
the patented product can be made by processes other than the
claimed process.
6. The Examiner does not advance any rationale as to why the
appealed process claims would have been obvious in view of the
patented product claims.
ANALYSIS
We conclude that Appellants have the better position.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . . After evidence or
argument is submitted by the applicant in response,
patentability is determined on the totality of the record, by a
preponderance of evidence with due consideration to
persuasiveness of argument.

In evaluating obviousness-type double patenting, the Federal Circuit
has explicitly “endorsed an obviousness determination similar to, but not
necessarily the same as, that undertaken under 35 U.S.C. § 103 in
determining the propriety of a rejection for double patenting.” In re Braat,
937 F.2d 589, 592-93 (Fed. Cir. 1991).
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Thus, in making an obviousness-type double patenting rejection, the
Examiner must show that a claimed invention is “a mere variation of [the
patented invention] . . . which would have been obvious to those of ordinary
skill in the relevant art . . . [and] there must be some clear evidence to
establish why the variation would have been obvious which can properly
qualify as „prior art.‟” In re Kaplan, 789 F.2d 1574, 1579-80 (Fed. Cir.
1986). Accordingly, in Kaplan, the Federal Circuit reversed an obviousness-
type double patenting rejection “because there [was] no proper evidence to
show that the claim [was] for a mere obvious variation of what is claimed in
the Kaplan patent relied on to support the rejection.” Id. at 1581.
Ultimately, therefore, under the “one way” test undisputedly applied
in this case, “the examiner asks whether the application claims are obvious
over the patent claims.” In re Berg, 140 F.3d 1428, 1432 (Fed. Cir. 1998).
In the instant case the Examiner has provided essentially no evidence
or explanation as to why the appealed process claims would have been
obvious over claims 1-20 of the „997 patent. We therefore conclude that the
Examiner has not met the burden required to show that the appealed claims
would have been obvious in view of the patented claims. Compare, In re
Kaplan, 789 F.2d at 1579-81.
The cases relied on by the Examiner do not persuade us that the
rejection should be affirmed. In this regard, we first note that the Examiner
appears to seek to rely on a caselaw-derived per se rule to the effect that
claims directed to a process of making a particular product are necessarily
obvious over the patented product claims, absent some applicant-supplied
evidence that an alternative method of making the patented product exists,
and that the Examiner therefore need not advance any evidence showing that
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the rejected process claims would have been obvious over the patented
product claims.
However, as stated in In re Ochiai, 71 F.3d 1565 (Fed. Cir. 1995)
“reliance on per se rules of obviousness is legally incorrect and must cease.”
Id. at 1572 (stating that “our precedents do not establish any per se rules of
obviousness” and that claims should be examined “in light of all . . . relevant
factors, free from any presumed controlling effect” of precedent). Thus,
while Ochiai may not have involved an obviousness-type double patenting
issue, given the analogous nature of the obviousness and obviousness-type
double patenting analyses (see, e.g., Braat, 937 F.2d at 592-93), we
conclude that Ochiai‟s proscription against per se rejections unsupported by
evidence applies equally in this case.
We are also not persuaded that the holdings in Takeda v. Dudas, 511
F.Supp.2d 81, or Takeda. v. Doll, 561 F.3d 1372, discharge the Examiner
from the burden of making a prima facie case of unpatentability based on
obviousness-type double patenting, nor do they support affirming the
Examiner‟s rejection.
We first note that Takeda v. Dudas seems to reject the premise
advanced by the Examiner, as well as the Examiner‟s interpretation of
Mosler Safe & Lock Co. v. Mosler, Bahmann & Co., 127 U.S. 354:
“[o]verall, neither Mosler nor any other Supreme Court case broadly
prohibits an inventor from receiving a process patent after earlier obtaining a
product patent where the inventor could have presented the claims in a
single patent. Rather, precedent is to the contrary.” Takeda v. Dudas 511 F.
Supp.2d at 95.

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Nonetheless, we acknowledge the following passage in Takeda. v.
Doll, 561 F.3d at 1375 (emphasis added):
[T]he double patenting doctrine is designed to prevent
“unjustified timewise extension of the right to exclude.” In re
Van Ornum, 686 F.2d 937, 943-44 (CCPA 1982). For instance,
the doctrine bars an applicant from obtaining separate patents
with separate terms for both a product and process for making
that product, unless the product and process are “patentably
distinct.” See In re Taylor, 53 C.C.P.A. 1187, 360 F.2d 232,
234 (1966); In re Cady, 22 C.C.P.A. 1190, 77 F.2d 106, 109
(1935) (instructing that “double patenting is not sustainable
when the product can be fabricated by processes other than that
secured by the issued process patent”) (quotation marks
omitted). The PTO‟s Manual of Patent Examining Procedure
(MPEP) explains that a product and its process are patentably
distinct if “the product as claimed can be made by another
materially different process.” MPEP § 806.05.

Notably, however, Takeda v. Doll did not address the question of
whether an examiner may establish a prima facie case of obviousness-type
double patenting merely by showing that an applicant filed claims to a
process of making a patented product. To the contrary, the only issue truly
addressed was the “novel legal question . . . ask[ing] if later-developed
alternative processes are relevant in the product-process „patentably distinct‟
inquiry.” Takeda v. Doll, 561 F.3d at 1375.
Specifically, in Takeda v. Dudas, this Board had affirmed a double
patenting rejection, but had explicitly declined to categorize it as an
obviousness-type double patenting rejection. See 511 F.Supp.2d at 84. On
appeal to the District Court for the District of Columbia, the court granted
Takeda‟s motion for summary judgment and reversed the rejection, finding
that Takeda had advanced sufficient evidence of alternative methods of
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preparation to show patentable distinctness between the previously patented
product and the later patented process. Id. at 96-97.
Thus, in Takeda v. Dudas, since the presence of alternative methods
warranted reversal regardless of whether a prima facie case had been made,
and since the rejection was never explicitly categorized as an obviousness-
type double patenting rejection, the court technically never reached the
question of whether a prima facie case of obviousness-type double patenting
could be established merely by showing the existence of an earlier patented
product and later-applied-for process claims. Similarly, when the case was
appealed to the Federal Circuit, that issue was not addressed. See, generally,
Takeda. v. Doll, 561 F.3d 1372.
We are therefore not persuaded that the Takeda cases compel us to
affirm the Examiner‟s rejection. Nor are we persuaded that In re Cady, 77
F.2d 106, compels affirmance.
The Cady court ultimately reversed a double patenting rejection based
on evidence of an alternative method of making a patented product, as well
as evidence that restriction was required during prosecution of the patent.
See id. at 109. However, the Cady decision does not mention obviousness-
type double patenting, nor did Cady consider whether the process claims at
issue would have been obvious in view of previously patented product
claims.
Rather, the analysis applied in Cady suggests that at that time (1935)
the Court of Customs and Patent Appeals considered the double patenting
issue involving a patented product and its sole process of making as falling
under a same-type double patenting analysis:
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It is not, of course, intended to indicate here that there
should be any modification of the doctrine stated by this court
in the case of In re Albert C. Fischer, 57 F.(2d) 369, 370, 19 C.
C. P. A. (Patents) 1077, where we said: „We think the weight of
authority is to the effect that an inventor is only entitled to one
patent for one invention, and that he cannot prolong his
monopoly by claiming nothing more than the same invention in
different language.‟
The rule there stated was sound; but, under the
circumstances of this case, where the Primary Examiner in
requ[i]ring division must have been of the opinion that the
inventive distinction between appellant‟s process and product
claims was clear, his decision should not be lightly overruled.

In re Cady, 77 F.2d at 109 (emphasis added).
We are also not persuaded that Phillips Petroleum Co. v. U.S. Steel
Corp., 604 F.Supp. 555, compels us to affirm the Examiner‟s rejection. To
the contrary, the court in Phillips declined to hold the patents in question
invalid for obviousness-type double patenting because the defendants had
failed to show that either set of allegedly conflicting claims would have been
obvious in view of the other set:
Equally important, movants have not, and cannot, make a
showing that the process for making polypropylene would have
been obvious from the claim of the '851 patent. Movants do not
contend, and no record support has been cited for the
proposition, that the process of claim 16 could be ferreted out
merely from knowledge of the product of the '851 patent. I am
therefore not persuaded that the '851 patent should fail under
the test for obvious type double patenting.

604 F.Supp. at 569. Thus, in finding no case of obviousness-type double
patenting, the Phillips court applied the very criterion urged by the Examiner
as being an incorrect standard.
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We also conclude that Geneva Pharmaceuticals v. GlaxoSmithKline,
349 F.3d 1373, In re Boylan, 392 F.2d 1017, and In re Byck, 48 F.2d 665,
are factually distinguishable from the instant case, and therefore do not
control the result here. Specifically, unlike the product/process of making
situation involved here, Geneva Pharmaceuticals involved invalidating
claims directed to “nothing more than [the patented product‟s] disclosed
utility as a method of using the [patented] compound”, 349 F.3d at 1386,
where a restriction requirement was insufficient to shield against a holding
of double patenting rejection. Id. at 1377-82.
In Boylan, the court did not decide the issue of obviousness-type
double patenting, since a terminal disclaimer had already been filed. See In
re Boylan, 392 F.2d 1017, 1018; see also id. at 1021 (citations omitted):
Where, as here, the subject matter claimed in the
application is not the same as subject matter claimed in the
patent, . . . questions of whether the two sets of claims
„overlap,‟ or are „patentably distinct,‟ one from the other, and
the like, are of no moment, so long as a terminal disclaimer has
been filed.

In In re Byck, the claims being rejected were directed to products
which the Board had characterized as involving “no invention” as compared
to the phenolic condensation product the appellant had already patented. See
In re Byck, 48 F.2d at 666. The court affirmed the Board, concluding,
among other things, that “that the application here in issue does not claim a
separate invention from that claimed in the issued patent, but only claims an
obvious use of the composition there patented.” Id.
Thus, not only do the facts of Byck not align with the facts in this
case, but the language in Byck suggests that the court applied precisely the
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obviousness analysis urged by the Examiner as being an incorrect standard
for obviousness-type double patenting.
In re Freeman is also distinguishable from the instant fact situation
because the patented claims were process claims, whereas the claims subject
to the rejection were product claims. See In re Freeman, 166 F.2d 178, 180:
The claims of appellant‟s patent are process claims,
whereas the claims here involved are product claims. However,
since the product in each of the appealed claims is defined
essentially in terms of the method by which it is made, the fact
that the claims of the patent and the application are, technically,
in different statutory classes, is not in itself, enough to avoid a
rejection on the ground of double patenting.

Thus, we are not persuaded that Freeman‟s fact situation is
sufficiently close to the instant fact situation to be controlling.
We are similarly unpersuaded that the BPAI decisions cited by the
Examiner are sufficiently close to the instant situation factually to control
our analysis. See Ex Parte Zoss, 114 USPQ 109 (double patenting rejection
of product claims reversed); see also, Ex parte MacAdams, 206 USPQ 445,
449 (double patenting rejection entered by Board where claims under
examination recited method of using patented composition in which the
claimed use “would be so recognized by those skilled in the art, as is
apparent from secondary references, [and therefore] not seen to be drawn to
a separate and patentably distinct invention”).
Lastly, we note the following statement in MPEP § 806.05 (emphasis
added):
Where two or more related inventions are claimed, the
principal question to be determined in connection with a
requirement to restrict or a rejection on the ground of double
patenting is whether or not the inventions as claimed are
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distinct. If they are distinct, restriction may be proper. If they
are not distinct, restriction is never proper. If nondistinct
inventions are claimed in separate applications or patents,
double patenting must be held, except where the additional
applications were filed consonant with a requirement to
restrict.

MPEP § 806.05 does not, however, explain how to make an
obviousness-type double patenting rejection, or what the requirements are
for doing so. Rather, consistent with the discussion herein, MPEP § 804
explains, in relevant part, that the “analysis employed in an obviousness-
type double patenting rejection parallels the guidelines for analysis of a 35
U.S.C. 103 obviousness determination.” MPEP § 804(B)(1) (citing In re
Braat, 937 F.2d 589 (Fed. Cir. 1991); In re Longi, 759 F.2d 887 (Fed. Cir.
1985)).
In sum, the Examiner urges that case law and the MPEP support the
proposition that the standard to be applied when evaluating claims for
obviousness-type double patenting is not a determination of whether the
claims under examination would have been obvious to an ordinary artisan
in view of the patented claims. The Examiner does not, however, point to
any specific language in any of the cited cases, or in the MPEP, to support
that proposition. As seen above, a review of the cited cases and relevant
MPEP sections does not support the Examiner‟s position.
We wish to reiterate, and make specific note of here, as to the
absence of evidence showing the claimed process to be the only way to
make the claimed product.
Accordingly, we conclude that, because the Examiner has not
adequately explained why the rejected claims would have been obvious in
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view of claims 1-20 of „997 patent, the Examiner has not met the burden
required to sustain the obviousness-type double patenting rejection. We
therefore reverse the Examiner‟s obviousness-type double patenting
rejection of claims 9-11, 13-30, and 32-40 over claims 1-20 of the „997
patent.

REVERSED

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