Ex parte Carter et al.

Board of Patent Appeals and Interferences

Sep 9, 1997

07756646 (B.P.A.I. Sep. 9, 1997)

Application for patent filed September 9, 1991.1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1)
was not written for publication in a law journal and (2) is not
binding precedent of the Board.
Paper No. 21
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte GUY T. CARTER,
DAVID R. WILLIAMS
and JOSEPH D. KORSHALLA
_____________
Appeal No. 95-4493
Application 07/756,6461
______________
ON BRIEF
_______________
Before WINTERS, METZ and WALTZ, Administrative Patent Judges.
WALTZ, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1, 4 and 5, which are the only claims
remaining in this application.
Appeal No. 95-4493
Application 07/756,646
An epimer is an isomer which differs from the compound2
with which it is being compared only in the relative positions of
an attached hydrogen and hydroxyl. The isomerism may be
represented as -HCOH- and -HOCH-. See The Condensed Chemical
Dictionary, page 343 (Ninth Ed., Van Nostrand Reinhold Company,
1977).
This rejection was a new ground of rejection made for the3
first time on page 5 of the examiner’s answer.
2
The subject matter on appeal is directed to the antibiotic
LL-E19020 Alpha , its composition and method of use in treating1
infections. The antibiotic LL-E19020 Alpha is the C-21 epimer1 2
of known antibiotic LL-E19020 Alpha (specification, page 3). The
subject matter on appeal is adequately illustrated by appealed
claim 1, which is reproduced and attached to this decision as an
Appendix.
The references relied upon by the examiner are:
Carter et al. (Carter) 4,705,688 Nov. 10, 1987
Carter et al. (Carter II), “LL-E19020" and $, Novel Growth
Promoting Agents: Isolation, Characterization and Structures”, 41
The Journal of Antibiotics, no. 10, 1511-1514 (October 1988).
Claims 1, 4 and 5 stand rejected under 35 U.S.C. § 103 as
unpatentable over Carter II. Claim 1 stands rejected under 35
U.S.C. § 102(b) as anticipated by Carter . We reverse both3
stated rejections.
Appeal No. 95-4493
Application 07/756,646
3
OPINION
A. The Rejection under 35 U.S.C. § 103
The claimed antibiotic compound LL-E19020 alpha (hereafter1
“alpha-1") is the C-21 epimer of the known antibiotic LL-E19020
alpha (hereafter “alpha”). Alpha-1 is prepared by the process
set forth on pages 10-13 of the specification.
Carter II describes the discovery of antibiotic alpha and
its preparation on page 1511.
From the properties recited for alpha in the Carter II
article and those properties of alpha-1 recited in appealed claim
1, it is apparent that the examiner and appellants agree that
alpha and alpha-1 are different compounds but have the same
structural formula. As stated by the examiner, the “sole
difference” between the prior art and the claimed compound “lies
in the configuration of the trisaccharide moiety at the C-21
position” (answer, page 4).
The examiner concludes that the claimed compound “is
rendered obvious” because the prior art compound is “structurally
similar” and both “possess similar antibacterial properties”
(answer, page 4). The examiner states that “the courts have
consistently held that if the claimed invention is structurally
Appeal No. 95-4493
Application 07/756,646
399 F.2d 269, 274, 158 USPQ 596, 601 (CCPA 1968).4
4
similar to the prior art compound, non-obviousness can exist only
if this novel structure produces results unexpectedly different
from those of the prior art” (answer, page 7).
Contrary to this assertion by the examiner, the court has
held that, irrespective of any close structural similarity, it is
essential that the prior art applied by the examiner disclose or
render obvious a method for making the claimed compounds. As
stated by the court in In re Hoeksema :4
Thus, upon careful reconsideration it is our view that
if the prior art of record fails to disclose or render
obvious a method for making a claimed compound, at the
time the invention was made, it may not be legally
concluded that the compound itself is in the possession
of the public [footnote omitted]. In this context, we
say that the absence of a known or obvious process for
making the claimed compounds overcomes a presumption
that the compounds are obvious, based on close
relationships between their structures and those of
prior art compounds.
See also In re Payne, 606 F.2d 303, 314-15, 203 USPQ 245, 255
(CCPA 1979), and In re Brown, 329 F.2d 1006, 1011, 141 USPQ 245,
249 (CCPA 1964). References relied upon to support a rejection
under 35 U.S.C. § 103 must provide an enabling disclosure, i.e.,
they must place the claimed invention in the possession of the
public. In re Payne, 606 F.2d at 314, 203 USPQ at 255.
Appeal No. 95-4493
Application 07/756,646
5
Appellants argue that there is a lack of enabling disclosure
in the applied prior art (brief, page 4). The compound alpha-1
is a natural product made by fermentation of streptomyces lidicus
ssp. tanzanius. As noted by the examiner (answer, page 10),
appellants and Carter II ferment the same microorganism.
However, without the use of hindsight from appellants’
specification, there is nothing in the Carter II reference that
discloses or suggests that an epimer of alpha can be obtained
from the method disclosed by the Carter II reference. It is
improper for the examiner to use hindsight based on information
gleaned only from appellants’ disclosure. See In re McLaughlin,
443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
The examiner alleges that preparing the claimed invention is
considered within the “purview of the skilled artisan because
both the claimed and the prior art compounds are obtained by the
fermentation of the same Streptomyces lydicus sp." and
“resolution of various epimers is also considered to be within
the purview of the skilled artisan” (answer, page 10).
Even though the claimed and prior art compounds are
concededly obtained from fermentation of the same microorganism,
the process of preparation disclosed by appellants is markedly
different from that disclosed by Carter II. For example, the
Appeal No. 95-4493
Application 07/756,646
6
nutrient mediums employed are different, appellants combine two
fermentations while Carter II apparently only uses one
fermentation, and appellants recognize that fraction 7 contains
impure alpha-1 and purify it using a particular process to
isolate certain fractions (see the specification, page 12) while
Carter II does not isolate any fraction or use any further
purification procedures.
Furthermore, the examiner has not cited any evidence to
support the allegation that resolution of epimers is within the
ordinary skill of the art.
For the foregoing reasons, we hold that the disclosure of
Carter II does not place alpha-1 in the possession of the public
at the time appellants’ invention was made. Accordingly, the
rejection of claims 1, 4 and 5 under 35 U.S.C. § 103 as
unpatentable over Carter II is reversed.
B. The Rejection under 35 U.S.C. § 102(b)
The examiner has rejected appealed claim 1, directed to the
alpha-1 compound, as being anticipated by Carter since “the
instant compound is obtained from the same strain, by the same
process and as such is inherently present in the prior art
concentrate” (answer, paragraph bridging pages 5-6).
Appeal No. 95-4493
Application 07/756,646
7
Appellants' response to this new ground of rejection is that
the law is clear that for a rejection based upon inherency to be
sustained, the inherency must be an inevitable result and not
merely a probability or possibility (reply brief, paragraph
bridging pages 2-3). Appellants argue that the presently claimed
alpha-1 material was not recognized or identified in Carter.
Thus it is not certain or inevitable that alpha-1 was present in
the fermentation materials produced in Carter and a rejection
based upon inherency is not proper (reply brief, page 3).
For a reference to anticipate a claim, “the disclosure need
not be express, but may anticipate by inherency where it would be
appreciated by one of ordinary skill in the art.” Glaxo Inc. v.
Novopharm Ltd., 52 F.3d 1043, 1047, 34 USPQ2d 1565, 1567 (Fed.
Cir. 1995), cert. denied, 116 S. Ct. 516 (1995). As correctly
stated by appellants, the inherency must be an inevitable result
and not merely a possibility. See In re Oelrich, 666 F.2d 578,
581-82, 212 USPQ 323, 326 (CCPA 1981).
The process of preparing compounds alpha and beta of Carter
is markedly different than the process of preparing alpha-1
disclosed by appellants (as specifically set forth on pages 10-13
of the specification). Appellants' process does not use a silica
column purification as set forth by Carter at column 8, lines 31-
Appeal No. 95-4493
Application 07/756,646
8
42. Appellants and Carter do use the same reverse-phase column
purification (compare column 8, lines 43-49, with the
specification, the paragraph bridging pages 11-12). However,
appellants then proceed with further purification using
chromatographic techniques (specification, page 12, line 6 to
page 13, line 17).
The examiner concludes that “inherency is a certainty”
because both the prior art and the instant process use the
identical microorganism strain and “subject it [to] substantially
identical fermentation procedures” (examiner’s response to reply
brief, page 3). However, it is clear from the above comparison
of the processes of Carter and appellants that the fermentation
procedures are not “substantially identical” and it has not been
shown by the examiner that it is inevitable that the same
products would be produced by each process. Therefore, the
examiner has not shown that the compound of appealed claim 1 is
inherently produced by the prior art process.
Rejection for anticipation requires, as noted above for
section 103 rejections, that a reference must describe the
applicants’ claimed invention sufficiently to have placed a
person of ordinary skill in the art in possession of it, i.e.,
Appeal No. 95-4493
Application 07/756,646
9
the reference must contain an enabling disclosure. See In re
Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990).
Appellants argue that the teaching of Carter is not enabling for
the separation of alpha-1 compound from the alpha and beta
components (reply brief, page 2). The reply to this argument by
the examiner is that “it is a matter of routine separation to
isolate the various components so formed” (examiner’s response to
reply brief, page 2). However, the examiner has presented no
evidence that a skilled artisan would expect epimers to be
produced and would know how to isolate and purify them from such
a fermentation mash process. See In re LeGrice, 301 F.2d 929,
936, 133 USPQ 365, 372 (CCPA 1962)(A reference anticipates a
claim if it discloses the claimed invention “such that a skilled
artisan could take its teachings in combination with his own
knowledge of the particular art and be in possession of the
invention.”, emphasis in original).
Even assuming arguendo that the alpha-1 product was produced
by Carter, there was no recognition by Carter that any fraction
contained a useful product other than the alpha and beta
compounds in fractions 7 and 11-13, respectively (see column 8,
lines 47-49). Carter does not recognize or appreciate that alpha
Appeal No. 95-4493
Application 07/756,646
496 F.2d 593, 596, 181 USPQ 706, 708 (CCPA 1974).5
10
has an epimer, that the epimer was produced by the process of
Carter, or how to isolate and purify any such epimer if present.
The examiner states that “unrecognized and unappreciated co-
production of a chemical by a process does not bar a patent on
the later invention of the same product”, citing Silvestri v.
Grant , but limits this principle of law to duplications of an5
invention that are “both accidental and unappreciated” (emphasis
examiner’s, answer, page 6). The examiner concludes that the
production of the claimed compound, though unappreciated, is “by
no means accidental” (answer, page 6).
Contrary to the examiner’s interpretation, any production of
alpha-1 by Carter would be considered accidental and
unappreciated. Carter never recognized that epimers of alpha
exist or how to isolate and purify them. As conceded by the
examiner, any production of alpha-1 by Carter was unappreciated
(examiner’s response to reply brief, page 1). This result may
also be considered “accidental”, i.e., not intended and not
appreciated. See Eibel Process Co. v. Minnesota & Ontario Paper
Co., 261 U.S. 45, 43 S. Ct. 322 (1923). A prior achievement of a
product may be considered accidental if it was a consistent
Appeal No. 95-4493
Application 07/756,646
Chisum on Patents, Vol. 1, § 3.03[2], p. 3-37 (Matthew6
Bender, 1997).
11
though unintended or incidental consequence of what was
deliberately intended . It is clear that any production of6
alpha-1 by Carter was unintended or incidental to the deliberate
production of alpha and beta.
For the foregoing reasons, the rejection of claim 1 under 35
U.S.C. § 102(b) as anticipated by Carter is reversed.
REVERSED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
ANDREW H. METZ ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS
) AND
) INTERFERENCES
)
THOMAS WALTZ )
Administrative Patent Judge )
)
Appeal No. 95-4493
Application 07/756,646
12
THOMAS S. SZATKOWSKI
AMERICAN CYANAMID COMPANY
PAT. LAW DEPT.
ONE CYANAMID PLAZA
WAYNE, NJ 07470-8426
Appeal No. 95-4493
Application 07/756,646
1
APPENDIX
1. A compound LL-El9020 Alpha comprising1

(a) the structure
(b) a molecular weight of 1225 (FABMS = M/Z 1248
corresponding to [M+Na]+);
(c) a molecular formula: C H NO65 95 21
(d) a characteristic ultraviolet absorption spectra as shown
in Figure I of the attached drawings;
(e) a charateristic infrared absorption spectrum as shown in
Figure II of the attached drawings;
(f) a characteristic proton nuclear magnetic resonance
spectrum as shown in Figure III of the attached drawings; and
(g) a characteristic carbon-13 nuclear magnetic resonance
spectrum as shown in Figure IV of the attached drawings;
(h) a characteristic HPLC retention time of 23.1 minutes
using a gradient of dioxane in aqueous acetic acid.