Ex Parte Carlino et al

Patent Trial and Appeal Board

Oct 20, 2016

13074636 (P.T.A.B. Oct. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/074,636 03/29/2011
27268 7590 10/24/2016
Faegre Baker Daniels LLP
300 NORTH MERIDIAN STREET
SUITE 2700
INDIANAPOLIS, IN 46204
FIRST NAMED INVENTOR
Stefano Carlino
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
REUT-P0015-0l 1177
EXAMINER
BERRY,LAYLAD
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
10/24/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
inteas@faegrebd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte STEFANO CARLINO and RENE-PIERRE BUNTER1
Appeal2015-004848
Application 13/074,636
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical preparation that have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Background
"Gangliosides ... are found abundantly in the cerebral and nervous
tissue of humans and animals. The monosialoganglioside GMl is known for
a number of pharmaceutical applications." (Spec. i-f 2.)
1 According to Appellants, the real party in interest is Laboratoire Medidom
SA. (Br. 4.)
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Application 13/074,636
"Gangliosides are conveniently extracted from bovine or porcine
cerebral tissue ... to be suitable for pharmaceutical applications, the
monosialoganglioside GMl must then be isolated and purified." (Id. i-f 3.)
Claims on Appeal
Claims 13, 19, and 20 are on appeal. (Claims Appendix, Br. 16.)
Claims 13 and 20 are illustrative and read as follows:
13. A pharmaceutical preparation, comprising:
a porcine monosialoganglioside GMl; and
at least one pharmaceutically acceptable carrier, wherein said porcine
monosialoganglioside GMl is purified by separating said porcine
monosialoganglioside GMl from a porcine derived lipidic mixture including
the porcine monosialoganglioside GMl as the main ganglioside component,
by ion exchange column-chromatography using an eluent comprising
potassium or caesium ions, wherein said preparation comprises less than
0.1% Fuc-GMl.
20. The preparation according to claim 13, wherein said porcine
monosialoganglioside is characterized by a ratio of 14 CH2 chains to 16 CH2
chains of about 100:85.
Examiner's Rejection
Claims 13, 19, and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Otakar2 and Shang.3 (Ans. 2-3.)
Claims 13 and 19 were not separately argued, and we therefore limit
our consideration of those claims to claim 13.
2 Otakar, High Performance Liquid Chromatography of Biopolymers and
Biooligomers: Separation of individual compound classes, J.
Chromatography Library, B326-28 (Elsevier 1988) ("Otakar").
3 Shang, CN 1814610, published Aug. 9, 2006, machine translation of record
("Shang").
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FINDINGS OF FACT
We adopt as our own the Examiner's findings and analysis concerning
the scope and content of the prior art. The following findings are included
for emphasis and reference convenience.
FF 1. Otakar teaches the separation of calf-brain gangliosides (including
GMl) using an HPLC method, and that the purity of each separated
ganglioside was at least 99%. (Ans. 3; Otakar B328.)
FF 2. Otakar teaches that Fuc-GMl was separated from GMl. (Otakar
B328 and Figure 12.4.)
FF 3. The Examiner finds that Figure 12.4 of Otakar does not disclose the
presence of Fuc-GMl in the GMl sample, and that the amount of Fuc-GMl
present in the GMl sample as taught by Otakar "is necessarily less than 1 %
since the purity of GMl is at least 99%." (Ans. 3.)
FF 4. Shang teaches a method for preparing high purity gangliosides
(including GMl) from pig brain for pharmaceutical use, in which the purity
is more than 98%. (Shang Abstract, 2, 4.)
ISSUE
Whether a preponderance of the evidence of record supports the
Examiner's conclusion of obviousness under 35 U.S.C. § 103(a).
ANALYSIS
The Examiner concludes that it would have been obvious to one of
ordinary skill in the art at the time of the invention to obtain and purify GMl
from porcine brain tissue. (Ans. 4.) Furthermore, according to the
Examiner, "[t]he skilled artisan would purify GMl because it is used for
medical treatment, and methods for purifying GMl are known, as taught by
Otakar and Shang." (Id.) In addition, the Examiner finds that "the mere
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purity of a product, by itself: does not render the product unobvious," and
that the claimed GMl product has the same utility as GMl taught by Otakar
and Shang, and that Otakar and Shang teach that a highly purified GMl
product is desirable. (Id.)
We find that the Examiner has satisfied the burden of showing "some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Accordingly, the Examiner has established a prima facie case of
obviousness and, as discussed below, Appellants have not overcome or
rebutted that prima facie case.
Claim Construction
The Examiner finds, and we agree, that the claims are written as
product-by-process claims. (Ans. 3.) It is well settled that "[t]he
patentability of a product does not depend on its method of production. If
the product in a product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior
product was made by a different process." In re Thorpe, 777 F.2d 695, 697
(Fed. Cir. 1985) (citations omitted). Here, independent claim 13, and
dependent claims 19 and 20, recite a product (pharmaceutical preparation) in
which the active component (GMl) "is purified by separating said porcine
monosialoganglioside GMl from a porcine derived lipidic mixture including
the porcine monosialoganglioside GMl as the main ganglioside component,
by ion exchange column-chromatography using an eluent comprising
potassium or caesium ions." (Br. 16.) Accordingly, the proper analysis is
the patentability of the claimed product over the products of the prior art,
even though the prior products may be made by a different process.
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Purity ofGMJ
Appellants argue that the combination of Otakar and Shang lacks a
"rational underpinning" and "is grounded in clear factual error." (Br. 8-14.)
These arguments focus on the claim limitation "wherein said preparation
comprises less than 0.1 % Fuc-GMI" and the differences between bovine and
porcine GMl. (Id.)
Appellants argue that one skilled in the art seeking to produce "a
pharmaceutical preparation containing pure porcine GMl with less than
0.1 % Fuc-GMl ... would not have considered applying preexisting methods
such as the one described in Otakar (1988) to the teaching of Shang." (Id. at
8.) In support of that argument, Appellants rely on the Carlino Declaration4
and its statements that "[t]he lipid extract containing GMl of porcine origin
contains a number and type of gangliosides that are different from the ones
contained in the lipidic extract of bovine or other origins" (Deel. i-f 7), and
that "a further distinction between the lipidic extract containing GMl of
porcine origin and that of bovine origin is the presence of an impurity called
fucosyl GMl which is abundant in lipidic extracts of porcine origin, whereas
only traces can be found in lipidic extracts of bovine origin" (Deel. i-f 12).
(Br. 9, 13.) Appellants also argue that Shang, published years after Otakar,
did not use the method of Otakar to produce high amounts of pure porcine
GMI. (Id. at 9.)
We are not persuaded by Appellants' arguments. As the Examiner
explains, the amount of Fuc-GMl present in the GMl sample as taught by
4 Declaration of Dr. Stefano Carlino, M.D., dated Mar. 8, 2013 ("Carlino
Declaration" or "Deel.").
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Otakar is less than 1 % (FF 3), and that "the burden is on [Appellants] to
show a novel or unobvious difference between the claimed product and the
product of the prior art." (Ans. 3.) In re Best, 562 F.2d 1252, 1254--55
(CCP A 1977). Here, Appellants have not shown that the pharmaceutical
preparation of Otakar or Shang contains an amount ofFuc-GMl that renders
claim 13 nonobvious over those references. Moreover, a claim to a degree
of purity in and of itself does not render the claim patentable over the prior
art. MPEP § 2144.04; In re Fink, 62 F.2d 103, 104 (CCPA 1932) (affirming
decision where purity of claimed product was merely a matter of degree and
there was no reason to believe that prior art product would not be as pure).
Appellants' arguments regarding the difference between bovine and
porcine GMl are similarly unpersuasive. For example, as explained by the
Examiner, "[t]here is no evidence that the apparent difference in the ratio of
C 14 to C 16 chains in a porcine versus bovine sample would change the
purification process or its result" and "the skilled artisan would expect
Ot[ a ]kar' s method to be successful even if the ratio of C 14 to C 16
compounds changed to the degree implied by the Carlino [D]eclaration."
(Ans. 7.) Moreover, Appellants' argument that Shang did not use the
method of Otakar does not mean that Otakar's method would not work for
porcine GMl; rather, it confirms that, prior to Appellants' invention, it was
known in the art to purify GMl and that more than one method was taught
for doing so. Again, claim 13 is not limited by its process recitation and
Appellants have not shown that the product of claim 13 is nonobvious over
the product of the prior art.
Criticality of Purity
Appellants argue that, even if the Examiner has established a prima
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facie case of obviousness, Appellants have established that the range recited
in claim 1 ("less than 0.1 % Fuc-GMI") is critical, thereby overcoming the
prima facie case. (Br. 11-12.) In support of that argument, Appellants point
to the Specification's statement that high purity is required for
pharmaceutical applications (Spec. i-f 7) and a statement in the Carlino
Declaration that the highest level of purity is necessary for use of a GMl
compound as a medicament (Deel. i-f 12). (Br. 11.) Appellants also argue
that neither Otakar nor Shang "discloses or suggests how an amount of less
than 0.1 % Fuc-GMl can be obtained." (Id. at 12.)
We are not persuaded. As Appellants acknowledge, criticality is
generally established "by showing that the claimed range achieves
unexpected results relative to the prior art range." (Id. at 11, quoting In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)). Here, both Otakar (FF 1,
3) and Shang (FF 4) suggest that the amount of Fuc-GMl may be less than
0.1 %, and Appellants have not shown by test data or other evidence that the
preparation of Otakar or Shang does not have less than 0.1 % Fuc-GMl. See
Best, 562 F.2d at 1255.
Long-felt Need
Appellants argue that the claimed invention satisfies a long-felt but
unsolved need because their invention occurred "19 years after Otakar, and
Shang did not use Otakar's process 18 years after Otakar's publication."
(Br. 10-11.) We are not persuaded. While objective evidence of
nonobvious may include a long felt but unsolved need, In re Rouffet, 149
F.3d 1350, 1355 (Fed. Cir. 1998), Appellants' argument regarding the dates
of the prior art does not establish a long felt but unsolved need. On the
contrary, prior to Appellants' claimed invention, different methods of
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achieving a high purity GMl were known, including Shang's teaching of a
high purity of porcine GMI. (FF 1--4.) Moreover, Appellants have not
shown that there was a long-felt, recognized need in the art for porcine GMl
having less than 0.1 % Fuc-GMl that was not met prior to Appellants'
invention (e.g. by Shang). 5 (Ans. 6.)
Claim 20
Appellants argue that an assay conducted by Dr. Carlino indicates that
porcine GMl is distinguishable from bovine GMl based on the ratio of
14 CH2 chains to 16 CH2 chains. (Br. 14, citing Deel. i-f 10.) The Examiner
found that the limitation of claim 20 is an inherent property of porcine GM 1.
(Ans. 4.)
"[I]t is elementary that the mere recitation of a newly discovered
function or property, inherently possessed by things in the prior art, does not
cause a claim drawn to those things to distinguish over the prior art." In re
Swinehart, 439 F.2d 210, 212-13 (CCPA 1971). Here, the Carlino
Declaration (i-f 10) establishes that the limitation of claim 20 is an inherent
property of porcine GMI. Accordingly, we affirm the rejection of claim 20.
5 We acknowledge, but are unpersuaded by, Appellants' argument regarding
"hindsight reasoning." (Br. 11.) Appellants point to no evidence that any of
the Examiner's findings were beyond the level of ordinary skill at the time
of the invention or could have been taken only from Appellants'
Specification. See In re McLaughlin, 443 F.2d 1392, 1395(CCPA1971).
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CONCLUSION
A preponderance of the evidence of record supports the Examiner's
conclusion that claims 13 and 20 are obvious under 35 U.S.C. § 103(a).
Claim 19 was not argued separately and falls with claim 13.
SUMMARY
We affirm the rejection of all claims on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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