Ex Parte Okamoto et al

Patent Trial and Appeal Board

Feb 27, 2017

13258108 (P.T.A.B. Feb. 27, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/258,108 11/28/2011 Yoshiharu Okamoto 20111452A 1726
513 7590 03/01/2017
WENDEROTH, LIND & PONACK, L.L.P.
1030 15th Street, N.W.,
Suite 400 East
Washington, DC 20005-1503
EXAMINER
MAIER, LEIGH C
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
03/01/2017 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):
ddalecki@wenderoth.com
eoa@ wenderoth. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YOSHIHARU OKAMOTO, SABURO MIN AMI,
TAKESHI TSUKA, and YASUNARI MIKI1
Appeal 2015-006454
Application 13/258,108
Technology Center 1600
Before RICHARD M. LEBOVITZ, TAWEN CHANG, and
RYAN H. FLAX, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating and/or preventing proliferative disease, which have been
rejected as anticipated and/or obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as National University
Corporation Tottori University. (Br. 2.)
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STATEMENT OF THE CASE
“Fucoidan, which is a natural product, is a polysaccharide containing
sulfated fucose, and can be extracted from for example marine algae or
brown algae . . . (Spec. 1:17—19.) According to the Specification, “this
polysaccharide has biological activities over a wide range, such as the
extinction of cancer cells . . . .” (Id. at 1:22—25.) The Specification states
that “[researches . . . about the antitumor effect of fucoidan have been made
over many fields.” (Id. at 2:8—9.) Further according to the Specification,
however, “there are . . . fucoidans which have various molecular weights,”
and while low molecular weight fucoidans have been used because they are
easily absorbable into a living body, “it has not yet been studied
systematically what size of fucoidan species has the antitumor effect.” (Id.
at 2:12—20.) The Specification states that “[t]he inventors have found that a
medium-molecular-weight fucoidan has an excellent antitumor effect” and
that “the medium-molecular-weight fucoidan can be produced effectively by
treating a raw fucoidan as a natural product under hydrothermal conditions.”
(Id. at 3:14—19.)
Claims 14 and 22—27 are on appeal. Claims 14 and 24 are illustrative
and reproduced below:
14. A method for treating and/or preventing a proliferative
disease, comprising orally administering a medium-molecular-
weight fucoidan having an average molecular weight of
330,000 in an effective amount to a subject for which the
treatment and/or the prevention is required.
24. A method for treating and/or preventing a proliferative
disease, comprising orally administering a medium-molecular-
weight fucoidan having an average molecular weight of 80,000
in an effective amount to a subject for which the treatment
and/or the prevention is required, wherein the medium-
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molecular-weight fucoidan is produced by hydrothermal
treatment.
(Br. 18 (Claims App’x).)
The Examiner rejects claims 24—26 under 35 U.S.C. § 102(b) as
anticipated by Ozawa.2 (Ans. 2.)
The Examiner rejects claims 14 and 22—27 under 35 U.S.C. § 103(a)
as obvious over Ozawa and Haroun-Bouhedja3 in view of Yang4 and JP
’299.5 (Ans. 3.)
I.
Issue
The Examiner rejected claims 24—26 under 35 U.S.C. § 102(b) as
anticipated by Ozawa. The Examiner finds that “Ozawa discloses the oral
administration of fucoidan having molecular weight of 79 kDa to mice in a
cancer treatment model.” (Ans. 2.) The Examiner finds that “a fucoidan
having a reported molecular weight of 79,000 would not be precluded from a
scope recited as molecular weight of 80,000,” since “there is an inherent
margin of error in determining the molecular weight of a polysaccharide.”
(Id.) The Examiner further finds that Ozawa is “silent regarding the use of a
2 Tomohiro Ozawa et al., Two fucoidans in the holdfast of cultivated
Laminaria japonica, 60 J. Nat. Med. 236—39 (2006) (“Ozawa”).
3 Ferial Haroun-Bouhedja et al., In Vitro Effects ofFucans on MDA-MB231
Tumor Cell Adhesion and Invasion, 22 Anticancer Res. 2285—92 (2002)
(“Haroun-Bouhedja”).
4 Chen Yang et al., Effects of molecular weight and hydrolysis conditions on
anticancer activity of fucoidans from sporophyll of Undaria pinnatifida, 43
Inf 1 J. of Biological Macromolecules 433—37 (2008) (“Yang”).
5 JP 2008-266299 A (“JP ’299”). Citations to JP ’299 refer to the English
translation of relevant parts of JP ’299 that has been made of record.
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fucoidan produced by hydrothermal treatment.” (Id.) However, the
Examiner finds that “it is not clear one can distinguish between a naturally
occurring fucoidan having a particular molecular weight from one produced
by depolymerizing [one with] a higher molecular weight.” (Id. at 2—3.)
Appellants contend that Ozawa does not disclose a fucoidan having an
average molecular weight of 80,000 as required by the claims. (Br. 8.)
Appellants further argue that Ozawa does not teach a fucoidan produced by
hydrothermal treatment.
The issue with respect to this rejection is whether a preponderance of
the evidence of record supports the Examiner’s finding that Ozawa discloses
each and every element of claims 24—26.
Findings of Fact
1. Ozawa teaches that “[fjucoidans are a family of polysaccharides
mainly composed of sulfated fticose, and are reported to have a variety of
biological activity, for example, . . . anti-tumor effects.” (Ozawa 236, right
column (citations omitted).)
2. Ozawa discloses two fucoidans isolated from cultivated
Laminaria japonica. (Id. at Abstract.)
3. Ozawa discloses that “the two fucoidans were proved to have
anti-tumor activity against Adenocarcinoma 755-transplated mice by i.p.
[(intraperitoneal)] andp.o. [(oral)] administration.” (Id.; see also id. at 237,
left column.)
4. Ozawa discloses that the molecular weights of these fucoidan
fractions were 79,000 and 221,000, respectively. (Id. at 236, right column.)
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Analysis
The Examiner and Appellants do not dispute that Ozawa discloses
fucoidans having molecular weight of 79,000. (See FF4.) As discussed
above, the Examiner concludes that, because “there is an inherent margin of
error in determining the molecular weight of a polysaccharide,” “it would
appear that a fucoidan having a reported molecular weight of 79,000 would
not be precluded from a scope recited as molecular weight of 80,000.” (Ans.
2.) Appellants argue in response that Ozawa does not necessarily disclose
fucoidan having an average molecular weight of 80,000, as recited in claims
24—26, both because Ozawa does not specify whether its disclosed molecular
weight is a weight average molecular weight, and because “Ozawa does not
disclose the margin of error in determining the molecular weight of 79 kDa
fucoidan.” (Br. 9—10.)
We agree with Appellants that the evidence of record does not support
the Examiner’s finding that Ozawa discloses a fucoidan having an average
molecular weight of 80,000. To the extent that the Examiner’s rejection
relies on construing the claim limitation “fucoidan having an average
molecular weight of 80,000” to include fucoidan having a reported
molecular weight of 79,000, we are not convinced. The Specification states
that “[t]he term ‘about’ used in the specification means any numerical value
in the range of ± 10% of a numerical value to which the term is attached.”
(Spec. 13:18—20.) Claims 24—26, however, do not use the term “about” in
connection with the recited average molecular weight, and the Examiner has
not cited to any intrinsic or extrinsic evidence suggesting that the average
molecular weight may vary from the recited value. Cf. Jeneric/Pentron, Inc.
v. Dillon Co., Inc., 205 F.3d 1377, 1381 (Fed. Cir. 2000) (“In general, ‘[a]
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term such as ‘about’ is not subject to [ ] a precise construction . . . but is
dependent on the factual situation presented.’ W.L. Gore & Assocs., Inc. v.
Garlock, Inc., 842 F.2d 1275, 1280 (Fed.Cir.1988). Without broadening
words that ordinarily receive some leeway, see Modine Manufacturing Co.
v. United States International Trade Commission,15 F.3d 1545, 1554
(Fed.Cir.1996), the precise weight ranges of [the claim] do not ‘avoid [ ] a
strict numerical boundary to the specified parameter,’ Pall Corp. v. Micron
Separations, Inc., 66 F.3d 1211, 1217 (Fed.Cir.1995).”)
To the extent that the Examiner is arguing that a fucoidan having a
reported molecular weight of 79,000 inherently discloses the claimed
“fucoidan having an average molecular weight of 80,000,” we are likewise
unconvinced. In essence, the Examiner argues that, given the existence of a
margin of error in the determination of the molecular weight of a
polysaccharide, fucoidan having a reported molecular weight of 79,000 may
in fact have an average molecular weight of 80,000. However, “[ijnherency
may not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient to
establish inherency.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378,
1384 (Fed. Cir. 1999) (citations omitted). The Examiner did not provide
persuasive evidence of a “margin of error in measurements” for molecular
weight determinations of this kind that would necessarily mean that the
reported molecular weight of 79,000 is the average molecular weight of
80,000 required by the claim. (Ans. 4.)
Accordingly, we reverse the Examiner’s rejection of claims 24—26 as
anticipated.
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II.
Issue
The Examiner rejected claims 14 and 22—27 under 35 U.S.C. § 103(a)
as obvious over Ozawa and Haroun-Bouhedja in view of Yang and JP ’299.
With respect to claim 14, the Examiner finds that “Haroun-Bouhedja
teaches that sulfate fucans (fucoidans) having molecular weight of 320 ± 30
kDa inhibit tumor cell invasion” and “suggests the use of this product for the
treatment of cancer.” (Id. at 3.)
With respect to claim 24, the Examiner finds that “Ozawa discloses
the oral administration of fucoidan having molecular weight of 79 kDa to
mice in a cancer treatment model” and “establishes that oral administration
of fucoidan is effective for the treatment of cancer.” (Ans. 3.) As discussed
earlier, the Examiner finds that Ozawa “is silent regarding the use of a
fucoidan produced by hydrothermal treatment,” but finds that “it is not clear
one can distinguish between a naturally occurring fucoidan having a
particular molecular weight from one produced by depolymerizing a higher
molecular weight.” (Id.) Furthermore, the Examiner finds that Yang
teaches that “it is known that fucoidans have a variety of biological effects
which are closely related to their sulfate content” and that “depolymerized
fucoidans maintain or increase their anticancer activity when the method of
depolymerization, such as a hydrothermal treatment, allows for retention of
more sulfate groups vs. a harsher treatment involving heating by
microwave.” (Id. at 3—4.) The Examiner also finds that JP ’299 teaches “the
preparation of depolymerized fucoidans having various molecular weights”
via hydrothermal treatment that “allows for retention of the fucoidan’s
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sulfate groups.” (Id. at 4.) The Examiner further finds that JP ’299 suggests
“the use of disclosed fucoidans in functional foods.” (Id.)
Appellants contend that Ozawa and Haroun-Bouhedja do not disclose
the average molecular weights of 80,000 and 330,000 claimed in claims 24
and 14, respectively. (Br. 11.) In particular, Appellants argue that Ozawa
and Haroun-Bouhedja do not indicate whether the molecular weights
disclosed are weight average molecular weight as required by the claims.
(Id.)
With respect to claims 24—27, Appellants argue that Ozawa only
discloses fucoidan having a molecular weight of 79,000, which does not
overlap with the claimed molecular weight of 80,000, and that the Examiner
has not shown that Ozawa inherently discloses fucoidan with a molecular
weight of 80,000. (Id.)
Appellants argue that the Examiner’s conclusion of obviousness is
based on impermissible hindsight and on conclusory findings regarding the
motivation of a skilled artisan to optimize the concentration and molecular
weight of administered fucoidan through routine experimentation. (Id. at
12-13.)
Finally, Appellants argue that the claimed subject matter exhibits
unexpected results. (Id. at 13—16.)
Appellants do not separately argue claims 25—27 and 22—23. (Id. at
11.) We thus focus our analysis on claims 14 and 24. The issue with respect
to this rejection is whether the preponderance of the evidence of record
supports the Examiner’s conclusion that Ozawa, Haroun-Bouhedja, Yang,
and JP ’299 render claims 14 and 24 prima facie obvious, and, if so, whether
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Appellants have provided evidence of unexpected results that outweigh the
evidence supporting the prima facie case of obviousness.
Findings of Fact
5. Haroun-Bouhedja teaches that “[fjucans are sulphated
polysaccharides extracted from brown seaweed, which display a wide scale
of activities including inhibition of tumor cell invasion.” (Haroun-Bouhedja
Abstract.)
6. Haroun-Bouhedja teaches that “[cjancer cell adhesion to the
sub-endothelial extracellular matrix (ECM) is an important step in metastasis
formation” {id. at 2286, right column), and suggests that “fucans reduce
tumor cell invasion ... by suppressing interaction between the tumour cell
and matrix proteins” {id. at 2285, right column).
7. Haroun-Bouhedja suggests that fucans’ effect on inhibiting
human breast carcinoma cell (MDA-MB231) invasion “depends upon the
sulphate content and the molecular weight of the fucans.” {Id. at Abstract,
2285, right column; see also id. at 2286, right column; 2289, left column.)
8. Haroun-Bouhedja discloses preparing different fiican fractions
to study the influence of molecular weight and sulphate content on the
fucans’ effect on cancer cells. {Id. at 2286, right column.) The fractions
include “a crude acidic extract (AE) and its under-sulphated (AEDS) and
over-sulfphated (AEDRHS) derivatives.” {Id.)
9. Haroun-Bouhedja discloses that the fucan fraction AE has a
molecular weight of 320,000 ± 50,000 g/mol; the fucan fraction AEDS has a
molecular weight of 250,000 ± 30,000 g/mol; and the fucan fraction
AEDRHS has a molecular weight of 7,200 ± 500 g/mol. {Id. at Table I.)
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10. Haroun-Bouhedja discloses that, compared with heparin and
dextran sulphate, which are non-fucan polysaccharides, “AE exhibited the
highest inhibitory effect on cell adhesion.” (Id. at 2287, left column; 2289,
left column (describing heparin and dextran sulphate as other
polysaccharides); see also id. at 2289, left column (“Both AEDS with
reduced sulphate groups and over-sulphated derivative AEDRHS with
reduced molecular weight independently showed a decrease in their anti­
adhesive activity.”).)
11. Haroun-Bouhedja discloses testing “the effect of AE and low
molecular weight over-sulphated fucan AEDRHS on the invasion of MDA-
MB231 cells,” which were compared to that of heparin. (Id. at 2287, right
column.) Haroun-Bouhedja teaches that “the 3 sulphated polysaccharides
inhibited the tumour cell invasion in a dose-dependent manner” and that
“AE showed the highest inhibitory activity” and “was the most active
compound.” (Id.)
12. Yang teaches that “[fjucoidans are water-soluble and sulfated-
fucans . . . commonly found in brown seaweeds,” which are known to have
anticancer activity. (Yang 433, left column.)
13. Yang teaches that “[t]he biological activities of fucoidans have
been reported to be closely related to their sulfate content and molecular
weight.” (Id. at 433, right column.)
14. Yang teaches determining the effects of molecular weight and
hydrolysis conditions on effect of hydrolyzed fucoidans on cancer cell
growth. (Id. at Abstract.) In its Materials and Methods section, Yang
teaches determining the weight average molecular weight (Mw) of fucoidan.
(Id. at 434, right column.)
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15. Yang teaches that “fucoidan polymers hydrolyzed in boiling
water had significantly greater anticancer activity than those hydrolyzed by
microwaving in the corresponding Mw values.” (Id. at 436, right column.)
16. Yang suggests that “the boiling water heating appeared to cause
less desulfation from fucoidan polymers during the hydrolysis than the
microwave treatment” and further suggests that “the boiling water heating
with an acid up to 10 min could be an effective method to produce partially
hydrolyzed fucoidan polymers with significantly enhanced anti-cancer
activity.” (Id. at 436-437, bridging paragraph.)
17. Yang suggests that “anticancer activity of fucoidans could be
significantly improved by lowering their molecular weight when they are
depolymerized by mild hydrolysis conditions without causing considerable
desulfation.” (Id. at 437, bridging paragraph; see also id. at Abstract.)
18. JP ’299 teaches that “[fjucoidan ... is a[n] . . . ingredient of
brown seaweeds” and has “various biological activities such as killing
cancer cells.” (JP ’299 12.)
19. JP ’299 teaches “[a] method of producing low molecular
[weight] fucoidan without elimination of sulfate groups.” (Id. at Abstract.)
20. JP ’299 teaches that:
in the method according to [its] invention, molecular weight of
fucoidan can be easily regulated and/or controlled by varying
the temperature of hydrothermal treatment and/or the time
period of hydrothermal treatment, or in addition of the above,
by adjusting an aqueous solution of fucoidan to almost neutral.
The higher the temperature of hydrothermal treatment is, the
lower the molecular weight of fucoidan obtained. The longer
the time period of hydrothermal treatment is, the lower the
molecular weight of fucoidan obtained. According to the
method of the present invention, by appropriately selecting the
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above conditions, fucoidan having a molecular weight of about
10,000 to about 300,000 can be easily obtained. In addition, the
low molecular fucoidan obtained by the above method does not
have unfavorable tastes and smells, and retains various
characteristics as fucoidan. Therefore, the low molecular
fucoidan obtainable by the above method is suitable for foods
(in particular, functional foods, healthy foods, etc.) and
pharmaceuticals. Thus, the present invention provides foods
and pharmaceuticals comprising the low molecular weight
fucoidan obtained by the above method.
{Id. at 120.)
21. JP ’299 discloses an untreated fucoidan having weight mean
molecular weight of 320,000. {Id. at Table 1, Table 4.)
Analysis
With the exception of the Examiner’s statement that “a scope of
[average molecular weight of] ‘80,000’ would overlap with ‘79,000’” (Ans.
4), we adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art with respect to the obviousness rejection
(Ans. 3—7; FF 1—21) and agree that the claims are obvious over Ozawa,
Haroun-Bouhedja, Yang, and JP ’299. We address Appellants’ arguments
below.
Appellants contend that Ozawa and Haroun-Bouhedja do not disclose
the claimed average molecular weights because the cited prior art do not
teach that the molecular weights disclosed are weight average molecular
weights. (Br. 11.) With respect to claims 24—27, Appellants further argue
that the claims are not obvious because Ozawa discloses fucoidan having a
molecular weight of 79,000 rather than the claimed molecular weight of
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80,000, and because the Examiner has not shown that Ozawa otherwise
inherently discloses the claimed molecular weight. (Id.)
We are not convinced. As discussed above, Ozawa discloses that
fucoidans with a molecular weight of 79,000 have anti-tumor activity when
administered orally. (FF2, FF3.) Haroun-Bouhedja discloses that fucans
with molecular weight of 320,000 ± 50,000 exhibit the inhibitory effect on
cell adhesion suggestive of anti-cancer activity. (FF6, FF7, FF9, FF10.) It
is not disputed the “fucans” described in Haroun-Bouhedja are also known
as fucoidans. While Ozawa and Haroun-Bouhedja do not explicitly state
that the molecular weight disclosed for their fucoidans is weight average
molecular weight, the Examiner found that the reported molecular weights
does not necessarily differ from a weight-average molecular weight. (Ans.
5—6). We agree that the disclosure in the prior art of fucoidan fractions of
molecular weights of 79,000 and 320,000 ± 50,000 is sound basis to shift the
burden to Appellants to show that such values do not suggest the claimed
weight average molecular weights of 80,000 and 330,000, respectively,
particularly given that Yang suggests that the weight average molecular
weight of fucoidans is relevant to their biological activity. (FF13—FF17;
Ans. 7.) As our reviewing court has explained, “when the PTO shows sound
basis for believing that the products of the applicant and the prior art are the
same, the applicant has the burden of showing that they are not.” In re
Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). In this case, because of “the
PTO’s inability to manufacture products or to obtain and compare prior art
products,” the burden is properly placed on Appellants to “to prove that the
prior art products do not necessarily or inherently possess” the recited weight
average molecular weights. In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
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Appellants have not shown, for instance, that the methods used to
determine molecular weight disclosed in Ozawa and Haroun-Bouhedja do
not disclose weight average molecular weights. (Ozawa 238, right column
(stating that molecular weights of fucoidans were determined by use of
HPLC method reported elsewhere); Haroun-Bouhedja 2286, left column
(stating that molecular weight is determined by high-performance steric
exclusion chromatography (HPSEC) as previous described).)
Neither are we convinced by Appellants’ argument that claims 24—27
are not obvious because Ozawa discloses fucoidan having a molecular
weight of 79,000 rather than 80,000. As our reviewing court has explained,
a prima facie case of obviousness may exist “when the claimed range and
the prior art range do not overlap but are close enough such that one skilled
in the art would have expected them to have the same properties.” In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). We find that to be the case
here. As JP ’299 disclosed, “by appropriately selecting the . . . conditions
[of the hydrothermal treatment], fucoidans having a molecular weight of
about 10,000 to about 300,000 can be easily obtained.” (FF20.)
Finally, and most importantly, we note that the cited art teaches that
molecular weight is a result-effective variable in fucoidan’s anti-tumor
effect. (FF7, FF8, FF10, FF13, FF14, FF17.) Appellants have not provided
objective evidence that the skilled worker would not have sought to “expand
the molecular weights around the art-disclosed ones” (Ans. 5), particularly
because, absent a showing of unexpected results, the discovery of an
optimum value of a variable such as molecular weight is obvious where the
variable is known to be result-effective. In reAller, 220 F.2d 454, 456
(CCPA 1955); In re Antonie, 559 F.2d 618, 620 (CCPA 1977); In re Geisler,
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116 F.3d 1465, 1469 (Fed. Cir. 1997); In re Boesch, 617 F.2d 272, 276
(CCPA 1980).
Appellants further argue that the Examiner’s conclusion of
obviousness is based on impermissible hindsight and on conclusory findings
regarding the motivation of a skilled artisan to optimize the concentration
and molecular weight of administered fucoidan through routine
experimentation. (Br. 12—13.) Appellants similarly argue that the
obviousness rejection is based on hindsight because Haroun-Bouhedja does
not disclose oral administration of fucoidan while Ozawa, which does
disclose oral administration, does not disclose molecular weight as high as
that disclosed in Haroun-Bouhedja. (Id. at 13.)
We do not find these arguments convincing. As discussed above, the
Examiner’s finding that a skilled artisan would be motivated to optimize
fucoidan molecular weights is supported by the prior art’s disclosure that
molecular weight is a result effective variable for fucoidan’s anti-tumor
effect.6 Likewise, we agree with the Examiner that Ozawa’s teaching of the
6 Appellants argue that the obviousness rejection is improper because the
Examiner’s statement regarding optimization of fucoidan concentration is
conclusory. (Id. at 12.) Claims 14 and 24, however, contain no limitation
regarding fucoidan concentration. The only claim containing a limitation
regarding concentration is claim 27, which was not separately argued. In re
Kao, 639 F.3d 1057, 1065 (Fed. Cir. 2011) (explaining that statements in a
brief that “merely mention [a] claim . . . and lack any type of separate,
substantive argument concerning the claim” are not sufficient to constitute
separate argument regarding that claim under 37 C.F.R. § 41.37(c)(l)(vii)).
Moreover, Ozawa teaches that the dosage of orally administered fucoidan is
a result effective variable with respect to anti-tumor effect. (Ozawa Table
4.) Thus, the Examiner’s finding that it would be obvious to optimize the
concentration of administered fucoidan through routine optimization is
supported by evidence of record.
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effectiveness of oral administration of fucoidans of certain molecular
weights establishes a prima facie case of obviousness as to oral
administration of fucoidans generally. (Ans. 7.) Appellants have cited to no
contrary evidence suggesting that oral administration is suitable only for
fucoidans of specific molecular weight. Indeed, as the Examiner points out,
JP ’299 also suggests oral administration (in the form of food) of fucoidans
having a molecular weight of about 10,000 to about 300,000. (Id.; FF20.)
Finally, Appellants argue that the claimed subject matter exhibits
unexpected results. (Br. 13—16.) Appellants cite to Examples 2 and 3, as
well as Figures 3—5 of the Specification, in support of this argument. We are
not persuaded because Appellants fail to compare the fucoidan of the
claimed molecular weight with the closest prior art, i.e., fucoidans of
molecular weight of 79,000 and 320,000 ± 50,000 as disclosed by Ozawa
and Haroun-Bouhedja, respectively. In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence
of nonobviousness, the results must be shown to be unexpected compared
with the closest prior art.”).
Accordingly, we affirm the Examiner’s rejection of claims 14 and 24.
Claims 22, 23 and 25—27, which were not separately argued, fall with claims
14 and 24. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
For the reasons above, we affirm the Examiner’s decision rejecting
claims 14 and 22—27 as obvious.
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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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