Ex Parte Shimohirao et al

Patent Trial and Appeal Board

Jun 29, 2018

14572958 (P.T.A.B. Jun. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/572,958 12/17/2014
23909 7590 07/03/2018
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Nilza Shimohirao
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.
8700-00-US-Dl-OC 2749
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
07 /03/2018 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):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NILZA SHIMOHIRAO, ODETE TIEKO YAMANE,
JOAO ABEL CORREIA, KA TRIN COSTA, ENZO UTIMA, and
ANDRES. DA VID 1
Appeal2017-008351
Application 14/572,9582
Technology Center 1600
Before RICHARD M. LEBOVITZ, DEVON ZASTROW NEWMAN, and
MICHAEL J. FITZPATRICK, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a composition comprising a
precipitated calcium carbonate and a polymeric biguanide. The Examiner
rejected the claims as obvious under 35 U.S.C. § 103. Appellants appeal the
rejections pursuant to 35 U.S.C. § 134. We have jurisdiction under 35
U.S.C. § 6(b) and affirm the rejections.
1 The Appeal Brief ("Appeal Br.") 2 lists Colgate-Palmolive Company as the
real-party-in-interest.
2 The application is referenced as "the '958 Specification" or "the '958
Spec."
Appeal2017-008351
Application 14/572,958
STATEMENT OF THE CASE
Claims 1-11 stand finally rejected by the Examiner as follows:
1. Claims 1 and 3-8 under 35 U.S.C. § 103(a) as obvious in view
of U.S. Patent Publication 2003/0044359 Al, pub. date of Mar. 6, 2003,
("Wuelknitz '359") (also "Wuelknitz I") and U.S. Patent 5,182,101, issue
date of Jan. 26, 1993 ("Wuelknitz '101") (also "Wuelknitz II").
2. Claims 1, 2, and 4--8 under 35 U.S.C. § 103(a) as obvious in view
of U.S. Patent 6, 113,887, issue date of Sep. 5, 2000 ("Mori") and Wuelknitz
'101.
3. Claims 1-8 under 35 U.S.C. § 103(a) as obvious in view of US
Patent 4,748,158, issue date of May 31, 1988 ("Biermann") and Wuelknitz
'101.
Claim 1, the only independent claim on appeal, is reproduced below:
1. A composition comprising:
a) precipitated calcium carbonate; and
b) a polymeric biguanide at a concentration no greater
than 0.04% by weight,
wherein the precipitated calcium carbonate and
polymeric biguanide form a complex.
Appellants have provided evidence of unexpected results. We
consider the Examiner's primafacie case of obviousness and also the
evidence of unexpected results and review all the evidence anew.
FPL
FINDINGS OF FACT
Wuelknitz '101
It has long been known that antimicrobial biguanide
compounds are effective in preventing the formation of dental
plaque. However, their effect is greatly reduced or even
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completely eliminated by many of the components typically
used in toothpastes, more particularly by certain polishes, such
as calcium carbonate for example ...
Wuelknitz '101, col. 1, 11. 15-20.
FF2.
A.ccording1y, a satisfactory toothpaste which is extremely
effective in inhibiting plaque forrnation, even despite low doses
of the antimicrobial biguanide compounds, is not known from
the prior art The problem addressed by the present invention
was to solve this problem for toothpastes containing chalk as
the polish cmnponenL The present invention relates to a
toothpaste in the form of an aqueous dispersion containing 10
to 60%) by weight of polish, 2 to 2()'% by weight ofhumectants,
0.5 to 5~'0 by weight of Vv'ater-soluble viscosity regulators, 0.05
to 0.5%, by weight of antimicrobial biguanides and l to 5 1~1;) by
weight of other additives from the group of surfactants,
flavoring oils and sweeteners, characterized in that calcium
carbon-ate (chalk) is predominantly present as the polish.
Wuelknitz '101, col. 1, 11. 37-51.
FF3. "The polish used is preferably a precipitated chalk." Wuelknitz
'101, col. 1, 1. 61.
FF4.
The 1, l '-hexamethylene-bis-{ 5-(4-chlorophenyl)-biguanide}
("chlorhexidine'') known from GB-/\-705,838 in the form of a
water-soluble, physiologically acceptable salt, for exarnp1e in
the form of the acetate or gluconate, is used as the antimicrobial
biguanide compound. Other antimicrobial biguanide
compounds suitable for the purposes of the invention are, for
example, 1, 1 '-hexamethylene-bis-{5-(4-fluoropheny1)-
biguanide} ("fluorhexidine'), the polyhexamethylene biguanide
compounds of the Vantocil lB (ICI) type known from GB-A-
702,268 and the antimicrobial biguanide compounds known
from U.S. Pat. Nos. 2,684,924, 2,990,425, 3,468,898,
4J)22,834, 4,053,636 and 4, 198,392.
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Wuelknitz '101, col. 2, 11. 5-18.
Wuelknitz '359
FF5. Wuelknitz '359 relates to dental care preparations for cleaning
and care of the teeth. Wuelknitz '359 i-f 2.
FF6. "Basically, suitable polishing agents are any of the known
toothpaste abrasives such as, for example, chalk ... " Wuelknitz '359 i-f 24.
FF7.
Antimicrobial compounds are effective against the protein-and
starch-degrading and acid-forming bacteria of dental plaque
and against the particularly obstinate germs of chronic
gingivitis .... Suitable antimicrobial compounds are, for
example, cationic surfactants such as, for example, cetyl
trimethyl ammonium bromide, benzethonium chloride, cetyl
pyridinium chloride or the N,N,N' -tris(2-hydroxyethyl)-N' -
octadecyl 1,3 diaminopropane dihydrofluoride known as amine
fluoride. Also suitable are the antimicrobial biguanide
compounds such as, for example, polyhexamethylene biguanide
(Vantocil® IB, ICJ) or 1, 1'-hexamethylene-bis-(4-
chlorophenyl)-biguanide ("chlorhexidine") in the form of a
water-soluble compatible salt,
Wuelknitz '359 i-f 31.
FF8. "Antimicrobial agents may be present in the dental care
preparations according to the invention in a quantity of 0.005 to 0.5% by
weight, based on the flowable preparation." Wuelknitz '359 i-f 32.
Mori
FF9.
There is disclosed a toothpaste composition containing: (1) a
water-soluble bactericide selected from the group consisting of
pyridinium compounds, quaternary ammonium compounds and
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biguanide compounds in an amount of 0.001 % to 5.0% by
weight, based on the total weight of the composition ...
Mori, Abstract.
Biermann
FFlO. "The biguanide compounds are preferably added in quantities
of from about 0.03 to about 1.2% by weight ... " Biermann, col. 3, 11. 66-
67.
OBVIOUSNESS REJECTION BASED ON WUELKNITZ '359 AND
WUELKNITZ '101
The Examiner found the Wuelknitz '359 discloses a dental care agent
with calcium carbonate and an "active" antimicrobial agent which can be
polyhexamethylene biguanide, the latter which is the "polymeric biguanide"
of claim 1. Final Act. 3. The Examiner also found the "active" can be
present in an amount of 0.005 to 0.5% by weight of the preparation, which
overlaps with the concentration range of the "polymeric biguanide" recited
in claim 1. Id.
The Examiner found that Wuelknitz '359 does not teach that the
calcium carbonate is "precipitated calcium carbonate" as required by claim
1, but found that Wuelknitz '101 discloses a toothpaste with antimicrobial
biguanide and precipitated chalk as required by the rejected claims. Id. The
Examiner stated that it would have been obvious to one of ordinary skill in
the art to have utilized the precipitated calcium carbonate chalk described in
Wuelknitz '101 as the calcium carbonate in Wuelknitz '359 because of its
suitability for oral compositions. Id. at 3. Wuelknitz '101 also specifically
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teaches the advantage of precipitated calcium carbonate when used with
biguanides, providing a reason to have used it in Wuelknitz '359. FFl, FF2.
Appellants contend that it has not been established that the range of
0.005 to 0.5% by weight of an antimicrobial agent disclosed in Wuelknitz
'359 would be an effective amount of the claimed polymeric biguanide.
Appeal Br. 4. Appellants contend that there are numerous different types of
antimicrobial agents disclosed in Wuelknitz '359, and there is no "linking"
"chemical characteristics" between them, and that to predict "efficacious
concentrations in a dentifrice composition containing a host of chemical
ingredients that could interact with the antimicrobial agents in a myriad of
ways would be impossible." Id. at 4--5.
This argument does not persuade us that the Examiner erred.
Wuelknitz '359 discloses a list of antimicrobial agents that can be used in
dental care products. FF7. Polyhexamethylene biguanide, which falls
within the scope of claim 1, is among the list of antimicrobial agents. Id. In
the paragraph that follows the list of antimicrobial agents, Wuelknitz '359
teaches that the agents may be present in "a quantity of 0.005 to 0.5% by
weight" (FF8), concentrations which overlap with the claimed range of "no
greater than 0.04% by weight" of the "polymeric biguanide." This is an
express teaching by Wuelknitz '359 that all of the antimicrobial agents in the
list (FF7) can be utilized in the disclosed range (FF8). Appellants contend
that this express teaching should be ignored because the antimicrobial
compounds in the list have different and unrelated chemical structures.
Appeal Br. 4. However, while it may be correct that the compounds have no
"linking" structures, Wuelknitz '359 disclosed a concentration range (FF8)
for all the disclosed antimicrobial agents (FF7). Appellants do not provide a
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scientific reason or other evidence to persuade us that the compounds in the
list would be ineffective at the ranges broadly disclosed in Wuelknitz '359.
One of ordinary skill in this art, who we find to be a person skilled in
formulating oral care compositions, would have been able to routinely
choose an effective amount of polyhexamethylene biguanide based on the
disclosure of Wuelknitz '359. Appellants do not provide evidence to the
contrary, only argument. Appeal Br. 45.
Appellants also contend that Wuelknitz '359 "has not taken relevant
safety considerations into account for using such a wide blanket
concentration range for each of the types of antimicrobial agents." Appeal
Br. 5. Appellants cite an EPA (Environmental Protection Agency)
regulation that the polyhexamethylene biguanide, disclosed in Wuelknitz
'359's list, "may not be safe for human consumption in high
concentrations." Id. Appellants argue that the "the concentration range
recited in Wuelknitz I ['359] extends far beyond the accepted safe
concentration of polyhexamethylene biguanide" and that therefore "the
concentration range of 0.005 to 5.0% by weight cannot apply to each of the
antimicrobial agents, and no reasonable conclusions can be drawn with
regard to teaching Appellants' claimed range of polymeric biguanide." Id.
Again, this argument does not persuade us that the Examiner erred.
As discussed by the Examiner (Ans. 10), the range disclosed in Wuelknitz
'359 overlaps with the claimed range and one of ordinary skill in the art
would know the properties of polyhexamethylene biguanide, namely its
antimicrobial activity and potential toxicity (guided by the EPA regulation).
Thus, the skilled artisan could have routinely choses an effective
concentration based on this guidance. The fact that Wuelknitz '359
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discloses a broad range (FF8), in our view, is evidence that Wuelknitz '359
considered it within the ordinary skill in the art to have picked an amount
that worked for each of the antimicrobials disclosed in the list (FF7), after
considering such factors as efficacy and toxicity, which is standard practice
in formulating oral care compositions.
Furthermore, Wuelknitz '101 discloses that even low doses of
antimicrobial biguanide compounds are effective when combined with the
precipitated calcium carbonate chalk. FF2. This fact, combined with the
guidance of the EPA regulation cited by Appellants (Appeal Br. 5), would
have provided sufficient motivation and direction to permit the skilled
artisan to have optimized the dosage of polyhexamethylene biguanide for
use withi 11 the clairned rarnre . .., __ ,
In their Reply Brief, Appellants challenge the findings of the
Examiner that Wuelknitz '101 teaches a dental composition with calcium
carbonate and a biguanide. Reply Br. 2. To support this position,
Appellants cite the example in Wuelknitz '101 in which "A standard
dispersion of 40% by weight chalk (calcium carbonate) and 0 .1 % by weight
chlorhexidine in water was prepared and increasing quantities of cationic
surfactants were added." Id., citing Wuelknitz '101, beginning at col. 4, 1. 5.
Appellants state this example was designed to test for free chlorhexidine (a
biguanide) in solution and is not an oral care composition. Reply Br. 2.
We agree that the example cited by Appellants is a test for free
chlorhexidine. However, the reason to test these components together was
to form an oral care composition, and the example which follows the test
description, is of a toothpaste with "Chalk (precipitated calcium carbonate)"
and "Chlorhexidine digluconate," a biguanide. Wuelknitz '101, col 4, 11.
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45---60 ("2. Toothpaste According to the Invention"). Thus, an oral care
product with precipitated calcium carbonate and a biguanide is expressly
disclosed in Wuelknitz '101.
OBVIOUSNESS REJECTION BASED ON MORI AND
WUELKNITZ '101
The Examiner found that Mori discloses a composition with calcium
carbonate and a biguanide, such as polyhexamethylene biguanide, where the
biguanide is present in a range of 0.001 % to 5.0% (FF9), which overlaps
with the claimed concentration range of the polymeric biguanide. Final Act.
7. The Examiner found that Mori does not describe that the calcium
carbonate is a precipitated calcium carbonate as claimed, but determined it
would have been obvious to have utilized a precipitated calcium carbonate
based on the teaching in Wuelknitz ' 101 of its suitability for oral
compositions. Id. at 8. Wuelknitz '101 also specifically teaches the
advantage of precipitated calcium carbonate when used with biguanides,
providing a reason to have used it in Wuelknitz '359. FFl, FF2.
Appellants contend that combination of Mori and Wuelknitz '101
would render Mori unsuitable for its intended purpose. Appeal Br. 6.
Appellants argue:
Mori teaches that the gel stability of toothpastes comprising
certain polymers (i.e., cellulose polymers) readily deteriorate
with time, such as solid-liquid separation. However, the
toothpastes taught by Wuelknitz II ['101] preferably include
hydroxyethyl cellulose and methyl hydroxypropyl cellulose.
(See, Wuelknitz II ['101], col. 2, lines 3-4).
Appeal Br. 6.
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This argument is not persuasive. As discussed by the Examiner, the
rejection is not based on incorporating the components of Wuelknitz '101
into Mori. Ans. 12. The rejection is based on utilizing the precipitated
calcium carbonate of Wuelknitz ' 101 as the calcium carbonate component of
Mori. Appellants have not provided evidence that precipitated calcium
carbonate would render Mori unsuitable for its intended purpose.
OBVIOUSNESS REJECTION BASED ON BIERMANN AND
WUELKNITZ '101
The Examiner found that Biermann discloses an oral care composition
comprising a biguanide, such as polyhexamethylene biguanide, where
biguanide is present in a range of 0.03 % to 1.2% (FFlO) which overlaps
with the claimed concentration range of a polymeric biguanide. Final Act. 9.
The Examiner also found that Biermann discloses that a polishing agent,
such as calcium carbonate, can be included. Id.
The Examiner found that Biermann does not describe that the calcium
carbonate is precipitated calcium carbonate as claimed, but determined it
would have been obvious to have utilized it based on the teaching in
Wuelknitz '359 of the suitability of precipitated calcium carbonate for oral
compositions. Id. at 10. The Examiner also found that Wuelknitz '101
specifically teaches the advantage of precipitated calcium carbonate when
used with biguanides. FFl, FF2.
Appellants contend that Biermann teaches away from the claimed
subject matter. Appeal Br. 6. Appellants state that Biermann teaches that
"biguanides are generally ineffective in killing bacteria without the presence
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of an alkyl glycoside .... [b ]y teaching that biguanides are not effective as
antibacterial agents without an alkyl glycoside." Id. at 6-7.
There is no factual support for Appellants' contention that Biermann
teaches that biguanides are ineffective without alkyl glycosides. To the
contrary, Biermann expressly teaches that biguanides are microbiocidal,
antiseptics, disinfectants, and antimicrobial agents, and thus are
characterized by name as active agents. Biermann, col. 1, 1. 64 to col. 2, 1.
31. Moreover, Biermann teaches that it "has now been surprisingly
discovered that alkyl glycosides, in combination with selected antimicrobial
agents, produce synergistic improvements in the antimicrobial performance
of the antimicrobial agents." Id. at col. 1, 11. 44--51. Thus, Appellants'
argument has no merit because Biermann teaches that the antimicrobial
activity of biguanides is improved by alkyl glycosides, not they are
ineffective against microbes when used alone. In addition to this, claim 1
uses the term "comprising" which is open-ended, and therefore does not
exclude the presence of an alkyl glycoside.
UNEXPECTED RES UL TS
Appellants argue that any prima facie case would be overcome by
their submitted evidence of unexpected results of an "unexpectedly" stable
complex of precipitated calcium carbonate and polymeric.
Is the claimed complex of precipitated calcium carbonate and polymeric
biguanide unexpectedly stable?
Appellants contend that the claimed complex of precipitated calcium
carbonate and polymeric biguanide is unexpectedly stable. Appeal Br. 3.
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This argument is not persuasive because adequate evidence has not
been provided that the claimed complex, which is unrestricted as to the
amount of the precipitated calcium carbonate, has unexpected stability as
compared to the closest prior art.
It is well-established that a showing of "unexpected results" can be
used to demonstrate the non-obviousness of the claimed invention. In re
Soni, 54 F.3d 746, 750 ("One way for a patent applicant to rebut a prima
facie case of obviousness is to make a showing of 'unexpected results,' i.e.,
to show that the claimed invention exhibits some superior property or
advantage that a person of ordinary skill in the relevant art would have found
surprising or unexpected."). Those results must be "surprising or
unexpected" to one of ordinary skill in the art when considered in the
context of the closest prior art. Soni, 54 F.3d at 750; Iron Grip Barbell Co.,
Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (A showing
of "new and unexpected results" must be "relative to the prior art."); 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").
In this case, Appellants directed us to Example 1 of the '958
Specification as describing a manufacturing process that forms a stable
complex between precipitated calcium carbonate ("PCC") and biguanide.
Appeal Br. 3. Example 1 shows that PCC preserved with 250 ppm and 500
ppm poly[ (hexamethylene) biguanide ("PHMB") exhibited more
antimicrobial activity as compared to a control. '958 Spec. i-f 52 (Example 1,
Table 1 ). Example 1 also shows similar antimicrobial activity between the
PCC/PHMB composition and PCC preserved with formaldehyde. Id.
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First, only one amount of PCC was tested, while the claims are
unrestricted as to the PCC amount. Thus, Appellants have not established
that alleged stability would be observed over all amounts of PCC within the
scope of the claim.
Second, we have not been directed to a statement in the '958
Specification indicating that the Example 1 composition comprising PHMB
and PCC showed unexpected stability as asserted by Appellants in the
Appeal Brief. Soni requires such a statement or other "factual evidence."
Soni, 54 F.3d at 750.
Third, Appellants have not established that the comparison was made
against the closest prior art. The only comparisons are to a control lacking
PCC and a composition using formaldehyde instead of PHMB as an
antimicrobial preservative. '958 Spec. at 14. Appellants have not
established these comparisons are the closest prior art, particularly when
Wuelknitz ' 101 teaches that calcium carbonate chalk, which Appellants did
not dispute is a precipitated calcium carbonate, makes biguanide "extremely
effective as an anti-antimicrobial", even at low doses. FFl, FF2.
Appellants also directed us to Example 2 of the '958 Specification as
purportedly showing that biguanide is effective to prevent bacterial
colonization of the precipitated calcium carbonate particles. Appeal Br. 3.
Example 2 shows that 0.03% poly [(hexamethylene) biguanide] ("PHMB"),
added to precipitated calcium carbonate ("PCC") during the manufacturing
process (Spec. i-f 52), exhibited anti-microbial activity over a 24-hour period.
Spec. i-f 54 (Example 2, Table 2). We have not been directed to a statement
in this example that the composition comprising PHMB and PCC showed
unexpected stability as asserted by Appellants, particularly in view of the
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disclosure in Wuelknitz '101 that precipitated calcium carbonate makes
biguanide "extremely effective as an anti-antimicrobial." FFl, FF2.
It is stated in the Appeal Brief that "very surprisingly, the complex of
biguanide bound to the precipitated calcium carbonate is maintained through
the processing of the oral composition, such as a toothpaste, so that the
biguanide provides a preservative effect at a level which is very low with
respect to the composition as a whole, yet has a high level of micro-
robustness." Appeal Br. 3 However, as explained above, the data in
Examples 1 and 2 referenced by Appellants does not support this statement,
and, further, this data is not a comparison to the closet prior art as required
by Soni and Baxter.
Mere attorney argument is insufficient to establish unexpected results.
An applicant cannot prove unexpected results with attorney
argument and bare statements without objective evidentiary
support. See In re Lindner, 59 C.C.P.A. 920, 457 F.2d 506, 508
(CCPA 1972); In re Geisler, 116F.3d1465 (Fed. Cir. 1997)
("attorney argument [is] not the kind of factual evidence that is
required to rebut a prima facie case of obviousness"); In re
Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) ("It is well settled that
unexpected results must be established by factual evidence.
Mere argument or conclusory statements ... [do] not suffice.")
(quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003).
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Is a complex of the recited precipitated calcium carbonate and
biguanide unexpected?
Appellants argue that "none of the references disclose the formation
of precipitated calcium carbonate followed by the addition of the polymeric
biguanide in a slurry prior to drying." Appeal Br. 4. Appellants contend:
The compositions ofWuelknitz I ['359]/Wuelknitz II ['101],
Mori/Wuelknitz II ['101], and Biermann/Wuelknitz II ['101]
would result in nothing more than a mixture comprising both
biguanide and precipitated calcium carbonate, since the
biguanide and precipitated calcium carbonate would not
complex. Thus, the resulting compositions of Wuelknitz I
['359]/Wuelknitz II ['101], Mori/Wuelknitz II ['101], and
Biermann/Wuelknitz II [' 101] would not be expected to have
the enhanced preservation longevity of Appellants'
composition.
Appeal Br. 4.
Appellants have not established that the teaching in Wuelknitz '101 of
precipitated calcium carbonate and a biguanide (FF2, FF3) would not have
resulted in the same "complex" as recited in claim 1. For example,
Appellants have not established that the asserted drying step is critical and
necessary to obtain the claimed "complex."
Because Wuelknitz '101 describes a composition comprising both
ingredients claimed by Appellants to form a complex, the burden properly
shifted to Appellants to prove that following the guidance provided by
Wuelknitz '101 would not have resulted in a complex as claimed. As held in
In re Best, 562 F.2d 1252 (CCPA 1977):
Where, as here, the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
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Whether the rejection is based on "inherency" under 35 U.S.C.
§ 102, on "prima facie obviousness" under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture
products or to obtain and compare prior art products.
Id. at 1255 (citation and footnote omitted).
This burden was not met.
Is the comparison to Biermann proper?
Appellants also contend that Appellants' Example 1 shows that the
claimed composition was more potent as an antimicrobial than the
composition of Biermann. Appeal Br. 6-7. Appellants contend that
"[b ]ased on the teachings of Biermann, the skilled artisan would find such
results to be highly unexpected, since they were obtained without the
presence of an alkyl glycoside." Id. at 7.
The example identified in Biermann by Appellants is of chlorhexidine
gluconate (Biermann, col. 2, 11. 32--49), while Example 1 of the '958
Specification is of polyhexamethylene biguanide ('958 Spec. i-f 52), a
compound within the scope of the claims. Two different compounds with
different structures have been compared. Thus, the comparison is not side-
by-side. For example, one compound might simply be more potent than the
other in its antimicrobial activity accounting for the observed differences in
activity.
While the results in the '958 Specification were obtained without the
presence of an alkyl glycoside as taught by Biermann, the biguanide
compound is different from the one used in Biermann, and the form of the
calcium carbonate is different, as well. Therefore, there are at least two
differences between Biermann's example and the example in the '958
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Specification, namely the form of the calcium carbonate and the type of
biguanide. Thus, it cannot be concluded whether it is the form of the
calcium carbonate or the specific biguanide which is responsible for the
differences in antimicrobial activity. Accordingly, these results are not
sufficient to support a conclusion of nonobviousness in light of the strong
prima facie case.
SUMMARY
For the foregoing reasons, the obviousness rejection of claim 1 based
on Wuelknitz '3 59 and Wuelknitz '101 is affirmed. Claims 3-8 were not
separately argued and therefore fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
For the foregoing reasons, the obviousness rejection of claim 1 based
on Mori and Wuelknitz ' 101 is affirmed. Claims 2 and 4--8 were not
separately argued and therefore fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
For the foregoing reasons, the obviousness rejection of claim 1 based
on Biermann and Wuelknitz '101 is affirmed. Claims 2-8 were not
separately argued and therefore fall with claim 1. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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