Ex Parte Kruzel

Board of Patent Appeals and Interferences

Nov 21, 2007

10023096 (B.P.A.I. Nov. 21, 2007)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MARIAN L. KRUZEL
__________

Appeal 2007-2713
Application 10/023,096
Technology Center 1600
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Decided: November 21, 2007
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Before ERIC GRIMES, NANCY J. LINCK, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of reducing microbial contamination of meat by treating the meat with
lactoferrin, which the Examiner has rejected on grounds of obviousness. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Appeal 2007-2713
Application 10/023,096

BACKGROUND
“Lactoferrin plays an important role in iron transport and utilization in
humans” (Specification 1). The Specification discloses that “human
lactoferrin is capable of binding two ferric ions with high affinity”
(Specification 1). “Because it sequesters iron, lactoferrin can neutralize
pathogenic microorganisms by preventing them from obtaining necessary
iron at the site of entry, thereby preventing the spread of infection”
(Specification 2). The Specification also teaches “[l]actoferrin can be
applied to food (either solid or liquid) to retard spoilage in accordance with
the present invention either alone or compounded with any of the aforesaid
nutritionally acceptable carriers or diluents” (Specification 14).
Appellant teaches a “method for inhibiting food spoilage comprising
adding to the food an effective amount of lactoferrin having less than about
25% metal loading” (Specification 3).
STATEMENT OF THE CASE
The Claims
Claims 1-7 are on appeal. The claims have not been argued separately
and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii). We will
focus on claim 1, which is representative and reads as follows:
1. A method for reducing the microbial contamination of a meat
product, comprising treating the meat product with a sufficient
amount of lactoferrin selected from the group consisting of bovine,
human, and recombinant human lactoferrin to reduce microbial
contamination.

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The Examiner has rejected claims 1-7 under 35 U.S.C. § 103(a) based on:
Chander et al., “Lactoferrin – Antibacterial Protein of Milk,” 32 India
Dairyman 417-18 (1980) (hereafter “Chander”).
Ryser et al., “’New’ Food Borne Pathogens of Public Health
Significance,” 89 J. Am. Dietetic Ass’n 948-54 (July 1989) (hereafter
“Ryser”).
Stiles et al., “Enterobacteriaceae associated with Meats and Meat
Handling,” 41 Applied and Envtl. Microbiology 867-72 (April 1981)
(hereafter “Stiles”).
Dickson et al., “Cell Surface Charge Characteristics and Their
Relationship to Bacterial Attachment to Meat Surfaces,” 55 Applied and
Envtl. Microbiology 832-36 (April 1989) (hereafter “Dickson”).
The Issue
The Examiner’s position is that Chander teaches “that lactoferrin,
including bovine, inhibits the growth of a variety of pathogenic and
nonpathogenic micro-organisms such as E. coli, Bacillus subtilus,
Salmonella typhi, Vibrio cholerae, Shigella dysentriae, Klebsiella
pneumoniae, and Staphylococcus aureus both in vitro and in vivo” (Answer
3). The Examiner states that the three secondary references, Ryser, Stiles
and Dickson, each teach contamination of meat with microorganisms
including those listed by Chander (see Answer 4-7).
The Appellant argues that the Chander reference does not teach
treating any product (App. Br. 8). The Appellant further notes that milk is
not treated by lactoferrin since lactoferrin is naturally present in milk (App.
Br. 8).
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The Examiner acknowledges that Chander does not teach treating a
product, but contends that
he has set forth non-technical, "common sense" suggestions
and/or motivations on how and why the references should be
combined for the simple purpose of inhibiting meat spoilage
and food poisoning that would render the instant claims
prima facie obvious to those of ordinary skill in the art, such
as food scientists or biochemists concerned with the problem
of meat spoilage and food poisoning.
(Answer 8.)
In view of these conflicting positions, we frame the issue before us as
follows:
Would there have been a reason for the ordinary artisan to use the
known antibacterial properties of lactoferrin as taught by Chander to treat
meat in order to reduce the bacterial contamination disclosed by Ryser,
Stiles or Dickson?
FINDINGS OF FACT
1. Chander teaches that lactoferrin has inhibitory effects on a
variety of pathogenic microorganisms, including Bacillus subtilis,
Staphylococcus aureus, Vibrio cholerae, Klebsiella pneumoniae,
Escherichia coli, Salmonella typhi, and Shigella dysentariae (Chander, at
418, col. 1-2).
2. Chander teaches that lactoferrin has an inhibitory effect in vivo
and in vitro (Chander, at 417, col. 2).
3. Chander specifically teaches that “lactoferrin plays an
important role in milk in controlling food poisoning, pathogenic and
spoilage organisms of considerable importance” (Chander, at 418, col. 2, ll.
19-23).
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4. Chander teaches that lactoferrin is present in natural milk and in
colostrum (see Chander, at 417, col. 1, ll. 22-35).
5. Ryser teaches that “it is imperative that appropriate precautions
be taken to control the presence of viable cells of these ‘emerging’
pathogens in our food supply “ (Ryser, at 948, col. 2, ll. 5-7).
6. Ryser teaches that Vibrio cholerae and Escherichia coli are
contaminants of various kinds of meat (Ryser, at 952-53).
7. Ryser teaches control measures to prevent bacterial
contamination including pasteurization, cooking and prevention of cross
contamination (see Ryser, at 949, table 1).
8. Ryser teaches that pathogenic bacteria are found in a variety of
foods, including beef (see Ryser, at 952-53).
9. Stiles teaches that E. coli is a contaminant of meat (see Stiles, at
867, col. 1, ll. 1-9).
10. Stiles teaches control measures to prevent bacterial
contamination including sanitation (Stiles, at 870, col. 2, ll. 26-34) and heat
treatment (Stiles, at 871, col. 1, ll. 12-13).
11. Stiles teaches that there is a risk of disease from contamination
of meat with coliform bacteria such as E. coli and Klebsiella pneumoniae
(see Stiles, at 867, col. 1-2).
12. Dickson teaches that bacteria such as E. coli attach to meat
surfaces (see Dickson, at 834, col. 1 (Table 3)).
13. Dickson teaches that some bacteria associated with meat
products are pathogenic (see Dickson, at 832, col. 2, ll. 25-27).

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DISCUSSION
The method of treating meat with lactoferrin to reduce microbial
contamination would have been obvious based on the teachings of Chander
and Ryser, Stiles, or Dickson. Chander teaches that lactoferrin inhibits
pathogenic bacteria in vitro and in vivo (FF 1-2). Chander also teaches that
lactoferrin plays a role in controlling pathogenic microorganisms (FF 3).
Ryser teaches that control of pathogenic organisms on meat is a significant
issue, which can be addressed by various treatments including heat and
sanitation (FF 5-8). Stiles and Dickson also teach that pathogenic organisms
are present on meat (FF 9-13).
In KSR Int’l v. Teleflex, the Supreme Court indicated that “ [w]hen a
work is available in one field of endeavor, design incentives and other
market forces can prompt variations of it, either in the same field or a
different one. If a person of ordinary skill can implement a predictable
variation, §103 likely bars its patentability.” KSR Int’l v. Teleflex Inc., 127
S. Ct. 1727, 1740 (2007).
In our opinion, it would have been predictable to apply an
antimicrobial compound naturally present in milk, and therefore known to be
completely safe for consumption, to control pathogenic organisms in other
food contexts (see FF 1-8). Treatment of food to control microbial growth is
not a new concept, for example, Ryser discloses the use of heat as in
pasteurization (see FF 7). Since lactoferrin is known to inhibit the growth of
pathogenic microorganisms (see FF 1-3), application of lactoferrin to meat
simply represents an obvious variation of Chander’s teaching. Ryser, Stiles,
and Dickson all teach that meat may be contaminated with pathogenic
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microorganisms, including the same microorganisms that Chander teaches
are inhibited by lactoferrin (see FF 1-12).
Appellant disputes that Chander combined with Ryser, Stiles or
Dickson teach anything regarding the treatment of products, especially meat,
to reduce microbial contamination (App. Br. 8-10). However, Ryser
specifically teaches several treatments which reduce microbial
contamination, including pasteurization, prevention of cross-contamination,
and cooking (see FF 7). Stiles teaches heating and cooking to remove
microbial contamination (see FF 10). As the Examiner noted,
[t]he economic and public health desire to reduce microbial
contamination by using a compound that is already known to
be effective against both microbes that are already known to
be present in raw or undercooked crab, shrimp, oysters,
ground beef and ground beef sandwiches (such as the germs
that cause E. coli food poisoning and cholera) renders the
instant claims prima facie obvious.
(Answer 7).
These health concerns are fully discussed in Ryser, who repeatedly
emphasizes that foods, including pork and beef, which are contaminated
with pathogenic microorganisms, represent a significant health hazard (see
FF 5). Stiles and Dickson also show that the ordinary artisan would have
been aware of the health impact of microbial contamination of meat (see FF
9, 13).
The Examiner has identified a specific reason to use lactoferrin on
meat, which is to reduce microbial contamination on meat that is known to
have contamination risks thereby reducing the risk of human disease (see FF
4-8). See KSR Int’l v. Teleflex Inc., 127 S. Ct. at 1741 (“it can be important
to identify a reason that would have prompted a person of ordinary skill in
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the relevant field to combine the elements in the way the claimed new
invention does”). We agree with the Examiner that those of ordinary skill in
the art would have considered obvious the predictable use of lactoferrin to
reduce microbial contamination in meat in view of Chander combined with
Ryser, Stiles, or Dickson.
We reject Appellant’s argument that there is no reasonable
expectation of success in the prior art. Appellant argues that the Examiner
makes an unwarranted and unfounded conclusion regarding obviousness
based upon public health concerns (App. Br. 11). As we discussed above,
Ryser provides specific statements that microbial contamination of meat is a
public health risk (see FF 5-8). Also, Chander provides a specific teaching
that lactoferrin inhibits microbial growth on substrates in vitro (see FF 1-4).
These teachings would have provided a foundation for a reasonable
expectation of success since it would be expected that if lactoferrin can
inhibit bacteria in vitro, it would inhibit bacteria on meat. See In re
O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988) (“Obviousness does not
require absolute predictability of success . . . . For obviousness under § 103,
all that is required is a reasonable expectation of success.”).
We also reject several of Appellant’s arguments that are specific to
the Dickson or Stiles references. Appellant argues that Dickson does not
teach bacteria which are normal contaminants of meat (App. Br. 9). Dickson
states: “The bacteria selected represent both pathogenic and nonpathogenic
strains which are associated with meat products” (Dickson, at 832, col. 2, ll.
25-27). Dickson clearly comments that some of the selected bacteria are
pathogenic strains associated with meat products.
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Appellant also argues that treatment of meat would destroy the
purpose of Stiles, which Appellant identifies as identifying contamination of
meat during the meat processing chain (App. Br. 10). There is no language
in Stiles which indicates that treatment of meat to remove bacteria is
undesirable. In fact, since Stiles specifically refers to both sanitation and
cooking in order to remove bacteria, Stiles teaches to remove contaminants
(see FF 10). Like our appellate reviewing court, we “will not read into a
reference a teaching away from a process where no such language exists.”
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1364 (Fed. Cir. 2006).
Based on our findings and those of the Examiner, Chander combined
with Ryser, Stiles, or Dickson would have suggested the invention of claim
1 to the skilled artisan. Thus, we conclude that the invention of claim 1
would have been obvious under § 103(a) based on the cited prior art.
Other issues
If Appellant resumes examination before the Examiner, the Examiner
should consider The Pioneer Heritage Wild Game Cookbook (1986)
(attached). We believe this reference may be anticipatory. At page 73, this
cookbook teaches a recipe in which meat is soaked in milk for one hour.
Bovine milk inherently comprises lactoferrin, and Chander evidences that
the lactoferrin in milk may inherently result in antibacterial activity
(Chander, at 418).

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CONCLUSION
In summary, we affirm the rejection of claim 1 under § 103(a).
Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection
of claims 2-7 under 35 U.S.C. § 103(a) as these claims were not argued
separately.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

lbg

KURT S. MYERS
7634 BRAESDALE
HOUSTON TX 77071
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