Ex Parte Lee et al

Board of Patent Appeals and Interferences

Feb 4, 2005

09392243 (B.P.A.I. Feb. 4, 2005)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 30
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte JOHN H. LEE, JOSEPH D. HAHN and ROBERT C. MUSSER
__________
Appeal No. 2003-2147
Application No. 09/392,243
__________
ON BRIEF
__________
Before SCHEINER, MILLS, and GREEN Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. §134 from the examiner's final
rejection of claims 21-27 and 36-54, which are all of the claims pending in this
application.
Claims 21, 36 and 42 are illustrative of the claims on appeal and read as follows:
21. A method for preserving mucosa tissue comprising mixing a quantity of
mucosa tissue with a preserving agent selected from the group consisting of hydrogen
peroxide and phosphoric acid to yield the preserved mucosa tissue.
36. A method of treating mucosa tissue, the method comprising combining the
mucosa tissue and a peroxide-containing compound to form an intermediate.
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42. The method of claim 36, the method further comprising mixing the peroxide-
containing compound and the mucosa tissue to form a mucosa product, the
concentration of the peroxide-containing compound remaining in the mucosa product
being undetectable when the concentration of the peroxide-containing compound in the
mucosa product is determined using KMnO4 titration.
The prior art references cited by the examiner are:
Van Gorp et al (Van Gorp) 5,607,840 Mar. 4, 1997
Balslev et al (Balslev) 4,438,100 Mar. 20, 1984
Oles 4,415,451 Mar. 20, 1979
Reference cited by the Merits Panel:
Hiles et al. (Hiles) 6,666,892 Dec. 23, 2003
(filed May 27, 1999)
Grounds of Rejection
Claim 42 stands rejected under 35 U.S.C. §112, second paragraph for
indefiniteness.
Claims 21-27 and 36-54 stand rejected under 35 U.S.C. §103(a), as obvious
over Van Gorp in view of Balslev and Oles.
We reverse these rejections.
DISCUSSION
35 U.S.C. §112, second paragraph
Claim 42 stands rejected under 35 U.S.C. §112, second paragraph for
indefiniteness.
Appeal No. 2003-2147
Application No. 09/392,243
3
As set forth in Amgen Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200,
1217, 18 USPQ2d 1016, 1030 (Fed. Cir. 1991):
The statute requires that “[t]he specification shall conclude with one or
more claims particularly pointing out and distinctly claiming the subject
matter which the applicant regards as his invention.” A decision as to
whether a claim is invalid under this provision requires a determination
whether those skilled in the art would understand what is claimed. See
Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758 F.2d 613, 624,
225 USPQ 634, 641 (Fed. Cir. 1985) (Claims must “reasonably apprise
those skilled in the art” as to their scope and be “as precise as the subject
matter permits.”).
Furthermore, claim language must be analyzed “not in a vacuum, but always in light of
the teachings of the prior art and of the particular application disclosure as it would be
interpreted by one possessing the ordinary skill in the pertinent art.” In re Moore, 439
F.2d 1232, 1235, 169 USPQ 236, 238 (CCPA 1971).
The examiner argues that claim 42 is confusing because “the claim initially
recites addition of a peroxide-containing compound to a composition, but then recites
that the added product must become undetectable when the amount of added product
is measured. It is therefore unclear how much peroxide-containing product can be
added, if any.” Answer, page 3.
Appellants argue that claim 42 is not indefinite. Brief, page 38. Appellants argue
that
[i]f the concentration of the peroxide containing compound remaining in
the mucosa product, when determined using KMnO4 titration, is not
“undetectable” (i.e. is “detectable”) or if the particular subject matter does
not entail “mixing the peroxide containing compound and the mucosa
tissue to form a mucosa product” as claim 42 requires, then the person
knows the particular subject matter falls outside the literal scope of claim
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42. If, on the other hand, the concentration of the peroxide-containing
compound remaining in the mucosa product, when determined using
KMnO4 titration, is “undetectable” and the particular subject matter does
entail “mixing the peroxide-containing compound and the mucosa tissue to
form a mucosa product,” as claim 42 requires, then the person knows the
particular subject matter falls within the literal scope of claim 42.
Brief, page 39.
In our view the examiner has failed to establish a prima facie case of
indefiniteness. In our view, the examiner has failed to fully analyze the claim 42
language in view of the application disclosure.
For example, Example 1 of the specification states that first porcine mucosa was
heated. A specific amount of hydrogen peroxide was added to the solution followed by
mixing for 10 minutes. “The color of the solution changed so that it was similar to the
color of a whey protein solution. The solution was analyzed to determine whether there
was any hydrogen peroxide remaining. This was carried out by adding 0.01 M KMnO4
to the diluted solution (1:150) and observing whether a color change took place. This
test indicated that there was no hydrogen peroxide remaining in the product.”
Specification, page 5.
Upon review of this portion of the specification, and the other examples 2-8 set
forth in the specification, in our view, one of ordinary skill in the art would have been
provided with an amount of hydrogen peroxide and an equivalent, to be added to the
solution. This amount of hydrogen peroxide, according to the examples, provides for an
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Application No. 09/392,243
1 The examiner also appears to understand that the prior art, Balslev, Column 6,
lines 39-68, teaches that hydrogen peroxide continuously decomposes over time,
eventually to a concentration of zero. Answer, page 11.
5
amount which, in some instances, is undetectable by KMnO4 titration.1
Furthermore, appellants concede that “if the concentration of the peroxide
containing compound remaining in the mucosa product, when determined by KMnO4
titration, is not “undetectable” (i.e. is “detectable”) ..., then the person knows the
particular subject matter fall outside the literal scope of claim 42.” Brief, page 39.
In view of the above, when claim 42 is read in view of the specification the claim
language is not indefinite. The rejection of claim 42 for indefiniteness is reversed.
35 U.S.C. §103(a)
Claims 21-27 and 36-54 stand rejected under 35 U.S.C. §103(a), as obvious
over Van Gorp in view of Balslev and Oles.
In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden
of presenting a prima facie case of obviousness. See In re Rijckaert, 9 F.3d 1531,
1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993). It is well-established that the
conclusion that the claimed subject matter is prima facie obvious must be supported by
evidence, as shown by some objective teaching in the prior art or by knowledge
generally available to one of ordinary skill in the art that would have led that individual to
combine the relevant teachings of the references to arrive at the claimed invention. See
In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598 (Fed. Cir. 1988).
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According to the examiner, Van Gorp teaches a process wherein mucosal protein
hydrolysate is added to protein-containing food or feed. Van Gorp also discloses the
preservation of the mucosa starting material using well known preservatives. Answer,
page 4; Final Rejection, page 3. The examiner finds that Van Gorp differs from the
claimed invention in that Van Gorp does not use the claimed peroxide or phosphoric
acid as a preservative. Id.
To make up for this deficiency in Van Gorp, the examiner relies on Balslev and
Oles for the teaching that both phosphoric acid and peroxide were well known
preservatives in food and/or pharmaceutical applications. Thus, according to the
examiner, the claimed substitution of well known preservatives for those used in Van
Gorp must be considered an obvious substitution of one known equivalent preservative
for another. Id, at 4. The examiner continues that, “the artisan of ordinary skill at the
time of applicant's invention would have had a reasonable expectation from Oles and
Balslev that phosphoric acid and/or peroxide would have functioned equivalently to the
preservatives disclosed by Van Gorp, the artisan of ordinary skill would have been
motivated to have substituted Oles' phosphoric acid and/or Balslev's peroxide for the
preservatives disclosed by Van Gorp.” Answer, pages 4-5.
Appellants respond, arguing, “there is no teaching or suggestion in the Van Gorp
patent to use any preservative other than an oxygen scavenger, an antioxidant, or in
low acidity environments, calcium propionate. ... In this regard, the Van Gorp patent
principally mentions use of sodium metabisulfite as an oxygen scavenger, while also
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referencing use of calcium propionate, BHT, and BHA as alternatively acceptable
preservatives...” Brief, page 13. Appellants argue that “[t]he Van Gorp patent suggests
the use of oxygen scavengers as preservatives. The Van Gorp patent does not suggest
the incorporation of either an oxidizer (such as hydrogen peroxide) or an acidifier (such
as phosphoric acid) in the process disclosed in the Van Gorp patent.” Brief, page 14.
In addition, appellants provide evidence, Exhibit D, Jay, James M., Modern Food
Microbiology, pages 259-296 (1986), which according to appellants, demonstrates there
is no support for the position that the Oles phosphoric acid “would have functioned
equivalently to the preservatives disclosed by Van Gorp...” Brief, page 14.
Appellants argue that Oles relies on a synergistic combination of acidifying
agents (a combination of (1) acetic acid or other organic acid and (2) phosphoric acid),
whereas the Van Gorp patent principally relies on an oxygen scavenging stabilizer ...
[and] demonstrates the wide difference in operating function between the preservatives
of the Van Gorp patent and the preservatives of the Oles patent. Brief, page 14.
Finally, appellants argue that Balslev “actually teaches away from using
hydrogen peroxide as a preservative in the process disclosed in the Van Gorp patent.
The Van Gorp patent principally teaches preservation by scavenging oxygen from the
mucosa tissue with oxygen scavengers. ... According to the Balslev patent the
hydrogen peroxide serves an oxidizing bactericide. ... An oxidizing agent provides
oxygen to an active site via a chemical reaction. Providing oxygen to mucosa tissue is
exactly the opposite result of that desired by the preservatives principally employed in
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the Van Gorp patent, namely scavenging oxygen.” Brief, page 16.
In response, the examiner finds with respect to Oles, that the claims are open
ended and do not exclude the combination of acetic acid and phosphoric acid as a
preservative. While the examiner is correct in his interpretation of the scope of claim
21, what is missing from the examiner's analysis is why one of ordinary skill in the art
would have been motivated to select the specific phosphoric acid and acetic acid
preservative in combination with mucosa tissue. Oles provides that the combination of
acetic acid and phosphoric acid has specific application to low acid food products. See
abstract. The examiner has not established that mucosa tissue would be considered an
equivalent to a low acid food product.
In view of the above, we agree with appellants that the examiner has failed to
establish a prima facie case of obviousness on the prior art evidence before us. “To
establish obviousness based on a combination of the elements disclosed in the prior art,
there must be some motivation, suggestion or teaching of the desirability of making the
specific combination that was made by the applicant.” In re Kotzab, 217 F.3d 1365,
1369-70, 55 USPQ2d 1313, 1316 (Fed. Cir. 2000). An adequate showing of motivation
to combine requires “evidence that ‘a skilled artisan, confronted with the same problems
as the inventor and with no knowledge of the claimed invention, would select the
elements from the cited prior art references for combination in the manner claimed.’”
Ecolochem, Inc. v. Southern Calif. Edison Co., 227 F.3d 1361, 1375, 56 USPQ2d 1065,
1075 (Fed. Cir. 2000).
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In the present case, the examiner has failed to provide sufficient evidence that
one of ordinary skill in the art would readily substitute one preservative for another, in
view of evidence present in the record that preservatives of the prior art in fact function
differently than the claimed preservative. Moreover, the evidence of record reasonably
appears to reasonably show that specific preservatives are for required for specific
applications and thus one of ordinary skill in the art would not readily substitute one
preservative for another. We particularly note appellants' Exhibit D, Tables 11-1 and
11-3, provides evidence that preservatives have distinct applications. From the
examiner's perspective Table 11-1 of Exhibit D provides that certain preservative have
multiple applications (Answer, page 7), but th examiner does not acknowledge the
reference's teaching that other preservatives do not have general application or provide
evidence that the specific claimed preservatives are known in the art to have general
application, or particular application to the preservation of mucosa tissue.
In view of the above, we reverse the rejection of the claims over Van Gorp in
view of Balslev and Oles.
Other Issue
Upon return of the application to the examiner, it is recommended that the
examiner carefully review the disclosure of Hiles, U.S. Patent No. 6,666,892 (attached)
and determine its relevance under 35 U.S.C. § 102(e) or 103(c), if any, to the claimed
subject matter. In particular, Hiles would appear to have a filing date, May 27, 1999,
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prior to the filing date of the present application, September 9, 1999. Hiles discloses the
treatment of tissue mucosa with a disinfecting agent which is desirably an oxidizing
agent, and preferably hydrogen peroxide. Col. 4, lines 44-67. Hiles states that the
process will eliminate contaminants but will also produce a tissue which “exhibits no
substantial degradation of physical and mechanical properties,” i.e., the tissue will be
preserved. (Col. 7, lines 1-8).
CONCLUSION
The rejection of claim 42 under 35 U.S.C. §112, second paragraph for
indefiniteness is reversed. The rejection of claims 21-27 and 36-54 under 35 U.S.C.
§103(a), as obvious in view of Van Gorp in view of Balslev and Oles is reversed.
The application is returned to the examiner to determine the relevance of Hiles to
the claimed subject matter.
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No time period for taking any subsequent action in connection with this appeal
may be extended under 37 CFR § 1.136(a).
REVERSED
)
TONI R. SCHEINER )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
DEMETRA J. MILLS )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
LORA M. GREEN )
Administrative Patent Judge )
Appeal No. 2003-2147
Application No. 09/392,243
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