Ex Parte Ikeda et al

Patent Trial and Appeal Board

Apr 24, 2018

14119071 (P.T.A.B. Apr. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/119,071 11120/2013 Masakazu Ikeda
22850 7590 04/26/2018
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
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.
424625US99PCT 1014
EXAMINER
GEBREYESUS, KAGNEW H
ART UNIT PAPER NUMBER
1656
NOTIFICATION DATE DELIVERY MODE
04/26/2018 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):
patentdocket@oblon.com
oblonpat@oblon.com
tfarrell@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MASAKAZU IKEDA, TADASHI SATO, KEIKO KASAHA, and
MASAHIKO ITO. 1
Appeal2017-005398
Application 14/119,071
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
bacterial lysate composition which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
STATEMENT OF THE CASE
There are many microorganisms that have a useful
enzymatic activity, and such microorganisms are widely used in
the production of functional food materials such as
1 Appellants identify the Real Party in Interest as Kabushiki Kaisha
Y akult Honsha. Appeal Br. 1.
Appeal2017-005398
Application 14/119,071
carbohydrates, amino acids, and phospholipids. Among these,
there are known many microorganisms which can be used in
the production of carbohydrate materials, particularly
oligosaccharides, and for example, it has been reported that a
galactooligosaccharide is produced by utilizing the B-
galactosidase activity of yeast belonging to the genus
Sporobolomyces singularis.
Spec. i12.
It is desirable to kill the microorganisms having an enzymatic activity
while maintaining the activity of the enzymes produced by the
microorganism. Spec. i1 3. This is problematic in that heat is often used to
kill the microorganism. Id. Heat can also deactivate the enzyme produced
by the microorganism. Id.
The Specification discloses a "technique for enabling a liquid of
microbial cells having an enzymatic activity to be easily stored and used."
Spec. i15.
Claims 11 and 18- 23 2 are on appeal. Claim 11 is representative and
reads as follows:
Claim 11: A bacterial lysate, comprising:
a plurality of killed cells of Sporobolomyces singularis;
and
less than 10 cfu/mL of live cells of Sporobolomyces
singularis,
wherein the bacterial lysate is prepared by a method
comprising adjusting a pH of a culture comprising a plurality of
live cells of Sporobolomyces singularis having B-galactosidase
activity to 4.5 to 5.7, and then heating the culture at 44 to 48 °C
2 Claims 24, 25, 29, 32, 36, and 40-42 are pending in the application but
have been withdrawn from consideration. Final Act. 2.
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Application 14/119,071
for at least 5 hours to kill the live cells of Sporobolomyces
singularis in the culture, and
a B-galactosidase titer of the bacterial lysate is 80% or
more of a B-galactosidase titer of the culture.
The claims have been rejected3 under 35 U.S.C. § 103(a) as
unpatentable over Sakai 4 in view of Sasaki. 5
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the pending claims would have been obvious over Sakai combined with
Sasaki.
The Examiner finds that "Saki teaches a procedure for evaluating
beta-galactosidase activity in Sporobolomyces singularis YI Tl 0047 cell
culture by[] method steps comprising first adjusting the pH to 3.5-6.0 and
subsequently to pH 5.5, followed by addition of lactose to 10 mass/vol% and
incubation at 40 C for 90 minutes." Advisory Act. 2, dated Jan. 22, 2016.
The Examiner finds that Sasaki teaches a method for maintaining enzyme
3 Claim 11 was rejected under 35 U.S.C. § 112, second paragraph and claims
11, 13, 15-21, and 23 were rejected under 35 U.S.C. § 102(b) as anticipated
by Sasaki. Ans. 7. The Examiner has withdrawn these rejections. Id.
4 Sakai et al., Repeated-batch production of galactooligosaccarides from
lactose at high concentration by using alginate-immobilized cells of
Sporobolomyces singularis YIT l 0047, 54 J. GEN. APPL. MICRO BIOL. 285-93
(2008) ("Sakai").
5 Sasaki et al., JP 2003-144144, published May 20, 2003 ("Sasaki").
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Application 14/119,071
activity wherein the microorganism is heat treated and the pH is adjusted
and where the culture of microorganism retains enzymatic activity. Id. The
Examiner concludes
Id.
Based on the above references it would have been
obvious to adjust the pH within the limitation of the claims
accord[ing] to Sakai. In addition [] it would have been obvious
to decipher the optimal temperature and the time required to
inactivate or kill the microorganism while retaining activity of
any given enzyme.
Appellants contend that the Examiner has failed to establish why one
skilled in the art would have been motivated to combine the references.
Appeal Br. 8. Appellants also argue that the method of Sakai would not
yield a B-galactosidase titer to 80% or more of the B-galactosidase titer of
the culture. Id. Appellants also argue that the combination of references
would not have led to the claimed composition. Id.
Analysis
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action, Advisory
Action, and Answer regarding this rejection. We find the Examiner has
established that the subject matter of the claims would have been obvious to
one of ordinary skill in the art at the time the invention was made based on
Sakai combined with Sasaki. Appellants have not produced evidence
showing, or persuasively argued, that the Examiner's determinations on
obviousness are incorrect. Only those arguments made by Appellants in the
Briefs have been considered in this Decision. Arguments not presented in
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Application 14/119,071
the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have
identified claim 11 as representative; therefore, all claims fall with claim 11.
We address Appellants' arguments below.
Appellants contend that the references are directed to two different
methods and that there is no reason or motivation to combine the teachings
of the references. Appeal Br. 8. We find this argument unpersuasive.
As the Examiner points out, both Sakai and Sasaki are directed to
controlling pH and temperature to maintain the activity of enzymes
produced by microorganisms. Ans. 9. Sasaki teaches the desirability to
create a composition where the microorganism is killed but where the
activity of the enzyme is retained. Sasaki i-fi-1 2 and 3. Sakai teaches the
temperature and pH ranges where galactosidase retains its activity. Sakai
288. We agree with the Examiner that the combination of references would
motivate one skilled in the art to assay enzyme stability or activity using
different pH and temperatures. Ans. 9.
Appellants argue that the references do not teach or suggest the
composition recited in the claims. Appeal Br. 9. Appellants contend that, as
show in the instant Specification, when a culture of S. singularis is cultured
at 50°C at a pH of 4.0 for 5 hours, only 67.3% of the B-galactosidase titer is
maintained. Id. Appellants further contend that Sakai and Sasaki would not
lead one skilled in the art to adjust the pH and temperature to the cited
ranges. Id.
We have considered Appellants argument and find it unpersuasive.
Sakai teaches that the enzyme activity is dependent on both pH and
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temperature and that at lower temperatures and higher pH, the activity of the
enzyme is greater than 80 %. For example, Figure 1 of Sakai shows that a
cell incubated at a temperature from 30° to 50° C and at a pH of 5.5, retained
100% of enzyme activity. Sakai 288. Sakai also teaches that the enzyme is
stable over a pH range of from 3.5 to 6. Id. This would motivate one skilled
in the art to use a lower temperature and a higher pH to ensure enzyme
activity while killing the microorganism.
Appellants next argue that Sakai only refers to live cells and is silent
about killing cells. Appeal Br. 9, Reply Br. 2-3. We are unpersuaded by
this argument. As discussed above, Sakai teaches preparing compositions
containing B-galactosidase using the same microorganism cultured under
conditions which encompass those used to prepare the claimed
compositions. Sakai 88. We agree with the Examiner that one skilled in the
art would expect cell lysis to occur at the conditions recited in Sakai. Ans.
10-11. This would result in a composition that is the same or similar to that
claimed by Appellants. Where identical or substantially identical
compositions are found in the prior art, the burden shifts to Appellants to
show why the claimed composition is different from that disclosed in Sakai.
Under the circumstances, including the fact that the Patent and Trademark
Office has no laboratory in which to make compositions as disclosed in
Sakai and test their cells for viability after the requisite length of incubation,
the burden is reasonably shifted to Appellants to show that the compositions
of Sakai have live Sporobolomyces singularis cells in excess of 10 cfu/mL.
Compare In re Spada, 911 F.2d 705 (Fed. Cir. 1990); In re Best, 562 F.2d
1252, 1255 (CCPA 1977) (where the claimed and prior art products are
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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).
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 11 would have been
obvious over Sakai combined with Sasaki.
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
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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