MERCK PATENT GMBH

Patent Trials and Appeals Board

May 19, 2021

2020004819 (P.T.A.B. May. 19, 2021)

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.
15/121,944 08/26/2016 Wolfgang SCHMIDT MERCK-4499 2109
23599 7590 05/19/2021
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
PAGUIO FRISING, MICHELLE F
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
05/19/2021 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WOLFGANG SCHMIDT and TIM CSER
Appeal 2020-004819
Application 15/121,944
Technology Center 1600
Before ERIC B. GRIMES, ROBERT A. POLLOCK, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–20. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as Merck Patent GmbH.
Appeal Br. 1.
Appeal 2020-004819
Application 15/121,944
2
CLAIMED SUBJECT MATTER
The claims are directed to a method of detecting microbes carried in a
non-liquid sample such as food (vegetables, meats, dairy, etc.),
environmental samples (sponges, swabs, soil, etc.), cosmetic or
pharmaceutical preparations (creams, ointments, etc.), and various systems
for doing so. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A method, comprising
a. providing a single test sample to be tested,
b. providing a sample of from 1 g to 500 g of dehydrated
growth medium,
c. providing heated pure water from a water system with a
heater located upstream or downstream of a source of pure water,
which heater heats water to a temperature of about 30-45 °C, and
which heater is selected from the group consisting of tankless
water heaters and heat exchangers, wherein the total amount of
water provided in the heater for heating is sufficient to dissolve
the sample of dehydrated growth medium but insufficient to
dissolve multiple samples of dehydrated growth medium,
d. homogenizing the test sample,
e. reconstituting the sample of dehydrated growth medium
into a liquid form with the heated pure water from c) by
i. adding the heated pure water to the sample of
dehydrated growth medium and reconstituting the
sample of dehydrated growth medium and then
adding the reconstituted liquid medium to the
homogenized test sample in a container, or
ii. adding the heated pure water, sample of
dehydrated growth medium and the test
homogenized sample into a container together,
f. mixing the reconstituted liquid medium and
homogenized test sample to a homogenous consistency and
g. incubating the container containing the pure water,
reconstituted liquid medium and homogenized test sample for a
period of time sufficient to allow growth of microbes to form an
incubated sample.
Appeal 2020-004819
Application 15/121,944
3
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Novotny US 2003/0185548 A1 Oct. 2, 2003
Croteau WO 97/18455 May 22, 1997
De La Rosa Fraile EP 1,098,002 A1 May 9, 2001
Chandrapati WO 2009/052137 A1. April 23, 2009
Food Poultry Breeder
Improves
Environmental
Monitoring with
Innovative Dry-Bags,
FOOD SAFETY
MAGAZINE,
August/September 2007
Sept. 2007
de Boer Methodology for
detection and typing of
foodborne
microorganisms,
50 INT'L J. FOOD
MICROBIOL. 119–130
1999

REJECTIONS
Claims 1–12, 14, and 16–20 are rejected under 35 U.S.C. § 103 as
being unpatentable over Croteau and De la Rosa Fraile, in view of Food and
Novotny.2
Claims 1–20 are rejected under 35 U.S.C. § 103 as being unpatentable
over Croteau and De la Rosa Fraile in view of Food and Novotny, and in
further in view of Chandrapati and de Boer.

2 Claims 1–19 were also rejected under 35 U.S.C. § 112(a) for failure to
satisfy the written description requirement. Final Act. 5. That rejection was
withdrawn. Ans. 9.
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Application 15/121,944
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Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis
1–12, 14, 16–20 103 Croteau, De La Rosa
Fraile, Food, Novotny
1–20 103 Croteau, De La Rosa
Fraile, Food, Novotny,
Chandrapati, de Boer,

OPINION
Croteau Combined with De La Rosa Fraile, Food, and Novotny
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
claims 1–12, 14, and 16–20 would have been obvious to one of ordinary
skill in the art at the time the invention was made over Croteau combined
with De La Rosa Fraile, Food, and Novotny.
The Examiner finds that Croteau teaches a method for performing
microbiological tests on a sample comprising “liquefying the sample, and
then mixing it with water and medium to a homogeneous consistency.” Final
Act. 9. The Examiner finds that Croteau teaches that the mixture is then
incubated at 37°C to allow bacterial growth. Id. The Examiner finds that
Croteau teaches that the process can be performed on a unit dose basis. Id.
The Examiner finds that while Croteau does not teach the specific amounts
of dehydrated growth medium recited in the claims, “a person with ordinary
skill in the art would have determined the appropriate amount through
routine experimentation and optimization especially since it would depend
on the amount and type of sample being tested.” Id. at 10.
The Examiner finds that De La Rosa Fraile “teaches a method of
performing microbiological tests by homogenizing a semi-solid and/or solid
Appeal 2020-004819
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5
sample through shaking and suspending the powdered media in sterile
distilled water, which is provided at room temperature or about 25°C and
can also be ‘about 30°C’.” Id.
The Examiner finds that Food teaches the use of a tankless water
heater upstream with a source of pure water. Id. at 10–11.
The Examiner concludes
Given the convenience of preheating pure water with the
aid of an instant heater and employing it for reconstitution of
dehydrated medium in a bag, a person with ordinary skill in the
art before the effective filing date of the claimed invention
would have modified the process of Croteau et al. and De la
Rosa Fraile by using a water deionizer and instant heater such
that deionized water is provided to an instant water heater,
heated to 42°C, and then filtered through a filter prior to mixing
with dehydrated medium in a bag as taught by Food Safety
Insider and Novotny et al.. [sic] It can be predicted that such
modification would allow easy preparation of reconstituted
medium and make microbial testing of a sample more efficient
and less labor-intensive. The water deionizer is a device that
yields pure water for the instant water heater to heat, which
fulfills “providing heated pure water from a water system with a
heater located upstream or downstream of a source of pure
water”. And since the instant water heater provides hot water on
demand, it can be expected that only the water needed to
dissolve the dehydrated medium is instantaneously heated,
thereby satisfying the limitation “wherein the total amount of
heated water provided in the heater is sufficient to dissolve the
sample of dehydrated growth medium but insufficient to
dissolve multiple samples of dehydrated growth medium”.
Furthermore, use of a bag containing sterile medium such as the
one shown by Food Safety Insider would advantageously keep
the dehydrated medium sterile. The obviousness of the instant
claim is based on some teaching, suggestion, or motivation in
the prior art that would have led one of ordinary skill to modify
the prior art reference or to combine prior art reference
teachings to arrive at the claimed invention. See MPEP §
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2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S.
398, 82 USPQ2d 1385, 1395-97 (2007).
Thus, the claimed invention is obvious over Croteau et
al. and De la Rosa Fraile, in view of Food Safety Insider and
Novotny et al.

Id. at 11–12.
Appellant contends that the references fail to teach all of the elements
of the claims. Appeal Br. 5. Specifically, Appellant contends that the
references do not teach or suggest a system where the total amount of water
in the heater is sufficient to dissolve a sample of dehydrated growth medium,
but insufficient to dissolve multiple samples. Id. Appellant contends that the
Examiner has improperly pieced together teachings from various references
without considering the teachings of the references as a whole. Id. Appellant
contends that Croteau is silent as to the relation of the water in the heater and
the sample size and that the remaining references teach the use of heaters
designed to heat bulk amounts of water. Id. at 6. Appellant also contends
that modifying the heater taught in Food would render the system
unsatisfactory for its intended purpose. Id. at 7–8.3
Principles of Law
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If

3 In its reply brief Appellant presents additional arguments distinguishing
Croteau and De La Rosa Fraile. Reply Br. 5–8. These arguments do not
respond to arguments made by the Examiner in the Answer but respond to
the original Final Rejection. As such they should have been raised in the
Appeal Brief. See 37 C.F.R. § 41.41 (B)(2). As Appellant has not advanced
any argument demonstrating good cause why we should consider these
arguments now, we decline to consider them. Id.
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7
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
A proper § 103 analysis requires “a searching comparison of the
claimed invention—including all its limitations—with the teaching of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
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 and
Answer regarding this rejection. We find the Examiner has established a
prima facie showing that the subject matter of the claims would have been
obvious over Croteau combined with De La Rosa Fraile, Food, and Novotny
to a person of ordinary skill in the art at the time the invention was made.
Appellant has not produced evidence showing, or persuasively argued, that
the Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellant in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R. §
41.37(c)(1)(iv) (2015). We have identified claim 1 as representative;
therefore, all claims fall with claim 1. We address Appellant’s arguments
below.
Appellant contends that the references fail to teach the claim element
calling for the total amount of water provided in the heater to be sufficient to
dissolve the sample but insufficient to dissolve multiple samples of the
dehydrated growth medium. Appeal Br. 5. Appellant argues that the claim
requires that the water heater be sized to produce a single unit amount of
heated water and the references do not teach resizing the water heater. Id. at
5–6. Appellant argues that while Croteau may teach unit dosing, this is not
the same as limiting the heated water to a single dose. Id. at 6. Appellant
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contends that Food teaches heating bulk amounts of water not a single unit
amount of water. Id. at 6–7. Appellant argues that when read as a whole,
Croteau is also directed to bulk amounts of water to reconstitute the
dehydrated medium. Id.
We have considered Appellant’s arguments and are not persuaded that
the rejection is in error. While Croteau teaches the bulk preparation of the
growth medium to prepare a number of samples, Example 2 of Croteau is
clearly limited to single unit preparation and teaches the use of only enough
water to rehydrate the growth medium. Croteau, 13. While Food discloses
the preparation of a bulk amount of growth medium, Food is only relied
upon for the teaching of using heated water to reconstitute the medium and
the use of a tankless water heater to heat the water. See Final Act. 10–11.
We agree with the Examiner that Croteau’s teaching of using only an
amount of water to reconstitute the dehydrated growth medium combined
with Food’s teaching to use heated water and the use of a tankless water
heater would have led one skilled in the art to the present invention. Final
Act. 11–12.
Appellant argues that modification of Food would render the system
disclosed in Food unfit for its intended purpose, negating the combination
proposed by the Examiner. Appeal Br. 7–8. Appellant contends that Food is
directed to bulk sample preparation and that modifying the heater in Food to
produce only sufficient water for one sample would defeat that purpose. Id.
Once again we are not persuaded by Appellant’s argument. As noted
above, Food is cited only for the teaching of using heated water to
reconstitute the dehydrated growth medium and to use a tankless hot water
heater. Final Act. 10–11. The Examiner did not propose modifying Food but
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Application 15/121,944
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instead argues that it would have been obvious to modify Croteau to use
heated water produced by a tankless water heater. Id. at 11–12.
Appellant also contends that the claims require that water be provided
in the water heater and that the water heater of Food “provides no water in
its heater.” Appeal Br. 8.
We remain unpersuaded. As the Examiner points out, Novotny
teaches that water is always present in a tankless water heater and that a
tankless system delivers heated water in the amount needed. Ans. 11. The
Examiner goes on to point out
[N]ot having a tank for storing heated water does not
mean that water is not being provided in the heater. According
to Novotny et al., a typical instant water heater has a water inlet
that introduces water into chambers and also a water outlet
through which heated water exits (Figure 1; par. [0041]-
[0043]). When a faucet is opened during use, water flows
through the chambers and is heated upon contact with the heater
coils present therein (par. [0044]). What a user collects from the
water outlet is therefore water that was just heated. Instant
water heaters are called tankless, not because there is no water
provided in the heater, but because it does not have a tank for
storing water that is already heated. Thus contrary to
Appellants’ argument, use of Food Safety Insider’s instant
water heater necessitates having water in the water heater
(specifically in the chambers). More importantly, an instant
water heater is capable of providing a single unit of heated
water sufficient for reconstituting a single amount of water [sic,
medium] since only the amount of water needed is heated and
dispensed.

Id. at 12. Thus, we agree with the Examiner that the combined teachings of
the references render the present invention obvious.
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Conclusion
Based on the foregoing we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of claim
1 would have been obvious to one of ordinary skill in the art at the time the
invention was made over Croteau combined with De La Rosa Fraile, Food,
and Novotny. Claims 2–12, 14, and 16–20 have not been argued separately
and therefore fall with claim 1.
Croteau combined with De La Rosa Fraile, Food,
Novotny, Chandrapati, and de Boer
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
claims 1–20 would have been obvious to one of ordinary skill in the art at
the time the invention was made over Croteau combined with De La Rosa
Fraile, Novotny, Food, Chandrapati, and De Boer.
The Examiner reiterates the findings with respect to the teachings of
Croteau, De La Rosa Fraile, Food, and Novotny. Final Act. 13. The
Examiner finds that Chandrapati teaches the use of paddles to homogenize
samples for microbiological testing. Id. The Examiner also finds that de
Boer taches the use of a StomacherTM to homogenize samples. Id. at 13–14.
With respect to claim 13, the Examiner concludes
One with ordinary skill in the art before the effective filing date
of the claimed invention would have liquefied the sample using
a stomaching device and have reasonable expectation that
microbes in the sample would be released. This would ensure
that accurate results regarding the presence and/or amount of
microbes in the sample being tested would be obtained.
Id. at 14.
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Turning to claim 15, the Examiner finds that the combination of
references teach a method that
uses a water deionizer and instant water heater to generate
heated deionized water, which are the same as “a system for
producing pure water, a system for heating water”, respectively.
The bag containing sterile dehydrated medium is analogous to
“a bag of sterile granular growth medium”. The stomaching
device is analogous to “a blender for homogenizing”. The
incubator that provides an environment conducive for growth of
bacteria in the sample reads on “an incubator for growing
microbes contained within the test sample”.

Id.
Appellant contends that the teachings of Chandrapati and de Boer
conflict with each other and that it would not be obvious to combine the
references. Appeal Br. 9. Appellant contends that Chandrapati teaches
mixing with paddles inside a bag whereas de Boer eliminates the use of
paddles. Id. at 10. Appellant also contend that the claims require several
homogenization steps and Chandrapati and de Boer only teach one
homogenization step. Id.
Analysis
We have considered the arguments presented by the Examiner and
Appellant as well as the evidence of record and conclude that the Examiner
has the better position.
As discussed above, the combination of Croteau, De La Rosa Fraile,
Food, and Novotny teach the elements of claim 1. Appellant has only
presented arguments regarding claims 13 and 15, which we will now
address.
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12
Depending from claim 1, claim 13 requires that “the test sample is
homogenized by a blender selected from the group consisting of a stationary
blender and a paddle blender.” Claim 15 recites that the method of claim 1
is performed by a system for detecting microbes in a sample,
said system comprising: a bag of sterile granular growth
medium, a system for producing pure water, a system for
heating water, a blender for homogenizing the test sample and
the combined sample, medium and water and an incubator for
growing microbes contained within the test sample.
Appellant contends that the disclosures of Chandrapati and de Boer
contradict each other making a combination of the references improper.
Appeal Br. 9. We are unpersuaded by this argument. The Examiner cited
Chandrapati and de Boer as teaching homogenization of samples for
microbiological samples and did not suggest combining the teachings of the
references. See Final Act. 13–14. Moreover, as admitted by Appellant,
Chandrapati teaches the use of a paddle mixer to homogenize a sample.
Chandrapati, 5. This is one of the two homogenization methods recited in
claim 13. Thus Chandrapati combined with Croteau, De La Rosa Fraile,
Food and Novotny renders claim 13 obvious.
Appellant argues that the present claims call for at least two
homogenization steps, namely homogenization of the sample to be tested
and then homogenization of the mixture of the test sample and the growth
medium. See Appeal Br. 10–11. Appellant argues that Chandrapati and de
Boer only teach a single homogenization step. Id.
We remain unpersuaded by Appellant’s argument. While Chandrapati
and de Boer may teach only one homogenization step, Croteau teaches both
steps. Croteau teaches that the method may include liquefying the sample.
Croteau 3. Croteau also teaches that the tube containing the food sample and
Appeal 2020-004819
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13
the growth medium is shaken to completely mix the two components. Id. at
13. We agree with the Examiner that these two steps are the equivalent to the
homogenization steps recited in the claims. Ans. 14.
Conclusion
Based on the foregoing we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of
claims 1, 13, and 15 would have been obvious over Croteau combined with
De La Rosa Fraile, Novotny, Food, Chandrapati, and De Boer. Claims 2–12,
14, and 16–20 have not been argued separately and, therefore, fall with
claim 1.
CONCLUSION
The Examiner’s rejections are affirmed. More specifically,
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–12, 14,
16–20
103 Croteau, De La
Rosa Fraile, Food,
Novotny
1–12, 14,
16–20

1–20 103 Croteau, De La
Rosa Fraile, Food,
Novotny,
Chandrapati, de
Boer,
1–20
Overall
Outcome
1–20

Appeal 2020-004819
Application 15/121,944
14
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