Rotman, M. Boris.

Patent Trials and Appeals Board

Jan 11, 2021

2020000778 (P.T.A.B. Jan. 11, 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.
15/627,415 06/19/2017 Mindy A. Marshall 1827-0002 7284
107840 7590 01/11/2021
Olav M. Underdal
IDP Patent Services
7863 E Viewmount Court
Anaheim, CA 92808
EXAMINER
AFREMOVA, VERA
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
01/11/2021 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):
carol.gault@ez-patent.com
eofficeaction@appcoll.com
olav.underdal@ez-patent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MINDY A. MARSHALL,
M. BORIS ROTMAN, and LINDA M. OLMSTED
____________

Appeal 2020-000778
Application 15/627,415
Technology Center 1600
____________

Before FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of using engineered spores to test adequacy of a
sterilization process. Appellant appeals the rejection of claims 1–14 and 29
under 35 U.S.C. § 112(b), § 102(a)(1) and § 103.1 We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R.
§ 1.42. Appellant identifies “M. Boris Rotman,” as the real party in interest.
Appeal Br. 2.
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RELATED MATTERS
Appellant states, “[t]here was an appeal in the parent application,
11/708,829, with a decision on appeal dated 04/21/2017, and a decision on
request for rehearing dated 07/24/2017.” Appeal Br. 2. We note that this
refers to Appeal No. 2017-004001, wherein the Board affirmed the
examiner’s rejections; the request for rehearing was denied and,
subsequently, the related appeal to the Federal Circuit (No. 2017-2561) was
dismissed, whereafter the related application was abandoned.
STATEMENT OF THE CASE
Claim 1 is representative and is reproduced below:
1. A method of using engineered spores to test
adequacy of a sterilization process for a system, comprising:
a) introducing the engineered spores into the
system;
b) sterilizing the system, wherein the system with
the engineered spores is subjected to the sterilization
process;
c) exposing the engineered spores to a germinant for
a predetermined germination period;
d) measuring fluorescence, wherein the
fluorescence of the engineered spores is measured to
obtain a fluorescence measurement; and
e) determining sterilization adequacy, such that:
if the fluorescence measurement is above a
predetermined zero-baseline value, the sterilization
process is determined to be inadequate, and
if the fluorescence measurement is equal to or less
than the predetermined zero-baseline level, the
sterilization process is determined to be adequate;
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wherein the engineered spores each comprise:
a first spore; and
an at least partially hydrophobic compound, which
is incorporated into the first spore;
wherein the at least partially hydrophobic compound is
fluorogenic, such that the at least partially hydrophobic
compound is configured to become fluorescent by hydrolysis;
wherein a sole fluorogenic compound in the engineered
spores is the at least partially hydrophobic compound that is
incorporated into the first spore in each of the engineered spores;
wherein the at least partially hydrophobic compound is
present solely within the first spore in each of the engineered
spores;
wherein the engineered spore is configured to be capable
of germination; and
wherein the engineered spore is non-fluorescent;
wherein the engineered spore does not comprise a
germinant;
such that the engineered spore is configured to become
fluorescent upon germination.
Appeal Br. 20–21 (Claims Appendix)
The following rejections are appealed:
Claims 1–14 and 29 stand rejected under 35 U.S.C. § 112(b) as
indefinite. Answer 4.
Claims 1, 4–6, 11–14, and 29 stand rejected under 35 U.S.C.
§ 102(a)(1) over Dalmasso.2 Id. at 5.

2 U.S. Patent 5,770,393 (issued June 23, 1998) (“Dalmasso”).
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Claims 1–6, 11–14, and 29 stand rejected under 35 U.S.C. § 103 over
Dalmasso and Matner.3 Id. at 8.
Claims 1–14 and 29 stand rejected under 35 U.S.C. § 103 over
Dalmasso, Matner, Guibault,4 and Vepachedu.5 Id. at 9.
DISCUSSION
“[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
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).
I. INDEFINITENESS
For claims under examination, “a claim is indefinite when it contains
words or phrases whose meaning is unclear,” i.e., “ambiguous, vague,
incoherent, opaque, or otherwise unclear in describing and defining the
claimed invention.” In re Packard, 751 F.3d 1307, 1310–13 (Fed. Cir.
2014).
With such standards of law in mind, we analyze the Examiner’s
rejection and Appellant’s arguments regarding indefiniteness below.
The Examiner determined that claims 1 and 29 (and, therefore, the
dependent claims depending therefrom) are indefinite because (1) it is
unclear from the claim language what spores incorporate the recited

3 U.S. Patent 5,073,488 (issued Dec. 17, 1991) (“Matner”).
4 George G. Guibault and David N. Kramer, Lipolysis of fluorescein and
eosine esters. Kinetics of hydrolysis, 14(1) ANALYTICAL BIOCHEMISTRY 28–
40, Abstract (1966) (“Guibault”).
5 Venkata Ramana Vepachedu and Peter Setlow, Analysis of the germination
of spores of Bacillus subtilis with temperature sensitive spo mutations in the
spoVA operon, 239 FEMS MICROBIOLOGY LETT. 71–77 (2004)
(“Vepachedu”).
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fluorogenic compound, and (2) the meaning of “within” is unclear because
the Specification describes mere mixing spores and fluorogenic compound
as incorporating the latter into the former and, based on the Specification,
“within” could mean encapsulated or on the surface. Answer 4–5. We
disagree with the Examiner’s positions.
We read the recited “a first spore” in the independent claims to refer
to an exemplary spore of the claimed “engineered spores,” which is
engineered to incorporate the “partially hydrophobic compound [that] is
fluorogenic.” When the independent claims recite that “the at least partially
hydrophobic compound is present solely within the first spore in each of the
engineered spores,” we read this to mean that the fluorogenic compound is
inside, not outside, the exemplary first spore, per the plain meaning of the
claim language, which is not expressly redefined in the Specification. The
claims are verbose, but we do not find them to be unclear as asserted by the
Examiner. For this reason, we reverse this rejection.
II. ANTICIPATION
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009). To anticipate “it is not enough that the
prior art reference discloses part of the claimed invention, which an ordinary
artisan might supplement to make the whole, or that it includes multiple,
distinct teachings that the artisan might somehow combine to achieve the
claimed invention.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359,
1371 (Fed. Cir. 2008); see also Microsoft Corp. v. Biscotti, Inc., 878 F.3d
1052, 1068 (Fed. Cir. 2017) (“In order to anticipate the claimed invention, a
prior art reference must ‘disclose all elements of the claim within the four
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corners of the document,’ and it must ‘disclose those elements ‘arranged as
in the claim.’”). “[A] reference can anticipate a claim even if it ‘d[oes] not
expressly spell out’ all the limitations arranged or combined as in the claim,
if a person of skill in the art, reading the reference, would ‘at once envisage’
the claimed arrangement or combination.” Microsoft, 878 F.3d at 1068
(quoting Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376,
1381 (Fed. Cir. 2015)).
With these standards of law in mind, we analyze the Examiner’s
rejection and Appellant’s arguments regarding anticipation below.
The Examiner determined that Dalmasso anticipates the method of
independent claims 1 and 29 because it teaches a sterilization adequacy test
based on whether spores that have undergone a sterilization process then
germinate and release chemicals that react with a fluorogenic compound,
where fluorescing indicates inadequate sterilization because such chemicals
would not be released by sterilized spores. Answer 5–7. The Examiner
determined that the spores of Dalmasso are the claimed engineered spores,
in part, because
The meaning of the term “within” some entity includes being on
a surface of this entity. In view of specification dye is on the
surface of the spore; and the “engineered” spore is not genetically
manipulated to incorporate a foreign (unnatural) compound.
Therefore, the cited embodiment drawn to indicator dye being”
interspersed with microorganisms” encompasses idea of
indicator dye being in contact with the surface of
microorganisms.
Id. at 7. We do not agree with the Examiner’s determination.
As we noted above, the term “within,” recited in the claims in relation
to “an at least partially hydrophobic compound, which is incorporated into
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the first spore,” and expressly recited at “the at least partially hydrophobic
compound is present solely within the first spore in each of the engineered
spores,” does not allow for such hydrophobic compound being on the
surface of the spores, but requires that it be inside the spores. Based on the
plain meaning of the words “solely within,” a thing that is solely within a
container (e.g., a spore) cannot also be on the outside of the container, as
“solely” means only and “within” means inside.
Thus, the claimed engineered spore carries within itself the
fluorogenic material that will fluoresce upon germination “to give the spore
self-reporting capability,” as stated in the Specification. Spec. ¶ 22.
Although, as indicated by the Examiner, an embodiment disclosed in the
Specification has “the hydrophobic molecular probes self-assemble forming
a discrete boundary around the spore’s outer coat,” the Specification states
repeatedly that other embodiments have the hydrophobic compound
incorporated into the spores, not onto their surface. Spec. ¶¶ 27, 50–51, 55,
62, 94, 106; see Final Action 4–7. Nowhere does the Specification equate
the claim term (or concept) of “solely within” to include on the surface or
exterior of.
The fundamental problem with the Examiner’s rejection is that
Dalmasso does not disclose that an indicator (a fluorogenic compound) is
within spores, but, rather, teaches only that such an indicator is in the
associated growth medium (germinant), which is outside the spores.
Dalmasso 5:1–14 (“[T]he substrate-indicator complex is disposed within the
growth medium 12, the reaction of the enzymes with the complex following
the penetration of the barrier by the microorganism carrier commences
immediately on the growth of any surviving viable microorganisms”).
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Nowhere does Dalmasso teach engineering spores to have such an indicator
solely within the spores.
For this reason, Dalmasso does not disclose the method of
independent claims 1 and 29, or that of any dependent claim. We reverse
the anticipation rejection.
III. OBVIOUSNESS
When analyzing obviousness, “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007). “[W]hen the question is whether a patent claiming the
combination of elements of prior art is obvious,” the answer depends on
“whether the improvement is more than the predictable use of prior art
elements according to their established functions.” Id. at 417. “If a person
of ordinary skill can implement a predictable variation [of a known work],
§ 103 likely bars its patentability.” Id.
With these standards of law in mind, we analyze the Examiner’s
rejection and Appellant’s arguments regarding obviousness below.
The Examiner determined that most claims would have been obvious
over Dalmasso and Matner, and that all appealed claims would have been
obvious over Dalmasso, Matner, Guibault, and Vepachedu. Answer 8–11.
The Examiner premised these obviousness rejections on the determinations
made over Dalmasso’s asserted anticipation, discussed above. Id. at 9–10
(“Dalmasso . . . is relied upon as explained above”). Nowhere does the
Examiner assert that the other cited prior art references teach the missing
claim elements not taught by Dalmasso, which, on our reading, they do not,
or that it would be obvious to modify Dalmasso such that its indicator is
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solely within its spores. Thus, the obviousness rejections are also deficient
for the same reasons discussed above regarding the anticipation rejection,
and we reverse these rejections for the same reason.
CONCLUSION
The rejection of claims 1–14 and 29 under 35 U.S.C. § 112(b) as
indefinite is reversed.
The rejection of claims 1, 4–6, 11–14, and 29 under 35 U.S.C.
§ 102(a)(1) over Dalmasso is reversed.
The rejection of claims 1–6, 11–14, and 29 under 35 U.S.C. § 103
over Dalmasso and Matner is reversed.
The rejection of claims 1–14 and 29 under 35 U.S.C. § 103 over
Dalmasso, Matner, Guibault, and Vepachedu is reversed.
In summary:
Claims
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–14, 29 112(b) Indefiniteness 1–14, 29
1, 4–6, 11–
14, 29
102(a)(1) Dalmasso 1, 4–6, 11–14, 29
1–6, 11–
14, 29
103 Dalmasso, Matner 1–6, 11–14, 29
1–14, 29
103 Dalmasso, Matner,
Guibault,
Vepachedu
1–14, 29
Overall
Outcome
1–14, 29

REVERSED