NOVASTERILIS INC.

Patent Trials and Appeals Board

Sep 8, 2020

15332572 - (D) (P.T.A.B. Sep. 8, 2020)

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.
15/332,572 10/24/2016 Julien P. Fey NOVA-017 5076
21884 7590 09/08/2020
WELSH FLAXMAN & GITLER LLC
1451 Dolley Madison Blvd., Suite 210
McLean, VA 22101
EXAMINER
LYONS, MARY M
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
09/08/2020 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JULIEN P. FEY, KELLY M. S. BLATT, DAVID C. BURNS, and
ANTHONY R. EISENHUT
____________

Appeal 2020-001597
Application 15/332,572
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review,2 under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 1, 6, 21, and 22. (Appeal Br. 3.)
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as
NOVASTERILIS, INC. (See Appeal Br. 1.)
2 We consider the Specification dated August 2, 2018 (“Spec.”), Final Office
Action issued February 25, 2019 (“Final Act.”), the Appeal Brief filed
August 29, 2019 (“Appeal Br.”), the Examiner’s Answer issued October 28,
2019 (“Ans.”), and the Reply Brief filed December 27, 2019 (“Reply Br.”).
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INTRODUCTION
Appellant’s Specification provides a method for producing biological
vehicles impregnated with cargo molecules. (Spec. 2.) The Specification
defines the term “impregnating” as “physical penetration of the biological
vehicle(s) by the cargo molecule(s).” (Id. at 12.) The biological vehicles
may include bacterial and fungal spores, cells, vesicles, or viruses. (Id. at
13.) The cargo molecules may include drugs, imaging reagents, ions, natural
compounds, and synthetic compounds. (Id.)
The Specification explains that applying subcritical and supercritical
fluids provides solvation and penetration to effectively impregnate
biological vehicles with cargo molecules. (Id. at 12–13.) The Specification
describes the preferred treatment fluid as supercritical carbon dioxide at a
temperature exceeding 31.1° C and a pressure exceeding 1071 psi, or
subcritical carbon dioxide at a temperature of 25–35° C and a pressure of
750–1070 psi. (Id. at 13–14.)
Appellant’s claim 1 recites:
A method for impregnating a biological vehicle
with a cargo molecule, comprising:

mixing the biological vehicle and the cargo molecule in a
suspension to create a cargo molecule and biological vehicle
mixture, the biological vehicle is a spore, cell, virus, or cell-
derived vesicle and the cargo molecule consists essentially of a
drug, a prodrug, an imaging reagent, an ion, a natural
compound, a synthetic compound, a polypeptide, a small
peptide, a protein, an enzyme, an antigen, an antibody, a
carbohydrate, a nucleic acid, DNA, RNA, or PNA;

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placing the cargo molecule and biological vehicle
mixture inside a pressure vessel;

subjecting the cargo molecule and biological vehicle
mixture to subcritical or supercritical fluid to affect the surface
of the biological vehicle allowing the cargo molecule to bind to
and penetrate the biological vehicle;

returning pressure and temperature within the pressure
vessel to ambient conditions; and

recovering a biological vehicle with bound cargo
molecule.
(Appeal Br. 18.)
The Examiner rejects the claims as follows3:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Final Office
Action
1, 6, 21 102(a)(1) Truong-Le4 3–5
1, 6, 21, 22 102(a)(1) Christensen5 8–12
1, 6 Nonstatutory
double patenting
Claims 1–9 of
Christensen
15–17

ANALYSIS
Claims 1, 6, 21, and 22 anticipated by Christensen
The Examiner finds Christensen discloses a method including the
steps of mixing a biological vehicle, e.g., spores, with a cargo molecule, e.g.,

3 The Examiner’s rejections based on Christopher et al., U.S. Patent
7,771,652 B2 were withdrawn.
4 Truong-Le et al., U.S. Patent 7,258,873 B2, issued August 21, 2007.
5 Christensen, U.S. Patent 7,919,096 B2, issued April 5, 2011.
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natural or synthetic compounds, in a fluid, and subjecting the fluid mixture
to subcritical or supercritical carbon dioxide. (Final Act. 8.) The Examiner
finds that Christensen discloses filtering the fluid, thereby separating excess
cargo molecules from the biological vehicle. (Id. at 8–9.) The Examiner
finds that Christensen’s process inherently results in the step of “affect[ing]
the surface of the biological vehicle allowing the cargo molecule to bind to
and penetrate the biological vehicle.” (Id. at 9.) As to claim 22, which
recites the closed transitional phrase “consisting of,” the Examiner finds
Christensen does not include any additional steps excluded by the claimed
process. (Id.) Accordingly, the Examiner concludes Christensen anticipates
the claims. (Id. at 10.)
Appellant contends that Christensen does not disclose contacting
biological vehicles with subcritical or supercritical fluid to affect penetration
by a cargo molecule. (Appeal Br. 14.) Rather, Appellant contends that
“Christensen discloses contacting microorganisms with subcritical or
supercritical fluid for the purpose of sterilization.” (Id.) Appellant contends
that without subjecting the mixture to subcritical or supercritical fluid to
affect the surface of the biological vehicle, it is impossible to perform the
last step of recovering a biological vehicle with bound cargo molecule. (Id.
at 10.)
We are not persuaded by Appellant’s argument. As found by the
Examiner, Christensen teaches the same process as claimed, including the
steps of: (1) mixing spores with a natural compound additive, e.g., yeast
extract, or synthetic compound additive, e.g., acetic acid or formic acid, in a
suspension; (2) placing the mixture inside a pressure vehicle; (3) subjecting
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the mixture to a supercritical fluid; (3) returning the pressure and
temperature to ambient conditions; and (4) removing the additive and
collecting the treated spores. (Christensen 10:50–11:13, 12:5–17 (Example
5).) Christensen does not disclose that the additives bind to and penetrate
the spores, and thus, Appellant may have identified a previously unknown
result of the prior art process. However, “merely discovering and claiming a
new benefit of an old process cannot render the process again patentable.”
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
Where the claimed and prior art processes are substantially identical,
the PTO can require an applicant to prove that the prior art process does not
necessarily or inherently result in the same product as the claimed
process. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellant has
not provided any evidence showing that Christensen’s process does not
necessarily result in the same biological vehicle with bound cargo molecule.
Absent evidence to the contrary, we agree with the Examiner that
Christensen inherently anticipates claim 1.
Appellant separately argues claim 6. (Appeal Br. 14.) Appellant
contends that Christensen’s disclosure of a filter for the pressure vessel does
not disclose separating a biological vehicle with a bound cargo molecule
from excess cargo molecules. (Id. at 14–15.)
We are not persuaded by Appellant’s argument. In rejecting claim 6,
the Examiner cites Christensen at Example 5 and column 8. (See Final Act.
8–9.) As found by the Examiner, Christensen teaches a filter for separating
liquid additive, i.e., cargo molecules, from a container for holding treated
organisms, i.e., biological vehicle. (Christensen 8:30–35, 50–53.)
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Moreover, Christensen’s Comparative Example 5 repeats the process of
Example 3A, except with different chemical additives, i.e., cargo molecules.
(Id. at 12:8–10.) Christensen’s Example 3A discloses treating the spore and
additive mixture with supercritical carbon dioxide, then removing the
additive and collecting the treated spores. (Id. at 11:4–11.) Accordingly,
Christensen discloses separating the biological vehicle with bound cargo
molecules from excess cargo molecules, and thus anticipates claim 6.
Appellant argues independent claim 22 separately. (Appeal Br. 15.)
Appellant contends that Christensen requires the step of sterilizing the
organism, which is excluded from claim 22 by the closed transitional phrase
“consisting of.” (Id.)
We are not persuaded by Appellant’s argument for two reasons. First,
we do not agree that the broadest reasonable interpretation of claim 22
excludes sterilization as a result of the claimed process. As the Examiner
finds, claim 22 does not exclude a sterilant from the listed cargo molecules,
which include natural and synthetic compounds. (Ans. 16.) The
Specification supports this finding by disclosing that “the present process
can also incorporate a sterilant where it is desired to produce impregnated
inactivated organisms.” (Spec. 22.) Using a sterilant as the cargo molecule
in the process of claim 22 would result in sterilizing the biological vehicle as
part of the subjecting step, regardless if the result is expressly claimed.
Second, Christensen discloses that none of the additives evaluated in
Example 5 were effective in achieving at least a 6-log reduction in colony
forming units of the tested spores. (Christensen 12:26–28.) Therefore,
Christensen discloses a process that does not include sterilization. Because
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the Examiner has identified the same process in the prior art and Appellant
has not provided evidence that the prior art produces a different result, we
sustain the Examiner’s rejection of the claims as anticipated by Christensen.

Claims 1, 6, and 21 anticipated by Truong-Le
The Examiner finds Truong-Le discloses a method including the steps
of: (1) mixing bioactive materials, e.g., bacteria, cells, or viruses, with
natural compounds, e.g., trehalose, in a solution; (2) exposing the mixture to
subcritical or supercritical carbon dioxide; (3) reducing the pressure; and (4)
recovering the treated bioactive material. (Final Act. 3.) The Examiner
finds that the treated bioactive material forms particles that are separated
from unbound cargo molecules. (Id.) The Examiner finds that Truong-Le’s
process inherently results in affecting the surface of the biologic vehicle
allowing the cargo molecule to bind and penetrate the biological vehicle.
(Id. at 3–4.)
Appellant contends that the process of Truong-Le is distinct from the
claimed process, and thus does not result in affecting the surface of the
biological vehicle allowing the cargo molecule to bind and to penetrate the
biological vehicle. (Appeal Br. 12.) Specifically, Appellant contends
Truong-Le’s process forms a bioactive solution which is mixed with a near
supercritical fluid. (Id. at 11.) Appellant contends that Truong-Le’s mixture
of bioactive solution and near supercritical fluid is then sprayed into liquid
droplets under reduced pressure and subjected to a drying gas to form
powder particles. (Id. at 12.) Appellant contrasts the claimed method,
contending that the subcritical or supercritical fluid does not mix with the
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suspension of biological vehicle and cargo molecule and, instead, the fluid is
released when the pressure is reduced. (Id.)
We are not persuaded by Appellant’s arguments. Truong-Le teaches
combining either suspensions or solutions of bioactive material and a polyol
with near supercritical fluid. (Truong-Le 3:16–20.) Moreover, Truong-Le’s
steps are the same as the broadest reasonable interpretation of Appellant’s
claim 1. For example Truong-Le’s step of mixing the bioactive suspension
with a near supercritical fluid discloses the step in claim 1 of “subjecting the
cargo molecule and biological vehicle mixture to subcritical or supercritical
fluid.” Likewise, Truong-Le’s steps of: (1) spraying under reduced pressure
discloses “returning pressure and temperature within the pressure vessel to
ambient conditions;” and (2) collecting particles discloses “recovering a
biological vehicle with bound cargo molecule.” (Id. at 3:20–21, 5:25–27.)
As to claim 6, Truong-Le discloses separating particles by particle size,
which necessarily separates larger particles (biological vehicle with bound
cargo molecule) from small particles (excess cargo molecules). (Id. at
22:19–30.)
Because Truong-Le discloses the same method under the broadest
reasonable interpretation of the claims, Appellant has the burden to provide
evidence showing Truong-Le’s method does not inherently “affect the
surface of the biological vehicle allowing the cargo molecule to bind to and
penetrate the biological vehicle.” See Best, 562 F.2d at 1255. Appellant
argues that the Truong-Le’s method results in a “fundamentally different”
product. (Appeal Br. 10–11.) However, as the Examiner finds, Appellant’s
attorney argument is no substitute for evidence. Johnston v. IVAC Corp.,
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885 F.2d 1574, 1581 (Fed. Cir. 1989). Absent evidence to the contrary, we
are not persuaded that the Examiner erred, and we sustain the Examiner’s
rejection of claims 1, 6, and 21 as anticipated by Truong-Le.

Claims 1 and 6: Nonstatutory double patenting
The Examiner finds claims 1 and 6 are not patentably distinct over
claims 1–9 of Christensen. (Final Act. 15–17.) The Examiner finds that
Christensen’s claims 1–9 are drawn to a method “comprising contacting
[i.e., mixing] whole microorganisms [i.e., biological vehicles] with a fluid
comprised of carbon dioxide at or near its supercritical pressure and
temperature conditions and wherein said fluid is further comprised of a
chemical additive [i.e., a cargo molecule; a natural or synthetic compound]
. . . .” (Id. at 16.) As discussed above, the Examiner finds that the prior art
method inherently results in affecting the surface of the biological vehicle
allowing the cargo molecule to bind to and penetrate the biological vehicle.
(Id.)
Appellant contends that instant claims 1 and 6 are patentably distinct
from Christensen’s claims 1–9 because the instant claims do not claim
reducing the infectivity and/or pathogenicity of microorganisms. (Appeal
Br. 16.)
We are not persuaded by Appellant’s argument. Christensen’s claims
are drawn to the same process as claims 1 and 6, although with a different
claimed result, namely sterilization rather than impregnation. (See
Christensen 16:16–62 (claims 1–9).) However, both claimed results appear
to be inherent to the process itself. Moreover, the broadest reasonable
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interpretation of Appellant’s claims 1 and 6 does not exclude sterilization as
a result of the claimed process. (See above as to claim 22.) Accordingly, we
agree with the Examiner that the claims are not patentably distinct and
sustain the rejection of claims 1 and 6 for nonstatutory double patenting.

CONCLUSION
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejections.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 6, 21 102(a)(1) Truong-Le 1, 6, 21
1, 6, 21, 22 102(a)(1) Christensen 1, 6, 21, 22
1, 6 Nonstatutory Double
Patenting
1, 6
Overall
Outcome
1, 6, 21, 22

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED