Ex Parte Ivanova et al

Patent Trial and Appeal Board

Apr 24, 2017

13481787 (P.T.A.B. Apr. 24, 2017)

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.
13/481,787 05/26/2012 Svetlana A. Ivanova 121846 6699
73325 7590 04/26/2017
Matthew G. McKinney
Allen, Dyer, Doppelt & Gilchrist, P.A.
255 South Orange Avenue
Suite 1401
Orlando, EL 32801
EXAMINER
CLARKE, TRENT R
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
04/26/2017 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):
mmckinney @ allendyer.com
creganoa @ allendyer. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SVETLANA A. IVANOVA, DENNIS W. DAVIS,
BRAD W. ARENZ, and THOMAS K. CONNELLAN
Appeal 2017-001946
Application 13/481,7871
Technology Center 1600
Before DONALD E. ADAMS, TAWEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims 21 and 22 (App.
Br. 2).2 Examiner entered rejections under 35 U.S.C. § 112, second
paragraph and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “Ziolase, LLC” (App. Br.
2).
2 “Claims 1-20 and 23-30 have been withdrawn pursuant to a restriction
requirement” (App. Br. 2).
Appeal 2017-001946
Application 13/481,787
STATEMENT OF THE CASE
Appellants disclose “compositions and methods to prevent and treat
biofilms” (Spec. 12). Claim 21 is representative and reproduced below:
21. A composition to prevent and treat skin and mucosal lining
biofilm based infections, the composition comprising an antimicrobial and
non-microbial trehalase, in an amount effective to enhance performance of
the antimicrobial. (App. Br. 32.)
The claims stand rejected as follows:
Claims 21 and 22 stand rejected under 35U.S.C. § 112, second
paragraph.
Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Olmstead,3 Petzold,4 Sigma,5 and
Ramage.6
DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that the phrase “non-microbial trehalase,” as set forth in Appellants’ claim
21, is indefinite?
3 Olmstead, US 2011/0129454 Al, published June 2, 2011.
4 Elizabeth Wills Petzold et al., Characterization and Regulation of the
Trehalose Synthesis Pathway and Its Importance in the Pathogenicity of
Cryptococcus neoformans, 74 Infection and Immunity 5877—87 (2006).
5 SIGMA QUALITY CONTROL TEST PROCEDURE, Enzymatic Assay of
TREHALASE (EC 3.2.1.28), www.sigma-aldrich.com, revised Dec. 18,
1998.
6 Gordon Ramage et al., Our Current Understanding of Fungal Biofilms, 35
Critical Reviews in Microbiology 340-55 (2009).
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Application 13/481,787
FACTUAL FINDINGS
FF 1. Appellants define the term “[aptimicrobials” as “substances that kill
or inhibit the growth of microorganisms such as bacteria, fungi, or
protozoans'’ (Spec. 1119 (emphasis added)).
FF 2. Appellants disclose that the “trehalase [enzyme] . . . has been reported
to be present in many micro- and macroorganisms, including animals and
plants” and “can be obtained from natural sources (plants, yeasts, fungi)”
(Spec. 11164 and 184).
FF 3. Examiner finds that the term “microbe” refers to “an organism which
spends its life at a size too tiny to be seen with the naked eye, including
bacteria, archaebacteria, viruses, prions, protists, and some fungi, animals
and plants” (Ans. 8, citing a Google search result of the term “microbe,”
which refers to the Feb. 1, 2001 Michigan State University website
“commtechlab.msu.edu/sites/dlc-me/zoo/ziwim.html” (“A microbe is any
living organism that spends its life at a size too tiny to be seen with the
naked eye. Microbes include bacteria and are archaebacterial, protists, some
fungi and even some very tiny animals that are too small to be seen without
the aid of a microscope”)).
FF 4. Examiner finds that Appellants’ “[Specification does not define ‘non-
microbial trehalase’ nor ‘microbial trehalase’” (Ans. 2 and 7).
ANALYSIS
As Appellants make clear, “any non-microbial trehalase is within the
scope of [Appellants’] Claim 21” (App. Br. 6). Examiner, however, finds
that Appellants’ “[Specification does not define ‘non-microbial trehalase’
nor ‘microbial trehalase’” (FF 4); that, on this record, it is unclear what the
phrase “non-microbial trehalase” means (FF 2—\\ Ans. 2 and 7—10); and,
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Application 13/481,787
thus, Appellants’ claims fail to “reasonably apprise those skilled in the art”
as to their scope. Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758
F.2d 613, 624 (Fed. Cir. 1985).
Notwithstanding Appellants’ failure to define the phrases “non-
microbial trehalase” or “microbial trehalase,” on this record, Appellants do
define the term “antimicrobial” (see FF 1). Therefore, we are not persuaded
by Appellants’ contention that because “Examiner did not reject the claim
term ‘antimicrobial’ as being indefinite, [] there is no reasonable basis to
reject the use of the term ‘non-microbial trehalase’ as being indefinite when
the totality of all the limitations of the claim and their interaction with each
other is considered” (Reply Br. 3).
Because Examiner established, on this record, that the phrase “non-
microbial trehalase” is indefinite, we are not persuaded by Appellants’
contention that “the ordinary and customary meaning given to the term ‘non-
microbial trehalase’ by those of ordinary skill in the art at the time of the
invention, in view of the Specification and claims themselves, is trehalase
that does not originate from the microbe [that produces the biofilm] itself or
any microbe” (App. Br. 5; cf. FF 1—3; Ans. 2 and 7—10).
CONCLUSION OF LAW
The preponderance of evidence supports Examiner’s conclusion that
the phrase “non-microbial trehalase,” as set forth in Appellants’ claim 21, is
indefinite. The rejection of claim 21 under 35 U.S.C. § 112, second
paragraph is affirmed. Claim 22 is not separately argued and falls with
claim 21.
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Application 13/481,787
OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 5. Olmstead discloses “[physiologically acceptable anti-biofilm
compositions comprising Serratia peptidase and optionally one or more of
bromelain, papain and a fibrinolytic enzyme,” wherein “[additional
components can include antimicrobials” and “a disaccharidase” (Olmstead,
Abstract and 119; see Ans. 3 4).
FF 6. Ramage discloses that “Cryptococcus neoformans . . . have been
shown to be implicated in biofilm-associated infections” (Ramage, Abstract;
Ans. 4).
FF 7. Ramage discloses that “Cryptococcus neof ormans, an encapsulated
opportunistic yeast that causes life-threatening meningoencephalitis in
immunocompromised individuals, has been shown to colonize and
subsequently form biofilms on ventricular shunts, peritoneal dialysis fistulas,
and cardiac valves” (Ramage 341; Ans. 4—5).
FF 8. Petzold discloses that “[t]he potential pathobiological importance of
trehalose in cryptococcosis was identified by two in vivo screens.” First,
gene expression analysis of cerebrospinal fluid from rabbits infected with
cryptococcal meningitis identified trehalose-6-phosphate synthase (TPS1) as
one of the most highly expressed genes and “[sjecond, . . . NMR studies
[reported that] [o]ne of the most abundant metabolites identified in these
cryptococcomas was trehalose” (Petzold 5884; Ans. 4).
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FF 9. Examiner relies on Sigma to establish that “[tjrehalase from porcine
kidney . . . has been commercially available from Sigma since 1998” (Ans.
6).
ANALYSIS
Based on the combination of Olmstead, Petzold, Sigma, and Ramage,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie
obvious to use a non-microbial trehalase, such as porcine
trehalase, in the composition [made] obvi[ous] by Olmstead and
Petzold because porcine trehalase was commercially available
at the time of the invention and it is within the skill of a worker
in the art to select a known material (e.g. [,] porcine trehalase on
the basis of its suitability for the intended use (i.e. [,] as a
trehalase) [and] optimize the amount of non-microbial trehalase
and antimicrobial in the composition used to treat biofilms
[made] obvi[ous] by Petzold and Olmstead; thus, they would
naturally arrive at an amount of trehalase in the composition
which is effective to enhance performance of the antimicrobial;
therefore, [Appellants’] claimed invention[] [is] prima facie
obvious.
(Ans. 6.)
For the reasons set forth by Examiner (Ans. 12—16), we are not
persuaded by Appellants’ contention that, “[a]s exemplified in the laboratory
results summarized in the [] Declarations of Dr. Ivanova, the claimed
composition is able to enhance performance of the antimicrobials in an
efficient manner and far better than antimicrobials alone” (App. Br. 13).
Petzold discloses the “pathobiological importance of trehalose in
cryptococcosis,” i.e., cryptococcal disease, such as “cryptococcal
meningitis” (FF 8). Thus, we are not persuaded by Appellants’ contention
that a person of ordinary skill in this art would not have been “motivated to
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Application 13/481,787
select trehalase from all the disaccharidases” for use in Olmstead’s
composition (App. Br. 14—15; cf. FF 5). For the same reason, we are not
persuaded by Appellants’ contention that “Examiner’s rationale cannot
support a conclusion that the claim would have been obvious to one of
ordinary skill in the art because Olmstead does not recognize the problem
with trehalose in the biofilm” (Reply Br. 4—5).
For the foregoing reasons we are not persuaded by Appellants’
contention that Olmstead suggests “the use of cellulases, hemicellulases,
lysozyme, pectinases, amylases, DNase, (3—1, 6—N—acetylglucosaminidase,
and other hydrolases that are capable of digesting the exopolysaccharide,
exoprotein, and nucleotide matrix of biofilms,” whereas “trehalose is not an
exopolysaccharide nor can it be a component of exopolysaccharides because
it is a non-polymerizing sugar” (App. Br. 15; see Reply Br. 5).
For the same reasons, we are not persuaded by Appellants’ contention
that because Petzold discloses enzymes that process trehalose within a
microbial cell, a person of ordinary skill in this art would not include a
trehalase enzyme as the disaccharidase in Olmstead’s composition (App. Br.
15—16; see Reply Br. 5; cf. FF 5).
For the foregoing reasons we are not persuaded by Appellants’
contention that Examiner’s conclusion of obviousness is based in hindsight
(App. Br. 17).
We are not persuaded by Appellants’ contention that Ramage “does
not teach or suggest administering non-microbial trehalase, with or without
antimicrobials,” which fails to account for Ramage’s contribution to the
combination of Olmstead, Petzold, Sigma, and Ramage (see App. Br. 17; see
Reply Br. 6; cf. FF 5-9).
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As discussed above, Olmstead discloses a composition comprising an
antimicrobial and a disaccharidase, which according to the combination of
Petzold, Ramage, and Sigma may be a non-microbial trehalase (FF 5—9). As
Examiner explains, “optimization of the amount of trehalase and
antimicrobial in the composition would provide concentrations of trehalase
which are effective to enhance performance of the antimicrobial” (Ans. 20—
21). In re Geisler, 116 F.3d 1465, 1470, (Fed. Cir. 1997) (“‘[I]t is not
inventive to discover the optimum or workable ranges by routine
experimentation.’”) (quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
Therefore, we are not persuaded by Appellants’ contention that the
combination of “Olmstead, Petzold, Ramage, and [Sigma] do not describe or
suggest the use of non-microbial trehalase in an amount effective to enhance
performance of the antimicrobial” (App. Br. 18; see also Reply Br. 3 4).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 21 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Olmstead, Petzold, Sigma,
and Ramage is affirmed. Claim 22 is not separately argued and falls with
claim 21.
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)(l)(iv).
AFFIRMED
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