Ex Parte Williams et al

Patent Trial and Appeal Board

Jan 22, 2018

13066913 (P.T.A.B. Jan. 22, 2018)

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.
13/066,913 04/28/2011 Henry N. Williams 2010FAMU-001RT 6212
7590 01/22/2018
Robert Thompson
19371 Wrenbury Lane
Leesburg, VA 20175
EXAMINER
MARX, IRENE
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
01/22/2018 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 HENRY N. WILLIAMS, PAUL A. GULIG,
and HUAN CHEN
__________
Appeal 2016-004337
Application 13/066,9131
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RYAN H. FLAX, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134(a) involves claims 1, 3, 4, and
13–16, which are directed to methods of treating Gram negative bacterial
infections, such as Salmonella infections, by administering bacteria that prey
upon the Gram negative bacteria.
The Examiner entered rejections for indefiniteness, for failure to
comply with the written description requirement, for lack of enablement, and
for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the Examiner’s rejections for indefiniteness. Because the
Examiner’s indefiniteness rejections are dispositive as to the other

1 Appellants state that the “real party of interest in this appeal is the Florida
A & M University.” Appeal Br. 2.
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patentability issues relating to claims 1, 3, 4, 13, 14, and 16, we reverse, pro
forma, the Examiner’s written description, enablement, and obviousness
rejections as to claims 1, 3, 4, 13, 14, and 16.
As to claim 15, we affirm the Examiner’s written description and
enablement rejections. However, we reverse the Examiner’s obviousness
rejection of claim 15.
STATEMENT OF THE CASE
The Specification discloses that, “members of the saltwater genus
Bacteriovorax, formerly known as the marine Bdellovibrio, are obligate
predatory bacterium that prey selectively on other Gram-negative bacteria.”
Spec. ¶ 41.
The Specification explains:
The Bdellovibrio and like Organisms [BALOs] are
extremely small bacteria with the unique property of being
predators of other Gram-negative bacteria. In the presence of
viable and susceptible bacteria a BALO cell physically attacks a
prey cell, attaches to its surface, penetrates the cell wall, and
multiplies within the periplasmic space of its prey. . . . BALO
and its progeny degrade and consume the cellular constituents.
Id. ¶ 39.
The Specification discloses that a “bacteriophage is a virus that is
parasitic in bacteria. A bacteriophage uses the bacterium’s energy and
processes to produce more phages until the bacterium is destroyed and the
new phage particles are released to invade surrounding bacteria.” Id. ¶ 70.
Appellants’ invention is directed to “compositions comprising certain
Bdellovibrio and like organism (BALO) strains, acting in combination with
bacteriophage against, for example, infections of animals and humans
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caused by some Gram negative pathogenic bacteria including, for example .
. . Salmonella, . . . Vibrio sp., . . . and the like.” Id. ¶ 5.
Claims 1 and 15, the independent claims on appeal, are representative
and read as follows (Appeal Br. 42, indentation added):
1. A method to decrease, treat or provide prophylactic
support to a Vibrio vulnificus, Vibrio parahaemolyticus, or an
Aeromonas bacterial infection in an infected host wherein a
Gram negative bacterial infection is a prey bacteria to
Bacteriovorax, said method comprising
administering a Bacteriovorax and a bacteriophage
combination to said infected host of a said Gram negative
bacterial infection and in a ratio of from about ten to 1 to about
1 to one hundred, to inhibit, decrease, treat, or provide
prophylactic support against the growth of a Bacteriovorax
Gram negative prey bacteria in said infected host, and
wherein the Bacteriovorax and bacteriophage
combination are employed in a single combined preparation,
and
whereby the Bacteriovorax Gram negative prey bacteria
decreases by from about 1 log to from about 5 logs.

15. A method to decrease, treat or provide prophylactic
support to a Bacteriovorax Gram negative prey bacterial
infection comprising Acinetobacter calcoaceticus, Aeromonas
hydrophila, Enterobacter aerogenes, Escherichia coli ML-35,
Vibrio cholerae 01, Vibrio strain CMP6, Vibrio vulnificus M06,
and Vibrio parahaemolyticus strain P5, said method
comprising
contacting said Bacteriovorax Gram negative prey
bacterial infection with a composition comprising a
Bacteriovorax and a bacteriophage equal ratio combination in
an amount sufficient to inhibit, decrease, treat, or provide
prophylactic support against the growth of said Bacteriovorax
Gram negative prey bacterial infection, and
further wherein the Gram negative prey bacteria was
reduced by from about 1.0 logs to about 5.0 logs.
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Appellants state that claims 1–18 are on appeal. See Appeal Br. 2;
Reply Br. 2. However, only claims 1, 3, 4, and 13–16 stand rejected. See
Final Act. 1, 2.
Claims 1, 3, 4, and 13–16, therefore, are the claims on appeal. See 37
C.F.R. § 41.31(c) (appeal taken from rejected claims).
The following rejections are before us for review:
(1) Claims 1, 3, 4, and 13–16, under 35 U.S.C. § 112, second
paragraph, as being indefinite (Final Act. 7–9);2
(2) Claims 4, 15, and 16, under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement (id. at 4–6);
(3) Claims 4, 15, and 16, under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement (id. at 10–12); and
(4) Claims 1, 3, and 13–16, under 35 U.S.C. § 103(a), as being
unpatentable over Chen,3 Sockett,4 Hanlon,5 and Debarbieux6 (id. at 12–15).

2 Final Office Action entered May 7, 2015.
3 H. Chen, A Cruise Through Nice Waters! Also Aquatic Sciences Meeting
2009, Meeting Abstracts, Aquatic Sciences Meeting, American Society of
Limnology and Oceanography, Vol. 48 (2009) (abstract only).
4 R. Elizabeth Sockett and Carey Lambert, Bdellovibrio as therapeutic
agents: a predatory renaissance?, NATURE REVIEWS (MICROBIOLOGY), Vol.
2, 669–675 (2004).
5 Geoffrey William Hanlon, Bacteriophages: an appraisal of their role in
the treatment of bacterial infections, INT. J. ANTIMICROBIAL AGENTS, Vol.
30, 118–128 (2007).
6 Laurent Debarbieux et al., Bacteriophages Can Treat and Prevent
Pseudomonas aeruginosa Lung Infections, Phage Therapy for Lung
Infections, THE JOURNAL OF INFECTIOUS DISEASE, Vol. 2010:201, 1096–
1104 (2010).
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STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
INDEFINITENESS—CLAIMS 1, 3, 13, AND 14
In rejecting claim 1 for indefiniteness, the Examiner states that the
claim “lack[s] clear internal antecedent basis for ‘a Gram negative bacterial
infection[,]’ or ‘said Gram negative bacterial infection is a Bacteriovorax
Gram negative prey bacteria’ or ‘a Bacteriovorax Gram negative prey
bacteria’ inasmuch as the infection is a Vibrio vulnificus, Vibrio
parahaemolyticus or an Aeromonas bacterial infection.” Final Act. 7.
As the Examiner contends (Ans. 5), Appellants do not present any
argument specifically traversing the Examiner’s conclusion that claim 1 is
indefinite based on a lack of antecedent basis (see Appeal Br. 13–16; Reply
Br. 12–15 (Appellants’ arguments regarding the Examiner’s § 112, second
paragraph rejections)).
We are not persuaded that the Examiner erred in concluding that
claim 1 is indefinite on this basis.
A claim does not comply with 35 U.S.C. § 112, second paragraph,
“when it contains words or phrases whose meaning is unclear.” In re
Packard, 751 F.3d at 1310, 1314 (Fed. Cir. 2014) (approving, for pre-
issuance claims, the standard from MPEP § 2173.05(e).); see also Ex parte
McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25,
2017) (precedential) (adopting the approach for assessing indefiniteness
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approved by the Federal Circuit in Packard). That is, “claims are required to
be cast in clear—as opposed to ambiguous, vague, indefinite—terms.”
Packard, 751 F.3d at 1313.
In the present case, we conclude that Appellants’ claim 1 is
ambiguous as to the scope of the host that receives the treating agent.
Specifically, Appellants’ claim 1 recites in its preamble “[a] method to
decrease, treat or provide prophylactic support to a Vibrio vulnificus, Vibrio
parahaemolyticus, or an Aeromonas bacterial infection in an infected host
wherein a Gram negative bacterial infection is a prey bacteria to
Bacteriovorax.” Appeal Br. 42 (emphasis added).
Thus, the preamble of claim 1 is ambiguous because it initially states
that the claim is directed to a process of treating a host infected with Vibrio
vulnificus, Vibrio parahaemolyticus, or Aeromonas, but immediately
thereafter includes a statement that the host may be infected with any Gram
negative bacterial infection that is a prey bacteria to Bacteriovorax.
In the body of the claim, claim 1 recites administering a
Bacteriovorax/bacteriophage combination to “said infected host of a said
Gram negative bacterial infection . . . to inhibit, decrease, treat, or provide
prophylactic support against the growth of a Bacteriovorax Gram negative
prey bacteria in said infected host.” Id. (emphasis added).
Thus, in the body of the claim, the infected host that receives the
treating agent may be infected with any Gram negative bacterial infection
that is a prey bacteria to Bacteriovorax. Therefore, the body of claim 1
contrasts squarely with the language in the preamble of claim 1 requiring the
treated host to be infected with Vibrio vulnificus, Vibrio parahaemolyticus,
or Aeromonas.
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In sum, given the ambiguity in claim 1 as to the treated host, and
further given Appellants’ failure to advance specific argument traversing the
Examiner’s prima facie case in that regard as to a lack of antecedent basis, a
preponderance of the evidence supports the Examiner’s conclusion that
claim 1 is indefinite under § 112, second paragraph. We, therefore, affirm
the Examiner’s indefiniteness rejection as to claim 1. Based on their
dependency from claim 1, we also affirm the Examiner’s indefiniteness
rejections of claims 3, 13, and 14.
INDEFINITENESS—CLAIM 4
In rejecting claim 4 for indefiniteness, the Examiner determines that
the claim is vague and confusing “in the recitation of four Bacteriovorax
strains and three accession numbers, without an indication as to which strain
of Bacteriovorax corresponds to which accession number.” Final Act. 8.
In addition, the Examiner contends, “the depository for which the
‘accession number’ is provided is not indicated. Upon searching it was
determined that the numbers AF084854, AF084855 and AF084859 pertain
to partial sequences of 16S ribosomal RNA gene, rather than a deposit
designation for previously recited Bacteriovorax. These recitations render
the claim confusing.” Id.
Appellants contend that the Examiner erred in rejecting claim 4 as
indefinite, for a number of reasons. Appeal Br. 13–15; Reply Br. 12–14.
Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion of indefiniteness as to claim 4.
Claim 4 recites, in relevant part, “[t]he method of claim 1 wherein the
Bacteriovorax comprises Bacteriovorax Phylotype III, Bacteriovorax
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Phylotype V, Bacteriovorax Phylotype IX, Bacteriovorax Phylotype X,
accession numbers AF084854, AF084855 and AF084859.” Appeal Br. 43.
Because it may plausibly be interpreted in at least two ways, we agree
with the Examiner that claim 4 is indefinite under § 112, second paragraph.
See Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential)
(“[I]f a claim is amenable to two or more plausible claim constructions, the
USPTO is justified in requiring the applicant to more precisely define the
metes and bounds of the claimed invention by holding the claim
unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.”).
First, because of the presence of the word “and” between the last two
members of the list of administered Bacteriovorax types (see id.
(“AF084855 and AF084859”)(emphasis added)), claim 4 may reasonably be
interpreted as requiring the administration of all seven types of
Bacteriovorax listed.
Second, the accession numbers may reasonably be interpreted as
corresponding to the Bacteriovorax Phylotypes appearing previously in the
list in claim 4. This second interpretation is itself ambiguous because, as the
Examiner notes, four Bacteriovorax Phylotypes are listed, but only three
accession numbers are present in the claim.
Accordingly, given the ambiguity in the language at issue in claim 4,
we conclude that a preponderance of the evidence supports the Examiner’s
determination that claim 4 is indefinite under § 112, second paragraph.
Appellants’ arguments do not persuade us to the contrary.
Appellants contend that the Examiner failed to meet the burden
required to make a prima facie case against claim 4. Appeal Br. 13–14;
Reply Br. 12–13. We first note that the instant ground of rejection is for
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indefiniteness, which is based on a different provision of the statute (§ 112,
second paragraph) than enablement (§ 112, first paragraph). In the present
case, as seen above, the Examiner identified the language considered to be
indefinite, and provided an explanation why the language does not comply
with § 112, second paragraph.
Appellants contend that they “believe that the Examiner has erred
since one of ordinary skill in the art would easily recognize the strain
designations.” Appeal Br. 14; Reply Br. 13. Appellants, however, do not
direct us to any evidence supporting that assertion. Appellants’ unsupported
assertion, therefore, is not persuasive of Examiner error. See In re Geisler,
116 F.3d 1465, 1471 (Fed. Cir. 1997) (unsupported attorney argument is not
an adequate substitute for evidence).
Lastly, we acknowledge, as Appellants contend (Appeal Br. 14–15;
Reply Br. 13–14), that the language at issue in claim 4 includes the
transitional term “comprises” (Appeal Br. 43). As discussed above,
however, the indefiniteness of claim 4 is not based on the transitional term
used, but rather in the ambiguous way the accession numbers are recited in
the claim.
In sum, for the reasons discussed, we affirm the Examiner’s rejection
of claim 4 under § 112, second paragraph, for indefiniteness.
INDEFINITENESS—CLAIM 15
In rejecting claim 15 for indefiniteness, the Examiner determines that
claim 15 is vague and confusing “in the recitation of providing ‘prophylactic
support’ in an infected host, since ‘prophylactic’ refers to prevention. After
infection, there is no more prevention, i.e., prevention has stopped.” Final
Act. 8.
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Appellants contend that the use of the term “prophylactic” is
consistent with administration of the claimed Bacteriovorax/bacteriophage
combination to an infected host. Appeal Br. 15; Reply Br. 14.
Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion of indefiniteness as to claim
15.
Claim 15 recites “[a] method to decrease, treat or provide
prophylactic support to a Bacteriovorax Gram negative prey bacterial
infection comprising” a number of infecting organisms. Appeal Br. 45
(emphasis added).
Claim 15 requires “contacting said Bacteriovorax Gram negative prey
bacterial infection with a composition comprising a Bacteriovorax and a
bacteriophage equal ratio combination.” Id. at 46. Claim 15 also requires
that “the Gram negative prey bacteria was reduced by from about 1.0 logs to
about 5.0 logs.” Id.
Because claim 15 requires contacting an infection and producing a
reduction in bacterial population from about 1.0 to 5.0 logs, we agree with
the Examiner that the claimed process requires administering the treating
agent to an infected host.
In contrast, the Specification states that “‘[p]rophylactic treatment[,]’
‘prophylactic effects[,]’ ‘prophylactic support’ or ‘prophylaxis’ as used
herein, means measures to protect a person from symptoms or conditions of
a disease to which he or she has been, or may be expressed.” Spec. ¶ 38
(emphasis added).
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One condition of an infective disease is the invasion of a host by the
causative organism. Because “prophylactic support” as defined in the
Specification protects a person from conditions of a disease, i.e., protects the
host from being invaded by the infecting organism, we agree with the
Examiner that “prophylactic support,” as defined in the Specification, does
not encompass administering the treating agent to an already-infected host.
Because claim 15’s recitation of providing “prophylactic support” to
an already-infected host is inconsistent with the Specification’s definition of
providing “prophylactic support,” we agree with the Examiner that claim 15
is unclear and ambiguous, and therefore indefinite under § 112, second
paragraph.
Appellants do not persuade us to the contrary.
Although Appellants provide a number of unsupported alternative
meanings for “prophylactic” (see Appeal Br. 15; Reply Br.14) the definition
provided in the Specification is controlling. See Renishaw PLC v. Marposs
Societa’ per Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998) (In “the situation
in which a patent applicant has elected to be a lexicographer by providing an
explicit definition in the specification for a claim term . . . , the definition
selected by the patent applicant controls.”). In the instant case, Appellants
do not explain persuasively how or why the Examiner’s interpretation of
“prophylactic support” is inconsistent with the definition in the
Specification.
In sum, for the reasons discussed, we affirm the Examiner’s rejection
of claim 15 under § 112, second paragraph, for indefiniteness.
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INDEFINITENESS—CLAIM 16
In rejecting claim 16 for indefiniteness, the Examiner determines that
claim 16 is vague and confusing “in the recitation of an infection that ‘may
comprise’ various and assorted bacteria to be treated simultaneously with a
large number of assorted Bacteriovorax strains and a large number of
assorted bacteriophage strains in an ‘equal ratio combination in and amount
sufficient to . . . ’.” Final Act. 8.
The Examiner states:
The phrase “may comprise[“] does not constitute a positive
limitation of the claim. It is unclear what is intended to be
encompassed, since the circumstances are not set forth with any
particularity. The phrase “may comprise” does not set forth
with any particularity what the claimed invention is intended to
encompass, since it lacks a positive recitation and is open to
interpretation.
Id.
Appellants acknowledge that claim 16 has been amended to include
the transitional phrase “may comprise.” Appeal Br. 15; Reply Br. 14.
Appellants contend, however, that the “transitional term ‘comprising’, which
is synonymous with ‘including,’ ‘containing,’ or ‘characterized by,’ is
inclusive or open-ended and does not exclude additional, unrecited elements
or method steps.” Appeal Br. 14 (citing Mars Inc. v. H.J. Heinz Co., 377
F.3d 1369, 1376 (Fed. Cir. 2004); Reply Br. 13.
Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion of indefiniteness as to claim
16.
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We acknowledge the conventional meaning of the transitional term
“comprising.” Claim 16, however, uses a very different term: “may
comprise.” Appeal Br. 46 (emphasis added).
In contrast to the term “comprises,” which requires the recited
elements, but is open to unrecited elements, the term “may comprise” does
not require the recited elements to be used in the claimed process. Despite
the fact that “may comprise” does not require any additional elements, claim
16 includes lists of those elements (Bacteriovorax and bacteriophages) that
may be used in the claimed process.
Because claim 16, therefore, is unclear and ambiguous as to whether
the recited Bacteriovorax types and bacteriophages are required in the
claimed process, we agree with the Examiner that claim 16 is indefinite.
Accordingly, we affirm the Examiner’s rejection of claim 16 under § 112,
second paragraph.
WRITTEN DESCRIPTION
In rejecting claims 4, 15, and 16 under 35 U.S.C. § 112, first
paragraph, for failure to comply with the written description requirement,
the Examiner determined that a number of recitations in the rejected claims
lacked support in the Specification. Final Act. 5–6.
As an initial matter, we note the Examiner’s determination that “[n]o
basis or support is found in the present specification for a method wherein
the infection is caused by a non-sterile medical device, medical equipment
or an implant with regard to at least Vibrio vulnificus and/or Vibrio
parahaemolyticus.” Final Act. 5. None of the claims subject to this ground
of rejection recite a non-sterile medical device, medical equipment or an
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implant, however. Therefore, it is unclear which claims the Examiner
intends to reject in this regard.
In any event, to determine whether particular claim elements are
supported by the Specification, we must compare the claim elements at issue
to the portions of the Specification cited in support of those elements. As to
claims 4 and 16, however, we find, for the reasons discussed above in
relation to § 112, second paragraph, that the scope of the claimed subject
matter is so uncertain that we cannot meaningfully perform the required
comparison. See In re Steele, 305 F.2d 859, 863 (CCPA 1962) (obviousness
rejection of indefinite claim reversed where claim interpretation required
resort to “unsupported speculative assumptions” as to scope of claimed
subject matter).
Because review of the merits of the appealed written description
rejections of claims 4 and 16 would require resort to unsupported speculative
assumptions as to the scope of the claimed subject matter, we reverse the
written description rejections of claims 4 and 16 pro forma. See Ex parte
Miyazaki, 89 USPQ2d at 1217 (precedential) (reversing rejections pro forma
under In re Steele when consideration of merits of rejections requires
“speculative assumption as to the meaning of the claims”).
As to claim 15, we agree with the Examiner that the recited
prophylactic treatment of an already-infected host renders the claim unclear,
for the reasons discussed above. Claim 15, however, recites alternative
non-indefinite embodiments in which a bacterial infection is decreased or
treated by administering a combination of Bacteriovorax and bacteriophage.
Appeal Br. 45–46. We, therefore, address the Examiner’s written
description rejection of claim 15 on the merits.
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As to claim 15, the Examiner states as follows:
No basis or support is found in the present specification
for a method wherein the infection comprises various and
assorted bacteria [treated] with unidentified Bacteriovorax and
various and asserted unidentified bacteriophages in an “equal
ratio combination in and amount sufficient to ...”. Such
amounts are not disclosed in the present record, and wherein
“the Gram negative prey bacteria was reduced” in the required
amounts as in claim 15.
Final Act. 5.
Appellants contend, for a number reasons, that the Specification
supports the methods recited in claim 15. See Appeal Br. 7–9; Reply Br. 6–
9.
Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, we conclude that a preponderance of the
evidence supports the Examiner’s determination that claim 15 fails to
comply with the written description requirement.
Claim 15 recites “[a] method to decrease, treat or provide prophylactic
support to a Bacteriovorax Gram negative prey bacterial infection
comprising Acinetobacter calcoaceticus, Aeromonas hydrophila,
Enterobacter aerogenes, Escherichia coli ML-35, Vibrio cholerae 01, Vibrio
strain CMP6, Vibrio vulnificus M06, and Vibrio parahaemolyticus strain P5
. . . .” Appeal Br. 45 (emphasis added).
Because of the presence of the word “and” between the last two
organisms listed, the treated infection must include all of the organisms
recited in the list. Claim 15, therefore, is consistent with the Examiner’s
determination that the claimed method encompasses “treat[ing] a
super-infection with a large number of pathogens.” Ans. 4.
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Although Appellants contend that the Specification supports treating
infections with various combinations of Bacteriovorax and bacteriophage in
equal amounts (Appeal Br. 7–9; Reply Br. 6–9), Appellants do not explain
with any particularity how or why the Specification provides support for
treating an infection composed of the specific combination of organisms
recited in claim 15.
We acknowledge the Specification’s disclosure that the infecting
organisms recited in claim 15 are prey bacteria to Bacteriovorax. See Spec.
¶ 6. Nonetheless, because Appellants do not identify, nor do we discern, a
specific disclosure in the Specification of treating an infection composed of
all of the infecting organisms recited in claim 15, we agree with the
Examiner that claim 15 lacks descriptive support.
Moreover, it is insufficient for the purposes of the written description
requirement that Specification might make it obvious to treat an infection
composed of all of the infecting organisms recited in claim 15. See Ariad
Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir.
2010) (“[A] description that merely renders the invention obvious does not
satisfy the requirement.”).
In sum, for the reasons discussed, we find that a preponderance of the
evidence supports the Examiner’s written description rejection as to claim
15. We, therefore, affirm the Examiner’s rejection.
ENABLEMENT
In rejecting claims 4, 15, and 16 under 35 U.S.C. § 112, first
paragraph, for failure to comply with the enablement requirement, the
Examiner states:
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The invention appears to employ . . . specific strains of
Gram-negative bacteria, Bacteriovorax and bacteriophages. It
is not clear if the written description is sufficiently repeatable to
avoid the need for a deposit. Further it is unclear if the starting
materials were readily available to the public at the time of
invention.
Final Act. 10. The Examiner then explains how Appellants may comply
with the requirements for depositing biological material, and thereby comply
with the enablement requirement as to the claimed microbial strains. Id. at
10–11.
Appellants contend, for a number reasons, that the Specification
enables the claimed methods by describing how the claimed microbial
strains may be obtained. See Appeal Br. 7–9; Reply Br. 6–9.
As to claims 4 and 16, because of the ambiguities in the claim
language discussed above, we conclude that a review of the merits of the
Examiner’s enablement rejection would require resort to unsupported
speculative assumptions as to the scope of the claimed subject matter. We,
therefore, reverse the Examiner’s enablement rejections of claims 4 and 16
pro forma. See Ex parte Miyazaki, 89 USPQ2d at 1217 (precedential)
(reversing rejections pro forma under In re Steele when consideration of
merits of rejections requires “speculative assumption as to the meaning of
the claims”).
Claim 15, however, in addition to unclear and ambiguous
embodiments, recites alternative non-indefinite embodiments in which a
bacterial infection is decreased or treated by administering a combination of
Bacteriovorax and bacteriophage, as discussed above. We conclude,
therefore, that the ambiguities in claim 15 do not foreclose meaningful
review of those non-indefinite embodiments.
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Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, we conclude that a preponderance of the
evidence supports the Examiner’s determination that claim 15 fails to
comply with the written description requirement.
Claim 15 recites “[a] method to decrease, treat or provide prophylactic
support to a Bacteriovorax Gram negative prey bacterial infection
comprising Acinetobacter calcoaceticus, Aeromonas hydrophila,
Enterobacter aerogenes, Escherichia coli ML-35, Vibrio cholerae 01,
Vibrio strain CMP6, Vibrio vulnificus M06, and Vibrio parahaemolyticus
strain P5.” Appeal Br. 45 (emphasis added).
Thus, in addition to the other bacteria required to be present in the
claimed infection, claim 15 requires five specific strains of bacteria: E. coli
ML-35, V. cholerae 01, Vibrio strain CMP6, V. vulnificus M06, and V.
parahaemolyticus strain P5. In order to practice the claimed process, one
must determine whether an infection includes these specific strains.
Appellants contend that Examples 1 and 2 of the Specification
describe “in detail the preparation and maintenance of the prey bacterial
Vibrio vulnificus and other similar prey suspensions which are well known
in the art. The instant application is easily and reasonabl[y] described by the
written word alone and does not require the deposit of biological materials.”
Appeal Br. 19; Reply Br. 17.
We are not persuaded.
Having reviewed Examples 1 and 2 in the Specification, the sole
reference therein to any of the specific strains recited in claim 15 states that
“Vibrio parahaemolyticus P-5 were grown on Sea Water Yeast Extract Agar
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(SWYE: 10 g/L Peptone, 3 g/L Yeast Extract, 15 g/L agar) (Kaneko and
Colwell, 1973) at 30°C.” Spec. ¶ 76 (Example 1).
Although this disclosure suggests that the claimed V.
parahaemolyticus strain P5 might have been known in the art, neither
Appellants nor the Specification identify the reference cited in the quoted
passage. Nor do Appellants identify any evidence, in the Specification, prior
art, or elsewhere in the record, supporting Appellants’ contention that E. coli
ML-35, V. cholerae 01, Vibrio strain CMP6, V. vulnificus M06, and V.
parahaemolyticus strain P5 were known or identifiable strains of bacteria
that could be readily obtained by the public, absent a deposit of the strains.
Because a preponderance of the evidence, therefore, supports the
Examiner’s conclusion that claim 15 does not comply with the enablement
requirement, we affirm the Examiner’s enablement rejection as to claim 15.
OBVIOUSNESS
In rejecting claims 1, 3, and 13–16 over Chen, Sockett, Hanlon, and
Debarbieux, the Examiner summarizes the obviousness rationale as follows:
[I]t would have been obvious to one having ordinary skill in the
art at the time the claimed invention was made to modify the
process of Chen [et al.] of administering Bacteriovorax to
Vibrio species by combining Bacteriovorax and bacteriophages
as suggested by Sockett et al. (2004), Hanlon et al. (2007) and
Debarbieux et al. (2010) for the expected benefit of
successfully treating, decreasing or providing prophylaxis
support to recalcitrant Vibrio vulnificus, Vibrio
parahaemolyticus, Aeromonas and other Gram negative
bacterial infections in hosts such as humans and in particular, to
treat infections, including biofilms in medical devices, such as
implants, particularly due to the pervasive resistance of Gram
negative bacteria to known antibiotics.
Final Act. 14–15.
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Appellants contend, for a number reasons, that the Examiner did not
establish a prima facie case of obviousness as to the rejected claims. See
Appeal Br. 21–40; Reply Br. 19–37.
As to claims 1, 3, 13, 14, and 16, because of the ambiguities in the
claim language discussed above, we conclude that a review of the merits of
the Examiner’s obviousness rejection would require resort to unsupported
speculative assumptions as to the scope of the claimed subject matter. We,
therefore, reverse the Examiner’s obviousness rejection of claims 1, 3, 13,
14, and 16 pro forma. See Ex parte Miyazaki, 89 USPQ2d at 1217
(precedential).
Claim 15, however, in addition to unclear and ambiguous
embodiments, recites alternative non-indefinite embodiments in which a
bacterial infection is decreased or treated by administering a combination of
Bacteriovorax and bacteriophage, as discussed above. We conclude,
therefore, that the ambiguities in claim 15 do not foreclose meaningful
review of those non-indefinite embodiments.
It is well settled that “the Examiner bears the burden of establishing a
prima facie case of obviousness based upon the prior art.” In re Fritch, 972
F.2d 1260, 1265 (Fed. Cir. 1992).
It is also well settled that “obviousness requires a suggestion of all
limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Having carefully considered the arguments and evidence advanced by
both Appellants and the Examiner, Appellants persuade us that the Examiner
has not established a prima facie case of obviousness as to claim 15.
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Claim 15 requires contacting the recited infection “with a composition
comprising a Bacteriovorax and a bacteriophage equal ratio combination.”
Appeal Br. 46 (emphasis added).
Appellants contend, among other things, that “none of the combined
references teach the limitation of combining the BALO and bacteriophage in
the ratios claimed by the Appellants. Further, none of the references alone
nor in combination teach the limitation of a BALO and bacteriophage in
combination and in equal ratios.” Appeal Br. 35–36; Reply Br. 32–33
(repeating identical argument).
The Examiner, in response, does not explain with any specificity why
it would have been obvious to contact an infection with a composition
comprising an equal ratio of Bacteriovorax and a bacteriophage. See Ans.
7–11 (section entitled “Response to Argument regarding the rejection under
pre-AIA 35 U.S.C. 103(a)”).
Nor does the Examiner’s statement of the rejection explain, or provide
evidence supporting an explanation, why it would have been obvious to
contact an infection with a composition comprising an equal ratio of
Bacteriovorax and a bacteriophage. See Final Act. 12–15.
Because the Examiner, therefore, does not address all of the
limitations in claim 15, Appellants persuade us that the Examiner has not
made out a prima facie case of obviousness as to claim 15. Accordingly, we
reverse the Examiner’s rejection of claim 15 under § 103(a).
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1, 3, 4, and 13–16 under 35 U.S.C. § 112, second paragraph, for
indefiniteness.
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For the reasons discussed, we reverse pro forma the Examiner’s
rejection of claims 4 and 16 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
For the reasons discussed, affirm the Examiner’s rejection of claim 15
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
For the reasons discussed, we reverse pro forma the Examiner’s
rejection of claims 4 and 16 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the enablement requirement.
For the reasons discussed, affirm the Examiner’s rejection of claim 15
under 35 U.S.C. § 112, first paragraph, as failing to comply with the
enablement requirement.
For the reasons discussed, we reverse pro forma the Examiner’s
rejection of claims 1, 3, 13, 14, and 16 under 35 U.S.C. § 103(a) for
obviousness over Chen, Sockett, Hanlon, and Debarbieux.
For the reasons discussed, we reverse, on the merits, the Examiner’s
rejection of claim 15 under 35 U.S.C. § 103(a) for obviousness over Chen,
Sockett, Hanlon, and Debarbieux.

TIME PERIOD
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