Xcellence in Bio Innovations and TechnologieS Pvt. Ltd.

Patent Trials and Appeals Board

Nov 1, 2021

2021001097 (P.T.A.B. Nov. 1, 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.
15/746,424 01/21/2018 Suman Kapur Kapur_1 6141
127270 7590 11/01/2021
Rattan Nath
1417 Pleasant Valley Way
West Orange, NJ 07052
EXAMINER
DAVIS, RUTH A
ART UNIT PAPER NUMBER
1699
MAIL DATE DELIVERY MODE
11/01/2021 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 SUMAN KAPUR1
Appeal 2021-001097
Application 15/746,424
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a kit
for detecting microbiological pathogens, which have been rejected as
indefinite and anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.
STATEMENT OF THE CASE
Claims 18 and 19 are on appeal and are reproduced below:
18. A kit for detection and separation of microbiological
pathogens present in a biological sample comprising:

1 Appellant identifies the real party in interest as Xcellence in Bio
Innovations and TechnologieS Pvt. Ltd.. Appeal Br. 2. “Appellant” refers to
“applicant” as defined in 37 C.F.R. § 1.42.
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at least one container that is used for collecting the
biological sample;
at least one vial containing culture growth media;
one or more multi-well strips wherein at least one well is
pre-loaded with an antibiotic and at least one well is a reference
well, wherein the reference well does not contain any antibiotic;
at least one vial containing sterile water; and
a needle,
a syringe;
a cap; and
at least one filter for filtering out bacteria from a
clinical or biological sample.

19. The kit of claim 18 further comprising a specific
provided reference having specific chromogenic endpoints to
identify and quantify bacteria.

The claims stand rejected as follows:
Claim 19 under 35 U.S.C. § 112(b) as indefinite (Final Action2 2) and
Claims 18 and 19 under 35 U.S.C. §§ 102(a)(1) and 102(a)(2) as
anticipated by Trainor3 (Final Action 4).
OPINION
Indefiniteness
Claim 19 stands rejected on the basis that “the phrases ‘specific
provided reference’ and ‘specific chromogenic endpoints’ render the claim
indefinite because the phrases are not adequately defined by the claim
language or specification.” Final Action 2–3. The Examiner also states that

2 Office Action mailed Dec. 26, 2019.
3 US 2003/0138874 A1, published July 24, 2003.
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“[f]or purposes of examination, the claim is interpreted to be drawn to a
control for comparison, to include paper images, reference charts and the
like.” Id. at 3.
We affirm this rejection because, although we do not agree with the
Examiner that the phrase “specific chromogenic endpoints” is indefinite, we
do agree that the meaning of “specific provided reference” is unclear even
when that phrase is read in light of the Specification.
With respect to “specific chromogenic endpoints,” the Specification
describes an embodiment of the claimed kit that includes a “strip Pi [that] is
functionalized to identify the five most prevalent UTI_causing pathogens.”
Spec. ¶ 23. The Specification states that “[t]he strip contains a propriety mix
of reagents which when mixed with the BITGEN [growth] media result in
specific chromogenic endpoints in the presence of specific bacterial
species.” Id. ¶ 24 (emphasis in original). Thus, the Specification makes it
reasonably clear that the phrase “specific chromogenic endpoints” refers to a
specific range of color values that indicate the presence of particular
bacterial species.
With respect to the phrase “specific provided reference,” however, the
Specification provides no such clarity. The Specification, in fact, does not
appear to use this phrase; at least, Appellant has not pointed to any use of the
phrase in the Specification, and we have not located one. The Examiner
interpreted the phrase, “[f]or purposes of examination,” to mean “a control
for comparison, to include paper images, reference charts and the like.”
Final Action 3. That indeed is one plausible interpretation, but not the only
one. The phrase could also refer to a reference sample of a specific pathogen
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for comparison with the results produced by the assayed sample. Or it could
refer to something else; the Specification simply provides no direction
regarding the meaning of the phrase “specific provided reference.”
“[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.” Ex
parte Miyazaki, 2008 WL 5105055, at *5 (BPAI 2008) (precedential). See
also In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014) (“[C]laims are
required to be cast in clear—as opposed to ambiguous, vague, indefinite—
terms. It is the claims that notify the public of what is within the protections
of the patent, and what is not.”).
Appellant argues that “the Examiner and the Applicant agreed on the
same meaning for ‘specific provided reference’ and ‘specific chromogenic
endpoints’ as understood by a person having ordinary skill in the art” and
“there really is not a basis to continue to dispute it as if such an
understanding is impossible.” Appeal Br. 6.
We disagree with Appellant’s reasoning. As the Examiner noted, “an
examiner[’s] interpretation of the claim for purposes of search does not
constitute an implicit agreement on what is regarded as the invention, a
clearly defined phrase, or a clear scope for what is included or excluded
from the claimed subject matter.” Ans. 6. Rather, the Examiner’s tentative
interpretation is simply a guess at what the indefinite claim language might
mean, for the purpose of searching the prior art. “It is the applicants’ burden
to precisely define the invention, not the PTO’s. See 35 U.S.C. § 112, ¶ 2.
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. . . [T]his section puts the burden of precise claim drafting squarely on the
applicant.” In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997).
Appellant also argues that “the specification as filed provides at
11:14–17 and at 17:3–6 that the endpoints are encoded into the software—
which meets the ‘provided’ aspect of the terms highlighted by the
Examiner.” Reply Br. 2.
As we understand it, Appellant’s citations to the Specification refer to
paragraphs 24 and 41. The Specification’s paragraph 24, quoted above at
page 3, refers to a strip that contains reagents that result in “specific
chromogenic endpoints in the presence of specific bacterial species,” but
does not refer to a “specific provided reference.” Paragraph 41 reads: “Based
on the preset ratio of any given well with the reference well, the programme
calculates whether the given sample is sensitive or resistant to the antibiotic
in the well on the basis of frequency recorded as a data point per well.”
Again, paragraph 41 does not refer to a “specific provided reference.”
Appellant’s argument based on these passages in the Specification is
therefore unpersuasive.
Appellant also cites two references that are said to “reveal what is
known to one having ordinary skill in the art.” Reply Br. 3. However, the
cited references do not appear to be part of the record and we have not
considered them. See 37 C.F.R. § 41.41(b)(1) (“A reply brief shall not
include . . . any new or non-admitted affidavit or other Evidence.”).
Finally, Appellant argues that the Examiner provided “no evidence
. . . even in response to Applicant arguments that this was routine
knowledge.” Reply Br. 3. (As we understand it, “this” in the quoted sentence
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refers to what was stated in the references that were newly cited in the Reply
Brief.)
We will not consider this argument, because Appellant did not
previously argue that the Examiner had not provided evidence to support the
rejection. Rather, in the Appeal Brief, Appellant simply argued that they and
the Examiner agreed on the interpretation of claim 19, which the Examiner
disputed.
For the reasons discussed above, we affirm the rejection of claim 19
under 35 U.S.C. § 112(b).
Anticipation
Claims 18 and 19 stand rejected as anticipated by Taintor. The
Examiner finds that Taintor discloses a kit comprising, among other things,
“a multi-chamber plate (multi well strip), susceptibility media (at least one
vial containing growth media) . . . , [and] disk dilution filters (wells having
preloaded antibiotics, negative controls, or those that do not contain
antibiotics, filters).” Final Action 4. The Examiner reasons that, “[a]lthough
the reference does not teach the intended uses of each component as
claimed, these limitation are regarded as intended use limitations of the kit,”
and “the intended use fails to create a structural difference, thus, the
intended use is not limiting.” Id.
Appellant argues that “[a] person having ordinary skill in the art will
not read the claim to indicate the use of a cigarette filter, or a filter that kills
bacteria, but instead a filter suitable for ‘filtering out bacteria from a clinical
or biological sample.’” Appeal Br. 4. Appellant argues that “the so called
intended use does provide a patentably distinct description in the pending
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claim . . . a bacteria-killing AST filter disc cannot be held to be the same as
. . . a filter to filter out bacteria for culturing.” Id. at 5. Appellant argues that
“Taintor does not describe a filter that filters out bacteria.” Reply Br. 4.
We agree with Appellant that the Examiner has not shown that
Taintor discloses a kit that includes a “filter for filtering out bacteria from a
clinical or biological sample,” as recited in claim 18. “Under 35 U.S.C.
§ 102, every limitation of a claim must identically appear in a single prior art
reference for it to anticipate the claim.” Gechter v. Davidson, 116 F.3d 1454,
1457 (Fed. Cir. 1997). See also In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992) (“[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.”).
Taintor discloses a “kit [that] relates to the ID of microorganisms and
concurrent or consecutive determination of antimicrobial susceptibilities
(AST).” Taintor ¶ 26. “The Kit employs a disposable multi-chambered plate
with . . . media in addition to AST medium. Broth medium is provided for
growing up the microorganisms for eventual dilutions and inoculation onto
the kit plate. AST disk-quarters are included as well.” Id. ¶ 27.
Taintor states that “[t]here are a number of different ways of doing
antimicrobial susceptibility testing (AST). Two of them are disk diffusion
and micro dilution.” Id. ¶ 17. Taintor states that the disk diffusion test
involves using an “AST disk” or an “antibiotic-impregnated AST disk,” and
that “antimicrobial disk-quarters” can be made by “[q]uartering Standard
Kirby-Bauer AST disks using a plastic jig and a razor blade.” Id. ¶¶ 20–21,
187. Taintor also states that “the basic principle of the disk diffusion method
of AST testing [is that] . . . the antibiotic-impregnated AST disk 124 is
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exposed to the moist agar surface, water is absorbed into the filter paper and
the antibiotic 128 diffuses into the surrounding medium” inhibits the growth
of antibiotic-susceptible bacteria. Id. ¶ 21. Taintor does not, however,
provide any further description AST disks.
We conclude that the Examiner has not shown, by a preponderance of
the evidence, that the AST disks disclosed by Taintor meet claim 18’s
limitation of a “filter for filtering out bacteria from a clinical or biological
sample.” Consistent with the claim language, the Specification describes the
disclosed kit as including “a filter for harvesting pathogens from [a] fluid
sample.” Spec. ¶ 16. Thus, under the broadest reasonable interpretation, the
claim language requires a filter capable of separating (“filtering out” or
“harvesting”) bacteria from a biological sample.
The Examiner reasons that the “kit disclosed by Taintor includes a
filter paper disk. While it may not teach the filter paper disk is for filtering
bacteria, it is noted that this limitation is a recited intended use of the filter.”
Final Action 5. The Examiner concludes that “[t]he recited intended use fails
to create a structural difference between the claimed filter and the filter of
the prior art.” Ans. 8.
The Examiner, however, did not point to evidence showing that the
AST disks disclosed by Taintor are capable of separating bacteria from a
biological sample. Nor did the Examiner identify any supporting evidence
showing that the filters of Taintor would inherently or necessarily function
to concentrate bacteria for improved assay sensitivity, to select particular
bacterial species based on pore size, or to otherwise function in a filtering
capacity. Thus, the Examiner did not meet the initial burden of showing that
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the filters disclosed by Taintor are capable of “filtering out bacteria from a
clinical or biological sample,” as required by claim 18. In other words, the
Examiner did not show that Taintor’s filters have the structure required to be
used as recited in claim 18.
We therefore reverse the rejection of claims 18 and 19 under 35
U.S.C. §§ 102(a)(1) and 102(a)(2) based on Taintor.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
19 112(b) Indefiniteness 19
18, 19 102(a)(1),
102(a)(2)
Taintor 18, 19
Overall
Outcome
19 18

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED-IN-PART