TAKARA BIO USA, INC.

Patent Trials and Appeals Board

Dec 9, 2021

2021000534 (P.T.A.B. Dec. 9, 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.
15/917,384 03/09/2018 Victor Joseph CLON-144DIVCON2 5023
93726 7590 12/09/2021
EPA - BOZICEVIC FIELD & FRANCIS LLP
BOZICEVIC, FIELD & FRANCIS
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
BOYER, RANDY
ART UNIT PAPER NUMBER
1771
NOTIFICATION DATE DELIVERY MODE
12/09/2021 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VICTOR JOSEPH, AMJAD HUDA, and ALNOOR SHIVJI
Appeal 2021-000534
Application 15/917,384
Technology Center 1700
Before TERRY J. OWENS, JENNIFER R. GUPTA, and
SHELDON M. McGEE, Administrative Patent Judges.
OWENS, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 58–77. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. The
Appellant identifies the real party in interest as Takara Bio USA, Inc.
(Appeal Br. 3).
Appeal 2021-000534
Application 15/917,384

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CLAIMED SUBJECT MATTER
The claims are directed to a chip comprising physically isolated
nanowells. Claim 58, reproduced below, is illustrative of the claimed subject
matter:
58. A chip comprising from 1,000 to 200,000 physically
isolated nanowells such that the passage of liquid between the
nanowells is restricted, wherein one or more of the nanowells
comprises one or more dried assay reagents coated on an inner
surface thereof.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Knapp US 6,235,471 B1 May 22, 2001
Corn US 6,489,102 B2 Dec. 3, 2002
Ishida US 2004/0029152 A1 Feb. 12, 2004
REJECTIONS
The claims stand rejected as follows: 1) claims 58–73 under
35 U.S.C. § 102(b) over Knapp; 2) claims 74–76 under 35 U.S.C. § 103(a)
over Knapp; and 3) claim 77 under 35 U.S.C. § 103(a) over Knapp in view
of Corn and Ishida.
OPINION
Rejection under 35 U.S.C. § 102(b)
“Anticipation requires that every limitation of the claim in issue be
disclosed, either expressly or under principles of inherency, in a single prior
art reference.” Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868
F.2d 1251, 1255–56 (Fed. Cir. 1989).

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Application 15/917,384

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Claim 58
Knapp discloses a chip such as a small microtiter plate having
hundreds or thousands of wells (1,000/cm2 or more) that can comprise dried
assay reagents coating their inner surfaces (col. 37, ll. 8–10, 16–25, 32–38,
53–54, 66–67).
The Appellant argues that the thousands of wells in Knapp’s
column 37 embodiment are fluidly connected to one another (Appeal Br. 7,
11).
Knapp discloses that the dried samples in the microtiter plate wells
preferably are suspended in an aqueous solution, selected by an
electropipettor, and transferred by the electropipettor to a microfluidic
substrate (col. 37, ll. 50–62, 66–67). The microtiter plate’s wells selected for
transfer by the electropipettor are isolated, not fluidly connected.
The Appellant argues that “while discussing the FIG. 14 embodiment,
Knapp is silent regarding any wells located on storage substrate 1455”
(Appeal Br. 8), and that in Knapp’s column 38 embodiment, the samples are
stored on a porous membrane matrix (Appeal Br. 8–10).
Knapp is not limited to Figure 14 or the column 38 embodiment, but,
rather, also includes the above-discussed column 37 microtiter plate
embodiment.
Accordingly, we affirm the rejection of claims 58, 62–64, 71, and 72.2

2 Claims 62–64, 71, and 72 are not separately argued from the independent
claim (58), and therefore stand or fall with that claim (Appeal Br. 4). See
37 C.F.R. § 41.37(c)(1)(iv) (2013).
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Application 15/917,384

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Claims 59–61, 65–70, and 73
The Examiner does not establish that Knapp discloses that the dried
samples in the microtiter plate wells can include an enzyme (claim 59), a
polymerase (claim 60), reverse transcriptase (claim 61), RNA (claim 65), a
probe (claim 66), a detectable label (claims 67 and 68), a fluorescent label
(claim 69), or a binding member (claim 70), or have a volume from 1 nl to
1 µl (claim 73). The Examiner points out, in various parts of Knapp’s
disclosure, the limitations in the Appellant’s claims 59–61, 65–70, and 73
(Final 2–3). The Examiner, however, does not establish that Knapp discloses
a chip that meets the requirements of independent claim 58 and also meets
the requirement of any of its dependent claims 59–61, 65–70, and 73. We
therefore reverse the rejection of those dependent claims as anticipated by
Knapp.
Rejections under 35 U.S.C. § 103(a)
Claim 74
The Appellant argues that “Knapp fails to teach or suggest: (i) that the
chip has a nanowell density ranging from 1 to 1,000 nanowells per mm2, and
(ii) 1,000 to 200,000 nanowells that are physically isolated such that passage
of liquid between the nanowells is restricted” (Appeal Br. 21).
Knapp discloses a chip having a reagent deposit density of 1,000 or
greater per square centimeter (10 or greater per square millimeter), and
discloses that the deposits can be in hundreds or thousands of wells in a
small microtiter plate which, due to being separate wells, have restricted
Appeal 2021-000534
Application 15/917,384

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flow between them (col. 37, ll. 15–25, 35–37).3 Hence, we affirm the
rejection of claim 74).
Claims 75 and 76
Regarding claim 75, the Appellant argues that “[a] skilled artisan
would recognize that the statement of ‘thousands’ by Knapp does not
include numbers above 9,999” (Appeal Br. 21), “since if Knapp meant to
include a number such as 30,000 then Knapp would have also stated ‘tens of
thousands’” (id.). The Appellant makes a similar argument regarding the
claim 76 requirement of 100,000 or more wells (Appeal Br. 22).
Those arguments are not well taken because they are merely
unsupported attorney argument, and arguments of counsel cannot take the
place of evidence. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Claim 77
Claim 77 depends from claim 58 and requires that the chip is
fabricated from a metal or a metal alloy.
Corn discloses “a multi-step chemical modification procedure to
create biomolecule and/or cellular arrays on metal substrates, the arrays
being specifically tailored for the study of biomolecular and cellular
interactions using surface plasmon resonance imaging” (col. 3, ll. 15–19).
The metal substrate is a thin film of noble metal, preferably gold (col. 6,
ll. 13–14).
Ishida performs fluorescence analysis by depositing on a substrate a

3 The Appellant’s Specification states: “A nanowell can be open at the top,
but is physically isolated from other wells to restrict passage of liquids”
(¶ 76).

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film of metal such as gold or silver, forming nanowells in the metal film,
fixing an active group or detecting DNA to the bottom of each nanowell,
hybridizing with the detecting DNA an antigen that is coupled to the active
group or an objective DNA and has a fluorescent reagent bonded thereto,
and exciting the fluorescent reagent with luminescent energy to emit
fluorescence (¶¶ 16, 17).
The Examiner finds that Corn’s fabrication of biomolecular or cellular
arrays on noble metal surfaces (col. 1, ll. 13–17; col. 6, ll. 13–14) is
consistent with Knapp’s systems capable of performing integrated
manipulation and analysis of biological, biochemical, and chemical
experiments such as DNA sequencing (col. 1, ll. 18–24) (Ans. 14).
The Examiner does not establish that the alleged consistency would
have been sufficient to provide one of ordinary skill in the art with an
apparent reason to combine Corn’s noble metal thin film with Knapp’s
wells. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(establishing a prima facie case of obviousness requires an apparent reason
to modify the prior art as proposed by the Examiner).
The Examiner finds that “Ishida notes that ‘[a] metallic nano-well is
[ ] advantageous for improvement of detection efficiency’ (see Ishida,
paragraph [0032])” (Ans. 15) and that “the person having ordinary skill in
the art would have had motivation to modify Knapp to provide for use of a
metal chip, such modification achieving the same detection efficiency noted
by Ishida. Such modification would also be consistent with Knapp’s
disclosure of conductive substrates for the chip material (see Knapp,
column 41, lines 40-43)” (id.).
Ishida discloses:
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The sample enclosed in the metallic nano-well is exposed
to the intensified surface plasmon electromagnetic field and
excited by an energy from the surface plasmon electromagnetic
field. Consequently, the fluorescent sample is excited with
extremely high efficiency, compared with a conventional
exciting process wherein a sample is directly irradiated with
light. [(¶ 31)]
The metallic nano-well is also advantageous for
improvement of detection efficiency. [(¶ 32)]

The portion of Knapp relied upon by the Examiner discloses: “In the
case of conductive or semi-conductive substrates, it is occasionally desirable
to include an insulating layer on the substrate.” (col. 41, ll. 42–44). The
substrate is a microfluidic substrate (col. 41, l. 31).
The Examiner does not establish that Knapp’s disclosure of a
conductive microfluidic substrate and Ishida’s disclosure that nanowells in a
film of gold or silver are advantageous for improving detection efficiency
when a fluorescent sample is excited by energy from a surface plasmon
electromagnetic field would have provided one of ordinary skill in the art
with an apparent reason to make a chip that is fabricated from metal or metal
alloy and meets the requirements of the Appellant’s independent claim 58.
See KSR, 550 U.S. at 418.
Thus, the record indicates that the Examiner’s rejection of claim 77 is
based upon impermissible hindsight in view of the Appellant’s disclosure.
See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (“A rejection based on
section 103 clearly must rest on a factual basis, and these facts must be
interpreted without hindsight reconstruction of the invention from the prior
art”). Accordingly, we reverse that rejection.
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CONCLUSION
The Examiner’s rejections are affirmed in part.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
58–73 102(b) Knapp 58, 62–64,
71, 72
59–61, 65–
70, 73

74–76 103(a) Knapp 74–76
77 103(a) Knapp, Corn,
Ishida
77
Overall
Outcome
58, 62–64,
71, 72, 74–
76
59–61, 65–
70, 73, 77
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