Noha Elmouelhi et al.

Patent Trials and Appeals Board

Apr 23, 2020

13340405 - (D) (P.T.A.B. Apr. 23, 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.
13/340,405 12/29/2011 Noha Elmouelhi 400342-20001 1340
25570 7590 04/23/2020
Roberts Calderon Safran & Cole, P.C.
7918 Jones Branch Drive
Suite 500
McLean, VA 22102
EXAMINER
BREDEFELD, RACHAEL EVA
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/23/2020 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):
docketing@rcsc-ip.com
lgallaugher@rcsc-ip.com
secretaries@rcsc-ip.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte NOHA ELMOUELHI, KEVIN COOPER,
SRIRAM NATARAJAN, HONG YEE LOW,
ISABEL RODRIGUEZ, and EMMA KIM LUONG-VAN
____________

Appeal 2019-001500
Application 13/340,405
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–8 and 11–21 (Final Act.2 2; Appeal Br. 2).3 We
have jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

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 “Depuy
Synthes Products, LLC” (Appellant’s March 16, 2018 Appeal Brief (Appeal
Br.) 2).
2 Examiner’s June 16, 2017 Final Office Action.
3 Appellant’s pending claims 22–27 and 30–39 stand withdrawn from
consideration (see Final Act. 2; Appeal Br. 2).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to polymer-based structures having
shapes and mechanical properties that optimize adsorption of biologics, e.g.,
proteins” (Spec.4 ¶ 2). Appellant’s claim 1 is reproduced below:
1. A biologic adsorbent structure comprising a polymer
structure comprising a substrate with pillar-like cylindrical
protrusions, said protrusions having dimensions ranging from
about 100 nanometers to about 50 microns, formed by contact
with a shaped surface, said polymer comprising a cyclic
poly(olefin), a non-cyclic polyolefin or blends thereof, wherein
the polymer structure is treated with an oxygen plasma at 50 to
150 watts for 15 to 45 seconds.
(Appeal Br. i.) Appellant’s claims 2–8 and 11–20 depend directly or
indirectly from Appellant’s claim 1. The diagnostic test device of
Appellant’s claim 21 comprises the biologic adsorbent structure of
Appellant’s claim 1.
Grounds of rejection before this Panel for review:
Claims 1, 2, 4–8, 11–18, and 21 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Agrawal5 and Miyauchi.6
Claims 1, 2, 4–8, and 11–21 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Agrawal, Miyauchi, and Ivanov.7
Claims 1–8, 11–18, and 21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Agrawal, Miyauchi and Diaz-
Quijada.8

4 Appellant’s March 19, 2012 Specification.
5 Agrawal et al., US 7,195,872 B2, issued Mar. 27, 2007.
6 Miyauchi et al., US 2005/0095699 A1, published May 5, 2005.
7 Ivanov et al., US 2011/0063610 A1, published Mar. 17, 2011.
8 Diaz-Quijada et al., US 2008/0124246 A1, published May 29, 2008.
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Claims 1, 2, 4–8, 11–18, and 21 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Miyauchi and Agrawal.
Claims 1, 2, 4–8, and 11–21 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Miyauchi, Agrawal, and Ivanov.
Claims 1–8, 11–18, and 21 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Miyauchi, Agrawal, and Diaz-Quijada.
Claims 1, 4–8, and 11–21 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1–4 and 9–25 of Elmouelhi.9
Claims 1–8 and 11–21 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1–4 and 9–25 of Elmouelhi in view of Diaz-
Quijada.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Agrawal relates to
methods of preparing substrates, having a high surface area for
use as a microarray device, that involve forming structural
microfeatures on a surface of the substrate that increase surface
area and accessibility thereto. Further, the textured surface
further comprises microstructures and/or physical surface
features, such as pits, that further contribute to the increased

9 Elmouelhi et al., US 2012/0302465 A1, published Nov. 29, 2012.
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surface area. Compositions directed to the substrates of the
invention are also described.
(Agrawal 1:17–25.)
FF 2. Agrawal discloses that a substrate within the scope of its disclosure
may be a polymer, “such as polystyrene polycarbonate, acrylic, nylon,
polyolefin and silicone” (Agrawal 16:56–60).
FF 3. Agrawal discloses that its structure may comprise a plurality of
microfeatures that “may comprise a pit, a trench, a pillar, a cone, a wall, a
micro-rod, a tube, a channel or a combination thereof,” wherein “[t]he
plurality of microfeatures may have an aspect ratio less than about 10. Each
of the plurality of microfeatures may have a height of about 0.1 to about 100
microns. Each of the plurality of microfeatures may have a cross-section of
about 0.01 to about 500 sq. microns” (Agrawal 4:50–67).
FF 4. Agrawal discloses that “if the microfeatures are etched directly into
the surface of the substrate, then the material of the microfeature is the same
as the material of the substrate” (Agrawal 17:15–17).
FF 5. Agrawal discloses that
embossing is employed to pattern the surface. For example, a
well plate or a micro-well plate, a green ceramic, a glass
composition, or a polymer comprising a thermoplastic or
thermoset polymer, is applied to the surface of the substrate.
The method of applying includes, but is not limited to, a sol-gel
process or a wet chemical process comprising, for example,
spraying, dipping, spinning, meniscus, or depositing. While the
coating is soft, unconsolidated, or green, a tool resembling a
negative microfeature (i.e. the inverse or female of the structure
desired on the surface) is used to emboss the coating employing
methods well known in the art, such as applying pressure and/or
heat or photolithography to set the embossed microfeatures.
The setting step allows permanent capture of the microfeatures
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and is conducive to large volume and cost-effective
manufacturing of the substrates.
(Agrawal 29:20–35.)
FF 6. Agrawal discloses that “surface modification processes are
applicable to any surface, including plastic, metal and glass surfaces” and
“several chemical and radiative methods . . . are well known in the art,”
wherein “[s]urface modification may be performed in those embodiments in
which the surface is desired to be compatible with . . . biological molecules
in order to promote binding” (Agrawal 42:11–17).
FF 7. Agrawal discloses that “[t]he bombardment of the surface with
energetic species[, such as gas plasma,] may result in etching, adhesion
promotion, binding improvements of biological species, surface
functionalization, barrier property modification, or other such alterations in
chemical and/or physical characteristics” and that “[o]ne of ordinary skill in
the art is aware that bombardment processes involve consideration of
parameters such as gas type, treatment power, treatment time and operating
pressure, and the skilled artisan is also aware of methods well known in the
art to determine these parameters for carrying out the process” (Agrawal
42:25–36; see also id. at ll. 52–61 (Agrawal discloses that “oxygen plasma is
demonstrated to be more effective in surface etching” and “may cause a fine
pitting of the structures created by molding, which leads to further increases
in the surface area of the substrate”)).
FF 8. Miyauchi “relates to a functioning substrate or a functional element
equipped with a micro pillar group of organic polymer and to its
manufacturing method” (Miyauchi ¶ 2; see generally Final Act. 7 and 13–
14).

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FF 9. Miyauchi discloses:
To manufacture the film or substrate equipped with a group of
micro pillars of the present invention, a micro mold (a precision
mold) with a concave portion (hereinafter referred to as “pit”)
having specific arrangements formed thereon is pressed against
the thin film made of thermoplastic resin or uncured
thermosetting resin, thereby forming a pattern in conform to the
aforementioned group of pits of the mold.
(Miyauchi ¶ 31; see also ¶ 40 (Miyauchi discloses that “[i]t is easy to form a
micro pillar of a small aspect ratio”); ¶ 106 (Miyauchi discloses a “group of
columnar micro pillars has a height of 3 μm, and micro pillars are arranged
at a cycle of 1 μm (pitch),” wherein “[t]he equivalent diameter of the
columnar micro pillar is 300 nm at the intermediate position in the direction
of height and is 330 nm at the root. Accordingly, the aspect ratio of the
micro pillar is 10”); Final Act. 14.)
FF 10. Miyauchi discloses that the organic material for producing
“columnar micro pillars can be a [high molecular weight] substance selected
from cyclo-olefin polymer, polymethyl methacrylate, polystyrene,
polycarbonate, polyethylene terephthalate (PET), polylactic acid and
polypropylene” (Miyauchi ¶ 36; see generally Final Act. 7 and 14).
FF 11. Miyauchi discloses that the high molecular weight material can be
provided with a hydrophilic treatment by plasma treatment (Miyauchi
¶ 109; see Final Act. 14).
FF 12. Examiner finds that Miyauchi does not disclose a plasma treatment
that is an oxygen plasma at 50 to 150 watts for 15 to 45 seconds, as required
by Appellant’s claimed invention (see Final Act. 14; cf. Appeal Br. i).
FF 13. Examiner finds that Appellant’s claims are directed to products,
whereas the requirement in Appellant’s claimed invention that, inter alia,
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“the polymer structure is treated with an oxygen plasma at 50 to 150 watts
for 15 to 45 seconds” is a process limitation (see Final Act. 8 and 15–16; cf.
Appeal Br. i).
FF 14. Examiner finds that Agrawal and Miyauchi alone, or in combination,
fails to disclose “the protrusion density” required by Appellant’s claims 19–
20, and relies on Ivanov to make up for this deficiency (Final Act. 10–11
and 18–20; cf. Appeal Br. iii).
FF 15. Examiner finds that that Agrawal and Miyauchi alone, or in
combination, fails to disclose
the elected polymeric material comprising a cyclic poly(olefin)
and more specifically, a cyclic poly(olefin) comprising an
amorphous polyolefin having a cyclic structure polymerized by
ring opening metathesis polymerization of norbornene or
norbornene derivatives, followed by hydrogenation of double
bonds, as required by . . . [Appellant’s] claim 3,
and relies on Diaz-Quijada to make up for this deficiency (Final act. 12–13
and 20–21; cf. Appeal Br. i).
ANALYSIS
The rejections over Agrawal and Miyauchi alone or in combination:
Based on Agrawal and Miyauchi alone or in combination, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious to have a product comprising a poly(olefin)
polymer structure comprising a substrate with pillar-like cylindrical
protrusions having dimensions that fall within range set forth in Appellant’s
claims (see Final Act. 4–8 and 13–15; FF 1–11). In this regard, Examiner
finds that Agrawal and Miyauchi both suggest treating a product suggested
by the combination of Agrawal and Miyauchi with oxygen plasma (see FF
4–7 and 11; see Final Act. 4 (Examiner finds that Agrawal disclose “oxygen
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plasma treatment causes a fine pitting of the structures created by molding,
which leads to further increases in the surface area of the substrate”); FF 14
(Examiner finds that Miyauchi discloses that “it is possible to subject its
substrate with plasma treatment”)).
Examiner recognizes, however, that neither Agrawal nor Miyauchi
suggest, inter alia, the specific plasma treatment required by Appellant’s
claimed invention (see FF 12–13). To make up for this deficiency,
Examiner finds that the plasma treatment requirements, set forth in
Appellant’s claimed invention, are process limitations and, because, “the
product rendered obvious by . . . [Agrawal and Miyauchi alone or in
combination] meets all the limitations of the structure implied by the process
steps” it is Appellant’s burden to establish that the claimed product differs
from that suggested by the combination of Agrawal and Miyauchi (see Final
Act. 8–9 and 16; see also Ans. 3–4). We are not persuaded.
As explained in In re Best, 562 F.2d 1252, 1255 (CCPA 1977) if the
claimed and prior art products are identical or substantially identical, the
USPTO can require an applicant to prove that the prior art product does not
necessarily or inherently possess the characteristics of the claimed product.
We note, however, that in order to invoke the principles of Best, Examiner
must first make factual findings that support a conclusion that the claimed
and prior art products are indeed “identical or substantially identical.” That
factual determination must be made case-by-case based upon the facts in the
individual case.
On this record, Examiner failed to establish an evidentiary basis to
support a conclusion that Agrawal or Miyauchi alone, or in combination,
disclose, or otherwise make obvious, a product that is “identical or
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substantially identical” to the product set forth in Appellant’s claims. To the
contrary, the evidence on this record establishes that gas plasma treatment of
structures may result in any number of different structural modifications (FF
7; see also Appeal Br. 10). Further, although Agrawal may suggest that
those of ordinary skill in this art would have found it obvious to modify the
plasma treatment parameters to achieve a particular result (see FF 7),
Examiner failed to establish an evidentiary basis on this record to support a
conclusion that one of ordinary skill in this art would have had a reason to
select the precise oxygen plasma parameters set forth in Appellant’s claimed
invention or that, in the absence of hindsight, the selection such parameters
would have been expected to achieve any particular desired result.
Obviousness requires more than a mere showing that the
prior art includes separate references covering each separate
limitation in a claim under examination. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d
705 (2007). Rather, obviousness requires the additional
showing that a person of ordinary skill at the time of the
invention would have selected and combined those prior art
elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.
Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011); see In re Stepan, 868 F.3d 1342, 1347 (Fed. Cir. 2017) (to “have a
reasonable expectation of success, one must be motivated to do more than
merely to vary all parameters or try each of numerous possible choices until
one possibly arrived at a successful result.”) (citations and quotations
omitted).
On this record, Examiner failed to establish an evidentiary basis to
support a conclusion that Agrawal or Miyauchi alone, or in combination,
suggest the specific oxygen plasma treatment parameters, set forth in
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Appellant’s claims, that necessarily result in Appellant’s claimed product.
Examiner further failed to explain how Agrawal or Miyauchi alone, or in
combination, would have necessarily led a person of ordinary skill in this art
to produce the specific product required by Appellant’s claims. Thus,
although Agrawal discloses that oxygen plasma “may cause a fine pitting of
the structures created by molding, which leads to further increases in the
surface area of the substrate” (FF 7), Examiner failed to establish that
Agrawal discloses the specific oxygen plasma treatment required by
Appellant’s claimed invention to achieve the fine pitting of the structure.
Thus, Examiner failed to establish an evidentiary basis on this record to
support a conclusion that the product suggested by the combination of
Agrawal and Miyauchi was necessarily produced by the oxygen plasma
treatment required by Appellant’s claimed invention (cf. Final Act. 8–9 and
16; Ans. 3–4).
As Appellant explains, Examiner “failed to show that ‘all process
limitations . . . are expressly disclosed in either of Agrawal or Miyauchi’
(and so failed to show they are disclosed in their combination)” (Appeal Br.
6). In addition, Appellant contends that Examiner failed to establish that any
characteristic or property of the product made obvious by the combination of
Agrawal and Miyauchi necessarily results from the oxygen plasma treatment
required by Appellant’s claimed invention (see Appeal Br. 6–11; see
generally Reply Br. 2–6). See, e.g., In re Robertson, 169 F.3d 743, 745
(Fed. Cir. 1999) (“Inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.”) (citations and internal quotation marks
omitted).
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In sum, we find that Examiner failed to establish an evidentiary basis
on this record to support a conclusion of obviousness. See In re Kahn, 441
F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds
cannot be sustained by mere conclusory statements; instead, there must be
some articulated reasoning with some rational underpinning to support the
legal conclusion of obviousness.”).

The rejection over Agrawal and Miyauchi alone or in combination further in
view of either Ivanov or Diaz-Quijada:
Examiner failed to establish an evidentiary basis to support a
conclusion that either of Ivanov or Diaz-Quijada make up for the deficiency
discussed above with respect to Agrawal and Miyauchi alone or in
combination (see FF 14–15; Ans. 6 (Examiner states that “Diaz-Quijada and
Ivanova were only relied upon to render obvious a cyclic poly(olefin) and
protrusion density respectively”); see generally Appeal Br. 8–9 (Appellant
contends that “neither Ivanov . . . nor Diaz-Quijada . . . remedy the failure of
Agrawal or Miyauchi to disclose or suggest the combination of the polymer
material with plasma treatment conditions recited in [Appellant’s] claims”)).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1, 2, 4–8, 11–18, and 21 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Agrawal and Miyauchi is
reversed.
The rejection of claims 1, 2, 4–8, and 11–21 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Agrawal, Miyauchi, and Ivanov is
reversed.
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The rejection of claims 1–8, 11–18, and 21 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Agrawal, Miyauchi and Diaz-
Quijada is reversed.
The rejection of claims 1, 2, 4–8, 11–18, and 21 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Miyauchi and Agrawal is
reversed.
The rejection of claims 1, 2, 4–8, and 11–21 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Miyauchi, Agrawal, and Ivanov is
reversed.
The rejection of claims 1–8, 11–18, and 21 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Miyauchi, Agrawal, and Diaz-
Quijada is reversed.

Obviousness-type Double Patenting:
Office records report that Elmouelhi abandoned August 8, 2019.
Thus, the provisional obviousness-type double patenting rejections on this
record are reversed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 4–8,
11–18, 21
103 Agrawal, Miyauchi 1, 2, 4–8,
11–18, 21
1, 2, 4–8,
11–21
103 Agrawal,
Miyauchi, Ivanov
1, 2, 4–8,
11–21
1–8, 11–18,
21
103 Agrawal,
Miyauchi, Diaz-
Quijada
1–8, 11–
18, 21
1, 2, 4–8,
11–18, 21
103 Miyauchi, Agrawal 1, 2, 4–8,
11–18, 21
1, 2, 4–8,
11–21
103 Miyauchi,
Agrawal, Ivanov
1, 2, 4–8,
11–21
1–8, 11–18,
21
103 Miyauchi,
Agrawal, Diaz-
Quijada
1–8, 11–
18, 21
1, 4–8, 11–
21
Provisional
Obviousness-type
Double Patenting,
Elmouelhi
1, 4–8,
11–21
1–8, 11–21 Provisional
Obviousness-type
Double Patenting,
Elmouelhi, Diaz-
Quijada
1–8, 11–
21
Overall
Outcome
1–8, 11–
21

REVERSED