AMOLIFESCIENCE CO., LTD.

Patent Trials and Appeals Board

Jun 4, 2021

2020004448 (P.T.A.B. Jun. 4, 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.
15/561,763 09/26/2017 In Yong SEO JLE0179US 3537
23413 7590 06/04/2021
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
06/04/2021 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):
usptopatentmail@cantorcolburn.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte IN YONG SEO, SEUNG HOON LEE,
SONG HEE KOO, and JI HYUN LEE
____________

Appeal 2020-004448
Application 15/561,763
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims directed to
a dental membrane comprising a first, second, and third support.2 The
Examiner has rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. §
1.42(a). Appellant identifies Amolifescience Co., Ltd. as the Real Party in
Interest (Appeal Br. 3). We have considered the Specification of Sept. 26,
2017 (“Spec.”); Final Office Action of Aug. 1, 2019 (“Final Act.”); Appeal
Brief of Jan. 15, 2020, (“Appeal Br.”); and Examiner’s Answer of Feb. 21,
2020 (“Ans.”).
2 Note that “support” and “layer” are interchangeable terms used throughout
this Opinion (see, e.g., Spec. ¶ 43 “a three-layer laminated structure of the
first to third supports”).
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Statement of the Case
Background
“[A] dental shielding membrane . . . can be implanted into injured
bones or periodontal tissues during implant or periodontal surgery, to
regenerate bones and periodontal tissues, thereby preventing penetration of
adjacent soft tissues or undesirable cells, and has recently been used in
dental procedures” (Spec. ¶ 7). “[I]t is possible to secure safer treatment by
controlling the decomposition rate of the supports according to the function
of the multifunctional membrane during completion of a dental procedure or
operation” (id. ¶ 28).
The Claims
Claims 1, 3–10, and 12 are on appeal. Claim 1 is representative of the
claims on appeal and reads as follows:
1. A dental membrane comprising:
a first support formed of electrospun and accumulated
first nanofibers and having a plurality of pores formed therein,
the first nanofibers having a first diameter and made of a
biodegradable polymer, wherein the first support is configured
to be in contact with a living tissue to be grown;
a second support laminated on the first support and
formed of electrospun and accumulated second nanofibers and
having a plurality of pores formed therein, the second
nanofibers having a second diameter and made of a
biodegradable polymer; and
a third support laminated on the second support and
formed of electrospun and accumulated third [sic] nanofibers
and having a plurality of pores formed therein, the third
nanofibers having a third diameter and made of a biodegradable
polymer,
wherein the second diameter is larger than the first
diameter and the third diameter, and the third diameter is
smaller than the first diameter.
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The Rejection
The Examiner rejected claims 1, 3–10, and 12 under 35 U.S.C. §
103(a) as being unpatentable over Tornero Garcia3 (Final Act. 3–7).
The Examiner finds Tornero Garcia teaches “a membrane comprising
electrospun nanofibers of a biocompatible and biodegradable polymer”
comprising three layers, two of them laminated, with “equal or different
nanofiber diameters, equal or different thickness and/or can comprise
nanofibers made of equal or different biocompatible polymers” (Final Act.
3). The Examiner finds Tornero Garcia teaches overlapping diameter ranges
with those recited in dependent claims 3 and 4 (id.). The Examiner finds
Tornero Garcia teaches “the membrane wherein the therapeutic active
agent(s) are growth factors and regenerating (i.e., regrowth) factors” (id. at
4).
The Examiner acknowledges Tornero Garcia does “not specify that
the second nanofibers have diameters larger than the diameters of the first
nanofibers and the third nanofibers have diameters smaller than the
diameters of the second nanofibers and first nanofibers” (Final Act. 5).
However, the Examiner finds “an ordinary skilled artisan would routinely
optimize the diameter of each layer in order to determine the optimum or
workable ranges (id.).
Does a preponderance of the evidence of record support the
Examiner’s conclusion that Tornero Garcia renders claims 1 and 10
obvious?

3 Tornero Garcia et al., WO 2013/144206 A1, published Oct. 3, 2013.
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Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Findings of Fact
1. Tornero Garcia teaches a “nonwoven membrane for the
controlled and sustained release of a therapeutic or cosmetic active agent in
the area of the body to be treated. This nonwoven membrane comprises one
single type of biocompatible electrospun nanofibers and microparticles of a
pure active agent which are entangled between the nanofibers” (Tornero
Garcia 1:5–11).
2. Tornero Garcia teaches:
In a most preferred embodiment, the nonwoven membrane of
the invention consists of one first layer comprising one single
type of biocompatible electrospun nanofibers, one second layer
comprising one single type of biocompatible electrospun
nanofibers and microparticles of at least one therapeutic or
cosmetic active agent entangled between the nanofibers; and
one third layer comprising one single type of biocompatible
electrospun nanofibers.
(Tornero Garcia 15:24–31).
3. Tornero Garcia teaches examples where the third layer is
laminated on the second layer and the second layer is laminated on the first
layer, specifically teaching “a nonwoven membrane had regular PLA
nanofibers . . . This first layer served as support for the upcoming drug-
loaded layer,” then a “second layer was formed of a PLA nonwoven
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membrane loaded with drug and having 50 mm diameter and 0.2 mm
thickness,” followed by “a third layer of a PLA nonwoven membrane
without drug and having 50 mm diameter and 0.2 mm thickness” (Tornero
Garcia 52:1–19; cf. Figures 4–5).
4. Tornero Garcia demonstrates that the membrane was
configured to be in contact with a living tissue to be grown in teaching that
“[m]embranes were cut into 12 mm diameter circular pieces . . . One
membrane was inserted subcutaneously in CD1 nude mice” (Tornero Garcia
57:18–20).
5. Tornero Garcia teaches: “The at least first layer, second layer
and third layer of the nonwoven membrane of the invention can have equal
or different nanofiber diameters, equal or different thickness and/or can
comprise nanofibers made of equal or different biocompatible polymers”
(Tornero Garcia 16:1–5).
6. Tornero Garcia teaches in “the nonwoven membrane of the
invention, the biocompatible electrospun nanofibers have a mean diameter
of 50-1000 nm” (Tornero Garcia 26:1–3). Tornero Garcia teaches “the fiber
diameter of obtained membranes could increase with increasing solution
concentration” (Tornero Garcia 41:14–16).
7. Tornero Garcia teaches “the thickness of the nonwoven
membrane ranges from 0.05 to 0.5 mm. In a preferred embodiment of the
method of the invention, the thickness of the nonwoven membrane is of 0.2
mm” (See Tornero Garcia 43:1–4).
8. Tornero Garcia teaches that “the biocompatible electrospun
nanofibers are composed of one single type of biocompatible and
biodegradable polymer” and in one embodiment “the biocompatible
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electrospun nanofibers are composed of poly-D, L-lactic acid (PLA)”
(Tornero Garcia 19:28 to 20:4).
9. Tornero Garcia teaches that an “active agent to be included in
the nonwoven membrane of the invention can be a therapeutic agent . . .
such as a growth factor” and growth factors include “PDGF, TGF-B, EGF,
VEGF, IGF-I, bFGF and HGF” (Tornero Garcia 18:14 to 19:2)
10. Tornero Garcia teaches “release from active agent-loaded
polymer fibers is highly dependent on the composition of the fibers, the
active agent-to-polymer ratio, the co-loading of other substances and the
thickness of the fibers” (Tornero Garcia 5:27–31).
11. Tornero Garcia teaches “release kinetics . . . depends upon its
diffusion out the corresponding fiber, the degradation of this fiber as well as
the degradation of the polymeric microsphere shell” (Tornero Garcia 6:9–
12).
12. Tornero Garcia teaches
electrospun nanofibers have been reported to incorporate and
release antibiotics, drugs and proteins in a sustained manner.
Drugs and bioactive agents are encapsulated, embedded or
incorporated within the bulk phase of the fibers, so that their
release kinetics depends on their diffusion out of the fiber and
the fiber degradation/erosion.
(Tornero Garcia 3:18–24).
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (See
Final Act. 3–7; FF 1–12) and agree that Tornero Garcia renders claims 1, 3–
10, and 12 obvious. We address Appellant’s arguments below.
Appellant asserts that “the claimed electrospun and accumulated
nanofibers are made of a biodegradable polymer (not simply a
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biocompatible material as in Tornero Garcia), in order to be decomposed
over time . . . .” (Appeal Br. 11) Further, Appellant contends, “the claimed
electrospun and accumulated nanofibers have different diameters . . . .
thereby being able to control decomposition rates of the dental
membrane.” (Id.) Therefore, Appellant asserts that the membrane taught by
Tornero Garcia is “basically different from the claimed invention, in terms
of their structures and originally intended purposes.” (Id.) Appellant
argues that there is no reason for an ordinary skilled artisan to be tempted to
modify Tornero Garcia to arrive at the claimed invention, “in the way that
this new claimed invention is and does.” (Id.)
We are not persuaded. As to being biodegradable, Tornero Garcia
expressly teaches that the electrospun nanofibers “can be made of any
suitable biocompatible and biodegradable polymer of the art.” (FF 8; cf.
Ans. 8) (emphasis added). Thus, contrary to Appellant’s argument, Tornero
Garcia expressly teaches that the nanofibers may comprise a biodegradable
polymer.
Also as to being biodegradable, dependent claim 5 demonstrates that
polymers including PLA necessarily satisfy this requirement. Tornero Garcia
teaches “the biocompatible electrospun nanofibers are composed of poly-D,
L-lactic acid (PLA)” (FF8) and would therefore be expected to obtain the
same result as the claims because “[p]roducts of identical chemical
composition can not have mutually exclusive properties.” In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990). Appellant provides no evidence rebutting
this finding by the Examiner (see Ans. 8).
As to control of decomposition rates, Tornero Garcia “release kinetics
depends on their diffusion out of the fiber and the fiber degradation/erosion”
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(FF 12; cf. FF 11). Tornero Garcia teaches a three layer, laminated
composition composed of degradable polymers (FF 1, 2, 8) with diameter
values that overlap dependent claims 3 and 4 (FF 3, 6) and recognizes
thickness as an optimizable variable (FF 3, 7). Indeed, Tornero Garcia
explains the “first layer, second layer and third layer of the nonwoven
membrane of the invention can have equal or different nanofiber diameters,
equal or different thickness and/or can comprise nanofibers made of equal or
different biocompatible polymers” (FF 5). Appellant has provided no
evidence of any secondary consideration showing unexpected results for
thickness values relative to the composition of Tornero Garcia. “It is well
settled that unexpected results must be established by factual evidence.
Mere argument or conclusory statements . . . [do] not suffice.” In re Soni,
54 F.3d 746, 750 (Fed. Cir. 1995).
As to Appellant’s argument mentioning the intended use of the
composition as a dental membrane in the claim preamble:
If the body of a claim fully and intrinsically sets forth all of the
limitations of the claimed invention, and the preamble merely
states, for example, the purpose or intended use of the
invention, rather than any distinct definition of any of the
claimed invention’s limitations, then the preamble is not
considered a limitation and is of no significance to claim
construction.

Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999). A “mere statement of a new use for an otherwise old or obvious
composition cannot render a claim to the composition patentable.” In re
Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Therefore, we conclude that
the preamble of claims 1 and 10 does not impart a structural limitation and
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therefore does not patentably distinguish the obvious membrane of Tornero
Garcia (FF 1–12).
Appellant also contends that Tornero Garcia does not teach or suggest
that the nanofiber diameter is a result–effective variable because the reason
for optimizing the diameter sizes of the instant invention (i.e., the
decomposition rate) differs from the prior art (see Appeal Br. 13–15). Thus,
Appellant contends “[t]herefore, there is no reason, for a person having
ordinary skill in the art, but not knowing the claimed invention, to be
tempted to conduct routine experimentation in order to obtain the claimed
number of supports and associated nanofiber diameters (Appeal Br. 15).
We are not persuaded. As to the number of supports required in claim
1, claim 1 recites three supports and Tornero Garcia expressly teaches three
layers/supports in a most preferred embodiment (FF 2). As to the nanofiber
diameters, Tornero Garcia teaches an overlapping range of diameters (FF 6).
In “cases involving overlapping ranges, [courts] have consistently held that
even a slight overlap in range establishes a prima facie case of obviousness.”
In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Appellant provides
no persuasive evidence of any secondary consideration associated with the
particular diameter relationships recited in claim 1.
Moreover Tornero Garcia expressly teaches that the at least first,
second, and third layers of the nonwoven membrane “can have equal or
different nanofiber diameters, equal or different thickness and/or can
comprise nanofibers made of equal or different biocompatible polymers.”
(FF 5). As such, Tornero Garcia recognizes thickness as a routinely
optimizable variable and provides an ordinary skilled artisan with reasons to
optimize the diameter of each layer of the membrane. “[D]iscovery of an
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optimum value of a result effective variable . . . is ordinarily within the skill
of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellant does
not demonstrate otherwise. Indeed, Appellant acknowledges that the
“electrospinning process, itself, is a well-known technology. Further, there is
no difficulties in obtaining fibers having different diameters” (Appeal Br.
15).
Appellant contends:
The disclosed and claimed invention is not intended for an
electrospinning process to achieve different diameters of
nanofiber, but for a dental membrane having a three-layered
structure being formed of nanofibers having different diameters
from neighboring layers, and thus providing unexpected results
and having solved the prior art problems, as discussed above
and disclosed in the present application.
(Appeal Br. 15).
We are not persuaded. “It is well settled that unexpected results must
be established by factual evidence. Mere argument or conclusory statements
. . . [do] not suffice.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). Here,
Appellant does not identify any statement in the Specification that the
diameters of the layers results in unexpected results. Nor is there a
Declaration or other evidence that supports a finding of unexpected results.
The only indication that selection of the particular layer diameters constitute
an unexpected result is attorney argument in the brief and attorney argument
is not persuasive. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984).
Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that Tornero Garcia renders claims 1 and 10 obvious.
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DECISION SUMMARY
In summary:

Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–10, 12 103(a) Tornero Garcia 1, 3–10, 12

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