Hyung-Il Kim

Patent Trials and Appeals Board

Jul 18, 2019

15282500 - (D) (P.T.A.B. Jul. 18, 2019)

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.
15/282,500 09/30/2016 Hyung-Il Kim 0147.0007-01 6555
39878 7590 07/18/2019
MH2 TECHNOLOGY LAW GROUP, LLP
TIMOTHY M. HSIEH
1951 KIDWELL DRIVE
SUITE 310
TYSONS CORNER, VA 22182
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
07/18/2019 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@mh2law.com
doreen@mh2law.com
lgalvin@mh2law.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HYUNG-IL KIM
____________

Appeal 2019-0007581
Application 15/282,5002
Technology Center 3700
____________

Before ANTON W. FETTING, KENNETH G. SCHOPFER, and
TARA L. HUTCHINGS, Administrative Patent Judges.

SCHOPFER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of
claims 14–16 and 18. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Our decision references the Appeal Brief (“Appeal Br.,” filed July 20,
2018), the Reply Brief (“Reply Br.,” filed Nov. 6, 2018), the Examiner’s
Answer (“Ans.,” mailed Sept. 7, 2018), and the Final Office Action (“Final
Act.,” mailed Jan. 17, 2018).
2 According to Appellants, the real party in interest is Dotter Intellectual Pte.
Ltd. Appeal Br. 3.
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Application 15/282,500

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BACKGROUND
The Specification “relates to polymeric stents, and in particular
methods of manufacturing such devices.” Spec. ¶ 2.
ILLUSTRATIVE CLAIM
Claim 14 is the only independent claim on appeal and recites:
14. A polymeric stent, wherein the polymeric stent
comprises a polylactic acid tube and wherein a pattern is cut on
the polylactic acid tube using a second harmonic generator laser
in which a first wavelength of 940 nm to 1,552 nm is converted
to a second wavelength of 470 nm to 776 nm,
wherein a pulse width of the second harmonic generator
laser is 1 fs to 900 fs and wherein a repetition rate of the second
harmonic generator laser is 2 kHz to 200 kHz, and
wherein the polymeric stent comprises a variation in
polydispersity index (PDI), represented by the following
Equation 1, of 20% or less:
Equation 1
Variation in Polydispersity Index (%) = B−A
A
X 100
wherein in Equation 1,
A is a polydispersity index of the polymeric stent before
the pattern is cut on the polylactic acid tube, and
B is a polydispersity index of the polymeric stent after the
pattern is cut on the polylactic acid tube.

REJECTIONS3
1. The Examiner rejects claims 14, 16, and 18 under 35 U.S.C. § 103(a) as
unpatentable over Weber.4

3 The Examiner has withdrawn a rejection under 35 U.S.C. § 112(b).
4 Weber, US 2002/0065553 A1, pub. May 30, 2002.
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2. The Examiner rejects claim 15 under 35 U.S.C. § 103(a) as unpatentable
over Weber in view of Kleiner.5
DISCUSSION
As discussed below, we are persuaded by Appellant’s argument that
the Examiner has not established that the art of record teaches or otherwise
renders obvious a stent as claimed, and in particular, a stent that includes a
20% or less variation in polydispersity index (“PDI”) as claimed.6
With respect to claim 14, the Examiner finds that Weber teaches a
polymeric stent that comprises a polylactic acid tube that is cut with a
pattern using a second harmonic generator lasor. Final Act. 5. The
Examiner determines that the claim includes product by process limitations
with respect to the cutting of the polylactic acid tube such that the
patentability of the device does not depend on the specific method of its
production. Id. Thus, the Examiner finds that Weber discloses a stent as
claimed even though Weber uses different parameters of a second harmonic
generator laser to cut the polylactic acid tube. See id. at 5–6. Further, the
Examiner finds that even though Weber is silent regarding variation in PDI,
Weber inherently discloses a variation of 20% or less. Id. at 6–7 (citing
Weber ¶¶ 20–21). Alternatively, the Examiner determines that “it would
have been obvious to the person of ordinary skill in the art . . . to read Weber
and consider that the PDI would not vary, since Weber specifically indicates
that their method does not disrupt the molecules or heat the material of the
stent at all.” Id. at 7.

5 Kleiner, US 2010/0262223 A1, pub. Oct. 14, 2010.
6 PDI is defined in the Specification as Mw/Mn, i.e., weight average
molecular weight over number average molecular weight.
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Application 15/282,500

4
To establish inherency, the extrinsic evidence must make clear
that the missing descriptive matter is necessarily present in the
thing described in the reference, and that it would be so
recognized by persons of ordinary skill. Inherency, however,
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.

In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (internal quotations and
citations omitted). We agree with Appellant that the Examiner has not
adequately established that Weber’s stent inherently includes a PDI variation
of 20% or less, as required by the claim.
In support of the determination of inherency, the Examiner finds that
“Weber’s PDI is considered to not vary from before and after cutting”
because “Weber teaches an almost identical method of production” and
“Weber teaches that their method does not damage or alter the molecules of
the PLA stent.” Final Act. 6–7 (citing Weber ¶¶ 20, 21). The Examiner
relies on the following passages from Weber:
When a material is ablated by a conventional laser, the
material is removed by thermal ablation wherein the material is
locally heated to near melting point or boiling point. Thus,
ablation using conventional lasers has various problems. For
example, the ablation is furthermore accompanied by a heat
transfer and a strong thermal shock to surrounding material
which might cause serious damage, such as cracking. Also, the
material once removed tends to redeposit or re-solidify on the
surrounding surface. Thus, a material ablated by a conventional
laser must be cleaned to remove the redeposited material
surrounding the cut surface. Hence, if a material having an
immobilized molecule on its surface is ablated by a conventional
laser, because a clearing step is required, the immobilized
molecule may be washed away at the cleaning step. Also, since
process parameters for a conventional laser ablation, such as
boiling point and absorption of the laser light, varies according
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to materials to be ablated, a layered material consisting of layers
made of different materials cannot be ablated by a conventional
laser.
On the other hand, ablation using an ultrashort-pulse laser
is free from such problems. The ultrashort-pulse deposits its
energy so quickly that it does not interact at all with the plume
of vaporized material, which would distort and bend the
incoming beam and produce a rough-edged cut. The plasma
plume leaves the surface very rapidly, ensuring that it is well
beyond the cut edges before the arrival of the next laser pulse.
Since the pulse is very short, atoms in a material to be ablated
are stationary in space with respect to the pulse duration. As a
result, the ultrashort-pulse laser does not react differently
between dielectric materials and electric materials. Thus, any
material, including glasses, polymers, ceramics, silicon, and
metals, can be ablated with very high precision without damage
in surrounding area by ultrashort-pulse lasers due to the absence
of heat shock waves. In addition, the surface ablated with a
ultrashort-pulse laser has an excellent quality which does not
need further polishing as required for a surface ablated with a
conventional laser because redeposition is less or absent.
Weber ¶¶ 20, 21 (emphasis added). Thus, Weber describes problems with
ablating a material with a conventional laser, including causing damage,
such as cracking, to surrounding material from heat shock; redepositing of
removed materials; washing away of material during a cleaning step; and an
inability to use conventional lasers on layered material. Weber then
describes that using an ultrashort-pulse laser is free from these problems.
Weber discloses that the pulses do not interact with the previously vaporized
material, and that the atoms are stationary with respect to the pulse duration,
such that the laser does not react differently between materials and no
damage from heat shock waves occurs.
The Examiner determines from this disclosure that Weber “relies
upon a laser that does not interact with the (polymer) atoms of the stent, [and
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thus,] it is inherent that the laser does not change the molecular weight of the
atoms within the polymer.” Id. We disagree that Weber discloses that the
laser does not interact with the atoms of the stent. Weber necessarily
interacts with certain atoms of the stent by cutting them away from the tube
material. Further, Weber is completely silent regarding any effect on the
molecular weight of a polylactic acid tube that results from cutting using
Weber’s ultrashort-pulse laser. Thus, although Weber may indicate less
harmful interaction between the laser and the stent material during cutting,
we disagree that Weber inherently discloses no change to the molecular
weight of the device. As noted above, inherency requires a showing that the
claimed matter is necessarily present in the prior art, which the Examiner has
not established here.
The Examiner alternatively determines that the claimed variation in
PDI would nonetheless have been obvious to a person of ordinary skill in the
art in reading Weber. See Final Act. 7; see also Ans. 4. However, the
Examiner relies on the explanation above to show that Weber “indicates that
their method does not disrupt the molecules or heat the material of the stent
at all.” Final Act. 7. We disagree that Weber teaches that the molecules are
not “disrupt[ed]” or that the material is not heated “at all.” Final Act. 7.
Rather, as discussed, Weber teaches that certain disadvantages of
conventional lasers are avoided by using ultrashort-pulse lasers. Weber does
not indicate how the advantages or disadvantages described are related to the
molecular weight of the device before and after cutting, in particular with
respect to a polylactic acid tube, such that one of ordinary skill in the art
would have understood that minimal change in molecular weight is
suggested by Weber. Thus, we determine that the Examiner has not
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established adequately that one of ordinary skill in the art would have found
it obvious to provide a stent with the claimed variation in PDI based on the
cited portions of Weber.
Based on the foregoing, we are persuaded of reversible error in the
rejection of claim 14. Accordingly, we do not sustain the rejection of claim
14. We also do not sustain the rejection of claims 16 and 18 for the same
reasons. Regarding claim 15, the Examiner has not established that Kleiner
cures the deficiency in the rejection of independent claim 14. Thus, we also
do not sustain the rejection of claim 15.
CONCLUSION
We REVERSE the rejections of claims 14–16 and 18.

REVERSED