Mulholland, R. Stephen

Patent Trials and Appeals Board

Feb 21, 2020

12573923 - (D) (P.T.A.B. Feb. 21, 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.
12/573,923 10/06/2009 R. Stephen Mulholland 0118207 7146
45191 7590 02/21/2020
HERBERT L. ALLEN
ALLEN, DYER, DOPPELT, MILBRATH & GILCHRIST, P.A.
255 SOUTH ORANGE AVENUE, SUITE 1401
P. O. BOX 3791
ORLANDO, FL 32802-3791
EXAMINER
GOOD, SAMANTHA M
ART UNIT PAPER NUMBER
3794
NOTIFICATION DATE DELIVERY MODE
02/21/2020 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):
jlong@allendyer.com
skemraj@allendyer.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte R. STEPHEN MULHOLLAND
__________

Appeal 2019-004319
Application 12/573,923
Technology Center 3700
__________

Before MICHAEL L. HOELTER, ANNETTE R. REIMERS, and
LISA M. GUIJT, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL
Appellant0F1 appeals under 35 U.S.C. § 134(a) from the Examiner’s
rejection of claims 1–5, 7, 8, and 16–22. Final Act. 1. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM–IN–PART.

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 Invasix Ltd.
Appeal Br. 2.
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STATEMENT OF THE CASE
Claims 1 and 16 are the independent claims on appeal. Claim 1,
reproduced below with disputed limitations italicized for emphasis, is
exemplary of the subject matter on appeal.
1. An apparatus for use in a skin resurfacing and collagen
remodeling procedure through creating of a mechanical trauma
transdermally, the apparatus comprising:
a needle array comprising a plurality of needles;
a needle tip protector attached over the plurality of
needles;
a reciprocating mechanism connected to the needle array
and providing cyclic in and out movement of the plurality of
needles between a completely retracted position within the
needle tip protector to a completely extended position
corresponding to a maximum skin penetration depth, with
oscillating frequency at a predetermined cycles per second; and
an RF source connected to the needle array such that RF
energy from the RF source is deliverable transdermally through
the plurality of needles during the cyclic skin penetration.

THE REJECTIONS
I. Claims 1–5, 7, 8, and 16–22 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Manstein (US 2005/0222565 A1; published Oct.
6, 2005) and Merchant (US 2008/0195036 A1; published Aug. 14, 2008).
II. Claims 1, 2, 4, 7, 8, 16, 17, 19, 21, and 22 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Ericksson (US 6,090,790; issued
July 18, 2000) and Avrahami (US 2003/0212397 A1; published Nov. 13,
2003).
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III. Claims 3 and 18 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ericksson, Avrahami, and Britva (US 2009/0171424 A1;
published July 2, 2009).

ANALYSIS
Rejection I – Obviousness over Manstein and Merchant
As an initial matter, we determine that the field of endeavor of
Appellant’s invention is skin treatment devices. In support, we refer to the
background section of the Specification, and specifically, the section titled,
“Industry and Device Comparisons,” which describe skin treatment devices
such as monochromatic lasers, intense broad band light systems,
radiofrequency devices, plasma technology, laser resurfacing and chemical
peel, Fraxel laser, and more particularly, Medical Roll CIT (i.e., a hand held
roller with needles). Spec. pp. 1–4. We also determine that Merchant,
which discloses a device, comprising a needle array, for “treating skin
irregularities,” is in the same field of endeavor as the invention, namely, skin
treatment devices, and therefore, is properly relied on by the Examiner in the
rejection of the claims in view of Manstein and Merchant. Merchant,
Abstract, ¶ 13; see Appeal Br. 13 (arguing that Merchant is non-analogous
art improperly relied on by the Examiner); In re Klein, 647 F.3d 1343, 1348
(Fed. Cir. 2011) (quoting In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004))
(establishing precedentially a twofold test for determining whether art is
analogous: “‘(1) whether the art is from the same field of endeavor,
regardless of the problem addressed and, (2) if the reference is not within the
field of the inventor’s endeavor, whether the reference still is reasonably
pertinent to the particular problem with which the inventor is involved’”).
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Regarding independent claims 1 and 16, the Examiner finds that
Manstein discloses an apparatus for use in a skin resurfacing and collagen
remodeling procedure by creating mechanical trauma transdermally, the
apparatus comprising, inter alia, a needle array (i.e, needles 350, 410), a
needle tip protector (i.e., spacer substrate 315), and a reciprocating
mechanism (i.e., a “vibrating means”) connected to the needle array and
“providing cyclic in and out movement” of the needles between a
completely retracted position to a completely extended position
corresponding to a maximum skin penetration depth, with oscillating
frequency at a predetermined cycles per second. Final Act. 2–3 (citing
Manstein ¶¶ 39, 43, Figs. 3–4) (emphasis added). The Examiner finds that
because Manstein discloses that the needles are “subsequently inserted, . . .
the vibrations are therefore causing in and out reciprocation of the needles.”
Ans. 3 (citing Manstein ¶ 39).
The Examiner relies on Merchant for disclosing “a reciprocating
mechanism connected to the needle array” (i.e., needle 218), which provides
“cyclic in and out movement of the plurality of needles between a
completely retracted position within the needle tip protector” (i.e., fluid
injection device 202) “to a completely extended position.” Final Act. 3
(citing Merchant ¶¶ 20, 111). The Examiner reasons that it would have been
obvious “to modify the completely retracted position, as taught by Manstein,
to be within the needle tip protector, as taught by Merchant . . . to protect the
needles from breakage.” Id. at 3.
Appellant argues, inter alia, that although “Manstein teaches that a
vibrating means can be coupled to the base and/or housing to induce
vibrations in the needles . . . , Manstein does not teach or suggest that the
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vibration causes in and out reciprocation of the needles relative to the base
310 and/or spacer substrate 315.” Appeal Br. 10–11 (citing Manstein ¶ 39).
Claims 1 and 16 require a “reciprocating mechanism . . . providing
cyclic in and out movement of the plurality of needles . . . with oscillating
frequency at a predetermined cycles per second.” Appeal Br. 19, 21 (Claims
App.); see, e.g., Spec. 11:1–2, 15. The Specification discloses that “[t]he
reciprocating hand piece provides the rapid oscillating, reciprocating back
and forth (“in and out”) motion of the needle tips.” Id. at 4:26–28; see also
id. at 5:4 (describing the needle tip as “reciprocating in and out rapidly”);
5:23–24 (describing “reciprocating oscillations” as “‘in and out’ motions of
the needle tip”). The Specification also discloses a “reciprocating rate” and
a “reciprocating frequency.” Id. at 6:6, 9–10.
The Specification discloses that “[r]eciprocation of the needles can be
done using a solenoid, motor with eccentric mechanism or a piezoelectric
element.” Spec. 6:20, 21. The Specification also discloses that
needle-based device 12 comprises a hand-held portion 12a
housing means for oscillating and reciprocating an elongate
needle portion 12b. This is a commercially available hand piece,
also referred to as head piece, which houses the motor and
oscillating means (not shown) and to which the elongate needle
portion 12b is connected at one end and in mechanical
communication with the means for oscillating the reciprocating
said needle portion 12b. Typically, the needles 12d
oscillate/reciprocate at about 1 cycles second to about 500 cycles
per second.
Spec. 10:3–9. Notably, the Specification discloses that an oscillating means
causes reciprocation (or the in and out motion) of needle portion 12b.
With respect to the dermatological treatment and tissue reshaping
apparatus, Manstein discloses that
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vibrating means, such as a piezoelectric transducer or a small
motor with an eccentric weight fixed to the shaft, may be
mechanically coupled to housing 340 and/or base 310 that
supports the array of needles 350. Vibrations conductively
induced in needles 350 by such vibrating means can facilitate the
piercing of the skin by the needle tips and subsequent insertion
of the needles into the tissue.

Manstein ¶ 39. Regarding the insertion of the needles into the skin,
Manstein discloses that
the sharp distal ends of the needles 350 pierce the surface 306 of
skin tissue 305 and are inserted into the tissue until the bottom
surface 316 of spacer substrate 315 (or the bottom surface 311 of
base 3109 if a spacer substrate 315 is not used) contacts the
surface 306 of the skin 305.

Id. ¶ 34.
Thus, although Manstein discloses the same mechanical mechanisms
for vibrating the needles as the Specification (i.e., a piezoelectric transducer
or element, or a motor), a preponderance of the evidence fails to support the
Examiner’s finding that Manstein’s vibrating means is a reciprocating
device, as claimed, which requires, for example, an oscillating means as
disclosed in the Specification, for producing the in-and-out motion of the
needles. In other words, we agree with Appellant that Manstein’s disclosure
that the vibrations facilitate piercing the skin by the needle tips and
subsequent insertion of the needles into the tissue is insufficient to support
the Examiner’s finding that Manstein’s vibrating means is also a
“reciprocating mechanism,” as claimed, which must cause an in-and-out
motion of the needles. Manstein is silent regarding how the needles pierce
and become inserted into the tissue, until the spacer substrate or base
contacts the skin’s surface; however, there is also a lack of support for the
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Examiner’s finding supra that Manstein discloses a completely retracted
position of the needle array.
Notably, Merchant discloses “a needle deployment mechanism
operably connected to the needle array for deploying the at least one
needle(s) between a retracted and an extended position.” Merchant ¶ 20; see
also id. ¶ 111. However, Merchant fails to cure the deficiency in the
Examiner’s finding with respect to Manstein, because Merchant fails to
disclose that Merchant’s reciprocating device (or needle deployment
mechanism) is “reciprocating mechanism . . . providing cyclic in and out
movement of the plurality of needles . . . with oscillating frequency at a
predetermined cycles per second,” as required by claims 1 and 16. Rather,
Merchant merely discloses connecting “an ultrasound transducer” to “the
needle array.” Merchant ¶ 27.
Accordingly, we do not sustain the rejection of claims 1 and 16, and
claims 2–5, 7, 8, and 17–22 depending therefrom, under 35 U.S.C. § 103(a)
as unpatentable over Manstein and Merchant.

Rejection II– Obviousness over Ericksson and Avrahami
Appellant does not offer arguments in favor of independent claim 16
and dependent claims 2, 4, 7, 8, 17, 19, 21, and 22 separate from those
presented for independent claim 1. Appeal Br. 14–17. We select claim 1 as
the representative claim, and claims 2, 4, 7, 8, 16, 17, 19, 21, and 22 stand or
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Appellant argues that both Eriksson and Avrahami are non-analogous
to the claimed invention, and therefore, improperly relied on by the
Examiner in the rejection of the claims pursuant to 35 U.S.C. § 103(a).
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Appeal Br. 14–15. Appellant submits that neither Eriksson nor Avrahami
are “directly concerned with any type of cosmetic procedure.” Id. at 16.
Appellant submits that the Examiner relies on hindsight. Id. at 15.
We determine that Eriksson is in the same field of endeavor as
Appellant’s invention, namely, skin treatment devices, and therefore,
properly relied on by the Examiner as analogous art. In support, Eriksson
discloses “a microneedle delivery apparatus” (Eriksson 3:5–6) for the
“[d]irect delivery of genetic material . . . by repetitive microneedle injection
into intact skin cells.” Id. at 2:15–17. Notably, the “field of endeavor” test
asks if the structure and function of the prior art is such that it would be
considered by a person of ordinary skill in the art because of the similarity to
the structure and function of the claimed invention as disclosed in the
application. Bigio, 381 F.3d at 1325–27. Here, Erikkson involves a similar
structure as the claimed invention (i.e., microneedles are oscillated at a
predetermined rate of oscillations per second to repeatedly enter a treatment
site on the skin to a desired depth). See, e.g., Erikkson 8:23–33. Regarding
similarity in function, we note that it is known in the field of cosmetic skin
treatment devices to deliver analgesic or anesthetic into the region of the
skin being treated using hollow needles interspersed among treatment
needles, which is similar to the function provided by Erikkson’s needles
(i.e., as a drug delivery device). See, e.g., Manstein ¶ 20.
For essentially the same reasons, we also determine that Avrahami is
in the same field of endeavor as Appellant’s invention, namely, skin
treatment devices, and therefore, properly relied on by the Examiner as
analogous art. For example, Avrahami discloses “devices for puncturing the
outer layer of living skin . . . for transdermal drug delivery.” Avrahami ¶ 2;
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see also id. ¶ 21 (disclosing that an object of the invention is “to provide
improved apparatus . . . for creating narrow channels through the stratum
corneum of living skin by puncturing”). Notably, Avrahami discusses, in
the Background Section, prior art involving an “electrosurgical apparatus . . .
for inducing tissue contraction, without ablation or dissociating of
surrounding tissue, in order to reduce wrinkles in skin” as relevant to the
disclosure of Avrahami’s transdermal drug delivery device, evidencing that
skin treatment devices for transdermal delivery of drugs would be
considered by a person of ordinary skill in the art concerned with cosmetic
therapies, and vice versa, because of the similarity in the structures and
functions of the devices. Avrahami ¶ 15 (citing US Pat. No. 6,159,194).
Moreover, the Specification discloses that “[i]n order to reduce
bleeding, thermal energy can be applied to coagulate the blood vessels in the
wound,” wherein “[t]o coagulate the blood, the needles can be preheated
prior to each insertion or RF energy can be applied to the needles.” Spec.
6:1–3. Similarly, Avrahami discloses that “the applied current may be
configured so as to have a local coagulation effect, optionally using
parameters known in the art of electrosurgery.” Avrahami
¶ 35. Thus, Avrahami is reasonably pertinent to the particular problem
which Appellant is involved, namely creating coagulation, pursuant to prong
two of the analogous art test supra.1F2 Cf. Appeal Br. 16 (arguing that
because “[Avrahami’s] needles are not used to repeatedly penetrate the

2 Appellant does not dispute the Examiner’s finding that Avrahami discloses
the use of RF energy. See Final Act. 5; Appeal Br., passim.
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epidermis into the dermis, Avrahami cannot reasonably be related to the
problems addressed by [Appellant’s] invention”).
Regarding independent claim 1, the Examiner finds that Ericksson
discloses an apparatus comprising, inter alia, a reciprocating mechanism
(i.e., power source 18, piston 20) connected to a needle array (i.e,
microneedles 12) and providing “cyclic in and out movement of needles
between a completely retracted position within a needle tip protector to a
completely extended position corresponding to a maximum skin penetration
depth, with oscillating frequency at a predetermined cycles per second.”
Final Act. 5 (citing Ericksson 2:15–20, 5:55–6:9; Figs. 3A–3B); see also
Ericksson, Fig. 1. The Examiner also finds that although Eriksson teaches
“the advantages of heat with respect to wound response,” Eriksson fails to
expressly teach “an RF source connected to the needle array.” Id. (citing
Ericksson 11:26–35). The Examiner relies on Avrahami for disclosing “an
RF source connected to [a] needle array such that the RF energy from the RF
source is deliverable transdermally through the needle.” Id. (citing
Avrahami ¶¶ 153–161, Figs. 1–4). The Examiner reasons that it would have
been obvious to modify Ericksson’s apparatus “to comprise an RF source
connected to a needle array,” as taught by Avrahami, “to allow for
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electrically-promoted drug delivery through the creation of micro-channels.”
Id. (citing Avrahami ¶¶ 29, 34, 203, 225).2F3,3F4
Appellant argues that Avrahami “does not teach a needle array,” but
rather, “a transdermal drug delivery/analyte extraction device with arrays of
electrodes (24, 44, 64, 100, 220, 320, etc.).” Appeal Br. 16. The Examiner
responds that Avrahami’s multiple electrodes are inserted into the skin, and
therefore, comprise a needle array. Ans. 5 (citing Avrahami ¶¶ 153, 165).
Avrahami discloses that “a generally conical tip 120 of the electrode
is intended for insertion in the skin 108 of the subject.” Avrahami ¶ 165.
However, Avrahami itself distinguishes “ablation of the stratum corneum by
[the tip 120 of the electrode intended for insertion in the skin]” and “prior art
mechanical devices for puncturing the stratum corneum (particularly those
involving needles).” Avrahami ¶ 165. In other words, the tips of

3 Notably, Eriksson discloses that “[i]t has been found that heating the
wound . . . accelerates wound healing,” however, rather than heating the
needle array, Eriksson teachings that “[t]he temperature of the wound area
can be achieved be heating the treatment fluid.” Eriksson 11:27–35. Britva
discloses a skin treatment apparatus including “an RF-signal supplying
assembly 185 of electrical components for generating an RF output signal
useful for deliver to biological tissue to heat the biologic tissue,” wherein the
RF applicator and the vibration device are the same component, or put
another way, “a vibration generation device 190 [is] operative to generate
mechanical vibrations of at least a portion of the applicator/RF coupler 240.”
Britva ¶ 71.
4 Notably, as discussed supra, Avrahami discloses that “[f]or some
applications it is desirable to stop transdermal flow of a substance (e.g., an
analyte or a drug) at a certain point after ablation of the stratum corneum,”
and that “[p]referably, the flow is stopped by . . . a local coagulation effect,
optionally using parameters known in the art of electrosurgery.” Avrahami
¶ 35.
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Avrahami’s electrodes, which are inserted in the skin, are for the purpose of
micro-channel formation because “device 60 is operative to generate sparks
in order to ablate skin 68” or “[a]lternatively, device 60 drives current into
skin 68 in order to ablate the stratum corneum.” Id. ¶ 164; see also id. ¶ 26.
Notwithstanding, Appellant does not apprise us of error in the Examiner’s
interpretation of the tips of Avrahami’s conical electrodes as needles.
Appellant also argues that “Eriksson and Avrahami would not be
properly combined” to disclose the claimed subject matter, because
“Avrahami applies electrical energy to the skin so that transdermal transport
is facilitated,” while “Eriksson does not deliver its genes transdermally.”
Appeal Br. 16–17. Appellant submits that “[i]f Eriksson were modified so
far as to substitute transdermal gene delivery (if that is even feasible for the
gene therapy application contemplated by Eriksson), then Eirksson would no
longer use its multiple, reciprocating injection needles either.” Appeal Br.
16–17.
Eriksson discloses that “[g]enetic material can be delivered directly to
target cells of a patient using a microneedle delivery apparatus to repeatedly
puncture a target area, and to deliver, with each puncture, a small amount of
the genetic material provided in an aqueous solution.” Eriksson 5:29–33;
see also id. 5:55–6:9 (“microneedles 12 are reciprocally driven by a power
source 18,” wherein “[a] piston can oscillate the microneedles at a wide
range of speeds between 8 and 50 oscillations per second” and “[b]oth the
speed and amplitude can be predetermined by, for example, varying the
power applied to the motor”); id.at 6:22–29 (“[i]f solid microneedles are
used, . . . [n]o fluid delivery structure is needed if the device is to be used for
delivery only to an external target site, such as an intact skin or wound target
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site because fluid delivery can be readily accomplished by manual delivery
of the solution to the site before applying the microneedle device”).
Avrahami, as discussed supra, discloses that electrode tips are
inserted in the skin to form micro-channels because “device 60 is operative
to generate sparks in order to ablate skin 68” or “[a]lternatively, device 60
drives current into skin 68 in order to ablate the stratum corneum.” Id.
¶ 164; see also id. ¶ 29 (“such micro-channels are formed . . . due to spark
generation between the electrode and the skin as a result of sufficiently large
applied voltages”).
As set forth supra, the Examiner proposes modifying Eriksson’s
“needle array for cyclic skin penetration . . . to comprise an RF source
connected to [the] needle array . . . to allow for electrically-promoted drug
delivery through the creation of micro-channels.” Final Act. 5 (emphasis
added). In other words, Appellant is correct in that the Examiner is
proposing modifying Eriksson’s needles to provide spark generation to form
micro-channels as taught in Avrahami, in addition to maintaining Erikson’s
needle array as a puncturing mechanism due to the reciprocating motion of
the needle array. However, Appellant’s argument does not apprise us of
error in the Examiner’s combination which utilizes both methods for
creating channels in the skin, for the purpose of delivering genetic material
to target cells. In other words, Appellant does not provide sufficient
argument or evidence as to why Avrahami’s creation of micro-channels
cannot facilitate and supplement the gene delivery of Ericksson because both
Avrahami’s and Ericksson’s processes require delivery under the skin.
Accordingly, we sustain the Examiner’s rejection of claim 1, and
claims 2, 4, 7, 8, 16, 17, 19, 21, and 22 fall therewith.
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Rejection II– Obviousness over Ericksson, Avrahami, and Britva
Claims 3 and 18 depend from claims 1 and 16, respectively, and
recite, in relevant part, “wherein said oscillating frequency of said plurality
of needles is about from 1 Hz to 500 Hz.” Appeal Br. 20, 22 (Claims App.).
The Examiner relies on Britva for disclosing a treatment apparatus that has a
reciprocation speed from about 1 Hz to 100 Hz. Final Act. 8; see, e.g.,
Britva, Abstract. The Examiner reasons that it would have been obvious “to
modify the speed of the needles, as taught by Eriksson, to be from 1 Hz to
100 Hz, because this is an optimization of a range, which could be
discovered by one of ordinary skill in the art by routine experimentation,”
noting the “lack of disclosed criticality or unexpected results,” in the
Appellant’s Specification relative to the claimed range. Id.
Appellant submits that Britva’s application of RF energy to the skin is
for a purpose related to Appellant’s invention, which “has nothing to do with
either Eriksson or Avrahami,” and therefore, the Examiner’s reliance on
Britva is “arbitrary.” Appeal Br. 17. Appellant submits that “Britva does
not teach or suggest skin penetration, or that it would be advantageous for
any reason to apply RF energy in connection therewith.” Id.
To the extent Appellant’s argument addresses Britva’s disclosure of
skin penetration and/or RF energy application, Appellant’s argument does
not address the Examiner’s rejection, which relies on Eriksson for disclosing
skin penetration, on Avrahami for disclosing an RF source, and on Britva
solely for disclosing an oscillating speed. Further, although Britva fails to
disclose skin penetration, Britva does disclose a vibrating mechanism, and
Appellant does not apprise us of error in the Examiner’s reliance on the
disclosed oscillating frequency of Britva’s vibrating mechanism as
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instructing an appropriate oscillating frequency for Ericksson’s reciprocating
needle array.
Accordingly, we sustain the Examiner’s rejection of claims 3 and 18
as being unpatentable over Ericksson, Avrahami, and Britva is sustained.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7, 8,
16–22
103(a) Manstein,
Merchant
1–5, 7, 8,
16–22
1, 2, 4, 7, 8,
16, 17, 19,
21, 22
103(a) Ericksson,
Avrahami
1, 2, 4, 7,
8, 16, 17,
19, 21, 22

3, 18 103(a) Ericksson,
Avrahami, Britva
3, 18
Overall
Outcome
1–4, 7, 8,
16–19, 21,
22
5, 20

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–IN–PART