Ex Parte Ross

Patent Trial and Appeal Board

May 2, 2016

12636281 (P.T.A.B. May. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/636,281 12/11/2009
22827 7590 05/02/2016
DORITY & MANNING, PA
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
FIRST NAMED INVENTOR
Russell F. Ross
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
ATTORNEY DOCKET NO.
KCX-1761
(64590276US01)
CONFIRMATION NO.
1030
EXAMINER
BOSQUES, EDELMIRA
ART UNIT PAPER NUMBER
3763
MAILDATE DELIVERY MODE
05/02/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RUSSELL F. ROSS
Appeal2014-004950
Application 12/636,281
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PER CURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a
transdermal delivery device. The Examiner rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellant identifies the Real Party in Interest as Kimberly-Clark
Worldwide, Inc. (see Br. 1 ).
Appeal2014-004950
Application 12/636,281
Statement of the Case
Background
Appellant's invention relates to products "which deliver therapeutic
substances through the skin of a user using a plurality of very small needles"
(Spec. 1 :5-6).
The Claims
Claims 1-8 and 10-1 7 are on appeal. Independent claim 1 is
representative and reads as follows (emphasis added):
1. A transdermal delivery device comprising:
a support comprising a first surface and a second
surface;
a plurality of microneedles projecting outwardly from
the second surface of the support, at least one microneedle
comprising a base, a tip and an exterior surface;
a pathway comprising an aperture extending between
the first surface of the support and the second surface of the
support;
a first channel disposed on the exterior surface of the at
least one microneedle extending from the base of the
microneedle towards the tip and forming a substantially linear
path from the base towards the tip, the first channel at the base
being in alignment with a first portion of the aperture to form
a first junction through which substances may pass, the first
junction being formed in the plane of the second surface at
the base of the microneedle;
a second channel disposed on the exterior surface of the
microneedle extending from the base of the microneedle
towards the tip and forming a substantially linear path from
the base towards the tip, the second channel at the base being
in alignment with a second portion of the aperture to form a
second junction through which substances may pass, the
second junction being formed in the plane of the second
surface at the base of the microneedle, the second junction
being at a distance from the first junction, wherein the first
channel and the second channel are parallel to one another.
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Application 12/636,281
The Issues
A. The Examiner rejected claims 1---6, 8, and 10-17 under 35 U.S.C.
§ 103(a) as obvious over Gartstein2 (Ans. 2-12).
B. The Examiner rejected claim 7 under 35 U.S.C. § 103(a) as obvious
over Gartstein and Yuzhakov3 (Ans. 12).
Because the same issue is dispositive for both rejections, we will
consider them together.
The Examiner finds that Gartstein teaches
a transdermal delivery device (Figs. 4 and 18) comprising: a
support comprising a first surface (area under 184) and a
second surface (184); a plurality of microneedles (182)
projecting outwardly from the second surface (184) of the
support, ... ; a first channel (188, Fig. 18) disposed on the
exterior surface of at least one microneedle (182) extending
from the base of the microneedle (the channel extends from
the base of the microneedle towards the tip, see fig. 18)
towards the tip and forming a substantially linear path from
the base towards the tip, . . . a second channel (188; See
Annotated Fig. 18) disposed on the exterior surface of the
microneedle (182) extending from the base of the
microneedle (the channel extends from the base of the
microneedle towards the tip, See fig. 18) towards the tip and
forming a substantially linear path from the base towards the
tip, ...
(Ans. 3--4 (emphasis removed); see also Ans. 7-8.)
The Examiner acknowledges that "Gartstein discloses the claimed
invention except that the second and the first channel are parallel to one
another" (id. at 4). The Examiner concludes that "it would have been
2 Gartstein et al., US 2002/0045859 Al, published Apr. 18, 2002.
3 Yuzhakov et al., US 2005/0209565 Al, published Sept. 22, 2005.
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Appeal2014-004950
Application 12/636,281
obvious to provide parallel channels in the exterior surface of the
microneedle [of] Gartstein to facilitate the manufacturing procedure of the
microneedle" (id.; see also Ans. 9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Gartstein renders the claims
obvious?
Findings of Fact
1. Gartstein teaches
a system to deliver a composition, preferably a medical or
pharmaceutical composition or active, through the stratum
comeum of skin, without introducing bleeding or damage to
tissue, and absent pain or other trauma. The dimensions and
shapes of the microelements are controlled so as to control the
penetration depth into the skin. The microelements can be
"hollow" such that passageways are created therethrough to
allow the composition to flow from a chamber, through the
microelements, and into the skin.
(Gartstein Abstract; see also Ans. 3--4, 7-8.)
2. Figure 18 of Gartstein is reproduced below:
FIG. 18
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Application 12/636,281
Figure 18 shows that:
there are three separate channels 188 in the surface of the
elongated side wall 192. . . . These channels 188 lend
themselves well for capillary action to allow at least one
active to flow through the holes 186 and along the channels
188 into the stratum comeum, even if the areas between the
microelements 182 become substantially full of dead skin
cells and other foreign substances.
(Gartstein i-f 129; see also Ans. 3--4, 7-8, 13.)
3. Gartstein teaches that "[t]he base elements ... may have any
shape or configuration" (Gartstein i-f 65).
4. Gartstein teaches that
The articles of manufacture ... may compnse a
multitude of arrays, each array comprising the same or
different types or sizes of microelements, in which the various
attributes of the microelements, including microelement
density, appendage type, microelement angle, hollow
elements vs. solid elements with or without grooves, degree
of flexibility; protrusion distance; etc. may vary from array to
array or within a single particular array.
(Gartstein i-f 86.)
5. Gartstein teaches that "[a] capillary force will work to the
advantage of delivering a drug or other active [substances]" (Gartstein ,-r
101; see also Ans. 8, 13.)
6. The Specification teaches that "[t]he dimensions of the support,
microneedle, apertures, channels and junctions will be interdependent and
may vary substantially, depending on the desired use of the transdermal
delivery device" (Spec. 6:3-5).
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Appeal2014-004950
Application 12/636,281
7. The Specification teaches that
[t]he channel 30 may be variously positioned on the exterior
surface 24, forming a substantially linear path from the base
20 towards the tip 22, or forming a winding or circuitous path
along the exterior surface 24. In microneedles where two or
more channels are present, the channels 30 may be variously
spaced around the microneedle 18 in a symmetrical or
asymmetrical manner.
(id. at 6:27-7:2.)
Principles of Law
"If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007). As noted by the Court in KSR, "[a] person of ordinary skill
is also a person of ordinary creativity, not an automaton." Id. at 421.
"[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Analysis
Claims 1-6, 8, and 10--17
We agree with the Examiner that claims 1 and 10 are obvious over
Gartstein. We address Appellant's arguments below.
Appellant contends that
[ n Jot only are transdermal delivery devices in general far from
being "notoriously old," but, as discussed above, the scope
and content of Gar[ t] stein, et al. fails to disclose or suggest
limitations of the pending claims. The Examiner has not
pointed to any teaching of Gar[ t] stein et al. or to any
knowledge generally available in the art at the time of the
invention that teaches or suggests the limitations of the
claims. In other words, the first analysis that was carried out
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Application 12/636,281
in Kuhle, in which the claim element was found to be well
known in the prior art, has not been successfully carried out
in the present case.
(Br. 7-8 (emphasis removed).) Appellant argues that "the modifications of
Gar[ t] stein, et al. that would be required to meet the limitations of the
pending claims would entail much more than simply moving a well-known
component of a device from one location to another, i.e., more than a mere
rearrangement of existing parts as a design choice" (id. at 8 (emphasis
removed)). Appellant contends that "[t]o arrive at the pending claims, one
of skill in the art would need to significantly redesign the microelement of
Gar[t]stein, et al.," and that "[t]hese significant modifications would raise
additional issues of design that one of skill in the art would be required to
address, for instance regarding the overall volumetric flow parameters, and
so forth, of the device" (id. at 8-9 (emphasis removed)).
Appellant argues that "[o]nly with Appellant's specification could the
structures of the pending claims be attained, and any attempt to arrive at the
structures of the pending claims through study of the cited references is only
reachable from improper hindsight analysis after viewing Applicant's
specification" (id. at 10).
We do not find these arguments persuasive. As the Examiner points
out, Appellant "has not provided any criticality, novelty or unexpected
results related to the positioning of the channels in the claimed invention.
For instance, the examiner sustains that Gartstein's channels (188, Seen in
Figure 18) could be arranged paralle[l] to one another and permit flow
through the hole (186)" (Ans. 13). The Examiner also explains that:
[ o ]ne of ordinary skill in the art would have expected
Applicant's invention to perform equally well with a different
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Application 12/636,281
junction cross-sectional area because the junction area of the
invention of Gartstein permits simultaneous penetration and
delivery of a drug through a desired area of the skin (Refer to
paragraph [O 101 ]).
(id. at 8; see also Ans. 9.)
Gartstein teaches that "[t]he dimensions and shapes of the
microelements are controlled so as to control the penetration depth into the
skin" (FF 1 ), and that "channels 188 lend themselves well for capillary
action to allow at least one active to flow through the holes 186 and along
the channels 188 into the stratum comeum" (FF 2). Gartstein teaches that
"[t]he base elements ... may have any shape or configuration" (FF 3), and
that "[t ]he articles of manufacture ... may comprise a multitude of arrays,
each array comprising the same or different types or sizes of microelements,
in which the various attributes of the microelements, ... may vary from
array to array or within a single particular array" (FF 4).
Similarly; Appellant's Specification teaches that "[t]he dimensions of
the support, microneedle, apertures, channels and junctions will be
interdependent and may vary substantially, depending on the desired use of
the transdermal delivery device" (FF 6), and that "[t]he channel 30 may be
variously positioned on the exterior surface 24, forming a substantially linear
path from the base 20 towards the tip 22, or forming a winding or circuitous
path along the exterior surface 24 ... " (FF 7).
While we are fully aware that hindsight bias often plagues
determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36
(1966), we are also mindful that the Supreme Court has clearly stated that
"[i]f a person of ordinary skill can implement a predictable variation, § 103
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Application 12/636,281
likely bars its patentability" and that "[a] person of ordinary skill is also a
person of ordinary creativity, not an automaton." KSR, 550 U.S. at 417, 421.
In this case, we conclude that the person of ordinary skill would have
recognized that the use of parallel channels is a predictable variation that
would yield predictable results in which "[a] capillary force will work to the
advantage of delivering a drug or other active [substances]" (FF 5) and
represents, at best, an optimized configuration obtained by routine
experimentation of an element recognized as optimizable (FF 2-5). See In
re Aller, 220 F.2d at 456. Appellant provides no secondary consideration
such as unexpected results to demonstrate that selection of parallel channels
provides a secondary consideration that, when considered with the prima
facie case of obviousness, renders the claims unobvious.
Accordingly, the evidence of record supports the Examiner's
conclusion that Gartstein renders claims 1 and 10 prima facie obvious.
Appellant does not argue separately the claims for this obviousness
rejection. Therefore, claims 2---6, 8 and 15 fall with claim 1 and claims 11-
14, 16, and 17 fall with claim 10.
Claim 7
Appellant contends that "dependent claim 7 patentably defines over
the cited references for at least the reason that the claim depends from an
allowable independent claim" (Br. 11 ). Having affirmed the obviousness
rejection of claim 1 over Gartstein for the reasons given above, we also
affirm the rejection of claim 7.
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Application 12/636,281
SUMMARY
In summary, we affirm the rejection of claims 1 and 10 under 35
U.S.C. § 103(a) as obvious over Gartstein. Claims 2---6, 8 and 15 fall with
claim 1 and claims 11-14, 16, and 17 fall with claim 10.
We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) as
obvious over Gartstein and Yuzhakov.
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
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