Ex Parte Kingsford

Patent Trial and Appeal Board

Oct 4, 2012

11739244 (P.T.A.B. Oct. 4, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte HOWARD A. KINGSFORD
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Appeal 2010-010134
Application 11/739,244
Technology Center 3700
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Before CHARLES N. GREENHUT, JAMES P. CALVE, and
BRADFORD E. KILE, Administrative Patent Judges.

CALVE, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the rejection of claims
1 and 3-31. App. Br. 3.1 Claim 2 has been cancelled. Id. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

1 Refers to Brief on Appeal on Behalf of Appellant Under 37 C.F.R. § 41.37,
filed October 27, 2009. A Response to Notice of Non-Compliant Appeal
Brief was filed December 18, 2009 to revise the Summary of Claimed
Subject Matter.
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Application 11/739,244

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CLAIMED SUBJECT MATTER
Claim 1 is illustrative of the claimed subject matter on appeal:
1. A skin attachment member comprising;
a backing having a first surface and a second surface;
a plurality of skin penetrating elements extending
integrally from the first surface of the backing to a distal tip, the
skin penetrating elements being sized to avoid contact with
nerves below the epidermal skin layer; and
a foam disposed on the first surface of the backing,
wherein at least a portion of the foam is disposed between at
least some of the skin penetrating elements, wherein at least
some of the skin penetrating elements each include a retention
barb extending from an outer side surface of the skin
penetrating element.

REJECTIONS
Claims 1, 3, 4, 6-13, 20, and 23 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Kingsford (US 2005/0118388 A1; pub. Jun. 2,
2005) and Cleary (US 2005/0228340 A1; pub. Oct. 13, 2005).2
Claims 5, 14-19, 21, 22, and 24-31 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Kingsford, Cleary, and Sun (US
2005/0010161 A1; pub. Jan. 13, 2005).3
ANALYSIS
Claims 1, 3, 4, 6-13, 20, and 23 as unpatentable over Kingsford and Cleary
Appellant argues claims 1, 4, 6-13, and 20 as a group. We select
claim 1 as representative. See 37 C.F.R. 41.37(c)(1)(vii) 2011). Claims 4,
6-13, and 20 stand or fall with claim 1.

2 The Examiner’s findings for claims 8 and 23 were made in this rejection.
Ans. 4, 5; cf. Supp. Ans. 1; see App. Br. 5 n.3, 9.
3 Findings for claim 24 were made in this rejection. Ans. 7; see App. Br. 9.
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Application 11/739,244

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Claims 1, 4, 6-13, and 20
The Examiner found that Kingsford discloses a skin attachment
member 10 with backing 12 and skin penetrating members 14 but does not
disclose a foam between skin penetrating elements. Ans. 3. The Examiner
found that Cleary discloses foam 60 between microneedles 19b that acts as a
recoil device to assist in placing the device at a certain depth and concluded
that it would have been obvious to use the Cleary’s foam on Kingsford to act
as a recoil layer. Id. at 3, 8 (citing fig. 6 and paras. [0077]-[0080]).
Appellant argues that “the present invention involves the synergistic
cooperation of a foam with the retention barbs, for enhanced retention of the
pierced skin layer” so that “[w]hen engaged in the skin, the retention barbs
are disposed below the surface of the skin, and the gentle withdrawal force
caused by the foam compression helps to preload the retention barbs into
active engagement with the skin layer to resist accidental dislodgement.”
App. Br. 5. This argument is not commensurate with the scope of claim 1.
Appellant also argues that a skilled artisan would not have been led to
add Cleary’s foam to Kingsford because Cleary uses the foam to pull the
needles back from their maximum penetration to provide enhanced flow and
nothing in Kingsford or Cleary suggests that it would be advantageous to
pull back on barbed elements of Kingsford that engage the skin to retain the
product against the skin. App. Br. 6. Appellant also argues that the barbed
elements are intended to remain fully engaged with the skin during use
whereas Cleary’s foam pad causes recoil or withdrawing of microneedles
from the skin (not preloading a barb against the skin). App. Br. 8. These
arguments are not commensurate with the scope of claim 1, which calls for
“the skin penetrating elements being sized to avoid contact with nerves
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Application 11/739,244

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below the epidermal skin layer” but does not recite any cooperative
structure, purpose or function of the foam with retention barbs of the skin
penetrating elements. Nor do these arguments persuade us of error in the
Examiner’s findings that Kingsford’s barbs “will still perform their function
fully and the recoil layer of Cleary will perform its function” because
“[e]ven though the barbs may be slightly pulled out, the wide section of the
barb still encounters and hooks into the skin, preventing the device from
being pulled off.” Ans. 8; see In re Kahn, 441 F.3d 977, 990 (Fed. Cir.
2006) (skilled artisan need not be motivated to combine the prior art for the
reason contemplated by an inventor). This finding is consistent with
Kingsford’s disclosure that epidermis thickness varies among patients and as
a result barbs 20 are disposed at varying locations to take advantage of
greater elasticity of the skin below the stratum corneum. Paras. [0030],
[0033]. We sustain the rejection of claims 1, 4, 6-13, and 20.
Claim 3
Claim 3 depends from claim 1 and recites that “at least a portion of
the foam extends to a height greater than the height of at least some of the
skin penetrating elements.” The Examiner found that Figure 6 of Cleary
discloses this feature. Ans. 3. We agree with Appellant that Figure 6 shows
the outer surface 61 of the foam 60 at the same height as the tips of the
microneedles 19b. The Examiner has not identified any disclosure in Cleary
regarding the height of the foam and microneedles. Hockerson-Halberstadt,
Inc. v. Avia Gp. Int’l, Inc., 222 F.3d 951, 956 (Fed. Cir. 2000) (“it is well
established that patent drawings do not define the precise proportions of the
elements and may not be relied on to show particular sizes if the specifica-
tion is completely silent on the issue”). We cannot sustain this rejection.
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Claim 23
Independent claim 23 recites a skin attachment member comprising a
backing, a plurality of skin penetrating elements, and a foam disposed on the
first surface of the backing and between at least some of the skin penetrating
elements, the foam having a pharmaceutical composition disposed therein.
The Examiner found that Kingsford and Cleary disclose this subject matter
as set forth for claim 1 and that it would have been obvious to include a
pharmaceutical composition of Kingsford in the foam of Cleary to increase
the device storage and the area over which medication is delivered. Ans. 4,
5. Appellant argues that the same reasoning regarding the synergistic effect
between foam and barbs noted for claim 1 applies and illustrates the non-
obviousness of claim 23. App. Br. 9. This argument is not persuasive for
the reasons set forth supra for claim 1. We sustain the rejection of claim 23.
Claims 5, 14-19, 21, 22, and 24-31 as unpatentable over Kingsford, Cleary,
and Sun
Appellant argues that Sun does not provide any teaching that would
have encouraged a skilled artisan to add the foam recoil layer of Cleary to
Kingsford as discussed for claims 1 and 23. App. Br. 10. This argument is
not persuasive for the reasons discussed supra. We sustain the rejection of
claims 5, 14-19, 21, 22, 25, 26, and 28-31.
Claim 24
Independent claim 24 recites a method of delivering a pharmaceutical
composition by attaching a skin attachment member to the skin of a subject,
the skin attachment member including a backing, skin penetrating elements,
and a foam with a pharmaceutical composition, and maintaining the skin
attachment member on the subject’s skin for a time sufficient to allow at
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least a portion of the pharmaceutical composition to permeate the epidermis
of the subject. The Examiner relied on Kingsford and Cleary to disclose this
method. Ans. 7. Appellant argues that claim 24 recites a method with a
product having all the features of claim 1 and the arguments for claim 1
apply to claim 24. These arguments are not persuasive for the reasons set
forth supra for claim 1. We sustain the rejection of claim 24.
Claim 27
Dependent claim 27 calls for “heating the skin attachment member.”
App. Br. 10-11. The Examiner found that Cleary discloses heat sealing the
skin attachment member. Ans. 7, 9. Appellant argues that the heating step
is done to cause the drug to permeate the skin more readily. This argument
is not commensurate with the scope of claim 27. Claim 27 does not specify
a particular order of the claimed method or require heating to occur while
the skin attachment member is maintained on the skin of a subject. See
Interactive Gift Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1342-43
(Fed. Cir. 2001). We sustain the rejection of claim 27.
DECISION
We AFFIRM the rejection of claims 1 and 4-31 and REVERSE the
rejection of claim 3.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED-IN-PART

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