Ex Parte Lambino et al

Board of Patent Appeals and Interferences

Jun 30, 2010

11113937 (B.P.A.I. Jun. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte JOHNSON & JOHNSON CONSUMER COMPANIES, INC.
____________________

Appeal 2009-013144
Application 11/113,937
Technology Center 3700
____________________

Decided: June 30, 2010
____________________

Before RICHARD E. SCHAFER, JAMESON LEE, and
RICHARD TORCZON, Administrative Patent Judges.

LEE, Administrative Patent Judge.

DECISION ON APPEAL

A. STATEMENT OF THE CASE
This is a decision on appeal by the real party in interest Johnson &
Johnson Consumer Companies, Inc. (“J & J”) under 35 U.S.C. § 134(a) from
a final rejection of claims 1-24. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm-in-part.
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References Relied on by the Examiner
Rosenberg et al. (“Rosenberg”) 5,910,147 Jun. 8, 1999
Connelly et al. (“Connelly”) 6,689,100 Feb. 10, 2004
Cormier et al. (“Cormier”) 2002/0128599 Sep. 12, 2002
Skover 2003/0078518 Apr. 24, 2003
Lastovich et al. (“Lastovich”) 2004/0064087 Apr. 1, 2004

The Rejections on Appeal
The Examiner rejected claims 19 and 21-24 under 35 U.S.C. § 102(b)
as anticipated by Lastovich.
The Examiner rejected claims 1-3, 8, and 9 under 35 U.S.C. § 103(a)
as unpatentable over Skover and Lastovich.
The Examiner rejected claims 4-7 under 35 U.S.C. § 103(a) as
unpatentable over Skover, Lastovich, and Cormier.
The Examiner rejected claims 10-16 and 18 under 35 U.S.C. § 103(a)
as unpatentable over Rosenberg and Connelly.
The Examiner rejected claim 17 under 35 U.S.C. § 103(a) as
unpatentable over Rosenberg, Connelly, and Lastovich.
The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as
unpatentable over Lastovich and Cormier.

The Invention
The invention relates to a method and device for treating acne. (Spec.
1:17-19.) The device includes a microprotrusion member that is pressed
against a patient’s skin with a pressure that is sufficient to pierce a layer of
skin known as the stratum corneum. (Id. at 1:21-25.)
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Claim 1 is reproduced below (App. Br. 8 Claims App’x.):1
A method of treating acne, wherein said method comprises

piercing the stratum corneum of skin in need of such treatment
with a stratum corneum-piercing device,

said device comprising a microprotrusion member having
a skin-contacting surface and plurality of stratum corneum-
piercing microprotrusions thereon,

wherein said device provides an impact pressure when
applied to said skin of from about 0.5 lbs/cm2 to about 7
lbs/cm2.

B. ISSUES
1. Has J & J shown that the Examiner was incorrect in finding that
Lastovich anticipates a devices that provides an impact pressure to skin of
from about 0.5 lbs/cm2 to about 7 lbs/cm2?
2. Has J & J shown that the Examiner erred in determining that a
person of ordinary skill in the art would have concluded that providing an
impact pressure of 0.5 lbs/cm2 to about 7 lbs/cm2 would have been obvious
based on the teachings of the prior art?
3. Has J & J shown that the Examiner erred in determining that a
person of ordinary skill in the art would have recognized that the teachings
of Rosenberg and Connelly may be combined?
4. Has J & J shown that the Examiner erred in determining that
claim 20 is obvious in light of the teachings of Lastovich and Cormier?

1 Claim 1 has been reproduced in a manner that complies with 37 C.F.R.
§ 1.75(i) (“[w]here a claim sets forth a plurality of elements or steps, each
element or step of the claim should be separated by a line indentation.”).
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C. FINDINGS OF FACT
1. Skover generally discloses a method of treating skin (Skover
Abstract), which includes creating an opening in the stratum corneum (id. at
2: ¶ 0019).
2. Lastovich discloses an abrader device for abrading and
penetrating the stratum corneum of skin. (Lastovich Abstract; 3: ¶ 0037.)
3. Lastovich describes that the amount of pressure supplied by the
device “may be controlled to provide optimum reproducible abrasion of the
desired area of the skin.” (Id. at 2: ¶ 0015.)
4. Lastovich also specifies that the amount of pressure is selected
so as to sufficiently penetrate the stratum corneum while not so great to as to
penetrate other epidermal layers of skin. (Id. at 6: ¶ 0066.)
5. Lastovich further describes that the appropriate pressure
supplied is determined as a matter of “routine experimentation.” (Id. at 3: ¶
0040.)
6. Lastovich does not set forth a specific range of pressure values.
7. Connelly discloses a device for withdrawing or delivering a
substance through a patient’s skin and includes a skin penetrating device
with a plurality of skin penetrating members. (Connelly Abstract.)
8. Connelly describes that the skin penetrating device is
positioned on a target site of a patient’s skin and “[p]ressure sufficient for
the skin penetrating device to penetrate the skin” is provided. (Id. at 2:65-
67.)
9. Connelly specifically describes that the skin penetrated is the
stratum corneum. (Id. at 3:59-64.)
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10. Rosenberg discloses a device for removing pus from a pimple
and includes one end with a lancet and another with a pimple drain member.
(Rosenberg Abstract.)
11. In Rosenberg, the lancet operates to pierce a pimple formed in a
patient’s skin. (Id. at 4:25-34.)
D. PRINCIPLES OF LAW
Anticipation is established only when a single prior art reference
discloses all elements of the claimed invention. In re Spada, 911 F.2d 705,
708 (Fed. Cir. 1990).
Where 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).
It is not necessary that the inventions of the references be physically
combinable, without change, to render obvious the invention under review.
In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983).
The test for obviousness is what the combined teachings of the
references would have suggested to those of ordinary skill in the art. In re
Keller, 642 F.2d 413, 425 (CCPA 1981).
E. ANALYSIS
The Anticipation Rejection
The Examiner rejected claims 19 and 21-24 as anticipated by
Lastovich. Claims 21-24 are dependent on, and argued collectively with,
independent claim 19. We focus on the limitations that are in dispute.
Claim 19 is drawn to a device that includes a plurality of microprotrusions
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for contacting and piercing a patient’s skin and which “provides an impact
pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7
lbs/cm2.” (App. Br. 10 Claims App’x.) J & J contends that Lastovich does
not disclose a device that provides that specific range of impact pressure,
i.e., about 0.5 lbs/cm2 to about 7 lbs/cm2.
Lastovich discloses an abrader device that delivers a substance into
the skin by pressing the device against the skin. (Lastovich Abstract.) The
Examiner does not disagree with J & J that Lastovich does not describe the
application of a particular pressure value that falls within the range of impact
pressures specified in the claims. According to the Examiner, however, the
requirement that the device “provides” the specified impact pressure is met
by a device that is simply capable of providing that pressure. The Examiner
concludes that Lastovich’s device is capable of supplying the required
impact pressure and meets the requirement of claim 19. (Ans. 10:4-7.)
We reject the Examiner’s position as it is based on an incorrect
interpretation of the claim recitation that it is the device that provides the
specified impact pressure. J & J’s specification describes embodiments in
which the device is configured to include components, such as springs or
other potential energy storage devices, that provide the pressure necessary to
pierce the skin. (E.g., Spec. pp. 23-26 and pp. 30-33.) In the context of J &
J’s specification, the claim requirement that the device provides certain
impact pressure means the device itself is suitably set and configured to
output the necessary level of impact pressure. The Examiner does not point
to any portion of Lastovich establishing that its device is already configured
to supply an impact pressure within the specified range. Neither does the
Examiner find that such a setting is inherent to Lastovich’s device. That
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Lastovich’s abrader device may possibly be configured and arranged to
output a necessary pressure level is not enough to meet the claimed
limitation of J & J’s claim 19.
We do not sustain the rejection of claim 19 as anticipated by
Lastovich. We also do not sustain the rejection of dependent claims 21-24,
which include all the features of claim 19, as anticipated by Lastovich.
The Obviousness Rejections
The Examiner rejected each of claims 1-18 and 20 as obvious in view
of the prior art. Specifically, the Examiner rejected the claims as follows:
(1) claims 1-3, 8, and 9 as unpatentable over Skover and Lastovich; (2)
claims 4-7 as unpatentable over Skover, Lastovich, and Cormier; (3) claims
10-16 and 18 as unpatentable over Rosenberg and Connelly; (4) claim 17 as
unpatentable over Rosenberg, Connelly, and Lastovich; and (5) claim 20 as
unpatentable over Lastovich and Cormier.
The rejections of claims 1-9
Claims 1-3, 8, and 9 were rejected based on the combined teachings of
Skover and Lastovich. Claims 4-7 were rejected over those references along
with Cormier. The patentability of claims 2-9 is not argued apart from that
of claim 1. Claim 1 is drawn to a method of treating acne on skin and
includes using a stratum corneum-piercing device that “provides an impact
pressure when applied to said skin of from about 0.5 lbs/cm2 to about 7
lbs/cm2.” (App. Br. 8 Claims App’x.) J & J contends that neither Skover
nor Lastovich discloses that an impact pressure in that range is provided. J
& J also argues that its invention is not an obvious modification of the
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teachings of the references. In support of that argument, J & J states the
following (App. Br. 5:8-11):
Applicants have experimentally identified an optimum pressure range
for use in their methods and device, so that they may be used on facial
skin. As neither Skover nor Lastovich is concerned with facial skin
(or skin on any other specific area of the body), they cannot teach this
improvement.

J & J’s argument is misplaced. The claims do not refer to “facial
skin.” The claims refer only generally to “skin.” The record does not reflect
that the specified impact pressure range appearing in the claims is
“optimum” only for a specific area of skin, to the exclusion of any other
area. The assertion is merely argument of counsel, which cannot take the
place of evidence lacking in the record. Estee Lauder Inc. v. L'Oreal, S.A.,
129 F.3d 588, 595 (Fed. Cir. 1997).
In any event, the Examiner reasoned that in view of the teachings of
Skover and Lastovich, a person of ordinary skill in the art would have
recognized that the impact pressure applied to skin for stratum corneum
piercing devices is a result effective variable and would have optimized the
impact pressure to values within the range called for in J & J’s claims. (Ans.
10:18-11:3.) That reasoning is sound.
Skover generally discloses a method of treating skin (Skover
Abstract), which includes creating an opening in the stratum corneum. (Id.
at 2: ¶ 0019.) Lastovich discloses an abrader device for abrading and
penetrating the stratum corneum of skin. (Lastovich 3: ¶ 0037.) Lastovich
describes that the amount of pressure supplied by the device “may be
controlled to provide optimum reproducible abrasion of the desired area of
the skin.” (Id. at 2: ¶ 0015.) Lastovich also specifies that the amount of
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pressure is selected so as to sufficiently penetrate the stratum corneum while
not so great to as to penetrate other epidermal layers of skin. (Id. at 6: ¶
0066.) Lastly, Lastovich describes that the appropriate pressure provided is
determined as a matter of “routine experimentation.” (Id. at 3: ¶ 0040.)
Thus, a person of ordinary skill in the art would have recognized that
the teachings of the prior art, and in particular those of Lastovich, apply to
the penetration of any “desired area of skin,” e.g., facial skin. Furthermore,
where 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 at 456. The teachings of Lastovich
reflect that a person of ordinary skill in the art would have determined
through routine experimentation the impact pressures which are suitable for
the penetration of the stratum corneum. We reject J & J’s argument that it
would not have been obvious to optimize the impact pressure to a value
within the range specified in J & J’s claims. That argument does not
adequately account for the ability of one of ordinary skill in the art in
following the teachings of Lastovich with respect to determining an
appropriate impact pressure for penetrating a patient’s skin.
We sustain the rejection of claim 1 over Skover and Lastovich.
Because claims 2-9 are not separately argued apart from claim 1, we also
sustain the rejection of claims 2, 3, 8, and 9 over Skover and Lastovich, and
the rejection of claims 4-7 over Skover, Lastovich, and Cormier.
The rejections of claims 10-18
The Examiner rejected claims 10-16 and 18 over Rosenberg and
Connelly, and claim 17 over Rosenberg, Connelly, and Lastovich. J & J
argues dependent claims 11-18 collectively with independent claim 10.
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Claim 10 is drawn to a method of removing pus from a pimple and includes
a device that “provides an impact pressure when applied to said skin of from
about 0.5 lbs/cm2 to about 7 lbs/cm2.” (App. Br. 9 Claims App’x.)
J & J contends that neither Rosenberg nor Connelly, taken singly or in
combination, describe the use of an impact pressure within that stated range.
According to J & J, each of the references is “completely silent about
pressure.” (Id. at 6:8; 6:12.)
Rosenberg discloses a device for removing pus from a pimple and
includes one end with a lancet and another with a pimple drain member.
(Rosenberg Abstract.) The lancet operates to pierce a pimple formed in a
patient’s skin. (Id. at 4:25-34.) Connelly discloses a device for withdrawing
or delivering a substance through a patient’s skin and includes a skin
penetrating device with a plurality of skin penetrating members. (Connelly
Abstract.) Connelly describes that the skin penetrating device is positioned
on a target site of a patient’s skin and “[p]ressure sufficient for the skin
penetrating device to penetrate the skin” is provided. (Id. at 2:65-67.) The
Examiner explained that in light of the teachings of those references, a
person of ordinary skill in the art would have recognized that the impact
pressure to penetrate a patient’s skin is a result effective variable and would
have known to optimize that variable by selecting an impact pressure that is
within the range set forth in J & J’s claims. (Ans. 11:20-21:1.)
The Examiner’s explanation is reasonable. J & J’s assertion that each
reference, including Connelly, is “silent about pressure” is inaccurate and
does not account for Connelly’s disclosure of supplying a “sufficient”
pressure to penetrate skin. J & J does not meaningfully explain why impact
pressures falling within the range “about 0.5 lbs/cm2 to about 7 lbs/cm2” are
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outside of the known pressures values that a person of ordinary skill in the
art would have readily appreciated as sufficient for skin penetration.
J & J also argues that the teachings of Rosenberg and Connelly are not
combinable because the references “approach withdrawing substances from
the skin in two different ways.” (App. Br. 6:20-22.) According to J & J (Id.
at 6:22-27):
Rosenberg uses separate tools to cut and then withdraw a substance
from the skin in sequence, using the one end and then the other end of
the device. Connelly is designed to cut the skin and withdraw a
substance at the same time through a single location. The devices
cannot be combined without changing their essential structures and
operating them in ways contrary to what each references teaches.

J & J’s argument is misplaced. It is not necessary that the inventions
of the references be physically combinable, without change, to render
obvious the invention under review. In re Sneed, 710 F.2d 1544, 1550 (Fed.
Cir. 1983). Rather, the test for obviousness is what the combined teachings
of the references would have suggested to those of ordinary skill in the art.
In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Here, each of Rosenberg and Connelly describe devices that operate
to penetrate skin. Connelly teaches that the amount of pressure necessary
for skin penetration must be “sufficient.” That the particular configurations
of the two devices are not identical to one another or may not be
immediately implementable onto one another, without change or adjustment,
does not mean that their teachings can not be combined. The level of
ordinary skill in the art is such that one with ordinary skill would have
appreciated from the combined teachings of the references that there are a
number of known configurations for skin penetrating devices and that those
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devices operate to pierce skin upon application of a range of impact
pressures. A person of ordinary skill in the art would have readily
recognized that the teachings of Rosenberg and Connelly may be combined
and that they adequately account for the features of claim 10.
For the foregoing reasons, we sustain the rejection of claim 10. We
also sustain the rejection of claims 11-16 over Rosenberg and Connelly and
claim 17 over Rosenberg, Connelly, and Lastovich.
The rejection of claim 20
Claim 20 is dependent on claim 19. Claim 19 recites (App. Br. 10
Claims App’x.):2
A device comprising
(i) a microprotrusion member having a skin-contacting surface
and plurality of stratum corneum-piercing microprotrusions thereon
and
(ii) a composition comprising an anti-acne agent,
wherein said device provides an impact pressure when applied
to said skin of from about 0.5 lbs/cm2 to about 7 lbs/cm2.

Claim 20 adds features specifying that the composition is “coated”
onto portions of the device including the stratum-corneum piercing
microprotrusions.
The Examiner rejected claim 20 as unpatentable over Lastovich and
Cormier. The Examiner determined that Lastovich accounts for all the
limitation of claim 20 with the exception of microprotrusions that are coated.
To make-up for the deficiency the Examiner pointed to Cormier as teaching

2 Claim 19 has been reproduced with indentations in accordance with 37
C.F.R. § 1.75(i).
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the coating of a stratum corneum piercing member 10 with a therapeutic
agent. (Ans. 9:1-4.)
J & J challenges the Examiner’s rejection, stating the following (App.
Br. 7:15-16).
Cormier does not teach or suggest a device for use on the face or to
treat acne. Applicants maintain this combination does not arrive at the
claimed invention.

J & J, however, does not explain the significance of those statements.
Neither claim 20 nor claim 19 refer to a “face.” Nor does either claim refer
to treating acne. Claim 19 does refer to its composition as being an “anti-
acne agent.” However, each of Lastovich and Cormier disclose that a
variety of “pharmaceutical agents” may be delivered to the skin of a patient.
(Lastovich 3: ¶ 00036; Connelly 4:1-15.) J & J does not explain why a
person of ordinary skill in the art would not have appreciated that the
pharmaceutical agents described in those references can include anti-acne
agents, or that one with ordinary skill would not have recognized acne as a
skin condition treatable by a pharmaceutical agent.
We sustain the rejection of claim 20 as unpatentable over Lastovich
and Cormier.
New Ground of Rejection
Pursuant to 37 C.F.R. § 41.50(b), the following new ground of
rejection is applied to J & J’s claim 19.
Claim 19 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Lastovich and Cormier.
Because claim 20 is unpatentable over the combination of Lastovich
and Cormier, the broader claim 19, all of whose features are included in
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claim 20, is also unpatentable over Lastovich and Cormier. See Ormco
Corp. v. Align Tech., Inc., 498 F.3d 1307, 1319-20 (Fed. Cir. 2007); In re
Muchmore, 433 F.2d 824, 825 (CCPA 1970).
F. CONCLUSION
1. J & J has shown that the Examiner was incorrect in finding that
Lastovich anticipates a devices that provides an impact pressure to skin of
from about 0.5 lbs/cm2 to about 7 lbs/cm2.
2. J & J has not shown that the Examiner erred in concluding that
a person of ordinary skill in the art would have concluded that providing an
impact pressure of 0.5 lbs/cm2 to about 7 lbs/cm2 would have been obvious
based on the teachings of the prior art.
3. J & J has not shown that the Examiner erred in determining that
a person of ordinary skill in the art would have recognized that the teachings
of Rosenberg and Connelly may be combined.
4. J & J has not shown that the Examiner erred in determining that
claim 20 is obvious in light of the teachings of Lastovich and Cormier.
G. ORDER
The rejection of claims 19 and 21-24 under 35 U.S.C. § 102(b) as
anticipated by Lastovich is reversed.
The rejection of claims 1-3, 8, and 9 under 35 U.S.C. § 103(a) as
unpatentable over Skover and Lastovich is affirmed.
The rejection of claims 4-7 under 35 U.S.C. § 103(a) as unpatentable
over Skover, Lastovich, and Cormier is affirmed.
The rejection of claims 10-16 and 18 under 35 U.S.C. § 103(a) as
unpatentable over Rosenberg and Connelly is affirmed.
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The rejection of claim 17 under 35 U.S.C. § 103(a) as unpatentable
over Rosenberg, Connelly, and Lastovich is affirmed.
The rejection of claim 20 under 35 U.S.C. § 103(a) as unpatentable
over Lastovich and Cormier is affirmed.

This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). That section provides that the Appellant, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to the
examiner….

(2) Request rehearing. Request that the proceeding
be reheard under § 41.52 by the Board upon the
same record….

AFFIRMED-IN-PART

rvb

PHILLIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003