Ex Parte 6,387,380 et al

Patent Trial and Appeal Board

Dec 26, 2012

90010161 (P.T.A.B. Dec. 26, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
90/010,161 05/09/2008 6,387,380 RX380 1327
83438 7590 12/26/2012
WOOD , HERRON & EVANS, LLP (SOLTA)
441 VINE STREET
2700 CAREW TOWER
CINCINNATI, OH 45202
EXAMINER
JONES, DWAYNE C
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
12/26/2012 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 SOLTA MEDICAL, INC.
____________

Appeal 2012-010520
Application 90/010,161
Patent 6,387,380
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal by the Patent Owner and real party in
interest of U.S. Patent No. 6,387,380, Solta Medical, Inc. (App. Br. 1), from
the Patent Examiner’s rejections of claims 1-4 and 12 in an ex parte
reexamination proceeding. The Board’s jurisdiction for this appeal is under
35 U.S.C. §§ 6(b), 134(b), and 306. We affirm.

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STATEMENT OF THE CASE
U.S. Patent No. 6,387,380 (hereinafter “the ‘380 Patent”) issued May
14, 2002. The named inventor is Edward W. Knowlton. A Request for Ex
Parte Reexamination of claims 1-4 and 10-13 of the ‘380 Patent was filed by
a Third-Party Requester on May 9, 2008 pursuant to 37 C.F.R § 1.510.
Reexamination was sought on the basis of prior art publications.
Reexamination was granted by the Examiner. Order Granting Request for
Reexamination, mailed July 24, 2008. Claims 10, 11, and 13 were cancelled
during the reexamination proceeding. App. Br. 2.
Patent Owner informs us that the ‘380 Patent was involved in
litigation in which a final judgment was made. Patent Owner states, that in
this final judgment, it was determined “that the third party Requestor and
real party in interest, Alma Lasers Inc., has not sustained its burden of
proving the invalidity of any patent claim of U.S. Patent No. 6,387,380. The
Order is from the United States District Court of Delaware in Civil Action
No. 07-224-GMS and was entered on May 21, 2010.” App. Br. 2.
This reexamination is related to ex parte reexamination of US
5,660,836, Application 90/010,160 (Appeal 2012-010518), which is being
decided concurrently.
The appealed claims are directed to a method of liposculpturing the
body. The claims stand rejected by the Examiner as follows:
1. Claims 1-4 and 12 under 35 U.S.C. § 102(b) as anticipated by
Storm1 as evidenced by Lax, 2 Sand, 3 and Weiss. 4 Answer 5.

1 U.S. Patent 4,140,130 (filed May 31, 1977) (issued February 20, 1979).
2 U.S. Patent 5,458,596 (filed May 6, 1994) (issued October 17, 1995).
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2. Claims 1-4 and 12 under 35 U.S.C. § 102(e) as anticipated Weiss as
evidenced by Lax or Sand. Answer 8.
3. Claims 1-4 and 12 under 35 U.S.C. § 102(e) as anticipated Lax as
evidenced by Basic Anatomy5 and Weiss. Answer 12.
4. Claims 1-4 and 12 under 35 U.S.C. § 103(a) as obvious over Izawa6
in view of Weiss or Storm as evidenced by Lax and Grant. 7 Answer 16.
5. Claims 1-4 and 12 under 35 U.S.C. § 103(a) as obvious over
Nagano8 in view of Weiss or Storm as evidenced by Lax, Sand, and Grant.
Answer 20.
As all the claims were disposed of in Rejections 1, 2, and 4, we have
not reached Rejections 3 and 5.
Claim 1, the only independent claim on appeal, is representative and
reads as follows. Bracketed numbers [1]-[5] have been added to facilitate
reference to the major limitations of the claim:
A method of liposculpturing an area of the body
including a skin with multiple layers, and an underlying area
made of a loculation of fat that has collagen tissue as a fibrous
septae, comprising:
[1] providing a thermal energy source;

3 U.S. Patent 5,484,432 (filed April 14, 1994) (issued January 16, 1996).
4 U.S. Patent 5,507,790 (filed March 21, 1994) (issued April 16, 1996).
5 Basic Anatomy – Tissues and Organs, available at
http://web.jjay.cuny.edu/~acarpi/NSC/14-anatomy.htm (last visited April 10,
2009).
6 Japanese Patent Application Publication Hei 04-89068 (published March
23, 1992).
7 Grant & Hackh’s Chemical Dictionary 492 (Roger Grant & Claire Grant
eds., McGraw-Hill Book Co., 5th ed. 1987)
8 Japanese Patent Application Publication Hei 06-285175 (published October
11, 1994).
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[2] positioning an energy delivery surface of the thermal
energy delivery source on an external surface of the skin;
[3] creating a reverse thermal gradient which cools a top
surface of the skin while heating the underlying loculation of
fat, wherein a temperature of the external skin surface is lower
than a temperature of the underlying loculation of fat;
[4] heating the skin and underlying loculation of fat
sufficiently to contract the collagen tissue of the fibrous septae
while minimizing cellular destruction of the melanocytes; and
[5] tightening at least a portion of the external surface of
the skin.

CLAIM INTERPRETATION
Claim interpretation is at the heart of patent reexamination because
before a claim can be compared to the prior art, it must be properly
interpreted. We therefore begin by interpreting claim 1. During
reexamination, the PTO must give claims their broadest reasonable
construction consistent with the specification. In re Am. Acad. of Sci. Tech
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Suitco Surface, Inc., 603
F.3d 1255, 1259 (Fed. Cir. 2010).
One of the disputes in this appeal is whether the claimed steps of [4]
contracting collagen tissue and [5] skin tightening require a minimum of
43°C to be produced by the [3] reverse thermal gradient.

Reverse thermal gradient, collagen contraction, and skin tightening
A [3] “reverse thermal gradient” is described in the ‘380 Patent as one
which “cools the top surface of the skin while heating the underlying
loculation of fat.” Col. 3, ll. 8-10. The cooling in the ‘380 Patent is said to
be produced by a cooling fluid that “can create a reverse thermal gradient at
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the epidermis to underlying desired layers of about 30 degrees to about 80
degrees C.” Col. 3, ll. 20-23. The gradient is used to partially denature
collagen in fibrous septae tissue and produce a contouring effect. Col. 2, ll.
50-55. The reverse thermal gradient is said to cause thermal lipolysis
(denaturing) of the collagen which allows for skin tightening and tightening
of the fibrous septae around fat loculations by “non invasive methods.” Col.
3, ll. 50-55; col. 4, ll. 21-29. The ‘380 Patent does not identify a temperature
at which these results are achieved, nor does it describe specific
characteristics of the gradient, such as steepness of it. Rather, the only
guidance provided by the ‘380 Patent is that the heating is produced without
damaging epithelial cells and melanocytes, to partially denature the collagen,
and reduce loculations of fat. Col, 2, ll. 41-54. Accordingly, we interpret
the “reverse thermal gradient” to encompass any difference in temperatures
between the overlying skin and underlying fat tissue which serves to
partially denature the collagen in the latter layers and cause skin tightening,
while not damaging the epithelial and melanocytes.
Step [4] of claim 1 recites “heating the skin and underlying loculation
of fat sufficiently to contract the collagen tissue.” Step [5] recites
“tightening at least a portion of the external surface of the skin.” While the
claim does not contain express language that would require the skin
tightening to be a consequence of the collagen contraction, the ‘380 Patent
expressly describes an association between the denaturation and skin
tightening.
For example, in the “Summary of the Invention,” it is stated that the
claimed liposculpturing is accomplished using a reverse thermal gradient in
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which the “[c]ollagen tissue of the fibrous septae is partially denatured and
contracted.” Col. 3, ll. 12-14. The collagen denaturation and subsequent
contraction is described as causing “a ‘tightening’ effect on the overlaying
skin.” Col. 2, ll. 1-3; col. 3, ll. 25-39; col. 5, ll. 50-53; col. 6, l. 66 to col. 7,
l. 8. Consistently, the “Background of the Invention” states that the
invention addresses the need for a method to accomplish skin tightening
through collagen contraction without damaging melanocytes and epithelial
cell. Col. 2, ll. 1-6 & 28-32.
As collagen shrinkage or contraction is the only mechanism described
in the ‘380 Patent for causing skin tightening, and the invention is said to
specifically address the need for skin tightening, it would be unreasonable to
read the claim any broader than warranted by the written description.
Accordingly, we interpret the step of [5] skin tightening to be a result of [4]
heating the skin surface to sufficiently contract the collagen tissue. As none
of these steps requires a specific amount of collagen contraction and
subsequent skin tightening, we interpret the claim to cover even minimal
amounts.

Temperature at which collagen contraction and skin tightening occur
The ‘380 Patent does not disclose the temperature to which the tissue
is heated in order to [4] “sufficiently to contract the collagen tissue” and
cause [5] skin tightening. However, the patent teaches that a thermal
gradient can be created with a cooling fluid from about 30 to 80°C. Col. 3,
ll. 20-23. While we do not limit the heating step to these values, the claimed
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step of [4] causing collagen contraction by heat would be reasonably
interpreted to occur within this disclosed range.
Despite the lack of disclosure in the ‘380 Patent of a specific value at
which collagen contraction tissue occurs, Patent Owner contends that the
prior art teaches a minimum of 43°C is needed to shrink collagen and
produce skin tightening, and thus the claim should be read to require this
value. App. Br. 6-7. Patent Owner supports this argument by the Lax and
Sand patents.
With respect to a numerical value for the minimum tissue
temperature of collagen and, hence, collagen containing tissue,
Lax teaches that "thermally induced contracture of collagen
fibrils" occurs at temperatures in a temperature range of 43°C to
90°C. See column 4, line 65 - column 5, line 5; column 10, lines
30-33; lines 41-45. Lax specifically teaches that "[l]ower
temperatures do not provide maximum thermal induced
contracture of the collagen fibrils". See column 5, lines 3-5.
Sand teaches that collagen fibers are stable when heated to a
temperature between 58°C to 60°C and only shrink when
heated within a narrow temperature range between 60°C and
70°C. See column 11, lines 44-51. Hence, the teaching in Lax as
confirmed by Sand is that a minimum tissue temperature higher
than 43°C is needed to denature and permanently shrink
collagen in order to induce contraction of the collagen
containing tissue.
App. Br. 7.
The issue is whether the claims should be construed to require a
minimum of 43°C to cause collagen contraction and skin tightening as
required by steps [4] and [5] of claim 1. The following findings of fact
(“FF”) are pertinent to this question:

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FF1
In the temperature range of 43 to 90 degrees C., maximum
collagen contraction is achieved. Additional temperature ranges
are 43 to 75 degrees C., and 45 to 60 degrees C. Lower
temperatures do not provide maximum thermal induced
contracture of the collagen fibrils. Greater temperatures create
excessive destruction and disintegration of the collagen fibrillar
pattern. Thus, the present invention is a method and apparatus
which accurately controls the application of heat within a
desired thermal range. This heat is delivered the collagen soft
tissue, thereby contracting and restricting the soft tissue
elasticity and improving stability.
Lax, col. 4, l. 67 to col. 5, l. 11.

FF2
A previously recognized property of hydro-thermal shrinkage
of collagen fibers when elevated in temperature to the range 60°
to 70° C. (an increase of about 30° C. above normal body
temperature) is but one of the unique characteristics of this
tissue not exhibited by other body tissues. Temperature
elevation ruptures the collagen ultrastructural stabilizing cross-
links, and results in immediate contraction in the fibers to about
one-third of their original lineal dimension, while increasing the
caliber of the individual fibers without changing the structural
integrity of the connective tissue.
Sand, col. 2, ll. 9-19.
The evidence does not establish that the claims should be limited to
require a minimum of 43°C to contract collagen and produce skin tightening
– as argued by Patent Owner. Lax describes the temperature range of 43-
90°C for “maximum collagen contraction.” FF1. This does not rule out
contraction happening at lower temperatures. Lax also states that “[l]ower
temperatures do not provide maximum thermal induced contracture of the
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collagen fibrils.” FF1. Patent Owner attempts to argue that the latter
sentence refers to the upper limits of 90°C, 75°C, and 60°C, but we discern
no language in this paragraph that would support that interpretation. App.
Br. 7. Patent Owner further points to Sand’s disclosure of 60-70°C to
support their contention that a minimum of 43°C is need to achieve collagen
contraction. However, at these temperatures, Sands states that “immediate
contraction in the [collagen] fibers to about one-third of their original lineal
dimension” occurred. FF2. The claims, however, do not require a specific
amount of collagen contraction.
Patent Owner argues that the claims should be read to require
denaturation and permanent contraction of the collagen found in the collagen
containing tissue. App. Br. 7. The ‘380 Patent refers to denaturation as
causing collagen contraction and skin tightening. ‘380 Patent, col. 7, ll. 3-
11. Denaturation is described as “cleaving heat labial cross links of the
collagen molecules.” Col. 7, ll. 37-38. This passage does not require that
the collagen cleavage, and subsequent contraction, be permanent and non-
reversible as argued. The claims, when read in the light of the Specification,
thus do not require permanent contraction as argued by Patent Owner.
Patent Owner cites commonly assigned US 6,749,624 (“the ‘624
Patent) as evidence that a lower temperature threshold will cause a
permanent modification to collagen tissue. App. Br. 7-8. Patent Owner
argues that the ‘624 Patent teaches that collagen contraction does not occur
unless the bond cleavage within the collagen molecule is permanent. Id. at
8.
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The earliest priority date of the ‘624 Patent is September 30, 1997,
which is after the April 17, 1996 filing date of the ‘380 Patent. Patent
Owner did not establish that the information in the ‘624 Patent was available
on the filing date of the ‘380 Patent. Thus, to the extent the teachings of the
‘624 Patent are said to bear upon the interpretation of claim 1, Patent Owner
did not show that one of ordinary in the art at the time the ‘380 Patent was
filed would have had the knowledge set forth in the ‘624 patent disclosure.
In any event, the ‘624 Patent does set forth the bright line temperature of
43°C as argued by Patent Owner. Rather, the ‘624 Patent teaches the “use of
low level thermal treatments over several days provides an additional way to
contract skin with minimal blistering and cell necrosis,” which may be
consistent with a temperature of 43°C, but also with lower temperatures.
‘624 Patent, col. 11, ll. 44-46.
Patent Owner also stated that Sands confirmed Lax’s teaching that a
minimum of 43°C is needed to denature and permanently to induce
contraction of the collagen containing tissue. App. Br. 6-7 (reproduced
above). This argument is not persuasive. Sands refers to a much higher
temperature range of 60-70°C to achieve “immediate contraction” of the
collagen fibers. FF2. Thus, Sands does not confirm Lax’s temperature of
43°C, but rather teaches a higher temperature to cause immediate
contraction of the collagen fibers.
In sum, we do not find that Patent Owner provided persuasive
evidence that claim 1 would be reasonably interpreted to require a minimum
of 43°C to achieve the recited “tightening the skin.”

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FF7
In the chart on the right part of FIG. 17, the beneficial effect of
surface cooling is clearly indicated and even greater deep heat to 9
centimeters is accomplished with the surface at physiologic
temperatures. As shown in this chart, with surface cooling the skin
is maintained at a fairly uniform temperature of below 20° C.; the
subcutaneous tissue is at fast cooled and then gradually rises to
about 40° C. after 30 minutes, and the deep (9 centimeters) muscle
heat gradually rises after 10 minutes to about 41°, 42° C.; the deep
muscle temperature recedes slightly and then increases to about
42° to 43° C. after 30 minutes.
Col. 9, ll. 21-34,
Analysis
The Examiner found that Storm applied a reverse thermal gradient to
the skin and subcutaneous tissue as in step [3] of claim. Answer 5. The
Examiner’s finding is factually supported by Storm’s disclosure. FF6
(rightmost graph). The Examiner found that the Storm did not describe its
methods for “liposculpturing an area of the body” nor “tightening the skin.”
Answer 5-6. However, the Examiner found that because Storm applied heat
to the underlying tissues as in claim 1, Storm implicitly met the
liposculpturing limitation and would achieve skin tightening as recited in the
claim. Id. To support this position the Examiner cited Lax and Sand which
teach applying heat as taught by Storm produces shrinkage of collagen as
recited in step [4] of the claim. Id. at 6.
“Inherent anticipation requires that the missing descriptive material is
‘necessarily present,’ not merely probably or possibly present, in the prior
art.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1295 (Fed.
Cir. 2002). Thus, the issue in this case is whether the Examiner had
sufficient evidence to establish that Storm’s method necessarily resulted in
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collagen contraction and skin tightening as claimed. To meet this burden,
the Examiner must have a sound basis for believing that process carried out
by Storm is the same as the claimed process. In re Spada, 911 F.2d 705, 708
(Fed. Cir. 1990); see also In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
In this case, Storm teaches that the subcutaneous tissue layer, which
contains collagen and fat deposits, rises to about 40°C in one example. FF7.
Lax describes maximal collagen contraction occurring in the temperature
range of 43°C to 90°C. FF1. While about 40°C is not necessarily 43°C, the
latter is the temperature at which maximal contraction occurs, and the claims
do not require maximal collagen contraction. The claim requires a quantity
of contraction that results in skin tightening. See supra at p. 6. No specific
amount of skin tightening is required. Id. Thus even a modicum of skin
tightening would satisfy the limitation of the claim. Because about 40°C is
close to value of 43°C disclosed in Lax at which maximal contraction
occurs, the Examiner had a reasonable basis to believe that some collagen
contraction and associated skin tightening would necessarily occur at the
somewhat lower temperatures taught by Storm. The burden thus shifted to
Patent Owner to show that Storm’s process did not produce any collagen
contraction or associated skin tightening.9
Patent Owner contends that Storm does not teach that collagen
contraction and the resulting skin tightening necessarily occurred in Storm.

9 “Where, as here, the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially identical
processes, the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.” In re Best, 562 F.2d 1252.

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App. Br. 10-11. Citing Lax’s teaching “that a minimum tissue temperature
higher than 43°C is needed to denature and permanently shrink collagen in
order to induce contraction of the collagen containing tissue,” Patent Owner
contends that Storm did not heat the subcutaneous fat layer to this
temperature. Id. at 7 & 10. As a consequence, Patent Owner contends that
the temperatures taught in Storm are not necessarily sufficient to contract
collagen or tighten skin as required by the claim. Id. at 9-10.
Patent Owner’s reading of Lax to require a minimum of 43°C to
achieve collagen contraction and skin tightening is not supported by
sufficient evidence. Lax expressly teaches a range of 43-90°C to achieve a
“maximum collagen contraction.” FF1. The Examiner’s position therefore
that collagen contraction occurs below this temperature is reasonable
because if the maximum occurred at 43°C, then at least some collagen
contraction would be expected to occur at lower temperatures, just not at
maximal amounts.
Patent Owner contends that this reading of Lax is improper:
When Lax states that “[l]ower temperatures do not provide
maximum thermal induced contracture of the collagen fibrils”,
Lax is clearly referring to reducing the upper threshold of the
temperature range from 90°C to either 75°C or 60°C, and then
concluding that reducing the upper temperature in the
temperature range would cause less than "maximum" collagen
contraction.
Reply Br. 3.
Patent Owner interprets the sentence “Lower temperatures do not
provide maximum thermal induced contracture of the collagen fibrils” to
mean lower temperatures than the 90°C, not lower than 43°C. However, this
is not what the paragraph teaches as a whole. Lax states that “maximum
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collagen contraction” is achieved “[i]n the temperature range of 43 to 90
degrees C.” Lax therefore does not pinpoint a specific temperature at which
the maximal contraction occurs, but leaves it open to occurring at the lowest
value of 43°C or at the highest value of 90°C. Because there is a broad
range of 43°C to 90°C disclosed at which maximal contraction could occur,
Patent Owner seems to infer that maximal contraction occurs closer to the
highest range of 90°C rather than at the lower temperatures. But this is only
conjecture, unsupported by meaningful evidence, such as expert testimony.
Patent Owner also argues that Storm teaches away from using
temperature to denature collagen because Storm discloses heating “while
maintaining the skin surface and subcutaneous tissue at a substantially lower
temperature to prevent damage thereto or burning of the skin surfaces.”
Storm, col. 8, ll. 22-25; App. Br. 10-11.
This argument is not persuasive. Storm describes an example with a
temperature of 40°C in the subcutaneous tissue, which the Examiner found
was sufficient to have resulted in some amount of skin tightening, a finding
we conclude is supported by the evidence. FF1, FF6 & FF7.
For the foregoing reasons, we affirm the rejection of claim 1 as
anticipated by Storm. Claims 2-4 and 12 were not argued separately and
therefore fall with claim 1. 37 CFR § 41.37(c)(1)(vii).

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2. ANTICIPATION BY WEISS
Findings of Fact
FF8 Weiss describes a method of reducing fat in subcutaneous
adipose tissue by accelerating non-destructive metabolic lipolytic activity
without killing or traumatizing associated tissues. Col. 6, l. 61 to col. 7, l. 1.
FF9 Weiss teaches:
According to one aspect of the present invention, there is
provided an electromedical method for noninvasively,
nondestructively and without tissue trauma, accelerating
lipolysis of subcutaneous adipose ("fat") tissue. The method
comprises the preliminary steps of:
. . .
focusing radiant energy on the work site to raise the
temperature thereof to range of about 40.0° to 41.5° C.,
but less than 43° C.; and
maintaining the radiant energy focused on the work site to
increase lipolysis rates thereof sufficiently . . . , thereby
reducing the volume of the adipose cells.
Col. 7, ll. 26-31; col. 59-65.
FF10
One skilled in this art is aware that the heating of the work zone
should be only to an effective temperature and for an effective
duration, and should not exceed an amount of heating that will
damage or kill tissue at the work zone or the surrounding tissue.
The key to this method is to apply energy to the work zone
sufficient to raise this site to a temperature of about 40°-41.5°
C., yet not exceed 42° C., thereby accelerating fat lipolysis
without killing the fat cells or adipocytes.
Col. 11, ll. 6-14.
FF11 According to Weiss, the energy is applied with a focusing
element through a temperature controlled water bolus “which protects the
skin and top layer of epidermis 12 and dermis 14 from damaging and painful
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effects of too much heating/energy absorption that skin absorbs.” Col. 9, ll.
7-15.
FF12 “The water bolus 38 can hold the top layers of skin and
underlying dermis and epidermis at ‘body’ temperatures or lower (28°-35°
C.) as desired by the operator in accordance with procedures well known to
those skilled in the art.” Col. 9, ll. 16-19.

Analysis
Weiss describes a method of reducing fat in subcutaneous adipose
tissue by accelerating non-destructive metabolic lipolytic activity without
killing or traumatizing associated tissues. FF8. The Examiner found the
Weiss applied heat in a reverse thermal gradient to achieve such effect as
recited in claim 1. Answer 9. The Examiner found that the tissues heated
by Weiss comprise collagen and therefore “the heated collagen of Weiss is
inherently contracted; thus tightening of the skin is achieved.” Id. at 10.
As summarized in the Findings of Fact, Weiss describes raising the
subcutaneous adipose tissue to a temperature of about 40.0° to 41.5° C., but
less than 43° C. FF9 & FF10. The issue is whether the Examiner had
reasonable basis to believe that such temperatures were sufficient to produce
contraction of the collagen containing tissue, and tightening the skin as
recited in claims, and if so, whether Patent Owner rebutted it.
The same reasoning relied upon in Storm applies here. While Lax
describes maximal collagen contraction occurring in the temperature range
of 43°C to 90°C, the claims do not require maximal collagen contraction.
The claims require only an amount of contraction that results in skin
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tightening, such that even a modicum of skin tightening would satisfy.
Because about 40°-41.5° C. is close to the value of 43°C disclosed in Lax at
which maximal contraction occurs, the Examiner had a reasonable basis to
believe that some collagen contraction and associated skin tightening would
occur at lower temperatures. The burden thus shifted to Patent Owner to
show that Weiss’s process did not result in skin tightening.
As with the Storm rejection, Patent Owner contends the Examiner did
not establish that the temperatures taught in Weiss are necessarily sufficient
to contract collagen containing tissue. App. Br. 16. Patent Owner argues
that Weiss teaches heating the subcutaneous adipose layer to a maximum
temperature of 41.5°C to 42°C. Id. Patent Owner contends that the
temperature for the subcutaneous fat layer in Weiss is less than the 43°C
threshold needed to contract collagen containing tissue as needed to perform
skin tightening. Id. For these reasons, Patent Owner concludes that the
tissue temperatures disclosed in Weiss would not necessarily provide
contraction of collagen containing tissue in the subcutaneous fat layer or
provide skin tightening. Id.
For the reasons described above in the Claim Interpretation section
and the analysis of Storm, we concluded that Patent Owner did not provide
sufficient evidence to establish that a temperature of at least 43°C is a
necessary threshold to produce collagen contraction and skin tightening a
required by claim 1. As stated above, any amount of collagen contraction
and skin tightening would satisfy the claims. Thus, the fact that Weiss does
not describe temperatures of 43°C is unavailing alone.
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Patent Owner cited three reexaminations in related patents in which
the Examiner was said to have withdrawn inherency rejections based on
Weiss. App. Br. 13. First, we are not bound by determinations made in a
different proceeding on a different patent. Second, the claims of the three
cited patents are not the same as those involved in this proceeding, so the
issues may be different. For example, US 6,241,753 has claims to inducing
the formation of scar collagen; US 6,381,498 to treating a skin surface with a
wrinkle; and US 6,405,090 to a skin treatment apparatus and a method of
tightening the skin without causing necrosis.
We note additionally that Weiss teaches that the lipolysis rates of fat
cells increased at the temperatures utilized in its method, i.e., temperatures
less than 43°C. FF8-FF10. The ‘380 Patent also describes the application of
a reverse thermal gradient to produce lipolysis as part of its liposculpturing
method. ‘380 Patent, col. 3, ll. 52-54. The ‘380 Patent does not distinguish
between the temperatures used to produce lipolysis and partial denaturation
of the collagen containing layers. Thus, the fact that both Weiss and the
‘380 Patent used heat to produce lipolysis is further basis to believe that
methods are the same.
For the foregoing reasons, we affirm the rejection of claim 1 as
anticipated by Weiss. Claims 2-4 and 12 were not argued separately and
therefore fall with claim 1. 37 CFR § 41.37(c)(1)(vii).

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20
4. OBVIOUSNESS IN VIEW OF IZAWA IN VIEW OF WEISS OR
STORM AS EVIDENCED BY LAX AND GRANT
The Examiner found that Izawa teaches an EM device for cosmetic
treatment. Answer 16. Izawa specifically described its device as “effective
for wrinkle removal and skin tension enhancement with facial treatment.”
Izawa, 6, ll. 3-5. The Examiner determined that the difference between the
claims and Izawa was that Izawa does not describe a reverse thermal
gradient. For the reverse thermal gradient, the Examiner relied upon the
teachings of Weiss and Storm. Answer 18. The Examiner found that it
would have obvious to one of ordinary skill in the art to apply the teachings
of Weiss and Storm to Izawa:
it would have been obvious to one having ordinary skill in the
art to use the cooling methods on the top surface of the skin as
taught by either Weiss or Storm in the skin tightening process
of Izawa with a reasonable expectation of success in achieving
a method that creates a reverse thermal gradient, wherein the
external (top) surface of the skin is lower than the temperature
of the underlying tissue (collagen) in order to minimize cellular
damage and patient discomfort; thus arriving at the claimed
invention.
Answer 18.
Patent Owner contends that Izawa does not teach collagen contraction,
nor the temperatures which are achieved by its device or the mechanism for
the skin tightening produced by the device. App. Br. 25. Therefore, Patent
Owner argues that skin tightening as a consequence of the contraction of
collagen containing tissue would not be necessarily present. Id. In support
of this argument, Patent Owner argues that Izawa teaches the skin tightening
can occur by mechanisms other than collagen contraction, such as with a
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Application 90/010,161

21
warm towel, and therefore there is no certainty that Izawa’s method causes
skin tightening. Id. at 25-27.
These arguments are not persuasive. The Examiner relied upon Izawa
for its teaching of a device to apply heat energy and the Storm and Weiss
publications, as evidenced by Lax, for their teaching of a reverse thermal
gradient. Applying the reverse thermal gradient described by Storm and
Weiss would have resulted in collagen contraction and skin tightening for
the reasons already discussed above. Thus, the fact that Izawa does not
describe the mechanism or operating temperatures to cause skin tightening
does not detract from the Examiner’s rejection because such temperatures
would be supplied by the cited Storm and Weiss publications which would
result in skin tightening for the reasons already described.
Patent Owner states Izawa also discloses the skin tightening can be
achieved by decreasing temperature. App. Br. 26. However, Izawa
expressly states that the “most significant advantage of the high-frequency
cosmetic device of the present invention is the heat generating effect.”
Izawa, p. 5, “Effect of the Invention.” This high frequency device that
produces heat is described as “effective for wrinkle removal and skin tension
enhancement with facial treatment.” Id. at 6. Accordingly, Izawa suggests
using heat treatment, which would reasonably suggest the heating
temperatures described in Storm and Weiss, as evidenced by Lax.
Patent Owner contends that neither Weiss nor Storm describes
temperatures at which collagen contraction would occur and therefore
following their teachings would not result in skin tightening. App. Br. 28-
32. We have already addressed this argument and found it flawed because
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22
the 43°C temperature described by Lax is the value at which maximal
contraction occurs, and therefore at least at some collagen contraction would
occur at lower temperature resulting in a least some degree of skin
tightening. As discussed above, the claims do not require a specific amount
of skin tightening. Consequently, any amount would satisfy the claims.
Patent Owner argues that Weiss teaches not to exceed the killing
temperature of 43°C, teaching away from the claimed invention. App. Br.
16. We have already found that the temperatures of Weiss would meet the
claimed limitations. Moreover, Weiss in fact teaches that temperatures
above 43°C had been used in the prior art to remove body fat tissues, albeit
causing pain. Weiss, col. 6, ll. 10-25. While such step might have been
inferior, that alone does not constitute a teaching away from using it, as long
as it was taught in the prior art as “usable” and had “been used” for the
stated purpose. In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). A “finding
that the prior art as a whole suggests the desirability of a particular
combination need not be supported by a finding that the prior art suggests
that the combination claimed by the patent applicant is the preferred, or most
desirable, combination.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir.
2004).
In addition, based on Izawa’s teaching that skin tightening is produced
by its heat generating device, it would have been obvious to find the
temperature to achieve it, as guided by the temperature ranges described in
Storm and Weiss, as evidenced by Lax. See Answer 20. Weiss, for
example, teaches applying heat to fat issue beneath the skin (FF9), the same
region targeted by Izawa (Page 3 [Mechanism] “With the above constitution,
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a high-frequency current is directly applied onto the skin to generate heat
due to molecular friction in biological tissues immediately underneath skin.
This heat generation is particularly focused on sites important for cosmetic
treatment.”) Lax specifically mentions dermatology applications (FF14),
which would be reasonably understood to include cosmetic treatments.
Thus, the skilled worker would have had reason to utilize Izawa’s device at
Weiss’s and Storm’s operating temperatures, as evidence by Storm.
Patent Owner argues that it was determined in reexaminations of
related patents that Izawa was deficient. App. Br. 27-28. However, Patent
Owner did not establish that the claims and rejections are the same as those
in this case. Moreover, we are not bound by the reexamination Examiner’s
determination in another application.
For the foregoing reasons, we affirm the rejection of claim 1 as
obvious in view of Izawa in view of Weiss or Storm as evidenced by Lax
and Grant. Claims 2-4 and 12 were not argued separately and therefore fall
with claim 1. 37 CFR § 41.37(c)(1)(vii).

TIME PERIOD FOR RESPONSE
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

KMF
Appeal 2012-010520
Patent 6,387,380
Application 90/010,161

24
Patent Owner
WOOD, HERRON & EVANS, LLP
2700 Carew Tower
441 Vine Street
Cincinnati, OH 45202

Third Party Requester
Hugh A. Abrams
SIDLEY AUSTIN LLP
One South Dearborn
Chicago, IL 60603