Ex Parte Levinson et al

Patent Trial and Appeal Board

Jun 6, 2016

11741271 (P.T.A.B. Jun. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111741,271 04/27/2007 Mitchell E. Levinson
68981 7590 06/08/2016
Zeltiq Aesthetics, Inc.
Perkins Coie LLP
P.O. BOX 1247
SEATTLE, WA 98111-1247
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. CONFIRMATION NO.
579688008US 2666
EXAMINER
SHAY,DAVIDM
ART UNIT PAPER NUMBER
3769
NOTIFICATION DATE DELIVERY MODE
06/08/2016 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):
patentprocurement@perkinscoie.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MITCHELLE. LEVINSON, DONALD JOHNSON,
JESSICA PRECIADO, EDWARD A. EBBERS, and DANIEL BUCKS
Appeal2014-004637
Application 11/741,271 1
Technology Center 3700
Before JENNIFER D. BAHR, STEFAN STAICOVICI, and
SEAN P. O'HANLON, Administrative Patent Judges.
O'HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Mitchell E. Levinson et al. (Appellants) appeal under 35 U.S.C. § 134
from the Examiner's Final decision rejecting claims 1, 2, 4--8, 12, 15-17,
19-27, 33, 35-37, 40-45, and 47-50.2 We have jurisdiction over this appeal
under 35 U.S.C. § 6(b ).
1 According to Appellants, the real party in interest is Zeltiq Aesthetics, Inc.
App. Br. 1.
2 Claims 3, 9-11, 13, 14, 18, 28-32, 34, 38, 39, and 46 are canceled. See
Apr. 26, 2012 Amendment.
Appeal2014-004637
Application 11/741,271
We AFFIRM.
SUMMARY OF DECISION
SUMMARY OF INVENTION
Appellants' invention is directed to "devices, systems, and methods
for cooling subcutaneous lipid-rich cells with a heat exchanging element and
a thermally conductive cryoprotectant." Spec. i-f 19. Claim 1, reproduced
below from page 20 (Claims Appendix) of the Appeal Brief, is illustrative of
the claimed subject matter:
1. A system for removing heat from subcutaneous lipid rich
cells of a subject having skin, the system comprising:
a treatment device having a heat exchanging element
having a first side in thermal communication with a heat
exchanging surface and a second side opposite the first side, the
heat exchanging element being configured to reduce a
temperature of a target region such that lipid rich cells in the
target region are affected while preserving non-lipid rich cells
proximate to the heat exchanging surface;
a bioabsorbable temperature depressant with a freezing
point in the range of about -40°C to about 0°C configured to
contact at least one of the skin of the subject at a target region
and the heat exchanging surface, wherein the temperature
depressant comprises propylene glycol, and wherein the
temperature depressant is configured to reduce the risk of
intracellular and/or extracellular ice formation in the epidermis
and/or dermis; and
an absorbent containing the temperature depressant, the
absorbent being configured to be applied to the skin at the
target region and positioned to be proximate to the heat
exchanging surface.
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Application 11/741,271
REFERENCES
The Examiner relies on the following prior art references in rejecting
the claims on appeal:
Mignault us 681,806 Sept. 3, 1901
Mason us 4,764,463 Aug. 16, 1988
Hagan us 5,427,772 June 27, 1995
Meserol us 5,505, 726 Apr. 9, 1996
Kuri-Harcuch US 6,548,297 B 1 Apr. 15, 2003
Kipp US 2003/0077329 Al Apr. 24, 2003
Tang US 2004/0009936 Al Jan. 15,2004
Anderson US 2005/0251120 Al Nov. 10, 2005
Elkins US 2007/0129714 Al June 7, 2007
REJECTIONS
Claims 1, 4, 7, 8, 10-18, 21, 22, 25-27, 33, 35-37, 41, and 47-50 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over Anderson in
combination with Kuri-Harcuch, Hagan, Kipp, Elkins, and Mignault.
Claims 2, 19, 20, and 41--45 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Anderson in combination with Kuri-Harcuch,
Hagan, Kipp, Elkins, Mignault, and Mason.
Claims 5 and 23 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Anderson in combination with Kuri-Harcuch, Hagan,
Kipp, Elkins, Mignault, and Meserol.
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Application 11/741,271
Claims 6 and 24 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Anderson in combination with Kuri-Harcuch, Hagan,
Kipp, Elkins, Mignault, and Tang.
ANALYSIS
The Independent Claims
Appellants argue independent claims 1, 17, 27, 35, and 47 together.
App. Br. 13-17. We select claim 1 as representative, treating claims 17, 27,
35, and 47 as standing or falling with representative claim 1. See 37 C.F.R.
§ 41.37(c)(l)(iv).
Regarding independent claim 1, the Examiner finds that Anderson
discloses the treatment device as claimed, including, inter alia, the use of "a
substance such as glycerol or alcohols on the skin surface," but does not
"teach the use of polypropylene glycol per se as the cryoprotectant" or
"provide [any] details of the applicator." Final Act. 2-3. The Examiner
relies on Kuri-Harcuch to teach that glycerol is a cryoprotectant and on Kipp
to "teach that polypropylene glycol is a recognized cryoprotectant," and
concludes that it would have been obvious to a skilled artisan "to employ
polypropylene glycol, since this is not critical; is well within the scope of
one having ordinary skill in the art; provides no unexpected result." Id. at 3.
The Examiner relies on Mignault to "teach[] an applicator for applying
medicaments with apertures which are fed by an absorbent member, which
can be made of cotton," and concludes that it would have been obvious to a
skilled artisan
to employ [the] applicator of Mignault in the device of
Anderson et al, since Anderson et al provide no details of the
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Application 11/741,271
applicator, to employ gauze since this is well within the scope
of one having ordinary skill in the art, provides no unexpected
result, since cotton can be made into gauze, and since cotton
and gauze are recognized equivalents in the art, official notice
of which is hereby taken.
Id. (citing Mignault, 1, 11. 81-90).
Appellants first argue that "Mignault's lung protector is highly
thermally insulative," and, therefore, "a person of ordinary skill in the art
would have had no reason to use the lung protector of Mignault with the
cooling system of Anderson in the manner proposed by the Examiner
because Mignault' s lung protector would reduce or otherwise interfere with
thermal conductivity." App. Br. 14--15. We are not persuaded by
Appellants' argument because:
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test 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). As noted by the Examiner,
Anderson discloses that its cooling agent can be applied continuously and by
external means, and Mignault discloses a device for continuously
transmitting a liquid medical preparation to a subject. Ans. 5---6 (citing
Mignault, 1, 11. 79-89; Anderson, i-f 68). The Mignault device includes "a
coating of absorbent cotton" that "is saturated with the desired medical
preparation." Mignault 1, 11. 44--45, 88-89. We therefore find that the
Examiner's combination of Anderson and Mignault appears reasonable, and
Appellants do not apprise us why the Examiner's reading is unreasonable.
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Application 11/741,271
Furthermore, Mignault's cotton coating appears to be equivalent to
Appellants' absorbent. See Spec. i-f 51 ("The cryoprotectant may be
continually supplied using an absorbent (e.g., a cotton pad, a gauze, or other
absorbents) pre-loaded with the cryoprotectant"). Moreover, Anderson
suggests warming areas of the subject surrounding the treatment site (see
Anderson, i-f 182), so Appellants' argument that the Mignault device
provides thermal insulation is of no moment.
Next, Appellants argue that the rejection "fails to establish a
motivation for combining Anderson and Mignault that does not rely on
impermissible hindsight based on Appellants' disclosure." App. Br. 15. The
Examiner responds by finding that "Anderson et al teach the application of
cooling agents directly to the skin ... , and also teach that such agents may be
applied pulsed or continuously," and concludes that "[t]his demonstrates a
recognition of the need to replenish the agent by Anderson et al." Ans. 6
(citing Anderson, i-fi-1 67, 68).
We are unpersuaded by Appellants' argument. As noted by the
Examiner, and as discussed above, Anderson discloses that its cooling agent
can be applied continuously and by external means, and Mignault discloses a
device for continuously transmitting a liquid medical preparation to a
subject. See Id. at 6-7. We thus find that the Examiner has satisfied the
burden of showing "some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." KSR Int'! Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006)).
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Appellants next argue that the proposed combination of Anderson and
Mignault is improper because
[n]owhere in Anderson, however, is it suggested that glycerol
or any other substance may be absorbed into a patient's skin to
act as a temperature depressant. Rather, it is clear in context
that glycerol was included in the lotion disclosed in Anderson
because it has a relatively low freezing point and, therefore,
would tend to protect the lotion from freezing.
App. Br. 15-16. We find this argument to be unpersuasive. Although it is
not necessary that a reference explicitly state a feature of a disclosed
component in order to disclose such feature (see, e.g., Verdegaal Bros., Inc.
v. Union Oil Co. of Cal., 814 F.2d 628, 631-34 (Fed. Cir. 1987) (discussing
inherency)), as noted by Appellants, Anderson does disclose using a
"thermoconductive lotion consist[ing] mainly of glycerol" (see Anderson,
i-f 186; see also App. Br. 15). It is axiomatic that a lotion applied to skin will
be absorbed by the skin. This is bolstered by the fact that Anderson teaches
that its cooling agents-such as glycerol---can be applied topically and
should be non-toxic. See Anderson, i-fi-1 61, 67, 68. Additionally, an artisan
must be presumed to know something about the art apart from what the
references disclose. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962). We
therefore find that Anderson discloses glycerol to be a bioabsorbable
temperature depressant. The fact that Anderson may not have realized that
its lotion might act in such a manner, as suggested by Appellant, is of no
moment because such recognition is not required for disclosure. See
Verdegaal Bros., 814 F.2d at 632-33.
Next, Appellants argue that "[p]ropylene glycol, as recited in claims 1
and 47, and polypropylene glycol, as recited in the rejection, are different
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Application 11/741,271
compounds with different properties. Disclosure of polypropylene glycol as
a cryoprotectant in Kipp does not necessarily suggest use of propylene
glycol for the same purpose in other contexts." App. Br. 16. The Examiner
answers that a skilled artisan is "one versed in the art of treatments for
removing heat from subcutaneous lipid-rich tissues," and as such an artisan
would readily perceive, both polypropylene glycol and
propylene glycol are alcohols (this is evident from the ---ol
suffix on the chemical names of these compounds), thus while
these compounds may have "different properties" as alleged by
appellant, they will also have similar properties, such as a lower
freezing point than water (since they are alcohols) and thus
would be recognized as equivalents by one having ordinary
skill in the art. It is additionally noted that polypropylene
glycol, is merely propylene glycol with additional propylene
chains (to make polypropylene), and as such would not behave
significantly differently from propylene glycol in the context of
being a cooling agent, or cryoprotectant . . . . Kipp et al ...
express[ly] teach[] that polypropylene glycol is a cryoprotectant
(see paragraph [0071]), [and] that that [sic] carbohydrates such
as sugar alcohols (a group which includes both propylene
glycol and polypropylene glycol) are appropriate to use as
cryoprotectants ....
Ans. 7-8 (brackets around "0071" in original).
We agree with the Examiner that, at least in the instant context,
polypropylene glycol is an equivalent to propylene glycol. Kipp discloses
that polypropylene glycol is a cryoprotectant (Kipp i-f 71) and further that it
is used as an excipient (id. i-f 62) and that it can be applied topically (id.
i-f 46}-in other words, polypropylene is a bioabsorbable cryoprotectant.
The Examiner's assertion that substituting propylene glycol in place of
Kipp's polypropylene glycol appears reasonable, and Appellants do not
apprise us why the Examiner's assertion is unreasonable. See In re Pearson,
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494 F.2d 1399, 1405(CCPA1974) (citing In re Cole, 326 F.2d 769 (CCPA
1964)) ("Attorney's argument in a brief cannot take the place of evidence.");
see also In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (citing In re
Lindner, 457 F.2d 506, 508 (CCPA 1972)) ("It is well settled that
unexpected results must be established by factual evidence. Mere argument
or conclusory statements in the specification does not suffice.").
Finally, Appellants argue that because Kipp "is in the field of
pharmaceutical and cosmetic compositions" and "discloses polypropylene
glycol for protecting suspensions of poorly water soluble pharmaceutical
compounds during lyophilization," and because "the subject matter of claims
1 and 47 is in the field of systems for non-invasive surgery" and "disclose[s]
propylene glycol for increasing the ability of skin cells to resist cold-induced
damage," "Kipp is non-analogous art at least with respect to the subject
matter of claims 1 and 4 7 ." App. Br. 17 (citing Kipp, i-fi-1 4, 8, 71 ). We
disagree.
The analogous-art test requires that the Board show that a
reference is either in the field of the applicant's endeavor or is
reasonably pertinent to the problem with which the inventor
was concerned in order to rely on that reference as a basis for
rejection. In re Oetiker, 977 F.2d 1443, 1447 (Fed. Cir. 1992).
References are selected as being reasonably pertinent to the
problem based on the judgment of a person having ordinary
skill in the art. Id. ("[I]t is necessary to consider 'the reality of
the circumstances, '-in other words, common sense-in
deciding in which fields a person of ordinary skill would
reasonably be expected to look for a solution to the problem
facing the inventor." (quoting In re Wood, 599 F.2d 1032, 1036
(C.C.P.A.1979))).
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In re Kahn, 441F.3d977, 986-87 (Fed. Cir. 2006). We agree with the
Examiner that Kipp is analogous because it is pertinent to the problem of
selecting a temperature depressant, or cryoprotectant. See Ans. 8-9. In
addressing this problem, we find that one of ordinary skill in the art would
reasonably be expected to look for a solution in references related to
topically-applied therapeutic agents, including Kipp.
Accordingly, for the foregoing reasons, we sustain the Examiner's
rejection of claim 1 and of claims 1 7, 2 7, 3 5, and 4 7, which fall with claim
1, as being unpatentable over Anderson, Kuri-Harcuch, Hagan, Kipp, Elkins,
and Mignault.
The Dependent Claims
With respect to the rejections of claims 2, 4--8, 12, 15, 16, 19-26, 33,
36, 37, 40-45, and 48-50, Appellants rely solely on the arguments presented
above in regards to the respective independent claims. See App. Br. 18-19.
Accordingly, for the same reasons as discussed above, we also sustain the
rejections of claims 2, 4--8, 12, 15, 16, 19-26, 33, 36, 37, 40-45, and 48-50. 3
DECISION
The Examiner's decision to reject claims 1, 2, 4--8, 12, 15-17, 19-27,
33, 35-37, 40-45, and 47-50 is affirmed.
3 Claim 33 depends from cancelled claim 31. Consequently, there is
insufficient antecedent basis for the limitation of claim 33. It appears that
claim 33 should instead depend from claim 27. In the event of further
prosecution of the subject matter of claim 3 3, Appellant and the Examiner
may wish to consider taking appropriate action to correct this informality.
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Application 11/741,271
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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