Ex Parte Patil et al

Patent Trial and Appeal Board

Oct 10, 2018

11650919 (P.T.A.B. Oct. 10, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/650,919 01/08/2007
27752 7590 10/12/2018
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
FIRST NAMED INVENTOR
Pankaj Yadav Patil
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.
10678 9644
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
10/12/2018 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):
centraldocket.im @pg.com
pair_pg@firsttofile.com
mayer.jk@pg.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte P ANKAJ Y ADA VP ATIL, RICHARD TWEDDELL III, and
SASWATI DATTA
Appeal2017-006491
Application 11/650,919
Technology Center 1600
Before MICHAEL J. FITZPATRICK, ULRIKE W. JENKS, and
TA WEN CHANG, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeals from Examiner's
decision to reject claims 1, 3-5, 8, 11-13, 15-20, and 32 as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the real party in interest as The Procter & Gamble
Company of Cincinnati, Ohio. Br. 1.
Appeal2017-006491
Application 11/650,919
STATEMENT OF THE CASE
Claims 1, 3-5, 8, 11-13, 15-20, and 32 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Br. 10-13. Claim 1 is
representative of the claims on appeal, and reads as follows:
Claim 1: A substrate that mimics mammalian skin comprising:
a) a discrete first layer that resembles an outermost layer
of skin and includes a first surface, an opposing second surface
and a polymeric first material comprising polyurethane
polymer, wherein the first layer has a thickness of from 1
micron to 1000 microns and a hardness of from about 10 to
about 80 on the Shore A scale;
b) a discrete second layer comprising a first surface, an
opposing second surface, and a second material comprising
silicone gel, wherein the second layer has a hardness of from
about 1 to about 70 on the Shore 000 scale and a thickness of
from 0.001 cm to 2.0 cm;
c) a discrete third layer comprising a first surface and a
third material comprising polyurethane polymer, wherein the
third layer has a hardness of from about O to about 90 on the
Shore D scale; and
wherein the second surface of the first layer is in
substantially fixed and continuous contact with the first surface
of the second layer; the second surface of the second layer is in
substantially fixed and continuous contact with the first surface
of the third layer; and wherein the ratio of the average thickness
of the second layer to the average thickness of the third layer is
from 4:96 to 25:75; and
d) at least one coating material that is stably affixed to
the first surface of said first layer, wherein said coating material
imparts to the first layer at least one physical property that is
representative of mammalian skin.
Br. 10 (formatting added).
2
Appeal2017-006491
Application 11/650,919
Appellants request review of Examiner's rejection of the claims under
35 U.S.C. § 103(a) as obvious over Graham,2 JP '339, 3 Skin Flex III, 4
Toms, 5 and Gennisson. 6
The issue is: does the evidence of record support Examiner's
conclusion that the skin model disclosed in the combination of references
meets all the claimed elements?
Findings of Fact
FF 1. Graham teaches a skin model for practicing intradermal injections.
Figure 2, is reproduced below, and shows the skin model having three
layers:
In Figure 2 above, Graham describes "three basic layers: (1) a
subdermal tissue-simulating layer 11; (2) a dermis-simulating layer
2 Graham et al., US 4,481,001, issued Nov. 6, 1984 ("Graham").
3 JP 11-009339 (1999), translation of record ("JP'339").
4 SkinFlex III, product information BJB Enterprises, Inc., May 31, 2000
("SkinFlex III").
5 Toms et al., US 6,093,468, issued July 25, 2000 ("Tome").
6 Gennisson et al., Assessment of Elastic Parameters of Human Skin Using
Dynamic Elastography, 51 IEEE TRANSACTIONS ON ULTRASONICS,
FERROELECTRICS, AND FREQUENCY CONTROL, 980-989
(2004 )("Gennisson").
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Application 11/650,919
12; and (3) an epidermis-simulating layer 13171 _ The model is
contained in a shallow dish-shaped container 14[, and]. ... [w]hen
packaged for storage the container will be fitted with a hermetically
sealed lid or peel off cover (not shown)." Graham 2: 13-20.
FF2. Graham teaches a human skin model containing an elastomeric
subcutaneous tissue-simulating layer, a dermis-simulating layer, and
an epidermis-simulating layer. Id. 1 :45---60. Graham's "subcutaneous
tissue-simulating layer is made of synthetic or natural elastomer such
as natural rubber, styrene-butadiene rubber, styrene-butadiene-
acrylonitrile rubber, polyisobutene, polyisoprene, silicone,
polyetherurethane and polyurethane." Id. 2:26-30. Graham's
elastomeric subcutaneous layer ranges in thickness from 3 to about
10 mm. Id. 2:32. "The [subcutaneous tissue-simulating] layer has a
Durometer hardness (Shore A scale) in the range of about 1 and about
3 and a compression deflection (measured at 25% deflection) of less
than about 1 psi, usually in the range of 0.3 and 1 psi." Id. 2:49-52.
FF3. Graham's dermis-simulating layer is made of an elastomer,
preferably silicone rubber because the tensile strength of silicone
rubber is easily varied and reproduced. Id. 2:53-54. "The thickness
of the derma layer approximates that found in natural skin and will
7 We note that Graham's Figure 2 is mislabeled, because the descriptive text
in the specification identifies element 16 as an interconnecting network of
pores that is part subcutaneous tissue-simulating layer. See Graham 2:33-
36. In other words, the subdermal tissue-simulating layer in Figure 2 should
have been identified as element 13, while the epidermal layer should be
identified as element 11. See Graham Figure 4 (providing a flow chart
detailing the system assembly); see id. 4: 34---64.
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Appeal2017-006491
Application 11/650,919
usually be in the range of about 1 to about 3 mm, preferably about 1 to
2 mm." Id. 2:63---65. The dermal layer may also contain fibrous
material for tensile strength. Id. 65---67. "The dermal layer has a
Durometer hardness in the range of about 2 and about 10." Id. 3: 10-
1 1.
FF4. Graham's "epidermis-simulating layer[] is made of a high rupture
strength, distensible, high tensile strength elastomer. Natural rubber
latex is preferred." Id. 3: 34--3 7. The thickness of the epidermis-
stimulating layer is from about 0.1 to about 1 mm, with the tensile
strength of about 3000 to about 4500 psi, and having a Durometer
hardness in the range of 25 to about 45, and elongation in the range of
750% to about 950%. See id. 3:43-57.
FF5. JP '339 teaches an artificial skin model containing layers that allow
cosmetics to be applied and cleaned off. See JP '339 ,r,r 1, 29. The
skin model can contain a surface coat and a basis layer each made of a
urethane resin. See id. ,r,r 9, 12.
FF6. JP '339 teaches that rubber "is deficient in a feeling of aesthetic
appreciation and textures as the false skin, ... and although a certain
thing is close to the skin in appearance, it differs from the skin by the
physical properties, especially textures." Id. ,r 3.
FF7. "SkinFlex III castable and brushable material systems can be applied
against many types of mold surfaces as a single system to make skin-
like parts." SkinFlex III, 1, see 2 ( application of Skin Flex III is also
brushable).
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Appeal2017-006491
Application 11/650,919
Principle of Law
"[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting aprimafacie case ofunpatentability." In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
Examiner finds that Graham teaches a "human skin model comprising
a laminate of three layers." Office Act. 8,9 6; FF1-FF4; see Final Act. 3
(maintaining prior rejection); see Ans. 2 (maintaining prior rejection).
According to Examiner, Graham does not exemplify that the first and third
layers are made of polyurethane. See Office Act. 7. Examiner additionally
acknowledges that, "[ m ]aterials having the physical properties of claims 3
and 12 are not explicitly disclosed by the applied prior art." Id.
Examiner relies on JP'339 for teaching that rubbers are deficient in
simulating skin textures (i.e. lacking aesthetic look and feel), as motivating
the use of urethane in Graham's layers because the urethane product better
resembles skin. Office Act. 7; see FF5-FF6.
Examiner also acknowledges that Graham does not teach an
epidermal simulating layer with an affixed coating resembling the outer
most layer of skin. Office Act. 7. In order to arrive at this additional coating
material as recited in claim 1, Examiner relies on SkinFlex III, for disclosing
the SC-89 polyurethane coating. Office Act. 8; FF7. The teachings of
8 Non-Final Office Action mailed Nov. 23, 2015 ("Office Act.").
9 Examiner in the Office Action identifies element 11 of Graham's Figure 2
(see FFl) as the epidermal simulating layer in the figure but relies on the
text associated with the subcutaneous tissue-simulating layer as meeting the
"discrete first layer" requirements of the claim. See Office Act. 6.
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Application 11/650,919
SkinFlex III suggest the use of polyurethane as a barrier coating that can be
applied either directly to the mold or brushed onto a surface. FF7.
Based on this combination, Examiner concludes that "[i]t would have
been obvious to the person of ordinary skill in the art at the time the
invention was made to use a material such as Skin-flex III as a surface
coating on the outermost layer of the skin model taught by Graham." Office
Act. 8.
Appellants contend that "[t]he Final Rejection does not provide an
identical first layer to the one recited in claim 1, and therefore has not shown
that the hypothetical skin model urged in the final rejection would
necessarily have the properties recited in claim 3." Br. 7.
We agree with Appellants that the evidence relied on by Examiner
does not support a conclusion that the combined references teach a skin
model as recited in the claims. Specifically, we note that Examiner finds:
Graham's Part 11 ... is made of an elastomer such as
polyurethane with a reticulated pore 16 structure that allows for
fluid to be injected in this layer without noticeable bulging and
while the thickness of this layer is not critical, it is typically in
the range of about 3 to about 10 mm (col 2, In 26 - 48). Part 11
has a Durometer hardness (Shore A scale) in the range of about
1 to about 3 ( col 2, ln 48 - 50).
Office Act. 6. Here, Examiner relies on this disclosure in Graham as
meeting the claimed "outermost layer" requirement. The "outermost layer"
as claimed, however, requires a hardness from about 10 to about 80 on the
Shore A scale. The portion of Graham's disclosure relied on by Examiner as
meeting this limitation has Durometer hardness (Shore A scale) in the range
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Application 11/650,919
of about 1 to about 3. This is outside the claimed range of 10 to 80
Durometer hardness. 10
Examiner has not explained why one of ordinary skill after
substituting urethane for rubber would adjust the hardness in the layer from
a range of 1-3 disclosed in Graham to a hardness of 10-80 on a Shore A
scale as required in claims 1 and 32. 11 See Office Act. 6. The burden is on
Examiner to set out a prima facie case of obviousness and this burden has
not been met.
In summary, the Examiner has not provided evidence sufficient to
support a conclusion that the cited references disclose or suggest all of the
limitations of independent claims 1 and 32 such that a person of ordinary
skill in the art would have considered it obvious to arrive at the disclosed
elements in the manner claimed. Therefore, we reverse the rejection of
claims 1 and 32, as well as dependent claims 3-5, 8, 11-13, and 15-20.
SUMMARY
We reverse the rejection of all claims.
REVERSED
10This board serves as a board of review, not a de novo examination tribunal.
See 35 U.S.C. 6(b) ("The [board] shall, on written appeal of an applicant,
review adverse decisions of examiners upon applications for patents.").
11 The only other independent claim, claim 32, similarly recites "a hardness
from about 10 to about 80 on the Shore A Scale." Br. 12-13 (Claims
Appendix).
8