Ex Parte Andersen

Patent Trial and Appeal Board

Jul 18, 2018

11865867 (P.T.A.B. Jul. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/865,867
22913 7590
Workman Nydegger
60 East South Temple
Suite 1000
10/02/2007
07/20/2018
Salt Lake City, UT 84111
FIRST NAMED INVENTOR
Scot N. Andersen
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.
7678.1052 6105
EXAMINER
MORAN, EDWARD JOHN
ART UNIT PAPER NUMBER
3732
NOTIFICATION DATE DELIVERY MODE
07/20/2018 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):
Docketing@wnlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOT N. ANDERSEN 1
Appeal2017-007503
Application 11/865,867
Technology Center 3700
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, CHRISTOPHER G.
PAULRAJ, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a self-customized dental
treatment tray. The Examiner rejected the claims as obvious under 35
U.S.C. § 103 and under 35 U.S.C. § 112 as lacking written description.
Appellant appeals the rejections pursuant to 35 U.S.C. § 134. We have
jurisdiction for the appeal under 35 U.S.C. § 6(b ). The obviousness
rejections are affirmed. The written description rejection is reversed.
1 The Appeal Brief ("Br.") 2 lists Ultradent Products, Inc., as the real party
in interest.
Appeal2017-007503
Application 11/865,867
STATEMENT OF THE CASE
Claims 30-33, 35-59, and 61-70 stand finally rejected by the
Examiner as follows:
1. Claims 58, 59, and 62---65 under pre-AIA 35 U.S.C. § I03(a) as
obvious in view of Jensen (U.S. Pat. No. 6,354,837 Bl, issued Mar. 12,
2002) ("Jensen") and Going et al. (U.S. Pat. No. 4,063,552, issued Dec. 20,
1977) ("Going"). Final Office Action ("Final Act.") (entered Nov. 13, 2014)
5.
2. Claim 70 under pre-AIA 35 U.S.C. § I03(a) as obvious in view of
Jensen, Going, and Suh et al. (U.S. Pat. No. 6,386,865 Bl, issued May 14,
2002) ("Suh"). Final Act. 8.
3. Claims 30-33, 35-57, 61, and 66-70 under 35 U.S.C. § 112(a) or
pre-AIA 35 U.S.C. § 112, first paragraph, as failing to comply with the
written description requirement. Final Act. 4.
Independent claims 30 and 58 are representative and reproduced
below.
30. A self-customized dental treatment tray, comprising:
a thin-walled, flexible, polymer barrier layer having a
wall thickness of 1 mm or less, wherein said barrier layer has a
non-adhesive impression-receiving surface, is tray-shaped so as
to form an interior trough, is flexible and has a Shore A
durometer value so as to readily bend, deform and contour to a
person's teeth without retaining an impression of the person's
teeth at body temperature during customization, and has a front
wall configured to overlap and cover frontal tooth surfaces
during customization; and
a customized impression layer within said interior trough
and in contact with said impression-receiving surface of said
barrier layer, said impression layer having a wall thickness at a
thinnest point of 1 mm or less and being comprised of an
elastomer material customized to the person's teeth at body
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temperature and cured to include contours that conform to the
size and shape of the person's teeth,
wherein the barrier layer and customized impression
layer together have a total thickness of less than 2 mm and a
Shore A durometer of less than about 100.
5 8. A kit for use in making a self-customized dental
treatment tray using teeth of a person, the kit comprising:
a thin-walled, flexible, polymer barrier layer having a
wall thickness less than 1 mm, wherein said barrier layer has a
non-adhesive impression-receiving surface and an interior
trough, is highly flexible so as to readily bend, deform and
contour to a person's teeth without retaining an impression of
the person's teeth at body temperature during customization,
and has a front wall configured to overlap and cover frontal
tooth surfaces and gums during customization; and
an uncured dental impression material contained in a
syringe, wherein said uncured dental impression material
comprises a curable elastomer material that is initially flowable
and dispensable through a syringe tip so that it can be dispensed
from said syringe into said trough and into contact with said
non-adhesive impression-receiving surface of said barrier layer,
wherein said curable elastomer material is curable and
initially moldable while at room temperature and has a
chemical formulation so that after it has been customized to a
person's teeth and cured to form a customized impression layer,
the impression layer will have flexibility and adaptability so as
fit comfortably within a person's mouth,
wherein said polymer barrier layer is configured so that
when said curable dental impression material is formed into an
impression layer, the self-customized dental treatment tray will
have a maximum wall thickness of less than 2 mm.
REJECTION BASED ON JENSEN AND GOING
Claim 5 8 is directed to a kit for making a self-customized dental
treatment tray. The kit comprises two components: 1) "a thin-walled,
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flexible, polymer barrier layer having a wall thickness less than 1 mm"; and
2) "an uncured dental impression material contained in a syringe."
The "polymer barrier layer is configured so that when said curable
dental impression material is formed into an impression layer, the self-
customized dental treatment tray will have a maximum wall thickness of less
than 2 mm."
Jensen describes making a dental bleaching tray for bleaching teeth by
placing a moldable material into a tray and then impressing the teeth of a
person into it to customize the tray to the person's bite. Jensen 2:14--18.
The moldable material corresponds to the "uncured dental impression
material" recited in the claim. The Examiner found Jensen describes a kit
comprising 2) uncured dental impression material in a syringe as required by
claim 58. Final Act. 5---6.
The Examiner found that Jensen does not teach the claimed 1)
polymer barrier layer. Id. at 6. However, the Examiner found that Going,
which teaches making a mouth guard by impressing teeth into a moldable or
curable material (the "uncured dental impression material" of claim 58),
describes a polymer barrier layer with the claimed features which holds the
dental impression material. Id.
As found by the Examiner, both Jensen and Going teach placing, into
a person's mouth, an external support tray (tray "107" in Jensen) holding the
moldable and curable material ("uncured dental impression material" of
claim 5 8) and then having the person press their teeth into the material to
make the desired impression of their teeth. Jensen 3: 1-28; Going 3: 11--4:68.
The Examiner determined it would have been obvious to one of ordinary
skill in the art at the time of the invention to include Going's barrier layer
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between the support tray 107 of Jensen and impression material because
"such modification would reduce the chance of tearing or deforming the
device when removing [it] from the support tray." Final Act. 7.
With respect to the requirement in claim 58 that the maximum
thickness of the tray made from the barrier layer and impression material is
less than 2 mm, the Examiner found:
the thickness of the final device is a result effective variable
which is dependent upon the amount of material used, spacing
between the outer tray and the teeth (see Jensen, column 3, lines
30-33)[, the] force that the user compresses the material with
during formation and the device[']s desired strength, longevity
and flexibility.
Final Act. 8. Thus, the Examiner determined that it would have been
obvious to vary the final thickness to have the recited wall thickness of less
than 2 mm as claimed. Id.
Appellant states that the impression support tray 107 described in
Jensen must necessarily be "sufficiently rigid so as to be self-supporting."
Appeal Br. 24. In contrast, Appellant states that Going describes an inner
tray 18 which is "limp" and cannot therefore perform the same function as
Jensen's rigid tray. Id. For this reason, Appellant contends that the skilled
worker "could not modify Jensen by simply replacing Jensen's rigid
impression tray 107 with Going's limp tray 18 because doing so would
render Jensen incapable of functioning as intended." Id.
This argument does not persuade us that the Examiner erred. Claim
58 is directed to a kit comprising 1) a polymer barrier layer; and 2) uncured
dental material. The claims are open-ended because of the "comprising"
language and do not exclude additional elements. As explained above, the
Examiner determined it would have been obvious to use the 1) polymer
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barrier layer described by Going with Jensen's dental treatment support tray
107 and 2) uncured dental impression material. Final Act. 8. The addition
of a rigid support tray is not excluded by the claim. The Examiner did not
propose replacing the tray 107 of Jensen with the 2) barrier layer as asserted
by Appellant. Thus, Appellant's argument has little merit because it does
not address the basis of the rejection set forth by the Examiner.
Appellant also argues that Jensen's impression tray 107 has only
enough space to accommodate a person's teeth and 2) the uncured dental
impression material. Appeal Br. 24--25. Appellant thus contends that
"Absent substantial modification (i.e., widening) of Jensen's impression tray
107, there would likely be insufficient space ... to accommodate an inner
barrier liner, such as a flexible barrier layer as recited in the claims." Id. at
25.
The Examiner found this argument unpersuasive because it is
unsupported and "merely opinion." Ans. 6. We agree with the Examiner.
An argument made by counsel in a brief does not substitute for evidence
lacking in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595
(Fed. Cir. 1997). Objective evidence was not provided that Jensen's tray
107 could not accommodate the barrier layer of Going.
Jensen teaches making a dental bleaching tray 301 by forming a mold
of a person's teeth with a moldable impression material in a dental tray 107
and then removing the molded bleaching tray 301 from the dental tray 107.
Jensen 3:13-28. Dental bleach is disposed into the molded tray 301 and
then used to bleach a person's teeth. Id. at 3:39-59. The Examiner
determined it would have been obvious to use Going's barrier layer between
the dental tray 107 and bleaching tray 301 to facilitate removal of 301 from
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107 and prevent "tearing or deforming the device [301] when removing from
the support tray [107]." Final Act. 7. Appellant did not identify a defect in
this reasoning. As explained by the Examiner, varying the thickness of the
barrier layer, which Going describes from 0.1 to 0.4 mm (at 6: 15-16; 25-26;
3 8--40), and the moldable dental impression material, would have been
obvious based on the spacing between the outer tray, teeth spacing, and the
desired strength, longevity, and flexibility of the finished treatment tray.
Final Act. 8. The argument that Jensen could not accommodate Going's
barrier layer ignores Going's teaching of a range of dimensions for it, and
the Examiner's determination, that Appellant did not rebut, of the
obviousness of adjusting dimensions to achieve the desired properties.
Appellant further argues that because "the purpose of Going is to form
a sports mouth guard having sufficient wall thickness to function as a sports
mouth guard (e.g., 3-5 mm as taught in the Application), the size of Going's
inner tray 18 [ flexible, polymer barrier] must be large enough so that the
space between the inner walls of inner tray 18 and a person's teeth will form
a mouth guard having adequate thickness to function as a sports mouth
guard." Appeal Br. 25. We do not find this argument persuasive because
the basis of the rejection is using Going's inner tray 18, namely, the flexible
polymer barrier, in Jensen's tray 107 to prevent Jensen's bleaching tray from
tearing when removing it from the rigid tray. Final Act. 7.
Appellant also argue that the required thickness of the sports mouth
guard formed by Going would not yield a dental treatment tray as defined in
the claims, including a barrier layer as claimed and an impression layer as
claimed. Appeal Br. 26-27. However, again, the rejection is not based on
modifying the mouth guard-making kit of Going, but rather on using
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Going's barrier layer (inner tray 18) in Jensen's method. Appellant's
arguments are therefore directed to the size of Going's mouth guard and its
purpose in serving as a mouth guard, while the rejection is based on using
Going's barrier layer for Jensen's bleaching tray to facilitate the latter's
removal from the rigid tray. Appellant did not persuasively argue that
Jensen, when combined with Going's barrier layer, would not meet the
claimed dimensions.
Appellant also argues:
[The] "uncured silicone roll" of Going is likely too thick and
viscous to be placed into the narrower impression tray 107 of
Jensen further emphasiz[ing] that Going's method and
materials used to form a sports mouth guard are inconsistent
with both Jensen and the claimed invention. Moreover, the
"uncured silicone roll" clearly could not be placed into Going's
limp inner tray 18 absent an outer support tray, such as Jensen's
rigid impression tray 107.
Appeal Br. 2 7.
First, the fact that Going utilizes a different impression material to
make its sports mouth guard than the material in Jensen uses to make its
bleaching tray is not evidence that Going's barrier layer is inconsistent with
Jensen. Rather, Going's barrier is being used to protect Jensen's bleaching
tray when it is removed from the rigid tray 107.
Second, the Examiner did not suggest placing Going's silicon layer
into a limp tray without a rigid impression support tray. The Examiner
expressly found that "the modified device of Jensen/Going would include
the barrier tray between impression material (106, Jensen) and [rigid]
support tray (110 [107], Jensen), with the impression material being
dispensed in the trough and on an impression receiving surface of the barrier
layer." Final Act. 7
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Appellant also states "Jensen teaches that using a rigid impression
tray 107 together with a curable silicone material dispensed from a syringe
works well" and thus "there would be no reason to replace or augment
Jensen's rigid impression tray 107 with a flexible barrier layer as recited in
the claims." Appeal Br. 28. However, the Examiner found that Jensen's
soft bleaching tray would be protected from tearing by utilizing Going's
barrier layer. Final Act. 7. Appellant did not identify a flaw in this
reasoning, particularly in view of Jensen's description of the bleaching tray
301 as soft and flexible. Jensen 3:36-38.
For the foregoing reason, the obviousness rejection of claim 58 is
affirmed. Appellant did not provide separate arguments for dependent
claims 59 and 62---65. Consequently, these claims fall with claim 58. 37
C.F.R. § 4I.37(c)(l)(iv).
2. REJECTION BASED ON JENSEN, GOING, AND SUH
Clam 70 is rejected over the combination of Jensen, Going, and Suh.
Appellant contends that "the addition of Suh does not cure the deficiencies
in the combination of Jensen and Going relative to independent claim 58."
Appeal Br. 29. Because the arguments are therefore the same, we affirm the
obviousness rejection of claim 70 for the same reasons set forth above for
claim 58.
3. REJECTION BASED ON WRITTEN DESCRIPTION
Claim 30 is directed to dental treatment tray comprising "a thin-
walled, flexible, polymer barrier layer having a wall thickness of 1 mm or
less," having "a Shore A durometer value so as to readily bend, deform and
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contour to a person's teeth without retaining an impression of the person's
teeth at body temperature during customization" and where "the barrier layer
and customized impression layer together have a total thickness of less than
2 mm and a Shore A durometer of less than about 100." Independent claims
44 and 47 recite similar requirements of Shore A values. Claims 66-70,
which depend from claim 58 (which does not recite a Shore A value), recite
specific Shore A values.
The Examiner rejected the claims under 35 U.S.C. § 112 as lacking a
written description because "Shore A" values do not appear in the original
disclosure. Final Act. 2-5. The original Specification referred to
"durometer values", but did not define these values as corresponding to the
Shore A scale, which is a scale of material hardness. The Examiner also
objected to an amendment amending the Specification with "Shore A" as
introducing new matter into the Specification in contravention of 35 U.S.C §
132(a). Id. at 3--4.
The test for written description is an objective inquiry that considers
whether the original specification "show[ s] that the inventor actually
invented the invention claimed." Ariad Pharm., Inc. v. Eli Lilly & Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). To meet the written description
requirement, the inventor must "convey with reasonable clarity to those
skilled in the art that, as of the filing date sought, he or she was in possession
of the invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563---64
(Fed. Cir. 1991 ). In describing the claimed invention, there is no
requirement that the wording be identical to that used in the specification as
long as there is sufficient disclosure to show one of skill in the art that the
inventor "'invented what is claimed."' Union Oil Co. v. Atlantic Richfield
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Co., 208 F.3d 989, 997 (Fed. Cir. 2000) (internal citation omitted). An
amendment to correct an obvious error does not constitute new matter where
the ordinary artisan would not only recognize the existence of the error in
the specification, but also recognize the appropriate correction. In re
Oda, 443 F.2d 1200 (CCPA 1971).
Appellant provided a declaration by the sole inventor, Scot N.
Andersen ("Andersen Deel."), to establish that one of ordinary skill in the art
would have recognized that the inventor had possession of the Shore A
durometer scale that the claims and Specification had been amended to
recite.
Mr. Andersen stated in his declaration that one of ordinary skill in the
art would have understood the "durometer values" recited in the
Specification to refer to "Shore A" durometer values in the context of the
disclosed flexible polymers and elastomers described as useful for the
claimed self-customized dental treatment tray. Andersen Deel. ,r,r 6, 7. As
evidence, Mr. Andersen provided several exhibits.
Exhibit A, cited by Mr. Andersen, is titled the "Hardness of Rubber:
Durometer." Exhibit A shows three durometer types, Shore A, Shore D, and
Shore 00. Exhibit A discloses that Type A is applicable to "Soft rubber &
plastics," Type D to "Hard Rubber & plastics", and Type 00 to "Sponge &
foam." Mr. Andersen stated that the Specification at paragraphs 71-80
discloses materials for the barrier layer and that hard rubbers, plastics,
sponge materials, and foams are not listed among the exemplary materials.
Andersen Deel. ,r 9. Paragraph 72, for example, characterizes some of the
materials as "softer," consistent with the Type A scale of "Soft rubber."
Thus, based on this evidence, Mr. Andersen concluded that that one of
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ordinary skill in the art would have recognized that "the Shore A durometer
scale was intended and inherently disclosed based on the inherent and
known physical properties of the disclosed materials." Id.
Mr. Andersen also identified disclosure in the Specification of a
preferred durometer range of 40 to 80 and provided several publications that
established that several of the materials described in the Specification as
suitable for making a barrier layer fall within the preferred durometer range
of 40 to 80 as rated by the Shore A scale. Andersen Deel. ,r,r 10-14.
Mr. Andersen also directed attention to paragraph 7 6 of the
Specification which identifies U.S. Pat. No. 5,952,400 for its disclosure of
materials for making the claimed curable dental impression material.
Andersen Deel. ,r 15. Mr. Andersen referred to disclosure in the cited patent
where the impression materials are characterized as having Shore A values.
Id.
Thus, Mr. Andersen provided objective evidence that the durometer
values in the Specification would be recognized by one of ordinary skill in
the art as Shore A values.
The Examiner considered the declaration by Mr. Andersen, but found
that it did not overcome the rejection. The Examiner stated "that one of
ordinary skill would not have reasonably concluded that Appellant referred
to the Shore A range, since many of the listed materials can be measured in
either the Shore A, Shore 00 [00] or Shore D range, and are done so quite
frequently." Ans. 4. The Examiner further stated, in maintaining the
rejection, that "the Shore 00 [00] scale ... also describes soft and flexible
materials" and that "a Shore A hardness of less than 100 encompasses
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hardness values that can be measured in all three of the Shore 00 [00],
Shore A and Shore D scale." Id. at 5.
While the Examiner appears to be correct that a material can be
characterized under the Shore A, Shore D, and Shore 00 scales, Mr.
Andersen addressed this issue by explaining that the exemplary materials
disclosed in the Specification are not hard rubbers, plastics, sponge, or foam
materials which Exhibit A expressly teaches are characterized by the Share
D and Shore 00 scales. Andersen Deel. ,r,r 8-9. The Examiner did not
identify an objective or factual reason to doubt Mr. Andersen's testimony on
this issue.
Furthermore, as discussed above, Mr. Andersen provided evidence
that exemplary materials described in the Specification are characterized in
the prior art as having Shore A durometer values of less than 100. Andersen
Deel. ,r,r 10-15.
In sum, Mr. Andersen provided adequate factual evidence, which the
Examiner did not rebut, that one of ordinary skill in the art would have
recognized that the durometer values in the Specification are those of the
Shore A scale. Because of one of ordinary skill in the art would have
recognized that the inventor had possession of the durometer Shore A scale,
it does not contravene the written description requirement to recite these
values in the claims and it is not new matter to the Specification. The § 112
written description rejection of claims 30-33, 35-57, 61, and 66-70 is
reversed.
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TIME PERIOD
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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