Académique Documents
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Case IPR2017-00239
U.S. Patent No. 8,500,446
TABLE OF CONTENTS
I.
II.
III.
B.
C.
B.
B.
IV.
V.
VI.
2.
3.
4.
b)
c)
d)
e)
f)
g)
h)
i)
ii
LISTING OF EXHIBITS
Exhibit 1001 ........................................................ U.S. Patent No. 8,500,446 to Lowe
Exhibit 1002 ..................... U.S. Patent Application No. 2008/0233541 to De Vreese
Exhibit 1003 .......................................................... U.S. Patent No. 7,029,276 to Mao
Exhibit 1004 ..................................................... U.S. Patent No. 6,611,780 to Lundell
Exhibit 1005 ............................................................. Declaration of Dr. Sumit Yadav
Exhibit 1006 ................................. Prosecution History of U.S. Patent No. 8,500,446
Exhibit 1007 ......................................................... U.S. Patent No. 4,348,178 to Kurz
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I.
The 446 patent has numerous related applications, including U.S. App.
No. 12/615,049 (now U.S. Patent No. 9,028,250), U.S. App. No. 11/733,849
(pending), U.S. App. No. 11/733,858 (abandoned), Prov. App. No. 60/906,807
(expired), U.S. App. No. 15/019,865 (pending), U.S. App. No. 15/241,080, U.S.
App. No. 13/973,865, U.S. App. No. 14/548,072 (pending). The 446 patent is not
currently the subject of any other administrative proceeding or civil action between
the parties to this proceeding.
C.
Propel designates the following counsel at the addresses shown below and
consents to electronic service at the email addresses below.
Lead Counsel:
Back-Up Counsel:
Payment for the fees set forth in 37 C.F.R. 42.15(a) for this Petition
accompanies this request.
B.
Propel certifies that the 446 patent is available for review and that Propel is
not barred or estopped from requesting review challenging claim 1, the sole claim
3
The following are the prior art references relied upon in the present Petition:
1. U.S. Patent Application No. 2008/0233541 to De Vreese, filed
March 16, 2005, and published September 25, 2008 (De Vreese
attached hereto as Ex. 1002);
2. U.S. Patent No. 7,029,276 to Mao, filed November 14, 2003, and
issued April 18, 2006 (Mao attached hereto as Ex. 1003);
3. U.S. Patent No. 6,611,780 to Lundell, filed June 9, 1999, and issued
August 26, 2003 (Lundell attached hereto as Ex. 1004).
The 446 patent was filed on November 22, 2012, claiming priority as a
continuation-in-part to U.S. App. No. 12/615,049 filed November 9, 2009, and as a
continuation-in-part of U.S. App. Nos. 11/773,849 and 11/773,858, which were both
filed on July 5, 2007.
B.
Claim 1, the sole claim of the 446 patent, is challenged in the Petition on the
ground set forth below under 35 U.S.C. 103:
4
2012, as U.S. App. No. 13/684,220, which is a continuation-in-part of, and claims
5
priority to, U.S. App. No. 12/615,049 filed on November 9, 2009, and as a
continuation-in-part of U.S. App. Nos. 11/773,849 and 11/773,858, each of which
was filed on July 5, 2007.
The 446 patent merely covers an apparatus that is capable of vibrating at a
range frequencies and a particular force. The sole claim of the 446 patent (claim 1)
covers this apparatus, but does not limit the apparatus to a particular use, let alone a
use that results in accelerated tooth movement or bone remodeling. More
specifically, the 446 patent broadly claims an orthodontic remodeling device
having a U-shaped intraoral bite plate having inside and outside rims that is
operably connected to an extraoral housing that contains a rechargeable battery
operably coupled to a vibrator, which is operably coupled to a processor and vibrates
at a frequency of 0.1-400 Hz at a force of 5 Newtons. 446 patent, claim 1.
As best as can be discerned from the claim, the 446 patents alleged
improvements over the prior art appear to be that the claimed device does not have
a flat bite plate and that the device can be operated without the use of hands. The
device further claims additional non-novel features: that it can be used without the
use of other head attachment means, and that it has the ability to vibrate within a
certain range of frequency and at a particular force. 446 patent, claim 1.
Figures 1A-1B of the 446 patent illustrate one embodiment of an
orthodontic device of the invention. 446 patent, Figs. 1A-1B, 10:39-41. As shown
6
Prosecution History for U.S. Patent No. 8,500,446 (446 Prosecution History,
which is attached hereto as Ex. 1006) at 1540-51, 1568-69. In a supplemental
response, the Patent Owner amended the claim to add the frequency and force
limitation. Id. at 116. The Patent Owner also submitted a supplemental Rule 1.131
affidavit in an attempt to support this new limitation. Id. at 161-88. In the Rule 1.131
affidavit, the inventor asserted that original claim 4 had a priority date of November
9, 2009, and an invention date of February 2009. Id. at 161, 167. In the Reasons for
Allowance, the Examiner stated that [t]he prior art fails to teach or render obvious
an extraoral vibrator connected to a bite plate, wherein the vibrator is able to vibrate
at a force of 5 Newtons, in combination with the limitations of the claims. Id. at 21.
VI.
orthodontic remodeling. 446 patent, 1:24-25; see also Yadav Decl. 23. A person
of ordinary skill in this field would have had at least a Doctor of Dental Surgery
(DDS), Doctor of Dental Medicine (DMD), Bachelor of Dental Surgery (BDS), or
the academic equivalent thereof, and a Master of Science in orthodontics, or its
equivalent. Yadav Decl. 47-51. Such a person would have been familiar with the
standard components, methods, and protocols used in orthodontics at the time of the
invention of the 446 patent. Id. This is consistent with the Patent Owners definition
of a person of ordinary skill in the art during prosecution. See 446 Prosecution
10
constructions to any proposed claim term constructions offered by the Patent Owner.
VIII. GROUNDS FOR UNPATENTABILITY
A.
Overview of De Vreese
12
facemask to change the shape of facial bones, yet failed to realize the benefits of
rapid alignment of teeth through the use of cyclic mechanical forces. Mao, 3:5-17.
In short, Mao discloses that one of the benefits of cyclic mechanical treatment is to
shorten the duration of orthodontic treatment compared to existing technology by
being able to accelerate the movement and realignment of teeth. Id., 3:35-46, 4:1124. Mao also teaches that the method for realigning the teeth includes applying cyclic
forces at about 0.1 to about 5 Newtons, and at a frequency of about 0.1 to about 40
Hz, id., 3:36-46, and that higher frequency can further accelerate bone remodeling.
Id., 5:61-6:2.
3.
Overview of Lundell
where the accumulation of usage and operational information and data is critical to
the evaluation or performance of the device or patient treatment, versus having the
patient recall from memory his or her usage of the dental device. Id., 1:42-47, and
2:35-49.
As disclosed and shown in Figure 1A of Lundell, the system includes an
extraoral housing such as a handle portion 11 of a toothbrush 10. Id., Fig. 1A, 2:1026. Inside the handle 11 is a battery 18 that can be recharged through a charge control
base unit 12. Id., Fig. 1A, 2:27-34. The battery 18 is capable of powering an
electromagnetic motor 16 for vibrating a toothbrush head 15 about a lever arm 17.
Id., Fig. 1A, 2:10-26.
17
remodeling device. Yadav Decl. 75. The device of De Vreese can be used for oral
treatments. Id. Mao adds that the application of cyclic forces can be used to expedite
the remodeling of craniofacial bones to correct deformities and treat malocclusion.
Id. Mao also teaches that the method of realigning maloccluded teeth can be carried
out using any suitable vibratory dental apparatus capable of vibrating teeth at a
certain range of force and frequency. Id. As such, it would have been obvious to one
of ordinary skill in the art to combine the teachings of Mao with that of De Vreese
to arrive at the claimed orthodontic remodeling device. Id.
De Vreese further teaches that its autonomous, vibrating dental device can be
used for teeth cleaning purposes. Id. 76. While De Vreese does not explicitly teach
the benefits of storing and transmitting data from dental device, Lundell teaches the
importance of a system for communicating data between a battery-powered tool
where accumulation of usage and operational data is critical to the evaluation and
performance of the device or treatment. Id. And although the Lundell device is
directed to a vibrating toothbrush, it nevertheless is directed to a vibrating dental
device for cleaning purposes similar to that of the autonomous, vibrating dental
device of De Vreese. Id. Furthermore, Lundell recognizes the importance of oral
treatment and patient monitoring, and understands and appreciates the criticality of
gathering data for evaluation purposes. Id.
All the prior art patent application and patents are in the same field of dental
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treatment and manipulation via the use of a vibrational apparatus. Id. 77. As such,
it would have been obvious to one of ordinary skill in the art to combine the
teachings of Lundell with that of De Vreese to arrive at the claimed orthodontic
remodeling device for purposes of monitoring patient compliance and treatment
progress. Id.
a)
phrase does not affect the structure or steps of the claimed invention.).
At most, the preamble of claim 1 merely recites an expression of purpose or
intended use of the apparatus defined by the body of the claim, which is not limiting
under the broadest reasonable interpretation standard. See In re Taylor, 484 F. Appx
540, 543 (Fed. Cir. 2012) (unpublished) (holding that a preamble is not limiting
when the claim body defines a structurally complete invention and the preamble
states only a purpose or intended use.). Accordingly, the preamble of claim 1 is not
limiting.
Nevertheless, to the extent that the Board determines that the preamble of
claim 1 is limiting, it is obvious over the knowledge of a person of ordinary skill in
the art. As explained by Dr. Yadav, orthodontic remodeling devices were well
known at the time of the 446 patent. Yadav Decl. 81. Such devices included
orthodontic braces and aligners (such as Invisalign). Id. Further, even vibrating
orthodontic remodeling devices were well known by those of ordinary skill at the
time of the 446 patent. Id. 82. For example, a Vibration Orthodontic Appliance
was patented by Dr. Craven H. Kurz more than 30 years before the 446 patent. See
U.S. Patent No. 4,348,178 (178 patent, which is attached hereto as Ex. 1007). Id.
It is further obvious over the combination of De Vreese in light of Mao. The
combination of these references discloses an orthodontic remodeling device. Id.
83-84. As discussed herein, De Vreese discloses an autonomous dental device
22
that can be fitted on the dental arch of a subject. The dental device is capable of
providing therapies such as massage, pain relief, and tissue stimulation with
enhanced effects and minimal intrusion of the oral cavity. De Vreese, [0035]. The
dental device also includes one or more means for providing physical stimulation
including the use of a transducer for vibrational movement, such vibrational
movement suitable for assisting in the control of discomfort associated with wearing
orthodontic braces. De Vreese, [0166]-[0167], [0324]. In short, De Vreese discloses
a vibrating dental device that is capable of generating physical stimulation about
ones teeth and gums.
Mao adds that the application of using cyclic forces can be used to expedite
the remodeling of craniofacial bones to correct deformities and treat malocclusion.
Mao, 3:21-24. Mao further discloses that contemporary orthodontists only use
braces, headgear, and facemask to change the shape of facial bones, yet failed to
realize the benefits of rapid alignment of teeth through the use of cyclic mechanical
forces. Id., 3:5-17. Mao discloses that one of the benefits of cyclic mechanical
treatment is to shorten the duration of orthodontic treatment compared to existing
technology by being able to accelerate the movement and realignment of teeth. Id.,
3:35-46, 4:11-24. In other words, the teaching of Mao is to accelerate orthodontic
treatment through the use of vibration on the teeth.
Maos known technique of improving or accelerating the duration of
23
Limitation (a) recites an intraoral bite plate. This bite plate is not
expressly defined in the specification. As disclosed and shown in Fig. 1B, 10A-10B
of the 446 patent, an orthodontic device 10 includes an intraoral bite plate 20, 1000
that can be inserted into a users mouth for contacting the teeth at any or all points.
446 patent, Figs. 1A, 10A-10B, 4:4-8, 10:39-41, 16:50-61. Accordingly, one of
ordinary skill in the art would understand that an intraoral bite plate is an apparatus
that can be received through a persons mouth for contacting any or all of the
persons teeth. Yadav Decl. 88.
24
Limitation (ii) recites said bite plate having an outside edge having upper and
lower rims to contact upper and lower facial surfaces of teeth and gums. Facial
surface is not expressly defined in the specification. One of ordinary skill in the art
would appreciate that the facial surface of a tooth is the side of the tooth that is
adjacent to (or the direction towards) the inside of the lips. Yadav Decl. 95. In
some instances, the facial surface of tooth may also be referred to as the vestibular
surface of tooth. Id. This is consistent with the dictionary definition of facial surface
of tooth as the surface of a tooth that faces the buccal or labial mucosa of the
vestibule of the mouth; opposite to the lingual surface of tooth.3
Like the 446 patent, De Vreese discloses the bite plate having an outside edge
having upper and lower rims to contact upper and lower facial surfaces of teeth and
gums.
As disclosed and shown in Figure 5B of De Vreese, the dental device 51
includes an outside edge (labeled and dashed below for emphasis) that is formed by
a combination of the upper and lower troughs 53, 54. Yadav Decl. 96. The upper
trough 53 includes an upper, anterior-facing wall 52 for the upper dental arch, and
http://medical-dictionary.thefreedictionary.com/facial+surface+of+tooth (2 Oct.
2016).
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31
for any dental treatment to be effective the accumulation of operation data can assist
in not only studying the various types of usage but to also monitor and ensure patient
compliance. Yadav Decl. 106. One of the most effective ways of doing so,
therefore, is to record actual usage information such as the number of minutes used,
number of times used, the force and frequency of the device when used, among other
variables, and transmit the same to the practitioner, as opposed to having the patient
recall his or her usage from memory. Id. 110-11. By combining actual usage data
and regular visits to monitor progress, adjustments can be made, as necessary, to
ensure that the treatment program is working at the optimum level of effectiveness
for the patient. Id.
Lundell discloses a system for communicating data between a vibrating
toothbrush or similar device, and a separate control unit. Lundell, 6:6-21. The use of
such system can gather operation data to assist in the study of various types of usage
as well as monitor patient compliance. Lundell, 6:6-21. Lundell also teaches that it
will be appreciated by one of ordinary skill in the art that the disclosed invention can
be applied to other battery-powered tools or instruments where the accumulation of
usage and operational information and data is critical to the evaluation or
performance of the device or patient treatment, versus having the patient recall from
memory his or her usage of the dental device. Lundell, 1:42-47, 2:35-49; see also
Yadav Decl. 112.
35
36
a memory processor 32 in the charge control base unit 12, which also includes a
communication link 33 for transmitting the data to a separate device 34. Lundell,
Fig. 1A, 3:14-24. Accordingly, one of ordinary skill in the art can appreciate that
Lundell discloses an extraoral housing containing a rechargeable battery operably
coupled to a vibrator operably coupled to a processor for capturing usage data
operably coupled to a data-and-charging port for transmitting said data and charging
said battery. Yadav Decl. 113.
The motivation behind the Lundell invention is the same challenge facing the
dental device of De Vreese, i.e., the need to accumulate actual usage information so
as to monitor patient compliance against established guidelines. Id. 114. And since
the system disclosed by Lundell of monitoring, usage tracking, and transmitting of
such usage data for a vibrating, battery-powered tool, provides a solution to the same
problem facing the vibrating dental device of De Vreese, it would have been obvious
to one of ordinary skill in the art to combine the improved teachings of Lundell to
the basic device of De Vreese, especially in light of the fact that both references are
directed to the field of dental cleaning and treatment. Id.
As such, since De Vreese discloses an extraoral housing containing a
rechargeable battery, and Lundell teaches improving such configuration by operably
coupling the same to an extraoral vibrator, a processor for capturing usage data, and
a data-and-charging port for transmitting the data and charging the battery, one of
38
ordinary skill in the art would have made the obvious combination of the improved
teachings of Lundell to the basic device of De Vreese to arrive at the predictable
result of a vibrating dental device capable of capturing and transmitting data,
because the improvement solves the same problem facing the basic device.
Accordingly, the combination of De Vreese and Lundell teaches every element of
limitation (b).
g)
Limitation (c) recites said bite plate operably connected to said housing.
Like the 446 patent, De Vreese discloses the bite plate being operably connected to
the housing.
As disclosed and shown in Figure 6A of De Vreese, the autonomous device
includes a housing 64 having a power source such as a battery 65, both of which
can be coupled to the bite plate of dental device 61. De Vreese, [0361]. The dental
device 61 bite plate can include one or more LEDs in the wall of the dental device 61,
the LEDs being powered by the battery 65. De Vreese, [0361]. As such, De Vreese
discloses the bite plate being operably connected to the housing. Yadav Decl. 115.
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any other accessories about any part of the head. Id. This is also consistent with the
plain and ordinary meaning of head attachment means.
De Vreese discloses the device being held in place during usage by teeth
clamping on the bite plate and lacks other head attachment means. As discussed
above the autonomous device of De Vreese includes a bite plate which can be fitted
on the dental arch of a subject. De Vreese, [0368]. The bite plate can be shaped for
the immersion of teeth and/or gums of a dental arch. De Vreese, [0090]-[0091]. And
because the device is autonomous (self-contained), the use of a subjects own dental
arch can function as its own support thereby freeing up a practitioner to use both
hands for performing any other dental treatment. De Vreese, [0093], [0098].
Furthermore, the motivation behind De Vreese is to provide effective dental
therapies without a person having to visit a dental practitioner and sit in a dental
chair remaining open-mouthed for an extended period of time. De Vreese, [0024][0025]. Therefore, the autonomous device of De Vreese is self-contained such that
it can be fitted on the dental arch of a subject without any other attachments or
accessories. De Vreese, [0032]-[0035]. As such, De Vreese discloses the device
being held in place during usage by teeth clamping on the bite plate and lacks other
head attachment means. Yadav Decl. 117.
i)
Limitation (e) recites said vibrator being able to vibrate at a frequency of 0.1400 Hz and at a force of 5 Newtons. The combination of De Vreese and Mao
discloses this limitation.
De Vreese discloses that the ultrasonic transducer is capable of vibrating at
a frequency range of between 20 to 30 kHz. De Vreese, [0168]-[0172]. Mao adds
that a method for realigning the teeth may include applying cyclic forces at about
0.1 to about 5 Newtons, and at a frequency of about 0.1 to about 40 Hz. Mao, 3:3646. And even though Mao does not explicitly teach vibrating frequency at the entire
range of 41-400 Hz, the teachings of Mao nevertheless render the claimed range of
values obvious to one of ordinary skill in the art. Yadav Dec. 120-22.
In the case where the claimed ranges overlap or lie inside ranges disclosed
by the prior art a prima facie case of obviousness exists. MPEP 2144.05. For
example, in In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990), the Federal Circuit
affirmed an obviousness rejection by the Board of Patent Appeals and Interferences
for a process for inhibiting the growth of fungi. Id. at 1575. The process discussed
maintaining a modified gaseous atmosphere at specific percentages by volume. Id.
at 1575-76. While the majority of the ranges were clearly found in the prior art, the
prior art reference disclosed about 1-5% carbon monoxide whereas the claim
limitation required >5-25% carbon monoxide. Id. at 1576. The Federal Circuit
found that the prior art range and the claimed range overlapped because the statement
42
about 1-5% does allow for concentrations slightly above 5%, which established a
prima facie case of obviousness. Id. at 1577 (emphasis added).
Like the prior art at issue in Woodruff, Mao discloses vibrating at frequencies
of 0.1-40 Hz, a set of values that clearly overlaps with the claimed range of vibrating
frequencies of 0.1-400 Hz. Accordingly, this claim limitation is obvious in light of
Mao. Furthermore, Mao also teaches that higher frequency can further accelerate
bone remodeling. Mao, 5:61-6:2. As such, one of ordinary skill in the art would have
been motivated to try the higher frequencies for faster bone remodeling. Yadav Decl.
121-22. Therefore, it would have been obvious to vibrate the dental device at
frequencies ranges of 41-400 Hz as can be appreciated by one of ordinary skill in
the art. Id. Accordingly, the combination of De Vreese and Mao discloses the
vibrator being able to vibrate at a frequency of 0.1-400 Hz and at a force of
5 Newtons.
IX.
CONCLUSION
Each of U.S. Patent Application No. 2008/233541 to De Vreese, U.S. Patent
No. 7,029,276 to Mao, and U.S. Patent No. 6,611,780 to Lundell is prior art to the
446 patent under at least 35 U.S.C. 102(b).
As shown by this Petition, the combination of De Vreese, Mao, and Lundell
discloses every limitation of claim 1 of the 446 patent, and one of ordinary skill in
the art at the time of the filing of the 446 patent would have found it obvious to
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combine these references to achieve the claimed device of the 446 patent.
As such, claim 1 of the 446 patent is obvious in view of the prior art and
therefore rendered unpatentable under 35 U.S.C. 103.
Dated: November 10, 2016
Respectfully submitted,
Justin B. Kimble
Registration No. 58,591
Bragalone Conroy PC
2200 Ross Avenue, Suite 4500W
Dallas, TX 75201
Phone: (214) 785-6670
Email: jkimble@bcpc-law.com
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Justin B. Kimble
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CERTIFICATE OF COMPLIANCE
As required by 37 C.F.R. 42.24(a), the undersigned hereby certifies that the
foregoing Petition for Inter Partes Review contains 8,482 words, excluding those
portions identified in 37 C.F.R. 42.24(a)(1), as measured by the word-processing
system used to prepare this paper.
Justin B. Kimble
46