Nicola Crichigno

Patent Trials and Appeals Board

Jul 23, 2021

2021000674 (P.T.A.B. Jul. 23, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
13/850,027 03/25/2013 Nicola Crichigno 70051-007US-000 4746
28672 7590 07/23/2021
Walter | Haverfield LLP
The Tower at Erieview
1301 East 9th Street, Ste 3500
CLEVELAND, OH 44114-1821
EXAMINER
LEE, MICHELLE J
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
07/23/2021 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):
patents@walterhav.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NICOLA CRICHIGNO
Appeal 2021-000674
Application 13/850,027
Technology Center 3700
Before JENNIFER D. BAHR, BENJAMIN D. M. WOOD, and
LISA M. GUIJT, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–7, 11, and 14–18.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as the
inventor, Nicola Crichigno. Appeal Br. 1.
2 Claims 8–10, 12, 13, 20, and 21 have been withdrawn from consideration,
and claim 19 has been canceled. See Final Act. 1; Appeal Br. 16–22 (Claims
App.).
Appeal 2021-000674
Application 13/850,027

2
CLAIMED SUBJECT MATTER
Appellant’s invention is directed to “oral appliances, and more
particularly to oral appliances for use in exercise.” Spec. ¶ 1. Claim 1,
reproduced below with minor formatting changes for readability, is the only
independent claim involved in this appeal and is illustrative of the claimed
subject matter.
1. An oral appliance system for a human mouth, comprising:
at least one maxillary appliance, comprising:
two maxillary anchor portions adapted to
removably anchor the at least one maxillary appliance to
a human maxilla at least at opposed posterior segments
thereof;
each maxillary anchor portion including mounting
receptacles adapted to securely removably receive at least
an Ml maxillary molar tooth and an adjacent PM2
maxillary premolar tooth on one side of the human
mouth;
at least one mandibular appliance comprising:
two mandibular anchor portions adapted to
removably anchor the at least one mandibular appliance
to a human mandible at least at opposed posterior
segments thereof;
each mandibular anchor portion including
mounting receptacles adapted to securely removably
receive at least an Ml mandibular molar tooth and an
adjacent PM2 mandibular premolar tooth on one side of
the human mouth; and
biasing members carried by the at least one maxillary
appliance and the at least one mandibular appliance;
wherein the oral appliance system is configured so that,
when the at least one mandibular appliance is removably
anchored to the human mandible and the at least one
maxillary appliance is removably anchored to the human
maxilla of a common jaw, the biasing members act between the
at least one maxillary appliance and the at least one
mandibular appliance to urge the at least one mandibular
Appeal 2021-000674
Application 13/850,027

3
appliance inferiorly and anteriorly away from the at least one
maxillary appliance with a force between about 250 grams at
contact between the at least one mandibular appliance and the at
least one maxillary appliance and about 1200 grams at contact
between the at least one mandibular appliance and the at least
one maxillary appliance.
REJECTIONS
Claims 1–5, 11, and 14–18 stand rejected under 35 U.S.C. § 103 as
being unpatentable over Wagner3 and Dellinger.4
Claims 6 and 7 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Wagner, Dellinger, and Bailey.5
OPINION
Obviousness—Wagner and Dellinger
The Examiner finds that Wagner discloses an oral appliance
substantially as recited in claim 1, but that Wagner is silent as to the level of
force applied by the magnets to urge the mandibular appliance (lower
member 4) inferiorly and anteriorly away from the maxillary appliance
(upper member 2) at contact between the appliances, as recited in claim 1.
Final Act. 3–4. The Examiner finds that Dellinger teaches an oral appliance
for producing opposing force between the maxilla and mandible with
magnets applying a force of 675 grams, which, according to the Examiner,
falls within the claimed range of “about 250 grams at contact and about 1200

3 US 9,144,512 B2, issued Sept. 29, 2015.
4 Eugene L. Dellinger and Eric L. Dellinger, Active vertical corrector
treatment—long-term follow-up of anterior open bite treated by the
intrusion of posterior teeth, Am. J. of Orthodontics and Dentofacial
Orthopedics (Aug. 1996).
5 US 2007/0283967 A1, published Dec. 13, 2007.
Appeal 2021-000674
Application 13/850,027

4
grams at contact.” Final Act. 4 (citing Dellinger, pp. 145–146). The
Examiner determines it would have been obvious to set Wagner’s force
to be between about 250 grams at contact and about 1200 grams
at contact, as taught by Dellinger, since this specific force value
may be desired for a certain patient, as oral anatomy and
behavior of the upper and lower jaws differ per patient and
would require specific values of force to achieve the proper
outcome of treatment.
Final Act. 4 (emphasis added). The Examiner also points out that both
Wagner and Dellinger teach using neodymium-iron-boron magnets. Final
Act. 4 (citing Wagner, col. 7, ll. 65–67; Dellinger, p. 146); see Dellinger,
p. 146 (teaching use of “four neodymium iron (Nd2Fe14B) magnets, (two per
arch), that produced 675 gm of force in opposition”). Thus, according to the
Examiner, “one of ordinary skill in the art would have looked to Dellinger’s
similar neodymium-iron-boron magnet for a general idea of the force
provided by these types of magnets within the mouth.” Final Act. 4–5.
Appellant argues that Dellinger does not teach magnets applying a
force as recited in claim 1. Appeal Br. 2–3. Rather, Appellant submits,
Dellinger’s magnets are surrounded by an FDA-approved stainless steel
canister and placed in acrylic blocks in the appliance to ensure that, in use,
the magnets do not come in contact with one another and the actual forces
applied to the teeth fall into the 60 to 180 gram range. Appeal Br. 3–4
(citing Dellinger, pp. 146–147).
Appellant’s characterization of Dellinger’s teachings is correct.
Dellinger teaches using two neodymium-iron-boron magnets per arch that,
when placed in contact with one another, produce 675 grams of force in
opposition. Dellinger, p. 146. However, Dellinger also teaches surrounding
Appeal 2021-000674
Application 13/850,027

5
each magnet in a stainless steel canister and then placing the magnets in
acrylic blocks of the appliance so that, in use, the magnets will not come in
contact with one another, and the actual forces applied by the magnets “to
the teeth fall into the 60 to 180 gm range with normal ‘freeway space’
considerations” (i.e., when the mandible is in its normal resting position).
Dellinger, p. 147.
The Examiner attempts to dismiss Appellant’s argument by pointing
out that, “regardless of whether the magnets directly contact each other or
are encased in material and separated by a distance, the 675 gm force at
contact between the magnets is still a property of the magnet that does not
change.” Ans. 3. The Examiner’s point that the 675 gram force at contact
between the magnets is a material property of the magnet is not pertinent to
claimed force because claim 1 does not recite the force applied by the
biasing means (e.g., magnets) when the biasing means are in contact with
one another. Claim 1 recites the force applied by the biasing means to urge
the mandibular appliance inferiorly and anteriorly away from the maxillary
appliance when the mandibular appliance and maxillary appliance contact
one another. Appeal Br. 13 (Claims App.). The forces generated by the
polarities of the magnets decrease with increasing spacing between the
magnets.
The Examiner attempts to distinguish between the force to the teeth
discussed by Dellinger and the force to the appliances. See Final Act. 2.
However, as Appellant points out, “any purported distinction between the
forces on the appliances and the forces on the teeth is a distinction without a
difference – the magnets apply force to the teeth through the appliance but it
is always the same force.” Appeal Br. 4.
Appeal 2021-000674
Application 13/850,027

6
The Examiner finds that Wagner’s appliances have magnets exposed
on the surfaces of each appliance. Ans. 3 (citing Wagner, Fig. 3B; col. 5,
ll. 35–37). Thus, according to the Examiner, with the proposed modification
using magnets having the property of 675 grams of oppositional force as
taught by Dellinger, “when Wagner’s maxillary and mandibular appliances
and their respective magnets come into contact with each other, a 675 gm
oppositional force would be generated.” Ans. 3–4.
Wagner does not support the Examiner’s finding that Wagner’s
magnets would have exposed upper surfaces when mounted in the oral
appliances. Indeed, the portion of Wagner that the Examiner cites in support
of this finding contradicts the Examiner’s finding. Wagner discloses that
Figure 3 illustrates magnets “fully embedded in their respective molar
extensions.” Wagner, col. 5, ll. 35–37. Further, Wagner discloses that in the
apparatus illustrated in Figures 3A and 3B, the magnets “are all embedded in
their respective molar extensions.” Wagner, col. 6, ll. 14–17. Wagner’s
Figure 3A shows magnets 28C and 30C embedded within extensions 20 and
22 of the appliances, with material of the extensions covering all surfaces of
the magnets and no surface of the magnets exposed. The magnets are visible
in Figure 3B, cited by the Examiner, but this does not demonstrate that they
have exposed upper surfaces; they are visible because the outer tray shells of
Wagner’s appliances are made of “clear and transparent” material. Wagner,
col. 7, ll. 40–41; accord Reply Br. 4 (submitting that Wagner’s Figure 3B is
ambiguous as to whether the magnets are exposed because the appliance
appears to be transparent, while Figure 3A unambiguously shows the
magnets fully enclosed by the appliances).
Appeal 2021-000674
Application 13/850,027

7
Thus, to the extent that the rejection relies on Dellinger for its
teachings with regard to the level of force applied by the magnets to urge the
appliances away from one another, Dellinger is deficient. Applying
Dellinger’s teachings with respect to the force applied by the magnets to
Wagner would not yield an oral appliance system comprising magnets that
apply a force to the appliances as recited in claim 1; rather, Dellinger teaches
a lower force level than the claimed range.
Additionally, Appellant argues that it would not have been obvious to
combine Wagner and Dellinger in the manner proposed by the Examiner
because force levels as taught by Dellinger would be “too small and would
defeat the very purpose of Wagner.” Appeal Br. 2. Appellant contends that,
to achieve its purpose, Wagner’s device must “overcome the force of the jaw
muscles to keep the jaws apart.” Appeal Br. 6 (citing Wagner, col. 2,
ll. 54–58; col. 5, ll. 43–47). Moreover, Appellant submits that even the
upper limit of 1200 grams at contact of the appliances recited in claim 1
“would be utterly insufficient to prevent closure of the jaw; the forces that a
person may exert in attempting to close his or her jaw can be substantial
(even in the absence of bruxism).” Appeal Br. 7 (citing articles indicating
that about 70–150 N (7130–15,296 grams) of force is generated during
routine chewing of food); see also Reply Br. 6 (citing an article by
Nishigawa6 evidencing that bite force during sleep can be on the order of
5000 grams or higher).
The Examiner does not dispute Appellant’s assertion that, to achieve
its purpose, Wagner’s oral appliance system must overcome the force of the

6 K. Nishigawa et al., Quantitative study of bite force during sleep
associated bruxism, J. of Oral Rehabilitation 2001 28:485–491.
Appeal 2021-000674
Application 13/850,027

8
jaw muscles to keep the jaws apart. See Ans. 4–5 (discussing the forces
generated by the jaw while sleeping). The Examiner directs our attention to
Wagner’s teaching “that the magnetic repulsion can be adjusted depending
on the particular user and their jaw muscles.” Ans. 5 (citing Wagner, col. 6,
ll. 11–14). Appellant submits that the Examiner’s discussion of the forces
generated by the jaw while sleeping amounts effectively to an
acknowledgement “that the ‘forces generated by the jaw while sleeping’
must be overcome; there is no reason to overcome the ‘forces generated by
the jaw while sleeping’ except to hold the jaw open.” Reply Br. 8. The
Examiner states that, “even if the forces of Dellinger were to be found to be
weak for a sleeping person, a weaker oppositional force may be enough for
particular users with less developed jaw muscles.” Ans. 5 (emphasis added).
In the absence of evidence to support this assertion, the Examiner’s
statement is mere speculation.
The Examiner also points out that Wagner discusses the magnets of
several orthodontic devices in describing magnets that might be useful in
Wagner’s apparatus. Ans. 5 (citing Wagner, col. 8, ll. 17–24); see Wagner,
col. 7, l. 65–col. 8, l. 30. According to the Examiner, “Wagner would not
have referred to this orthodontic appliance as an example if orthodontic
devices were irrelevant and did not produce enough force to work with
Wagner’s own device.” Ans. 5.
Appellant counters by submitting that, “when read in context, it is
clear that Wagner is citing these orthodontic appliances merely as examples
of the types of magnet that may be used in the Wagner appliance, and not the
forces to be applied.” Reply Br. 8. According to Appellant, “Wagner
contains no teaching or suggestion of using small, orthodontic levels of
Appeal 2021-000674
Application 13/850,027

9
magnetic force, and to the contrary teaches that the force must be sufficient
to overcome ‘the strength of the user’s jaw muscles’ thereby ‘forcing the
mandible down and forward.’” Reply Br. 9 (quoting Wagner, col. 5, ll.
46–47).
In summary, the Examiner fails to articulate a reason with rational
underpinnings, given the evidence of record, why a person having ordinary
skill in the art would have been prompted to design Wagner’s oral appliance
so that the magnets act between the maxillary and mandibular appliances
(i.e., upper member 2 and lower member 4) to urge the mandibular appliance
inferiorly and anteriorly away from the maxillary appliance “with a force
between about 250 grams at contact between the at least one mandibular
appliance and the at least one maxillary appliance and about 1200 grams at
contact between the at least one mandibular appliance and the at least one
maxillary appliance” as recited in claim 1. Dellinger teaches forces falling
below this claimed range, and articles relied on by Appellant evidencing
what dental practitioners understand about biting forces generated by the
human jaw, including forces generated while sleeping, which are
uncontroverted by the Examiner, suggest that forces significantly higher
than the upper end of the claimed range would be required to overcome
anticipated jaw forces to force the mandible down and forward as Wagner
discloses. Indeed, the Examiner’s use of the term “may,” as discussed
above, in attempting to explain why the proposed modification would have
been obvious, reveals that the Examiner’s reasoning is premised on
unsupported speculation. See Final Act. 4 (speculating that “this specific
force value may be desired for a certain patient”); Ans. 5 (stating that “a
weaker oppositional force may be enough for particular users with less
Appeal 2021-000674
Application 13/850,027

10
developed jaw muscles”). Thus, the Examiner’s rejection lacks the requisite
factual basis to support the conclusion of obviousness. See In re Warner,
379 F.2d 1011, 1017 (CCPA 1967) (cautioning that rejections under
35 U.S.C. § 103 must rest on a factual basis without “resort to speculation,
unfounded assumptions[,] or hindsight reconstruction to supply deficiencies
in [the] factual basis”).
For the above reasons, we do not sustain the rejection of independent
claim 1, or of claims 2–5, 11, and 14–18, which depend from claim 1, as
being unpatentable over Wagner and Dellinger.
Obviousness—Wagner, Dellinger, and Bailey
The Examiner relies on Bailey for its teaching of using an elastic, with
anchors and tether mountings, in an appliance for treating sleep apnea to
provide “a gentle force urging forward the mandible, similar to Wagner’s
device, which causes the mandible to move forward.” Final Act. 10. The
Examiner determines it would have been obvious to further modify the oral
appliance of the Wagner/Dellinger combination to provide tether mountings
on the maxillary and mandibular appliances (upper member 2 and lower
member 4) as called for in claims 6 and 7 for receiving tethers to extend
between the maxillary and mandibular appliances “to limit movement of the
at least one maxillary appliance and the at least one mandibular appliance
away from each other, as taught by Bailey, to further provide an additional
gentle force urging the mandible forward . . . and prevent unwanted
extensive jaw opening.” Final Act. 11 (emphasis added) (citing Bailey
¶ 42); see also Final Act. 12 (articulating similar rationale, addressing claim
7). The Examiner’s application of Bailey does not cure the deficiencies of
Appeal 2021-000674
Application 13/850,027

11
the rejection of independent claim 1.7 Accordingly, we do not sustain the
rejection of claims 6 and 7 as being unpatentable over Wagner, Dellinger,
and Bailey.
CONCLUSION
The Examiner’s rejections of claims 1–7, 11, and 14–18 are
REVERSED.
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–5, 11, 14–
18
103 Wagner, Dellinger 1–5, 11, 14–
18
6, 7 103 Wagner, Dellinger,
Bailey
6, 7
Overall
Outcome
1–7, 11, 14–
18

REVERSED

7 Bailey teaches that the “elastics apply from about six to eight ounces of
force” to provide “a gentle, light force, primarily horizontal in nature, that
encourages the mandible to maintain an advanced position.” Bailey ¶ 41.
This primarily horizontal force does not appear to be in the direction called
for in claim 1 and would not appear to act on the maxillary and mandibular
appliances in the manner claimed. In any event, the Examiner does not
appear to rely on Bailey for its teaching regarding the level of force applied,
but, instead, relies on Bailey for a teaching to add elastics to provide an
additional force to that applied in the Wagner/Dellinger combination.