Ex Parte Mitchell

Patent Trials and Appeals Board

May 23, 2019

14213743 - (D) (P.T.A.B. May. 23, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/213,743 03/14/2014 Dale Mitchell
21917 7590 05/28/2019
MCHALE & SLAVIN, P.A.
2855 PGA BL VD
PALM BEACH GARDENS, FL 33410
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.
3649U.014 8255
EXAMINER
SUMMITT,LYNNSYM
ART UNIT PAPER NUMBER
3773
NOTIFICATION DATE DELIVERY MODE
05/28/2019 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):
uspatents@mchaleslavin.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DALE MITCHELL 1
Appeal 2018-005321
Application 14/213,743
Technology Center 3700
Before JENNIFER D. BAHR, EDWARD A. BROWN, and
LEE L. STEPINA, Administrative Patent Judges.
STEPINA, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant appeals under 35 U.S.C. § 134 from the Examiner's
decision rejecting claims 1, 2, 4-12, and 15-20.2 We have jurisdiction under
35 U.S.C. § 6(b ).
We affirm.
1 The Appeal Brief indicates that Beacon Biomedical, LLC (Appellant) is
the real party in interest. Br. 3.
2 Claims 3, 13, and 14 have been cancelled. Br. 35, 37 (Claims App.).
Appeal 2018-005321
Application 14/213,743
CLAIMED SUBJECT MATTER
The claims are directed to bone implants (for example, spinal
implants) with a bioactive glass coating. Claim 1, reproduced below, is the
sole independent claim on appeal.
1. A bone stabilizing implant comprising:
an implant for implantation into an animal, said implant
constructed from a material that includes the structural and
mechanical properties for orthopedic implants and said material
not containing bioactive glass, said implant including a plurality
of surfaces, at least one of said plurality of surfaces being a bone
contacting surface whereby a portion of said bone contacting
surface contacts a bone within said animal when secured in an
implanted position, said bone contacting surface of said implant
being at least partially coated with a bioactive glass, said
bioactive glass constructed and arranged to provide a
osteoproductive, or osteoconductive environment on the surfaces
of said implant, a wrap secured around said implant and said
bioactive glass for securing said bioactive glass coating in
position on an outer surface of said implant, whereby said wrap
is removed just prior to installation of said implant leaving said
bioactive glass coating in place.
Br. 34-35 (Claims App.).
REFERENCES RELIED ON BY THE EXAMINER
Brosnahan
Leroux
Peterman
Clineff
Bagga
us 5,766,253
US 6,478,822 Bl
US 2006/0217807 A 1
US 2010/0168798 Al
US 2011/0144764 Al
2
June 16, 1998
Nov. 12, 2002
Sept. 28, 2006
July 1, 2010
June 16, 2011
Appeal 2018-005321
Application 14/213,743
REJECTIONS
I. Claims 1, 2, 4-12, and 15-203 are rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
II. Claim 11 is rejected under 35 U.S.C. § 112, second paragraph,
as indefinite
III. Claims 1, 8, 10-12, and 15-17 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Brosnahan and Leroux.
IV. Claims 2, 4-7, and 9 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Brosnahan, Leroux, and Bagga.
V. Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as
unpatentable Brosnahan, Leroux, and Clineff.
VI. Claim 20 is rejected under 35 U.S.C. § 103(a) as unpatentable
over Brosnahan, Leroux, and Peterman.
OPINION
Rejection L Written Description
Claims 1, 2, 4-12, and 15-20
The Examiner determines that the original disclosure fails to support
the requirement in claim 1 that the implant be constructed from a material
that does not contain bioactive glass. Non-Final Act. 2-3.
Referring to paragraph 57 of the Specification, Appellant contends
that if the entire implant recited in claim 1 contained bioactive glass, "there
3 The heading for this rejection incorrectly lists cancelled claims 13 and 14
as being rejected. Non-Final Act. 2.
3
Appeal 2018-005321
Application 14/213,743
would be no contrast between the bioactive glass markers[4J and the implant
itself, and therefore the bioactive glass would no longer provide markers for
a surgeon to use as a visual indicator[5J while inserting the device." Br. 11.
Thus, Appellant asserts that the absence of bioactive glass in portions of the
implant is necessary for the implant' s proper function.
Paragraph 57 of the Specification indicates "the basic preferred
embodiment of the interbody spacer 100 is preferably constructed from
biocompatible material such as polyetheretherketone (PEEK),
polyaryletherketone (PEAK), stainless steel, titanium or the like," but does
not indicate that these materials are free ofbioactive glass. Appellant's
argument that these materials must be free of bioactive glass in order for the
bioactive glass coating ( or, as stated by Appellant, "markers") to provide a
visual indicator is without merit because (i) claim 1 does not explicitly recite
a visual indicator, and (ii) assuming arguendo that claim 1 requires a visual
indicator, Appellant provides no technical argument and points to no
objective evidence supporting a conclusion that providing bioactive glass on
( or in) the entire implant would defeat this purpose. In other words, it would
appear that if a surgeon were able to see the entire implant, any need for a
visual indication of the location of the implant would be fulfilled. Further,
there is no indication in the Specification that the presence of a small amount
of bioactive glass contained in, for example, a portion of the implant
containing PEEK would interfere with the function (relating to providing
visual contrast or otherwise) of the implant. Accordingly, Appellant's
argument on this point does not apprise us of Examiner error.
4 Claim 1 does not recite bioactive glass markers; it recites that the implant
is "at least partially coated with a bioactive glass." Br. 35 (Claims App.).
5 Claim 1 does not explicitly recite a visual indicator. Br. 35 (Claims App.).
4
Appeal 2018-005321
Application 14/213,743
Addressing a second part of claim 1, the Examiner determines that the
original disclosure fails to support the requirement that the recited wrap be
removed just prior to installation. Non-Final Act. 3.
In reply, Appellant asserts that if the wrap recited in claim 1 were not
removed, "the implant ridges would not be able to engage with the vertebrae
to prevent retrograde motion and slippage, as described in paragraph 0060,"
and, therefore, "[a] person of ordinary skill in the art would recognize that a
wrap around the implant would increase slippage and possible retrograde
motion during insertion, and would therefore understand that removing the
wrap would be advantageous." Br. 12 (emphasis added).
The Examiner has the better position on this point because whether or
not a person of ordinary skill in the art would understand removal of the
wrap to be advantageous is a different issue from whether this limitation has
adequate support under 35 U.S.C. § 112, first paragraph. "[A] description
that merely renders the invention obvious does not satisfy the [ written
description] requirement." Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010) (en bane) (citing Lockwood v. Am. Airlines, 107
F.3d 1565, 1571-72 (Fed. Cir. 1997). Additionally, Appellant's argument
does not address the entire limitation at issue in the rejection. Claim 1
recites "said wrap is removed just prior to installation of said implant." Br.
35 (Claims App.)(emphasis added). Even assuming, for the purposes of
argument, that the original disclosure supports removal of the wrap prior to
installation, Appellant does not direct our attention to any portion of the
disclosure that identifies this specific time period.
We have considered all of Appellant's arguments against the rejection
of claim 1 as failing to comply with the written description requirement, but
find them unavailing. Accordingly, we sustain the rejection of claim 1 and
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Application 14/213,743
associated dependent claims 2, 4-12, and 15-20 under 35 U.S.C. § 112, first
paragraph.
Claim 8
The Examiner determines that, in addition to the issues discussed
above regarding claim 1, claim 8 fails to comply with the written description
requirement because the original disclosure does not support the recitation of
two different wraps (a biocompatible shrink wrap as recited by claim 8 in
addition to the wrap recited by claim 1) or that one of the wraps remains in
place during installation of the implant. See Non-Final Act. 3.
Appellant argues that the original disclosure teaches the use of a
"bioresorbable wrap to aid the connection of the bioactive glass and the
implant" and that this wrap need not be removable. Br. 13.
Appellant's argument does not address the rejection of claim 8
because the Examiner determines that the original disclosure does not
support requiring two different wraps with the same implant or that one of
the wraps is removed while the other is not. See Non-Final Act. 3. Even
assuming that the original disclosure supported the recitation of a
bioresorbable wrap, such a teaching, by itself, would not also support
reciting two different wraps. Accordingly, for this additional reason, we
sustain the rejection of claim 8 as failing to comply with the written
description requirement.
Claim 9
The Examiner determines that the requirement in claim 9 for both an
adhesive and a wrap for securing the bioactive glass coating is not
supported. Non-Final Act. 3.
Appellant argues
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Application 14/213,743
The application discloses methods such as press-fitting the
bioactive glass into the pockets, using adhesives, using wraps,
locking tapers, or other mechanical mechanisms. The
application does not limit the disclosed invention to only one
method of aiding the connection of the bioactive glass to the
implant, and a person of ordinary skill in the art would recognize
that multiple methods are often preferable as it increases the
connection between two devices.
Br. 14.
We sustain the rejection of claim 9 as failing to comply with the
written description requirement for the additional reasons discussed below.
We agree with the Examiner that the Specification teaches that the use of an
adhesive for retaining the bioactive glass markers6 and the use of a wrap for
doing so are alternatives. See Spec. ,-J,-J 57, 65-67, 69. Paragraphs 66, 67,
and 69 state that a glass coating "may be adhered or otherwise impregnated
into the outer surface by any means known in the art for coating materials."
None of these paragraphs indicate that an adhesive is used in combination
with a wrap for retaining a bioactive coating ( or marker). Thus, the
requirement for using an adhesive (in addition to the wrap recited in claim 1)
for securing the bioactive glass coating is not supported by the original
disclosure.
Rejection IL Indefiniteness
Claim 11 recites that a plurality of pockets (introduced in claim 10)
"are filled with said bioactive glass to a level that is about even with said
bone contacting surface." Br. 37 (Claims App.)(emphasis added).
6 Paragraphs 57, 65-67, 69 refer to attaching markers with an adhesive and
do not specifically discuss attaching a coating with an adhesive. Appellant
does not direct our attention to any portion of the Specification that
explicitly refers to attaching a coating with an adhesive. See Br. 14-15.
7
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Application 14/213,743
The Examiner determines that, in claim 11, "it is unclear what 'about
even' means[, and i]t could mean below the contacting surface, above the
contacting surface, or anywhere between." Non-Final Act. 4.
Appellant contends "[a] person of ordinary skill would further
understand that, if the glass extends beyond the ridges of the implant, the
glass could create problems during insertion, and problems with regard to
the implant engaging with the vertebrae." Br. 16. Appellant also asserts
that, based on the Specification, a person of ordinary skill in the art "would
understand that the bioactive glass needs to be approximately level with the
surface of the implant so that a surgeon can use them as indicators during
implantation." Br. 15. Thus, Appellant seems to assert that the term "about
even" in claim 11 limits the glass to a level even with the bone contacting
surface or somewhat beneath the bone contacting surface (but not extending
beyond the bone contacting surface).
Appellant's asserted interpretation of claim 11 is contrary to the
ordinary meaning of the phrase "about even," which defines the position of
the glass as being nearly even with the bone contacting surface, but does not
limit deviation from this position as being only below the bone contacting
surface. In other words, the plain and ordinary meaning of "about even" in
claim 11 allows for deviation both above and below the bone contacting
surface. Appellant does not identify any portion of the Specification that
indicates that deviation in a direction beyond (above) the level of the bone
contacting surface is precluded. 7 Although we disagree with Appellant's
interpretation of claim 11, the Examiner has not identified any ambiguity in
7 Dependent claim 12 recites that "said pocket is filled with said bioactive
glass to a level that is above said bone contacting surface." Br. 3 7 ( Claims
App.).
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Application 14/213,743
the claim language inasmuch as a person of ordinary skill in the art would
understand the phrase "about even" in claim 11 to allow for a small amount
of deviation in either direction (above or below) the bone contacting surface.
Thus, we do not sustain the rejection of claim 11 under 35 U.S.C. § 112,
second paragraph.
Rejection III, Unpatentability, Brosnahan and Leroux
The Examiner finds that Brosnahan discloses many of the elements
recited in claim 1, including a bioactive glass coating, but does not disclose a
wrap secured around the implant and the bioactive glass coating for securing
the bioactive glass coating on the outer surface of the implant. Non-Final
Act. 5-6. The Examiner finds that Leroux teaches a "coating being applied
to the spinal implant via any number of mechanisms, including shrink
wrapping." Id. at 6 (citing Leroux 6:5-24, 6:53-7:5). The Examiner
determines that it would have been obvious to a person having ordinary skill
in the art to have constructed the device of Brosnahan with Brosnahan's
coating "being applied via a shrink wrap secured around the implant and the
coating, as taught by Leroux ... as this is one of many known ways to apply
a coating to a spinal implant, as disclosed by Leroux." Id.
Appellant argues "Leroux does mention the possibility of shrink
wrapping a coating onto the outside of an implant but for an entirely
different purpose than that disclosed in the present application." Br. 29, 33.
Appellant asserts "Leroux utilizes shrink wrapping to keep a smooth outer
surface and to prevent bone and tissue ingrowth." Id. at 29-30, 33.
Although Appellant's argument does not directly address the Examiner's
rationale regarding "known ways to apply a coating to a spinal implant," it
raises the question as to whether the method for applying a coating disclosed
by Leroux functions as the Examiner finds it does. Specifically, Appellant's
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Application 14/213,743
argument raises the question of whether Leroux discloses applying a coating
with a shrink wrap and "the wrap is inherently removed prior to installation
of said implant, leaving said bioactive coating in place" as the Examiner
finds. Non-Final Act. 6. We determine that Leroux does not. Rather, in
Leroux, the shrink wrap is the coating, not merely a vehicle by which the
coating is applied. In this regard, Leroux states, "the coated material can be
applied to the generally spherical or ellipsoidal body by adhesive bonding,
welding, soldering, shrink wrapping, melting, spray coating, bot dipping,
electroplating, immersion coating, brush coating, and/or the like." Leroux
6:20-24. Given the context of this statement, where all of the recited
methods directly apply the coating, we do not agree with the Examiner's
finding that the wrap is inherently removed prior to installation. Rather, it
appears from this statement that the shrink wrapping and the coating are one
and the same. Thus, the Examiner's reasoning for modifying the
arrangement disclosed by Brosnahan is based on an unsupported finding of
fact, namely, that Leroux discloses a coating separate from a wrap.
Accordingly, we do not sustain the rejection of claim 1 and claims 2, 4-12,
and 15-20 depending therefrom as unpatentable over Brosnahan and
Leroux.
Rejections IV-VI
The Examiner's use of Clineff, Bagga, and Peterman does not remedy
the deficiency discussed above regarding Rejection III. See Non-Final Act.
7-10. Accordingly, for the reasons discussed above regarding Rejection III,
we do not sustain Rejections IV-VI.
DECISION
I. The rejection of claims 1, 2, 4-12, and 15-20 as failing to
comply with the written description requirement is affirmed.
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Application 14/213,743
II. The rejection of claim 11 as indefinite is reversed.
III. The rejection of claims 1, 8, 10-12, and 15-17 as unpatentable
over Brosnahan and Leroux is reversed.
IV. The rejection of claims 2, 4-7, and 9 as unpatentable over
Brosnahan, Leroux, and Bagga is reversed.
V. The rejection of claims 18 and 19 as unpatentable Brosnahan,
Leroux, and Clineff is reversed.
VI. The rejection of claim 20 as unpatentable over Brosnahan,
Leroux, and Peterman is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a). See 37 C.F.R.
§ l.136(a)(l )(iv).
AFFIRMED
11