Ex Parte Berry et al

Patent Trial and Appeal Board

Feb 8, 2018

12339766 (P.T.A.B. Feb. 8, 2018)

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.
12/339,766 12/19/2008 Bret M. Berry 641-10 7798
27538 7590 02/12/2018
frihsinn Rr Dernier T T P
EXAMINER
89 Headquarters Plaza North
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SCHALL, MATTHEW WAYNE
Morristown, NJ 07960 ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
02/12/2018 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRET M. BERRY, RICHARD D. GUYER, JACK E. ZIGLER,
ADAM A. PIKE, and RANDALL F. LEE1
Appeal 2017-002879
Application 12/339,766
Technology Center 3700
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent .Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
intervertebral prosthesis. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Background
“The present disclosure generally relates to apparatus and methods
for treatment of spinal disorders using an intervertebral prosthesis which is
1 According to Appellants, the real party in interest is Amicus, LLC. (Br. 2.)
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Application 12/339,766
disposed in an intervertebral space (or cavity) following removal of a
damaged or diseased intervertebral disc.” (Spec. 11.)
Claims on Appeal
Claims 1—21 are on appeal. (Br. 14—18 (Claims Appendix).) Claims
1 and 21, the only independent claims, are illustrative and read as follows
(emphases added):
1. An intervertebral prosthesis, comprising:
a body including first and second spaced apart major
surfaces and at least anterior and posterior sidewalls extending
therebetween, the first major surface for engaging an endplate
of a first vertebral bone of a spine, and the second major surface
for engaging an endplate of an adjacent, second vertebral bone
of the spine, and the first and second major surfaces defining a
longitudinal axis extending substantially normal to said
surfaces;
a first aperture extending from within the body,
transversely with respect to the longitudinal axis, and opening
at the first major surface;
a first anchoring element disposed within the first
aperture and including a threaded shaft having proximal and
distal ends; and
a first gear disposed adjacent to and in meshed, threaded
communication with the threaded shaft of the first anchoring
element such that rotation of the first gear causes rotation of the
first anchoring element,
wherein a driving rotational force on the first gear causes
the first anchoring element to rotate, deploy from the body, and
thread into the first vertebral bone in a direction transverse to
the longitudinal axis of the body and the spine.
{Id. at 14.)
21. An intervertebral prosthesis, comprising:
a body including first and second spaced apart major
surfaces and at least anterior and posterior sidewalls extending
therebetween, the first major surface for engaging an endplate
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Application 12/339,766
of a first vertebral bone of a spine, and the second major surface
for engaging an endplate of an adjacent, second vertebral bone
of the spine, and the first and second major surfaces defining a
longitudinal axis extending substantially normal to said
surfaces; and
at least one anchoring element disposed within an
aperture within the body and including a threaded shaft, the at
least one anchoring element operating to deploy from the body
in response to a driving rotational force and thread into the first
vertebral bone in a direction transverse to the longitudinal axis
of the body and the spine.
(Id. at 18.)
Examiner’s Rejections
1. Claims 1—21 stand rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite. (Ans. 4—5.)
2. Claims 1—21 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Moskowitz2 and Michelson.3 (Id. at 5—6.)
DISCUSSION
Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under Section 112.
Analysis
The Examiner contends that “[t]he term ‘transverse’ in claims 1 and
21 is used by the claims to mean ‘extending at an angle less than 90 degrees
2 Moskowitz et al., US 2007/0049943 Al, pub. March 1, 2007
(“Moskowitz”).
3 Michelson, US 6,749,636 B2, issued June 15, 2004.
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Application 12/339,766
away from the longitudinal axis of the device’, while the accepted meaning
is ‘at a right angle from the longitudinal axis of the device.’” (Ans. 4—5.)
Although the Examiner agrees with Appellants that Merriam Webster’s
Collegiate Dictionary defines “transverse” as “(1) acting, lying or being
across; set crosswise, and/or (2) made at right angles to the anterior/posterior
axis of the body,” {id. at 6), according to the Examiner, “[o]ne of the
definitions in Merriam-Webster[’s] dictionary defines the term as ‘made at
right angles to the long axis of the body’” {id. at 5) (i.e. definition (2)). The
Examiner thus finds that “[t]he term [transverse] is indefinite because the
specification does not clearly redefine the term.” {Id.)
Appellants contest the rejection, relying on the Berry Declaration.4
(Br. 6—10.) Appellants argue that “[t]here should be no dispute as to the
actual accepted definition of the term ‘transverse,’ i.e., the definition
encompasses two axes or members ‘crossing’ one another at an angle within
a range of greater than 0 and including 90 degrees.” {Id. at 8, citing Decl.
1 6.) Appellants further argue that “the claims call for a configuration that is
both supported by the written description, the drawing, and the actual
accepted definition of ‘transverse’.” (Id. )
We find that Appellants have the better position. The conjunction
“and/or,” used in the definition of “transverse” agreed to by the Examiner
and Appellants, is “used as a function word to indicate that two words or
expressions are to be taken together or individually.”5 As applied to the
4 Declaration of Bret M. Berry, dated July 5, 2012 (“Berry Declaration” or
“Decl.”).
5 Meriam-Webster.com, https://www.merriam-
webster.com/dictionary/and/or (last visited Jan. 31, 2018).
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Application 12/339,766
definition of “transverse,” that definition is thus understood to include all
three of definitions (1) or (2), or both (1) and (2). Here, definition (1)
(acting, lying, or being across; set crosswise) is consistent with Appellants’
use of the term “transverse.” Accordingly, we find that the term
“transverse,” as used by Appellants in claims 1 and 21, is sufficiently clear
to a person of ordinary skill in the art. See In re Packard, 751 F.3d 1307,
1313 (Fed. Cir. 2014); see also Ex parte McAward, Appeal 2015-006416,
2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the
approach for assessing indefmiteness approved by the Federal Circuit in
Packard).
The Examiner’s rejection of claims 1—21 under Section 112, second
paragraph, is reversed.
Rejection No. 2
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under 35 U.S.C. § 103(a).
Analysis
The Examiner finds that Moskowitz discloses “an intervertebral
prosthesis comprising a body with first and second major surfaces, apertures
in the surfaces, and anchoring elements [screws] (102) (103) threaded with
gears (202) and capable of deploying from the body and threading into
vertebral bone.” (Ans. 5, citing Moskowitz Figure 1A and 140.) The
Examiner further finds that, although Moskowitz does not disclose the
screws deploying at an angle from the longitudinal axis, “Michelson teaches
an intervertebral prosthesis with screws deploying at an angle from the body
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of the device and into vertebral bone, in the same field of endeavor, for the
purpose of securing the device.” (Ans. 5, citing Michelson Figures 23—27
and col. 9,11. 5—20.) Based on those findings, the Examiner concludes that
“[i]t would have been obvious to one having ordinary skill in the art at the
time the invention was made to modify the implant of Moskowitz to have
the angled screws of Michelson, in order to secure the device in place.”
(Ans. 6.)
Appellants contest the rejection, and rely on the Berry Declaration.
(Br. 5—6, 11—13.) In particular, Appellants argue that the Examiner has not
addressed the Berry Declaration or provided any rebuttal or other response
to the statements in the Berry Declaration. (Br. 11.)
We separately address the rejection of independent claims 1 and 21.
Claim 1
Claim 1 recites, in pertinent part, “a first anchoring element. . . and a
first gear disposed adjacent to and in meshed, threaded communication with
the threaded shaft of the first anchoring element.” (Br. 14.) The Berry
Declaration states that “neither . . . [Moskowitz] nor . . . [Michelson]
provides disclosure of a suitable gear mechanism that would be required to
achieve the modification that the Examiner concludes is obvious.” (Decl.
114.) The Berry Declaration further states that “any attempt to take the axes
of the spur gear 202 and either screws 102, 103 [(Moskowitz Fig. 2)] out of
parallel (as would be required in order to deploy as illustrated in
[Michelson]) would cause the illustrated gearing therebetween to bind.”
(Decl. 115.)
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Notwithstanding Appellants’ clear reliance on the Berry Declaration,
the Examiner’s Answer fails to address the Berry Declaration or Appellants’
arguments with respect thereto. (See Ans. 3—7.) However, after a successful
Petition by Appellants, the Berry Declaration was entered by the Examiner
more than four years after the Berry Declaration was filed. (Advisory
Action dated Aug. 19, 2016.) At that time, the Examiner stated that “the
affidavit filed 7/23/2012 is entered for appeal purposes, however the
opinions in the affidavit are not persuasive.” (Id.)
On this record, we do not find the Examiner’s cursory response to be
sufficient to persuasively address the Berry Declaration, particularly as it
relates to the gear mechanism as recited in claim 1. Here, the Examiner
provides no reasoning as to why “the opinions in the affidavit are not
persuasive.” Accordingly, we reverse the rejection of claim 1 and dependent
claims 2—20, all of which depend directly or indirectly on claim 1.
Claim 21
We discern no error in the Examiner’s rejection of claim 21 for
obviousness.
Although Appellants acknowledge that “claims 1 and 21 are of
differing scope,” Appellants incorrectly assert that claim 21 includes “a first
gear disposed adjacent to and in meshed, threaded communication with the
threaded shaft.” (Br. 12.) Rather, the pertinent structure recited in claim 21
is limited to “at least one anchoring element disposed within an aperture
within the body and including a threaded shaft.” (Br. 18.) No gear
mechanism is recited, and the “driving rotational force” recited in claim 21
to deploy the anchoring element may be applied directly to the anchoring
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element with (for example) a wrench or screw driver. Thus, Appellants’
reliance on arguments and the Berry Declaration regarding a gear
mechanism are unavailing as to claim 21.
Appellants also argue that Moskowitz and Michelson are not enabled,
citing Manual of Patent Examining Procedure (“MPEP”) § 2121.01.
(Br. 12.) However, that argument is unpersuasive because the cited section
of the MPEP clearly states that “a non-enabling reference may quality as
prior art for the purpose of determining obviousness under [35 U.S.C.
§ 103].” (MPEP § 2121.01, quoting Symbol Techs., Inc. v. Opticon, Inc.,
935 F.2d 1569, 1578 (Fed. Cir. 1991).)
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 21.
Conclusions
A preponderance of evidence of record fails to support the Examiner’s
rejection of claims 1—21 under 35 U.S.C. § 112, second paragraph.
A preponderance of evidence of record fails to support the Examiner’s
rejection of claims 1—20 under 35 U.S.C. § 103(a).
A preponderance of evidence of record supports the Examiner’s
rejection of claim 21 under 35 U.S.C. § 103(a).
SUMMARY
The rejection of claim 21 under Section 103(a) is affirmed, and the
rejections of claims 1—21 under Section 112, second paragraph, and claims
1—20 under Section 103(a), are reversed.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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