Ex Parte Ahrens et al

Patent Trial and Appeal Board

May 13, 2013

11420055 (P.T.A.B. May. 13, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________
Ex parte MICHAEL AHRENS, ERIK O. MARTZ,
RONALD BURKE, and BENJAMIN F. CARTER
____________________

Appeal 2011-003567
Application 11/420,055
Technology Center 3700
____________________

Before: JAMES P. CALVE, SCOTT A. DANIELS, and
BEVERLY M. BUNTING, Administrative Patent Judges.

BUNTING, Administrative Patent Judge.

DECISION ON APPEAL

Appeal 2011-003567
Application 11/420,055
2
STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
3, 16, 23-25, 29-31, 42-48, 50, 54-59 and 63. We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claims are directed to a mold assembly for an intervertebral
prosthesis. Claims 1 and 63 are independent. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A mold assembly for in situ formation of a
resilient prosthesis in an intervertebral disc space between
adjacent vertebrae of a patient, the mold assembly comprising:
at least a first mold having at least one interior cavity
located in the intervertebral disc space;
at least a first lumen having a distal end fluidly coupled
to the mold at a first location;
one or more discrete reinforcing structures functionally
centered in the intervertebral disc space with the mold;
one or more resilient, in situ curable resilient biomaterials
delivered to the interior cavity through the first lumen in an
uncured form, substantially encapsulating the reinforcing
structure, the at least partially in situ cured biomaterials, the
reinforcing structures, and the mold cooperating to comprise the
resilient prosthesis; and
the resilient prosthesis comprising a resilient interface
between the adjacent vertebrae.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Felt
Gerber
US 5,556,429
US 2005/0251260 A1
Sep. 17, 1996
Nov. 10, 2005
Appeal 2011-003567
Application 11/420,055
3
Guinan
Cheng
Hudgins
US 7,083,639 B2
US 2007/0093903 A1
US 2007/0093906 A1
Aug. 1, 2006
Apr. 26, 2007
Apr. 26, 2007

REJECTIONS
The Examiner made the following rejections:
Claims 1-3, 23-25, 30, 31, 47, 48, 55, 56, 58, 59 and 63 stand rejected
under 35 U.S.C. § 103(a) as being unpatentable over Gerber and Felt. Ans.
3.
Claims 16 and 42 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Gerber, Felt and Guinan. Ans. 5.
Claims 1-3, 23-25, 29-31, 43, 46-48, 50, 54, 57-59 and 63 stand
rejected under 35 U.S.C. § 103(a) as being unpatentable over Hudgins and
Felt. Ans. 6.
Claims 16, 42, 44 and 45 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hudgins, Felt, and Guinan. Ans. 8.
Claims 55 and 56 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Hudgins, Felt and Cheng. Ans. 9.

ANALYSIS
Obviousness Rejections
Claims 1-3, 23-25, 30, 31, 47, 48, 55, 56, 58, 59 and 63, Gerber and
Felt
Appellants argue claims 1-3, 23-25, 30, 31, 47, 48, 55, 56, 58, 59 and
63 as a group. App. Br. 3-4. We select claim 1 as representative of the
group. See 37 C.F.R. § 41.37(c)(1)(vii) (2011).
Appeal 2011-003567
Application 11/420,055
4
Claim 1 describes a mold assembly for in situ formation of prosthesis
in an intervertebral space between adjacent vertebrae using an in situ curable
biomaterial.
The Examiner found that Gerber discloses a mold assembly that
includes a first lumen valve, one or more discrete reinforcing structures, and
one or more resilient biomaterials, for in situ formation of a resilient
prosthesis in an intervertebral space between adjacent vertebrae of a patient.
Ans. 3-4; citing Gerber paras. [0079], [0080] and [0082]. While
acknowledging that Gerber does not discuss a biomaterial that at least
partially cures in situ, the Examiner relied on Felt for this teaching. Ans. 4;
citing Felt, Abstract. The Examiner reasoned that it would have been
obvious to “incorporate the injection of the curable biomaterial of Felt with
the device of Gerber et al. due to the fact that a less invasive surgery can be
provided by using such a material.” Ans. 4-5; citing Felt, col. 2, ll. 18-23.
Appellants argue that the articulated reason provided by the Examiner
fails to provide a basis for combining the teachings of Gerber and Felt, since
“the implantation procedure of Gerber is not made less invasive by
substituting the curable biomaterial of Felt.” App. Br. 4. In support,
Appellants assert that the rigid preformed endplates of Gerber require that
the surgeon “create an opening in the intervertebral disc space to pass the
endplates.” Id. Appellants also argue that Gerber does not suggest
“[e]ncapsulating or functionally engaging the reinforcing structure with an
in-situ curable biomaterial,” nor does Gerber suggest “injecting an in-situ
curable biomaterial into the implant.” Id.
These arguments do not persuade us of error in the Examiner’s
findings. As the Examiner correctly noted, Gerber specifically discloses that
the intervertebral device can be used in a minimally invasive surgical
Appeal 2011-003567
Application 11/420,055
5
method. Ans. 10; citing Gerber, paras. [0032], [0079] and [0080]. The
Examiner reasonably explained that “implanting the device of Gerber before
it is filled with a fluid, and then filling the device with the hydrogel mix of
Felt (which falls within the scope of a fluid which is a gel) would provide for
a less invasive surgery by allowing for a smaller incision.” Ans. 11; citing
Gerber, para. [0080]. Further, the Examiner correctly pointed to Gerber’s
teaching of “filling space 26 of disc 10 with a fluid (including gas, liquid,
gel, or a combination thereof) thereby encapsulating the spring component
30 with the fluid” in support of a modification to encapsulate the spring
component. Ans. 11; citing Gerber, para. [0079].
The Examiner’s reason to combine the teachings of Gerber and Felt is
expressly articulated and supported by rational underpinnings. In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int'l Co. v.
Teleflex, Inc., 550 U.S. 398, 418 (2007). Therefore, we sustain the rejection
of claim 1 and claims 2, 3, 23-25, 30, 31, 47, 48, 55, 56, 58, 59 and 63 which
depend therefrom.

Claims 16 and 42 Gerber, Felt and Guinan
Claims 16 and 42 depend from claim 1. Appellants do not provide a
separate argument in addressing the rejection of claims 16 and 42, and rely
on the argument provided with respect to claim 1. App. Br. 5. For the
reasons discussed supra with respect to claim 1, we likewise sustain the
rejection of claims 16 and 42.

Appeal 2011-003567
Application 11/420,055
6
Claims 1-3, 23-25, 29-31, 43, 46-48, 50, 54, 57-59, and 63, Hudgins
and Felt
Appellants argue claims 1-3, 23-25, 29-31, 43, 46-48, 50, 54, 57-59,
and 63 as a group. App. Br. 3-4. We select claims 1 as representative of the
group.
The Examiner found that Hudgins likewise teaches a mold assembly
for the formation of a resilient prosthesis, but does not teach a biomaterial
that at least partially cures in situ. Ans. 6-8. Again, the Examiner relied on
Felt to teach a spinal implant that includes the use of biomaterial that can be
delivered and cured in situ. Ans. 8; citing Felt, Abstract. Based on these
findings, the Examiner reasoned that it would have been obvious to
“incorporate the injection of the curable biomaterial of Felt with the device
of Hudgins et al. due to the fact that a less invasive surgery can be provided
by using such a material.” Ans. 8; citing Felt, col. 2, ll. 18-23.
Appellants limit their challenge to arguing that Hudgins is not prior
art to the present invention and attempt to swear behind and thus remove
Hudgins as a reference via “Declaration of Prior Invention under 37 C.F.R. §
1.131 filed on July 14, 2009 and a Supplemental 37 C.F.R. § 1.131
Declaration of Prior Invention (‘Supplemental Declaration’) filed on
November 20, 2009.” 1 App. Br. 5. The Supplemental Declaration is signed

1 We note that Appellants’ Appeal Brief filed July 15, 2010 and
Supplemental Appeal Brief filed August 3, 2010 do not include a copy of
either the Declaration filed July 14, 2009 or Supplemental Declaration filed
August 11, 2009 in the “Evidence Appendix” as required by 37 C.F.R.
41.37(c)(1)(ix). Since the Examiner entered the Supplemental Declaration
into the record as indicated in the Office Communication dated September 4,
2009, and Appellants contested the Examiner’s adverse decision in the
Arguments section of the Appeal Brief, we will consider the Supplemental
Appeal 2011-003567
Application 11/420,055
7
by the inventors and includes Exhibits A through I (“Exhibits”) as evidence.
Although the Examiner considered the Supplemental Declaration, the
Examiner found that the Supplemental Declaration is “ineffective to
overcome the Hudgins et al. reference” as required by 37 C.F.R. § 1.31.
Ans. 12.
37 C.F.R. § 1.131 provides in relevant part:2
(a) When any claim of an application or a patent under
reexamination is rejected, the inventor of the subject matter of
the rejected claim, the owner of the patent under reexamination,
or the party qualified under §§ 1.42, 1.43, or 1.47, may submit
an appropriate oath or declaration to establish invention of the
subject matter of the rejected claim prior to the effective date of
the reference or activity on which the rejection is based ….

(b) The showing of facts shall be such, in character and weight,
as to establish reduction to practice prior to the effective date of
the reference, or conception of the invention prior to the
effective date of the reference coupled with due diligence from
prior to said date to a subsequent reduction to practice or to the
filing of the application. Original exhibits of drawings or
records, or photocopies thereof, must accompany and form part
of the affidavit or declaration or their absence must be
satisfactorily explained.
37 C.F.R. § 1.131 (2008).
To definitively swear behind Hudgins, Appellants must establish
invention of the subject matter of the rejected claims prior to the effective
date of Hudgins by showing facts sufficient to establish reduction to practice
prior to the effective date or conception of the invention prior to the effective
date coupled with due diligence from prior to each effective date to a

Declaration filed August 11, 2009 (and presume Appellants erroneously
cited the filing date on page 5 of the Appeal Brief).
2 The Appeal Brief was filed prior to the August 12, 2012 change to 37
C.F.R. § 1.131; therefore the rule in effect on the filing date is applied.
Appeal 2011-003567
Application 11/420,055
8
subsequent reduction to practice or to the filing of the application. 37 C.F.R.
§ 1.131. At the outset, we note that Appellants do not contest that the
effective date of Hudgins under 35 U.S.C. § 103(a) is October 26, 2005 in
the Supplemental Declaration or Appeal Brief. Supp. Decl. para. 1; App. Br.
5. Thus, to be effective in antedating Hudgins as a reference, the
Supplemental Declaration must establish reduction to practice prior to
October 26, 2005, or conception of the invention prior to that date coupled
with due diligence to a subsequent reduction to practice or to the filing of the
Appellant’s application on May 24, 2006.
We observe that the Supplemental Declaration alleges “completion in
the United States of the inventions claimed in the above-identified
application before October 26, 2005” and refers to Exhibits A, B and C as
evidence of conception prior to October 26, 2005. Supp. Decl. paras. 1-6;
App. Br. 5. Further, the Supplemental Declaration alleges that Exhibits A
and C include disclosure “supporting at least claims 1 and 63 of the present
invention.” Supp. Decl. paras. 4 and 6.
A careful review of the Declaration reveals that the Declaration fails
to address the claim limitations of “at least claims 1 and 63”; nor does the
Declaration address any of the dependent claims with any specificity. The
evidence submitted by the Appellants in the present appeal is similar in
weight and character to the evidence submitted in In re Borokowski, 505
F.2d 713 (CCPA 1974) and In re Harry, 333 F.2d 920, 921 (CCPA 1964).
In both of those cases, the court found the evidence insufficient to antedate
the prior art.3

3 In In re Borokowski, 505 F.2d 713 (CCPA 1974), the appellants
submitted a Rule 131 affidavit to antedate a prior art patent. Id. at 714. The
appellants asserted that they conceived and reduced to practice the disclosed
Appeal 2011-003567
Application 11/420,055
9

and claimed subject matter prior to the filing date of the prior art patent. Id.
at 716. The remainder of the affidavit referred to attached exhibits,
including notebook pages and laboratory data, which the appellants asserted
described a reduction to practice of the process of the application. Id. The
appellants also submitted a supplemental affidavit with a supplemental
progress report discussing the significance of the test runs described in the
earlier-submitted exhibits. Id. at 717.
In determining that the original and supplemental affidavits were
insufficient to antedate the prior art reference, the court in Borokowski
stated:
The original and supplemental affidavits together with the
accompanying comments do not adequately explain what facts
or data appellants are relying upon to show a completion of
their invention prior to [the effective date of the prior art]. The
affidavits for the most part consist of vague and general
statements in the broadest terms as to what the exhibits show
along with the assertion that the exhibits describe a reduction to
practice. This amounts essentially to mere pleading,
unsupported by proof or showing of facts.
Id. at 718 (citing In re Harry, 333 F.2d 920 (CCPA 1964)). In particular, the
court found that the fifteen notebook pages submitted in the exhibits to the
original affidavit were not clear on their face and that “[i]t was appellants’
burden to explain the content of these notebook pages as proof of acts
amounting to reduction to practice.” Id. at 719. The court concluded that
“[a]bsent a clear explanation of the [pertinent] notebook pages pointing out
exactly what facts are established therein and relied on by appellants, the
affidavits based thereon are of little assistance in enabling the Patent Office
and its reviewing courts to judge whether there was an actual reduction to
practice of the invention.” Id. (citing In re Harry, supra).
The court in Borokowski acknowledged that differences exist between
the requirements of interference practice and the ex parte showing of
completion of an invention prior to the effective date of a patent or
publication under Rule 131; nonetheless, the court upheld the Board’s
determination that the affidavits submitted in the case were insufficient to
meet the requirements of Rule 131. Id. (stating that the court’s holding in In
re Spiller, 500 F.2d 1170 (CCPA 1974), “nowhere weakens the requirement,
under Rule 131, of a factual showing of completion of the invention before
the critical date.”).
Appeal 2011-003567
Application 11/420,055
10
In the case before us, the Supplemental Declaration consists of only a
bald assertion in the broadest terms that the invention of “at least claims 1
and 63” was conceived of prior to the effective date. Appellants rely on
Exhibits A-C submitted with the Supplemental Declaration as evidence in
support of this assertion. However, as in Borokowski and Harry, the
Supplemental Declaration also fails to sufficiently explain the content of the
Exhibits or how the information therein establishes acts amounting to
conception and diligent reduction to practice of the claimed invention. Thus,
Appellants’ assertion of prior invention amounts to mere pleading
unsupported by proof or showing of facts of sufficient character and weight
to establish prior invention by Appellants. In re Borokowski, 505 F.2d at
718.
Further, Appellants have failed to point to specific information within
the identified Exhibits which they rely on to show conception of the
invention. Neither the Supplemental Declaration nor the arguments in the
Appeal Brief establish facts sufficient to tie the information found in the
Exhibits to the claim limitations of “at least claims 1 and 63” in a manner to

Similarly, in In re Harry, 333 F.2d at 921, the appellant filed two
affidavits attempting to antedate prior art references. The first affidavit
stated that the subject matter of a drawing annexed “was diligently reduced
to practice,” and the second affidavit stated that “steps were taken to reduce
the invention to practice in a commercial size unit by engineering
preparation of drawings, cost estimates and both construction and
installation of apparatus embodying the invention was done as promptly as
possible in all the circumstances.” Id. at 922. The court held that Rule 131
requires “not a statement that facts exist” but an “oath to facts showing a
completion of the invention” and “the showing of facts shall be such, in
character and weight, as to establish reduction to practice, etc.” Id. The
court found that the appellant’s affidavits were “not proof or ‘showing of
facts’ but mere pleading” and merely asserted “that facts exist but does not
tell what they are or when they occurred.” Id.
Appeal 2011-003567
Application 11/420,055
11
show conception of even the basic invention.4 The attached Exhibits are of
little assistance in enabling the Patent Office to judge whether there was
conception of the invention prior to the effective date of the prior art and
diligence thereafter until Appellants’ constructive reduction to practice.
As such, the Supplemental Declaration and accompanying Exhibits do
not establish a date of conception of every feature recited in the claims prior
to the effective date of Hudgins as required by 37 C.F.R. § 1.131. Since
Appellants have not established conception, we do not address whether
Appellants established due diligence to reduce the invention to practice.
Accordingly, the rejection of claims, 1-3, 23-25, 29-31, 43, 46-48, 50, 54,
57-59, and 63 is sustained.

Claims 16,42,44 and 45 Hudgins, Felt and Guinan
Claims 16, 42, 44 and 45 depend directly or indirectly from claim 1.
Appellants do not provide a separate argument in addressing the rejection of
claims 16, 42, 44 and 45, and rely on the argument provided with respect to
claim 1. App. Br. 6. For the reasons discussed supra with respect to claim
1, we likewise sustain the rejection of claims 16, 42, 44 and 45.

Claims 55 and 56, Hudgins, Felt and Cheng
Claims 55 and 56 depend directly from claim 1. Appellants do not
provide a separate argument in addressing the rejection of claims 55 and 56,
and rely on the argument provided with respect to claim 63.5 App. Br. 6.

4 See In re Spiller, 500 F.2d 1170, 1178 (CCPA 1974) (holding a Rule 131
declaration that shows reduction to practice of the inventor’s “basic
invention” is also sufficient as to claims differing therefrom in details which
are obvious to one of ordinary skill in the art).
5 We note that claims 55 and 56 depend from claim 1.
Appeal 2011-003567
Application 11/420,055
12
For the reasons discussed supra with respect to both claims 1 and 63, we
likewise sustain the rejection of claims 55 and 56.

DECISION
The rejection of claims 1-3, 16, 23-25, 29-31, 42-48, 50, 54-59 and 63
is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2009).

AFFIRMED

mls