Ex Parte Boden et al

Patent Trial and Appeal Board

Sep 7, 2017

13558409 (P.T.A.B. Sep. 7, 2017)

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.
13/558,409 07/26/2012 Mark Boden 11-00068US01 (4010/397) 4208
93427 7590 09/11/2017
Brake Hughes Bellermann LLP
c/o CPA Global
900 Second Avenue South
Suite 600
Minneapolis, MN 55402
EXAMINER
CHENG, JACQUELINE
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
09/11/2017 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):
docketing@brakehughes.com
uspto@brakehughes.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK BODEN,
STEVE KANGAS,
JERI'ANN HILLER, and
BRUCE FORSYTH
Appeal 2015-005749
Application 13/558,409
Technology Center 3700
Before LINDA E. HORNER, CHARLES N. GREENHUT, and
MICHAEL L. HOELTER, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from a rejection of claims
1—5 and 9—22. Final Act. 1 (Office Action Summary). Claims 6—8 have
been canceled. See Amendment dated April 23, 2014. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
THE CLAIMED SUBJECT MATTER
The disclosed subject matter “relates generally to medical articles, and
more particularly to surgical meshes.” Spec. 12. Apparatus claims 1, 20,
Appeal 2015-005749
Application 13/558,409
and 22 are independent. Claims 1 and 22, reproduced below, are illustrative
of the claimed subject matter:
1. A surgical mesh comprising (a) a core comprising a biostable
first polymer and (b) a coating comprising (i) a second polymer
selected from a poly(hydroxy acid) and a styreneisobutylene
copolymer and (ii) at least one antimicrobial agent in an amount
sufficient to reduce the risk of infection of the mesh by
Staphylococcus aureus, wherein said mesh is selected from a pelvic
floor repair mesh, a renal pelvis repair mesh, a urethral sling and a
vaginal sling.
22. A surgical mesh comprising (a) a core comprising a biostable
first polymer and (b) a coating comprising (i) a styrene-isobutylene
copolymer and (ii) at least one antimicrobial agent in an amount
sufficient to reduce the risk of infection of the mesh by
Staphylococcus aureus.
REFERENCES
Raad US 5,217,493 June 8, 1993
Goldmann US 5,722,992 Mar. 3, 1998
Chinn US 2001/0003599 A1 June 14, 2001
Chin US 2006/0079957 A1 Apr. 13, 2006
Suokas US 2007/0134292 A1 June 14, 2007
Fronio US 2009/0204129 A1 Aug. 13, 2009
Dinh US 2012/0022321 A1 Jan. 26, 2012
REJECTIONS
Claim 22 is rejected under 35 U.S.C. § 102(b) as anticipated by Chin
and evidenced by Raad.
Claims 1—4, 9, 10, 13, 14, 16, and 19 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Goldmann, as evidenced by Suokas, in view
of Dinh.
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Claims 5 and 18 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Goldmann, as evidenced by Suokas, in view of Dinh and Raad.
Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Goldmann, as evidenced by Suokas, in view of Dinh and Chin.
Claim 12 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Goldmann, as evidenced by Suokas, in view of Dinh and Fronio.
Claims 15 and 17 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Goldmann, as evidenced by Suokas, in view of Dinh and
Chinn.
Claims 20 and 21 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Dinh, as evidenced by Raad, in view of Goldmann.
ANALYSIS
The rejection of claim 22
as anticipated by Chin as evidenced by Raad
The Examiner finds that Chin teaches the recited surgical mesh which
is coated with therapeutic agents, including antibiotics such as rifampin and
minocycline.1 Final Act. 3 (citations omitted). Appellants argue that Chin
“does not teach or suggest a surgical mesh” as claimed. App. Br. 8; see also
Reply Br. 7. The claim term “surgical mesh” is not explicitly defined in
Appellants’ Specification.2 The Examiner states, “under a broadest
reasonable interpretation, a mesh is a woven, knit, or knotted material of
open texture with evenly spaced holes or a web like pattem/construction.”
1 Raad discloses that certain antibiotic combinations such as rifampin and
minocycline “are very effective in killing . . . Staphylococcus aureus.'” Raad
2:30-42
2 However, see Paragraph 13 thereof for a description of its attributes.
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Application 13/558,409
Ans. 3. Appellants contend that Chin’s device does not satisfy this
definition. Reply Br. 7—8.
The Examiner, in addressing claim 22, references Paragraphs 35, 38,
40, 41, 44, 45, and 54 of Chin. Final Act. 3; Ans. 3. These various
paragraphs describe Chin’s patch as being “in the shape of a sheet” or “any
other shape” that might be suitable, as well as constructed of a “resilient,
breathable” polymer. Chin 138. Chin describes the patch being formed of
“layers” (H 38, 40) and having a “porous structure” that can “be used as a
scaffold for cell replication” (144).
The Examiner does not explain how Chin’s description of Chin’s
patch (i.e., a “resilient” and layered material that may be “in the shape of a
sheet” for scaffold purposes) renders this patch “a woven, knit or knotted
material” in accordance with the Examiner’s definition. It is also not clear
how Chin’s description of the patch being “breathable” and having a “porous
structure” results in the patch being “of open texture with evenly spaced
holes.” Finally, it is not clear how the layered, porous structure of Chin’s
patch renders this structure the equivalent of “a web like
pattem/construction. ”3
We are instructed, “[a]n examiner’s belief, however, must be tethered
to or grounded in some rationale so as to establish a prima facie case of
3 The term “web” is variously defined as (a) “an intricate pattern or structure
suggestive of something woven” (https://www.merriam-
webster.com/dictionary/web, last visited August 24, 2017); (b) “a piece of
woven fabric” (https://en.oxforddictionaries.com/defmition/web, last visited
August 24, 2017); and, (c) “something formed by or as if by weaving or
interweaving” (http://www.dictionary.com/browse/web?s=t, last visited
August 24, 2017).
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anticipation.” In re Chudik, 674 Fed. Appx. 1011, 1015 (Fed. Cir. 2017)
(referencing In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)). In the
matter before us, the Examiner has not established by a preponderance of the
evidence that Chin, as evidenced by Raad, anticipates the claimed surgical
mesh in accordance with the Examiner’s stated definition (and as argued by
Appellants). Ans. 3; Reply Br. 7—8. We do not sustain the Examiner’s
anticipation rejection of claim 22.
The rejection of claims 1—4, 9, 10, 13, 14, 16, and 19
as unpatentable over Goldmann, Suokas, and Dinh
Appellants argue all these claims together. App. Br. 8—10. We select
independent claim 1 for review, with the remaining claims standing or
falling therewith. See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner primarily relies on the teachings of Goldmann for
disclosing the limitations of claim 1 but acknowledges that Goldmann “does
not explicitly teach the mesh is selected from” the group recited.4 The
Examiner relies on Dinh for such teaching.5 Final Act. 4. Dinh further
teaches a treatment coating on the mesh material (as does Goldmann). Final
Act. 4 (referencing Dinh 110); see also Goldmann 3:26—30. The Examiner
concludes that it would have been obvious “to modify the knitted prosthesis
of Goldmann to be used as a mesh sling to treat pelvic disorders as taught by
Dinh as a matter of obvious design choice.” Final Act. 4. The Examiner
reasons that this would have been the case so as “to provide support to a
region of the body in order to treat incontinence while also preventing
4 Claim 1 recites, “said mesh is selected from a pelvic floor repair mesh, a
renal pelvis repair mesh, a urethral sling and a vaginal sling.”
5 Paragraph 20 of Dinh is specifically directed to a “urethral sling,” one of
the group recited.
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infection and promoting healing.” Final Act. 4—5 (referencing Dinh Abstract
and 19).
Appellants initially contend, “[tjhere is no suggestion in Goldmann
that the textile implant of Goldmann can be used to treat pelvic disorders” or
that the material therein “would be dimensionally and mechanically suitable
for the task.” App. Br. 9; Reply Br. 9 (emphasis added). The Supreme
Court has provided instruction that the suggestion need not come from the
references themselves and warns against “overemphasis on the importance
of published articles and the explicit content of issued patents.” KSR Int 7
Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Accordingly, Appellants
reliance on a lack of a suggestion “in Goldmann” that the implant can be
used to treat pelvic disorders is not persuasive of Examiner error.
Appellants are also arguing the references individually when the rejection is
predicated upon a combination of prior art disclosures. See In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellants acknowledge Dinh’s description of a pelvic implant
device, “such as an incontinence sling,” but disputes that the “materials
suitable for vascular implants such as those described in Goldmann are
suitable for pelvic implants.” App. Br. 9-10; Reply Br. 9. According to
Appellants, “there is no connection drawn between vascular and pelvic
implants.” App. Br. 10; Reply Br. 9. We disagree. The Examiner explicitly
states that the design choice rationale is “to provide support” to the afflicted
area of the body. Final Act. 4. Goldmann and Dinh both disclose implants
that provide support to afflicted areas of the body.6 See Goldmann 3:14—16
6 Appellants’ Specification also states, “[pjelvic floor disorders are
commonly treated by implanting a surgical mesh within the patient’s pelvis
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(“for closing or sealing larger openings in vessels or body tissue”); Dinh ||
4, 9 (addressing the problem of pelvic disorders that “can result from
weakness or damage to normal pelvic support systems”). In view of such
commonality in purpose, Appellants do not explain how it would not have
been obvious “to modify the knitted prosthesis of Goldmann to be used as a
mesh sling to treat pelvic disorders as taught by Dinh” as stated by the
Examiner. Final Act. 4.
Appellants further contend that the coatings employed by Goldmann
and Dinh differ (i.e., “the coating polymers of Goldmann are resorbable
polymers, whereas the coating polymer in Dinh is polycarbonate” (i.e., not
resorbable)). App. Br. 10; Reply Br. 9. The Examiner responds stating that
there is “no evidence to suggest a resorbable implant [as in Goldmann] is not
capable of use in treating pelvic or vaginal disorders.” Ans. 4. More
specifically, the Examiner identifies “other art in the area of treating pelvic
and vaginal disorders” suggesting “that permanent materials or
bioabsorbable materials may be used.” Ans. 4 (citations omitted).
Appellants do not dispute this finding by the Examiner but instead assert that
the Examiner reached the stated conclusion of obviousness based on
“hindsight gained from Appellant’s disclosure.” App. Br. 10; Reply Br. 10.
We are not persuaded, in light of the teachings of Goldmann and Dinh, that
the Examiner’s rejection is based on information gleaned only from
Appellants’ disclosure.
Accordingly, and based on the record presented, we sustain the
Examiner’s rejection of claims 1—4, 9, 10, 13, 14, 16, and 19.
to support the organ or organs that require support.’ '’ Spec. 13 (emphasis
added).
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The rejection of claims 5 and 18
as unpatentable over Goldmann, Suokas, Dinh, and Raad
Claim 5
Claim 5 depends indirectly from claim 1 and includes the additional
limitation, “wherein the total antibiotic concentration ranges from 5 to 100
grams of antibiotics per square meter of mesh.” The Examiner identifies
where Raad explicitly states, “the concentration of each antibiotic can range
from about 0.01 mg per cm2 to about 10 mg per cm2.” Final Act. 7
(referencing Raad 3:20—25). Raad’s values convert to a range of about 0.1
g/m2 to about 100 g/m2.
Appellants initially contend that because Raad’s device differs from
meshes, that one skilled in the art “would not use the teachings of Raad to
determine suitable antibiotic concentration pgr unit area for a mesh as
claimed.” App. Br. 11; Reply Br. 12. However, the Examiner states, “there
is no indication that the structural differences between a catheter and a mesh
would require different amounts of antibiotics, particularly when both are
implanted/inserted into the body.” Ans. 4—5. Appellants are not persuasive
of error in the Examiner’s stated reasoning.
Appellants also contend claim 5 is directed to a concentration “on the
gross area of mesh, as opposed to the surface area of the material making up
the mesh.” Reply Br. 12. Appellants reference Paragraph 38 of their
Specification which describes an example wherein the mesh has “an
antibiotic loading of 0.25 g/0.01 m2 = 25 g/m2.” Reply Br. 12. Appellants’
distinction differentiates between a gross area of the mesh and the entire
surface area of the matrix material itself. Accordingly, as per Appellants’
contention, only that surface area of Raad’s matrix material contributing to
the gross area can be properly correlated to Appellants’ value. This would
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reduce Raad’s values by about half because only an exposed side of Raad’s
matrix material would be measured (and not any surface area on an opposite
side thereof). However, even in this scenario, Appellants’ stated example
would still fall within such a reduced range of Raad’s concentration (now
being about 0.05 g/m2 to about 50 g/m2).
Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claim 5 as being obvious over Goldmann,
Suokas, Dinh, and Raad.
Claim 18
Appellants’ argument with respect to claim 18 is that “Raad, which is
cited for teachings regarding sterile packaging, does not make up for the
deficiencies in Goldmann, Suokas and Dinh.” App. Br. 19; Reply Br. 21.
Appellants’ contention is not persuasive the Examiner erred in relying
on Raad for disclosing the additional limitation, “wherein the mesh is sterile,
and is disposed in a package that maintains the sterility of the mesh.” Final
Act. 11 (referencing Raad 4:1—14). We sustain the Examiner’s rejection of
claim 18 as being obvious over Goldmann, Suokas, Dinh, and Raad.
The rejection of claim 11 as unpatentable over
Goldmann, Suokas, Dinh, and Chin
Claim 11 depends directly from claim 1 and recites particular
compounds for the coatings/polymers. The Examiner relies on Chin for
such teachings stating, “a simple substitution of one biodegradable polymer
for another” would “yield [a] predictable result.” Final Act. 8. Appellants
first contend that Chin “does not make up for the deficiencies in Goldmann,
Suokas and Dinh” (App. Br. 12; Reply Br. 13), but such argument is not
persuasive in view of our discussion of claim 1 above. Appellants further
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contend, “Goldmann is not directed to a surgical mesh selected from” the
recited group (App. Br. 12; Reply Br. 14), but the Examiner relied on Dinh
for such teachings (Final Act. 4), not Goldmann, as also discussed above.
Appellants also contend that the Examiner’s “simple substitution” is not so
simple because Goldmann’s biodegradable polymer is being substituted with
Chin’s biostable polymer and that one skilled in the art would not make such
a substitution. App. Br. 13; Reply Br. 14—15. The Examiner responds
referencing Paragraph 41 of Chin which states, “[t]he polymers of the
polymeric coatings may be biodegradable or non-biodegradable.”7 Ans. 5;
see also Chin 140 (“the polymeric material may be either bioabsorbable or
biostable”). Thus, Appellants’ additional arguments that such substitution
“would clearly change ... the principle of operation” of Goldmann and
“would render the device of Goldmann unsatisfactory for its intended
purpose” (App. Br. 14; Reply Br. 16) are not persuasive.
Appellants’ further argue that Chin “does not pertain to meshes as
claimed” is not persuasive (unlike a similar argument made above with
respect to claim 22 under an anticipation rejection). This is because with
respect to claim 11 (dependent on claim 1), the Examiner relies on
“Goldmann, as evidenced by Suokas, in view of Dinh [to teach] the surgical
mesh of claim 1” and not Chin. Reply Br. 14; Final Act. 7.
7 Furthermore, while Goldmann’s polymers degrade, Goldmann teaches that
they degrade at different rates. See Goldmann 4:11—13 (although “the
release of the antimicrobiotic agent is controlled,” such release “is relatively
faster than the decomposition of the resorbable material”). More
specifically, the maximum duration of the antimicrobiotic agent is “up to
100 days” while the other can have a resorption time of “52 weeks.”
Goldmann 4:11^42.
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Accordingly, and based on the record presented, we are not persuaded
the Examiner erred in rejecting claim 11 as being obvious over Goldmann,
Suokas, Dinh, and Chin.
The rejection of claim 12
as unpatentable over Goldmann, Suokas, Dinh, and Fronio
Appellants argue, “Fronio, which is cited for teachings regarding
mesh pore size and filament diameter, does not make up for the deficiencies
in Goldmann, Suokas and Dinh.” App. Br. 15; Reply Br. 17. Appellants’
statement is not persuasive the Examiner erred in relying additionally upon
the teachings of Fronio. We sustain the Examiner’s rejection of claim 12 as
being obvious over Goldmann, Suokas, Dinh, and Fronio.
The rejection of claims 15 and 17
as unpatentable over Goldmann, Suokas, Dinh, and Chinn
Appellants appear to address claims 15 and 17 separately; however,
Appellants rely on the same argument to refute the Examiner’s rejection of
these claims. App. Br. 15—18: Reply Br. 17—20. Each claim depends from
different independent claims and recites certain compounds (with claim 15
also reciting a specific wt% of the indicated compounds). The Examiner
relies on the teachings of Chinn for disclosing these limitations. Final Act.
10-11. Paragraph 23 of Chinn teaches a solvent that “is generally selected
from one that will readily spread onto and/or along the particular medical
device surface to which it is applied” and “[t]he degree of this spreading
may be influenced by the surface tension of the solvent.” After which,
Paragraph 23 provides illustrative examples of suitable solvents (which
include the recited compounds).
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Appellants do not dispute that the recited compounds/solvents are
disclosed in Chinn, but instead that Chinn’s “list of solvents] includes a
very wide range of solvents” and that one skilled in the art “would have had
to pick tetrahydrofuran [or dimethyl formamide] from the very large list of
solvents set forth in Chinn.” App. Br. 18; Reply Br. 20. Appellants contend
that one skilled in the art would not have selected the recited compounds
“without the hindsight gained from Appellant’s disclosure.” App. Br. 18;
Reply Br. 20.
The Examiner reiterates, “Chinn does teach using the claimed
antibacterial agents with the claimed solids.” Ans. 5. The fact that Chinn
discloses a “wide range of solvents” is not a bar to a finding of obviousness
in view of instructions that when “there are a finite number of identified,
predictable solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp.” KSR, 550 U.S. at 421.
Further, we are instructed that if such pursuit “leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill and
common sense.” Id. Here, even if a “wide range of solvents” has been
disclosed in Chinn, it is nevertheless a limited range and Appellants do not
explain how the selection of the specifically recited solvents (disclosed in
Chinn) is beyond the ability of one skilled in the art. Accordingly, we are
not persuaded the Examiner erred in rejecting claims 15 and 17 as being
obvious over Goldmann, Suokas, Dinh, and Chinn.
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The rejection of claims 20 and 21
as unpatentable over Dinh, Raad, and Goldmann
In responding to this rejection, Appellants revert to arguments
previously presented including “that materials suitable for vascular implants
such as those described in Goldmann would [not] be suitable for pelvic
implants” and that the rejection “would not have been obvious to one of
ordinary skill in the art without the hindsight gained from Appellant’s
disclosure.” App. Br. 20; Reply Br. 22—23. Appellants’ contentions are not
persuasive for reasons previously expressed. We sustain the Examiner’s
rejection of claims 20 and 21 as being obvious over Dinh, Raad, and
Goldmann.
DECISION
For the above reasons, we reverse the Examiner’s anticipation
rejection of claim 22 under 35 U.S.C. § 102(b).
For the above reasons, we affirm the Examiner’s obviousness
rejections of claims 1—5 and 9-21 under 35 U.S.C. § 103(a).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED-IN-PART
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