Ex Parte Hardy et al

Patent Trial and Appeal Board

Aug 21, 2018

13063891 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/063,891 05/27/2011
3017 7590 08/22/2018
BARLOW, JOSEPHS & HOLMES, LTD.
101 DYER STREET
5THFLOOR
PROVIDENCE, RI 02903
FIRST NAMED INVENTOR
Craig Hardy
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.
W004 P02217-US 6783
EXAMINER
LAZARO, DOMINIC
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
08/22/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CRAIG HARDY and
STEWART ANDREW DARBY
Appeal2017-008136
Application 13/063,891 1
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify Medtrade Products Limited as the real party in interest.
App. Br. 1.
Appeal2017-008136
Application 13/063,891
STATEMENT OF CASE
The following claim is representative.
44. A non-gelled wound care device comprising a first
material and a second material, which materials individually do
not substantially gel when exposed to a fluid, the wound care
device does not gel when it has not been exposed to a fluid, and
the wound care device does gel when exposed to a fluid,
wherein the first material is in a dry fibrous form and comprises
a polysaccharide or a polysaccharide derivative, and wherein
the second material is in a dry fibrous form and has an acid
absorbed therein without permanent bonding occurring between
the acid and the second material, and further wherein the first
material has not been pre-treated with the acid.
Cited References
Saferstein
Court
Grounds of Rejection
us 5,134,229
US 6,268,544 B 1
July 28, 1992
July 31, 2001
Claims 44--47, 49-54, 58-62, and 64---69 are rejected under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over Court in view of Saferstein.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 5-13. The following facts are highlighted.
1. Court discloses wound dressings comprised of a mixture of
gel-forming fibres and textile fibres. Col 1, 11. 40-43.
2. Court teaches a wound dressing (Court, abstract) including
an exemplary embodiment, wherein the inlaid yam is
2
Appeal2017-008136
Application 13/063,891
composed of alginate fibres and viscose fibres. Court, col.
4, ln. 35-39, Ex. 2; Final Act 7.
3. Court discloses chitosan (Court, col. 2, In. 39) and alginate
fibres (Court, col. 4, In. 37, Ex. 2) are equivalent gel-
forming fibres (Court, col. 2, ln. 34 & 38-39; Court, col. 2,
ln. 39 & claim 11 ).
4. Court discloses regenerated cellulose (Court, col. 2, ln. 17)
and viscose fibres (Court, col. 4, ln. 38, Ex. 2) as equivalent
textile fibres (Court, col. 2, ln. 14-17).
5. Court discloses that the textile fibers are not hygroscopic. Col. 2,
11. 19-23; Col. 4, Ex. 3; Ans. 5.
6. Court discloses that the textile fibres can be cellulosic fibres, such
as viscose, cotton, or regenerated cellulose. Col. 2, 11. 14-23; Ans.
3.
7. Court further discloses that the gel forming fibres can be
carboxymethylated cellulose, alginate, chitosan fibers. Col. 2, 11.
34-40.
8. Court does not disclose that the gel forming fibers are gelled at the
time of manufacture of the wound care device.
9. Court does not expressly teach a second material (i.e., Court's
textile fibre) with an acid absorbed therein (claims 44, 46, 52, 58-
59, 61 and 67); Final Act 8.
10. The Examiner finds that Saferstein teaches:
"[an] Oxidized cellulose material [which] is neutralized, by
contacting an acidic oxidized cellulose material with a water
and alcohol solution of a basic salt of a weak organic acid,
e.g. sodium acetate, to elevate the pH of the cellulosic
3
Appeal2017-008136
Application 13/063,891
material to between 5 and 8," wherein "The resulting
neutralized product is storage stable and has therapeutic
applications, including hemostasis and adhesion
prevention," and "may be impregnated with acid-sensitive
hemostatic agents, such as thrombin, to enhance its
hemostatic properties, or with acid-sensitive adhesion-
preventive agents, such as t-PA, to enhance its adhesion-
prevention properties." Saferstein, title & abstract; similarly
at Saferstein, col. 2, ln. 25-32.
Final Act. 8.
11. Saferstein teaches:
"The neutralized cloth provides a scaffold of fibers to
reinforce the clot, and make it stronger" wherein "The
neutralized cloth being bioabsorbable will dissolve in 7-14
days" (Saferstein, col. 6, ln. 47-50), and teaches used of the
neutralized cloth for covering a wound or as a hemostat
(Saferstein, col. 3, ln. 45-53). Saferstein described the
properties of the oxidized cellulose: . . . . Saferstein, col. 4,
ln. 43-65.
Final Act. 8.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
4
Appeal2017-008136
Application 13/063,891
Where ... the claimed and prior art products are identical or
substantially identical, or are produced by identical or substantially
identical processes, the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the
characteristics of his claimed product. ... Whether the rejection is
based on "inherency" under 35 U.S.C. § 102, on "prima facie
obviousness" under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the PTO' s
inability to manufacture products or to obtain and compare prior art
products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.)
Obviousness Rejection
The Examiner finds that Court discloses wound dressings
comprised of a mixture of gel-forming fibres and textile fibres. Col 1,
11. 40-43. Court teaches a wound dressing (Court, abstract) including
an exemplary embodiment, wherein the inlaid yam is composed of
alginate fibres and viscose fibres. Court, col. 4, ln. 35-39, Ex. 2.
Court discloses chitosan (Court, col. 2, In. 39) and alginate fibres
(Court, col. 4, In. 37, Ex. 2) are equivalent gel-forming fibres (Court,
col. 2, ln. 34 & 38-39; Court, col. 2, ln. 39 & claim 11 ). Court
discloses regenerated cellulose (Court, col. 2, ln. 17) and viscose
fibres (Court, col. 4, ln. 38, Ex. 2) as equivalent textile fibres (Court,
col. 2, ln. 14-17). Court discloses that the textile fibers are not
hygroscopic. Col. 2, 11. 19-23; Col. 4, Ex. 3; Ans. 5. Court does not
disclose that the gel forming fibers are gelled at the time of
manufacture of the wound care device.
The Examiner admits that Court does not expressly teach a second
material (i.e., Court's textile fibre) with an acid absorbed therein (claims 44,
5
Appeal2017-008136
Application 13/063,891
46, 52, 58-59, 61 and 67). To make up for this deficiency in the cited prior
art, the Examiner finds that
Saferstein teaches: "[an] Oxidized cellulose material [which] is
neutralized, by contacting an acidic oxidized cellulose material
with a water and alcohol solution of a basic salt of a weak
organic acid, e.g. sodium acetate, to elevate the pH of the
cellulosic material to between 5 and 8," wherein "The resulting
neutralized product is storage stable and has therapeutic
applications, including hemostasis and adhesion prevention,"
and "may be impregnated with acid-sensitive hemostatic agents,
such as thrombin, to enhance its hemostatic properties, or with
acid-sensitive adhesion-preventive agents, such as t-PA, to
enhance its adhesion-prevention properties." Saferstein, title &
abstract; similarly at Saferstein, col. 2, In. 25-32. In this regard,
Saferstein teaches: "The neutralized cloth provides a scaffold of
fibers to reinforce the clot, and make it stronger" wherein "The
neutralized cloth being bioabsorbable will dissolve in 7-14
days" (Saferstein, col. 6, In. 47-50), and teaches used of the
neutralized cloth for covering a wound or as a hemostat
(Saferstein, col. 3, In. 45-53). Saferstein described the
properties of the oxidized cellulose: . . . . Saferstein, col. 4, In.
43-65.
Final Act. 8-9. The Examiner concludes that
it would have been prima facie obvious to one of ordinary skill
in the art at the time of the invention to rearrange Court's
wound dressing (Court, col. 4, In. 36-38, Ex. 2) by substituting
alginate fibres (Court, col. 4, ln. 37, Ex. 2), for chitosan (Court,
col. 2, ln. 39) and viscose fibres (Court, col. 4, ln. 38, Ex. 2) for
regenerated cellulose (Court, col. 2, ln. 17), and to have used
oxidized regenerated cellulose, as taught by Saferstein
(Saferstein, col. 2, ln. 25-32), as the regenerated cellulose
(Court, col. 2, ln. 17). One would have been motivated to do so
with a high expectation of success since both Court and
Saferstein are concerned with similar problems in the art,
namely the preparation of wound care devices (Court abstract)
or the materials suitable for incorporation into wound car
6
Appeal2017-008136
Application 13/063,891
devices (Saferstein, col. 2, ln. 25- 32). Further, it is well within
the skill of the ordinary artisan to select a suitable regenerated
cellulose. Court, col. 2, ln. 17. Doing so amounts to no more
than combining prior art elements according to known methods
to yield predictable results, namely the preparation of Court's
wound care device (Court, abstract) with regenerated cellulose
(Court, col. 2, ln. 17) in order to obtain the advantage of an
oxidized cellulose, which behaves as an ion exchanger
(Saferstein, col. 4,1. 43-48) and a buffered solution that
maintains a fairly constant pH (i.e., at a pH between 5 and 8,
Saferstein, col.. 3, ln. 36-38), thereby preventing complete
neutralization that renders the fiber weak and swollen when
exposed to water (Saferstein, col. 4, ln. 53-65).
Final Act. 10.
Appellants contend that
Saferstein creates a buffered, solution that is pH balanced at
neutral. Saferstein explicitly states that the acid is bound to the
cellulose cloth, which is expressly excluded from the claimed
subject matter. The Applicant has expressly claimed that the
acid is not permanently bonded to the second material, such as
cellulose material. Therefore, Saferstein does not teach the
claimed invention, even if combined with Court.
In any event, Court teaches that one of the fibres is gel-
forming which, upon the uptake of wound exudate, becomes
moist and slippery or gelatinous. Conversely, the first material
of the present invention [] individually does not gel when
exposed to a fluid. Court therefore also contains contradictory
teaching to the requirements of the claims and does not provide
a suitable basis for an obviousness objection.
App. Br. 6.
Appellants argue that
the combined teachings of Court and Saferstein do not arrive at
the wound care device having all of the essential features of the
independent claims. Specifically, the first and second material
must not gel individually, and then, only together in the
7
Appeal2017-008136
Application 13/063,891
presence of liquid. And further, the second material must
absorb an acid, but the acid must not bond with the second
material. Therefore, the combination fails.
App. Br. 6.
ANALYSIS
Appellants do not argue individual claims separately in the Appeal
Brief, therefore we select claim 44 as representative claim. We adopt the
Examiner's findings of fact, reasoning on scope and content of the claims
and prior art (e.g., what was well known, routine, and/or conventional in the
field), and conclusions set out in the Final Action and Answer. See Final
Act. 5-13; Ans. 3-12. Only those arguments made by Appellants in the
Appeal Brief and properly presented in the Reply Brief have been
considered in this Decision. Arguments not so presented in the Briefs are
waived. See 3 7 C.F .R. § 41.3 7 ( c )( 1 )(iv) (2015); see also Ex parte Borden,
93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any bases for
asserting error, whether factual or legal, that are not raised in the principal
brief are waived.").
We find that the Examiner has set forth a prima facie case of
obviousness on the evidence before us. In particular, the Examiner found
that
Court clearly teaches a wound dressing ( Court, abstract)
including an exemplary embodiment, wherein the inlaid yam is
composed of alginate fibres and viscose fibres. Court, col. 4,
ln. 35-39, Ex. 2. In light of Court's teachings, it would have
been prima facie obvious to one of ordinary skill in the art at
the time of the invention to rearrange Court's exemplary
embodiment (Court, col. 4, ln. 35-39, Ex. 2) according to
Court's disclosure.
8
Appeal2017-008136
Application 13/063,891
Ans. 3--4.
The Examiner argues that one of ordinary skill in the art would have
substituted chitosan (Court, col. 2, ln. 39) for alginate fibres (Court, col. 4,
ln. 37, Ex. 2) since Court discloses chitosan and alginate as equivalent gel-
forming fibres (Court, col. 2, ln. 34 & 38-39). The Examiner argues that one
of ordinary skill in the art would have substituted regenerated cellulose
(Court, col. 2, ln. 17) for viscose fibres (Court, col. 4, ln. 38, Ex. 2) since
Court discloses regenerated cellulose and viscose fibres as equivalent textile
fibres (Court, col. 2, ln. 14-17). Ans. 3--4. Court discloses that the textile
fibers are not hygroscopic. Col. 2, 11. 19-23; Col. 4, Ex. 3; Ans. 5. Court
does not disclose that the gel forming fibers are gelled at the time of
manufacture of the wound care device.
Appellants argue that Court and Saferstein do not teach that each of
the first and second materials, individually, must not gel, and that the
materials must gel only together in the presence of liquid. App. Br. 6.
Appellants argue in the Reply Brief that the chitosan fibre of the present
application "would not gel on contact with wound exudate." Reply Br. 3,
underline omitted.
However, the limitation that the chitosan fiber would not gel on
contact with wound exudate is not claimed. The pending claim 44 requires
that, "materials individually do not substantially gel when exposed to a fluid,
the wound care device does not gel when it has not been exposed to a fluid,
and the wound care device does gel when exposed to a fluid." Claim 44,
italicized emphasis added.
The Examiner argues that, in this case, the prior art teaches the
identical chemical structure, namely chitosan fibers (Court, col. 2, In. 34-
9
Appeal2017-008136
Application 13/063,891
40), and oxidized regenerated cellulose with acetic acid (Saferstein, col. 4,
In. 43-65 & col. 8, In. 35 to col. 9, In. 3-15, Ex. 1). Ans. 9. These fibers
may be mixed. FF 1. The Examiner finds that
the properties applicant discloses and/or claims (e.g., "which
[first and second] materials individually do not substantially gel
when exposed to a fluid, the wound care device does not gel when it
has not been exposed to a fluid, and the wound care device does gel
when exposed to a fluid" of claim 44, ... ) are necessarily (inherently)
present since the materials are the same or substantially the same as
those claimed. The wound care device of Court does not gel when it
has not been exposed to a fluid, but does gel when exposed to a fluid
Ans. 9.
Appellants have not provided evidence showing an error in the
Examiner's technical and/or legal analysis, and have not shown that the
fibers of Court and Saferstein are in a gelled state at the time of manufacture
of the wound care dressing/device. In re Best, 562 F.2d 1252, 1255 (CCPA
1977). See also, Advisory Action dated, July 31, 2016, p. 2. 2 Attorney
2 (''Therefore, if the prior art teaches the identical chemical structure, the
properties applicant discloses and/or claims are necessarily present. In this
regard, it is noted that in arguing that "the first material of the present
invention 'individually does not gel when exposed to a fluid,"' and
"therefore appears to contain contradictory teaching to the requirements of
the claims" (Remarks, p. 9, par. 1 ), are mere arguments of counsel. Since
the US PTO lacks the capacity of laboratory facilities to ascertain the
comparative gel forming or lack thereof of Court's chitosan versus the
chitosan first material of the instant claims, the burden falls on Applicant to
show/demonstrate facts (i.e., comparative gelling, or lack thereof) and not to
speculate about them. Applicants have not made a sufficient evidentiary
showing whereby one of ordinary skill in the art would conclude that the
10
Appeal2017-008136
Application 13/063,891
argument cannot take the place of evidence. In re DeBlauwe, 736 F.2d 699,
705 (Fed. Cir. 1984). Unsupported attorney argument, presented for the first
time on appeal, is an inadequate substitute for record evidence. See also,
Gemtron Corp. v. Saint-Gobain Corp., 572 F.3d 1371, 1380 (Fed. Cir. 2009)
( emphasizing that "unsworn attorney argument ... is not evidence"). 3 We
do not entertain Appellants' new argument and evidence presented for the
first time in the Reply Brief as we do not have the benefit of the Examiner's
position with respect to the new evidence. 3 7 C.F .R 41.41 (b ).
Appellants argue that the claimed second material must absorb an
acid, but the acid must not bond with the second material. App. Br. 6.
Appellants argue that the cited references do not disclose this claim
limitation. Id.
that
With respect to the acid treated fiber limitation, the Examiner finds
Saferstein teaches: "[an] Oxidized cellulose material [which] is
neutralized, by contacting an acidic oxidized cellulose material
with a water and alcohol solution of a basic salt of a weak
organic acid, e.g. sodium acetate, to elevate the pH of the
cellulosic material to between 5 and 8." Saferstein, title &
abstract. In this regard, it is noted that appellants arguments
that Saferstein discloses a "neutralized product" that is "a
chitosan material of Court's knitted dressing would have different gelling
properties than the chitosan first material of the instant claims.")
3 In the Reply Brief, Appellants submitted new evidence from Science Direct
and Wikipedia regarding the nature of chitosan. 3 7 C.F .R 41.41 (b )(1) states
that a Reply Brief shall not include any new evidence filed after the date of
filing of the appeal. Moreover, any argument raised in the reply brief which
was not raised in the appeal brief is non-responsive to the Examiner's
Answer, and will not be considered on appeal. 37 C.F.R 4I.41(b)(2). Such
arguments do not have the benefit of the Examiner's response.
11
Appeal2017-008136
Application 13/063,891
buffered, solution that is pH balanced at neutral" (Appeal Brief,
p. 5, par. 5, cont. on p. 6) mischaracterizes the scope of
Saferstein's oxidized cellulose as a material buffered at a
neutral pH of 7 (thereby excluding the presence of acid at pH's
lower than pH 7), WHEREAS the scope of Saferstein's
disclosure is directed to an "[ o ]xidized cellulose material [that]
is neutralized, by contacting an acidic oxidized cellulose
material with a water and alcohol solution of a basic salt of a
weak organic acid, e.g. sodium acetate, to elevate the pH of the
cellulosic material to between 5 and 8" (Saferstein, abstract).
Ans. 5. Regarding the claim limitation that the acid is not permanenetly
bonded to the second material, the Examiner argues that
In Saferstein's material, acetate salt molecules are not "bound" to the
oxidized cellulose, but instead exist in a state of equilibrium
associated with the oxidized cellulose whereby "the by-product of this
exchange is an acid from the salt [ ... ], a weak acid such as acetic acid
is produced" (Saferstein, col. 4, ln. 45-47), which appears to be the
weak acid that results in the weakly acidic pH 6.5 exhibited by
oxidized regenerated cellulose after treatment with sodium acetate,
washing and drying (Saferstein, col. 8, ln. 35 to col. 9, In. 3-15, Ex.
1).
Ans. 7. Appellants have not provided evidence showing an error in the
Examiner's technical or legal analysis, or showing that Safterstein's acetate
salt molecules are bound to the cellulose. In re Best, 562 F.2d 1252, 1255
( CCP A 1977). Where the claimed and prior art cellulose and chitosan
products are identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. Appellants have provided no such
evidence. Attorney argument is not evidence, and new evidence presented
12
Appeal2017-008136
Application 13/063,891
in the Reply Brief is not timely presented nor allows for the benefit of the
Examiner's position.
The preponderance of the evidence supports the Examiner's position.
The obviousness rejection is affirmed for the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejections,
which are affirmed for the reasons of record. All pending, rejected claims
fall.
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). See
37 C.F.R. § 4I.50(f).
AFFIRMED
13