Ex Parte McInnes et al

Patent Trials and Appeals Board

Apr 10, 2019

12677236 - (D) (P.T.A.B. Apr. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/677,236 08/04/2010 Rachael Louise Mclnnes
155519 7590 04/12/2019
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
109127-0140 8835
EXAMINER
CHUI, MEI PING
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
04/12/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED ST ATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RACHAEL LOUISE MCINNES, MARGARET STEDMAN,
SALLY STEPHENS, and SIMON BAYLIFF
Appeal2018-003373 1
Application 12/677,2362
Technology Center 1600
Before ERICA A. FRANKLIN, JAMES A. WORTH, and ELIZABETH A.
LA VIER, Administrative Patent Judges.
WORTH, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's fmal
rejection of claims 1-7 and 9-25, which are all pending claims. We have
jurisdiction under35 U.S.C. §§ 134and6(b).
We affrrm and enter a new ground of rejection.
1 Our Decision refers to Appellants' Appeal Brief ("Appeal Br.," filed June
30, 2017) and Reply Brief ("Reply Br.," filed Feb. 8, 2018), and
Specification ("Spec.," filed Mar. 9, 2010), and the Examiner's Final Office
Action ("Final Act.,"mailed Oct. 4, 2016), Answer("Ans.,"mailed Dec. 13,
2017), Advisory Action ("Adv. Act.,"mailed May 16, 2017), and Office
Action ("Previous Office Action," mailed Apr. 11, 2013).
2 According to Appellants, the real party in interest for this appeal is "KCI
Licensing, Inc., assignee of record, which is a subsidiary of Acelity, L.P.
Inc." Appeal Br. 2.
Appeal 2018-003373
Application 12/677,236
Statement of the Case
Background
Appellants' application relates to "a layered wound dressing
comprising an antimicrobial absorbent layer and an apertured sheet covering
the antimicrobial absorbent layer." Spec. 1:1-2.
According to the Specification, it is known that the adherency of
wound dressings based on nonwoven textile absorbent layers can be reduced
by providing a suitable apertured top sheet (wound contacting sheet) over
the textile layer in the wound dressing. Id. at 1 :6-8. However, the use of a
perforated top sheet potentially reduces the therapeutic effectiveness of more
advanced wound dressings, in which the absorbent layer further comprises a
therapeutic agent for delivery to the wound surface. Id. at 2: 11-15. The
invention addresses this problem by providing a wound dressing comprising
an antimicrobial absorbent layer containing silver, and an apertured sheet
covering the antimicrobial absorbent layer, wherein the apertured sheet is
formed from a liquid-impermeable sheet material having an array of
apertures therein, said apertures having a mean effective diameter of from
about O. 5 mm to about 2 mm, and wherein the percentage open area of the
apertured sheet is from about 7% to about 25%. See id. at 3 :5-10.
The Claims
Claims 1 and 15 are the independent claims on appeal. Claim 1
reproduced below, is illustrative of the subject matter on appeal:
1. A wound dressing comprising:
an antimicrobial absorbent layer of nonwoven fabric
having hydro gel-forming absorbent fibers and non-absorbent
textile fibers, wherein at least some of the non-absorbent textile
fibers contain silver; and
2
Appeal 2018-003373
Application 12/677,236
an apertured sheet covering the antimicrobial absorbent
layer of nonwoven fabric, wherein the apertured sheet is formed
from a liquid-impermeable sheet material having an array of
apertures therein, said apertures having a mean effective
diameter in a range of 1 mm to 2 mm, and wherein a percentage
open area of the aperture sheet is in a range of 17% to 25%.
Appeal Br., Claims App'x.
The Issues 3
A. The Examiner rejected claims 1-5, 9, and 12-25 underpre-AIA
35 U.S.C. § 103(a) as being unpatentable overChandra4 and Gilbert. 5
3 In the Final Office Action, the Examiner maintained a provisional
non-statutory obviousness type double patenting rejection (issued in the
Previous Office Action, at 2-7, as to then-pending claims 1-5 and 8-16 as
being unpatentable over claims 1-3 and 7-9 of co-pending Application
12/373,619, since issued as U.S. Patent No. 9,579,411). See Final Act. 2-3.
Although Appellants' frrst filing was deemed deficient (see Adv. Action 2),
Appellants subsequently filed a terminal disclaimer on May 26, 2017, which
was accepted as acknowledged in the file wrapper on June 1, 2017 (Terminal
Disclaimer review decision). As such, the provisional non-statutory
obviousness type double rejection is not on appeal.
Also in the Final Office Action, the Examiner issued a rejection of
claims 19, 21, and23 under 35 U.S.C. § 112, fourth paragraph, for improper
dependency. Final Act. 3. The Examiner checked two boxes on the
Advisory Action, i.e., for item 3 ("proposed amendments ... will not be
entered") and item 7 (b) ("For purposes of appeal, the proposed
amendment( s) ... will be entered"). Nevertheless, we understand that the
proposed amendments were entered because of a notation with the
Examiner's initials on the Amendments in the file wrapper(filed May 16,
2017). These amendments do not suffer from the deficiencies identified in
the Final Office Action. Accordingly, we do not recognize the rejection
under 35 U.S. C. § 112, fourth paragraph as a matter on appeal.
4 Chandra, WO 03/053484 Al, pub. July 3, 2003.
5 Gilbert, EP0275353Bl,pub.March31, 1993.
3
Appeal 2018-003373
Application 12/677,236
B. The Examiner rejected claims 6 and 7 under pre-AIA 35 U.S. C.
§ 103(a) as being unpatentable over Chandra, Gilbert, and Bowler. 6
C. The Examiner rejected claims 10 and 11 under pre-AIA 35 U.S. C.
§ 103(a) as being unpatentable over Chandra, Gilbert, and Silcock. 7
Principles of Law
"A pri ma faci e case of obviousness typically exists when the ranges
of a claimed composition overlap the ranges disclosed in the prior art." In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (citations omitted).
In general, an applicant may overcome a prima facie case of
obviousness by establishing "that the [ claimed] range is critical,
generally by showing that the claimed range achieves unexpected
results relative to the prior art range." That same standard applies
when, as here, the applicant seeks to optimize certain variables
by selecting narrow ranges from broader ranges disclosed in the
prior art.
Id. at 1330 ( citing, inter alia, In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997) ("Only if the 'results of optimizing a variable' are 'unexpectedly
good' can a patent be obtained for the claimed critical range" ( quoting In re
Antonie, 559 F.2d 618,620, 195 USPQ 6, 8 (CCP A 1977)));In re Wertheim,
541 F.2d257, 267, 191 USPQ 90, 100 (CCPA 1976) (recognizing that
"ranges which overlap or lie inside ranges disclosed by the prior art may be
patentable if the applicant can show criticality in the claimed range by
evidence of unexpected results")).
"To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
6 Bowler, WO 02/43743 Al, pub. June 6, 2002.
7 Silcock, WO 03/045294 Al, pub. June 5, 2003.
4
Appeal 2018-003373
Application 12/677,236
one of ordinary skill in the art at the time of the invention." Bristol-Myers
Squibb Co. v. TevaPharms. USA, Inc., 752 F.3d 967,977 (Fed. Cir. 2014).
Analysis
A. 35 USC§ 103 Over Chandra and Gilbert
Appellants argue the rejection of claims 1-5, 9, and 12-25 as a group.
We select claim 1 as representative such that claims 2-5, 9, and 12-25 stand
or fall therewith. See 37 C.F.R. § 41.37( c )(1 )(iv).
The Examiner fmds that Chandra discloses the recited absorbent layer
(including silver-coated fibers), but does not disclose an apertured sheet.
Final Act. 5-7 (citing, e.g., Chandra ,r,r 7, 12-14, 16-18). The Examiner
fmds that Gilbert discloses a perforated film, which constitutes the recited
apertured sheet. Final Act. 7-8 ( citing, e.g., Gilbert, col. 6:27--46, claim 1 ).
The sole issue on appeal is whether a person of ordinary skill would have
combined the teachings of Chandra and Gilbert to arrive at the claimed
invention.
The Examiner reasons that one of ordinary skill in the art would have
been motivated to add Gilbert's perforated film to Chandra's bandage in
order to promote "good release" characteristics. See id. at 8-10 ( citing
Gilbert, 1 :1-33, 3:30--40). Appellants contend that the Examiner has not
provided adequate rationale to add Gilbert's perforated film to Chandra's
bandage, e.g., because Chandra's bandage already has properties which
decrease the bandage's adhesion to the wound. Appeal Br. 7-8 ( citing
Chandra ,r,r 34--3 5). We agree with Appellants' contention in this regard.
See Chandra ,r 3 5.
Nevertheless, we determine that a person of ordinary skill would have
arrived at the combination of teachings by modifying Gilbert's apparatus
5
Appeal 2018-003373
Application 12/677,236
with Chandra's teachings ( even if not modifying Chandra's apparatus with
Gilbert's teachings). The Examiner also determines a person of ordinary
skill would have recognized other beneficial characteristics of the combined
teachings of Chandra and Gilbert, i.e., that Chandra's silver metal has
antimicrobial properties. See Ans. 6-7. We agree that Chandra discloses
that dressings with metallic silver-coated fibers have the benefit of
antimicrobial properties. See Chandra ,r,r2, 7, 12, 43. We determine that a
person of ordinary skill would have sought to substitute Chandra's silver
textile matrix 14 for Gilbert's pad 40 in Gilbert's bandage in order to
provide antimicrobial properties, as taught by Chandra.
Appellants assert that the claimed invention "may off er the particular
advantages of minimizing the shedding of silver-coated fibers into wound
sites, while maintaining antimicrobial effectiveness [ and that] testing yielded
the unexpected results that silver release does not necessarily correspond to
increasing aperture size and larger percentage open area, but rather optimum
dimensions were identified." Appeal Br. 4. Appellants assert that Gilbert
discloses that one cannot predict if a perforated film has "other
characteristics which mitigate against its use." Appeal Br. 10 ( citing Gilbert,
3:1-10). Appellants argue that Gilbert's perforatedftlm "maynegate the
adhesion-reduction properties of the silver as well as possibly interfere with
the antimicrobial activity of the silver." Id. Appellants thereby argue that
the claimed invention presents an unexpected result that a silver textile pad
maintains antimicrobial properties in the presence of a perforated ftlm, based
on Appellants' assertion that a person of ordinary skill would have expected
the antimicrobial properties of a silver textile pad to decrease in the presence
of a perforated ftlm present.
6
Appeal 2018-003373
Application 12/677,236
We are not persuaded that Appellants have demonstrated unexpected
results for several reasons. First, the portion of Gilbert on which Appellants
rely for the proposition that a perforated film has undesirable properties does
not state, as asserted, that a perforated film would be expected to decrease
antimicrobial properties. Rather, this portion of Gilbert states that large
apertures may interfere with release of the bandage. See Gilbert 3:1-10.
Second, even if a perforated film would be expected to decrease the
antimicrobial properties of a silver textile pad, Appellants at most are
arguing that they have identified "optimum dimensions" of apertures.
Appeal Br. 10. Independent claim 1 recites, "wherein a percentage open
area of the aperture sheet is in the range of 17% to 25%." Appeal Br.,
Claims App'x. However, Gilbert already discloses an optimum aperture size
of between 5% and 25% open area, i.e., to obtain optimal release
characteristics. See Gilbert, 3 :25-3 5. Appellants have not shown that the
recited range of 17% to 25% open area is unexpectedly improved over the
range identified by Gilbert, i.e., 5% to 25%.
7
Appeal 2018-003373
Application 12/677,236
Table 3 of the Specification is reproduced below:
i~·~""=>t=~ ~··-, : r'1~:G' (=~1= ,,, =I
i ! I .d:; :n1.:u i I ::iyr :H),~4
I · ·············, ··················· i·····_ :::: ~"~'.' + 1,, .. ffil6-J---·-·····:· .. ::: .. ~-~,:·~~:: ......... ~
/! i ~ ~ ·t· s·\\•:nh f ~
1·-·.•.•.•.•.•.• .. •.w.w.•••fj-... ······-1'1 ....... ?'.'iii"i)"jj""""""""l""""""""""""""" ... :: ············r····· ::;.,(i·i·-~;-ii:.fi ......... ,
l 'Ne,~ft,ive ;;:.v,·c~b ,, l ,: -, .. ,,v,a~, :
~~~ =r:,~:,,;:-; r~;:;;.\~~.: r=,.,~-,;~:-1
l i ':',,;g~lih-'\~ ::;:wHh 'I I Neg;~tivf s,v:8.b j
Lw ................ - ........ _L ..................... - .............. • .. - ............................. • -----------·w.-...... ·.·.·.·.·.·.·.·.·.·.·.·-------'
"The zone of inhibition (in mm) and swab results from dressings
tested against Staphylococcus aureus are given in Table[] 3." Spec.
13.
The Specification discloses data in Table 3 showing swab results for
Metallic Silver based on percentage open area ( Open Area % ) where "[ o ]ne
positive ( 1 +) swab result "is within the normal range of currently marketed
anti-microbial dressings, [ and] therefore acceptable." Spec. 13. Based on
these criteria, we find that Appellants' data do not demonstrate a meaningful
difference between the claimed range and the range disclosed in Gilbert. In
particular, we fmd that Table 3 teaches that open areas of 7%, 13%, 19%,
and 25% are marked by"-"; "Negative swab"; or "1 + swab," which are all
values defmed in the Specification as being "within the normal range."
Spec. 13. We, therefore, determine that the claimed range overlaps with
Gilbert's range, and Appellants have not shown a critical difference between
the claimed range and Gilbert's range based on the data provided. Thus,
Appellants have recited a range for aperture open area percentage which
8
Appeal 2018-003373
Application 12/677,236
does not show unexpected results relative to Gilbert's disclosed range for
aperture open area percentage.
Weighing the evidence as a whole, we conclude that the teachings of
Chandra and Gilbert render the claimed subject matter obvious.
Accordingly, we affirm the Examiner's rejection of claims 1-5, 9, and 12-
25 under35 U.S.C. § 103 as obvious over Chandra and Gilbert.
B.-C. 35 U.S. C. § 103 over Chandra, Gilbert, and one of Bowler and
Silcock
Appellants do not argue the rejections of claims 6, 7, 10, and 11 under
35 U.S.C. § 103 over Chandra, Gilbert, and one of Bowler and Silcock,
separately from the rejection of claim 1 under 3 5 U.S. C. § 103 over Chandra
and Gilbert. Accordingly, we affirm the Examiner's rejection of claims 6, 7,
10, and 11 under 35 U.S.C. § 103 over Chandra, Gilbert, and one of Bowler
and Silcock, for similar reasons.
DECISION
The Examiner's decision to reject claims 1-7 and 9-25 is affrrmed.
Because our decision contains additional findings and conclusions, however,
we designate this opinion as containing a new ground of rejection pursuant
to 37 C.F.R. § 4I.50(b).
Section 41. 5 O(b) provides " [a] new ground of rejection pursuant to
this paragraph shall not be considered final for judicial review." Section
41.50(b) also provides:
When the Board enters such a non-fmal decision, the appellant,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must
9
Appeal 2018-003373
Application 12/677,236
exercise one of the following two options with respect to the new ground of
rejection to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41. 52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Pa tent Examining Procedure § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED;37 C.F.R. §4I.50(b)
10