Ex Parte Yang et al

Patent Trial and Appeal Board

Mar 23, 2016

11960010 (P.T.A.B. Mar. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111960,010 12/19/2007
25570 7590 03/25/2016
Roberts Mlotkowski Safran & Cole, PC
7918 Jones Branch Drive
Suite 500
McLean, VA 22102
FIRST NAMED INVENTOR
Chunlin Yang
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.
14700 3744
EXAMINER
BERTOGLIO, VALARIE E
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/25/2016 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):
lgallaugher@rmsclaw.com
docketing@rmsclaw.com
dbeltran@rmsclaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHUNLIN YANG, THOPPIL MATHEW JOHN,
ANNA GOSIEWSKA, CHARITO S. BUENSUCESO,
DAVID C. COLTER, AGNIESZKA SEYDA, and
RAYMOND S. SHISSIAS
Appeal2013-007348
Application 11/960,010
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1-13, 16, 17,
19-25, 27, and 30-36 (Ans. 3; see App. Br. 22). 3 Examiner entered a
rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as "Ethicon, Inc." (App. Br.
1 ).
2 All reference to Appellants' Brief (App. Br.) refers to the Brief filed
December 12, 2012.
3 "Claims 26, 28[,] and 29 [stand] withdrawn" from consideration (Ans. 3).
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Application 11/960,010
STATEMENT OF THE CASE
Appellants' "invention relates generally to the field of biomatrix for
tissue repair and regeneration" (Spec. i-f 1 ). Claims 1 and 19 are
representative and reproduced in the Claims Appendix of Appellants' Brief.
Claims 1-13, 16, 17, 19-25, 27, and 30-36 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination of Freyman,4
Schmidt,5 Suresky,6 Xu,7 HuaZhu,8 and Catsimpoolas. 9
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Examiner relies on Freyman and Schmidt to suggest methods of
making tissue scaffolds (see Ans. 5; see id. (Freyman discloses the "use of a
number of body tissues in making the scaffold including omentum
(paragraph [0044]") (alteration original))).
FF 2. Examiner finds that Freyman and Schmidt fail to suggest
"dehydrating, defatting and devitalizing tissues using a series of polar and
nonpolar organic solvents" (Ans. 6).
4 Freyman et al., US 2005/0013870 Al, published Jan. 20, 2005.
5 Christine E. Schmidt & Jennie M. Baier, Acellular vascular tissues:
natural biomaterials for tissue repair and tissue engineering, 21
Biomaterials 2215-2231 (2000).
6 Suresky, US 4,707,369, issued Nov. 17, 1987.
7 Xu, US 2007/0027529 Al, published Feb. 1, 2007.
8 HuaZhu et al., US 2003/0065017 Al, published Apr. 3, 2003.
9 Catsimpoolas et al., US 4,767,746, issued Aug. 30, 1988.
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FF 3. Examiner relies on Suresky to suggest the removal of fat from tissue
(Ans. 6; see Suresky, Abstract (Suresky relates to a "process of
simultaneously defatting and dehydrating [comminuted] tissues")).
FF 4. Xu discloses the preparation of a
[B]iological artificial blood vessel [] made from the following
steps:
1. Pretreatment: Initial sterilization is performed using a
broad spectrum, highly-effective, low-toxicity bacteriacide such
as benzalkonium chloride or chlorhexidine, followed by
trimming excess tissue.
2. Defatting: The fatty substances in the substrate [] are
extracted with an organic solvent such as chloroform, ethyl
acetate, anhydrous alcohol or mixtures thereof
3. Fixation: The protein molecules in substrate [] are
crosslinked and fixed using a bicyclic epoxide.
4. Minimizing antigens: An active reagent such as a low
molecular weight organic acid anhydride, acyl chloride,
acylamide or monocyclic oxide is utilized to block the specific
active groups such as -OH, -NH2, -SH, etc., in the proteins
of the substrate [], and a reagent having strong hydrogen
bonding power such as a guanidine compound is utilized to
replace the specific hydrogen bonding on the spiral chains of
the protein molecules in the substrate [] and alter its specific
conformation.
5. Tanning process: Utilizing PLA as the grafting
reagent, a small amount of lactide is used as the
polycondensative primer.
6. Anticoagulant modification: A coupling agent is
utilized to couple the anticoagulant (heparin) to the inner
surface of the substrate [] to form the anticoagulant surface
layer[].
7. Coupling polypeptide: A diamide is utilized as a
coupling agent to couple a polypeptide consisting of 16 lysines
(K16), glycine (G), arginine (R), aspartic acid (D), serine (S),
proline (P) and cysteine (C) capable of binding a wide variety
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Application 11/960,010
of growth factors on surface layer [], and the sequence of the
composition of the polypeptide is K16-G-R-G-D-S-P---C.
(Xu i-fi-150-56 (emphasis added); see generally id. i-fi-130-39; id. i136 (''5.
Tanning process: First, the preformed polymers are produced from
monomers by synthesis. Second, the substrate is dehydrated with alcohol.
Third, the preformed polymers are then grafted into collagen molecules by
means of polycondensative primers"); Ans. 6 (Xu suggests "defatting
techniques including dehydration with alcohol and fat extraction using
organic nonpolar solvents (see paragraph [0051] for example), such as
chloroform, which is fat soluble" and "dehydration with mixtures of alcohol
(polar) and chloroform (nonpolar)").)
FF 5. HuaZhu suggests a method wherein "[t]he proximal portion of [tibial
metaphyseal cancellous bone] was fixed in 70% ethanol, dehydrated in
graded concentrations of ethanol, defatted in acetone, and embedded in
methyl methacrylate" (HuaZhu i1220; Ans. 6).
FF 6. Examiner finds that Catsimpoolas suggests "removing lipids from
omentum using hexane for extraction" (Ans. 6).
FF 7. Examiner finds that Freyman discloses "various and diverse means
of decellularizing tissues" (Ans. 5; see Freyman i-fi-f 103-113).
ANALYSIS
Based on the combination of Freyman, Schmidt, Suresky, Xu,
HuaZhu, and Catsimpoolas, Examiner concludes that, at the time
Appellants' invention was made, it would have been prima facie obvious to
combine the method of producing tissue scaffolds as suggested by the
combination of Freyman and Schmidt with the various methods of defatting
and/or dehydrating tissue suggested by Suresky, Xu, HuaZhu, and
Catsimpoolas (see Ans. 7-8).
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Claim 1:
The method of Appellants' claim 1 comprises, inter alia, the
dehydration of omentum "before the fat is extracted from the dehydrated
omentum" (App. Br. 14; see Appellants' claim 1 ("provid[e] an omentum,
dehydrat[ e] the omen tum ... extract[] fat from the dehydrated omentum ")
(emphasis added)).
We recognize, but are not persuaded by, Appellants' contention that
Freyman suggests "no fewer than 3 5 specific types of tissues from which to
select for use in their process" of producing a tissue scaffold (App. Br. 11
and 26; see id. at 12; Reply Br. 2-3). See, e.g., Merck & Co. v. Biocraft
Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) ("Disclos[ure of] a
multitude of effective combinations does not render any particular
formulation less obvious"). Therefore, we are not persuaded by Appellants'
contention that Examiner's prima facie case of obviousness is based in
hindsight, because Examiner finds that a person of ordinary skill in this art,
interested in obtaining a tissue scaffold, would have selected omentum from
Freyman's list of tissues (App. Br. 11; see 27).
We recognize, but are not persuaded by, Appellants' contention that
their Specification "provide[ s] a cogent explanation of their reasons for
selecting omentum as the target tissue," wherein "[t]he greater omentum is
highly vascularized" and "the vascular channels of decellularized omentum
can serve as tracks for neovascularization" (Reply Br. 3--4, citing Spec.
i-fi-13-5) (emphasis omitted). Appellants fail to establish an evidentiary basis
on this record to support a conclusion that neovascularization would not
occur when any tissue suggested by Freyman is used as a tissue scaffold as
suggested by the combination of Freyman and Schmidt (FF 1 ). In addition,
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we find that Appellants' claimed invention is not limited to the use of the
greater omentum (see Reply Br. 3--4; cf Appellants' claim 1 ).
Examiner finds that Freyman and Schmidt fail to suggest
"dehydrating, defatting and devitalizing tissues using a series of polar and
nonpolar organic solvents" (FF 2; see App. Br. 12, 17, and 26; Reply Br. 4--
5). Examiner, however, relies on a number of prior art references that
suggest: (1) simultaneous dehydration and defatting (FF 3); (2) defatting
tissue followed by dehydration (FF 4); and (3) dehydrating prior to defatting
tissue (FF 5).
Appellants contend that Suresky discloses the "simultaneous defatting
and dehydration" of tissue (App. Br. 12 and 28; see also FF 3). See New
Wrinkle, Inc. v. Watson, Comr. Pats., 204 F.2d 35, 37 (D.C. Cir. 1953)
("Where the result accomplished is substantially the same, steps taken
concurrently or simultaneously are the equivalent of and not patentable over
steps taken successively"). Thus, absent evidence to the contrary,
"Appellants' claimed method [step], [which requires] the omen tum [] first be
dehydrated before the fat is extracted from the dehydrated omentum" is
obvious in view of Suresky' s disclosure of a method step drawn to the
simultaneous defatting and dehydration of tissue (App. Br. 14; see FF 3).
Therefore, we are not persuaded by Appellants' contention that a person of
ordinary skill in this art would have been "directed away from [Appellants']
multi-step process" (App. Br. 13 and 28; see also Reply Br. 5---6).
Xu discloses method steps that comprise defatting tissue followed by
dehydration (FF 4). See In re Hampel, 162 F.2d 483, 485-86 (CCPA 1947)
("There is nothing in the instant record which indicates that the particular
order of steps produces results differing in any way from those which would
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be brought about if another order of steps were followed"); see also Jn re
Burhans, 154 F .2d 690, 692 ( CCP A 1946) (where a combination of prior art
suggests the claimed process, reordering the steps is not patentable absent
proof in the record that the order of performing the steps produces a new and
unexpected result). We are not persuaded by Appellants' contention that
Examiner's reliance on Xu to disclose method steps that comprise defatting
tissue followed by dehydration are "essentially irrelevant to the presently
claimed process," because Xu fails to disclose "a tissue scaffold" (App. Br.
17; see FF 4 (Xu discloses the preparation of an "artificial blood vessel")).
In this regard, we recognize, but are not persuaded by, Appellants'
unsupported contention that "[t]anning according to Xu would certainly
cause [] undesirable alterations in the extracellular matrix of Freyman"
(App. Br. 18).
HuaZhu discloses method steps that comprise dehydrating tissue prior
to defatting the tissue (FF 5). While, HuaZhu's method relates to defatting
and dehydrating bone prior to embedding the bone in methyl methacrylate,
HuaZhu builds on the Suresky and Xu disclosures further evidencing that the
order of the dehydrating and defatting method steps is, absent evidence to
the contrary, not critical. Therefore, we are not persuaded by Appellants'
contention that HuaZhu fails to "disclose dehydration of omentum ... for
use as a tissue scaffold" (App. Br. 15; see also id. at 18 and 31-32; Reply
Br. 6-7).
"A person of ordinary skill is also a person of ordinary creativity, not
an automaton." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Therefore, when the prior art is taken in combination, we are not persuaded
by Appellants' contentions that: (1) Suresky would have led a person of
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ordinary skill in this art to have comminuted Freyman's tissue, intended for
use as a tissue scaffold as disclosed by Freyman, prior to dehydrating and
defatting the tissue (FF 1; see FF 2; cf App. Br. 14 and 28; Reply Br. 6-7)
and (2) HuaZhu would have lead a person of ordinary skill in this art to
embed the tissue scaffold suggested by Freyman in methyl methacrylate
after defatting dehydrated omentum (see App. Br. 15-16 and 31).
For the foregoing reasons, we are not persuaded by Appellants'
contention that Examiner's prima facie case of obviousness requires
"impermissible hindsight picking-and-choosing" or that HuaZhu "represents
non-analogous art" (App. Br. 16; see id. at 32-33).
We recognize, but are not persuaded by, Appellants' contention that
HuaZhu "disclose[ s] only acetone ... and entirely fail[ s] to disclose ... a
non-polar solvent, nor serial, gradient fat extraction with the specified
combinations of polar and non-polar solvents" and Xu fails to suggest
"serial, gradient fat extraction with [Appellants'] specified combinations of
polar and non-polar solvents" (App. Br. 18 and 33). As Examiner explains,
the combination of prior art relied upon by Examiner suggests "the general
acceptance in the art of defatting and decellularizing tissues to make tissue
scaffolds using an ethanol series followed by extraction with any of a
number of polar and nonpolar organic solvents including [mixtures of]
acetone, [] and[] chloroform" (Ans. 6; see FF 4--5; FF 4 ("[d]efatting ...
with an organic solvent such as chloroform, ethyl acetate, anhydrous alcohol
or mixtures thereof')). Stated differently, "where[, as here,] the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation." In re
Aller, 220 F.2d 454, 456 (CCP A 1955). For the foregoing reasons, we are
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not persuaded by Appellants' contentions regarding routine optimization
(App. Br. 21 and 35-36; see generally Reply Br. 7-8).
For the foregoing reasons, we are not persuaded by Appellants'
contention that Examiner "engage[d] in a classic so-called 'Raguâ„¢
rejection;' i.e. rather than pointing to specific instances of prior art
disclosures meeting the claimed limitations, asserting[, instead,] that 'it's in
there"' (App. Br. 20). The obviousness inquiry "not only permits, but
requires, consideration of common knowledge and common sense." DyStar
Textilfarben GmbH & Co. v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed.
Cir. 2006); see KSR, 550 U.S. at 421 (eschewing "[r]igid preventative rules
that deny factfinders recourse to common sense"); Perfect Web Techs., Inc.
v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009) (explaining that the
obviousness analysis "may include recourse to logic, judgment, and common
sense available to the person of ordinary skill that do not necessarily require
explication in any reference or expert opinion"); Leapfrog Enters., Inc. v.
Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007) (emphasizing that
"the common sense of those skilled in the art" can be sufficient to
"demonstrate[] why some combinations would have been obvious where
others would not"). In sum, we are not persuaded by, Appellants' rigid
dissection of individual references in isolation, which fails to account for
what the combination of references suggests to a person of ordinary skill in
this art.
Claims 2-13, 16, 17, and 25:
Appellants' contend that claims 2-13, 16, 17, and 25 "stand or fall
with claim 1" (App. Br. 23).
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Claim 19:
Appellants contend that their claim 19 requires the step of
decellularizing the defatted omentum (App. Br. 37; see Appellants' claim
19). In this regard, Appellants contend that Examiner's reliance on Freyman
to suggest the use of alcohol to decellularize omentum is in error because
"Examiner is relying on the same disclosure [in Freyman] to address two
separate and distinct process steps, which, it is respectfully submitted,
constitutes legal error" (App. Br. 37). We are not persuaded.
Notwithstanding Appellants' contention to the contrary, Examiner finds that
Freyman discusses a number of means to decellularize tissue (FF 7).
Claims 20--24, 27, and 30--36:
Appellants' contend that claims 20-24, 27, and 30-36 "stand or fall
with claim 19" (App. Br. 38). 10
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claims 1 and 19 under
35 U.S.C. § 103(a) as unpatentable over the combination of Freyman,
Schmidt, Suresky, Xu, HuaZhu, and Catsimpoolas is affirmed. Because they
are not separately argued claims 2-13, 16, 17, and 25 fall with claim 1.
Because they are not separately argued claims 20-24, 27, and 30-36 fall
with claim 19.
10 We recognize Appellants' reference to claims "20-24 and 27-36" (App.
Br. 38). Claims 28 and 29 stand withdrawn from consideration (Ans. 3; see
App. Br. 2).
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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
11