Ex Parte Armitage et al

Patent Trial and Appeal Board

Aug 4, 2016

13653829 (P.T.A.B. Aug. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/653,829 10/17/2012
50855 7590 08/08/2016
Covidien LP
555 Long Wharf Drive
Mail Stop SN-I, Legal Department
New Haven, CT 06511
FIRST NAMED INVENTOR
Paul ARMITAGE
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.
203-8923PCTUSCON 7504
EXAMINER
REYNOLDS, FRED H
ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
08/08/2016 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):
mail@cdfslaw.com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAUL ARMITAGE and CHRISTINE ELIZABETH DAWSON
Appeal2014-008025
Application 13/653,829
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. 1 The Examiner has rejected
claims 27--43, 50, and 51 for obviousness. We have jurisdiction under 35
U.S.C. § 6(b ). We affirm, but designate our affirmance as New Grounds of
Rejection.
STATEMENT OF CASE
The following claim is representative.
27. A process for the manufacture of a collagenous
material from a plurality of collagen particles, wherein the
collagen particles are derived from a natural tissue material and
1 The Real Party in Interest for this application is the Assignee of record,
Tissue Science Laboratories Limited.
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Application 13/653,829
are substantially free of non-fibrous tissue proteins, cellular
elements and lipids or lipid residues, comprising the steps of:
forming collagen particles which comprise fragments of
collagen fibres displaying an original collagen fibre architecture
and molecular ultrastructure of the natural tissue material;
treating the collagen particles with an aqueous acid
solution to swell the collagen particles; and
collectively dehydrating the swollen collagen particles.
In our Discussion, we separately address claim 39, which reads as
follows:
39. A process according to claim 27, further comprising cross-
linking the collagenous material after dehydration.
References and Grounds of Rejection
1. Claims 27--43 are rejected under 35 U.S.C. §103(a) as being
unpatentable over i\.rtandi (US 3,157,524, issued Nov. 17, 1964) in
view of Oliver et al. (US 5,397,353, issued Mar. 14, 1995) and
Smestad et al. (US 4,865,602, issued Sept. 12, 1989).
2. Claims 27, 43, 50, and 51 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Artandi in view of Oliver, Smestad,
Sopade (et al., A Rapid In-vitro Digestibility Assay Based on
Glucometry for Investigating Kinetics of Starch Digestion, 61
CENTRE FOR NUTRITION AND FOOD SCIENCES, 245-255 (2009)),
and Taherzadeh (et al., Pretreatment of Lignocellulosic Wastes to
Improve Ethanol and Biagas Production: A Review, 9 INT. J. MAL.
SCI. 1621-1651 (2008)).
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Application 13/653,829
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
2-9. The following facts are highlighted.
1. The Appellants' Specification discloses that, "[ t ]he lipid
extraction may be achieved by solvent extraction using an organic
solvent, such as acetone. Other non-limiting examples of suitable
solvents include nonaqueous solvents such as ethanol and ether."
Spec. 6.
2. Appellants' Specification indicates that the collagenous material
may be dehydrated by air drying. Spec. 9, 11. 11-15.
3. Artandi discloses steps of treating collagen by comminuting and
washing "with water and, if desired, treated with an enzyme
solution to remove the elastin which encircles and ties together the
native collagen fibers. The collagen is then swollen in an aqueous
acid solution." i\.rtandi, col. 1, 11. 49-57.
4. Depending on the end product desired, in Artandi, the collagen
may be formed and frozen and may then be dehydrated. Col. 2, 11.
10-24.
5. As a dehydrating step, Artandi discloses the use of a dehydrating
liquids, including ethers such as dioxane, or low molecular ketones
such as acetone, with isopropanol and acetone, particularly
preferred. Col. 2, 11. 25-32.
6. Artandi discloses that the collagen may be air dried at elevated
temperatures. Col. 2, 11. 58-60.
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Application 13/653,829
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).
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
"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); see also Ex parte
Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a
process of making a laminated sheet \~1herein a base sheet is first coated \~1ith
a metallic film and thereafter impregnated with a thermosetting material was
held to render prima facie obvious claims directed to a process of making a
laminated sheet by reversing the order of the prior art process steps.); In re
Burhans, 154 F .2d 690 ( CCP A 1946) (selection of any order of performing
process steps is prima facie obvious in the absence of new or unexpected
results); andin re Gibson, 39 F.2d 975 (CCPA 1930) (Selection of any order
of mixing ingredients is prima facie obvious.).
Re} ections 1 and 2
Both rejections are addressed together, as they present similar issues
and were similarly argued by Appellants. We find that the Examiner has
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Application 13/653,829
provided evidence to support a prima facie case of obviousness, but because
our reasoning differs somewhat from that of the Examiner, we designate our
affirmance as New Grounds of Rejection. We provide the following
additional comment to the Examiner's argument set forth in the Final
Rejection and Answer. Appellants do not argue individual claims separately
in the Brief, except for claim 39 (App. Br. 8-9). We treat claim 27 as
representative of the grouped claims, and separately address claim 39.
Claim Interpretation
We interpret claim 27's process for the manufacture of a collagenous
material from a plurality of collagen particles to require three steps:
1. forming collagen particles, which comprise fragments of collagen
fibres displaying an original collagen fibre architecture and
molecular ultrastructure of the natural tissue material;
2. treating the collagen particles \~1ith an aqueous acid solution to
swell the collagen particles; and
3. collectively dehydrating the swollen collagen particles.
The claimed process must result in a collagen particle product of
collagenous material that is substantially free of non-fibrous tissue proteins,
cellular elements and lipids or lipid residues. We interpret the claim so that
the process steps result in a collagen particle product that is substantially
free of non-fibrous tissue proteins. 2 Giving the claim its broadest reasonable
2 We assume that the claim includes all required process steps to provide a
product which is substantially free of non-fibrous tissue proteins, otherwise,
the claim is missing critical steps to provide the claimed product.
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interpretation3, we find no requirement in claim 27 of a preprocessing step to
remove lipids. According to the Specification, "substances said to be
'substantially free' of materials generally contain less than 5% of, and
preferably less than 1 %, of said materials." Spec. 6, 11. 21-22.
Discussion
The Examiner finds that Artandi discloses a similar process for the
manufacture of a collagenous material (Ans. 2-3), but does not preprocess
the collagen to remove lipids. Ans. 4. These deficiencies, according to the
Examiner, are remedied by Oliver and Smestad. Id.
We agree with the Examiner that Artandi discloses the claimed
process steps, but do not agree that claim 27 requires a step of preprocessing
the collagen to remove lipids. Artandi discloses steps of treating collagen by
comminuting (forming particles) and washing "with water and, if desired,
treated \~1ith an enzyme solution to remove the elastin \~1hich encircles and
ties together the native collagen fibers. The collagen is then swollen in an
aqueous acid solution. Artandi, col. 1, 11. 49-57. Depending on the end
product desired, in Artandi, the collagen may be formed and frozen and may
then be dehydrated. Col. 2, 11. 10-24. As a dehydrating step, Artandi
discloses the use of a dehydrating liquids, including ethers such as dioxane,
alcohols including ethanol, or low molecular ketones such as acetone, with
isopropanol and acetone, particularly preferred. Col. 2, 11. 25-32. Artandi
3 Cuozzo Speed Technologies, LLCv. Lee, 136 S. Ct. 2131, 2016 WL
3369425, 579 U. S. __ (June 20, 2016).
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discloses that the collagen may be air dried at elevated temperatures. Col. 2,
11. 58---60.
Thus, Artandi discloses each step of claim 27. In addition, since
Artandi treats the collagen with an organic solvent including ketones, such
as acetone, ethanol, or ether, similar to those disclosed in the Specification to
remove lipids (FF 1 ), Artandi' s disclosed acetone treatment step would
inherently remove lipids from the collagen. Artandi also treats collagen
particles with enzymes to remove proteins, such as elastin. Example 1.
Appellants have come forth with no evidence showing that the resulting
collagen particle of Artandi, treated with the claimed process steps or
additionally treated with enzymes and acetone, is not substantially free of
non-fibrous tissue proteins, cellular elements and lipids or lipid residues.
Moreover, Oliver is also relied on for its disclosure of:
[A] method of preparing collagen to render it non-antigenic and
non-cytotoxic and substantially free of non-fibrous tissue
proteins, cellular elements, lipids and lipid residues (column 4,
line 24--29). The material is extracted with acetone, then
digested with trypsin (column 4, line 57---64). Afterwards, to
stabilize it, the tissue is crosslinked (column 5, line 1-3). This
reference demonstrates a method to remove non-fibrous tissue
proteins, cellular elements, lipids and lipid residues, rendering
the collagen non-antigenic and non-cytotoxic.
Ans. 3. Thus, Oliver discloses it is well known to treat collagen with
enzymes such as trypsin and acetone to provide collagen substantially free of
non-fibrous tissue proteins, cellular elements, lipids and lipid residues.
In rebuttal, Appellants contend:
The combination of Artandi, Oliver, and Smestad is improper
because to combine the method of preparing a collagen sheet
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Application 13/653,829
described in Oliver with the method of swelling collagen
particles described in Artandi, as alleged on page 4 of the Final
Office Action and page 2 of the Advisory Action, would render
Oliver inoperable for its intended purpose, i.e., to remain a
sheet of collagen which retains the natural structure and original
architecture of the natural tissue.
Br. 4. Appellants argue that Artandi describes the swelling of collagen
particles, and that "comminuting the collagen material of Oliver into
particles would no longer render the material of Oliver a collagen sheet. Id.,
at 4--5. In response the Examiner argues that
the rejection is based on modification of the process of Artandi
using the teachings of Oliver et al and Smestad et al, not a
modification of Oliver et al in view of Artandi. Artandi teaches
all the elements of the claimed method, merely in a different
order than what is claimed, and hence was selected as the
primary reference.
Ans. 6. We agree with the Examiner that, "Artandi mills the collagen as part
of their disclosed process (which meets a claim limitation in applicant's
invention), this process does not destroy the fibrillar network of collagen
(col. 1, line 38--48), and the product generated by their process can be a film
(col. 2, line 12-14) which, in the common usage of the terms, is a sheet."
Ans. 6-7.
Appellants' next argument is that there is no motivation to combine
the references, and that the Examiner has engaged in hindsight reasoning.
App. Br. 5. In view of the discussion above, Artandi teaches each of the
claimed process steps. Therefore, motivation to combine Artandi with
secondary references is not an issue here. However, if we follow the
Examiner's reasoning, Oliver does also disclose that it was well known at
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the time of the invention to use of enzymes followed by washes in organic
solvent produce a material that is free of non-fibrous tissue proteins, cellular
elements, lipids, and lipid residues, and, hence, is non-antigenic and non-
cytotoxic. Ans. 7. We agree with the Examiner that Appellants fail to
provide a convincing explanation in the Brief as to why Artandi does not
disclose each element claimed or why the motivations cited by the Examiner
in the rejection are somehow improper or incorrect. Ans. 7.
Appellants argue that Oliver teaches away from the invention of
Artandi, because Oliver teaches it is preferable to generate a compound
containing elastin, while Artandi states that it is important to remove the
elastin. Br. 9. Artandi alone meets each process limitation claimed, and
states that their process, which explicitly removes elastin, retains the fibrillar
structure of collagen (col. 1, line 3 8--48), and that the compounds formed
will have outstanding strength (col. 1, line 21-23 and column 4, line 7-13).
Anc Q
.L -'... .. LLIJe Ve
Appellants raise new arguments in the Reply Brief, which were not
raised in the Brief. 37 CPR 41.41(b)(2) states that: "Any argument raised in
the reply brief which was not raised in the appeal brief, or is not responsive
to an argument raised in the Examiner's answer, including any designated
new ground of rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown." Appellants argue for the
first time in the Reply Brief that Artandi discloses absorbable collagen
sponges and Oliver discloses non-resorbable collagenous sheets, and
therefore teach away from one another or their combination. Reply Br. 3--4.
We are not persuaded by Appellants' teaching away argument. First,
we do not entertain the argument as it was not raised in the Brief, and
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Appellants have not shown good cause as to why the argument was not
previously presented. Second, even if we were to entertain the argument,
Artandi suggests each process step claimed. Finally, Appellants have not
provided evidence as to how the steps of treating collagen with enzymes and
acetone as disclosed in Oliver would alter the collagen particles of Artandi,
which also may be treated with enzymes or acetone.
Claim 39
Claim 3 9 is directed to a process according to claim 2 7, further
comprising cross-linking the collagenous material after dehydration.
Appellant argues:
that Artandi and Oliver do not disclose cross-linking of the
collagenous material after dehydration .... Artandi is silent with
regards to cross-linking and discloses only tanning of the collagen
particles. Oliver discloses cross-linking of the sheet of material (not
particles) prior to dehydration. Therefore any reasonable
interpretation of Oliver and i~\~rtandi cannot disclose or suggest to one
skilled in the art the method specifically recited in claim 39.
App. Br. 8-9.
We are not persuaded. Artandi discloses that collagen masses may be
frozen after dehydration. Col. 2, 11. 4--9. Artandi further discloses that, [t]he
tanning agents [ crosslinking agents] may be added to the dehydrating bath or
to the swollen collagen mass prior to freezing. Col. 3, 11. 20-24. Thus, if
Artandi freezes after dehydration, then addition of crosslinking/tanning
agents prior to freezing would be after a deyhydration step, as claimed.
Oliver also discloses a step of dehydrating collagen with acetone, and
then sterilizing the collagen with radiation. Col. 7, 11. 1-19. Smestad
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Application 13/653,829
discloses that sterilizing radiation itself effects the desired level of
crosslinking collagen. Col. 3, 11. 44--54. Thus, the combination of Oliver
and Smestad also disclose a step of cross-linking after dehydration.
We also agree with the Examiner that Appellants have neither claimed
nor argued nor demonstrated any new or unexpected results from performing
the method steps in the claimed order. Ans. 8. Ex parte Rubin, 128 USPQ
440 (Bd. App. 1959).
Additional arguments made by the Appellants in the Brief, have been
fully addressed by the Examiner in the Answer. Appellants present no
specific arguments with respect to Rejection 2, Sopade, or Taherzadeh, other
than those presented for Rejection 1. Rejection 2 is affirmed for the same
reasons as rejection 1, as set forth above.
Rejections 1 and 2 are affirmed for the reasons of record and herein.
Because our analysis differs somewhat from that of the Examiner, we
designate that this Decision contains 1'-Je\Y..f Grounds of P'"-ejection.
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.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 3 7
C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that "[a] new ground of
rejection ... shall not be considered final for judicial review." 37 C.F.R. §
41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM
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THE DATE OF THE DECISION, must 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
proceeding will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same record ....
AFFIRMED and 41.50(b)
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