Ex Parte Muratoglu et al

Patent Trial and Appeal Board

Jan 25, 2018

12597050 (P.T.A.B. Jan. 25, 2018)

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.
12/597,050 12/22/2009 Orhun K. Muratoglu 125141.00242 7258
26710 7590 01/29/2018
QUARLES & BRADY LLP
Attn: IP Docket
411 E. WISCONSIN AVENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
EXAMINER
SASTRI, SATYA B
ART UNIT PAPER NUMBER
1762
NOTIFICATION DATE DELIVERY MODE
01/29/2018 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):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE
THE PATENT TRIAL AND APPEAL BOARD
Ex parte ORHUN K. MURATOGLU1
and Hatice Bodugoz-Senturk
Appeal 2017-004622
Application 12/597,050
Technology Center 1700
Before BEVERLY A. FRANKLIN, MARK NAGUMO, and
N. WHITNEY WILSON, Administrative Patent Judges.
NAGUMO, Administrative Patent Judge.
DECISION ON APPEAL
Orhun K. Muratoglu and Hatice Bodugoz-Senturk (“GHCB”) timely
appeal under 35 U.S.C. § 134(a) from the Final Rejection2 of claims 3—5, 8,
1 The real party in interest is identified as The General Hospital Corp.,
Boston, Massachusetts (“GHCB”). (Appeal Brief, filed 14 July 2016
(“Br.”), 2.)
2 Office Action mailed 16 July 2015 (“Final Rejection,” cited as “FR”).
Appeal 2017-004622
Application 12/597,050
13, 17, 18, 21, 23, 25, 26, 29, 31, and 35, as modified in response to
amendments filed after the notice of appeal.3,4
We have jurisdiction. 35 U.S.C. § 6. Because, for reasons well-stated
by the Examiner, GHCB has not shown harmful error in the prima facie case
of obviousness or in the finding that the evidence supporting unexpected
results is inadequate, we affirm.
OPINION
A. Introduction3 4 5
The subject matter on appeal relates to creep resistant, lubricious, and
tough hydrogels made by contacting an aqueous solution of poly(vinyl
alcohol) (“PVA”) with an aqueous solution of polyacrylamide (PAAm) and
then subjecting the blend to a free-thaw cycle. The resulting hydrogel
compositions are said to be especially useful for cartilage repair or as
interpositional devices in human joints that require mechanical integrity,
creep resistance, high water content, and excellent lubricity.
3 See the amendment filed 23 February 2016 (“Arndt.”), under
37 C.F.R. § 41.33; entered 15 March 2016 (Advisory Action, “Adv.”).)
4 Remaining copending claims 1, 2, 9, 14, 32, 36, 50, and 51 have been
withdrawn from consideration by the Examiner (FR 1, § 5a), and are not
before us. Claims 59 and 60 have been canceled. (Arndt. 9,11. 1—2; Adv.)
5 Application 12/597,050, PVA hydrogels having improved creep
resistance, lubricity, and toughness, filed 22 December 2009, as the national
stage under 35 U.S.C. § 371 of PCT/US08/61250, filed 23 April 2008,
which claims the benefit of a provisional application filed 23 April 2007.
We cite the Specification as “Spec.”
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Application 12/597,050
An example of such a device is illustrated in Figure 1 from
Muratoglu-16, reproduced below.
Axial load
I
Interpositional device
{Muratoglu-1 Fig. 1 shows an interpositional device in a human joint}
The Specification provides definitions for the following terms as
applied to hydrogels according to the disclosed invention:
• contact “includes physical proximity with or touching, mixing or
blending of one ingredient with another.” (Spec. 40,11. 3—4.)
• tough hydrogel refers to “networks of hydrophilic polymers
containing absorbed water that can absorb a large amount}] of
energy, such as mechanical energy, before failure.” {Id. at 11. 12—14.)
• creep resistance “generally refers to the resistance to continued
extension or deformation, which results from the viscoelastic flow of
the polymer chains under continuous load.” {Id. at 11. 15—17.)
• lubricity “generally refers to [] physical properties of a hydrogel, for
example, it is a measure of the slipperiness of a hydrogel surface,
which also relates to the hydrophilicity of the same surface.”
(Id. at 11. 18-20.)
6 Full cite infra at 5 n. 12.
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Application 12/597,050
The Specification explains that [increased] “creep resistance of PVA
is currently achieved in the field by reducing the equilibrium water content
(EWC) of the hydrogel,” but at the cost of reducing the lubricity of the
hydrogel. {Id. at 2,11. 19-21.) According to the Specification, “creep
resistant, lubricious and tough PVA-PAAm-hydrogels and methods of
making such compositions were not known until the present invention.”
{Id. at 11. 23-24.)
GHCB seeks patent protection for a method of providing improved
hydrogels in which a solution of PVA is contacted with a solution of PAAm,
“thereby forming a homogenous PVA-PAAm solution”; and then subjecting
the solution to one or more freeze-dry cycles, “thereby forming a tough
PVA-PAAm hydrogel.” {Id. at 3,11. 18—23; 9,11. 1—2.) Although not
required by the independent claims, the so-formed gels may be further
treated by dehydration, annealing, and rehydrating {see, e.g., id. at 9,11. 22—
23, claim 4 {id. at A-2) and claim 8 {id. at A-3) (dependent from claims 3
and 5, respectively), as well as crosslinking and other treatments (id. at 15-
lb). The '050 Specification explains that “[djehydration of PAAm
containing PVA gels can render PAAm molecules physically trapped inside
the PVA gel network by densification, pore collapse, or further PVA
crystallization. . . . [and that the] thermal treatments can improve mechanical
strength of the gels by further increasing PVA crystallinity.” {Id. at 14,
11. 25—31.) The Specification explains further that “the non-volatile
ingredient [here, the PAAm] remains in the hydrogel structure during heat
dehydration and prevents the collapse of the molecular porosity, and thus
allowing these hydrogels to re-hydrate following heat dehydration.”
{Id. at 20,11. 9-11.)
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Application 12/597,050
In summary, the Specification teaches that the PAAm enables
formation, via freeze-thaw cycles, of a gel with PVA that does not collapse
upon subsequent dehydration treatment that lead to further toughening, and
that can be rehydrated to a large extent, thereby recovering lubricity.
Claim 3 is representative and reads:
A method of making a creep resistant, lubricious and tough
PVA-PAAm-hydrogel comprising:
a) contacting an aqueous solution of poly(vinyl alcohol)
(PVA) with an aqueous solution of poly(acrylamide) (PAAm),
thereby forming a homogenous PVA-PAAm solution; and
b) subjecting the PVA-PAAm solution to at least one
freeze-thaw cycle,
thereby forming a tough PVA-PAAm hydrogel,
wherein the total polymer content in the PVA-PAAm solution
is 10 wt.%o to 50 wt.%o based on the PVA-PAAm solution.
(Corrected Br.,7 Claims App. A-2; some indentation, paragraphing, and
emphasis added.)
Remaining independent claim 5 is similar, but adds steps of pouring
the PVA-PAAm solution into a mold and specifies further conditions of the
freeze-thaw cycle. (Claims App. Br. A-2.)
7 Filed 4 October 2016.
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Application 12/597,050
The Examiner maintains the following ground of rejection8,9-10:
Claims 3—5, 8, 13, 17, 18, 21, 23, 25, 26, 29, 31, and 35 stand
rejected under 35 U.S.C. § 103(a) in view of the teachings of
Muratoglu-1.* 11
B. Discussion
The Board’s findings of fact throughout this Opinion are supported by
a preponderance of the evidence of record.
Briefly, the Examiner finds, inter alia, that Muratoglu-1 describes
similar processes of forming tough hydrogels by freeze-drying (and
subsequent dehydration, annealing, and rehydration) with PVA and
polyethylene glycol (“PEG”), and mentions, but does not provide working
examples, that other hydrophilic water soluble polymers, including
polyacrylamides, may be used in addition to or instead of PEG, as functional
equivalents. (FR 7.) In particular, the Examiner finds that Muratoglu-1
describes, in Example 1, “a 15/28 PVA/PEG blend with a total polymer
8 Examiner’s Answer mailed 28 November 2016 (“Ans.”).
9 The statement of rejection has been corrected to reflect the entry of
amendments filed after the notice of appeal, including the cancellation of
claims 59 and 60. A rejection for indefmiteness and certain formal issues
were also resolved by the post notice-of-appeal submission. (Adv. 1, §§ 5,
15.)
10 Because this application was filed before the 16 March 2013, effective
date of the America Invents Act, we refer to the pre-AIA version of the
statute.
11 Orhun K. Muratoglu et al., Tough hydrogels, WO 2006/132661 A1
(14 December 2006). Present inventor Bodugoz-Senturk is also listed
among the co-inventors listed on this document. (The national stage under
35 U.S.C. § 371 of this application was issued 19 July 2016, as U.S. Patent
No. 9,394,384 B2.
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Application 12/597,050
content of 43 which meets the claimed polymer content.” (FR 9,11. 7—8.)
The Examiner reasons that the worker would have had a reasonable
expectation of successfully making a similar hydrogel with PAAm instead of
PEG, based on their disclosed functional equivalency. {Id. at 11. 3—6.)
GHCB, while not conceding the prima facie case of obviousness
(Br. 9,1. 8), does not come forward with substantive arguments against it.
Rather, GHCB urges that the Declarations12 of inventor Bodugoz-Senturk
establish “unusual or unexpected results commensurate in scope with the
claims.” (Br. 5, last para.) In the first Declaration, Bodugoz-Senturk
testifies that he prepared mixtures of PVA in water and PAAm in water,
with a total polymer content above 50%, and upon mixing them, “it did not
work in that the mixture went to phase separation,” in contrast to the
requirement recited in the claims that the contact of the two solutions result
in a “homogenous PVA-PAAM solution.” (Bodugoz-Senturk 1,14.) In the
Second Declaration, Bodugoz-Senturk testifies similarly, and testifies further
that the five Examples in Table 1 of Example 3 of the Specification
(Spec. 45) “formed clear solutions.” (Bodugoz-Senturk 2,14.)
As the Examiner points out (FR 12,1. 5), however, these reports do
not provide any comparison to the closest prior art, namely, the PVA:PEG
tough hydrogels described by Murtoglu-1. While GHCB makes much of the
Examiner’s reference (FR 12,1. 7) to the “modified” hydrogel disclosed by
Muratoglu-1, we find that is a reference to what the Examiner determines
would have been obvious, not what should have been the basis of
comparison. The Examiner makes this point clear in the Answer:
12 Declarations by inventor Bodugoz-Senturk filed on 5 December 2013
(“Bodugoz-Senturk 1”) and on 8 April 2015 (“Bodugoz-Senturk 2”).
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Application 12/597,050
“Applicant[]s[’] data fails to establish criticality for the
claimed 15/28 PVA/PAAm blend solution in comparison to
Muratoglu’s 15/28-PVA/PEG hydrogel.” (Ans. 11,11. 9-10.) Moreover, as
the Examiner points out (Ans., para, bridging 7—8), of the five examples
presented in Table 1 of Example 3, only two represent the claimed process.
The three examples describing an interpenetrating network (“IPN”) were
formed by 90°C polymerization and freeze-thaw. (Spec. 45, caption to
Table 1.) It is not clear, and GHCB does not adequately explain, what
relevance the method of polymerization has to unexpected results for freeze-
thaw methods of forming a hydrogel. Additionally, one of the two freeze-
thaw method hydrogels is characterized as “softer than IPN,” not as a “tough
hydrogel.” Thus, as the Examiner finds (Ans. 10, last para.), only one
example of the five is unambiguously relevant to a demonstration of
unexpected results for the claimed process. The Examiner’s conclusion that
the proffered data is not reasonably commensurate in scope with the claimed
process is well-supported by the evidence of record.
We have considered GHCB’s remaining arguments, including those
raised in the Reply13, but do not find that they cure the deficiencies of the
principal arguments discussed supra.
In summary, the evidence offered in support of unexpected results has
not been shown to compare to the PVA:PEG tough hydrogels described by
Muratoglu-1; nor has that evidence been shown to be reasonably
commensurate in scope with the claimed processes.
13 Reply Brief filed 25 January 2017 (“Reply”).
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Application 12/597,050
Accordingly, we are not persuaded of harmful error in the appealed
rejection.
C. Order
It is ORDERED that the rejection of claims 3—5, 8, 13, 17, 18, 21, 23,
25, 26, 29, 31, and 35 is affirmed.
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
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