Ex Parte Ishihara et al

Patent Trial and Appeal Board

Nov 28, 2018

10572332 (P.T.A.B. Nov. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/572,332 07/11/2011 Kazuhiko Ishihara
38834 7590 11/30/2018
WESTERMAN, HATTORI, DANIELS & ADRIAN, LLP
8500 Leesburg Pike
SUITE 7500
Tysons, VA 22182
UNITED ST A TES OF AMERICA
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.
033036.105 7560
EXAMINER
BOWERS, ERIN M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/30/2018 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAZUHIKO ISHIHARA,
SOHEI FUNAOKA, and KANEHISA YOKOYAMA
Appeal2017---007606
Application 10/572,332
Technology Center 1600
Before TA WEN CHANG, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to a biochip. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the real parties in interest as Sumitomo Bakelite Co.
Ltd. and Kazuhiko Ishihara. App. Br. 3.
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Application 10/572,332
STATEMENT OF THE CASE
According to the Specification, Appellants' invention "provides a
biochip having excellent detection sensitivity, the biochip suppressing
nonspecific absorption or bonding of a detection target substance without
coating with an absorption inhibitor." Spec. ,r 18. The Specification
describes a biochip that includes a substrate, on which a macromolecular
substance comprising first, second, and third units is provided. Id. ,r,r 29--21.
The "first unit" includes "a phosphorylcholine group," the "second unit"
contains "an active ester group," and the "third unit" contains "a butyl
methacrylate group." Id.; see also id. ,r,r 122-123.
Claims 1, 17, 24, 25, 40, 41, 45, 46, 52, 57-59, and 69 are on appeal.
Claim 1, the only independent claim, is illustrative and is reproduced below:
1. A biochip substrate for detection or analysis of a
biologically active substance comprising:
a substrate having a surface; and
a macromolecular substance on the substrate surface, the
macromolecular substance being a copolymer of a first monomer
having a phosphorylcholine group, a second monomer having an
active ester group, and a third monomer having a butyl
methacrylate group,
wherein the active ester group has a higher activity than
alkyl esters, and
wherein the macromolecular substance is a 2-
methacryloyloxyethyl phosphorylcholine I butyl methacrylate
I p-nitrophenylcarbonyloxyethyl methacrylate copolymer.
App. Br. 16 (Claims App'x) (emphasis added).
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Application 10/572,332
The claims stand rejected2 under 35 U.S.C. § I03(a) as obvious over
Koulik, 3 Torchilin, 4 Yokoyama, 5 and ( optionally) Pluster. 6
DISCUSSION
Claim 1 recites a biochip substrate with a surface, which surface
includes a macromolecular substance that is a copolymer comprising first,
second, and third monomers. The copolymer includes a first monomer of 2-
methacryloyloxyethyl phosphorylcholine ("MPC"), a second monomer of p-
nitrophenylcarbonyloxyethyl methacrylate (''p-NPMA" or "NPMA"), and a
third monomer of butyl methacrylate ("BMA"). App. Br. 16; Spec. ,r,r 122-
123 (describing the copolymer and its formula). Claim 1 requires the second
monomer have an active ester group and, as explained in the Specification, a
p-nitrophenyl group (part of the NPMA monomer) is an active ester group.
Spec. ,r 120.
Regarding claim 1, the Examiner finds that Koulik teaches surfaces
coated with a copolymer that includes MPC, BMA, and a functional group.
Ans. 3; see, e.g., Koulik, 6:23-35 (describing the "functional group"). As
noted by the Examiner, Koulik teaches that heparin is immobilized on the
2 The Examiner withdrew the rejection of claim 1 (and other claims, which
are now canceled or withdrawn) under§ I02(a) based on a different
reference than the references cited in this appeal. Ans. 8.
3 Koulik et al., US 6,258,371 Bl, issued July 10, 2001.
4 V.P. Torchilin et al., p-Nitrophenylcarbonyl-PEG-PE-liposomes: fast and
simple attachment of specific ligands, including monoclonal antibodies, to
distal ends of PEG chains via p-nitrophenylcarbonyl groups, 1511
BIOCHIMICA ET BIOPHYSICA ACTA 397--411 (2001).
5 Yokoyama et al., US 2005/0176003 Al, published Aug. 11, 2005.
6 Pluster et al., US 2002/0187249 Al, published Dec. 12, 2002.
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Application 10/572,332
coating through this functional group. Ans. 3. According to the Examiner,
Koulik also teaches a polyethylene glycol methacrylate monomer. Ans. 3.
Although Koulik teaches a polymer comprising MPC, BMA, and a
functional group for attachment of biomolecules (e.g., heparin), the
Examiner finds that Koulik does "not teach an active ester or an active ester
in the form of a p-nitrophenyl group." Id. at 4. Thus, the Examiner
acknowledges that Koulik does not teach a coating with a copolymer that
includes the second monomer (p-NPMA) as required by claim 1. The
Examiner turns to Torchilin in combination with Koulik for suggestion of
this claim element.
The Examiner finds that Torchilin "teach[es] p-nitrophenylcarbonyl-
polyethylene glycol (an active ester) which is suitable for attachment of
biomolecules, such as ligands and monoclonal antibodies." Id.; see also
Torchilin, Abstract ( describing a "new amphiphilic PEG derivative,"
described as pNP-PEG-DOPE, which "could serve as a very convenient tool
for protein attachment to the distal ends of liposome-grafted PEG chains.").
The Examiner finds that Torchilin does "not teach a p-
nitrophenylcarbonyl- polyethylene glycol methacrylate unit." Ans. 4. But,
according to the Examiner, Koulik teaches a PEG methacrylate unit and,
therefore, "it would have been obvious to utilize a p-nitrophenylcarbonyl-
polyethylene glycol unit because it would have been obvious ... to combine
one known element (i.e., p-nitrophenylcarbonyl-polyethylene glycol as
taught by Torchilin et al.) with another known element (i.e., polyethylene
glycol methacrylate as taught by Koulik et al.)." Ans. 4. The Examiner
reasons that "[ o ]ne would have been motivated to utilize p-
nitrophenylcarbonyl- polyethylene glycol because Torchilin et al. teach that
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Application 10/572,332
p-nitrophenylcarbonyl readily binds amino-group containing compounds and
beneficially forms a stable non-toxic bond." Id. at 5 (reasoning it would be
obvious to "apply[] a known technique (p-nitrophenyl (PNP) activation ...
to a known device (PEG support) ready for improvement").
The Examiner cites Yokoyama as teaching a polyolefin biochip and
an organosiloxane coating (relevant to claims 17, 25, and 46). Ans. 5-6.
And the Examiner cites Pluster as teaching a use of methacrylates in
coatings on biochips. Id. at 6.
Appellants argue that claim 1 is nonobvious over the asserted art for at
least three reasons. First, Appellants argue the Examiner's proposed
modification of Koulik would impermissibly change Koulik's principle of
operation by changing Koulik's functional group from a compound that
includes a primary amino group to one with an active ester group. App. Br.
11. Appellants contend Koulik' s purpose is development of blood-
compatible, anti-thrombogenic coatings for medical articles, which Koulik
does by including in its coating composition a functional group that includes
a primary amino that couples to a bioactive molecule - particularly heparin.
Id.; Reply Br. 2 ("[T]he Koulik inventors thus developed a new coating with
MPC, heparin, and a primary amino group as the functional group to
immobilize the heparin."). Second, Appellants argue none of the cited
references actually disclose p-NPMA, and hence the Examiner's prior art
combination would not have created a reasonable expectation of success in
designing a biochip as claimed. App. Br. 12-13. Third, Appellants contend,
the Examiner's rejection is based on improper hindsight because nothing in
the cited art taught or suggested the specific MPC/BMA/p-NPMA biochip
coating as claimed. Id. at 13-14.
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We are persuaded the Examiner did not meet the burden to show, by a
preponderance of the evidence on this record, that claim 1 would have been
obvious over the asserted prior art. In re Oetiker, 977 F.2d 1443, 1445 (Fed.
Cir. 1992) (The Examiner "bears the initial burden ... of presenting a prima
facie case of unpatentability.").
The mere fact that various features of the cited references could be
combined, does not mean that they predictably would have been combined.
Sufficient evidence and/or persuasive reasoning for the combination must be
provided in the record. And, where a proposed combination or modification
would render the prior art invention being modified unsuitable for its
intended purpose, there is generally no sufficient reason or motivation for
making such a modification - and the modification is not obvious as a
result. See In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984); In re Ratti,
270 F.2d 810,813 (CCPA 1959); MPEP § 2143.01.
Insofar as the Examiner is proposing to modify Koulik' s copolymer
coating to include a monomer having an active ester group (p-NPMA) in
place of Koulik's "functional group," we are unpersuaded the ordinarily
skilled person would have made that modification. 7 Reading the reference
as a whole, Koulik's principle of operation is not as broad as the Examiner
7 If that is not the modification intended or proposed by the Examiner (i.e.,
replacement of Koulik's functional group with a group from Torchilin), the
Examiner did not clarify the record in the face of Appellants' arguments on
this point. Quite the opposite, the Examiner responded that Koulik' s
principle of operation is broader than that argued by Appellants and, further,
stated that "any modification of a primary reference with a secondary
reference necessarily involves at least some small change to the mode of
operation of the primary reference." Ans. 9.
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asserts: "the attachment of biomolecules to the surfaces of medical article
through copolymer coatings." Ans. 9. To the contrary, the object and
principle of operation of Koulik is (more narrowly) the development of
coatings for medical articles ( devices such as stents) that are blood
compatible and avoid the attachment of plasma proteins ( coagulation factors,
immunoglobulins, etc.) on the article when in contact with blood. See
Koulik, 1:5-2:46. The principle of operation of Koulik relies on coatings
that are resistant to clotting and undesirable immune responses when in use.
This is repeatedly described, exemplified, and claimed in Koulik with
specific coatings having a functional group that is a monomer with a primary
amino group that couples to the anticoagulant heparin. See, e.g., Koulik
2:28--46, 9:60-10:46, 13:48-14:24. Koulik describes suitable functional
groups as monomers that include a primary amino group. Id. at 6:27-36.
And the Examiner has not provided a persuasive reason why the skilled
artisan would use a different functional group (with an active ester) or, on
this record, explained how Koulik' s coating composition would still function
as intended if it was modified in that way.
The Examiner also fails to explain sufficiently and persuasively how
the combination of Koulik and Torchilin ( with or without Yokoyama and
Pluster) would have resulted in the specific macromolecular copolymer
claimed having all three of its recited parts: MPC/BMA/p-NPMA. The
Examiner mentions a teaching in Koulik of polyethylene glycol (PEG)
methacrylate. Ans. 3. As Appellants point out, however, "Koulik teaches
PEG methacrylate as an alternative for MPC in Koulik' s hydrophilic block"
- one of the three blocks (hydrophilic, hydrophobic, functional) that are
used in Koulik's coatings. App. Br. 14; see Koulik, 5:64---6:12. If the
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Examiner is suggesting the ordinarily skilled person would have used PEG
methacrylate as the hydrophilic block instead of MPC, the resulting
copolymer would lack MPC and, thus, not satisfy the claim. If the Examiner
is proposing that both MPC and a PEG methacrylate would have been used,
the Examiner did not make that position clear. And, with no art cited on the
record here that discloses claim 1 's second monomer, p-NPMA, if the
Examiner is suggesting the ordinarily skilled person would have made that
compound based on Torchilin's teaching of a specific p-nitrophenycarbonyl
PEG derivative grafted to liposomes and Koulik's mention of a PEG
methacrylate, and used it with MPC and BMA in a coating, we are
unpersuaded on this record that such a combination or modification would
have occurred absent hindsight using the Appellants' Specification for
direction.
For the reasons above, the preponderance of the evidence does not
support the Examiner's conclusion of obviousness. Accordingly, we reverse
the rejection of claim 1 and dependent claims 17, 24, 25, 40, 41, 45, 46, 52,
57-59, and 69. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992)
("[D]ependent claims are nonobvious if the independent claims from which
they depend are nonobvious.").
SUMMARY
We reverse the rejections for obviousness on appeal.
REVERSED
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