Ex Parte Jung et al

Patent Trial and Appeal Board

Jan 27, 2016

11881803 (P.T.A.B. Jan. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111881,803 07/26/2007 Edward K.Y. Jung
80118 7590 01/27/2016
Constellation Law Group, PLLC
P.O. Box 580
Tracyton, WA 98393
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.
SEl-0923-US 2105
EXAMINER
LIN, JERRY
ART UNIT PAPER NUMBER
1631
MAILDATE DELIVERY MODE
01127/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWARD K. Y. JUNG, ROYCE A. LEVIEN,
ROBERT W. LORD, MARK A. MALAMUD, and
LOWELL L. WOOD, JR. 1
Appeal2013-008534
Application 11/881,803
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
RICHARD J. SMITH, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims related to
ingestion-dependent allergy information, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 According to Appellants, the Real Party in Interest is Searete LLC, which
is wholly owned by Intellectual Ventures Management, LLC. (Appeal Br.
5).
Appeal2013-008534
Application 11/881,803
STATEMENT OF THE CASE
Claims 34, 68, 76, 86, 93, 95, 105, 112, 114, and 116-120 are on
appeal. Claim 34 is illustrative and reads as follows:
34. A method comprising:
accepting an input identifying at least one ingested agent associated with at
least one of a food allergy at one or more user interfaces; and
transmitting data from the one or more user interfaces to at least one data
analysis system, the data including at least the at least one food
allergy:
the data analysis system being capable of accessing medical history
data containing at least one innate determinant, including a
genetic determinate, associated with the at least one food
allergy, and accessing data containing at least one acquired
determinant associated with the at least one food allergy;
presenting a signal related to ingestion-dependent allergy
information associated with a defined level of the at least one
food allergy in response to accessing data containing at least
one innate determinant associated with the at least one food
allergy, and accessing data containing at least one acquired
determinant associated \vith the at least one food allergy; and
the data analysis system further being capable of sending a signal to
either the one or more user interfaces or a different user
interface in response to presenting a signal related to ingestion-
dependent allergy information associated with a defined level of
the at least one food allergy, which signal transmits the
ingestion-dependent allergy information.
Claims 68, 114, and 118 are the other independent claims and are
directed to a system (claims 68 and 118) or a computer program product
(claim 114) for carrying out method steps similar to those of claim 34,
except that the other independent claims recite an "allergy" rather than an
"ingested agent associated with at least one of a food allergy," and recite
accessing "data" rather than "medical history data."
Appeal2013-008534
Application 11/881,803
DISCUSSION
Issue
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103(a) as obvious based on Qiao2 and Liew. 3 (Final Rej. 4 3.) The
Examiner finds that Qiao discloses all of the manipulative steps of claim 34
but "do[ es] not explicitly teach using a user interface." (Id. at 4.) The
Examiner finds that Liew discloses a computer-based method of obtaining
biomarkers and identifying an allergy predisposition. (Id.)
The Examiner concludes that it would have been obvious "to
implement the processes of Qiao et al. on a computer and with computer
programming" for two reasons. (Id. at 5.) "First, implementing a known
function on a computer has been deemed obvious to one of ordinary skill in
the art." (Id.) Second,
one of ordinary skill in the art would have combined the
computer system of Lie\~1 \~1ith the process of Qiao et al. to gain
the benefit of creating a system to determine if a patient has an
allergy. . . . [O]ne of ordinary skill in the art would have been
motivated to use the genetic polymorphisms discovered by Qiao
et al. as biomarkers in the system of Liew to determine if an
individual has a penicillin allergy.
(Id. at 5.)
Appellants' main contention is that the Examiner has not made out a
prima facie case of obviousness with respect to claim 34 because the cited
2 Qiao et al., Specific serum IgE levels and Fcc:RI/J genetic polymorphism in
patients with penicillins allergy, 59 ALLERGY 1326-1332 (2004).
3 Liew, US 2007 /0054282 Al, published Mar. 8, 2007.
4 Office Action mailed Oct. 26, 2012.
Appeal2013-008534
Application 11/881,803
references do not recite the text of the claim and the Examiner has not
provided objectively verifiable evidence to show that the references teach or
suggest the limitations of the claim. (See, e.g., Appeal Br. 47-73.)
Appellants also contend that combining the references as proposed by the
Examiner would change Qiao' s principle of operation (id. at 73-7 6) and
would render the technology of Qiao unsatisfactory for its intended purpose.
(Id. at 76-81.)
The issue presented is whether the Examiner has provided evidence
and reasoning sufficient to show prima facie obviousness.
Findings of Fact
1. The Specification states that "[a Jn innate determinant, as used
herein, may be, for example, a genetic sequence, including, for example, a
single nucleotide polymorphism, haplotypes, and/or other gene sequence
information. . . . An innate allergy determinant may be an innate
determinant that has an association with an allergy." (Spec. 13-14 i-f 52.)
2. The Specification states:
An acquired determinant, as used herein, may be, for example,
environmental exposure information or immunologic measures
that reflect environmental exposure information. For example,
... dietary, nutraceutical, or medical regimen information may
be the acquired determinant. An acquired allergy determinant
may be an acquired determinant that has an association with an
allergy.
(Id. at 14 i-f 54.)
3. The Specification states:
Allergy information, including ingestion-dependent allergy risk
information, may be, for example, a combination of innate and
acquired allergy determinants together with associated allergy
Appeal2013-008534
Application 11/881,803
symptoms. Such allergy information may be reported in, for
example, allergy studies. Allergy information provides an
improved marker for groups of people that experience defined
levels of allergy.
(Id. at 14 if 55.)
4. Qiao states that "[ n ]umerous studies have suggested that both
genetic and environmental influences are involved in the pathogenesis of
allergic disease." (Qiao 1326, abstract.)
5. Qiao discloses that "[a]llergy to B-lactam drugs is commonly
reported, ... especially penicillins allergy." (Id. at 1326, left col.)
6. Qiao discloses that an "amino acid substitution (glutamic acid ---+
glycine) at position 23 7 in the F cERIB gene has been associated with total
and specific IgE levels and with atopic asthma." (Id. at 1327, left col.)
7. Qiao' s study involved "448 patients with penicillins allergy ...
and 101 control subjects. . . . Patient selection was based on a positive skin
test or clinical symptoms after penicillins therapy.'' (Id.)
8. Qiao "genotyped the FcERIB polymorphism in 158 patients and 87
healthy subjects using polymerase chain reaction." (Id. at 1327, right col.)
9. Qiao discloses that the "radioallergosorbent test (RAST) ... with
major antigenic determinants has been described previously in the diagnosis
of IgE-mediated penicillin allergy." (Id. at 1326, right col., reference
citations omitted.)
10. Qiao discloses that major and minor antigenic determinants
"include[] benzylpenicilloyl-polylysine (BPO-PLL), phenoxomethyl-
penicilloyl-polylysine (PVO-PLL), [and] ampicilloyl-polylysine (APO-
PLL)." (Id. at 1327, left col.)
Appeal2013-008534
Application 11/881,803
11. Qiao "found significant differences in E23 7 G genotype between
positive and negative BPA-, PVO- as well as APO-IgE patients ....
Therefore, there were associations between genotype and allergic reactions
to BPA, PVO, and APO antigens." (Id. at 1329, right col.)
12. Qiao's "results showed the positive reaction degree of skin test
was significantly correlated with specific IgE antibodies. This fact suggests
that RAST is a safe, effective approach to identifying patients at risk or
those not at risk for allergic reaction to penicillin." (Id. at 1330, right col.)
13. Liew discloses "methods to identify biomarkers useful for
diagnosing a condition." (Liew 5 i-f 8.)
14. Liew states that,
[i]n a preferred embodiment, expression levels of one or more
species of RNA transcripts from a population of samples having
a condition of interest are compared [to] those levels from a
population of samples not having the condition of interest so as
to identify biomarkers \vhich are able to differentiate betv,reen the
two populations.
(Id. at 8 i-f 44.)
15. Liew states that "[f]ollowing hybridization of an array with one or
more labeled target nucleic acid samples, arrays are scanned immediately
using a GMS Scanner 418 and Scanalyzer software ... , followed by
GeneSpringâ„¢ software analysis." (Id. at 15 i-f 106.)
16. Liew discloses that a "linear regression approach is used for
normalization .... The average of the ratios is calculated and ... used to
identify differentially expressed genes." (Id. at 16 i-f 112.)
Appeal2013-008534
Application 11/881,803
Principles of Law
[T]he PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in
"notify[ing] the applicant ... [by] stating the reasons for [its]
rejection, or objection or requirement, together with such
information and references as may be useful in judging of the
propriety of continuing the prosecution of [the] application."
In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (quoting 35 U.S.C. § 132,
alterations by the Jung court).
"[A ]ll that is required of the office to meet its prima facie burden of
production is to set forth the statutory basis of the rejection and the reference
or references relied upon in a sufficiently articulate and informative manner
as to meet the notice requirement of§ 132." Id. at 1363.
"If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability." KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007).
"[T]he analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ." Id. at 418.
Analysis
We agree with the Examiner that the combined disclosures of Qiao
and Liew would have made obvious the method of claim 34. Qiao discloses
identifying an ingested agent (penicillin) associated with an allergy (FF5).
Appellants do not dispute that penicillin is an "ingested agent associated
with at least one of a food allergy," as recited in claim 34. (See, e.g., Appeal
Br. 51-52.)
Appeal2013-008534
Application 11/881,803
Qiao also discloses identifying an innate allergy determinant of that
allergy (FFl 1, FF12), identifying an acquired allergy determinant (ingestion
of penicillin; FF2, FF7, FF12), and presenting a signal related to ingestion-
dependent allergy information (patient is or is not at risk for allergic reaction
to penicillin, FF12).
Liew discloses a computer-based method for identifying biomarkers
that are useful in diagnosing a condition (FF12-FF16). We agree with the
Examiner that it would have been obvious to a person of ordinary skill in the
art to combine Qiao's disclosure that the E237G polymorphism in the
FcERIB gene is associated with increased risk of an allergic reaction to
penicillin with Liew's computer-based system for diagnosing a condition
based on biomarkers.
As the Examiner found, "implementing a known function on a
computer has been deemed obvious to one of ordinary skill in the art."
(Final Rej. 5.) And, as the Examiner also found (id.), Qiao provides the
skilled artisan with a specific reason to combine its teachings with Liew: m
order to create a computer-based system for determining whether a patient
has an E237G polymorphism in the FcERIB gene and therefore is at
increased risk of having a penicillin allergy. See KSR, 550 U.S. at 416 ("The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results."); id. at 421
("When there is a design need or market pressure to solve a problem and
there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp.").
Appeal2013-008534
Application 11/881,803
Appellants argue that "the USPTO is asserting one or more
characterizations that each cited reference 'teaches' at least some of the text
of Independent Claim 34, but has not provided any objectively verifiable
evidence supporting these assertions." (Appeal Br. 49.) Appellants
conclude that "the USPTO-identified portions of Qiao do not recite the text
of ... Claim 34." (Id. at 59.) According to Appellants, "insofar as that Qiao
does not recite the text of ... Independent Claim 34, ... the USPTO-cited
technical material does not a [sic] establish a prima facie case of the
unpatentability of Independent Claim 34." (Id. at 60.) Appellants make a
similar argument with respect to Liew. (Id. at 62-70.)
These arguments are unpersuasive. "[A ]ll that is required of the office
to meet its prima facie burden of production is to set forth the statutory basis
of the rejection and the reference or references relied upon in a sufficiently
articulate and informative manner as to meet the notice requirement of
§ 132." Jung, 637 F.3d at 1363. Section 132, in tum, requires notice to the
applicant sufficient to inform him of the reasons for rejection, "together with
such information and references as may be useful in judging of the propriety
of continuing the prosecution of his application." 35 U.S.C. § 132.
Here, the Examiner notified Appellants that the claims were being
rejected as unpatentable under 35 U.S.C. § 103(a) (Final Rej. 3) and cited
specific passages in Qiao and Liew, by page and column or paragraph, that
were the basis for the conclusion of obviousness. (Id. at 3-5.) The
Examiner's rejection satisfies the notice requirement of§ 132, and therefore
meets the burden of establishing a prima facie case of unpatentability. Cf
Jung, 637 F.3d at 1363 ("[T]he examiner's discussion of the theory of
Appeal2013-008534
Application 11/881,803
invalidity ... , the prior art basis for the rejection ... , and the identification
of where each limitation of the rejected claims is shown in the prior art
reference by specific column and line number was more than sufficient to
meet this burden.").
Appellants also argue that "the USPTO has attempted to support the
present rejection based on a 'mere conclusory statement[]."' (Appeal Br.
73, quoting KSR.)
This argument is unpersuasive because the Examiner provided a
reasoned basis for the conclusion of obviousness. (Final Rej. 5: using the
genetic polymorphism disclosed by Qiao in Liew's computerized system
would allow a skilled artisan to determine whether a particular individual
had a penicillin allergy.) The Examiner's conclusion is supported by the
evidence (see FF12).
Appellants also argue that combining Qiao and Liew as proposed by
the Examiner would change Qiao's principle of operation (Appeal Br. 73-
7 6) and would render the technologies of Qiao unsatisfactory for their
intended purposes. (Id. at 76-81.)
These arguments are also unpersuasive. Appellants have not
persuasively shown that combining Qiao's polymorphic biomarker with
Liew's computer-based method of using biomarkers to distinguish between
populations with and without a condition of interest (FF14) would change
Qiao' s principle of operation or render Qiao unsatisfactory for identifying
individuals with a penicillin allergy.
With regard to dependent claims 86 and 93, Appellants present
arguments similar to those presented for claim 34: Qiao does not recite the
Appeal2013-008534
Application 11/881,803
text of these claims and therefore does not support a prima facie case of
obviousness. (Appeal Br. 82-90.) The Examiner, however, pointed to
specific teachings in Qiao that meet the limitations of these claims. (Final
Rej. 4--5.) Appellants have provided no basis for concluding that the
Examiner's findings are incorrect; their argument is therefore unpersuasive.
Conclusion of Law
The Examiner has provided evidence and reasoning sufficient to show
that claim 34 would have been prima facie obvious based on Qiao and Liew.
Appellants have not provided persuasive evidence or reasoning to support a
contrary conclusion. We therefore affirm the rejection of claim 34 and
separately argued claims 86 and 93. Claims 68, 76, 95, 105, 112, 114, and
116-120 have not been argued separately and therefore fall with claim 34.
37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 34, 68, 76, 86, 93, 95, 105, 112,
114, and 116-120 under 35 U.S.C. § 103(a) based on Qiao and Liew.
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
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