Yun, Anthony Joonkyoo. et al.

Patent Trials and Appeals Board

Apr 2, 2020

11592027 - (D) (P.T.A.B. Apr. 2, 2020)

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.
11/592,027 11/01/2006 Anthony Joonkyoo Yun PALO-015 8460
93726 7590 04/02/2020
EPA - BOZICEVIC FIELD & FRANCIS LLP
BOZICEVIC, FIELD & FRANCIS
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
MEDWAY, SCOTT J
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
04/02/2020 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY JOONKYOO YUN and
PATRICK YUARN-BOR LEE

Appeal 2019-004691
Application 11/592,027
Technology Center 3600
BEFORE LYNNE H. BROWNE, JAMES J. MAYBERRY, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 7, 14–16, 20–22, 24, 34, 38–40, and
46–51. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). The real party in interest is Palo Alto Investors. Appeal
Br. 1.
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Application 11/592,027
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CLAIMED SUBJECT MATTER
The claims are directed to a method of preventing contrast-induced
nephropathy. Sole independent claim 1, reproduced below, is illustrative of
the claimed subject matter:
1. A method of preventing contrast-induced nephropathy in a
subject, said method comprising:
evaluating the subject for sympathetic bias induced by
administration of a contrast agent; and
modulating at least one portion of the autonomic nervous
system in said evaluated subject having sympathetic bias by
selectively administering a beta blocker or a renin inhibitor to
the kidney by intrarenal infusion, in a manner effective to
prevent said contrast-induced nephropathy,
wherein said modulating comprises increasing
parasympathetic activity and decreasing the sympathetic bias in
said subject to prevent contrast-induced nephropathy in said
subject.
REFERENCE(S)
The prior art relied upon by the Examiner is:
Name Reference Date
Ellinwood US 4,003,379 Jan. 18, 1997
Place US 6,117,446 Sept. 12, 2000
Oung US 2004/0111033 A1 June 10, 2004
Elkin US 2005/0245882 A1 Nov. 3, 2005
Hangeland US 2005/0245545 A1 Nov. 3, 2005
Levin US 7,162,303 B2 Jan. 9, 2007
Pilz Pilz et al., Aliskiren, a
Human Renin
Inhibitor,
Ameliorates Cardiac
and Renal Damage in
Double-Transgenic
Rats, Hypertension:
Journal of the
American Heart
Assoc., 2005.
2005

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REJECTIONS2
Claims 1, 20, 34, and 46–51 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Hangeland, Elkins, Oung, and Ellinwood.
Claims 7, 14–16, 21, and 22 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Hangeland, Elkins, Oung, Ellinwood, and Levin.
Claims 24 and 40 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hangeland, Elkins, Oung, Ellinwood, and Place.
Claims 38 and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hangeland, Elkins, Oung, Ellinwood, and Pilz.
OPINION
Claims 1, 20 34, and 46–51
The Examiner finds that Hangeland discloses all of the limitations of
claim 1 except that “Hangeland does not appear to disclose that the method
is used to prevent contrast induced nephropathy, for instance by infusion
intrarenally to the kidney” and “Hangeland does not appear to explicitly
disclose evaluating the subject for low parasympathetic activity and a
sympathetic bias induced by administration of a contrast agent.” Final Act.
5. The Examiner finds that “Elkins discloses a system and method for
treating or preventing contrast-induced nephropathy by the infusion of drugs
(paras [0076], [0240] and [0241]) using a renal flow system that injects the

2 All of the pending claims stand rejected under 35 U.S.C. § 112, second
paragraph based on language that was deleted from claim 1 in the
amendment filed June 22, 2018 (subsequently entered by the Examiner).
Final Act. 3. Appellants do not address this rejection in the Appeal Brief
and the Examiner does not address it in the Answer. Thus, it appears that
both Appellants and the Examiner understand this rejection to be withdrawn.
As the language at issue is no longer in claim 1, we also understand this
rejection to be withdrawn.
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drug bilaterally into two renal arteries.” Id. (citing Elkins Abst., ¶ 247). The
Examiner asserts that “a skilled artisan would have found it obvious at the
time of the invention to perform the method using intrarenal infusion, if one
wished to achieve a relatively high localized concentration of agent to
maximize the intended effects while minimizing unintended peripheral
effects.” Id. (citing Elkins ¶¶ 6, 76). The Examiner further finds that
“Oung discloses a method of measuring low sympathetic activity (para
[0060]) and sympathetic bias (para [0061]) within the autonomic nervous
system in order to determine a sympathovagal imbalance” and that
“Ellinwood discloses a system that senses and monitors a patient condition
and then evaluates the sensed data to control the conditions under which a
dispensing of a medication takes place.” Id. at 6 (citing Ellinwood, Abst.,
2:52–56). In view of these findings, the Examiner asserts that
a skilled artisan would have found it obvious at the time of the
invention to modify the method of Hangeland according to the
teachings in Oung and Ellinwood, in order to improve the
measurement of the specificity in the autonomic nervous system
to result in better medical care of patients (as taught in Oung at
para [0069]) and to evaluate the need for release of the active
agent (e.g., a beta blocker or renin inhibitor) for example, to only
release the medication when it is necessary to do so.
Id.
Appellant contends that “the teachings of the cited art to allegedly
arrive at the method of instant Claim 1 is insufficient to support a legal
conclusion of obviousness and, furthermore, would not lead to a
modification of the teachings of the cited references that arrives at the
instantly claimed method.” Appeal Br. 6. Specifically, Appellant contends
that “the method recites preventing contrast-induced nephropathy in a
subject and modulating at least one portion of the subject’s autonomic
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nervous system by administering the recited agents in a manner effective to
prevent contrast-induced nephropathy.” Id. at 7. Thus, “because the claim
states that the modulating is performed in the evaluated subject, it is clear
that the evaluating is performed prior to the modulating.” Id. In addition,
Appellant asserts that “evaluating the subject for sympathetic bias induced
by administration of a contrast agent occurs before administering a beta
blocker or a renin inhibitor to the kidney by intrarenal infusion.” Id. at 8.
Given this understanding of the claim, Appellant asserts that “‘to ensure that
medications have the desired effects’ or that ‘a combination of medications
is not creating an undesirable effect’ are insufficient reasons to perform the
evaluating of Claim 1 at least because no medications have been
administered in the method at the point where the evaluating takes place.”
Id. at 8–9. Therefore, according to Appellant,
to ensure that the beta blocker or the renin inhibitor “have the
desired effect” or “do not have undesired effects” cannot be
legitimate reasons for performing the evaluation step of Claim 1
because the beta blocker or the renin inhibitor have yet to be
administered at the point in the method where the evaluating
takes place.
Id. at 9.
The Examiner responds that Appellant’s arguments are “predicated on
Appellant’s proffered definition of the term ‘preventing’ as meaning that the
method occurs prior to the onset of any contrast-induced nephropathy.”
Ans. 4 (citing Appeal Br. 7). The Examiner asserts that “the definition of
‘preventing’ proffered by Appellant is narrower than that which would be
understood by one of ordinary skill in the art, and moreover, is not informed
by the specification.” Id. According to the Examiner, “[a] skilled artisan
would recognize that the term ‘preventing’ does not necessarily require
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keeping something from happening before its onset, but may also mean
keeping something from continuing after its onset (e.g., ‘action must be
taken to prevent further accidents’).” Id. The Examiner does not indicate a
source for this definition.
The Examiner also contends that “the method claims do not, in fact,
impose a specific order on the performance of the method steps.” Ans. 5. In
support of this assertion, the Examiner quotes the statement in the
Specification “that ‘any recited method can be carried out in the order of
events recited or in any other order which is logically possible.’” Id.
(quoting Spec. ¶ 14).
“Appellant[] respectfully disagree[s] and note[s] that the Examiner’s
alternative definition of the word ‘preventing’ is not supported by reference
to any evidence.” Reply Br. 3. Appellant proffers the following dictionary
definitions of “preventing” in support of its position: “[t]he word ‘prevent’ is
defined as ‘to keep from occurring’ (see ‘prevent’ (n.d.) Random House
Kernerman Webster’s College Dictionary. (2010); see also ‘to keep from
happening, esp. by taking precautionary action’, ‘prevent’ (n.d.) Collins
English Dictionary-Complete and Unabridged, 12th Edition 2014. Retrieved
May 26, 2019 from https://www.thefreedictionary.com/prevent).” Id.
Thus, according to Appellant, “in the context of the instant claims, ‘to
prevent said contrast-induced nephropathy’ would be reasonably understood
to mean: to keep contrast-induced nephropathy from occurring or
happening.” Reply Br. 3. Appellant reiterates that
as the modulating of the instant methods is performed ‘in said
evaluated subject . . . in a manner effective to prevent said
contrast-induced nephropathy’, an ordinarily skilled artisan
would readily understand that the modulating is performed to
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keep contrast-induced nephropathy from occurring and is thus
performed after evaluating the subject for sympathetic bias.
Id. In view of this understanding of the claim, Appellant maintains that
to ensure that the beta blocker or the renin inhibitor ‘have the
desired effect’ or ‘do not have undesired effects’ cannot be
legitimate reasons for performing the evaluation step of Claim 1
because the beta blocker or the renin inhibitor have yet to be
administered at the point in the claimed method where the
evaluating takes place.
Id.
We agree with and adopt Appellant’s proffered definition of
“preventing” as it is consistent with the plain language of the claim and the
Specification.3 See, e.g., Spec. ¶ 49 (addressing prevention and treatment as
two separate actions), see also ¶ 156 (defining “prevented” as equivalent to
inhibited, stopped, or terminated); Appeal Br. 29. Applying this definition,
it is clear that the proposed modification would not modulate “at least one
portion of the autonomic nervous system in said evaluated subject . . . in a
manner effective to prevent said contrast-induced nephropathy” as required
by claim 1. Appeal Br. 29 (emphasis added). Thus, the combined teachings
of Hangeland, Elkins, Oung, and Ellinwood, would not have rendered this
limitation obvious to one of ordinary skill in the art at the time of the
invention.
We also disagree with Examiner’s contention that “the method claims
do not, in fact, impose a specific order on the performance of the method
steps.” Ans. 5. Although, the Specification indicates the steps could be

3 We note that the Examiner’s proffered definition of “preventing” also
requires stopping something from happening in the future. Ans. 4. Thus,
even if we apply this definition, the proposed combination would not have
rendered claim 1 obvious at the time of the invention.
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performed in a different order if such is logically possible, the claim recites a
specific order when it claims “evaluating the subject” and then “modulating
. . . in said evaluated subject.” See Reply Br. 4. The Examiner provides no
logical reason for changing this order, and thus, lacks rational underpinning.
For these reasons, we do not sustain the Examiner’s decision rejecting
claim 1, and claims 20, 34, and 46–51, which depend therefrom.
Claims 7, 14–16, 21, 22, 24, and 38–40
The Examiner’s rejections of the remaining dependent claim suffer
from the same deficiencies as the rejection of claim 1 discussed above.
None of Levin, Place, or Pilz cure these deficiencies. Accordingly, we do
not sustain the Examiner’s decisions rejecting claims 7, 14–16, 21, and 22 as
unpatentable over Hangeland, Elkins, Oung, Ellinwood, and Levin, rejecting
claims 24 and 40 as unpatentable over Hangeland, Elkins, Oung, Ellinwood,
and Place, and rejecting claims 38 and 39 as unpatentable over Hangeland,
Elkins, Oung, Ellinwood, and Pilz.
CONCLUSION
The Examiner’s rejections of claims 1, 7, 14–16, 20–22, 24, 34, 38–40
and 46–51 under 35 U.S.C. § 103(a) are REVERSED.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 20, 34,
46–51
103(a) Hangeland, Elkins,
Oung, Ellinwood
1, 20, 34,
46–51
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7, 14–16,
21, 22
103(a) Hangeland, Elkins,
Oung, Ellinwood,
Levin
7, 14–16,
21, 22
24, 40 103(a) Hangeland, Elkins,
Oung, Ellinwood,
Place
24, 40
38, 39 103(a) Hangeland, Elkins,
Oung, Ellinwood,
Pilz
38, 39

REVERSED