Board of Regents of the University of Nebraska

Patent Trials and Appeals Board

May 28, 2021

2020003616 (P.T.A.B. May. 28, 2021)

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.
15/487,263 04/13/2017 Irving H. Zucker 01223-0028-00US 8015
161735 7590 05/28/2021
McNeill Baur PLLC/Sorrento Therapeutics, Inc.
125 Cambridge Park Drive
Suite 301
Cambridge, MA 02140
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
05/28/2021 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):
IP@sorrentotherapeutics.com
docketing@mcneillbaur.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IRVING H. ZUCKER and HANJUN WANG
Appeal 2020-003616
Application 15/487,263
Technology Center 1600
Before RICHARD M. LEBOVITZ, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellant has requested rehearing of the decision entered on February
25, 2021 (“Decision”). The Decision affirmed the obviousness rejection
made by the Examiner in the Final Rejection of December 18, 2018.
Appellant filed a Request for Rehearing (“Request”) pursuant to
37 C.F.R. § 41.52, on April 23, 2021. Specifically, Appellant requests that
we designate our affirmance of the Examiner’s rejection as a new grounds of
rejection because “the Board relied upon facts other than those relied upon
by the Examiner.” (Request 1, 2.) For the reasons set forth below, we
decline to so designate.

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DISCUSSION
Appellant asserts that “a Board decision that relies on new facts
constitutes a new ground of rejection even when the same prior art is relied
upon. See, e.g., [In re] Leithem, 661 F.3d [1316,] 1320 [(Fed. Cir. 2011)].”
(Request 2.) However, that is not an altogether accurate statement of the
law.
“It is well-established that the Board is free to affirm an examiner’s
rejection so long as ‘appellants have had a fair opportunity to react to the
thrust of the rejection.’ In re Kronig, 539 F.2d 1300, 1302–03 (CCPA
1976).” In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011). And the Federal
Circuit has explained that “[t]he thrust of the Board’s rejection changes
when . . . it finds facts not found by the examiner regarding the differences
between the prior art and the claimed invention, and these facts are the
principal evidence upon which the Board’s rejection was based.” In re
Adler, 723 F.3d 1322, 1327 (Fed. Cir. 2013) (quoting In re Leithem, 661
F.3d at 1327) (emphasis added)). However, a new ground of rejection
“generally will not be found based on the Board ‘further explain[ing] the
examiner’s rejection’ or the Board’s thoroughness in responding to an
applicant’s argument.” Honeywell Int’l Inc. v. Mexichem Amanco Holding
S.A., 865 F.3d 1348, 1357 (Fed. Cir. 2017). In other words, it is within our
purview to “elaborate on the examiner’s findings,” so long as the appellant
had an adequate opportunity to react to the thrust of the Examiner’s
rejection. Rambus Inc. v. Rea, 731 F.3d 1248, 1255 (Fed. Cir. 2013).
Our Decision does not rely on new facts regarding the differences
between the prior art and the claimed invention that differ from the
Examiner’s position or the reasons that one of ordinary skill in the art would
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have found the claimed invention obvious from the teachings of Zucker,
Szabo, and Ipe.
The Examiner’s rejection discussed the prior art teachings of drug
administration intrathecally (Zucker, Szabo, Ipe) and epidurally (Szabo,
Ipe). (Final Action 4–6.) And the Examiner took the position during
prosecution that the “prior art establishes that epidural and intrathecal routes
of administration are both utilized to reduce total dose of agent administered
while achieving regional control” (Final Action 5), that resiniferatoxin
(RTX) had been administered epidurally (id.), and that “Ipe establishes that
it was known in the art that the same volume of drug can be injected
intrathecally and epidurally.” (Id. at 6.) And the Examiner concluded that
one of ordinary skill in the art would have found it obvious to have
administered the RTX compound to the T1-T4 epidural space instead of
intrathecally to the T1-T4 region as described by Zucker for treating
hypertension, and to use the volume of administration taught by Zucker as a
starting point for optimizing the volume of RTX to administer in light of the
teachings of Szabo and Ipe. (Id. at 5–6.)
Nothing in our Decision rejected the Examiner’s findings regarding
the prior art teachings or changed the rationale the Examiner relied on for
obviousness. See Honeywell, 865 F.3d at 1357. Appellant, thus, had fair
opportunity to react to the thrust of the rejection. Id.
That the Examiner did not rely on O’Donohue (Request 3 (referring to
Decision 6)) does not establish that the Appellant did not have an adequate
opportunity to react to the thrust of the Examiner’s rejection. We do not
disagree that O’Donohue was newly cited by the Board in the Decision, but
it did not raise a new fact that changed the thrust of the Examiner’s rejection.
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As we noted in the Decision, Appellant contested the Examiner’s conclusion
that one of ordinary skill in the art would have considered an epidural route
for RTX administration to treat a cardiovascular condition given the
teachings of the prior art. (Decision 4–5.) To address that dispute, we
elaborated on the Examiner’s findings regarding the alternative of delivering
RTX to the intrathecal space and epidural space in the treatment described
by Zucker (to “ablate dorsal root ganglion [cells]”). (Decision 6–7.) We
relied on O’Donohue merely as support for where the epidural and
intrathecal spaces are with respect to the dorsal root ganglion—the specific
ganglion which Zucker teaches is important for the treatment of a
cardiovascular condition—in concluding that there was sufficient evidence
from the teachings of Zucker, Szabo, and Ipe to affirm the Examiner’s
conclusion that one of ordinary skill in the art would have found
administration of RTX to the T1-T4 epidural space to be an obvious
alternative to the T1-T4 intrathecal delivery taught by Zucker with a
reasonable expectation of success.
It is well settled that, when evaluating whether the teachings of a
reference would have suggested the subject matter recited in a claim at issue,
the test “not only permits, but requires, consideration of common knowledge
and common sense.” Dystar Textilfarben Gmbh & Co. Deutschland KG v.
C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006) (emphasis in
original). O’Donohue was used only to highlight anatomical knowledge that
would have been known to one of ordinary skill in the art; it did not change
the thrust of the Examiner’s rejection. As noted above, a new ground of
rejection “generally will not be found based on the Board ‘further
explain[ing] the examiner’s rejection’.” Honeywell, 865 F.3d at 1357.
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We explained, just as the Examiner did, that Szabo teaches that RTX
can be administered epidurally and act on nerves locally. (Decision 7.)
And, we noted that Ipe teaches that efficacy of a drug can be achieved
whether the drug is administered intrathecally or epidurally using the same
volume of injection with the same amount of active. (Id. at 8.)
Appellant’s arguments concerning the Decision’s reliance on Ipe
(Request 3 (referring to Decision 8)) are equally unpersuasive that the
affirmance should be designated a new ground of rejection. First, contrary
to Appellant’s intimation (id.), there is no contradiction between the
statement in the Decision that
Ipe suggests that effects based on a drug that interacts with
receptors in the brain and spinal cord can achieve efficacy both
intrathecally and epidurally using the same volume of injection
with the same amount of active agent.
(Decision 8), and the Examiner’s statement that:
It is not the Examiner’s position that one would expect the
same efficacy between the routes of administration.
(Ans. 15). We note that Appellant is misconstruing the Board’s finding.
The Board did not find that a person of skill in the art would have expected
the “same efficacy” between the two routes of administration, just that some
efficacy would be expected via either route. Thus, there is no contradiction
between the Board’s position and the Examiner’s. In addition, that the
“same efficacy” would not be expected between the two routes of
administration, does not contradict that the prior art teaches that some
amount of efficacy would reasonably be expected using the same volume of
injection with the same amount of active when administering the drug
epidurally as compared to intrathecally given Ipe’s teachings and Szabo’s
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teachings. This was both the Examiner’s position in the rejection of the
claims and our position in affirming that rejection.
Second, that “[t]he Examiner did not rely on Ipe for any alleged
teaching about side effects” (Request 3 (referring to Decision 6)), does not
establish that the Appellant did not have an adequate opportunity to react to
the thrust of the Examiner’s rejection. In its Appeal Brief, Appellant argued
that one of ordinary skill in the art would have lacked motivation to
administer RTX to an epidural space to treat a cardiovascular condition as
the Examiner’s rejection asserted because a person of ordinary skill in the art
would have expected that a less direct route of administration to nerve
endings or neural tissue than taught by Zucker “would increase the risk of
off target effects” that “would certainly be undesirable in non-target cells or
tissues.” (Appeal Br. 14.) Appellant further argued “Ipe’s results also
suggest that there could be a greater risk of side effects because the lower
efficacy and duration observed in Ipe mean that the drug likely diffused
away from the target site, where it could act on non-target cells.” (Id. at 15.)
The Examiner did not find Appellant’s argument persuasive given the
teachings of Szabo regarding the known use of epidural and intrathecal
routes of administration generally to reduce the total dose of agent while
achieving regional control and the specific teaching of administering RTX
epidurally and the prior art’s teaching (Ipe) that the same volume of drug can
be injected intrathecally and epidurally. (See Ans. 10–12.) We echoed these
same reasons in our Decision. (See, e.g., Decision 7–8.) However, the
Decision also addressed Appellant’s side effect argument more thoroughly,
calling out that Ipe, in contrast to Appellant’s assertion, specifically states
that “side effects were greater with drug injected intrathecally than
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epidurally.” (Decision 6 (citing Ipe Abstr. and CONCLUSION1).)
Therefore, the Decision was simply addressing Appellant’s argument about
the risk of side effects purportedly described in Ipe, and was not bringing up
this point for the first time. Addressing Appellant’s conjecture as to Ipe
regarding side effects with teachings in Ipe that are specifically contrary to
that conjecture hardly can be deemed Board findings that changed the thrust
of the Examiner’s rejection.
Finally, Appellant’s argument that the Decision rejects Appellant’s
asserted evidence of unexpected results on a different basis than the
Examiner is not persuasive to establish our affirmance should be designated
a new ground of rejection.
Appellant waited until the filing of the Appeal Brief to argue
unexpected results. Appellant bore the burden of providing evidence
sufficient to establish unexpected results upon raising the argument in the
Appeal Brief. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (“[T]he
burden of showing unexpected results rests on he who asserts them.”). Thus,
Appellant had to establish with evidence of record that what was tested and
compared to establish unexpected results was the claimed invention and the
closest prior art. In other words, Appellant was not permitted to supplement
the record in the Appeal Brief or in the Reply Brief regarding the tests in the
Specification on which Appellant relied to establish unexpected results
(Decision 8). That is because by the time Appellant raised the issue of

1 In its Abstract, Ipe states: “The minor side effects were more with
intrathecal Buprenorphine than epidural Buprenorphine.” In its
CONCLUSION, Ipe states: “4. The minor side effects of Buprenorphine are
more when administered intrathecally, compared to Buprenorphine
administered epidurally.”
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unexpected results, the record was closed to the admission of new evidence,
unless the Examiner’s Answer contained a new ground of rejection, see 37
C.F.R. § 41.33 (c)(2); MPEP § 1206, which it did not. The Decision points
out that Appellant failed to meet its threshold burden, In re Soni, 54 F.3d
746, 750 (Fed. Cir. 1995), regarding showing that something within the
scope of the claimed invention was tested because there was simply no
information as to the volume of the injection of how much active agent was
administered either epidurally or epicaridally. (Decision 8–9.) Even though
this was a different basis to reject the evidence of secondary considerations
than relied on by the Examiner, our finding did not change the thrust of the
Examiner’s rejection. It also did not entitle Appellant to offer evidence in
rebuttal.
The outcome in In re Kumar, 418 F.3d 1361 (Fed. Cir. 2005) (Request
2) is not controlling here. In that case, a rejection for obviousness was made
based on overlapping values in the prior art and it was the Board who
identified the values deemed to overlap in the first instance based on sua
sponte calculations. Kumar, 418 F.3d at 1367–69. The Federal Circuit
found that “the Board found facts not found by the examiner regarding the
differences between the prior art and the claimed invention, which in
fairness required an opportunity for response.” Id. at 1368. That fairness
stems from the fact that it was the Examiner’s burden to establish a prima
facie case of obviousness, but that case was not made until the Board’s new
facts concerning the differences between the prior art and the claimed
invention were made. After that point, it was only fair to allow applicant the
opportunity to come forward with rebuttal evidence where the decision of
obviousness would have to be made anew on the entirety of the evidence.
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Id. at 1366. In the present case, as discussed above, it was Appellant’s
burden to establish that there was sufficient evidence of record to
demonstrate unexpected results. Our Decision established that the evidence
of record was deficient on a threshold matter regarding unexpected results,
i.e., showing that something within the scope of the claimed invention was
tested; it did not present new facts concerning the differences between the
prior art and the claimed invention establishing prima facie obviousness.
Apart from the foregoing, the Decision also noted that we agreed with
the Examiner that the unexpected results evidence failed for the additional
reason that it was not commensurate in scope with the claims. (Decision 9
(citing Ans. 20–21).)
Thus, for the foregoing reasons, Appellant’s Request fails to establish
that the Decision contained any undesignated new ground of rejection.
Accordingly, we decline to modify our original Decision entered February
25, 2021.
DECISION SUMMARY
Outcome of Decision on Rehearing:
Claims 35 U.S.C. § Reference(s)/Basis Denied Granted
1, 5–14, 18–23, 26,
36–38
103 Zucker, Szabo, Ipe 1, 5–14,
18–23, 26,
36–38

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Final Outcome of Appeal after Rehearing:
Claims 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 5–14, 18–23, 26,
36–38
103 Zucker, Szabo, Ipe 1, 5–14,
18–23, 26,
36–38

REHEARING DENIED