Antonio J. Grillo-L¿pez

Patent Trials and Appeals Board

Jan 31, 2020

13524837 - (R) (P.T.A.B. Jan. 31, 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.
13/524,837 06/15/2012 Antonio J. Grillo-López P04644-US-5 8212
9157 7590 01/31/2020
GENENTECH, INC.
1 DNA WAY
SOUTH SAN FRANCISCO, CA 94080
EXAMINER
KOLKER, DANIEL E
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
01/31/2020 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):
docketing-uspto-d@gene.com
pair_roche@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte ANTONIO J. GRILLO-LOPEZ
____________________

Appeal 2018-006082
Application 13/524,837
Technology Center 1600
____________________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.

CHANG, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant1 requests rehearing of the decision entered August 28, 2019
(“Decision”), which affirmed the Examiner’s rejections of claims 15–17 as
obvious but designated the affirmance as a new ground of rejection.
We deny the requested relief.

DISCUSSION
In the Decision, we found that the transcript of the July 25, 1997
meeting of FDA’s Biological Response Modifiers Advisory Committee
(“FDA Transcript”) was made sufficiently accessible to the public interested

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42.
Appeal 2018-006082
Application 13/524,837

2
in the art so as to render it a printed publication within the meaning of §
102(b). Appellant contends that the Decision “is contrary to the previous
board decisions finding that this very FDA Transcript was not a printed
publication.” Req. Reh’g 4. We are not persuaded.
A. Examination and IPR Proceedings have Different Standards for
Establishing a Printed Publication
As an initial matter, the previous board decisions involving the FDA
Transcript were in IPR proceedings,2 where “a petitioner is required to
present evidence and arguments sufficient to show that it is reasonably likely
that it will prevail in showing the unpatentability of the challenged claims.”
Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13
(PTAB Dec. 20, 2019) (precedential) (citing 35 U.S.C. §§ 312(a)(3),
314(a)).
In contrast, the examination context involves a burden-shifting
framework under which the USPTO can shift the burden to the applicant to
come forward with rebuttal evidence or argument to overcome a prima facie
case. Ex Parte Albert, 18 USPQ 2d 1325 (BPAI 1984) (“[T]he examiner
met his burden of proof by setting forth the nominal publication date. . . .
The Patent and Trademark Office is in no position to establish any thing
beyond that. The burden is clearly upon appellants to disprove the prima
facie publication date established by the examiner.”); see also In re Antor
Media Corp., 689 F.3d 1282, 1287–89 (Fed. Cir. 2012) (establishing a
burden-shifting framework regarding presumptive enablement of a prior art
printed publication cited by an examiner); In re Jung, 637 F.3d 1356, 1362

2 Celltrion, Inc. v. Biogen, Inc., IPR2017-01094, IPR2017-01230, IPR2017-
01227, and IPR2017-01229.
Appeal 2018-006082
Application 13/524,837

3
(Fed. Cir. 2011) (establishing that the prima facie case is a procedural device
that shifts the burden of production to the applicant and that the USPTO sets
forth a prima facie case when its rejection satisfies the notice requirement of
35 U.S.C. § 132); In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993)
(establishing a burden-shifting framework regarding prima facie cases of
obviousness); In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (establishing a
burden-shifting framework regarding rejections based on findings of
inherency). Given the different legal frameworks and burdens for
establishing a reference as prior art in IPR proceedings and examination, the
Decision is not contrary to the Board decisions finding that a petitioner
failed to meet its burden of showing that the FDA transcript is a printed
publication. In other words, the framework set forth in the Hulu decision for
IPR proceedings does not apply to examination.
B. The Examiner Sufficiently Established That the FDA Transcript is
a Printed Publication
More importantly, as the Decision notes, the petitioner in those IPR
proceedings “did not cite to publication of the Notice of Hearing in the
Federal Register, attendance of the hearing by an interested member of the
public pursuant to the notice, or the requirements of FACA [Federal
Advisory Committee Act] in support of the public accessibility of the FDA
Transcript.” Dec. 15, fn. 12. As the predecessor to our reviewing court has
explained, “[e]ach [printed publication] case must be decided on the basis of
its own facts.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981).
Appellant contends that the Decision nevertheless does not “lay out a
prima facie case that ‘persons interested and ordinarily skilled in the subject
Appeal 2018-006082
Application 13/524,837

4
matter or art exercising reasonable diligence’ would have been able to obtain
a copy of the actual FDA Transcript.”3 Req. Reh’g 3.
Appellant first contends that the Decision “conflat[es] the concept of
the hearing itself being public with the question of whether the FDA
Transcript is a printed publication.” Id. Appellant contends that the
Decision “does not articulate any reason an ordinarily skilled person would
have read the Federal Register.” Id. at 5. Appellant further contends that
“notification of a public hearing is not evidence that a later printed
publication was made sufficiently available to an ordinarily skilled person
exercising reasonable diligence,” that “there is no evidence that an ordinarily
skilled person would have learned anything about the transcript from the
notice,” and that “attendance at the oral hearing by an ‘interested member of
the public’ is not evidence that a later printed publication was made
sufficiently available to an ordinarily skilled person exercising reasonable
diligence.” Id.
We are not persuaded. As to Appellant’s argument that the Decision
does not explain why an ordinarily skilled person would have read the
Federal Register, the Decision notes that publication of the notice of the
advisory committee meeting is intended to “insure that all interested persons
are notified of such meeting prior thereto.” Dec. 13. A person of ordinary
skill in the art, such as an oncologist or medical researcher of ordinary skill,

3 Appellant asserts that “[t]he alleged evidence [of public accessibility] that
the Board identifies did not appear until the Examiner’s Answer and the
Board’s decision” and that “the evidence presented in the Examiner’s
Answer was presented only in the context of public use.” Req. Reh’g 3. We
are not persuaded: As noted in the Decision, our affirmance was designated
as a new ground of rejection under 37 C.F.R. § 41.50(b), and such a
rejection need not be based solely on the reasoning set forth in the Answer.
Appeal 2018-006082
Application 13/524,837

5
would have been such an “interested person.” Given the intent behind
publishing the notice of meeting, we find that a prima facie case exists that
an interested artisan would have been aware of the notice of meeting
published in the Federal Register.
Likewise, contrary to Appellant’s apparent understanding, the
Decision does not suggest that either the public notice of meeting, the public
meeting, and/or attendance of an interested member of the public at the
meeting render the transcript of the hearing publicly accessible, whether
together or by themselves. Dec. 13–14. Rather, the Decision explains that
the notice and the hearing establishes a prima face case that “an ordinarily
skilled artisan for purposes of the claimed invention (e.g., an oncologist or a
medical researcher of average experience) would have been aware of the
Biological Response Modifiers Advisory Committee meeting regarding
rituximab.” Id. The Decision then explains that, given that “there is a
reasonable expectation, if not a legal requirement, that transcripts of FDA
advisory committee meetings would be publicly available at a designated
place at the agency,” a prima facie case also exists that, once an ordinarily
skilled artisan is aware of the meeting regarding rituximab, he or she also
would have known of the existence of the transcript and been able to obtain
a copy with the exercise of reasonable diligence. Id. at 14–15. In short,
there is no conflation between the public nature of the meeting and whether
a subsequent transcript of the meeting was sufficiently publicly accessible.4

4 The cases cited by Appellant are inapposite. AT&T Corp. v. Microsoft,
2004 WL 292321, No. 01 Civ 4872 (WHP), 2004 WL 292321 (S.D.N.Y.
Feb. 17, 2004), merely stands for the proposition that oral presentation of a
paper, without more, does not constitute, or transform the paper into, a
“printed publication.” Id. at *6. Here, we do not suggest that the advisory
Appeal 2018-006082
Application 13/524,837

6
Appellant also misunderstands the Decision when it argues that
presence of an interested member of the public at the advisory committee
meeting is not evidence that the transcript of the meeting was made
sufficiently available to an ordinarily skilled artisan exercising reasonable
diligence, because there is no evidence that the interested member of the
public was an ordinarily skilled artisan and because, even if an ordinarily
skilled artisan had been present at the meeting and even if such a person had
known about the existence of the transcript, knowledge of a single individual
is not sufficient to establish public accessibility. Req. Reh’g 5–6.
As discussed above, the intent of the notice of the advisory committee
meeting is to “insure that all interested persons are notified of such meeting
prior thereto.” Dec. 13. The presence of an interested member of the public
at the meeting, even if he or she is not an ordinarily skilled artisan for

committee meeting, without more, transforms the transcript of the meeting
into a printed publication.
In In re Cronyn, the Court held that three student theses were not
accessible to the public where cards listing the theses are filed alphabetically
by the author’s name, because the only “research aid” (i.e., the author’s
name) “bears no relationship to the subject of the student’s thesis.” Id. at
1159, 1161. Similarly, the court in In re Bayer, 568 F.2d 1357 (CCPA
1978), held that “[a]ccessibility to appellant’s thesis by the three members of
the graduate committee . . . does not raise . . . a presumption” that “‘the
public concerned with the art would know of (the invention).’” Id. at 1361.
In this case, in contrast to the facts of In re Bayer and In re Cronyn, the FDA
advisory committee meeting as well as the topic of the meeting (i.e.,
Rituximab as treatment for patients with relapsed or refractory low grade or
follicular B-cell non-Hodkin’s Lymphoma) was announced in the Federal
Register, with the intent of “insur[ing] that all interested persons are notified
of [the] meeting prior thereto.” Dec. 13.
Appeal 2018-006082
Application 13/524,837

7
purposes of the claimed invention,5 suggests that the notice achieved that
goal, and thus supports a prima facie case that ordinarily skilled artisans
(who are also interested persons) would have been aware of the advisory
committee meeting. Neither are we persuaded by Appellant’s argument that
knowledge of a single individual is not sufficient to establish public
accessibility of the transcript and its citation to Bayer, 568 F.2d at 1358–
1359, and SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1195–96
(Fed. Cir. 2008), for support. As explained above, our finding of public
accessibility in the Decision is not based solely, or even primarily, on the
fact that a member of the public was present at the advisory committee
meeting. This factual point does, however, tend to support a finding of
public availability.
Appellant contends that, “assuming an ordinarily skilled person might
have known about the oral hearing . . . , and . . . assuming a copy of the FDA
Transcript was publicly available,” there is no evidence that such a person
“would have known of the existence and accessibility of the transcript.”
Req. Reh’g 4. Appellant contends that “a law . . . requiring a transcript of a
hearing be made, and be made available, is not evidence that the transcript
was made sufficiently available to an ordinarily skilled person exercising
reasonable diligence.” Id. at 6.
We are not persuaded. Appellant has not disputed that the FACA
requires the creation of a transcript of the FDA committee meeting at issue
and to make such a transcript publicly available; instead, Appellant argues

5 The member of the public who attended and spoke at the meeting was
Kathryn Adams, Vice President of the Cure for Lymphoma Foundation in
1997. FDA Transcript 8:10–12.
Appeal 2018-006082
Application 13/524,837

8
only that “[a]n ordinarily skilled person in this case is not a lawyer” and that
the Decision “presents no explanation or proof that a person with ordinar[y]
skill in the pertinent art would have been aware of the FACA requirements.”
Req. Reh’g.
We disagree with Appellant’s apparent suggestion that only lawyers
would be aware of the requirements set forth in FACA.6 As discussed above
and in the Decision, an ordinarily skilled artisan in this case includes an
oncologist or medical researcher of average experience.7 Dec. 13–14. It
does not matter that such individuals are not lawyers, but that they are able
to obtain pertinent information relating to the work of FDA advisory
committees regarding cancer drugs such as rituximab, because they work in
an industry whose products are regulated by the FDA and/or because they
prescribe such products.
CONCLUSION
We have carefully reviewed the original decision in light of
Appellant’s request, but we find no point of law or fact which we
overlooked or misapprehended in arriving at our decision. Therefore,
Appellant’s request is denied with respect to making any modifications to
the Decision.

6 Appellant asserts that FACA “was enacted to cure specific ills, above all
the wasteful expenditure of public funds for worthless committee meetings
and biased proposals.” Req. Reh’g 6 (internal quotation marks and citation
omitted). Appellant does not provide any reasoning for its apparent position
that this goal is incompatible with an intent to make documents related to
advisory committee meetings publicly accessible, particular to ordinarily
skilled artisans in the field(s) to which the subject matter of the meetings
pertain.
7 Appellant has neither disputed this characterization of the ordinarily skilled
artisan nor proposed different qualifications for such an individual.
Appeal 2018-006082
Application 13/524,837

9

Outcome of Decision on Rehearing:

Claims 35 U.S.C § Reference(s)/Basis Denied Granted
15–17 103(a) FDA Transcript 15–17

Final Outcome of Appeal after Rehearing:

Claims 35 U.S.C.
§
Reference(s) /
Basis
Affirmed Reversed New
Ground
15–17 102(b) Prescribing
information for
Rituxan®, dated
November 1997
15–17
15–17 103(a) FDA Transcript 15–17 15–17
Overall
Outcome
15–17 15–17

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

REHEARING DENIED