Siva Rama Krishna. Nutalapati

Patent Trials and Appeals Board

Jul 29, 2019

13518038 - (D) (P.T.A.B. Jul. 29, 2019)

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.
13/518,038 06/21/2012 Siva Rama Krishna Nutalapati AI0025US.NP 5329
26259 7590 07/29/2019
LICATA & TYRRELL P.C.
66 E. MAIN STREET
MARLTON, NJ 08053
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
07/29/2019 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):
PTOactions@licataandtyrrell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SIVA RAMA KRISHNA NUTALAPATI1
____________

Appeal 2018-004192
Application 13/518,038
Technology Center 1600
____________

Before RYAN H. FLAX, RACHEL H. TOWNSEND,
and CYNTHIA M. HARDMAN, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a functionally coated multilayer tablet for oral administration and a
method of formulating the same. The Examiner’s rejection of claims 1, 3–5,
7, 8, and 10 under 35 U.S.C. § 103(a) is appealed. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.

1 The Real Party in Interest is identified as “AptaPharma, Inc.” Appeal
Br. 1.
Appeal 2018-004192
Application 13/518,038

2
STATEMENT OF THE CASE
The Specification states:
The present invention relates to multilayer functionally
coated tablets for oral administration of one or more active
pharmaceutical ingredients (API). The multilayer functionally
coated tablets contain one or more quick release API containing
layers and one or more modified release API containing layers
separated by an inert layer. Methods for formulation and use of
these tablets are also provided.
Spec. 1:8–15. The Specification describes the quick release API-containing
layer or layers as providing “a dissolution profile relatively faster than the
modified release layer. In one embodiment, the dissolution profile of the
quick release layer ranges from 0 to 120 minutes.” Id. at 6:29–32. The
Specification further describes the modified release API-containing layer or
layers as providing “a dissolution profile which is extended, delayed or
controlled as compared to the in vitro dissolution of the quick release layer.
In one embodiment, the modified release layer has a release profile of 4
hours or greater,” although it could be shorter than 4 hours. Id. at 7:13–24.
Independent claim 1, reproduced below, is representative:
1. A functionally coated multilayer tablet for oral
administration comprising:
(a) a core tablet comprising
(i) a quick release layer or layers comprising one or
more active pharmaceutical ingredients (APIs);
(ii) a modified release layer or layers comprising
one or more APIs and a release retarding excipient; and
(iii) an inert layer separating said quick release layer
or layers and said modified release layer or layers, wherein
said inert layer is insoluble and impermeable;
Appeal 2018-004192
Application 13/518,038

3
(b) a functional coating or film surrounding the core tablet,
wherein said coating or film comprises a pore-forming agent
which permits quick release of the API from the quick release
layer regardless of the functional coating or film being present
while providing release of the API from the modified release
layer controlled by [ ] the release retarding excipient, inert layer
and functional coating or film.
Appeal Br. 14 (Claims Appendix). Independent claim 8 is directed to a
method of producing a tablet as defined by claim 1. Id. at 15.
The following rejection is on appeal:
Claims 1, 3–5, 7, 8, and 10 stand rejected under 35 U.S.C. § 103(a)
over Seroff2 and Dharmadhikari.3 Final Action 2.
DISCUSSION
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability.
[Only once] that burden is met, [does] the burden of coming forward with
evidence or argument shift[] to the applicant.” In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992). “[O]bviousness requires a suggestion of all
limitations in a claim.” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
The Examiner determined the claims would have been obvious over
Seroff and Dharmadhikari. Final Action 2–3; see also Answer 5–7. The
Examiner points to Seroff’s Figure 3 as illustrating a tablet as claimed and
determined the figure shows the claimed quick release layer as feature 16,
the claimed modified release layer as feature 17, the claimed inert layer as

2 US 6,387,403 B1 (issued May 14, 2002) (“Seroff”).
3 US 8,470,367 B2 (issued June 25, 2013) (“Dharmadhikari”).
Appeal 2018-004192
Application 13/518,038

4
feature 18, and the claimed coating as feature 19. Final Action 2–3 (citing
Seroff columns 12 and 13). In response to Appellant’s argument that Seroff
states layer 17 “does not contain drug,” the Examiner asserted that Seroff’s
disclosed layer 17 is a drug layer because Seroff says as much at column 13,
which the Examiner determined refers to “a lesser preferred embodiment[].”
Answer 5.
Appellant presents several arguments, the first of which is that the
prior art combination does not teach or suggest the claimed modified release
API layer because Seroff’s layer 17, identified by the Examiner as this claim
element, is not a drug-containing layer, but is a push layer that facilitates
drug release by swelling adjacent to Seroff’s drug-containing layer 16.
Appeal Br. 5. We find this argument persuasive.
Reading Seroff in its entirety, it is apparent that the portions of
column 13 cited by the Examiner to support his determination that Seroff’s
layer 17 is a drug-containing modified release layer are errors within the
reference. The Examiner is correct that Seroff’s column 13 states twice,
“drug layer 17.” See Seroff 13:33 and 13:45–46. However, within the
context of Seroff’s disclosure as a whole, it is apparent that a person of
ordinary skill in the art would have understood Seroff intends to discuss
layer 16 at these portions, and we conclude that the identification of layer
“17” instead is an apparent typographical error. See In re Yale, 434 F.2d
666, 668–69 (Fed. Cir. 1970) (when a prior art reference’s typographical
error, e.g., as exemplified by internal inconsistencies in the reference, would
lead the skilled artisan to disregard the related disclosure, reliance on that
Appeal 2018-004192
Application 13/518,038

5
express disclosure to establish the obviousness of what it expressly states is
error).
In particular, nothing in the column 13 portions of Seroff relates to the
push layer 17 elsewhere discussed in the reference, but the cited portions
relate to materials for the drug-containing layer 16. Moreover, Seroff
describes the push layer 17 as “compris[ing] osmotically active
component(s) but does not contain drug.” Seroff 8:17–20, 8:56–58. Seroff
also describes providing the inert layer 18 to prevent drug from migrating
from layer 16 to layer 17. Seroff 8:58–63. Thus, we find the balance of
evidence supports Appellant’s position on this issue.
Because we conclude the Examiner’s cited prior art combination fails
to teach or suggest the claimed invention, we reverse the obviousness
rejection.
SUMMARY
The obviousness rejection of claims 1, 3–5, 7, 8, and 10 under
35 U.S.C. § 103(a) is reversed.

REVERSED