Ex Parte Haley

Patent Trial and Appeal Board

Mar 14, 2017

12325194 (P.T.A.B. Mar. 14, 2017)

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.
12/325,194 12/01/2008 Jeffrey T. Haley 15001.203 1019
39124 7590 03/16/2017
CAROL NOTTENBURG
264 SENECA PLACE NW
RENTON, WA 98057
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
03/16/2017 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):
c arol. nottenburg @ cougarlaw. com
chris.pratt@cougarlaw.com
cnot@comcast.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY T. HALEY
Appeal 2016-000053
Application 12/325,1941
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and
ELIZABETH A. LaVIER, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant seeks review of the
Examiner’s rejection of claims 42-46 and 50—53. We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification relates to topical applications of cobalamin (vitamin
B12) to epithelial tissues subject to mucositis. Spec. 1 8. Claim 42 is
illustrative:
1 Appellant states the real party in interest is OraHealth Corp. Appeal Br. 4.
Appeal 2016-000053
Application 12/325,194
42. A method for treating or preventing oral mucositis in a
patient’s mouth, comprising:
providing an effectively adhering, slowly dissolving troche
adapted for adhering in the mouth and for slowly releasing
bioactive cobalamin selected from the group consisting of one
or more of methylcobalamin, adenosylcobalamin and
hydroxocobalamin topically delivered to mucosal epithelial
tissues in an area where mucositis occurs to reduce or prevent
mucositis in the mouth.
Appeal Br. 26 (Claims Appendix).
APPEALED REJECTION2
Claims 42-46 and 50-53 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Sarill,3 Ben-Sasson,4 Haley ’178,5 Wick,6 Haley ’930,7
andEngstad.8 Final Action 4.
DISCUSSION
We agree with, and adopt, the Examiner’s reasoning and conclusions
that the claims are obvious over the cited prior art references cited by the
Examiner. We address Appellant’s arguments below.
2 In the Answer, the Examiner refers to rejections under 35 U.S.C. § 112, first
and second paragraphs, which were part of the Final Rejection. See Ans. 2.
As Appellant points out, however (see Reply Br. 2), the § 112 rejections were
subsequently overcome. See Advisory Action, Sept. 18,2014. Accordingly,
we review only the § 103 rejection.
3 Sarill et al., US 2002/0119947 Al, published Aug. 29, 2002.
4 Ben-Sasson, US 2005/0232981 Al, published Oct. 20, 2005.
5 Haley, US 2003/0124178 Al, published July 3, 2003.
6 Wick et al., 6,010,715, issued Jan. 4, 2000.
7 Haley, US 2004/0156930 Al, published Aug. 12, 2004.
8 Engstad, US 2006/0079481 Al, published Apr. 13, 2006.
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Application 12/325,194
As to illustrative claim 42, the Examiner finds that Sarill discloses
cobalamin compositions that can promote the healing of aphthous ulcers
(which occur in oral mucosa). Final Action 4 (citing Sarill || 26, 65).
Administration may be topical. Id. at 4—5 (citing Sarill || 65, 67). Sarill
states “[a]s defined herein, the term cobalamin refers to vitamin B12 in any
of its biologically active forms, including cyanocobalamin,
hydroxocobalamin, methylcobalamin, and adenosylcobalamin” (id. at 5
(quoting Sarill 132)), and can be formulated as a dissolving troche or tablet
{id. (citing Sarill 174)).
Sarill does not teach an “effectively adhering” troche, however, as
recited in claim 42, or the adhesion thereof in the mouth near the site of
mucositis. See Final Action 5—6. For these limitations, the Examiner relies
on Haley ’178, which teaches adhesion of a patch on the site of canker sores.
See id. at 6 (citing Haley ’178 17)). The Examiner also relies on Ben-
Sasson, which describes tablets or suppositories to deliver vitamin B12, with
adhesive polymers to assist adherence of the formulation to mucosal
surfaces. See id. (citing Ben-Sasson ]f]f 18, 66, 85).9
The Examiner finds that claim 42 “contains the same components in
the same configuration of the prior art,” and thus would have the same
release properties. Final Action 6. Further, the Examiner finds that
combining the references as claimed would have been obvious, because
doing so would have been “useful in the delivery of active agents such as
9 The Examiner cites the other references (i.e., Wick, Haley ’930, and
Engstad) in regard to certain dependent claims. See Final Action 6. We
discuss the separately-argued dependent claims below.
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Application 12/325,194
vitamin B12 (i.e. cobalamin) across mucosal epithelia, as explained by BEN-
SASSON.” Id. at 7.
Appellant first argues that certain limitations of claim 42 are missing
from the prior art. See Appeal Br. 10—17. Specifically, Appellant maintains
that Sarill does not teach topical administration in the mouth, but rather oral
administration for delivery of cobalamin into the bloodstream. Id. at 10—12
(discussing Sarill || 39, 65, 67); see Reply Br. 3. In other words, according
to Appellant, Sarill teaches separate oral and topical modes of
administration. Appeal Br. 12. As such, Appellant alleges, the Examiner’s
findings amount to “cherry-pick[ing]” from Sarill, and are not based on
Sarill’s actual teachings, Appellant maintains. Id. at 13.
This is not persuasive. First, Appellant’s argument relies on an
overly-strained reading of Sarill. Sarill discloses wide applications for its
cobalamin compositions, including for treatment of ulcers and other skin
conditions, and that topical application is “especially useful” for cellular
uptake. Sarill | 65. Thus, this is not a case of too much “picking and
choosing,” so much as one of modest, obvious modification of the prior art.
Cf. KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007) (“[I]n many
cases a person of ordinary skill will be able to fit the teachings of multiple
patents together like pieces of a puzzle.”). Second, claim 42 recites that the
cobalamin is “topically delivered to mucosal epithelial tissues.” Thus, claim
42 does not limit what happens to the cobalamin after delivery. In other
words, claim 42 does not exclude a mechanism of action involving uptake
into the bloodstream.
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Application 12/325,194
Next, Appellant argues10 that Sarill does not teach or suggest the
claimed “bioactive cobalamin,” because Sarill includes cyanocobalamin
(which requires conversion in the human body before it can be effective)
among a list of what Sarill calls “biologically active forms” of cobalamin
suitable for its compositions. Appeal Br. 14 (discussing Sarill 132); Reply
Br. 4. However, as the Examiner points out, Sarill also includes forms of
cobalamin (hydroxocobalamin, methylcobalamin, and adenosylcobalamin)
specifically listed as “bioactive” in Appellant’s specification and recited as
such in claim 42. Ans. 5 (citing Sarill 132; Spec. 1 8); see also Final Action
5 (citing Sarill 132). We thus agree with the Examiner that Sarill’s failure
to differentiate cyanocobalamin from other, directly biologically active
forms does not undermine Sarill’s express teaching of claimed forms of
cobalamin—or, as the Examiner puts it, “such differentiation is not required
10 Appellant also attempts to distinguish the claimed bioactive cobalamin from
Sarill by pointing to a declaration (and accompanying article) allegedly
demonstrating surprising results. See Appeal Br. 15, 22. However, this
declaration was never entered into the record. See Ans. 11; see also Advisory
Action, Sept. 18, 2014. Appellant argues the Examiner’s failure to do so was
erroneous (see Reply Br. 6), but an Examiner’s refusal to enter evidence is a
petitionable matter, not an appealable one (see MPEP § 1204.04). Even
assuming, arguendo, that the declaration should have been entered, we do not
find it persuasive in overcoming the Examiner’s prima facie case of
obviousness because the allegedly surprising results relate to the use of a
known compound (methylcobalamin) for a known use (topical treatment of
apthous ulcers), as taught in Sarill, over cyanocobalamin. Appellant’s
reliance on the differences in mechanisms of activity between
methylcobalamin and cyanocobalamin is no more persuasive in the context of
rebutting the prima facie case any more than it is in attacking it, as discussed
above.
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Application 12/325,194
to reject the limitation when there is an explicit teaching of bioactive
cobalamin.” Ans. 6.
Ben-Sasson, according to Appellant, does not teach or suggest “an
effectively adhering, slowly dissolving troche” for the mouth. Appeal Br.
15. According to Appellant, Ben-Sasson focuses on delivery of vitamin B12
“across mucosal epithelia of the gastrointestinal tract,” and that “[i]ts
reference to mucosal or vascular epithelia as including, but not limited to GI
or respiratory epithelia, is only an explanation of locations where biological
barriers are found,” not “sites of administration.” Id. at 16 (discussing Ben-
Sasson 117). These arguments are not persuasive because Ben-Sasson was
not cited for these purposes. See In re Keller, 642 F.2d 413, 426 (CCPA
1981) (“But one cannot show non-obviousness by attacking references
individually where, as here, the rejections are based on combinations of
references.”). As the Examiner points out, the rejection relies on Sarill, not
Ben-Sasson, for a troche formulation. Ans. 6 (citing Final Action 5). And
Haley ’178 was cited for troche adhesion to canker sores, i.e., in the mouth.
See Final Action 6 (citing Haley ’178 1 7)). Likewise, as discussed above
with respect to Sarill, Appellant’s distinction between topical delivery and
delivery across a biological barrier (see Appeal Br. 17) is not borne out by
the language of claim 42.
Appellant also argues that the Examiner’s rationale for combining the
references is conclusory. See Appeal Br. 20-21; see also Reply Br. 5—6. In
particular, Appellant alleges that the Examiner provides no facts or analysis
“to explain use of bioactive cobalamin to treat mucositis by topical
application in an area where mucositis occurs, as recited in the claims.”
Appeal Br. 20. Relatedly, Appellant also argues that the Examiner’s
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Application 12/325,194
combination is the product of impermissible hindsight. See id. at 22—23.
We are not persuaded. As discussed above, Sarill itself teaches much of
claim 42, i.e., using cobalamin in a troche to treat mucositis. See also Ans.
10. The other references, which the Examiner finds are in the same field of
endeavor (of formulations for mucosal administration (see id. at 9)), thus
each “logically would have commended itself to an inventor’s attention in
considering [the] problem,” Innovention Toys, LLC v. MGA Entertainment,
Inc., 637 F.3d 1314, 1321—22 (Fed. Cir. 2011) (quoting In re Clay, 966 F.2d
656, 658 (Fed. Cir. 1992)), i.e., to improving the usefulness of Sarill (see
Final Action 7).
Having considered each of Appellant’s arguments in light of the
evidence of record, we are unpersuaded that the Examiner erred in rejecting
claim 42.
We are also unpersuaded that the Examiner erred in rejecting claims
43 46 and 50—53. Appellant’s arguments for claim 43 and 44 regarding
Sarill’s alleged failure to teach “bioactive” cobalamin (see Appeal Br. 17—
18) recapitulate those made in regard to claim 42 and are unpersuasive for
the same reasons. Appellant’s argument regarding claim 50, that the
references fail to teach an adhesive “having at least 79.2% acacia gum” (see
Appeal Br. 18) is not persuasive in view of the Examiner’s position that
claim 20 of Wick encompasses an adhesive layer “exclusively comprised of
acacia gum” (Ans. 9). Appellant’s alternative argument that claims 43 46
and 50-53 are patentable for the same reasons as claim 42 (see Appeal Br.
18) is unpersuasive in light of our affirmance of the Examiner’s rejection of
claim 42.
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Application 12/325,194
CONCLUSION
The rejection of claims 42^46 and 50-53 under 35 U.S.C. § 103(a) is
affirmed. No time period for taking any subsequent action in connection
with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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