James W. Davis et al.

Patent Trials and Appeals Board

Oct 31, 2019

15421513 - (D) (P.T.A.B. Oct. 31, 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.
15/421,513 02/01/2017 James W. Davis PAT905114-US-CNT 2661
26356 7590 10/31/2019
ALCON
IP LEGAL
6201 SOUTH FREEWAY
FORT WORTH, TX 76134
EXAMINER
MILLER, DALE R
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
10/31/2019 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):
alcon_pair@firsttofile.com
patent.docketing@alcon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES W. DAVIS,
HOWARD ALLEN KETELSON, ELAINE E. CAMPBELL,
DAVID L. MEADOWS, and REKHA RANGARAJAN
__________

Appeal 2019-004383
Application 15/421,513
Technology Center 1600
__________

Before DONALD E. ADAMS, RYAN H. FLAX, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3, 5–13, and 16. Final Act. 2. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 We use the word “Appellant” to refer to “Applicant” as defined in
37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as
“Novartis AG.” Appeal Br. 3.
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STATEMENT OF THE CASE
The claims are directed to ophthalmic compositions. Claim 1,
reproduced below (with formatting added for readability), is illustrative of
the claimed subject matter:
1. An ophthalmic composition comprising
0.17 to 0.18 w/v% hydroxypropyl guar,
0.13 to 0.17 w/v% sodium hyaluronate, and
1.0 to 2.0 w/v% cis-diol.
Amended Appeal Br. 2 (Claims Appendix).
Claims 1, 3, 5–13, and 16 are on appeal. Final Act. 2. The claims
stand rejected as follows:
Claims 1, 3, 5, 7–10, and 16 are rejected under 35 U.S.C. § 103 as
being unpatentable over Xia.2 Final Act. 3.
Claim 6 is rejected under 35 U.S.C. § 103 as being unpatentable over
Xia and Ketelson ’294.3 Final Act. 5.
Claims 6 and 11–13 are rejected under 35 U.S.C. § 103 as being
unpatentable over Xia and Ketelson ’345.4 Final Act. 6.
Claims 1, 3, 7–9, and 16 are rejected under 35 U.S.C. § 103 as being
unpatentable over Chowhan ’2805 and Xia. Final Act. 7.

2 Xia et al., US 2009/0196845 A1, published Aug. 6, 2009 (“Xia”).
3 Ketelson et al., WO 2009/132294 A1, published Oct. 29, 2009
(“Ketelson ’294”).
4 Ketelson et al., US 2009/0270345 A1, published Oct. 29, 2009
(“Ketelson ’345”).
5 Chowhan et al., US 2004/0253280 A1, published Dec. 16, 2004
(“Chowhan ’280”).
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Claims 1, 3, 7–9, and 16 are rejected under 35 U.S.C. § 103 as being
unpatentable over Chowhan ’4076 and Xia. Final Act. 9.
ANALYSIS
Obviousness of Claims 1, 3, 5, 7–10, and 16 Over Xia
The Examiner determined that Xia “teaches ophthalmic
composition[s] comprising an anionic biopolymer, specifically exemplified
as . . . 0.2-2.0 % sorbitol, 0.01-0.5 % hydroxypropyl guar and 0.005-0.03%
hyaluronic acid.” Final Act. 3 (citing Xia ¶ 61, Table 4). The Examiner
further found that Xia teaches that the concentration of anionic biopolymer
can be in the range of 0.005–2.0%. Final Act. 4 (citing Xia ¶ 16); Ans. 11.
We adopt these findings, and determine that the amounts of hydroxypropyl
guar, hyaluronic acid, and sorbitol (a cis-diol) taught in Xia overlap with or
encompass the amounts recited in claim 1.
Appellant argues that Xia does not teach the claimed amount of
hyaluronic acid (i.e., 0.13–0.17%). Appeal Br. 5–7. Appellant
acknowledges Xia’s teaching that anionic biopolymer may be present in the
range of 0.005–2.0% (see Appeal Br. 7), but argues that Xia teaches many
anionic biopolymers, and specifically teaches that when the anionic
biopolymer is hyaluronic acid, it is present in amounts from 0.002–0.04%,
i.e., amounts that are “substantially lower” than the claimed range. Appeal
Br. 6–7 (citing, e.g., Xia ¶ 18).
We are not persuaded by Appellant’s argument. We agree with the
Examiner that, although Xia discloses a preferred embodiment of hyaluronic
acid in the range of 0.002–0.04%, Xia is not limited to only its preferred

6 Chowhan et al., US 2008/0193407 A1, published Aug. 14, 2008
(“Chowhan ’407”).
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embodiments. Ans. 11. As stated by the Examiner, “[t]he disclosure of Xia
is relevant for all that it would reasonably suggest to one of ordinary skill in
the art, which includes that the genus of anionic biopolymers may have a
concentration range of 0.005–2.0%,” and Xia identifies hyaluronic acid as
such an anionic biopolymer. Ans. 11; Xia ¶¶ 16, 18; see also Merck & Co.
v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re
Lamberti, 545 F.2d 747, 750 (CCPA 1976) (“[I]n a section 103 inquiry, the
fact that a specific [embodiment] is taught to be preferred is not controlling,
since all disclosures of the prior art, including unpreferred embodiments,
must be considered.”).
We agree with the Examiner that “[a]bsent some evidence or
discussion to the contrary, it is reasonable for one of ordinary skill in the art
to apply the broad concentration range of anionic biopolymers to hyaluronic
acid because Xia specifically teaches that hyaluronic acid is among the
polysaccharides that fall within the genus of anionic biopolymers.” Ans. 11.
We further agree with the Examiner that there is no disclosure in Xia “that
specifically teaches away from employing the broader concentration range
for anionic biopolymers” with hyaluronic acid. Ans. 11–12. Nor does the
record reflect any criticality to the claimed concentration of hyaluronic acid.
See id. In short, Appellant has not demonstrated any persuasive reason why
one of ordinary skill in the art would not have applied Xia’s broad range of
anionic biopolymer concentrations to hyaluronic acid.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
obvious over Xia. Because Appellant did not separately argue the dependent
claims 3, 5, 7–10, and 16, they fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
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Obviousness of Claim 6 Over Xia and Ketelson ’294; Obviousness of Claims
6 and 11–13 Over Xia and Ketelson ’345
Claim 6 indirectly depends from claim 1, and specifies that the
claimed composition further comprises a demulcent that is polypropylene
glycol or polyethylene glycol. Claim 11 likewise indirectly depends from
claim 1, and specifies that the claimed composition further comprises a
demulcent that is polypropylene glycol and polyethylene glycol. Claims 12
and 13 depend from claim 11, and specify concentrations of polyethylene
glycol and polypropylene glycol, respectively.
The Examiner found that Ketelson ’294 teaches an ophthalmic
composition that comprises polypropylene glycol or polyethylene glycol as a
demulcent, and that Ketelson ’345 teaches an ophthalmic composition that
comprises a mixture of polypropylene glycol and polyethylene glycol as a
demulcent, in the claimed concentrations. Final Act. 5 (citing Ketelson ’294
at, e.g., claim 10), 6 (citing Ketelson ’345, e.g., Example). The Examiner
asserted that it would have been prima facie obvious to substitute the
propylene glycol or PVP of Xia (e.g., Xia ¶¶ 52–54) with the polypropylene
glycol/polyethylene glycol of Ketelson ’294 or Ketelson ’345, because
substituting one known element for another yields predictable results to one
of ordinary skill in the art. Final Act. 5–7.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 5–7), and agree that claim 6
would have been obvious over Xia and Ketelson ’294, and that claims 6 and
11–13 would have been obvious over Xia and Ketelson ’345, for the reasons
the Examiner articulated.
In response to these rejections, Appellant relies only on the same
arguments discussed above with respect to the rejection of claims 1, 3, 5, 7–
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10, and 16 over Xia. Appeal Br. 7–8. Accordingly, for the same reasons
discussed above, we affirm the rejection of claim 6 over Xia and Ketelson
’294, and the rejection of claims 6 and 11–13 over Xia and Ketelson ’345.
Obviousness of Claims 1, 3, 7–9, and 16 over Chowhan ’280 and Xia
The Examiner found that Chowhan ’280 discloses an ophthalmic
composition comprising, among other things, 4% mannitol and a mixture of
two polymers, one of which can be 0.1% hydroxypropyl guar, and the other
of which can be hyaluronic acid. Final Act. 7 (citing, e.g., Chowhan ’280
¶ 29 (Composition 6), claim 7). The Examiner found that Chowhan ’280
does not specifically disclose a composition comprising 1.0–2.0% of a cis-
diol and hyaluronic acid. Final Act. 7.
The Examiner found that Xia teaches an ophthalmic composition
comprising, among other things, a sugar alcohol such as sorbitol, at a
concentration of 0.4–5%. Final Act. 8 (citing, e.g., Xia ¶ 49). The Examiner
argued that
mannitol and sorbitol are both sugar alcohols used in
ophthalmic compositions as excipients. . . . There is no
criticality taught by Xia or Chowhan for selecting a particular
sugar alcohol or using a particular sugar alcohol concentration.
Hence, one of ordinary skill in the art may select any sugar
alcohol known [for use] in ophthalmic formulations, within a
concentration known in the art. When considering the
combined teachings of Chowhan and Xia, the use of either
mannitol or sorbitol, in the concentration range of 0.4–5%, is a
prima facie obvious modification.
Ans. 13; see also Final Act. 8–9.
We adopt the Examiner’s findings of fact, and agree that claim 1
would have been obvious over Chowhan ’280 and Xia for the reasons the
Examiner articulated. We address Appellant’s arguments below.
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Appellant argues that neither Chowhan ’280 nor Xia disclose or
suggest the amount of hyaluronic acid recited in claim 1. Appeal Br. 8. We
disagree. Although Chowhan ’280 does not appear to disclose or suggest
any specific amount of hyaluronic acid, as discussed above, Xia discloses
that anionic biopolymers—which specifically include hyaluronic acid—are
provided at a concentration range of 0.005–2.0%. Xia ¶¶ 13, 16. This
encompasses the claimed amount and, as noted, the record does not reflect
any criticality to the claimed concentration of hyaluronic acid. See Ans. 11–
12.
Appellant additionally argues that the Examiner failed to provide a
sufficient rationale why a person of ordinary skill in the art would have
changed Chowhan ’280’s 4% mannitol to a different cis-diol (sorbitol) at a
lower concentration. Appeal Br. 9–10. We are not persuaded by this
argument. We agree with the Examiner that together, Xia and
Chowhan ’280 teach the functional equivalency of mannitol and sorbitol as
ophthalmic excipients, and neither reference teaches any criticality for
selecting a particular sugar alcohol or sugar alcohol concentration. See Ans.
13–14; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007)
(“The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”).
Xia, for example, teaches that contact lens solutions can include sorbitol or
xylitol at amounts ranging from 0.4–5%, which covers the claimed range of
cis-diol component as well as Chowan ’280’s disclosed amounts of
mannitol. Xia ¶ 49.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
obvious over Chowhan ’280 and Xia. Because Appellant did not separately
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argue the dependent claims, they fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
Obviousness of Claims 1, 3, 7–9, and 16 over Chowhan ’407 and Xia
The Examiner found that Chowhan ’407 discloses an ophthalmic
composition comprising, among other things, 4% mannitol, 0.1–0.3%
hydroxypropyl guar, and 0.1–0.3% sodium hyaluronate. Final Act. 9 (citing,
e.g., Chowhan ’407 ¶ 35 (Tables 6A and 6B)). The Examiner found that
Chowhan ’407 does not specifically disclose a composition comprising
mannitol (or any other cis-diol) at the claimed concentration of 1.0–2.0%.
Final Act. 10.
The Examiner found that Xia teaches an ophthalmic composition
comprising a sugar alcohol, such as sorbitol, at a concentration of 0.4–5%.
Final Act. 10 (citing, e.g., Xia ¶ 49). The Examiner again determined that
Xia and Chowhan ’407 teach the functional equivalency of mannitol and
sorbitol as ophthalmic excipients, and neither teaches any criticality for
selecting a particular sugar alcohol or sugar alcohol concentration. Ans. 12–
13.
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 9–11; Ans. 12–14), and agree
that claim 1 would have been obvious over Chowhan ’407 and Xia for the
reasons the Examiner articulated. We address Appellant’s arguments below.
Appellant argues that it is “undisputed” that neither Chowhan ’407
nor Xia disclose or suggest the amount of hyaluronic acid recited in claim 1.
Appeal Br. 10. We are not persuaded by this argument for the reasons set
forth above regarding the first-discussed rejection and, also, because it is
inconsistent with both the Examiner’s findings and the disclosure of
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Chowhan ’407. The Examiner found that Chowhan ’407 teaches
compositions comprising 0.1–0.3% sodium hyaluronate. Final Act. 9.
Indeed, Chowhan ’407 discloses compositions comprising 0.1% and 0.2%
sodium hyaluronate, i.e., amounts that bracket the claimed amount. See,
e.g., Chowhan ’407 ¶ 35 (Tables 6A and 6B). As noted above, the record
does not reflect any criticality to the claimed concentration of hyaluronic
acid. See also Ans. 11–12.
Appellant next argues that the Examiner has failed to provide a
sufficient rationale why a person of ordinary skill in the art would have
changed Chowhan ’407’s 4% mannitol to a different cis-diol (sorbitol) at a
lower concentration. Appeal Br. 11. For the reasons discussed above, we
are not persuaded by this argument.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
obvious over Chowhan ’407 and Xia. Because Appellant did not separately
argue the dependent claims, they fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).
CONCLUSION
We affirm the rejection of claims 1, 3, 5, 7–10, and 16 under 35
U.S.C. § 103 as being unpatentable over Xia.
We affirm the rejection of claim 6 under 35 U.S.C. § 103 as being
unpatentable over Xia and Ketelson ’294.
We affirm the rejection of claims 6 and 11–13 under 35 U.S.C. § 103
as being unpatentable over Xia and Ketelson ’345.
We affirm the rejection of claims 1, 3, 7–9, and 16 under 35 U.S.C.
§ 103 as being unpatentable over Chowhan ’280 and Xia.
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We affirm the rejection of claims 1, 3, 7–9, and 16 under 35 U.S.C.
§ 103 as being unpatentable over Chowhan ’407 and Xia.
DECISION SUMMARY
In summary:
Claims
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5, 7–10, 16 103 Xia 1, 3, 5, 7–10, 16
6 103 Xia, Ketelson ’294 6
6, 11–13 103 Xia, Ketelson ’345 6, 11–13
1, 3, 7–9, 16 103 Chowhan ’280, Xia
1, 3, 7–9,
16
1, 3, 7–9, 16 103 Chowhan ’407, Xia
1, 3, 7–9,
16
Overall
Outcome
1, 3, 5–
13, 16
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).
AFFIRMED