Ex Parte TUCKER et al

Patent Trials and Appeals Board

Jun 12, 2019

14898426 - (D) (P.T.A.B. Jun. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/898,426 12/14/2015
31781 7590 06/14/2019
ALCON RESEARCH, LTD.
PA TENT DEPARTMENT
11460 JOHNS CREEK PARKWAY
JOHNS CREEK, GA 30097-1556
FIRST NAMED INVENTOR
Robert Carey TUCKER
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PAT055796-US-PCT 3925
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
06/14/2019 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):
patent. docketing@alcon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT CAREY TUCKER, JOHN DALLAS PRUITT, and
LEROY W AINAINA MUY A 1
Appeal2019-000739
Application 14/898,426
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
HARDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an aqueous lens care solution. The Examiner rejected the claims as obvious
over the prior art. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the real party in interest as "Novartis AG." Appeal Br.
1. Herein, we reference the Specification filed Dec. 14, 2015 ("Spec.");
Final Office Action mailed Jan. 11, 2018 ("Final Act."); Appeal Brief filed
June 6, 2018 ("Appeal Br."); Examiner's Answer mailed Sept. 17, 2018
("Ans."), and Reply Brief filed Nov. 7, 2018 ("Reply Br.").
Appeal2019-000739
Application 14/898,426
STATEMENT OF THE CASE
The Specification states that the "present invention is generally
directed to an aqueous lens care solution for use in an ozone-based lens care
system for disinfecting and cleaning of contact lenses." Spec. 3.
Claims 1, 5, 6, and 8-15 are on appeal. Final Act. 2. Claim 1, the
only independent claim, reads as follows:
1. An aqueous lens care solution for disinfecting and/or
cleaning contact lenses in an ozone-based lens care system,
having an osmolality at about 25 °C of from about 180 to
about 240 mOsm/kg, a conductivity of from about 0.5
mS/cm to about 6 mS/cm, and a pH of from about 6.5 to
about 7.0 which is maintained by a borate/acetate buffer
system which comprises (a) boric acid, sodium
tetraborate or potassium tetraborate and (b) acetic acid,
sodium acetate or potassium acetate;
comprising about 0.05 mM/L or less of chloride ions and
an ozone-reactive dye present in an amount sufficient to
ensure that the aqueous lens care solution becomes
colorless under naked eyes over the time period of from
about 3 to about 30 minutes, so as to provide a visual
indicator for the completion of disinfection and cleaning
of contact lenses in the ozone-based lens care system;
and
being free of any ozone-interfering buffering agents
selected from the group consisting of phosphoric acid,
phosphates, citric acid, citrates, bicarbonates, carbonates,
propionic acid, propionates, 2-amino-2-hydroxymethyl-
1,3-propanediol and salts thereof, Bis-(2-hydroxyethyl)-
imino-tris-(hydroxymethyl)-methane and salts thereof,
bis-aminopolyols and salts thereof, triethanolamine and
salts thereof, ACES (N-(2-hydroxyethyl)-2-
aminoethanesulfonic acid) and salts thereof, BES (N,N-
Bis(2-hydroxyethyl)-2-aminoethanesulfonic acid) and
salts thereof, HEPES ( 4-(2-hydroxyethyl)-1-
piperazineethanesulfonic acid) and salts thereof, MES (2-
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Appeal2019-000739
Application 14/898,426
(Nmorpholino )ethanesulfonic acid) and salts thereof,
MOPS (3-[N-morpholino ]propanesulfonic acid) and salts
thereof, Pl PES (piperazine-N, N'-bis(2-ethanesulfonic
acid) and salts thereof, TES (N-
[Tris(hydroxymethyl)methyl ]-2-aminoethanesulfonic
acid) and salts thereof, and mixtures thereof,
wherein the aqueous lens care solution is compatible with
ozone electrolytically generated in an ozone-based lens care
system and is characterized by having at least 86% degradation
of the ozone-reactive dye after 300 seconds ozone production at
150 mA in the ozone-based lens care system.
Appeal Br. 9 (Claims Appendix).
The claims stand rejected as follows:
Claims 1, 5, 6, and 15 are rejected under 35 U.S.C. § I03(a) as
obvious over Rathore, 2 Matsumura, 3 and Lane. 4 Final Act. 3.
Claims 8-11 are rejected under 35 U.S.C. § I03(a) as obvious over
Rathore, Matsumura, Lane, Boyd, 5 and Auten. 6 Id. at 8.
Claims 12-14 are rejected under 35 U.S.C. § I03(a) as obvious over
Rathore, Matsumura, Lane, Boyd, Auten, and Ketelson. 7 Id. at 10.
2 Rathore et al., U.S. Patent Pub. 2008/0299179 Al, published Dec. 4, 2008
("Rathore ").
3 Matsumura et al., U.S. Patent Pub. 2013/0244978 Al, published Sept. 19,
2013 ("Matsumura").
4 Lane et al., U.S. Patent Pub. 2009/0324466 Al, published Dec. 31, 2009
("Lane").
5 Boyd et al., U.S. Patent Pub. 2007/0045354 Al, published Mar. 1, 2007
("Boyd").
6 Auten et al., US Patent 5,618,492, issued Apr. 8, 1997 ("Auten").
7 Ketelson et al., US Patent Pub. 2008/0138310 Al, published June 12, 2008
("Ketelson").
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Appeal2019-000739
Application 14/898,426
DISCUSSION
"[T]he examiner bears the initial burden ... of presenting a prima
facie case ofunpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant." In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellants in the Appeal and Reply Briefs; arguments not so
presented in Appellants' briefs are waived. See 37 C.F.R. § 4I.37(c)(l)(iv)
(2015); see also Ex Parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
Appellants focus their arguments on claim 1 (see, e.g., Appeal Br. 3-
8), and thus we do the same. Further, Appellants did not separately argue
dependent claims 8-11 and 12-14, but instead relied on the arguments they
made for claim 1. See id. at 7-8. Accordingly, all of the appealed claims
stand or fall with claim 1. See, e.g., In re Kaslow, 707 F.2d 1366, 1376
(Fed. Cir. 1983).
The Examiner found that Rathore discloses aqueous lens care
solutions that meet all of the limitations of claim 1, except that Rathore does
not teach ( 1) that "the pH is maintained by a buffering system comprising
boric acid, sodium or potassium tetraborate, acetic acid, and sodium or
potassium acetate," and (2) "the presence of ozone-reactive dyes including
FD&C Blue 1." Final Act. 5-8, 11-15. The Examiner found that
Matsumura teaches ophthalmic solutions for contact lenses containing
"buffering agents inclusive of boric acid, sodium acetate, potassium
tetraborate, and acetic acid," and that "[i]t would have been prima facie
obvious before the time of filing to substitute the buffering agents of Rathore
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Application 14/898,426
such as boric acid, for a buffering system comprising boric acid, sodium
acetate, acetic acid, [and] potassium tetraborate." Id. at 6. The Examiner
further found that Lane teaches "lens care compositions comprising ozone
reactive dyes such as FD&C Blue 1" (id. at 6-7), and that it would have
been prima facie obvious to include such a dye in Rathore' s lens care
solutions "to provide a lens care disinfectant product which can notify the
user when the solution has successfully disinfected the lens." Id. at 7.
As to the final "wherein" clause of claim 1, the Examiner found that
because the lens care solutions of Rathore, modified as discussed above,
teach the same structural requirements of claim 1, in the absence of evidence
to the contrary, those solutions would necessarily have the properties of
being "compatible with ozone electrolytically generated in an ozone-based
lens care system" and "having at least 86% degradation of the ozone-
reactive dye after 300 seconds ozone production at 150 mA in the ozone-
based lens care system." Id. at 7-8, 12, 14--15; Ans. 5, 6-7, 9-11.
We adopt the Examiner's findings of fact (Final Act. 5-15; Ans. 4--
11 ), and agree that the claims would have been obvious over the cited prior
art. We address Appellants' arguments below.
Many of Appellants' arguments flow from the premise that their
claimed solutions are for use in, and must be compatible with, ozone-based
disinfecting systems, whereas the references cited by the Examiner do not
mention ozone. Thus, we begin by addressing the scope of claim 1. The
Examiner found that the preamble's reference to "disinfecting and/or
cleaning contact lenses in an ozone-based lens care system" is a statement of
intended use, which is not entitled to patentable weight. Ans. 4--5. We
agree.
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Application 14/898,426
As our reviewing court has stated, "as a general rule preamble
language is not treated as limiting." Arctic Cat Inc. v. GEP Power Prods.,
Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019) (citations omitted). Exceptions
arise where, for example, the preamble recites "essential structure." Id. But
"a preamble is not limiting 'where a patentee defines a structurally complete
invention in the claim body and uses the preamble only to state a purpose or
intended use for the invention."' Id. at 1328 ( quoting Catalina Mktg. Int 'l,
Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). "[T]he
rule against giving invention-defining effect to intended-use preamble
language reflects a longstanding substantive aspect of the patent statute-
specifically, the 'well settled' fundamental principle 'that the recitation of a
new intended use for an old product does not make a claim to that old
product patentable."' Arctic Cat, 919 F.3d at 1328 (quoting In re Schreiber,
128 F.3d 1473, 1477 (Fed. Cir. 1997)).
Claim 1 is directed to certain aqueous lens care solutions. It is not
directed to a method of using those solutions in any fashion, e.g. using ozone
to disinfect or clean contact lenses in an ozone-based lens care system. The
body of claim 1 recites the components required to be present in the claimed
solutions, and we do not perceive, nor have Appellants explained, how
stating that such a solution is "for disinfecting and/or cleaning contact lenses
in an ozone-based lens care system" further limits the compositional
elements required. See, e.g., Arctic Cat, 919 F.3d at 1328 (finding preamble
language reciting "personal recreational vehicle" not limiting where it
merely identified an intended use for the claimed power distribution module,
and did not impose any structural requirement on the claimed module). As
in Catalina, "deletion of the disputed phrase from the preamble ... [ would]
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Application 14/898,426
not affect the structural definition ... of the [invention] itself." Catalina,
289 F .3d at 810. Thus, we conclude that the preamble does not limit the
scope of protection of the claimed solutions, and like the Examiner, do not
give it patentable weight. Ans. 4--5. For this reason, we are not persuaded
by Appellants' argument that the claims are non-obviousness because the
cited references fail to disclose or suggest anything related to ozone or
disinfection of contact lenses by ozone. See, e.g., Appeal Br. 3--4.
We next tum to claim 1 's "wherein" clause, which mentions ozone.
Appellants argue that the claims are non-obviousness because the cited prior
art combination does not address whether the prior art solutions meet claim
1 's requirements of being "compatible with ozone electrolytically generated
in an ozone-based lens care system" and "having at least 86% degradation of
the ozone-reactive dye after 300 seconds ozone production at 150 mA in the
ozone-based lens care system." See, e.g., id. at 4, 6. Appellants further
argue that the Examiner is improperly using inherency to supply these
missing limitations, which Appellants assert is improper for an obviousness
rejection. Id. at 6-7; Reply Br. 2.
We agree with the Examiner that the lens solutions suggested by the
prior art have all of the structural components required by claim 1, and thus,
absent evidence to the contrary, are reasonably deemed to necessarily have
the properties specified in claim 1 's "wherein" clause. See, e.g., Ans. 10-11.
As the Examiner explained, the claimed composition is shown in the prior
art and the burden shifted to the applicant to prove that the prior art products
would not necessarily or inherently possess the claimed characteristics. In
re Best, 562 F.2d 1252, 1255 (CCPA 1977); Final Act. 7-8, 12, 14--15; Ans.
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5, 6-7, 9-11. This burden-shifting framework is proper under either an
anticipation rejection or an obviousness rejection:
Where ... the claimed and prior art products are identical
or substantially identical ... the PTO can require an applicant
to prove that the prior art products do not necessarily or
inherently possess the characteristics of his claimed product.
Whether the rejection is based on "inherency" under 35 U.S.C.
§ 102, on "prima facie obviousness" under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO' s inability to manufacture
products or to obtain and compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote
omitted). Appellants, however, provided no evidence or argument as to why
Rathore's solutions as modified with Matsumura's buffer system and Lane's
FD&C Blue 1 dye would lack either compatibility with ozone or the claimed
degradation rate. Accordingly, in view of the absence of evidence to the
contrary, we agree with the Examiner that the modified Rathore solutions
would have the properties specified in claim 1 's "wherein" clause.
Appellants also assert that various differences between Rathore and
claim 1 preclude a finding of prima facie obviousness. First, Appellants
argue that the claimed solutions can be used to disinfect lenses, whereas the
solutions in Rathore are for packing, storing, or cleaning, and Rathore does
not include the word "disinfect." Appeal Br. 4--5. We are not persuaded by
this argument, because claim 1 's reference to "disinfecting" occurs in the
preamble, which as discussed above, is non-limiting. And even if we were
to consider the preamble, claim 1 recites "disinfecting" in the disjunctive
with "cleaning." Thus, as noted by the Examiner, claim 1 is directed to
"disinfecting or cleaning and not merely disinfecting contact lenses," and
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Application 14/898,426
thus overlaps with Rathore' s disclosure of a solution for cleaning lenses.
Ans. 6; Rathore ,r,r 12, 40.
Appellants argue that the second difference between Rathore and
claim 1 is that:
claim 1 requires that an aqueous lens care solution must be
compatible with ozone electrolytically generated therein,
whereas Rathore teaches that contact lenses can comprise
antimicrobial metal salts (claims 15 and 37; paragraph [0004])
and "[ c ]ontact lens solutions which are compatible with these
lenses [comprising antimicrobial metal salts] are desired"
(paragraph [004]).
Appeal Br. 5. Appellants additionally assert that the Examiner improperly
relies on hindsight because Rathore does not teach that its solutions are
compatible with ozone, but rather teaches that its solutions are compatible
with contact lenses that comprise antimicrobial metal salts. Id.; see also
Reply Br. 2. We are not persuaded by these arguments, because even if
Rathore' s solutions are compatible with lenses that can comprise
antimicrobial metal salts, as discussed above, in view of the absence of
evidence to the contrary, we also find that the solutions are compatible with
electrolytically-generated ozone. This conclusion flows not from hindsight,
but from the fact that the modified Rathore solutions have the same
structural components as the claimed compounds. As discussed above,
Appellants have not demonstrated why the modified Rathore compositions
would be incompatible with electrolytically-generated ozone.
Finally, Appellants argue that the third difference between Rathore
and claim 1 is that "claim 1 requires ozone in the aqueous lens care
solution," whereas Rathore's solutions can comprise "antibacterial agents,"
which Appellants argue are not synonymous with ozone. Appeal Br. 5. We
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Application 14/898,426
are not persuaded by this argument, because it mischaracterizes claim 1. As
the Examiner pointed out, claim 1 does not require the presence of ozone in
the claimed solution. Ans. 7-8, 9.
SUMMARY
We affirm the rejection of claims 1, 5, 6, and 15 under 35 U.S.C.
§ 103(a) as obvious over Rathore, Matsumura, and Lane.
We affirm the rejection of claims 8-11 under 35 U.S.C. § 103(a) as
obvious over Rathore, Matsumura, Lane, Boyd, and Auten.
We affirm the rejection of claims 12-14 under 35 U.S.C. § 103(a) as
obvious over Rathore, Matsumura, Lane, Boyd, Auten, and Ketelson.
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)(l)(iv).
AFFIRMED
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