Robert Beck et al.

Patent Trials and Appeals Board

Sep 27, 2021

2021001731 (P.T.A.B. Sep. 27, 2021)

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.
13/291,687 11/08/2011 Robert A. Beck CHROMA 3.0-003 1003
530 7590 09/27/2021
LERNER, DAVID, LITTENBERG,
KRUMHOLZ & MENTLIK
20 COMMERCE DRIVE
CRANFORD, NJ 07016
EXAMINER
BERRY, LAYLA D
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
09/27/2021 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):
eOfficeAction@lernerdavid.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT A. BECK and ROBERT A. MATEER, JR.
____________

Appeal 2021-001731
Application 13/291,6871
Technology Center 1600
____________

Before DONALD E. ADAMS, CHRISTOPHER G. PAULRAJ, and
DAVID COTTA Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 relating to a collyrium
composition. Spec., Abstract. The Examiner rejected the claims on appeal
under 35 U.S.C. § 103 as obvious. A hearing was held on August 10, 2021,
the transcript from which has been entered into the record (“Tr.”). We
affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. According to Appellant, the real party in interest is
Chromaceutical Advanced Technologies, Inc. Appeal Br. 1.
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STATEMENT OF THE CASE
The Specification states that “the invention relate[s] to an eyewash or
eye drops, both referred to herein as a collyrium, for deactivating irritant and
pollutant gases that readily adsorb to exposed ocular tissues, periocular
fluids, or contact lenses.” (Spec. ¶ 2). The “collyria compositions
compris[e] hydroxocobalamin (HO-Cbl) and its pharmaceutically and
physiologically acceptable derivatives.” (Id. ¶ 39).
“Hydroxocobalamin . . . originates from vitamin B12 or
cyanocobalamin (CN-Cbl) upon the loss of its cyanide moiety by photolysis
or suitable reducing conditions.” (Spec. ¶ 39). “The hydroxyl group of
hydroxocobalamin . . . may . . . become tautomeric upon the attachment of a
water molecule to the sixth coordinate bond of the cobaltic ion to give
aquocobalamin, which . . . is also sometimes referred to as
hydroxo(aquo)cobalamin.” (Id.)
Claims 1–7 and 21 are on appeal. Claim 1 is representative and reads
as follows.
1. A collyrium composition comprising hydroxocobalamin,
hydroxo(aquo)cobalamin or both hydroxocobalamin and
hydroxo(aquo)cobalamin, said composition
(A) exhibiting a pH from 4.5-6.0; and
(B) exhibiting deactivating or substantially deactivating
characteristics as a collyrium for irritant and pollutant gases that
adsorb to exposed ocular tissues, periocular fluids, or contact
lenses;
(C) comprising a viscosity modifying component selected
from natural hydrogels, synthetic polymers, dextrans, hyaluronic
acid, and modified cellulose; and
(D) exhibiting a viscosity greater than water.
Appeal Br. 22.

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The Examiner rejected claims 1–7 and 21 under 35 U.S.C. § 103(a) as
obvious over the combination of Merkus2 and Remington.3
ANALYSIS
Appellant argues claims 1–7 and 21 together. Appeal Br. 3–20. We
designate claim 1 as representative.
The Examiner found that Merkus discloses a composition for nasal
administration comprising “0.5% hydroxocobalamin in an isotonic aqueous
solution (column 2, Table 1) and 1–2% methylcellulose or
hydroxypropylmethylcellulose to give a viscosity of about 4000 mPas
(column 3, lines 14–20).” Final Act. 3.4 In addition, the Examiner found
that Merkus disclosed “including agents to adjust the pH, agents to adjust the
osmolarity, surfactant, stabilizing agents, or solubilizers.” Id. The Examiner
acknowledged, however, that Merkus did not disclose the pH of its
composition. Id.
To address the requirement of claim 1 that the composition have a pH
from 4.5–6.0, the Examiner relied on Remington. The Examiner found that
Remington disclosed that “nasal solutions are prepared so that they are
similar in many respects to nasal secretions, so that normal ciliary action is
maintained” and thus that “aqueous nasal solutions usually are isotonic and
slightly buffered to maintain a pH of 5.5 to 6.5.” Final Act. 3.
Based on the combination of Merkus and Remington, the Examiner
concluded that “[i]t would have been obvious to one of ordinary skill in the
art at the time the invention was made to adjust Merkus’s composition to pH

2 Merkus, US Patent No. 5,801,161, issued Sept. 1, 1998 (“Merkus”).
3 Remington: The Science and Practice of Pharmacy, 19th ed., Alfonso R.
Gennaro, ed. (1995) (“Remington”).
4 Office Action mailed October 8, 2019 (“Final Act.”).
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5.5 to 6.5.” Final Act. 3. The Examiner explained that the ordinary artisan
“would adjust the pH because addition of a pH adjusting agent is suggested
by Merkus, and pH 5.5 to 6.5 is the appropriate pH for nasal solutions.”
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art and agree that the claims would have been
obvious over Merkus and Remington. We address Appellant’s arguments
below.
Appellant argues that “the recitations to ‘a collyrium composition’ in
independent claims 1 and 21 and to ‘deactivating’ or functional
characteristics with respect to irritant and pollutant gases that adsorb to
exposed ocular tissues, periocular fluids, or contact lenses, distinguish the
claimed compositions from the combined references Merkus and
Remington.” Appeal Br. 4. Appellant relies on Union Oil Co. of Cal. v.
Atlantic Richfield Co., 208 F.3d 989 (Fed. Cir. 2000), where the Federal
Circuit found that claims directed to a composition suitable for combustion
in an automotive engine were distinguishable over prior art disclosing
aviation and racing fuels. Union Oil, 989 F.3d at 996. Appellant argues that
in Union Oil, “whether or not standard automotive fuel has a different
composition than aviation or racing fuel . . . [was] not relevant to the holding
. . . regarding the import of the preamble.” Reply Br. 7. According to
Appellant, in Union Oil, the court “did not opine that a structural difference
based on fuel properties was required” instead holding “that the intended use
recited in the preamble was sufficiently distinguishing.” Id. We are not
persuaded.
Union Oil does not hold, as Appellant suggests, that the mere
recitation of an intended use in a composition claim is sufficient to
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distinguish the claimed composition over an otherwise identical composition
suggested by the prior art. To the contrary, the Federal Circuit expressly
stated that composition claims are not properly limited to an intended use.
[T]he ’393 patent claims compositions of matter. The scope of
these composition claims cannot, as the appellant refiners
argue, embrace only certain uses of that composition. See In re
Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657
(Fed.Cir.1990). Otherwise these composition claims would
mutate into method claims. The district court correctly applied
this principle, refusing to narrow the scope of the claimed
compositions to specific uses.
Union Oil, 208 F.3d at 995.
Consistent with Union Oil, we decline Appellant’s invitation to
impose a specific use limitation on the composition claims at issue here.
Contrary to Appellant’s arguments, claim 1 is obvious if the prior art
suggests a composition that has the recited ingredients and properties
regardless of whether it is used for a different purpose. See In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990) (“The discovery of a new property or use of a
previously known composition, even when that property and use are
unobvious from the prior art, can not impart patentability to claims to the
known composition”); In re Pearson, 494 F.2d 1399, 1403 (CCPA 1974)
(“[T]erms [that] merely set forth the intended use for, or a property inherent
in, an otherwise old composition . . . do not differentiate the claimed
composition from those known to the prior art.”).
Claim 1 is an open-ended claim reciting a “collyrium composition.”
As the Examiner explained, Merkus discloses a composition including all of
the components of the claimed composition. Final Act. 2–3. As to the
claimed property that the composition have a pH of 4.5–6, the Examiner
finds, and we agree, that it would have been obvious to formulate the
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composition of Merkus to have a pH falling within that range because
Remington teaches that nasal solutions are usually buffered to “maintain a
pH of 5.5. to 6.5.” Remington 1502; Final Act. 3. As to the claimed
property that the composition has a viscosity greater than water, the
Examiner finds, and we agree, that Merkus teaches this by disclosing that its
composition has a viscosity of 4000 mPas. Merkus 3:14–20; Final Act. 3.
As to the claimed property that the composition “exhibit[] deactivating or
substantially deactivating characteristics as a collyrium for irritant [and
pollutant] gases,” the Examiner finds, and we agree, that because the prior
art suggests a composition “containing the same components in the same
concentration, and within the pH range recited in the instant claims, . . . the
composition would be suitable for the purposes recited in the claims.” Final
Act. 4. We find this to be true even though Merkus only discloses its
composition for use as a nasal solution rather than a collyrium.
Appellant does not identify any structural feature that distinguished
the claimed composition from the composition suggested by the combination
of Merkus and Remington. Indeed, Appellant concedes that a composition
having the structural features recited in the claims would function as a
collyrium composition at the lower end of the pH range suggested by
Remington. Tr. 7–8. Accordingly, we are not persuaded that the collyrium-
related properties recited in claim 1 distinguish claim 1 over the combination
of Merkus and Remington.
Appellant argues that “[a]lthough the Examiner refers to a specific
nasal composition in Table 1 of Merkus, it is inaccurate to suggest that
Merkus discloses a composition comprising a pH adjusting additive.”
Appeal Br. 5. This is not persuasive because Appellant acknowledges that
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Merkus discloses that its compositions “may also contain a number of
excipients or additives, known from the pharmaceutical literature to be
added to nasal formulations, such as . . . agents to adjust the pH.” Id.
(quoting Merkus 4:40–44).
Appellant argues that although the object of Merkus is to “facilitate
enhanced vitamin B12 (hydroxocobalamin) absorption,” Merkus does not
“suggest modification of the pH of its composition in order to do so.”
Appeal Br. 5. According to Appellant, “there is no proper basis in the Final
Rejection to refer to the Remington[] secondary reference for pH adjustment
because Merkus doesn’t reasonably teach that there is any need for pH
adjustment of its nasal composition.” Id. at 7 (emphasis omitted). In
addition, Appellant argues that a “2 in 100 solution” of hydroxocobalamin
would have a pH “between 8 and 10” and points to a disclosure that, for
solutions of hydroxocobalamin, “[i]t is preferable to make aqueous solutions
in acetate buffer at a pH between 3.5 and 4.5.” Id. at 6 (citing Remington:
The Science and Practice of Pharmacy, 20th ed., Alfonso R. Gennaro, ed.
(2000) (“Remington 20th Ed.”)). According to Appellant, because
Remington 20th Ed.’s preferred pH range for hydroxocobalamin solutions is
“between 3.5 and 4.5” it does not overlap with the claimed range. Id. We
are not persuaded.
Merkus discloses a nasal composition but does not identify a pH for
that composition. Remington discloses that nasal solutions are “prepared so
that they are similar in many respects to nasal secretions” and thus, “the
aqueous nasal solutions usually are isotonic and slightly buffered to maintain
a pH of 5.5 to 6.5.” Remington 1502. Accordingly, we agree with the
Examiner that “[i]t would have been obvious to one of ordinary skill in the
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art at the time the invention was made to adjust Merkus’s composition to pH
5.5 to 6.5.” Final Act. 3.
We are not persuaded by Appellant’s arguments that Remington 20th
Ed. suggests a different pH because the disclosures that Appellant relies
upon are not directed to nasal solutions and because they do not teach away
from the 4.5–6.0 pH range recited in claim 1. See DyStar Textilfarben
GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364
(Fed. Cir. 2006) (“[M]ere failure to discuss immediate use of his leuco
indigo solution for dyeing is not the same thing as Brochet stating in his
article that . . . his leuco indigo solution may only be concentrated in paste
form. We will not read into a reference a teaching away from a process
where no such language exists.”) (emphasis omitted); In re Susi, 440 F.2d
442, 446 n.3 (CCPA 1971) (“We cannot accept the suggestion that one is
significantly ‘taught away’ from a ‘particularly preferred embodiment’ by
the suggestion (whether true or false) that something else may be even
better.”).
Appellant argues that “if the Merkus composition relating to nasal use
is selected as the starting point for modification of a composition relating to
ocular use, . . . it should at least be modified according to pH conditions for
ocular use.” Appeal Br. 9 (emphasis omitted). This argument is not
persuasive because the Examiner found that using Merkus’s solution at a pH
of 5.5 to 6.5 would have been obvious for use as a nasal composition, not for
ocular use. As discussed above, we do not consider the composition covered
by claim 1 to be limited to any particular use.
Appellant argues that “Merkus itself is not a proper reference because
a person skilled in the art of collyria would not consider a reference that
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addresses nasal compositions for delivery of hydroxocobalamin to the
bloodstream when faced with a problem relating to toxic substances
associated with eye tissues or contact lenses.” Appeal Br. 11–12. Appellant
further argues that “the Examiner’s analysis disregards the problem to be
solved by the Appellant,” which was “not to provide a composition capable
of efficiently delivering vitamin B-12 in order to treat vitamin B-12
deficiency as in Merkus . . . , but of developing a solution capable of
deactivating toxic substances attacking ocular tissues.” Id. at 18.
Appellant’s argument that Merkus is not analogous art because it is
directed to a different goal than that of the inventor’s is not persuasive. “As
long as some [reason,] motivation or suggestion to combine the references is
provided by the prior art taken as a whole, the law does not require that the
reference be combined for the reasons contemplated by the inventor.” In re
Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992). Moreover, for the reasons
discussed above, we decline to limit the claimed composition to its intended
use. Here, claim 1 is drawn to a composition comprising hydroxocobalamin.
Accordingly, we agree with the Examiner that Merkus, which relates to
pharmaceutical formulations comprising hydroxocobalamin, is in the same
field of endeavor even though the compositions have different intended uses.
Final Act. 7.
Accordingly, we affirm the Examiner’s rejection of claim 1 as
obvious over the combination of Merkus and Remington. Because they
were not argued separately, claims 2–7 and 21 fall with claim 1.

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CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–7, 21 103(a) Merkus, Remington

1–7, 21

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