LONZA LLC

Patent Trials and Appeals Board

Jun 16, 2021

2020004743 (P.T.A.B. Jun. 16, 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.
15/008,937 01/28/2016 Angela Marie Sangirardi LZA-66 (LP2400US00) 6558
22827 7590 06/16/2021
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
ZHANG, YANZHI
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/16/2021 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):
USDOCKETING@DORITY-MANNING.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANGELA MARIE SANGIRARDI and
SUSAN AHRENDT MILLS1
Appeal 2020-004743
Application 15/008,937
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
preservative product, which have been rejected as indefinite and obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.

1 Appellant identifies the real party in interest as Lonza LLC. Appeal Br. 1.
We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42.
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Application 15/008,937

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STATEMENT OF THE CASE
Claims 1, 2, 4–9, 13, 14, 16–21, 25, and 26 are on appeal. Claim 1,
reproduced below, is illustrative:
1. A fluid preservative composition comprising:
(i) about 3 to about 15% by weight of an organic acid, the organic acid
comprising sorbic acid, benzoic acid, dehydroacetic acid, formic acid, acetic
acid, propionic acid, undecanoic acid, salicylic acid, or glycolic acid;
(ii) about 3 to about 15% by weight of a C8-C18 fatty alcohol, the fatty
alcohol comprising capryl alcohol, nanoyl alcohol, decyl alcohol, undecyl
alcohol, lauryl alcohol, tridecyl alcohol, myristyl alcohol, pentadecyl
alcohol, palmityl alcohol, margaryl alcohol, stearyl alcohol, or mixtures
thereof;
(iii) about 30 to about 60% by weight of an aromatic alcohol, the aromatic
alcohol comprising benzyl alcohol, phenoxyethanol, or phenethyl alcohol;
(iv) about 30 to about 60% by weight of an organic solvent, wherein the
organic solvent is a diol compound comprising propanediol, butanediol,
pentanediol, hexanediol, heptanediol, or mixtures thereof; and
(v) about 1% to about 20% by weight of a solubilizer comprising at least
one triglyceride;
wherein the percentages of (i)-(v) are based on the total amount of (i)-(v).

The claims stand rejected as follows:
Claim 25 under 35 U.S.C. § 112(b) as being indefinite (Ans. 4) and
Claims 1, 2, 4–9, 13, 14, 16–21, 25, and 26 under 35 U.S.C. § 103 as
obvious in view of Ranft,2 Gradtke,3 and Cremer4 (Ans. 5).

2 WO 2014/207179 A1, published Dec. 31, 2014.
3 WO 2014/009157 A1, published Jan. 16, 2014.
4 Cremer Oleo GmbH & Co. KG; MIGLYOL® 810, 812 (2013).
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OPINION
35 U.S.C. § 112(b)
Claim 25 stands rejected as being indefinite. The claim recites,
among other limitations, a “solubilizer comprising a glycerin compound.”
The Examiner finds that Appellant has not defined the term “glycerin
compound,” and the “plain meaning of ‘a glycerin compound’ can be
interpreted as a compound is glycerin or a compound containing a structural
feature of glycerin” (Ans. 4).
Appellant argues that the disclosure clearly states that glycerin
compounds are solubilizers and also provides exemplary compounds
(Appeal Br. 9–10).
Appellant has the stronger position, because it is clear from the
Specification that the term “glycerin compounds” is not limited to glycerin.
The Specification states that: “Suitable solubilizers include[] components
such as mineral oil, and glycerin compounds. . . . Glycerin compounds, such
as a caprylic/capric triglyceride, which is believed to be a mixed triester of
glycerin and caprylic and capric acids, is of particular interest” (Spec. ¶ 36,
emphasis added).
Thus, the Specification makes clear that the term “glycerin
compounds” is not limited to glycerin. Therefore, interpreting the phrase to
be limited to glycerin would not be reasonable in light of the Specification,
which makes clear that the term encompasses triglycerides, and therefore
encompasses compounds containing a structural feature of glycerin. We
reverse the rejection under 35 U.S.C. § 112(b).
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35 U.S.C. § 103
Claims 1, 2, 4–9, 13, 14, 16–21, 25, and 26 stand rejected as being
obvious in view of Ranft, Gradtke, and Cremer. The Examiner finds that
Ranft teaches a preservative for use in cosmetics and personal care products
comprising 1 to 20% of sorbic acid or a salt thereof (part (i) of claim 1), 10
to 89% of benzyl alcohol (part (iii) of claim 1), and 10 to 89% of a solvent
comprising a mixture of propanediols and butanediols (part (iv) of claim 1)
(Ans. 6–7).
The Examiner finds that Ranft does not teach a C8-C18 fatty alcohol,
but Gradtke teaches an antimicrobial composition (i.e., preservative)
comprising a C3–C5 alkane diol (including propanediols and butanediols), an
aromatic alcohol (including phenoxyethanol or benzyl alcohol), and a C8–
C14 alkanol (including decanol or undecanol (part (ii) of claim 1) (Ans. 7–8).
The Examiner finds that Gradtke suggests 10–90% by weight of alkane diol,
5–60% by weight of aromatic alcohol, and 1–50% by weight of alkanol
(Ans. 8).
The Examiner finds that Cremer teaches a composition called
“MIGLYOL® 810, 812” comprising caprylic/capric triglycerides (CCTs)
(part (v) of claim 1) that have multiple advantages, including good skin
absorption and very good solubility characteristics (Ans. 8–9).
The Examiner reasons that Gradtke teaches an advantage of adding
C8–C14 alkanols is that they have an improved effect on stability at low
temperatures relative to octanediol or decanediol (Ans. 9). The Examiner
also points out that Cremer teaches that its CCTs are versatile components
for personal care products and have several advantages (Ans. 8–9). The
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Examiner concludes that it would have been obvious to include the
components taught by Gradtke and Cremer in Ranft’s composition because
they are taught to have specific advantages that would motivate the ordinary
artisan to include them in the preservative formulation taught by Ranft
(Ans. 9).
With regard to the claimed concentrations of the components, the
Examiner reasons that it would have been obvious to determine the
concentration of each of the five components that was optimal for the
preservative composition and that there is no evidence of record showing the
claimed concentrations are critical (Ans. 10).
We conclude that the Examiner has set forth a proper prima facie case
for obviousness, and we adopt the findings and conclusions set out in the
Final Action and the Answer.
Appellant argues that the Examiner did not provide any rationale or
articulated reasoning for modifying the concentration of the solubilizer
(Appeal Br. 11). This is not persuasive because the Examiner reasoned that
a skilled artisan would have modified concentrations as part of a routine
optimization, citing to In re Aller, 220 F.2d 454, 456 (CCPA 1955) (Ans.
10). This is an articulated reasoning and rationale. Appellant has not
persuasively explained why the Examiner’s reliance on Aller is misplaced.
Appellant argues that all elements of the claims must be taught, that
hindsight must be avoided, and that the Office must establish that a skilled
artisan would consult the prior art references simultaneously (Appeal Br.
11–12). The Examiner addressed the assertion of hindsight by pointing out
that the rejection relies only on knowledge that was within the level of
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ordinary skill (Ans. 12). We agree that the Examiner has addressed all
limitations using references that were publicly available at the time of filing,
combined with routine optimization within the scope of the ordinary artisan,
and that the applied references are among those that the ordinary artisan who
was formulating cosmetics or personal care products would have consulted.
Appellant argues that claim 1 recites an amount of triglyceride based
upon only the components contained in the preservative whereas the
Examiner cites to a portion of Cremer that teaches a cream and a lotion
(Appeal Br. 13). Appellant also notes that the additional ingredients in
Cremer are not components of the claimed formulation (id.).
We are not persuaded that this argument shows error in the rejection.
The Examiner has pointed out that both Ranft and Gradtke teach
compositions in the form of a concentrate as well as an end-user form, and
reasons that it is within the knowledge of the ordinary artisan to adjust the
percentage depending on whether the formulation is a concentrate or an end-
user product (Ans. 12–13). “[W]here there is a range disclosed in the prior
art, and the claimed invention falls within that range, there is a presumption
of obviousness. But the presumption will be rebutted if it can be shown: (1)
That the prior art taught away from the claimed invention, In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and unexpected
results relative to the prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990).” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322
(Fed. Cir. 2004).
In the instant claims, the recited ranges for claim 1’s components (i),
(ii), (iii), and (iv) fall completely within the ranges taught by Ranft and
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Gradtke, and the Examiner has pointed out that Cremer teaches different
amounts (6% or 35%) MIGLYOL in lotion or cream compositions. (Ans.
9.) Appellant has not shown that the prior art taught away from the claimed
amounts of the components of claim 1, or that the claimed amounts provide
new and unexpected results relative to the prior art.
Appellant argues that the Examiner mistakenly relied upon the listed
numbers of Cremer as percentages by weight, because the cited
compositions contain at least 146 “parts” as well as “q.s.” ingredients.
(Appeal Br. 13). Appellant thus “submits that it is clear that the ‘parts’
listed in Cremer are not weight percentages” (id. at 14.) Appellant also
asserts that Cremer teaches an amount of CCT that is suitable for an end use
composition rather than for a preservative which can change the resulting
concentration in the final product by 10–100 times (id.)
We are not persuaded. Cremer’s compositions each contains several
phases, with specific amounts of ingredients listed, including “35.00”
MIGLYOL® 810 or “6.00” MIGLYOL® 812 (Cremer 5–6). Both of
Cremer’s compositions also include “Aqua ad 100,00” (Cremer 5, 6). In the
pharmaceutical arts, “ad 100” means “up to 100.”5 And “q.s.” simply means
“a sufficient quantity.”6 Thus, Cremer would be understood by those skilled
in the art to mean that the compositions comprise the recited parts of specific
components, including MIGLYOL, and enough water to make 100 parts
overall, with the “q.s.” ingredients added in sufficient quantity to produce

5 See, e.g., the definition at pharmlabs.unc.edu/labs/prescriptions/latin.htm
(last accessed June 10, 2021).
6 See id.
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the desired effect. In any event, as the Examiner has reasoned that “it is
within the knowledge of ordinary skill[] in the art to adjust the percentage
depending on whether the formulation is a concentrate or end-user product”
(Ans. 13). We agree with the Examiner’s reasoning.
Appellant argues that Ranft teaches that glycerin is used in the base of
the personal care composition rather than in the preservative portion, and
that Cremer also uses capric/caprylic triglycerides in the final formulation
and not in a preservative (Appeal Br. 15–16). This is not persuasive,
however, because claim 1 requires a triglyceride, not glycerin, and Cremer
specifically teaches that the its caprylic/capric triglycerides (CCTs) have
very good solubility characteristics; therefore, CCTs would have been an
obvious choice for a solubilizer of a preservative that is intended to be used
in a personal care product. In this regard, Ranft states that its preservative
compositions “may contain auxiliaries such as solvents, anti-oxidants,
stabilizers, colorants, fragrances and perfumes, or other additives known in
the art.” Ranft 3:14–15. “In determining whether obviousness is established
by combining the teachings of the prior art, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
Appellant argues that the Examiner has failed to set forth parameters
for the solubilizer to be recognized as a result effective variable, and
therefore, has failed to provide a range and a rationale for optimizing the
amount (Appeal Br. 16). We are not persuaded. Claim 1 requires about 1%
to about 20% of a solubilizer containing a triglyceride. Cremer teaches
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multiple phases to be mixed together to arrive at the final product, and the
Examiner has pointed out that both Ranft and Gradtke teach compositions in
the form of a concentrate as well as end-user form, and reasons that it is
within the knowledge of the ordinary artisan to adjust the percentage
depending on whether the formulation is a concentrate or an end-user
product (Ans. 12–13). A skilled artisan would readily recognize that Ranft’s
concentrates (Ranft 9, Table 4) contain much higher concentrations of
ingredients than its end-user products (id. at 8, Table 3). Thus, a skilled
artisan would recognize that the ingredient concentrations are “result
effective,” and determining what percentage is effective for solubilizing
would have been within the scope of the skill of an ordinary artisan.
Appellant separately argues claim 18, which recites:
18. A personal care product comprising
(i) a base formulation and
(ii) an effective amount of a preservative composition to aid
in preventing a bacterial and/or fungal infection or
contamination of the base formulation, the preservative
composition comprising:
a. about 4 to about 9% by weight of the organic acid;
b. about 4 to about 9% by weight of the C8–C18 fatty
alcohol;
c. about 37.5 to about 42.5% by weight of the aromatic
alcohol; and
d. about 40 to about 45% by weight of the organic
solvent; and
e. about 1% to about 20% by weight of at least one
triglyceride
wherein the percentages of (a)-(e) are based on the
total amount of (a)-(e).
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Appellant argues that claim 18 recites a base formulation and a
preservative, where the triglyceride is contained in the preservative (Appeal
Br. 17). Appellant argues that “Ranft and Cremer both teach that a
glycerin/triglyceride is part of the base formulation,” and the Examiner “has
failed to provide any rationale or articulated reasoning as to why one having
skill in the art would remove the glycerin from the test base of Ranft and/or
Gradtke, and instead include the glycerin in the preservative” (Appeal Br.
17).
This is not persuasive. Claim 18 requires a triglyceride, not glycerin,
and for the reasons discussed above, Gradtke and Cremer provide reasons to
include their components in Ranft’s composition. Ranft teaches that its
composition is a preservative (Ranft 1:3) “which can be easily admixed to
cosmetic and personal care formulations” (id. at 1:26–27). Thus, the cited
references would have reasonably suggested a composition comprising the
preservative composition defined in part (ii) of claim 18, combined with a
cosmetic or personal care base formulation (part (i) of claim 18).
With regard to claim 25, Appellant has argued that Ranft specifically
suggests that a propanediol is important for its composition and discloses
that there is a substantial synergistic effect from its disclosed combination as
compared to the components taken alone (Appeal Br. 18).
The Examiner responds by pointing out that other diols are taught by
Gradtke and Ranft (Ans. 11) and that the teachings should be considered as a
whole (id. at 13). We do not agree with the Examiner’s reasoning. Ranft
teaches a synergistic effect from the combination of a propanediol, a
butanediol, and other components. See, e.g., Ranft 1:30–37. Given that the
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rejection is based upon starting with the preservative compositions taught by
Ranft and modifying them based on the teachings of Gradtke and Cremer, a
fair reading of these references would not have led one of ordinary skill in
the art to leave out propanediol completely, as required by claim 25. The
Examiner has not persuasively shown that a skilled artisan would have been
motivated to make that particular change to the compositions taught by
Ranft.
We affirm the rejection under 35 U.S.C. § 103 with regard to claims
1, 2, 4–9, 13, 14, 16–21, and 26. However, we reverse the rejection with
regard to claim 25.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
25 112(b) 25
1, 2, 4–9, 13,
14, 16–21,
25, 26
103 Ranft, Gradtke,
Cremer
1, 2, 4–9,
13, 14, 16–
21, 26
25
Overall
Outcome
1, 2, 4–9,
13, 14, 16–
21, 26
25
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-IN-PART