Johnson & Johnson Consumer Inc.

Patent Trials and Appeals Board

Nov 18, 2021

2021001229 (P.T.A.B. Nov. 18, 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.
16/202,198 11/28/2018 Michael James Fevola JCO5239USDIV1 5230
27777 7590 11/18/2021
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
PROSSER, ALISSA J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
11/18/2021 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):
jnjuspatent@its.jnj.com
lhowd@its.jnj.com
pair_jnj@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL JAMES FEVOLA, SIMARNA KAUR,
MICHAEL D. SOUTHALL, and ALI FASSIH
____________

Appeal 2021-001229
Application 16/202,198
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–4 and 6–11 (Appeal Br. 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. Appellant identifies the real party in interest as “Johnson &
Johnson Consumer Inc.” (Appellant’s August 17, 2020, Appeal Brief
(Appeal Br.) 2).
Appeal 2021-001229
Application 16/202,198

2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to methods of treating skin in need of
treatment with retinoids, which comprise cleansing the skin with a cleansing
composition comprising a low irritation polymeric cleansing agent prior to
treating with the retinoids” (Spec.2 1). Appellant’s claim 1 is reproduced
below:
1. A method for treating skin, comprising in sequence:
(a) cleansing skin in need of treatment for signs of skin
aging, acne, or rosacea with a cleansing composition
comprising a low molecular weight hydrophobically modified
polymer; and
(b) topically applying to the skin a leave-on composition
comprising a retinoid selected from the group consisting of
retinol, retinal, retinoic acid, retinyl acetate, and retinyl
palmitate.
(Appeal Br. 7.)

Claims 1–4 and 6–11 stand rejected under 35 U.S.C. § 103 as
unpatentable over the combination of Librizzi,3 Gunn,4 Bikowski,5
Wikipedia,6 and Oddos.7

2 Appellant’s November 28, 2018, Specification.
3 Librizzi et al., US 8,025,902 B2, issued Sept. 27, 2011.
4 Gunn et al., US 8,329,627 B2, issued Dec. 11, 2012.
5 Joseph Bikowski, MD, The Use of Cleansers as Therapeutic Concomitants
in Various Dermatologic Disorders, 68 CUTIS 12–19 (2001).
6 Wikipedia, Tretinoin, https://en.wikipedia.org/wiki/Tretinoin, last accessed
Jan. 10, 2018.
7 Oddos et al., US 2011/0251273 A1, published Oct. 13, 2011.
Appeal 2021-001229
Application 16/202,198

3
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
As Appellant explains:
Examiner argues Librizzi teaches low-irritation compositions
comprising a low molecular weight, non-crosslinked linear
acrylic copolymer and at least one surfactant suitable for use as
mild cleansers. The copolymer may be a low molecular weight
hydrophobically modified polymer (“HMP”) as used in the
present invention, and the Examiner cites Librizzi, Column 16
for a teaching that such compositions may be used for anti-
aging and anti-acne applications and may be used in cleansing
methods with a variety of additional, optional steps including
lathering, rinsing and the like.
The Examiner acknowledges Librizzi does not teach
topically applying a retinoid, or a retinoid selected from retinol,
retinal, retinoic acid, retinyl acetate, and retinyl palmitate, or
use of compositions containing the foregoing, or treating signs
of rosacea.
Accordingly, Bikowski is cited for a teaching that a mild
cleansing agent is useful in the adjunctive management of
various skin conditions such, as acne, rosacea, photoaging, and
retinoid-induced irritant dermatitis. Bikowski is also cited for
disclosing the use of topical tretinoin (retinoic acid) and
adapalene for treatment of photoaging.
Oddos is cited to show compositions containing a
retinoid for skin conditions including aging, acne and rosacea.
Retinoids include retinol, retinal and retinal esters such as
retinyl palmitate.
The Examiner concludes it would have been obvious to
one of ordinary skill in the art to modify the cleansing methods
of Librizzi to further comprise the step of applying a topical
retinoid as taught by Bikowski and Oddos. The Examiner
argues one skilled in the art would have had a reasonable
Appeal 2021-001229
Application 16/202,198

4
expectation of success because Librizzi teach [sic] his methods
may further comprise additional steps and because Bikowski
teach [sic] the use of mild cleansers as part of an adjunctive
management together with dermatological treatment agents.
The Examiner argues it would have been obvious to topically
apply retinoids inclusive of retinoic acid as taught by Bikowski
or retinol as taught by Oddos to skin in need of treatment
subsequent to cleansing because each of these species of
retinoid is taught by the art as a suitable treatment for skin
conditions inclusive of aging, acne and rosacea.
(Appeal Br. 3–4; see also Final Act.8 4–6.)
Appellant does not contest Examiner’s prima facie case of
obviousness. Instead, Appellant contends that the rejection of record
“should be reversed,” because Appellant “discovered that certain cleansers
comprising an HMP increase the bioactivity of retinoids when the former is
used as the first step in a two-step regimen or kit with application of a leave-
on retinoid composition as the second step” and “use of other ‘mild’
cleansers before use of a leave-on retinoid composition does not increase the
activity of the retinoid” (Appeal Br. 4).
Appellant directs attention to the data set forth in Tables 1–3 of its
Specification (see Spec. 21–26) contending that this “data shows not all
cleansers, and not even all mild cleansers, provide the observed increase in
retinol activity. Only cleansers comprising an HMP increase the bioactivity
of retinoids” (Appeal Br. 5). We are not persuaded.
The data presented in Appellant’s Specification relates to comparisons
of “[t]he activity of a leave-on retinol product (NEUTROGENA® Rapid
Wrinkle Repair® (‘RWR’)) . . . when combined in a regimen with various

8 Examiner’s March 19, 2020, Final Office Action.
Appeal 2021-001229
Application 16/202,198

5
mild cleansers” (Spec. 21). Appellant defines the various mild cleansers as
follows:
[]NEUTROGENA® Ultra Gentle Daily Cleanser
commercially available from Johnson & Johnson Consumer
Inc. containing : Water, Glycerin, Cocamidopropyl Betaine,
Lauryl Glucoside Potassium Acrylates Copolymer, PEG-120
Methyl Dioleate, Disodium Lauroamphodiacetate, Sodium
Cocoyl Sarcosinate, Ethylhexylglycerin, Caprylyl, Potassium
Sorbate, Fragrance.
[]OLAY® Sensitive Foaming Face Wash, commercially
available from Procter & Gamble containing: Water/Eau,
Glycerin, Sodium Myristoyl Sarcosinate, PEG-120 Methyl
Glucose Dioleate, Sodium Lauroamphoacetate, Aloe
Barbadensis Leaf Juice, Polyquaternium-10, PEG-150
Pentaerythrityl Tetrastearate, Glycol Distearate, Sodium
Laureth Sulfate, Cocamide MEA, Laureth-10, Disodium
Lauroamphodiacetate, Sodium Trideceth Sulfate, Citric Acid,
Disodium EDTA, Phenoxyethanol, DMDM Hydantoin.
. . . .
[]CETAPHIL Gentle Skin Cleanser, commercially
available from Galderma containing: Water, Cetyl Alcohol,
Propylene Glycol, Sodium Lauryl Sulfate, Stearyl Alcohol,
Methylparaben, Propylparaben, Butylparaben.
[]CETAPHIL Daily Foaming Cleanser, commercially
available from Galderma containing: Water (Purified), Sodium
Lauroyl Sarcosinate, Acrylates/Steareth 20 Methacrylate
Crosspolymer, Glycerin, PEG 200 Hydrogenated Glyceryl
Palmate, Sodium Laureth Sulfate, Butylene Glycol, PEG 7
Glyceryl Cocoate, Phenoxyethanol, Masking Fragrance
(Parfum), Panthenol, PEG 60 Hydrogenated Castor Oil,
Disodium EDTA, Methylparaben.
(Spec. 22–24; see also Ans. 5–6.) The ingredient lists make clear that there
are significant differences in the various cleansers tested by Appellant. In
addition, Appellant’s Specification makes no attempt to identify the
Appeal 2021-001229
Application 16/202,198

6
concentration of any ingredient in any cleanser tested. Nonetheless,
Appellant observed that
pre-treatment of tissues with a cleansing composition
comprising a [particular low irritation polymeric cleansing
agent, such as NEUTROGENA® Ultra Gentle Daily Cleanser
commercially available from Johnson & Johnson Consumer
Inc.] . . . before application of a retinol product led to an
increase in the downstream retinol bioactivity as compared to
the retinol product alone, and as compared to pretreatment with
cleansing compositions not containing LIPCAs,
such as OLAY® Sensitive Foaming Face Wash, commercially available
from Procter & Gamble (Spec. 24; see also id. at 1 (defining the acronym
“LIPCA” as “particular low irritation polymeric cleansing agents”)).
Again, it is clear from the list of ingredients Appellant disclosed that
NEUTROGENA® Ultra Gentle Daily Cleanser differs from OLAY®
Sensitive Foaming Face Wash in more than just the presence of a LIPCA
(see Spec. 22). Appellant does not, however, offer an explanation as to why
its observed result can be attributed solely to the presence of a particular
LIPCA. Similarly, Appellant does not explain why the result observed for
the particular LIPCA tested is representative of the entire class of LIPCAs
encompassed by Appellant’s claimed invention. Appellant also fails to
identify the concentration of LIPCA in the composition, or offer an
explanation as to why a composition comprising any concentration of
LIPCA, within the scope of Appellant’s claimed invention, would have been
expected to exhibit a similar result.
The same deficiencies are found in Appellant’s comparisons of
NEUTROGENA® Ultra Gentle Daily Cleanser against CETAPHIL Gentle
Skin Cleanser and CETAPHIL Daily Foaming Cleanser, which are both
commercially available from Galderma (see Spec. 23–26).
Appeal 2021-001229
Application 16/202,198

7
For the foregoing reasons, we are not persuaded by Appellant’s
contention that its “data clearly shows when an HMP is present in the
cleanser, retinoid activity is boosted. When an HMP is absent, it is not”
(Appeal Br. 6).
Thus, we find that the weight of the evidence on this record falls in
favor of Examiner’s finding that “[t]he compositions of these cleansers
substantially differ and it cannot be concluded that the comparison ‘clearly
shows when an HMP is present in the cleanser, retinoid activity is boosted’
as argued by Appellant” (Ans. 6; see also id. at 7). See In re Huai-Hung
Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (“Evidence of secondary
considerations must be reasonably commensurate with the scope of the
claims.”).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103 as unpatentable over
the combination of Librizzi, Gunn, Bikowski, Wikipedia, and Oddos is
affirmed. Claims 2–4 and 6–11 are not separately argued and fall with claim
1.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 6–11 103 Librizzi, Gunn,
Bikowski,
Wikipedia, Oddos
1–4, 6–11

Appeal 2021-001229
Application 16/202,198

8
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) (2019).

AFFIRMED