Anastasia Christopher

Patent Trials and Appeals Board

Aug 13, 2021

2020006551 (P.T.A.B. Aug. 13, 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.
15/170,337 06/01/2016 Anastasia M. Christopher 08461.001US1 5765
161097 7590 08/13/2021
FisherBroyles, LLP - Dayton, Ohio
1893 Stonewater Drive
Centerville, OH 45458
EXAMINER
MOSS, NATALIE M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
08/13/2021 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):
docketing@fisherbroyles.com
susan.oiler@fisherbroyles.com
tj.dovale@fisherbroyles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte ANASTASIA M. CHRISTOPHER
________________

Appeal 2020-006551
Application 15,170,337
Technology Center 1600
________________

Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

MAJORS, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to a composition for topical administration in a urogenital area and/or
the vagina. The claims have been rejected for obviousness under 35 U.S.C.
§ 103. We have jurisdiction under 35 U.S.C. § 6.
We AFFIRM but designate our affirmance as a NEW GROUND OF
REJECTION.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42(a). Appellant identifies Durga Enterprises, LLC as the real
party-in-interest. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification explains that “[a]trophic vaginitis, peri- and post-
menopausal dyspareunia, and/or oopherectomized females prior to
menopause can occur in women with the progression of aging or sometimes
as a result of medical treatments.” Id. ¶ 3. “Treatments using estrogen may
be suitable for some women, but are not suitable for women who are at risk
of breast, uterine,” and some other cancers. Id. ¶ 4.
The invention relates to “compositions for topical administration in a
urogenital area and/or the vagina,” and “in particular compositions that are
free of estrogen.” Spec. ¶ 5. “The compositions have a therapeutically
effective amount of a selective estrogen receptor modulator (SERM), an
intracellular carrier for carrying the SERM into a cell, and a therapeutically
effective amount of a cellular anti-inflammatory agent.” Id. (“The SERM is
one or more of droloxifene, idoxifene, raloxifene, tamoxifen, toremifene,
and TAT-59”); id. ¶ 6 (“The intracellular carrier is a natural oil,” such as
avocado or olive oils.); id. ¶ 7 (“The cellular anti-inflammatory agent is
preferably a medicinal grade honey, for example Manuka honey.”).
According to the Specification, “[t]he [disclosed] compositions for
administration in the vagina . . . are effective at soothing and reducing
symptoms of atrophic vaginitis.” Id. ¶ 31. “[T]he composition reverses
much of the urogenital atrophy of the urogenital cells so that dryness and
inflammation are reduced and homeostasis and integrity return to the
urogenital tissue.” Id. ¶ 33. “The composition also relieves vaginal pain
associated with atrophic vaginitis, as well as decreases itching, vaginal
dryness, vaginal bleeding and mild spotting, and the occurrence of
urogenital infections.” Id.
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Claims 1, 4–6, 11, 24, 26–28, 30–36 are on appeal. Claim 1 is
illustrative and is reproduced below:
1. A composition for topical administration in a urogenital
area and/or a vagina comprising:
an emulsion of Phase A and Phase B:
Phase B
a therapeutically effective amount of raloxifene in a
solvent selected from the group consisting of glycerin, propylene
glycol, butylene glycol, hexylene glycol, polyethylene glycol,
and combinations thereof;
Phase A
about 23% by volume to about 54% by volume of a natural
oil acting as an intracellular carrier for carrying the raloxifene
into a cell; and
about 30% by volume to about 62% by volume of a
medicinal grade Manuka honey acting as a cellular anti-
inflammatory agent; and
about 4% to about 15% by volume of one or more
tocopherol and tocotrienols that have Vitamin E activity;
wherein the % by volume is based on all liquid ingredients
except the SERM;
wherein the composition is free of estrogen.
Appeal Br. 21.
Appellant seeks review of the Examiner’s rejection of claims 1, 4–6,
11, and 32–35 under 35 U.S.C. § 103 as obvious over the combination of
Cullinan,2 Lopez,3 Mandal,4 Thompson,5 and Tocopherols,6 as further

2 Cullinan, US 5,461,064, issued Oct. 24, 1995.
3 Lani Lopez Natural Health an A–Z New Zealand Guide, 2005 (book
excerpts pages 1–4 from lani.lopez.com) (hereafter “Lopez”).
4 Manisha Deb Mandal, et al., Honey: its medicinal property and
antibacterial activity, Asian Pac. J. Trop. Biomed., 154–160 (2011)
5 Thompson et al., US 2001/0041718 A1, published Nov. 15, 2001.
6 Tocopherols, Technical Evaluation Report, 1–24 (Feb. 6, 2015).
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evidenced by definitions in several dictionaries. Final Act. 3–17.7 The
Examiner’s rejection of claims 30 and 31 as obvious over the combination
above, and the rejection of claims 24, 26–28, and 36 as obvious over the
combination above (without Tocopherols) are also on appeal. Id. at 17–23.
I. Claims 1, 4–6, and 32–35: Obviousness over Cullinan, Lopez,
Mandal, Thompson, and Tocopherols
The Examiner concludes that claims 1, 4–6, 11, and 32–35 would
have been obvious over Cullinan, Lopez, Mandal, Thompson and
Tocopherols. Final Act. 3–17. Except as noted below, Appellant’s
argument for this rejection is addressed to the claims as a group. We focus
on claim 1 as illustrative, and claims 5, 6, 11, and 32–35 will stand or fall
with claim 1. See 37 C.F.R. § 41.37(c)(iv). Appellant makes an additional
argument for dependent claim 4, which we address near the end of Section I.
Claim 1
We first summarize the Examiner’s findings and reasoning in support
of the conclusion that claim 1 would have been obvious. We then turn to
our analysis and address Appellant’s arguments. We note at the outset that,
although we agree generally with the Examiner’s findings and reasoning,
because our analysis expands upon the Examiner’s determinations, we have
designated our affirmance as a new ground of rejection under 37 C.F.R.
§ 41.50(b) so that the applicant will have a fair opportunity to respond
during further prosecution, if desired.

7 This citation refers to the Final Rejection dated February 13, 2020 (“Final
Act.”). We also refer herein to the Examiner’s Answer on Appeal dated July
21, 2020 (“Ans.” or “Answer”).
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The Examiner finds that Cullinan teaches compositions for inhibiting
atrophy of the skin or vagina in post-menopausal women. Final Act. 3.
(citing Cullinan, 1:15–22, Abstr.); see also Cullinan, 1:24–29 (teaching that
vaginal atrophy is associated with itching, dryness, and painful intercourse).
The Examiner finds that Cullinan identifies raloxifene as the preferred active
compound, and describes it as being safe and effective for treating vaginal
atrophy—with the active generally present from 0.5% to 95% (and typically
1–25%) by weight in topical formulations. Final Act. 3–4; Cullinan, 3:18–
25 (“Raloxifene and selected analogs are safe and effective agents which
have a positive effect on the underlying, physiological mechanisms seen in
skin and vaginal atrophy. The result . . . is the improvement of the
qualitative properties of the skin and vagina.”), 5:1–8 (describing topical
administration, and conventional forms like lotions).
Continuing, the Examiner finds that Cullinan teaches the composition
may be formed as an “emulsion” and that common excipients, solvents, and
carriers may be used. Final Act. 4 (citing Cullinan, 3:29–30, 5:11–13). As
noted by the Examiner, polyethylene glycol, and animal or vegetable oils
(i.e., natural oils) are expressly identified as suitable solvents. Id.; see
Cullinan, 5:14–24. Moreover, the Examiner finds that Cullinan teaches
tocopherol (i.e., a phenolic compound with Vitamin E activity) may be
added. Final Act. 4; Cullinan, 5:36–38 (identifying α-tocophrol and its
derivatives as example antioxidants). The Examiner finds that Cullinan’s
compositions are also free of estrogen as recited in claim 1. Final Act. 5; see
also Cullinan, 2:5–12 (teaching estrogen replacement for treating vaginal
atrophy may come with serious side-effects, like cancer development).
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The Examiner finds that Cullinan’s teachings differ from the claimed
composition in the following ways. Although Cullinan teaches that natural
oils and tocopherol may be added, Cullinan does not disclose the amounts of
those components as recited in claim 1. Final Act. 5. Furthermore, Cullinan
does not disclose a use of Manuka honey (or its amount) as in claim 1. Id.
The Examiner turns to the other asserted references. Id. at 5–6.
According to the Examiner, Lopez teaches that atrophy of the
reproductive organs of women may occur due to menopause and reduction
in estrogen production, where the vagina becomes dry and thin. Id.; Lopez,
1–2 (“The vagina may become dry, thin, and lose muscle tone & intercourse
may become painful.”). Moreover, the Examiner cites Lopez’s teaching that
“[v]aginal infections may become increasingly common as vaginal mucous
is reduced changing the normal protective pH of the vagina.” Lopez, 2;
Final Act. 5–6. The Examiner finds that “Lopez teaches vaginal irritation
and dryness can be treated with 10g of Manuka honey mixed with 100g of
aqueous cream obtained from the pharmacy and Vitamin E 400IU.” Id. at 6
(citing Lopez, 3); Lopez, 3 (teaching topical application).
Citing Mandal, the Examiner finds it teaches that medical grade
honeys, including Manuka honey (as best known among them), have potent
antibacterial effects. Final Act. 6; Mandal, 154, Abstr. (“The medical grade
honeys have potent in vitro bactericidal activity against antibiotic-resistant
bacteria causing several life-threatening infections to humans.”). According
to the Examiner, Mandal describes testing in which Manuka honey had a
minimum inhibitory concentration (“MIC”) for various bacterial pathogens
of about 25% v/v and that, in a zone-of-inhibition assay, “[t]he zone
diameter inhibition (zdi) increases at [a concentration of] 50% v/v when
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compared to honey concentrations of 25% and 12.5%.” Final Act. 6–7;
Mandal, 157, Fig. 1 (charting the diameter of the zone of inhibition (in mm)
versus honey concentration (%, v/v) of Ulmo and Manuka honeys), Fig. 2
(charting honey MIC (%, v/v) for Manuka and other honeys relative to
bacterial strains like E. coli and Streptococcus spp.); see also Final Act. 7
(citing Mandal, 158 as teaching that “the antibacterial activity of honey may
range from concentration 3% to 50% and higher” and “the higher the
concentration of honey the greater its usefulness as an antibacterial agent”).
The Examiner next turns to Thompson. Final Act. 7–8. The
Examiner finds that, like Cullinan and Lopez, Thompson relates to
compositions for treating conditions caused by the loss of estrogen. Id.
(citing Thompson ¶¶ 3, 29 (teaching reduced estrogen production results in
atrophic vaginitis), 31). The Examiner finds that Thompson lists raloxifene
as a preferred selective estrogen receptor modulator (SERM), that its
compositions may be formulated for topical application as an emulsion, and
that such compositions may include from 2–50% of a pharmaceutical
emollient. Id. at 7 (citing Thompson ¶¶ 44, 142, 189). The Examiner cites
Thompson’s teaching that natural oils, such as olive oil, avocado oil, and cod
liver oil are exemplary emollients. Id. (citing Thompson ¶ 192). Also, the
Examiner cites Thompson’s teaching that tocopherol (Vitamin E) is a
suitable antioxidant that may be added to Thompson’s compositions, in
amounts ranging from about 0.1–10% by weight.8 Id.; Thompson ¶ 221.

8 The Examiner’s reliance on the Tocopherols reference appears to be
limited to the teaching that tocopherol/vitamin E preparations commonly
include liquids diluted in oils. Final Act. 8 (citing Tocopherols, 2).
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The Examiner concludes it would have been obvious to add medicinal
grade Manuka honey in raloxifene-containing topical emulsions such as
disclosed in Cullinan, for treatment of vaginal atrophy. Final Act. 8. The
Examiner reasons that a skilled artisan would have been motivated to add
Manuka honey in view of Lopez and “to combine agents that treat the same
disorder [vaginal atrophy] to provide an enhanced effect.” Id. (noting that
both Cullinan and Lopez are directed to treat vaginal dryness and irritation
with topical emulsions). Citing Lopez’s teaching that atrophy is associated
with vaginal infections, the Examiner reasons that it would have also been
obvious to use Manuka honey and to optimize its concentration for a desired
bactericidal effect. Id. Although Lopez describes about 10% by weight of
Manuka honey in a lotion, the Examiner cites Mandel’s teaching that the
honey concentration may range from 3–50% or higher, a correlation between
higher concentrations and greater utility as an antibacterial agent, and the
Examiner reasons that the amount of honey would be optimized to inhibit
pathogenic bacteria. Final Act. 9; Ans. 29–30; see also Final Act. 16–17
(“Mandal is relevant because it teaches a concentration of said honey which
can be used to fight infections,” which Lopez suggests are “increasingly
common” and associated with atrophic vaginitis).
As for the amounts of natural oil and tocopherol in claim 1, the
Examiner concludes those amounts would have been obvious based on
Thompson’s overlapping concentration ranges, and that it would have been
obvious to modify Cullinan’s compositions to include the oil and tocopherol
components in the recited amounts with the other ingredients. Final Act. 9–
10. The Examiner reasons that a skilled artisan would have been motivated
to use such oils for their known function as emollients and tocopherol for its
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known function as an antioxidant, especially because both Cullinan and
Thompson are related to treating conditions caused by the loss of estrogen
with raloxifene-containing compositions and both references list natural oils
and tocopherol as suitable ingredients. Id.
For claim 1’s recitation of a Phase A and Phase B that comprise the
emulsion, the Examiner concludes that language imparts no patentable,
structural distinction over the composition rendered obvious by the prior art.
Final Act. 10–11. In support, the Examiner notes that claim 1 is directed to
a single composition, not a method of making it. Id. at 11. And, the
Examiner finds, the Specification simply describes the phases as ultimately
being blended together to form the final emulsion. Id. (citing Spec. ¶ 49);
see also id. at 11 (citing the MPEP for the proposition that a different order
of mixing ingredients, in any event, is generally prima facie obvious).
We agree with the Examiner that the combination of Cullinan, Lopez,
Mandal, Thompson, and Tocopherols teaches or suggests the subject matter
of claim 1. We need not decide if claim 1’s preamble is limiting because
there is no dispute a topical composition is taught in the prior art. Cullinan,
for example, teaches a “composition for topical administration in a
urogenital area and/or the vagina.” See, e.g., Cullinan, Abstr. (treating the
vagina by administering an active compound), 5:1–3 (“For topical
administration, the compounds may be formulated as is known in the art for
direct application to an area” such as in lotions or ointments). Nor is there
any dispute that Cullinan teaches that its compositions may be formulated as
emulsions like claimed. Id. at 5:9–11, 5:39–44.
Cullinan teaches that raloxifine (the claimed SERM) is preferred, safe,
and effective as an active agent, and that it may be added in amounts from
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0.5–95% by weight in a topical composition; polyethylene glycol is also
listed as a suitable solvent. Id. at 3:18–24, 5:1–24. Thus, Cullinan teaches
claim 1’s “therapeutically effective amount of raloxifene in a solvent”
limitation. There is no evidence that estrogen is included in Cullinan’s
compositions. Indeed, given the serious side effects with estrogen therapy
described by Cullinan at 2:1–16, the skilled worker would have had strong
reason to exclude estrogen—meeting claim 1’s final limitation that the
composition be “free of estrogen.”
Cullinan teaches that natural oils and tocopherol may be included, but
does not expressly teach that the amounts should be, respectively, 23–54%
oil and 4–15% tocopherol as recited in claim 1. Cullinan, 5:12–24, 5:36–38.
That difference is, however, remedied by Thompson, which suggests natural
oils (e.g., avocado oil) be added as emollients to its raloxifene-containing
topical compositions in amounts ranging from about 2–50% and that
tocopherol be included as an antioxidant in a concentration from about 0.1–
10%. Thompson ¶¶ 192, 221. There is, thus, substantial overlap in the
suitable ingredients and concentrations of such ingredients identified in the
prior art and claims. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)
(explaining that overlapping ranges in the art can be sufficient to support a
prima facie case of obviousness and “shift[] the burden to the applicant to
show that his invention would not have been obvious”). That overlap
persuades us that the oil and tocopherol limitations of claim 1 are met here.9

9 Insofar as the claims recite what certain compounds in the composition are
“acting as” (e.g., “natural oil acting as an intracellular carrier for carrying the
raloxifene . . .”), that is functional language. We are unpersuaded on this
record that such language creates any structural difference sufficient to
distinguish the claims over the composition rendered obvious by the prior
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That still leaves claim 1’s limitation of “about 30% by volume to
about 62% by volume of a medicinal grade Manuka honey.” Neither
Cullinan nor Thompson discloses adding Manuka honey. But Lopez, which
is directed to treating vaginal irritation and dryness caused by reduced
estrogen production, expressly teaches a use of a topical lotion that includes
Manuka honey and Vitamin E. Lopez, 1–3. Lopez further teaches that, with
reduced estrogen production and atrophy, vaginal infections may increase in
frequency due to reduced mucous and changes to the vagina’s normal
protective pH. Id. at 1–2.
Lopez does not explain why Manuka honey helps provide relief to
vaginal irritation and dryness, nor does Lopez provide further detail about
the potential “infections” it references. A skilled artisan would, however,
have known that there is a relationship or correlation between estrogen loss,
atrophic vaginitis, and urinary tract infections, which are predominantly
bacterial infections. This is evidenced by Thompson. Thompson ¶ 29
(“Women tend to lose pelvic muscle tone and to develop urinary
incontinence, cystitis [(i.e., a urinary tract infection that has progressed to
the bladder)], and vaginitis.”). A secondary reference of record, Raz,10
teaches that “[u]rinary tract infection (UTI) is the most common bacterial
infection . . . in postmenopausal women in particular.” Raz, Abstr.

art. In re Papesch, 315 F.2d 381, 391 (CCPA 1963) (explaining that a
compound and its functional properties are indistinguishable); Atlas Powder
Co. v. IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[D]iscovery of a
previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art’s functioning, does not render the old
composition patentably new to the discoverer.”).
10 Raul Raz, Urinary Tract Infection in Postmenopausal Women, Korean J.
Urol. 801–806 (2011).
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(emphasis added). Raz, like Lopez, explains that decreased estrogen leads to
changes of the vaginal pH and increased infections. Raz, 803. Yet Raz
provides details about this interrelationship that are not expressly discussed
in Lopez—but nevertheless, would have been known by the skilled artisan.
Raz teaches the “important factor in postmenopausal women . . . that
estrogen deficiency plays in the development of bacteriuria.” Id. (emphasis
added) (explaining that “[e]strogen stimulates the proliferation of
lactobacillus in the vaginal epithelium, reduces pH, and avoids vaginal
colonization of Enterobacteriaceae, which are the main pathogens of the
urinary tract”); see also id. (noting that vaginal atrophy and its clinical
manifestations “may sometimes imitate a UTI”), Fig. 1 (flowchart showing
that reduced vaginal pH permits increased “[c]olonization of the vaginal
with Enterobacteriaceae from the rectum”).11
With this more complete perspective in mind, we find that a skilled
artisan would, prompted by at least Lopez and the background knowledge as
explained above, have pursued further information about Manuka honey and
its medicinal and antibacterial properties. That path leads directly to
Mandal, and its teachings related to medicinal grade Manuka honey.

11 The Specification in “Background” also explains that symptoms related to
atrophic vaginitis include, not only itching and dryness, but “urogenital
infections.” Spec. ¶ 3. The testimony of the inventor that purports to show a
long-recognized but unmet need explains that lack of estrogen results in
vulvovaginal atrophy and “creates perpetual issues for women, including . . .
recurrent urinary and vaginal infections.” Christopher Decl. ¶ 6 (declaration
of Anastasia Christopher dated March 13, 2019); see also id. ¶ 29
(discussing administration to post-menopausal women suffering recurrent
cystitis and stating that, after six months the women were “free of infection
in the urinary tract”). This evidence further supports the known association
between post-menopausal estrogen loss, atrophy, and UTIs.
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Mandal teaches that “use of honey as a traditional remedy for
microbial infections dates back to ancient times” and remarks that
“[r]esearch has been conducted on Manuka (L. scoparium) honey, which has
been demonstrated to be effective against several human pathogens,
including Escherichia coli (E. coli), [and] S. aureus,” among others.
Mandal, 155.12 Mandal goes on to teach that “[f]ollowing the in vitro
methods, several bacteria (mostly multidrug resistant; MDR) causing human
infections that were found susceptible to honeys are presented in Table 1.”
Id. at 155–156. Notably, Table 1 lists E. coli and identifies its “[c]linical
importance” as being a cause of “[u]rinary tract infections.” Id. at 156
(Table 1); see also Raz (noting a compound in cranberries “that can prevent
the colonization of the E. coli uropathogen in the vaginal mucosa and reduce
the frequency of bacteriuria”). Mandal goes on to report a MIC range for
Manuka honey between 8.75–20% against wound and enteric
microorganisms.13 Mandal, 156–157 (listing E. coli, among others). And,
in a zone-of-inhibition test, Mandal shows the size of the protective zone

12 Mandal further teaches that the “healing properties of honey can be
ascribed to the fact that it offers antibacterial activity, maintains a moist
wound environment that promotes healing, and has a high viscosity which
helps provide a protective barrier to prevent infection.” Mandal, 155 (“The
honey, when applied topically, rapidly clears wound infection.”); see also id.
at 158 (explaining that honey is “characteristically acidic with pH between
3.2 and 4.5, which is low enough to be inhibitory to several bacterial
pathogens”). Mandal also cites “reports of honey being very effective as
dressing of wounds, burns, skin ulcers and inflammations.” Id. at 155
(teaching honey may work “as an anti-inflammatory agent” and citing
clinical observations that report “reduced symptoms of inflammation”).
13 As noted by the Examiner (Final Act. 8), Mandal appears to report a
somewhat higher MIC for Manuka honey (about 25%) in Figure 2 for at
least several microorganisms, including E. coli. Mandal, 157 (Fig. 2).
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increases as a function of Manuka honey concentration—with a larger zone
for 50% (v/v) compared to 25% or 12.5%. Mandal, 157, Fig. 1 (showing a
protective zone with E. coli of 15 mm (diameter), 12 mm, and 0 mm, at
concentrations of 50%, 25%, and 12.5%, respectively).
In a more general sense, Mandal also teaches that honeys vary in their
potency and antibacterial activity. Mandal, 158. Indeed, Mandal reports
that it has been shown that activities may range “from concentration < 3% to
50 % and higher,” and that “[t]he concentration of honey has an impact on
antibacterial activity; the higher the concentration of honey the greater its
usefulness as an antibacterial agent.” Id. Although this teaching may not be
specific to Manuka honey, it (along with the data discussed above) supports
the conclusion that honey concentration is a recognized result-effective
variable that can be tailored and optimized for a desired effect. In re Applied
Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (explaining that “the
prior art need not provide the exact method of optimization for the variable
to be result-effective. A recognition in the prior art that a property is
affected by the variable is sufficient to find the variable result-effective.”).
We conclude on this record that a skilled artisan would have arrived at
a Manuka honey concentration within the scope of claim 1 through routine
optimization. Lopez provides a reason to use Manuka honey in Cullinan’s
topical compositions for the reasons stated by Examiner. Final Act. 8–9.
And Mandal provides a further reason to use medicinal grade Manuka honey
and to optimize its concentration (e.g., between, at the lower end, the
roughly 20–25% minimum amounts to inhibit E. coli and, at the other end, a
50% (or higher) amount as reported in Mandal, providing an improved
protective zone against E. coli colonization). The skilled artisan would have
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had reasons for doing so, including to better address and protect against the
commonly-arising infections referenced in Lopez, which the skilled person
would have reasonably understood as including, especially, urogenital
infections like UTIs that arise with increased vaginal pH and the resulting
colonization of pathogenic bacteria.
We agree with and adopt on this record the Examiner’s finding that
claim 1’s recitation of a “Phase A” and “Phase B” does not patentably
distinguish the claimed composition over the prior art. Final Act. 10–11.
And, in any event, absent persuasive evidence to the contrary, we find that
the making of single and/or multiphase emulsion compositions for topical
application was well known and obvious, involving no more than routine
skill. See Thompson ¶ 212. We also agree with the Examiner that an
emulsion is understood as simply a dispersion of one liquid in another, and
that it would have been, thus, obvious to combine the liquid ingredients to
make an emulsion. Final Act. 10. Combining the liquids in this manner, at
the concentrations noted above, would meet claim 1’s recitation of “wherein
the % by volume is based on all liquid ingredients except the SERM.”
Accordingly, for the reasons given above, we find that the prior art
teaches or suggests the composition of claim 1, and that the skilled artisan
would have had reasons for modifying the art to arrive at that composition
with a reasonable expectation of success. We turn now to Appellant’s
counterarguments.
Appellant begins by giving an overview of what the inventor regards
as a mechanism of action by which the claimed composition is alleged to
function. Appeal Br. 4 (citing Spec. ¶ 31). That is, a cellular inflammatory
agent, such as medicinal grade honey, is alleged to decrease “inflammation
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inherent in atrophic cells,” and a carrier (e.g., natural oil) is said to facilitate
passage of the active SERM into the cells; the solvent selected and Vitamin
E is said to help with this transport as well. Id. On this record, however,
Appellant’s overview and possible mechanism of action does not
demonstrate a sufficient structural difference between the claimed
compositions and those of the prior art. If, for example, Manuka honey is
decreasing “inherent” cellular inflammation in Appellant’s composition, it is
doing the same when added in the composition rendered obvious by the art’s
combined teachings. And, as noted above, a recognition of a previously
unappreciated property of a prior art compound or composition is generally
not enough to establish patentability. Atlas Powder, 190 F.3d at 1347;
Southwire Co. v. Cerro Wire LLC, 870 F.3d 1306, 1311 (Fed. Cir. 2017)
(noting that an applicant may be required to show that the prior art does not
possess the cited functional characteristics, whether the rejection is based on
inherency or obviousness).
Appellant argues that the Examiner has not considered Lopez and
Cullinan as a whole. Appeal Br. 7–8; Reply Br. 2–3. According to
Appellant, the cream in Lopez is described as being “aqueous” and Lopez
teaches that one should “[a]void antihistamines, alcohol, and diuretics as
these tend to dry up mucous membranes and the walls of the vagina.”
Appeal Br. 8; Lopez 3. In contrast, Appellant contends, Cullinan’s topical
compositions in Examples 9–18 are all non-aqueous and most of those
examples contain an alcohol. Appeal Br. 8.
This argument is unavailing. When obviousness is the issue, the prior
art is not limited to any particular example or its preferred embodiments.
Merck & Co. Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
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17
Cullinan expressly teaches other organic solvents (e.g., PEG, natural oils)
are suitable alternatives, and its teachings are not limited to using an alcohol
for a solvent. Cullinan 5:1–24. If anything, Lopez’s teaching to avoid
alcohol (if interpreted to mean the use of alcohol in a topical composition)
provides a further reason for the skilled artisan to minimize or eliminate
alcohol in Cullinan’s compositions and to use other disclosed solvents.14
Cullinan also suggests that its compositions may include water, so Lopez’s
mention of an “aqueous cream” (which appears to simply be an off-the-shelf
cream “from a pharmacy”) reveals no error in the Examiner’s rejection.
Lopez, 3; Cullinan, 5:9–11 (“The compositions can take the form of an
aqueous or anhydrous solution or dispersion, or alternatively the form of an
emulsion or suspension.”); 5:39–40 (noting that topical application can take
the form of creams, dispersions, etc.).
Appellant next argues that Mandal is non-analogous art that cannot be
combined with Cullinan and Lopez. Appeal Br. 8–10. Appellant argues the
field of invention is “compositions for topical administration in a urogenital
area and/or the vagina.” Id. at 9; Reply Br. 4. According to Appellant,
Mandal relates to treatment of infections and is directed to a single
substance, honey. Appeal Br. 9. Thus, Appellant argues Mandal is not in
the same field of endeavor as the invention. Nor, Appellant contends, is
Mandal pertinent to the problem faced by the inventor, which Appellant
contends is “how to transport or ‘facilitate passage of the SERM into the

14 Appellant and Examiner dispute whether Lopez’s reference to alcohol
concerns its “consumption” (Examiner’s position) or also its use in the
composition (as argued by Appellant). Ans. 24–25; Reply Br. 2. We need
not decide which interpretation is correct because, even if we credit
Appellant’s interpretation, it does not support Appellant’s argument.
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18
urogenital cells at an intracellular level.’” Id. (quoting Spec. ¶ 31);
Christopher Decl. ¶ 25. In addition, Appellant criticizes the Examiner for
invoking Lopez’s teachings in an effort to show that Mandal is analogous
art. Id. at 10. Appellant argues this is improper because “Mandal must pass
the test to be analogous art by itself . . . [and] [t]here is no legal precedent
cited in the Office Action for looking to another secondary reference” to
establish that Mandal is analogous art. Id.
Appellant’s argument is unpersuasive. Assuming, for argument’s
sake, that Appellant has properly identified the field of invention and that
Mandal is outside that field, we find Mandal is at least reasonably pertinent
to the problem faced by the inventor. We do not agree that the problem is as
narrow as framed by Appellant (i.e., dealing only with intracellular transport
of the SERM). To the contrary, the Specification supports a broader
understanding of the problem. The problem also relates to providing more
effective treatments for atrophic vaginitis and its sequelae, which the
Specification states include vaginal pain, dryness, and “urogenital
infections.” Spec. ¶ 33; see also Spec. ¶ 3 (listing urogenital infection as a
symptom of atrophic vaginitis). This is also supported by the testimony of
the inventor, who testifies that the claimed compositions allegedly solved
this problem—treating antibiotic resistant UTIs. As explained above,
Mandal is very much reasonably pertinent to that problem, especially when
considered against the background prior art, including, for example, Lopez,
Thompson, and Raz. In re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992) (“[T]he
purposes of both the invention and the prior art are important in determining
whether the reference is reasonably pertinent to the problem the invention
attempts to solve.”).
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Inasmuch as Appellant argues that Mandal must be considered “by
itself” without resort to other prior art of record to show that Mandal is
analogous art, that argument is flawed. Indeed, in Airbus S.A.S. v. Firepass
Corp., 941 F.3d 1374, 1382–84 (Fed. Cir. 2019), the Federal Circuit held
that the Board erred by failing to consider cited references in addition to the
allegedly analogous one, and explained that, “an analysis of whether an
asserted reference is analogous art should take into account any relevant
evidence in the record cited by the parties to demonstrate the knowledge and
perspective of a person of ordinary skill in the art.” Id. at 1383–84 (“We
hold that the Board erred by refusing to consider these [secondary]
references in support of the reasonably pertinent test.”). The court also
explained that the “reasonably pertinent inquiry may consider where an
ordinarily skilled person would reasonably look, and what that person would
reasonably search for, in seeking to address the problem confronted by the
inventor.” Id. at 1382–83. If other prior art is probative on that issue, it not
only can but should be considered. Id. (describing the “reasonably pertinent
inquiry” as “inextricably tied to the knowledge and perspective of a person
of ordinary skill in the art at the time of the invention”). Accordingly, there
is no error in the Examiner’s consideration of Lopez on the subject of
whether Mandal is analogous art.15
Appellant contends that the skilled artisan would not combine the
asserted references to produce a composition with a Manuka honey
concentration between about 30–62% as claimed. Appeal Br. 10–14. The

15 Although the Examiner did not err in considering Lopez on this question,
the Examiner’s analysis was unclear and incomplete. Ans. 26. We have,
however, supplemented that analysis in this Decision.
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reason, Appellant argues, is threefold. First, Lopez used a concentration of
10% Manuka honey and provides no link between bacterial infection and
atrophy of the vagina. Id. at 10–11. Second, Mandal teaches honey
concentration depends on the type of bacteria, and the MICs for Manuka
honey in Mandal are all below 30%. Id. Further to this point, Appellant
contends that “introducing a bacterial inhibitory concentration that would
ultimately further decrease the normal [vaginal] bacterial flora” could be
harmful. Id. at 12–13; Reply Br. 5. Third, Appellant cites Thompson’s
teaching that an anti-inflammatory agent may be added in a concentration
from about 0.1–10%. Appeal Br. 13–14. According to Appellant,
Thompson thus teaches away from Mandal’s concentrations; and Appellant
poses the question: why would one disregard the teachings of 10% or lower
concentrations in Thompson or Lopez, which have a direct relationship to
the claims, for an allegedly speculative range in Mandal that lacks a nexus to
the claimed invention? Id.
None of these contentions is persuasive. The link between Lopez,
Mandal, and bacterial infections is addressed in detail above, as further
evidenced by secondary references such as Raz. Mandal’s teachings are not
limited to Manuka honey concentrations below 30%. As explained above,
Mandal shows an improved protective zone when higher concentrations (i.e.,
50%) are used against E. coli (a common UTI-causing pathogen). Mandal,
156–157. And Mandal teaches that “the higher the concentration of honey
the greater its usefulness,” evidencing that honey concentration is an
optimizable, result-effective variable. Id. at 158. Mandal describes the
minimal inhibitory concentrations for different types of bacteria, but does
not limit the usefulness of honey to these specific values.
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Even if we looked only at Mandal’s MIC values reported for Manuka
honey, we would not agree on this record that claim 1’s range, which starts
at “about 30%,” would be nonobvious. As shown by Mandal, the specific
MIC depends on the specific bacteria against which the honey was tested.
When the general conditions of a claim are disclosed, and there is
insufficient evidence of criticality specific to the claimed range, “it is not
inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re
Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997). Reading the applicant’s
disclosure, it does not demonstrate that Manuka honey, much less Manuka
honey only in concentrations from about 30–62%, are critical. To the
contrary, portions of that disclosure speak about use of a “cellular anti-
inflammatory agent” in generic terms, and other portions disclose that
“medicinal grade honey” is used as the anti-inflammatory agent in a
preferred embodiment—listing Manuka honey as merely an “example” of
such honeys. Spec., Abstr., ¶¶ 7, 19–20.16
Regarding Appellant’s suggestion that adding a bacteria-inhibiting
concentration of honey would not be desired because it could harm the
normal flora of the vagina, there is insufficient evidence cited to back this
argument. Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1043
(Fed. Cir. 2017) (“Attorney argument is not evidence.”). Mandal
specifically describes the efficacy of Manuka honey in inhibiting pathogenic

16 Cf. In re Goffe, 542 F.2d 564, 567 (CCPA 1976) (explaining, in a
description context, that “[b]road language in the disclosure (including the
abstract) omitting an allegedly critical feature tends to rebut the argument of
criticality” and that “features that are merely preferred are not critical.”).
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bacteria, especially antibiotic-resistant strains, and suggests its potential
usefulness in treating infections. Appellant cites no evidence to show that
Manuka honey harms the beneficial natural flora, like vaginal lactobacilli.
See Raz, 803. And even if there was such evidence, it would not necessarily
discourage the combination proposed by the Examiner—the respective
tradeoffs would need to be weighed. Medichem, S.A. v. Rolabo S.L., 437
F.3d 1157, 1165 (Fed. Cir. 2006) (“[A] given course of action often has
simultaneous advantages and disadvantages, and this does not necessarily
obviate motivation to combine.”).
We also disagree with Appellant’s contention that Thompson teaches
away from the claimed subject matter. The anti-inflammatories in
Thompson include, for example, steroids (e.g., prednisone). Thompson
¶¶ 219–220. But Thompson does not mention Manuka honey and, thus,
does not teach away from its use, nor the amount of it that may be used.
Moreover, Thompson does not discredit using higher amounts of an anti-
inflammatory. Rather, Thompson teaches that a “safe and effective amount
of an anti-inflammatory agent may be added”—the 0.1–10% range is
identified as only preferred, and Thompson goes on to state that the exact
amount to use ultimately depends on the particular anti-inflammatory that is
added. Id. ¶ 219. As explained above, Mandal suggests that higher
concentrations of Manuka honey provide beneficial antibacterial properties.
The reasons why the skilled artisan would have considered Mandal in
combination with the other references, and modified the prior art
compositions to account for its teachings, has been addressed above.
Appellant’s further contentions about the functional features of the
components of the claimed emulsion, and the recitation of a Phase A and
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Phase B, have also been addressed above. Appeal Br. 15–17. Appellant
fails to identify how those features provide a structural difference from the
compositions taught or suggested by the prior art.
Lastly, Appellant cites alleged objective indicia of nonobviousness,
arguing that the claimed composition shows unexpected results and meets a
long-felt, but unmet need. Appeal Br. 17–19. According to Appellant,
“topical application of the claimed composition to the urogenital area and/or
a vagina for a period of six months eliminated recurrent urinary tract
infections when treatment with chronic antibiotic therapy failed.” Id. at 17–
18 (citing Christopher Decl. ¶ 29). This, Appellant contends, is a
“surprising” result. Id. Appellant contends the claimed composition also
meets a long-felt need for treating UTIs in post-menopausal women. Id. at
18 (citing Raz’s teaching (Raz, 802) that, for example, “[t]he alarming
increase in multi-drug resistant uropathogens makes it imperative that
alternative strategies are found”). And finally, Appellant refers to a
comparative study in the pending application, which is said to show
unexpectedly superior relief from symptoms of vaginal atrophy (less itching,
dryness, and pain during intercourse) provided by Appellant’s topical
compositions. Id. at 18–19; see also id. at 4–5 (citing Spec. ¶¶ 51–55).17

17 Appellant also vaguely references paragraphs 6–13 of the Christopher
Declaration. Appeal Br. 5. This is an incomplete argument and, in addition
to suffering from some of the same problems as Appellant’s other arguments
on secondary considerations (inadequate nexus), the cited support in the
declaration lacks corroboration and detail that might persuasively support a
conclusion that applicant’s composition has met the allegedly long-felt need
where other treatments had not. Christopher Decl. ¶¶ 8–11 (including, for
example, vague and uncorroborated statements about other treatments like
“[s]uccess is limited” and “[s]ales are poor”).
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The Examiner offers two responses. First, the Examiner responds that
“because the claimed composition is rendered obvious by the teachings of
the prior art, it would be expected to function as claimed.” Final Act. 17.
Second, the Examiner responds that Appellant’s declaration was submitted
with claims filed on March 15, 2019, but those claims recite different
limitations than the current claims. Ans. 33–34. The Examiner is partly
correct on both points, and we discuss Appellant’s evidence in greater detail
below. We remind the Examiner, however, that a conclusion on the issue of
obviousness should be reserved until all relevant evidence (including
objective indicia of nonobviousness) has been considered and weighed.
To begin, we observe that objective indicia of nonobviousness, such
as unexpected results, are “only relevant to the obviousness inquiry ‘if there
is a nexus between the claimed invention and the [objective indicia].’” In re
Affinity Labs of Tex., LLC, 856 F.3d 883, 901 (Fed. Cir. 2017) (quoting
Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir. 2006)).
Appellant does not establish a sufficient nexus between claim 1, now
on appeal, and the composition referenced in paragraph 29 of the
Christopher Declaration, which is described as providing surprising UTI
treatment and satisfying a long-felt, unmet need. The declaration states that,
“in 2018, the composition according to claims 1 and 24 was administered to
two post-menopausal women suffering from recurrent cystitis.” Christopher
Decl. ¶ 29. No further detail about the composition is provided. Claims 1
and 24 that existed when the declaration was submitted are not the same as
claim 1 or 24 now on appeal, which have been materially amended since
March 15, 2019, when the declaration was filed with the Office. Among
other differences, neither claim 1 nor 24 from March 2019 requires
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raloxifene like the current claims. See March 15, 2019 (claim amendment).
And it is not clear that the declarant is referencing the March 15, 2019 claim
set, or some earlier set of claims. In fact, because the declaration was signed
before the 2019 claims were submitted, and it references administration of a
composition starting in 2018 (before any 2019 claim set existed), the
declaration may be referencing an even earlier composition. The claims
from March and September 2018 contain further differences (e.g., neither
claim 1 nor claim 24 required raloxifene or Manuka honey). See Sept. 4,
2018 (claim amendment); Mar. 20, 2018 (claim amendment). That elements
of the presently claimed subject matter may have been recited in certain of
the earlier dependent claims (see Reply Br. 15) does not help Appellant’s
argument because the declaration refers expressly to claims 1 and 24, not
any dependent claim.
There are other issues with Appellant’s evidence, which cause that
evidence to receive little weight on this record. Appellant’s declarant states
that the UTI treatment and comparative testing in the Specification show
“unexpected results.” Christopher Decl. ¶¶ 26–29.18 But, as is clear from
other portions of the declaration, the witness was considering a rejection
over a different set of references, not the combination of prior art that is now
on appeal. See id. ¶ 5 (considering an entirely different set of references,
none of which is asserted here). “[I]n order to properly evaluate whether a
superior property was unexpected” one must “consider[] what properties
were expected.” Pfizer, Inc., v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.

18 The Specification does not describe the cited comparative testing as
producing a surprising or unexpected result. That characterization comes
only from Appellant’s declarant (and counsel).
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2007). Because the declarant’s testimony does not account for what would
have been expected in view of the currently asserted prior art, the testimony
is less persuasive. Absent persuasive evidence to the contrary, we find that a
skilled artisan would, in view Lopez’s and Mandal’s teachings, have
reasonably expected that adding Manuka honey and Vitamin E to Cullinan’s
raloxifene-containing topical compositions would provide some improved
relief from, for example, dryness, itching, and UTIs—especially if alcohol
was avoided as already discussed.
Beyond the above, we are also unpersuaded on this record that
Appellant’s evidence establishes that the claimed composition treats
antibiotic resistant UTIs sufficient to meet a long-felt need, where prior
solutions allegedly do not. The Raz reference cited by Appellant describes
mixed results with pre-existing treatments. In some studies, existing
therapies provided effective treatment of UTIs, even if separate studies may
have shown contradictory results. See, e.g., Raz, Abstr. (describing two
studies where a vaginal estrogen cream and an estriol ring decreased
episodes of UTI, yet other studies did not find a benefit with oral estrogen
therapy). Raz also cites studies where, for example, probiotics and
cranberry capsules showed effective treatment of UTIs. See Raz, 805.
Indeed, Raz teaches that “an advantage in the use of cranberry juice or other
oral preparations in the prevention of bacteriuria has been shown,” although
Raz suggests that that result has not been conclusively established through
additional clinical trials on larger, less heterogeneric populations. Id. The
testing that Appellant relies on to show that its composition effectively treats
UTIs, while encouraging, involved only two subjects. Christopher Decl.
¶ 29. We do not see how such limited testing is any more robust or
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conclusive in establishing that applicant’s invention meets the alleged long-
felt need of treating resistant UTIs, yet compositions of the prior art do not.
The comparative test as described in the Specification does indicate a
material improvement in treating some of the symptoms of vaginal atrophy
with a composition within the scope of claim 1 (“Example 2”), compared to
the alleged prior art (“Formulation 10”). Spec. ¶¶ 50–55; see also id. ¶¶ 56–
61 (results). Those results, however, even when combined with the other
asserted objective indicia, are not sufficient to outweigh the evidence of
obviousness on this record. That is so for at least two reasons.
First, applicant’s “Example 2” includes only a single natural oil
(avocado oil) at a single concentration (31%), only a single concentration of
Manuka honey (46%), only a single salt of tocopherol at a single
concentration (7%), and a single amount of raloxifene (60 mg). Spec. ¶ 51.
Yet claim 1 does not specify any particular amount or raloxifene, and it
recites a broad range of concentrations for the oil, honey, and tocopherol
components. There is insufficient evidence on this record to show other
compositions embraced by claim 1’s much broader scope will behave in the
same way, and produce the results shown with Example 2. In re Lindner,
457 F.2d 506, 508 (CCPA 1972) (“It is well established that the objective
evidence of nonobviousness must be commensurate in scope with the
claims.”); In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) (explaining that
an applicant must provide an evidentiary basis to support the conclusion that
other embodiments within the scope of the claims will behave the same).
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Second, Formulation 10, against which Example 2 was tested, was
changed from what is actually exemplified in Cullinan.19 “To be particularly
probative, evidence of unexpected results must establish that there is a
difference between the results obtained and those of the closest prior art[.]”
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977
(Fed. Cir. 2014). Even assuming Cullinan’s Formulation 10 was the closest
prior art topical composition,20 what applicant tested against was not
Cullinan’s Formulation 10, but a formulation with a substantial change in
the amount of active agent (raloxifene). Cullinan’s Formulation 10 teaches
including 1.5 grams of raloxifene, yet the formulation that applicant tested
included only 60 mg of that compound. We recognize that applicant
justifies this change so that the amount of raloxifene was the same as in
applicant’s Example 2. But it changed the prior art nonetheless, and thus
does not provide persuasive evidence of the comparative therapeutic efficacy
that Cullinan’s Formulation 10 produces in treating atrophic vaginitis.
Altogether, we conclude that Appellant’s argument and evidence on
this record does not outweigh the evidence that claim 1 would have been
obvious. Pfizer, 480 F.3d at 1372 (“Although secondary considerations

19 Formulation 10, as described in the Specification, is a modified example
composition from U.S. Patent No. 5,610,167, which is a patent that issued
on a continuation application to the application that issued as Cullinan.
Appeal Br. 4; see Cullinan, 7:55–65 (Formulation 10).
20 There was no finding by the Examiner that Cullinan’s Formulation 10 was
the “closest prior art,” as that term is understood in the precedents. We need
not reach a conclusion on that issue in the first instance here. Other example
compositions in the art might be considered closer for comparison purposes,
such as Lopez’s topical composition, or perhaps Cullinan’s Formulation 13
(a topical gel that also includes a substantial triglyceride component (i.e., the
main component natural fats and oils)). See Cullinan, 8:25–31.
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must be taken into account, they do not necessarily control the obviousness
conclusion.”). Accordingly, we determine that the preponderance of the
evidence supports the conclusion that claim 1 would have been obvious over
Cullinan, Lopez, Mandal, Thompson, and Tocopherols. Claims 5, 6, 11, and
32–35 were not argued separately and fall with claim 1.
Claim 4
Claim 4 depends from claim 1, and adds that “the raloxifene
comprises about 0.038 mg/ml of the composition to about 1.9 mg/ml of the
composition.” Appeal Br. 21. The Examiner finds that Cullinan teaches that
the active ingredient (i.e., raloxifene) can be used at a concentration of 5 mg
in 5 ml (hence, 1 mg/ml), reading on claim 4. Final Act. 11–12; Ans. 34
(citing Cullinan’s Formulation 8, which describes a suspension with 0.1-
1000 mg of the active in 5 ml, thus indicating a range of 0.2–200 mg/ml).
Appellant contends that Formulation 8 “is an oral suspension and is
not application [sic] to the claimed invention, a topical composition.”
Appeal Br. 19; Reply 8; see also Ans. 34 (“Cullinan does not state that this
is an oral composition as alleged by the Appellant.”). We agree with
Appellant that Formulation 8 of Cullinan, more likely, relates directly to a
suspension for oral administration, not a topical composition. On the other
hand, Cullinan discloses a broad range of raloxifene may be used in topical
compositions (from 0.5–95% by weight) and, being the active agent in
Cullinan, suggests the skilled artisan would recognize raloxifene’s
concentration is result-effective and optimizable. As explained above,
absent persuasive evidence of criticality to the claimed range (not present on
this record), determining an optimal concentration of a result-effective
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variable is generally prima facie obvious. The totality of the evidence here
supports the Examiner’s conclusion that claim 4 would have been obvious.
II. Claims 24, 26–28, and 36: Obviousness over Cullinan, Lopez,
Mandal, and Thompson
The Examiner concludes that claims 24, 26–28, and 36 would have
been obvious over Cullinan, Lopez, Mandal, and Thompson. Final Act. 17–
22; Ans. 16–20. Independent claim 24 is illustrative, and the only material
difference between it and claim 1 is that claim 24 does not require inclusion
of tocopherol/Vitamin E. Appeal Br. 22. The Examiner’s analysis parallels
the analysis in support of the rejection of claim 1. Appellant provides no
separate argument for claim 24 or its dependent claims (except for claim 26,
which Appellant argues the same as claim 4). Appeal Br. 19. We adopt the
Examiner’s findings and reasoning for the rejection of claims 24, 26–28 and
36 (supplemented as above for claim 1). We affirm the rejection of claims
24, 26–28, and 36 as obvious for the reasons provided above on claims 1 and
4, but similarly designate that affirmance as a new ground of rejection.
III. Claims 30 and 31: Obviousness over Cullinan, Lopez, Mandal,
Thompson, and Tocopherols
Claim 30 depends from claim 24 and adds a thickening agent and
tocopherol to the composition. Appeal Br. 23. Claim 31 depends from
claim 30 and adds that the tocopherol concentration is about 1–15%. Id.
The Examiner’s rejection of claims 30 and 31 parallels the rejection of
claims 1 and 24, and Appellant provides no separate argument in response.
Final Act. 22–23; see generally Appeal Br. We adopt the Examiner’s
findings and reasoning in support of the rejection of claims 30 and 31
(supplemented as discussed above for claims 1 and 24). The rejection is
affirmed but again designated as a new ground of rejection.
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CONCLUSION
For the reasons explained above, we affirm the Examiner’s rejections
but designate our affirmance a new grounds of rejection.
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed New Ground
1, 4–6,
11, 32–35
103 Cullinan,
Lopez,
Mandal,
Thompson,
Tocopherols
1, 4–6,
11, 32–35
1, 4–6, 11,
32–35
24, 26–
28, 36
103 Cullinan,
Lopez,
Mandal,
Thompson
24, 26–
28, 36
24, 26–28, 36
30, 31 103 Cullinan,
Lopez,
Mandal,
Thompson,
Tocopherols
30, 31 30, 31
Overall
Outcome
1, 4–6,
11, 24,
26–28,
30–36
1, 4–6, 11, 24,
26–28, 30–36

We designated a new ground pursuant to 37 C.F.R. § 41.50(b).
Section 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.” Section
41.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision, must
exercise one of the following two options with respect to the new
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ground of rejection to avoid termination of the appeal as to the
rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the
claims, appellant may again appeal to the Board pursuant to this
subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.

AFFIRMED; 37 C.F.R. § 41.50(b)