Charles Gerald. Connor et al.

Patent Trials and Appeals Board

Dec 19, 2019

14139243 - (D) (P.T.A.B. Dec. 19, 2019)

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.
14/139,243 12/23/2013 Charles Gerald Connor 14597-21 3679
45473 7590 12/19/2019
BGL/RESEARCH TRIANGLE PARK
P.O. BOX 110285
RESEARCH TRIANGLE PARK, NC 27709
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
12/19/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte CHARLES GERALD CONNOR and
CHARLES L. HAINE1
________________

Appeal 2019-001465
Application 14/139,243
Technology Center 1600
________________

Before JEFFREY N. FREDMAN, JOHN G. NEW, and
JAMIE T. WISZ, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies Rhodes Pharmaceuticals, LP, as
the real party-in-interest. App. Br. 3.
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Application 14/139,243

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 14, 20–22, 27–31, and 34–35.
Specifically, claims 14, 20–22, 27–31 stand rejected as unpatentable under
35 U.S.C. § 103(a) as being obvious over the combination of Connor (US
6,659,985 B2, December 9, 2003) (“Connor”) and Lubkin (Re. 34,578, April
5, 1994) (“Lubkin”).
Claims 14, 20–22, 27–31, and 34–35 stand rejected as unpatentable
under 35 U.S.C. § 103(a) as being obvious over the combination of Connor,
Lublin, and Dale et al. (US 2,861,920, November 25, 1958) (“Dale”).
Claims 14, 20–22, 27–31 also stand rejected as unpatentable under the
doctrine of obviousness-type double patenting as being obvious over the
combination of claims 1–15 of Connor and Lubkin.
Claims 14, 20–22, 27–31, and 34–35 stand rejected as unpatentable
under the doctrine of obviousness-type double patenting as being obvious
over the combination of claims 1–15 of Connor, Lubkin, and Dale.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to a composition and
method of treating eye diseases using a composition having a therapeutically
effective amount of a progestagen and a pharmaceutically acceptable carrier.
Abstr.

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REPRESENTATIVE CLAIM
Claim 14 is representative of the claims on appeal and recites:
14. A method of treating dry eye comprising transdermally
administering to a palpebral part of an eye of a patient in need
thereof a composition comprising a therapeutically effective
amount of a sex steroid and at least one pharmaceutically
acceptable carrier, wherein said sex steroid is progesterone.

App. Br. 13.

ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s findings, reasoning, and
conclusion that the claims on appeal are obvious over the combined cited
prior art and under the nonstatutory doctrine of obviousness-type double
patenting. We address the arguments raised by Appellant below.

A. Rejection of claims 14, 20–22, 27–31, and 34–35 under 35 U.S.C.
§ 103(a)

Issue
Appellant argues that the Examiner erred in finding that the combined
cited prior art neither teaches nor suggest the limitation of claim 14 reciting
“wherein said sex steroid is progesterone.” App. Br. 8.

Analysis
The Examiner finds that Connor teaches a method of treating dry eye
by transdermally delivering androgenic hormones, such as testosterone or
dehydroepiandrosterone, in a pharmaceutically effective carrier to the
adnexa of the eye. Final Act. 11. However, the Examiner finds, Connor
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does not teach the use of progesterone as the active ingredient in the
composition. Id.
The Examiner finds that Lubkin teaches application of a dry eye-
treating composition to the eye, in which the active agent comprises a sex
steroid. Final Act. 11 (citing Lubkin, Title, Abstr., col. 1, ll. 13–15). The
Examiner finds that Lubkin expressly defines the term “sex steroid” as
including progesterone, testosterone, estrogen, dehydroepiandrosterone, and
derivatives thereof. Id. (citing Lubkin col. 1, ll. 19–22). The Examiner
notes that, although 17 beta-estradiol is used in a preferred embodiment, a
person of ordinary skill in the art would have understood from the teachings
of Lubkin that progesterone is also a sex steroid suitable for topical
application in a dry eye-treating composition. Id. at 11–12 (citing Lubkin,
Abstr.).
The Examiner concludes that a person of ordinary skill in the art
would have had a reasonable expectation of success in arriving at the
claimed invention, because Connor teaches treating dry eye by transdermally
delivering androgenic hormones such as testosterone or
dehydroepiandrosterone to the adnexa of the eye, and Lubkin teaches
treating dry eye by administering a sex hormone such as progesterone,
testosterone, estrogen and dehydroepiandrosterone. Final Act. 12. The
Examiner also concludes that a person of ordinary skill in the art would have
recognized that the sex hormones (e.g., progesterone, testosterone, etc.) are
equivalents that are interchangeable for treatment of dry eye. Id.
Appellant disputes the Examiner’s conclusion that a skilled artisan
would substitute the androgenic hormone taught by Connor with
progesterone, or would “understand that progesterone is also a suitable sex
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steroid suitable for topical application in a dry eye-treating composition as
described by Lubkin.” App. Br. 8 (quoting Final Act. 12). Appellant argues
that, although Lubkin defines the term “sex steroid” as including estrogen,
progesterone, testosterone, dehydroepiandrosterone, and chemical variants
and derivatives of the same, the definition in Lubkin does not teach that
these sex steroids are equivalent or interchangeable for treating dry eye, or
for any other purpose. Id. at 9.
Appellant argues that, reading Lubkin as a whole, a skilled artisan
would have understood that application of formulations of 17-beta estradiol
to the ocular surface is useful for treating dry eye syndrome in
postmenopausal or oophorectomized women. App. Br. 9. Appellant notes
that the studies described in the background of the invention section in
Lubkin include discussion of the presence of estrogen and testosterone in
human tear film and the effects of anti-estrogens, such as Tamoxifen, on the
lacrimal gland. Id. Appellant notes that the examples in Lubkin include
various estrogen-containing formulations for application to the ocular
surface to treat dry eye. Id.
Appellant further asserts that the Examiner does not articulate any
reasoning as to why a person of ordinary skill in the art would look to
Lubkin to modify the compositions of Connor, or why a skilled artisan
would modify the compositions of Connor using the teachings of Lubkin
with any reasonable expectation of success. App. Br. 9. Furthermore,
argues Appellant, the Examiner’s reliance on the allegations that Lubkin
teaches that sex hormones are equivalent and interchangeable are not only
mischaracterizations of the teachings of Lubkin but are also scientifically
nonsensical. Id.
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According to Appellant, it was well known in the art at the time of
Appellant’s filing that estrogen, testosterone, and progesterone are
sometimes collectively referred to as “sex steroids,” nor Appellant asserts,
does Lubkin teach anything different. App. Br. 9. Appellant contends that
Lubkin teaches what was already known: that estrogen, progesterone,
testosterone, dehydroepiandrosterone, and chemical variants and derivatives
of the same are all sex steroids. Id. Appellant contends, additionally, that it
was also well understood in the art that all sex steroids are not equivalent or
interchangeable with one another in, for example, their physiological effects.
Id. According to Appellant, there would have been no scientific rationale or
reason that the skilled artisan would somehow expect that substituting one
sex steroid for another would ever produce the same result. Id. at 10.
Furthermore, Appellant argues, the examples in Lubkin include
various estrogen-containing formulations for application to the ocular
surface to treat dry eye. App. Br. 10. Appellant asserts that nothing in
Lubkin teaches that androgenic hormones, progesterone, or any other sex
steroids are equivalent to 17-beta estradiol, or that either reference suggests
that application of any composition to the ocular surface is somehow the
same as application to the palpebral portion of the eye or would reasonably
be expected to be effective. Id.
We are not persuaded by Appellant’s arguments. As an initial matter,
the teachings of Lubkin are not limited to the exemplary embodiments set
forth in the reference. Rather, “‘all disclosures of the prior art, including
unpreferred embodiments, must be considered.’” Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re
Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)). Consequently, in our
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obviousness analysis we consider all of the teachings of the references cited
by the Examiner.
Connor teaches:
[A] method for treating dry eye or increasing contact lens wear
time through the transdermal delivery of androgenic hormones
to the adnexa of the eye. More specifically, an androgenic
hormone such as testosterone or dehydroepiandrosterone is
solubilized in pharmaceutically effective carrier such as a facial
cream or gel. The androgenic hormone in a pharmaceutically
effective carrier is applied to the adnexa of the eye, which is the
tissue adjacent to and surrounding the eyeball.

Connor Abstr. As Appellant notes, progesterone, as recited in Appellant’s
claims, although a steroid, is not an androgenic hormone.
However, Lubkin is also directed to the treatment of dry eye
syndrome by the topical application of sex steroids. See Lubkin, Title.
Specifically, Lubkin teaches: “A topical drug application for the alleviation
of keratoconjunctivitis sicca (dry eye syndrome) is comprised of a solution
of sex steroids or their derivatives suspended or dissolved in a vehicle, and
the method of preparation and application of the same.” Id. Abstr.
Furthermore, Lubkin teaches that:
This invention relates to drugs for the topical application of sex
steroids in the treatment of human dry eye syndrome
(keratoconjunctivitis sicca) …. In the specification and claims
hereinafter the term “sex steroids” is defined to include estrogen,
progesterone, testosterone, dehydroepiandrosterone and
chemical variants and derivatives of the same.

Lubkin col. 1, ll. 13–22.
We do not dispute Appellant’s contention that the examples of Lubkin
are directed primarily to the topical application of estrogens (e.g., 17-beta-
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estradiol 3-phosphate disodium) in the treatment of dry eye. See, e.g.,
Lubkin cols. 4–6, ll. 5–63. Nevertheless, Lubkin also teaches that sex
steroids generally can be used in the topical treatment of dry eye, and
expressly defines progesterone as being a member of the genus of “sex
steroids.” See Lubkin col. 1, ll. 18–22.
Nor do we dispute Appellant’s assertion that progesterone and other
sex steroids, including androgens, are not universally interchangeable for all
applications. Rather, we interpret the Examiner’s findings to mean that
Lubkin teaches that “sex steroids,” including progesterone as well as the
androgens taught by Connor, can all be used in the treatment of dry eye
syndrome. Thus, we agree with the Examiner that the ordinary artisan
would have found it obvious to use the known effective sex steroids of
Lubkin, including progesterone, for treatment of dry eye using the dry eye
treatment routes of Connor. Appellant provides no rebuttal evidence
suggesting ineffectiveness of the dry eye compounds disclosed by Lubkin.
“[A]ttorney argument [is] not the kind of factual evidence that is required to
rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997).
Finally, Appellant’s claim 14 recites application of the claimed
composition to “a palpebral part of an eye of a patient.” Appellant’s
Specification discloses that: “[a]s referred to in the instant specification, the
term ‘palpebral part of an eye’ is the external portion of the upper and lower
eyelids and the medial and lateral canthus.” Spec. 5.
Connor teaches that “the androgenic hormone in a pharmaceutically
effective carrier is applied to the adnexa of the eye, which is the tissue
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adjacent to and surrounding the eyeball. The adnexa of the eye includes the
eyelid, but is not limited to the eyelids.” Connor col. 2, ll. 57–61.
We agree with the Examiner that “the external portion of the upper and
lower eyelids and the medial and lateral canthus” disclosed by Appellant’s
Specification constitute part of the “tissue adjacent to and surrounding the
eyeball …. includ[ing] the eyelid, but [ ] not limited to the eyelids,” as
taught by Connor.
We consequently affirm the Examiner’s conclusion that Appellant’s
claims 14, 20–22, 27–31 are obvious over the combination of Connor and
Lubkin. Furthermore, Appellant relies upon the same arguments with
respect to the Examiner’s rejection of all of the claims on appeal over the
combination of Connor, Lubkin, and Dale. See App. Br. 11. For the reasons
that we have explained, we similarly affirm this rejection.

B. Rejection of claims 14, 20–22, 27–31, and 34–35 under the
nonstatutory doctrine of obviousness-type double patenting

Analysis
Independent claim 1 of Connor recites:
1. A method of treating dry eye disease comprising:

(a) transdermally administering a composition to a subject in
need of such treatment, said composition comprising a
therapeutically effective amount of an androgenic hormone in a
pharmaceutically effective carrier wherein said transdermally
administering involves administering said compound to the
adnexa of the eye of said subject and said androgenic hormone
comprised between 1 to 5% by weight of said pharmaceutically
effective carrier.

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Appellant advances substantively the same arguments presented with
respect to the Examiner’s rejections under Section 103 supra. App. Br. 6–8.
We have explained why we do not find these arguments persuasive.
Furthermore, our analysis of the Section 103 rejection does not necessarily
rely upon the disclosures of the Specification of Connor, nor need we do so
in this instance.
Connor recites, inter alia, treating dry eye disease by administering a
composition containing androgenic hormones, as the active agent, to the
adnexa of the eye. Connor claim 1. Lubkin teaches treating dry eye
syndrome by topically administering a composition containing sex hormones
as the active agent, and further teaches that sex steroids are defined as
including “estrogen, progesterone, testosterone, dehydroepiandrosterone and
chemical variants and derivatives of the same.” Lubkin col. 1, ll. 13–22.
We agree with the Examiner’s conclusion that Lubkin teaches that
progesterone and androgenic hormones (i.e., testosterone and
dehydroepiandrosterone) can both be employed effectively in the treatment
of dry eye syndrome, and that it would have therefore been obvious to
substitute progesterone for the androgenic hormone of Connor’s claim 1, as
recited in Appellant’s claim 14 with a reasonable expectation of success.
We consequently affirm the Examiner’s rejection of claims 14, 20–22, and
27–31 over the combination of Connor and Lubkin.
Furthermore, Appellant relies upon the same arguments with respect
to the Examiner’s rejection of claims 14, 20–22, 27–31, and 34–35 over the
combination of Connor, Lubkin, and Dale. For the reasons we have
explained, we similarly affirm the Examiner’s rejection of the claims.

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CONCLUSION
The Examiner’s rejection of claims 14, 20–22, 27–31, and 34–35
under 35 U.S.C. § 103(a) is affirmed.
The Examiner’s rejection of claims 14, 20–22, 27–31, and 34–35
under the nonstatutory doctrine of obviousness-type double patenting is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
AFFIRMED

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
14, 20–22,
27–31
103(a) Connor,
Lubkin
14, 20–22,
27–31

14, 20–22,
27–31, 34–35
103(a) Connor,
Lubkin, Dale
14, 20–22,
27–31, 34–35

14, 20–22,
27–31
Obviousness-
type double
patenting
Connor,
Lubkin
14, 20–22,
27–31

14, 20–22,
27–31, 34–35
Obviousness-
type double
patenting
Connor,
Lubkin, Dale
14, 20–22,
27–31, 34–35

Overall
Outcome
14, 20–22,
27–31, 34–35