Ex Parte Thornton

Patent Trial and Appeal Board

Jun 16, 2017

12547241 (P.T.A.B. Jun. 16, 2017)

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.
12/547,241 08/25/2009 Joseph P. Thornton 119095.010500 4902
29747 7590 06/20/2017
GREENBERG TRAURIG (LV)
77 West Wacker Drive, Suite 3100
Intellectual Property Department
Chicago, IL 60601
EXAMINER
VAN BUREN, LAUREN K
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
06/20/2017 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):
gtipmail @ gtlaw. com
clairt@gtlaw.com
rupickd@gtlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH P. THORNTON
Appeal 2016-004261
Application 12/547,2411
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN G. NEW, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal2 under 35 U.S.C. § 134(a) involves claims 3 and 4
(Response to Notice of Non-Compliant App. Br. 2). Examiner entered
rejections under 35 U.S.C. § 101, 35 U.S.C. § 102(b), and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the real party in interest as “Nevada Medical
Resources, LLC” (App. Br. 3).
2 This Appeal is related to Appeal 2014-003221 (Application 12/547,193),
Decision affirming the rejection of record entered August 4, 2016 and
Appeal 2015-000456 (Application 13/588,910) Decision affirming the
rejection of record entered September 13, 2016.
Appeal 2016-004261
Application 12/547,241
STATEMENT OF THE CASE
Appellant’s disclosure “relate[s] to a natural, topical composition for
the treatment of hemorrhoids” (Spec. ^ 2). Claims 3 and 4 are reproduced
below:
3. A topical composition for the treatment of hemorrhoids
comprising:
Bromelain; and
Hamamelis Virginiana.
4. The topical composition of claim 3 further comprising one
or more of the following ingredients:
alcohol, de-ionized water, Butylene Glycol, PEG-40
Hydrogenated Castor Oil, Hydroxyethylcellulose, Eucalyptus
Globulus Oil, Aloe Barbadensis Leaf Extract, Chamomilla
Recutita Flower Extract, Camellia Sinensis Leaf Extract, Avena
Sativa Kernel Flour, Benzophenone-4, Disodium EDTA,
Sodium Citrate, Sodium Hydroxide, Citric Acid, Caprylyl
Glycol, Chlorphenesin and Methylisothiazolinone.
(Response to Notice of Non-Compliant App. Br. 2.)
The claims stand rejected as follows:
Claims 3 and 4 stand rejected under 35 U.S.C. § 102(b) as anticipated
by a prior public use or sale as admitted by the 2011 Thornton Dec.3
Claims 3 and 4 stand rejected under 35 U.S.C. § 102(b) as anticipated
by a prior public use or sale of Appellant’s invention by gloProfessional
Purchase Order 13588,4 as evidenced by Glo Professional.5
3 Declaration of Dr. Joseph Thornton, signed Dec. 2, 2011.
4 gloProfessional Purchase Order 13588, printed Oct. 23, 2013.
5 Robin Olson, VP Marketing, Glo Professional Brands, letter dated Dec. 22,
2016.
2
Appeal 2016-004261
Application 12/547,241
Claim 3 stands rejected under 35 U.S.C. § 102(b) as anticipated by
Barak.6
Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kling,7 Buchholz,8 Jensen,9 and
Warren.10
Claims 3 and 4 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Barak.
Claims 3 and 4 stand rejected under 35 U.S.C. § 101, as directed to
non-statutory subject matter.
Anticipation'.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Appellant’s invention was in public use or on sale
prior to the filing date of Appellant’s claimed invention and/or that Barak
teaches Appellant’s claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Thornton declares that he “did not treat patients, sell, offer for sale or
otherwise publicly disclose the gel comprising [witch] hazel[, otherwise
known as Hamamelis Virginiana,] and Bromelian before 2009” (2015
Thornton Dec.* 11 ^ 1).
6 Barak, WO 2007/077551 A2, published July 12, 2007.
7 Kling et al., US 2007/0212342 Al, published Sept. 13, 2007.
8 Buchholz et al., US 2006/0246149 Al, published Nov. 2, 2006.
9 Jensen et al., US 2002/0187168 Al, published Dec. 12, 2002.
10 Warren et al., US 2004/0167479 Al, published Aug. 26, 2004.
11 Declaration of Dr. Joseph Thornton, signed Jan. 20, 2015.
3
Appeal 2016-004261
Application 12/547,241
FF 2. The gloProfessional Purchase Order 13588 identifies
gloProfessional’s “Back Bar - gloEnzyme” with a shipping due date of April
15, 2006 (gloProfessional Purchase Order 13588).
FF 3. Glo Professional discloses that:
Glo’s Enzyme is a chemical exfoliant used during professional
facial services in spas and salons worldwide[,] th[e] formula
was first formulated and manufactured for Glo in 2005 and
began being sold to [their] wholesale customers in Feb 2006[,
wherein the formula] has been a staple in [their] “back bar” or
professional product series since the launch of [their] skincare
line in Feb 2006 [, and that the Enzyme formula comprises, as is
reported on the Products’ label,] Hamamelis Virginiana
(Witch Hazel) Water [and] Bromelain [].
(Glo Professional; see also Product label for glo-therapeutics’ “FACIAL
ENZYME”.)
FF 4. Barak discloses that “[f]or treatment of the anal sphincter, topical
administration of a topical preparation directly to the rectal area is
preferred,” but “prior art dosage forms for direct topical application for the
treatment of anorectal disorders ... are messy and inconvenient to use” and
exhibit “the possible soiling of clothes, that might affect social activity”
(Barak 7: 12-13; Ans. 9).
FF 5. Barak discloses “[a] rectally insertable device for localized drug
delivery to the anal sphincter of a subject, a method of using the device,”
wherein:
The device comprises a shell for containing an active
pharmaceutical ingredient, the shell being substantially
impermeable to the active pharmaceutical ingredient wherein a
lower portion of the shell is configured to release the active
pharmaceutical ingredient from the shell and wherein when the
device is inserted into the rectum of the subject, the lower
portion of the shell is proximal to the anal sphincter, such that
4
Appeal 2016-004261
Application 12/547,241
the active pharmaceutical ingredient is released proximal to the
anal sphincter.
(Barak, Abstract (emphasis added); see generally Ans. 9 (Barak’s
pharmaceutical “application is [] topical, it is merely applied using the
rectally insertable device”).)
FF 6. Barak’s “method or device may be used in the treatment of a
condition associated with a disorder of the anal sphincter, such as, for
example . . . hemorrhoids” (Barak 10: 1—4; Ans. 3—4).
FF 7. Barak discloses:
Examples of APIs which may be used in accordance with the
teachings of the present invention of the present invention
include, without limitation, a herbal extract, bee pollen, a
muscle relaxant, a local anesthetic, an antibiotic, an anti­
inflammatory agent, a nitric oxide donor, botulinum toxin, a
muscarinic agent, a sympathetic neuromodulator, a calcium
channel antagonist, a phosphodiesterase inhibitor, a superoxide
scavenger, a cyclic adenosine monophosphate-dependent
protein kinase activator, an adenosine triphosphate-sensitive
calcium channel activator and mixtures thereof.
(Barak 19: 11-18.)
FF 8. Barak discloses that “[ejxamples of herbal extracts suitable for use in
the device or method of [Barak’s] invention include, without limitation . . .
bromelains . . . [and] witch hazel (.Hamamelis virginiana f (Barak
19:22 - 20: 1; see Ans. 4).
ANALYSIS
The rejection over a prior public use or sale as admitted by the 2011
Thornton Dec.
Examiner finds that the 2011 Thornton Dec. “mentions that [Dr.
Thornton] has been treating [] patients with his composition for a prolonged
period of time. Where this use has extended one year before the filing of
5
Appeal 2016-004261
Application 12/547,241
this application that would constitute a public use that would bar
patentability of the invention” (Ans. 3; see 2011 Thornton Dec.). In this
regard, Examiner posits that “it is possible that the use of such a product
could have gotten out into the general public” more than one year prior to
Appellant’s filing date (Ans. 8). Dr. Thornton, however, makes clear that he
“did not treat patients, sell, offer for sale or otherwise publicly disclose the
gel comprising [witch] hazel[, otherwise known as Hamamelis virginiana,\
and Bromelian before 2009” (FF 1). Therefore, the evidence on this record
fails to support Examiner’s finding of a prior public use or sale, of
Appellant’s claimed invention, by Dr. Thornton.
The rejection over a prior public use or sale of Appellant’s invention by a
prior public use or sale of Appellant’s invention by gloProfessional
Purchase Order 13588, as evidenced by Glo Professional'.
Examiner finds that “Glo Professional produced an enzyme
formulation that contained both bromelain and witch hazel [and] has records
detailing the sales of this composition dating back to December 2005/early
2006” (Ans. 3; see also id. at 9). For the foregoing reason, we are not
persuaded by Appellant’s contention that Examiner failed to establish an
evidentiary basis to support a finding that a topical composition comprising
bromelain and Hamamelis Virginiana was not in public use and on sale prior
to the filing date of Appellant’s claimed invention (see App. Br. 7; Reply Br.
2; cf. FF 2-3). In this regard, we are not persuaded by Appellant’s
contention that Examiner’s finding that a Glo Professional product that reads
on the topical composition set forth in Appellant’s claim 3, which was
offered for sale and publically used prior to Appellant’s filing date, is not
based on “public information available at the time the instant application
6
Appeal 2016-004261
Application 12/547,241
[w]as filed” (Reply Br. 2 ; see App. Br. 7). Glo Professional confirms the
ingredients of the Glo Professional product offered for sale and in public use
prior to filing date of Appellant’s claimed invention. Therefore, we are not
persuaded by Appellant’s contention “that the Letter from Robin Olsen of
Glo Professional Brands is not relevant to this appeal,” because “[a]n
internal letter detailing the ingredient list of the asserted Glo product is
simply not subject to verification by [Ajpplicant and thus should be ignored
for purposes of this [Ajppeal” (Reply Br. 2). In this regard, Appellant
offered no evidence, for example a product label, to support a contention
that Examiner’s finding is incorrect. Therefore, we find that the
preponderance of evidence on this record supports Examiner’s finding.
The rejection over Barak:
Examiner finds that Barak discloses a composition comprising
bromelain and Hamamelis Virginiana that is preferably topically applied
proximal to the anal sphincter, for the treatment of, inter alia, hemorrhoids
(FF 4-6). Barak discloses a device that provides for the topical
administration of a pharmaceutical formulation comprising bromelain and
Hamamelis Virginiana proximal to the anal sphincter that overcomes the
prior art concerns associated with direct topical application of anorectal
disorders (see FF 5, 6, and 8).
Examiner, however, failed to establish an evidentiary basis to support
a finding that a person of ordinary skill in this art would have selected the
specific combination of bromelain and Hamamelis Virginiana from among
the numerous possible active ingredients disclosed by Barak (see FF 7). See
In reArkley, 455 F.2d 586, 587 (CCPA 1972) (In order to support an
7
Appeal 2016-004261
Application 12/547,241
anticipation rejection, a prior art “reference must clearly and unequivocally
disclose the claimed [invention] or direct those skilled in the art to the
[invention] without any need for picking, choosing, and combining various
disclosures not directly related to each other by the teachings of the cited
reference” (emphasis added)).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Appellant’s claimed invention was publically used or on sale by
Glo Professional prior to Appellant’s filing date. Therefore, the rejection of
claim 3 over glo-therapeutics product label as evidenced by Glo Professional
and gloProfessional Purchase Order 13588 is affirmed. Claim 4 is not
separately argued and falls with claim 3.
The preponderance of evidence on this record fails to support
Examiner’s finding that Appellant’s claimed invention is anticipated by
Barak. The rejection of claim 3 under 35 U.S.C. § 102(b) as anticipated by
Barak is affirmed.
The preponderance of evidence on this record fails to support
Examiner’s finding that the 2011 Thornton Dec. supports a finding of a prior
public use or sale. The rejection of claims 3 and 4 under 35 U.S.C. § 102(b)
as anticipated by a prior public use or sale as admitted by the 2011 Thornton
Dec. is reversed.
Obviousness'.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
8
Appeal 2016-004261
Application 12/547,241
FACTUAL FINDINGS (FF)
FF 9. Kling’s disclosure “relates to the field of wound healing and
treatment of damaged tissue conditions and symptoms of disease such as
inflammation,” including “hemorrhoids” (Kling ^ 2 and 34; Ans. 5 and
9-10).
FF 10. Kling discloses “a mixture of proteases that is useful for wound
healing, reducing inflammation and promoting development of healthy
skin,” wherein “the protease mixture comprises at least one protease,” such
as “bromelain” (Kling 25, 30, and 31; Ans. 5).
FF 11. Kling discloses that “proteases can be formulated into a therapeutic
composition containing a therapeutically effective amount of one or more
proteases and a pharmaceutical carrier” for application “onto the skin or
tissues or into wounds in any manner chosen by one of skill in the art” “[t]o
promote healthy skin development and/or treat wounds” (Kling ^ 38; Ans.
5).
FF 12. Kling discloses that “[tjhickeners such as . . . modified celluloses[,
e.g., hydroxyethyl cellulose,] can [] be employed with liquid carriers to form
spreadable pastes, gels, ointments, soaps, and the like, for application
directly to the skin of the user” (Kling 46 and 52; Ans. 5).
FF 13. Examiner finds that Kling does not disclose a topical solution
comprising, inter alia, “Hamamelis virginiana (aka Witch Hazel)” (Ans. 5).
FF 14. Warren “relates to hemorrhoid treatment pads intended to be worn
by a person in need of hemorrhoid treatment” (Warren ^ 1; Ans. 6).
FF 15. Warren discloses that the “witch hazel” may be included in a
composition included on Warren’s hemorrhoid treatment pads (see Warren
^ 139; Ans. 6 and 10).
9
Appeal 2016-004261
Application 12/547,241
FF 16. Examiner relies on Jensen and Buchholz to disclose a number of
ingredients that may be included in conventional topical compositions (Ans.
6).
FF 17. Appellant’s Table 1 is reproduced below:
e
Gasde
t
Rtagimsis IfflLpmvement
Time
PTC
Products tie-1 Mote
Effective
Than
OTC
Meds?
Y&4M
Effecrivenes
s
0-5
64 Female Hemorrhoid
s
Swelling &
Pam
7 days Analprarn Yes 5
86 Female Hemonrheid
s
Bleeding &
Pam
! da y N/A N/A 5
m Male llemeffheid
s
Swelling 1 week Prep if Yes 4
w
A
Female Hemenribosd
a
Swelling 1 day N/A Yes 5
w
A
N/A Hemorrhoid
s
Pain &
Itching
7 'days Analpram Yes 3
42 Female Hemonrfadd
s
Pain 2 weeks N/A Yes 3
80 Male Hemorrhoid
s
Swelling 4%
Pain
todays Prep H Yes 5
78 Male Hemmtheid
s
Bleeding &
Pain
2 wee ks An&lpmni Yes 3
(Spec. ^ 19, as amended Dec. 26, 2011).
Table 1 details exemplary case studies [that] list[] the age and
gender of a majority of patients[,] the diagnosis, symptoms,
time for results, over-the-counter medications used by the
patients, each patient’s opinion of whether [Appellant’s]
gel/ointment has better results than the over-the-counter
10
Appeal 2016-004261
Application 12/547,241
medications and a rating score of effectiveness associated with
the gel/ointment.
(Spec. 18 and 20.)
FF 18. Appellant contends that “the gel/ointment in accordance with []
embodiments of [his] invention have dramatic synergistic effects over usage
of the active ingredients [, bromelian and Hamamelis virginiana,]
individually” (Spec. ^ 18).
FF 19. Thornton declares that “as detailed in Table 1 of [his Specification],
the combination of Bromelian and Hamamelis Virginiana in a gel/ointment
[] provided superior results relative [to] the over-the-counter and
prescription options” (2011 Thornton Dec. ^ 5; see generally id. ]fl[ 3-5).
FF 20. Examiner finds that Barak discloses a composition, for the treatment
of hemorrhoids, that comprises “Bromelain[,] Hamamelis Virginiana,”
“alcohols [] such as polyvinyl alcohols[,]” and “hydroxyethylcellulose”
(Ans. 7, citing Barak 10: 4, 16: 19-20, 17: 9, 18: 29, 19: 7, 19:25-26, and
20: 1; see also Ans. 11 (“Barak [] states that hemorrhoids can be treated with
witch hazel and bromelain”)).
ANALYSIS
The rejection over the combination ofKling, Buchholz, Jensen, and Warren:
Based on the combination ofKling, Buchholz, Jensen, and Warren,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been “prima facie obvious to combine two compositions^ e.g.,
the composition ofKling and Warren,] each of which is taught by the prior
art to be useful for the same purpose, [i.e. treating hemorrhoids,] in order to
form a third composition to be used for the very same purpose” (Ans. 6,
citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980); see also Ans. 10).
Therefore, Examiner concludes that, “in the absence of evidence to the
11
Appeal 2016-004261
Application 12/547,241
contrary,” Appellant’s “claimed invention was prima facie obvious to one of
ordinary skill in the art at the time the invention was made” (Ans. 6-7).
“Evidence that a combination of known components results in an
effect greater than the predicted additive effect of the components can
support a finding of nonobviousness”. Wm. Wrigley Jr. Co. v. Cadbury
Adams USA LLC, 683 F.3d 1356, 1362 (Fed. Cir. 2012). On this record,
however, we are not persuaded by Appellant’s contentions regarding
synergism (App. Br. 8-9). Notwithstanding Appellant’s contentions
regarding his gel/ointment formulation, the topical composition of
Appellant’s claim 3 is not limited to a gel or ointment (App. Br. 8-9; FF
17- 19; cf. Response to Notice of Non-Compliant App. Br. 2). Further, as
Examiner explains, “[t]he results presented on Page 4 including paragraphs
18- 19 and Table 1[, of Appellant’s Specification,] fail to illustrate synergy”
(Ans. 11). To the contrary, Examiner finds, and we agree, that Appellant’s
results just show how various patients feel after receiving []
treatment^] the results do not show how patients respond who
are only administered either just the bromelain or just the witch
hazel alone. Therefore, it is impossible to verify that the results
of the composition have a greater effect than what would have
been expected by just having the two ingredients present.
{Id.) In this regard, as Examiner finds, “it was already known that witch
hazel and bromelain could be used [] to treat hemorrhoids” {id.; FF 9-11, 14,
and 15; see Ans. 12 (“Kling and Warren show that bromelain and witch
hazel can be used to treat hemorrhoids”)).
The rejection over Barak:
Examiner concludes that, at the time Appellant’s invention was made,
Barak disclosed “a topical composition for the treatment of hemorrhoids
12
Appeal 2016-004261
Application 12/547,241
comprising Bromelain[] and Hamamelis Virginiana” (Ans. 7; FF 5, 6, 8, and
20). In this regard, we note that the “[d]isclos[ure of] a multitude of
effective combinations does not render any particular formulation less
obvious.” Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804,
807 (Fed. Cir. 1989).
Appellant’s claim 3 is not limited to a gel or ointment (Response to
Notice of Non-Compliant App. Br. 2; cf. App. Br. 10). Therefore, we are
not persuaded by Appellant’s contentions regarding a gel. Further, for the
reasons discussed above, we are not persuaded by Appellant’s contentions
regarding Barak’s device, problems “associated with direct topical
application^]” or that Barak teaches away from Appellant’s claimed
invention (App. Br. 10).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Kling, Buchholz, Jensen, and Warren is affirmed.
Claim 4 is not separately argued and falls with claim 3.
The rejection of claim 3 under 35 U.S.C. § 103(a) as unpatentable
over Barak is affirmed. Claim 4 is not separately argued and falls with claim
3.
Utility.
ISSUE
Does the evidence of record support Examiner’s finding that
Appellant’s claimed invention is directed to non-statutory subject matter?
13
Appeal 2016-004261
Application 12/547,241
ANALYSIS
We adopt as our own the findings and reasons set forth by Examiner
(Ans. 12-13). Moreover, we agree with Examiner that the composition set
forth in Appellant’s claim 3 represents patent-ineligible subject matter;
specifically, a composition comprising the combination of two naturally
occurring products: (1) “Bromelain” and (2) “witch hazel” (see Ans. 12). In
this regard, we find no error in Examiner’s conclusion that the “[ejven
though a composition containing bromelain and witch hazel are not typically
found in nature, each individual component of the composition is not
different from the wild type counterpart” and “[t]he characteristics of the
bromelain and the witch hazel in the claimed composition do not appear
different from what occurs naturally. Since the claimed bromelain and the
witch hazel do not have markedly different characteristics, they are ‘product
of nature’ exceptions” (Ans. 13). Stated differently, the elements of
Appellant’s claimed invention when considered individually or “as an
ordered combination” do not “transform the nature of the claim” into patent-
eligible subject matter. See Alice Corp. Pty. Ltd. v. CLS Banklnt’l, 134 S.
Ct. 2347, 2355 (2014), quoting Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 132 S. Ct. 1289, 1297 (2012).
On this record, Appellant failed to establish an evidentiary basis to
support a conclusion that the creation of a composition comprising
bromelain and witch hazel changes the structure, function, or other
properties of bromelain and witch hazel. Further, as discussed above, the
combination of bromelain and witch hazel into a topical composition was
“well-understood, routine, conventional activity already engaged in by the
scientific community” and “when viewed as a whole, add nothing significant
14
Appeal 2016-004261
Application 12/547,241
beyond the sum of their parts taken separately” (see generally FF 2-11, 15,
and 20). See, e.g., Mayo, 132 S. Ct. at 1298; see also Funk Brothers Seed
Co. v. Kala Inoculant Co., 333 U.S. 127, 131 (1948).
For the foregoing reasons, we are not persuaded by Appellant’s
contentions that “a topical composition comprising both Witch Hazel and
Bromelain [] is not a naturally occurring combination,” and that Appellant
“makes no claim to either ingredient separately and limits the combination to
a topical composition of the two ingredients” (Reply Br. 2).
CONCLUSION OF LAW
The evidence of record supports Examiner’s finding that Appellant’s
claimed invention is directed to non-statutory subject matter. The rejection
of claim 3 under 35 U.S.C. § 101, as directed to non-statutory subject matter
is affirmed. Claim 4 is not separately argued and falls with claim 3.
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).
AFFIRMED
15