Kannalnnovations LLC

Patent Trials and Appeals Board

Aug 3, 2020

2020001741 (P.T.A.B. Aug. 3, 2020)

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.
15/609,253 05/31/2017 Babek Ghalili 111292-0104 1642
22428 7590 08/03/2020
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
BARHAM, BETHANY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
08/03/2020 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BABEK GHALILI and KEVIN MCGOVERN
Appeal 2020-001741
Application 15/609,253
Technology Center 1600
Before ULRIKE W. JENKS, TAWEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 27, 31–34, and 36–38. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as
KannaInnovations, LLC. Appeal Br. 3.
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STATEMENT OF THE CASE
According to the Specification, “there is a need in the art for improved
treatment options for improving skin condition, delaying and reducing the
effects of skin aging and treating or preventing skin disorders.” Spec. 3.
The Specification states that “[c]annabinoids are . . . compounds found in
Cannabis sativa, an annual plant belong to the Cannabaceae family,” and
that “[e]xamples of organic cannabinoids include . . . hemp oil.” Id. at 7, 9.
The Specification also states that alpha hydroxyl acids, such as glycolic
acids, are chemical exfoliants. Id. at 8. Further according to the
Specification,
[t]he present inventors have unexpectedly discovered that
compositions containing hydroxy acids in combination with one
or more cannabinoids provide a number of advantages not
found when either active agent is used by itself, including
reduced skin irritation and fast healing of any skin condition
that is enhanced by inflammation including, but not limited to,
acne, aging spots, scar formation, eczema and wrinkles.
Id. at 9.
CLAIMED SUBJECT MATTER
The claims are directed to a method for reducing lines or wrinkles on
skin of a human subject. Claim 27 is illustrative:
27. A method for reducing lines or wrinkles on skin of a human
subject comprising

(i) selecting a human subject having skin with lines or
wrinkles in need of treatment, and

(ii) topically administering to the skin having the lines or
wrinkles of the human subject a
composition in the form of an ointment, a cream, an emulsion, a
lotion, a paste, an unguent, or a gel consisting of (a) a combination of
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hemp oil and an alpha hydroxy acid, wherein the hemp oil is present
in a concentration between 0.1 and 30 % by weight of the
composition; wherein the alpha hydroxy acid is present in a
concentration between 0.1 and 10[]% by weight of the composition;
(b) a carrier that forms the ointment, cream, emulsion, lotion, paste,
unguent, or gel; and (c) optionally one or more of a thickener,
stabilizer, an antibiotic, an antiseptic agent, an antifungal, an
antibacterial agent, an analgesic, an antiviral agent, or a UV-absorbing
agent.
Appeal Br. 11 (Claims App.).

REJECTION(S)
Claims 27, 31–34, and 36–38 are rejected under 35 U.S.C. § 103 as
being unpatentable over Yu,2 Pless,3 and Dazey.4

OPINION
A. Issue
The Examiner finds that Yu teaches all of the limitation of claim 27,
except that it does not teach a composition comprising “hemp oil present in a
concentration between 0.1 and 30% by weight of the composition.” Final
Act. 5.

2 Yu et al., US 4,363,815, issued Dec. 14, 1982.
3 Petra Pless & Gero Leson, Assessing the Impact of THC Uptake from
Hemp Oil Cosmetics on Workplace Drug Testing (Mar. 2001),
https://web.archive.org/web/20050530010327/http://nova-
institut.de/pdf/hempoilcosmet-drugtesting.pdf (last visited July 28, 2020).
4 About Hemp Seed Oil, DAZEYHEMP.COM,
http://web.archive.org/web/20120129032942/http://dazeyhemp.com/about-
hemp-seed-oil/ (last visited July 28, 2020).
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However, the Examiner finds that Pless teaches that “hemp oil can be
used in a variety of cosmetics or body care products such as creams” and
that it has “preventative and therapeutic benefits for the skin.” Final Act. 5.
The Examiner, more particularly, finds that Pless teaches that “hemp oil’s
PUFA content can slow down skin aging and the formation of wrinkles” and
further teaches that “products including creams typically have hemp oil
contents of 2–10 wt.%.” Id.
The Examiner finds that, in addition, “Dazey teaches hemp seed oil is
used for its great effects on moisturizing and hydrating the skin, while
bringing a host of other benefits such as recompensing for lower ceramide
levels in the skin and thereby reducing the appearance of wrinkles.” Final
Act. 5–6.
The Examiner finds that a skilled artisan would have been motivated
to incorporate hemp oil in Yu’s topical compositions because “Dazey, Pless
. . . , and Yu . . . are all . . . directed toward topical applications that are
drawn to slowing down the formation of . . . and reducing the appearance of
wrinkles.” Final Act. 6. The Examiner also finds that a skilled artisan
would have had “a reasonable expectation of success to incorporate hemp oil
in the compositions of Yu . . . since Pless . . . disclose[s] that hemp oil is
effective in topical compositions for reducing skin aging and Dazey teaches
hemp oil reduces the appearance of wrinkles just like [the] glycolic acid”
(i.e., an alpha hydroxy acid) in Yu’s composition. Id. Citing In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980), the Examiner concludes that
“[i]t is prima facie obvious to combine two compositions each of which is
taught by the prior art to be useful for the same purpose, in order to form a
third composition to be used for the very same purpose.” Id.
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Appellant contends that Pless and Dazey are not properly prior art to
the claimed invention because the Examiner has not established a prima
facie case that they were publicly accessible before the critical date. Appeal
Br. 6–8. Appellant also contends that, in any event, claims 36 and 37 are
separately patentable even if Pless and Dazey are prior art, because the cited
prior art combination does not “provide[] an expectation that hemp oil
combined with an [alpha hydroxyl acid] could be applied in a 28-day
treatment to reduce wrinkles or lines in the face area to a greater extent than
an identical composition with either active ingredient alone as claimed in
claims 36 and 37.” Id. at 6, 8–9.
The issues with respect to this rejection are (1) whether Pless and
Dazey are prior art to the claimed invention and, if so, (2) whether a
preponderance of evidence supports the Examiner’s conclusion that claims
36 and 37 are obvious over the combination of Yu, Pless, and Dazey.
B. Analysis
Whether a reference qualifies as a prior art “printed publication” for
purposes of an obviousness analysis is a legal conclusion based on
underlying factual determinations. In re Lister, 583 F.3d 1307, 1311 (Fed.
Cir. 2009). In order to qualify as a printed publication, a reference “must
have been sufficiently accessible to the public interested in the art.” Id.
(internal quotation marks omitted). “Whether a reference is publicly
accessible is determined on a case-by-case basis based on the facts and
circumstances surrounding the reference’s disclosure to members of the
public.” Id. (internal quotation marks omitted). Finally, “[a] reference is
considered publicly accessible if it was disseminated or otherwise made
available to the extent that persons interested and ordinarily skilled in the
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subject matter or art exercising reasonable diligence, can locate
it.” Id. (internal quotation marks omitted).
With the above framework in mind, we turn to the facts of this case.
The Examiner explains that she located Pless and Dazey through a Google
search. Ans. 3–4. Furthermore, the evidence of record suggests that Pless
and Dazey were archived on the Wayback Machine prior to the effective
filing date of the claimed invention, which would have meant that they were
available at the same web addresses prior to the effective filing date of the
claimed invention.5 Id. at 4.
Appellant appears to concede that Pless and Dazey were archived on
the Wayback Machine prior to the critical date. Appeal Br. 6. However,
Appellant contends that “merely showing that Dazey and Pless were
archived as of a certain date does not mean that either was indexed
meaningfully or that either could have been retrieved before the critical date
using reasonable diligence.” Id. at 6. Citing to In re Lister, 583 F.3d 1307,
1311 (Fed. Cir. 2009) and Apple Inc. v. DSS Tech. Mgmt., Inc., IPR 2015-
00369, Paper 14 (PTAB Aug. 12, 2015), Appellant contends that
“[e]vidence of archiving alone is not sufficient to shift the burden to
applicant to prove that a reference was not publicly accessible when none of

5 The Wayback Machine is a service provided by the Internet Archive that
allows “[v]isitors . . . [to] search [the Internet Archive’s web] archives by
URL (i.e., a website address).” Internet Archive, Standard Affidavit,
https://archive.org/legal/affidavit.php (accessed July 26, 2020). “If archived
records for a URL are available, the visitor will be presented with a list of
available dates. The visitor may select one of those dates, and then begin
surfing on the archived version of the Web.” Id.
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the other factors weighing in favor of accessibility are applicable.” Appeal
Br. 6.
We are not persuaded by Appellant’s arguments and find that the
Examiner has established a prima facie case that Pless and Dazey were
publicly accessible as of the effective filing date of the claimed invention.
As the Examiner points out, she was able to locate the articles via Google
search, and “[t]here have not been dramatic changes in the search power of
Google” between the effective filing date of the invention (August 11, 2015)
and the time of the Examiner’s Google search. Ans. 4; cf., e.g., Ex Parte
Albert, 18 USPQ 2d 1325 (BPAI 1984) (“[T]he examiner met his burden of
proof by setting forth the nominal publication date. . . . The Patent and
Trademark Office is in no position to establish any thing beyond that.”); In
re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (establishing that the prima
facie case is a procedural device that shifts the burden of production to the
applicant and that the USPTO sets forth a prima facie case when its rejection
satisfies the notice requirement of 35 U.S.C. § 132).
Appellant’s citation to DSS Technology Management and In re Lister
are inapposite. In DSS Technology Management there was no evidence of
what it meant, in terms of public accessibility, for a thesis to be “‘archived’
by the Massachusetts Institute of Technology (‘MIT’) Libraries.” DSS Tech.
Mgmt., IPR 2015-00369, Paper 14, 6–8. Similarly, the parties agreed in In
re Lister that the Copyright Office’s automated catalog, which allowed for
no searching of the catalog by keyword or subject matter, alone would have
been insufficient to support a finding of public accessibility, and the court
further found that, while “the evidence shows that at some point in time
Westlaw and Dialog incorporated the Copyright Office’s automated catalog
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information about the Lister manuscript into their own databases,” “[t]here is
no indication as to when that occurred or whether it was prior to the critical
date.” In re Lister, 583 F.3d at 1317.
In contrast, archiving by the Wayback Machine generally indicates
that the archived data was available on the World Wide Web on the archived
date,6 and, as discussed above, the Examiner was able to locate the
references at issue on the web by using a Google search during prosecution.
Thus, unlike the situation in DSS Technology Management and In re Lister,
the Examiner has provided evidence that, prior to the critical date, Pless and
Dazey would have been locatable by a skilled artisan exercising reasonable
diligence by, e.g., performing a Google search.
Appellant contends in the Reply Brief that “the need to show indexing
evidence when a prior art document does not display any other indicia
showing that it was widely disseminated or published by a well-known

6 In particular, the Standard Affidavit available on the Internet Archive
website explains that “[t]he archived data made viewable and browseable by
the Wayback Machine is compiled using software programs known as
crawlers that surf the Web and automatically store copies of website files,
preserving these files as they exist at the point of time of capture.” Internet
Archive, Standard Affidavit, https://archive.org/legal/affidavit.php (accessed
July 26, 2020). The Standard Affidavit provides some caveats: For
example, “[t]he [archive] date assigned by the Internet Archive applies to the
HTML file but not to image files linked therein,” and “[t]hus images that
appear on the printed page may not have been archived on the same date as
the HTML file.” Id. Similarly, the Standard Affidavit explains that, “if a
website is designed with ‘frames,’ the date assigned by the Internet Archive
applies to the frameset as a whole, and not the individual pages within each
frame.” Id. However, as explained below, Appellant has not timely argued,
or provided persuasive evidence, that such caveats apply to the references at
issue in this appeal.
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journal or publisher exists regardless of whether it is an internet document
from yesterday or a thesis from 20 years ago.” Reply Br. 2.
We are not persuaded. “The determination of whether a reference is a
‘printed publication’ . . . involves a case-by-case inquiry into the facts and
circumstances surrounding the reference’s disclosure to members of the
public.” In re Klopfenstein, 380 F.3d at 1350. The factual considerations
surrounding an Internet document located on the World Wide Web, which
may be searched using various Internet search engines, are very different
from the considerations surrounding a paper copy of a thesis located in a
single library. Appellant has cited no authority, and we are aware of none,
that indexing is required unless a reference was widely disseminated or
published by a well-known journal or publisher. In re Lister, 583 F.3d at
1312 (explaining that, “[w]hile cataloging and indexing have played a
significant role in our cases involving library references, . . . neither
cataloging nor indexing is a necessary condition for a reference to be
publicly accessible”); In re Klopfenstein, 380 F.3d 1345, 1348 (Fed. Cir.
2004) (explaining that precedent does not “limit [the] court to finding
something to be a ‘printed publication’ only when there is distribution and/or
indexing”).
Given that “the examination context involves a burden-shifting
framework under which the USPTO can shift the burden to the applicant to
come forward with rebuttal evidence or argument to overcome a prima facie
case,” Ex parte Grillo-Lopez, 2020 WL 597718 *1, Appeal No. 2018-
006082 (PTAB Jan. 31, 2020) (precedential), we next turn to Appellant’s
rebuttal.
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Appellant has not provided any evidence that the results of Google
searches would have been significantly different at the time of the effective
filing date of the claimed invention as compared to the time of the
Examiner’s search. Instead, Appellant alleges that PubMed, “one of the
most common search engines for prior art in the medical field[,] has not
indexed either [Pless or Dazey],” even though at least one other publication
by Pless has been indexed on PubMed. Appeal Br. 7. Appellant contends
that “[t]his suggests that Pless did not make the particular publication cited
by the rejection accessible, such as by publishing it in a journal.” Id. at 7–8.
Appellant further alleges that
the rejection [does not] suggest that any other prior art document has
ever cited the relevant portions of Pless or Dazey that are actually
quoted and relied upon in the rejection (evidencing that a person of
ordinary skill in the art could have located versions of the Pless or
Dazey references that contain the particular information actually
relied upon in the rejection before the filing date of the present
invention using reasonable diligence.
Reply Br. 2.
We are not persuaded. There is no requirement that a reference be
available in a database such as PubMed, or published in a journal, in order to
be considered publicly accessible. In re Klopfenstein, 380 F.3d at 1348.
Similarly, “once accessibility is shown, it is unnecessary to show that
anyone actually inspected the reference.” In re Lister, 583 F.3d at 1314.
Finally, in the Reply Brief, Appellant contends that “[t]he rejection
does not provide copies of archived versions to show that they contain the
same information as the recently retrieved . . . versions that are actually
quoted in the rejection (despite applicant’s request for the Office to provide
the archived versions . . . ).” Reply Br. 2.
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We are not persuaded. Appellant raises this argument only in the
Reply Brief, without providing an explanation as to why it could not have
been raised in the Appeal Brief. Thus, Appellant has waived the argument.
See Ex parte Nakashima, 93 USPQ2d 1834 (BPAI 2010) (informative)
(explaining that arguments and evidence not timely presented in the
principal Brief will not be considered when filed in a Reply Brief, absent a
showing of good cause explaining why the argument could not have been
presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1477
(BPAI 2010) (informative) (“Properly interpreted, the Rules do not require
the Board to take up a belated argument that has not been addressed by the
Examiner, absent a showing of good cause.”).
Furthermore, evidence suggests that the references in the record are
the archived versions or identical to the archived versions. The Dazey
reference in the record, for example, displays the following URL in its
footer: https://web.archive.org/web/20120129032942/
http://dazeyhemp.com/about-hemp-seed-oil/. This footer suggests that the
copy of the Dazey reference in the record is the HTML file archived on
January 29, 2012 at 3:29 a.m. and 42 seconds. Internet Archive, Standard
Affidavit, https://archive.org/legal/affidavit.php (accessed July 27, 2020)
(“The Internet Archive assigns a URL on its site to the archived files in the
format http://web.archive.org/web/[Year in yyyy][Month in mm][Day in
dd][Time code in hh:mm:ss]/[Archived URL].”). Likewise, although the
copy of Pless in the record does not include a similar footer, the cover page
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of the reference includes a date of March 2001.7 Appellant has not provided
persuasive evidence that the versions of the references quoted in the
rejection were, in fact, different from the archived versions.

Claims 36 & 37
Appellant has not disputed that, to the extent Pless and Dazey are
prior art within the meaning of 35 U.S.C. § 103, the cited combination of
prior art renders independent claim 27 obvious. However, Appellant argues
that, “[e]ven if the prior art would have been combined as asserted, and Pless
and Dazey were both shown to have been publicly accessible,” claims 36
and 37 are nevertheless separately patentable.
To facilitate our analysis, Claims 36 and 37 are reproduced below:
36. The method of claim 27, wherein the composition, if applied
daily for at least 28 days, reduces lines and wrinkles in the face area
of the treated human subject to a greater extent than an otherwise
identical composition with either hemp oil alone or alpha hydroxy
acid alone.

37. The method of claim 36, wherein the alpha hydroxyl acid is
glycolic acid.
Appeal Br. 12 (Claims App.).
Appellant argues that the combination of Yu, Pless, and Dazey does
not “provide[] an expectation that hemp oil combined with an AHA could be
applied in a 28-day treatment to reduce wrinkles or lines in the face area to a

7 As discussed above, there are situations where the archive date that appears
in the footer may not be the date certain information on the archived page
was, in fact, archived. See supra n. 6. However, Appellant has provided no
argument or evidence that any of these situations are applicable in the instant
case.
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greater extent than an identical composition with either active ingredient
alone as claimed in claims 36 and 37.” Appeal Br. 6; see also id. at 8–9.
In particular, Appellant contends that “[t]here is no data [in Pless and
Dazey], and
[n]othing in Pless or Dazey indicates that lines and wrinkles in the
face area can be reduced with topical administration of hemp oil to the
skin having lines or wrinkles within a 28–day period. Neither Pless
nor Dazey gives any disclosure of how much or how long to apply
hemp oil, nor any indication of whether topical administration of the
hemp oil itself is effective for reducing lines and wrinkles in the face
within 28 days, nor the extent of wrinkle reduction that can be
expected and whether it would approach the magnitude shown in the
examples of the present specification when used in combination with
alpha hydroxy acid.
Appeal Br. 8–9; Reply Br. 3.
We are not persuaded. Claims 36 and 37 do not require a step of
applying the composition recited in the claims for at least 28 days. Rather,
they merely require that the composition, “if applied daily for at least 28
days,” achieves the recited effects. Thus, the step of applying the
composition for 28 days is conditional and, as such, the Examiner does not
have to find that the prior art discloses this method step. Ex parte
Schulhauser, Appeal 2013-007847, 2016 WL 6277792, at *7-8 (Apr. 28,
2016) (precedential).
Furthermore, to the extent the claim is interpreted to require the
particular effect claimed after application of the composition for 28 days, we
note that Appellant has not disputed that the cited prior art combination
suggests the compositions recited in the claims. Thus, this claimed effect
would inherently be met if the composition were applied for at least 28 days.
Cf. In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990) (“When the claimed
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compositions are not novel they are not rendered patentable by recitation of
properties, whether or not these properties are shown or suggested in the
prior art.”).
Even if the claims were to require the application of the compositions
recited in the claims for at least 28 days, the claims would still be obvious.
“[W]here the general conditions of a claim are disclosed in the prior art, 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 this
case, the prior art generally suggests the claimed method of “topically
administering [the recited compositions] to the skin having the lines or
wrinkles of the human subject,” and it is not inventive to discover the
optimum or workable frequency and/or duration of administration, unless
the claimed method exhibits unexpected results. In re Antonie, 559 F.2d
618, 620 (CCPA 1977).
Appellant has made no persuasive showing of such unexpected
results. “[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
Similarly, “[a]ttorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). While Appellant
contends in the Appeal Brief that claims 36 and 37 should be separately
patentable over the cited references because they are “expressly limited to
the unexpected result recited in the present application,” Appeal Br. 9, they
cite no evidence supporting this attorney argument.
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Appellant does cite generally to “examples of the present
specification” and specifically to Example 5 in support of its unexpected
arguments in the Reply Brief. Reply Br. 3–4. These arguments are waived
because Appellant neither raised them in the Appeal Brief, nor explained
why they could not have been raised therein. See Ex parte Nakashima, 93
USPQ2d 1834 (BPAI 2010) (informative); Ex parte Borden, 93 USPQ2d
1473, 1477 (BPAI 2010) (informative).
In any event, the examples in the Specification do not suffice to show
that the subject matter of the invention exhibits unexpected results. “[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.” In re
Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Only Example 5
provided any results relating to the alleged efficacy of the claimed
compositions. However, all the compositions tested in Example 5 contain
cannabis sativa (hemp) seed oil and glycolic acid together. Spec. 21–22.
Thus, Example 5 does not provide evidence that any alleged efficacy of the
claimed composition is unexpected as compared to the closest prior art (e.g.,
either glycolic acid alone or hemp seed oil alone).
Finally, “[i]t is well established that the objective evidence of
nonobviousness must be commensurate in scope with the claims.” In re
Lindner, 457 F.2d 506, 508 (CCPA 1972). Example 5 does not provide
evidence of alleged unexpected results commensurate with the scope of
either claims 36 and 37. These claims depend from claim 27, which recites
compositions wherein hemp oil is present in a concentration between 0.1 and
30% by weight and the alpha hydroxy acid (glycolic acid in the case of
claim 37) is present in a concentration between 0.1 and 10% by weight of
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the composition. Appeal Br. 11, 12 (Claims App.). Appellant provides no
information regarding the weight percentages of the hemp oil or glycolic
acid present in the compositions tested in Example 5, much less evidence
that provides an adequate basis for concluding that the untested
embodiments encompassed by the claims would have behaved in the same
manner as the tested embodiments. In re Lindner, 457 F.2d at 508.
Accordingly, we affirm the Examiner’s rejection of claims 27, 31–34,
and 36–38 as obvious over Yu, Pless, and Dazey.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
27, 31–34,
36–38
103 Yu, Pless, Dazey 27, 31–34,
36–38

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED