Philip Robson et al.

Patent Trials and Appeals Board

Jul 18, 2019

15068707 - (D) (P.T.A.B. Jul. 18, 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.
15/068,707 03/14/2016 Philip Robson H0664.70033US01 3397
23628 7590 07/18/2019
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC AVENUE
BOSTON, MA 02210-2206
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/18/2019 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):
Patents_eOfficeAction@WolfGreenfield.com
WGS_eOfficeAction@WolfGreenfield.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PHILIP ROBSON and GEOFFREY GUY1
__________

Appeal 2019-004298
Application 15/068,707
Technology Center 1600
__________

Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

HARDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method of treatment of arthritis comprising administering a pharmaceutical
formulation comprising a therapeutically effective amount of a combination
of cannabidiol (CBD) and tetrahydrocannabinol (THC) in certain ratios. The
claims have been rejected as anticipated by and obvious over the prior art.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm, and designate our affirmance as New Grounds of
Rejection.

1 Appellants identify the real party in interest as “GW Pharma Limited.”
Appeal Br. 3.
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STATEMENT OF THE CASE
The Specification states:
A major disadvantage with the currently available drug therapies
to treat arthritis is that the patient often has to take a combination
of drugs in order to treat the symptoms of the disease such as the
pain and associated inflammation, and at the same time the
patient has to take a drug in order to modify the disease.
Spec.2 7:20–25. According to the Specification:
Surprisingly it has been found that the use of a cannabis based
medicine extract that contains approximately equal amounts of
the cannabinoids delta-9-tetrahydrocannabinol (THC) and
cannabidiol (CBD) can be used to both modify rheumatoid
arthritis disease and treat the symptoms of pain and inflammation
caused by the disease.
Id. at 7:31–8:2.
Claims 43, 45, 52, 55–62, and 64–66 are on appeal.3 Claim 43, the
only independent claim, reads as follows (spacing added):
43. A method for treatment of arthritis comprising
administering to a subject in need thereof a pharmaceutical
formulation comprising a therapeutically effective amount of a
combination of cannabidiol (CBD) and tetrahydrocannabinol
(THC),
wherein the ratio of CBD:THC by weight is 1.5:1 to 1:1.5, and

2 The Specification filed June 28, 2016 (“Spec.”) will be referenced
throughout this Decision.
3 In the Appeal Brief, Appellants do not acknowledge claims 55–58. See,
e.g., Appeal Br. 4. Nevertheless, Appellants do not appear to have
withdrawn or cancelled these claims during prosecution, and the Examiner
has listed them as subject to rejections. See, e.g., Final Act. 4 (listing claim
55 as subject to rejection); id. at 20 (listing claims 55–58 as subject to
rejection); Ans. 3 (listing claim 55 as subject to rejection); id. at 8 (same).
We, therefore, consider claims 55–58 along with the other claims on appeal.
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wherein the amount of the pharmaceutical formulation
administered to the subject is effective to decrease Disease
Activity Score.
Id. at 18 (Claims Appendix).
The claims stand rejected as follows:
Claims 43, 45, 55, 59–62, and 64–66 are rejected under 35 U.S.C.
§ 102 as anticipated by or, in the alternative, under 35 U.S.C. § 103 as
obvious over Werner.4 Final Act. 4.
Claim 52 is rejected under 35 U.S.C. § 103 as obvious over Werner.
Id.
Claims 43, 45, 52, 59–62, and 64–66 are rejected under 35 U.S.C.
§ 103 as obvious over Werner, Sofia,5 Bendele,6 and Malfait.7 Id. at 13.
Claims 43, 45, 52, 55–62, and 64–66 are rejected under 35 U.S.C.
§ 103 as obvious over Werner, Sofia, Bendele, Malfait, Whittle,8 and GW
Pharmaceuticals.9 Id. at 20.

4 Werner et al., US 2004/0138293 A1, published July 15, 2004.
5 R. D. Sofia et al., Anti-Edema & Analgesic Properties of Δ9-
Tetrahydrocannabinol (THC), 186(3) J. PHARMACOL. & EXP. THER. 646–55
(1973) (“Sofia”).
6 Alison Bendele et al., Animal Models of Arthritis: Relevance to Human
Disease, 27(1) TOXICOL. PATHOL. 134–42 (1999) (“Bendele”).
7 A. M. Malfait et al., The nonpsychoactive cannabis constituent cannabidiol
is an oral anti-arthritic therapeutic in murine collagen-induced arthritis,
97(17) PNAS 9561–66 (2000) (“Malfait”).
8 Whittle, US 2004/0034108 A1, published Feb. 19, 2004.
9 GW Pharmaceuticals, Cannabis-Based Medicines – GW Pharmaceuticals:
High CBD, High THC, Medicinal Cannabis – GW Pharmaceuticals,
THC:CBD, 4(5) DRUGS R&D 306–09 (2003).
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DISCUSSION
“[T]he examiner bears the initial burden . . . of presenting a prima
facie case of unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.” In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). We have considered those arguments
made by Appellants in the Appeal Brief and properly presented in the Reply
Brief; arguments not so presented in Appellants’ briefs are waived. See 37
C.F.R. § 41.37(c)(1)(iv) (2015); see also Ex Parte Borden, 93 USPQ2d
1473, 1474 (BPAI 2010) (informative) (“Any bases for asserting error,
whether factual or legal, that are not raised in the principal brief are
waived.”).
Appellants focus their arguments on the limitations in independent
claim 43, and thus, we do the same. Further, Appellants did not proffer any
separate arguments for dependent claims 52, 55, 59–62, and 64–66.
Accordingly, all of the appealed claims stand or fall with claim 43. See, e.g.,
In re Kaslow, 707 F.2d 1366, 1376 (Fed. Cir. 1983).
Anticipation
The Examiner rejected claims 43, 45, 55, 59–62, and 64–66 as
anticipated by Werner. Final Act. 4. The Examiner found that Werner
teaches the administration of a CBD/THC composition, including for the
treatment of arthritis. Id. at 4–5. The Examiner argued that the claimed
ratio of CBD:THC is anticipated by Werner (id. at 4–6, 7), that Werner
teaches therapeutically effective amounts (id. at 6), and that the final
“wherein” clause of claim 43 is merely “an expression of the intended result
of a process step, which is not given weight.” Id. at 7, 11.
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In response, Appellants argued that the wherein clause should be
given patentable weight because it is “an integral part of the invention,” and
because “only certain formulation quantities will effectively decrease a
Disease Activity Score when administered according to the claimed
method.” Appeal Br. 5. Appellants further argued that “Werner only
discloses therapeutic composition amounts for embodiments wherein the
disclosed composition is used in palliative cancer therapy . . . and multiple
sclerosis (MS)-related therapy . . . .” Id. at 6–7.
We determine that the Examiner has not made out a sufficient case of
anticipation. To begin, we disagree with the Examiner’s determination to
give no weight to the “wherein” clause recited in claim 43. See, e.g., Final
Act. 11. Claim 43 recites a “method for treatment of arthritis,” and requires
a “therapeutically effective amount,” “wherein the amount of the
pharmaceutical formulation administered to the subject is effective to
decrease Disease Activity Score.” Appeal Br. 18 (Claims Appendix). While
claim 43 does not recite specific dosage amounts, in the context of the claim,
the phrase “therapeutically effective amount” is defined in terms of efficacy
in decreasing the Disease Activity Score in a subject with arthritis. Id. As
noted by Appellants, “only certain formulation quantities will effectively
decrease a Disease Activity Score when administered according to the
claimed method.” Appeal Br. 5. As such, we conclude that the Examiner
erred in giving the “wherein” clause no weight because, together with the
claim language reciting a “therapeutically effective amount,” the “wherein”
clause impacts the dosages of the pharmaceutical formulations that are
administered in the claimed method. See, e.g., Griffin v. Bertina, 285 F.3d
1029, 1033–34 (Fed. Cir. 2002) (finding that a “wherein” clause limited a
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method claim where the clause gave “meaning and purpose to the
manipulative steps”).
We next turn to whether Werner teaches all limitations of claim 43, as
properly construed. The Examiner conceded that the exemplary dose ranges
in Werner reference palliative cancer therapy and MS-related spasms, but
nevertheless argued that Werner’s “dosage guidance . . . blazes a trail to the
use of these amounts for treating other disclosed conditions, including
arthritis.” Ans. 6.
This is not sufficient for anticipation. In an anticipation rejection, the
issue is not whether doses to decrease a Disease Activity Score in subjects
with arthritis would have been obvious in view of the palliative cancer
therapy and MS-related doses disclosed in Werner, but rather whether
Werner expressly or inherently teaches such dosages. See, e.g., In re
Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009) (“Anticipation requires that
all of the claim elements and their limitations are shown in a single prior art
reference.”). As acknowledged by the Examiner (Ans. 6), the dosage ranges
disclosed by Werner are for palliative cancer therapy and MS-related
spasms. Werner ¶ 16. Werner does not otherwise teach “therapeutically
effective amounts” sufficient to decrease Disease Activity Score in arthritis
patients.
Accordingly, because Werner fails to teach all limitations of the
claims, we reverse the rejection of claims 43, 45, 55, 59–62, and 64–66 as
anticipated by Werner.
Obviousness Over Werner
The Examiner rejected claims 43, 45, 52, 55, 59–62, and 64–66 as
obvious over Werner. Final Act. 4. The Examiner found that the claimed
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ratio of CBD:THC overlaps with the ratios taught in Werner, and argued that
“[s]electing an amount from within a range taught is clearly accompanied by
an expectation of success; this is routine in the art.” Ans. 11; see also, e.g.,
Final Act. 6. As to a “therapeutically effective amount” of the formulation
to administer in the claimed method, the Examiner pointed to the dosage
ranges disclosed in Werner for palliative cancer therapy and MS-related
spasms, and concluded that they read on the claimed amounts. Final Act. 6–
7; Ans. 10, 12 (“[T]he general dosing parameters are taught by Werner at
[0016] and claim 10, which anticipate and also alternately render obvious
the claimed therapeutically effective amounts.”).
In response, Appellants argued, among other things, that “Werner
does not teach, at least, the element of: ‘wherein the amount of the
pharmaceutical formulation administered to the subject is effective to
decrease the Disease Activity Score,’” and that a person of ordinary skill in
the art would not have had a reasonable expectation of success of arriving at
the claimed CBD:THC ratio or “the claimed formulation amount.” Appeal
Br. 8, 9.
We determine that the Examiner has not established a prima facie case
of obviousness based on Werner, because the rejection lacks any persuasive
rationale about how the prior art teaches or suggests the “therapeutically
effective amount” limitation of claim 43. While it does teach that the
analgesic effect of the composition can be used to therapeutic effect on
chronic pain arising from arthritis (Werner ¶ 21), as discussed above,
Werner does not teach “therapeutically effective amounts” to decrease a
Disease Activity Score in arthritis patients. The Examiner rested on the
erroneous finding that the dosages in and of themselves in Werner read on
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the claims (see, e.g., Ans. 5–6, 10), while failing to address why a person of
ordinary skill in the art would have been motivated to use or start with the
dosage amounts disclosed by Werner for palliative cancer therapy and MS-
related spasms to treat a subject with arthritis, with a reasonable expectation
of success. And, although we find that the prior art supports such a
motivation and expectation (as discussed further below), the Examiner’s
rejection is deficient in failing to articulate such a motivation and
expectation.
Accordingly, we reverse the rejection of claims 43, 45, 52, 55, 59–62,
and 64–66 as obvious over Werner.
Obviousness of Claims 43, 45, 52, 59–62, and 64–66 Over Werner,
Sofia, Bendele, and Malfait; Obviousness of Claims 43, 45, 52, 55–62,
and 64–66 over Werner, Sofia, Bendele, Malfait, Whittle, and GW
Pharmaceuticals
With respect to the rejections of (i) claims 43, 45, 52, 59–62, and 64–
66 over Werner, Sofia, Bendele, and Malfait, and (ii) claims 43, 45, 52, 55–
62, and 64–66 over Werner, Sofia, Bendele, Malfait, Whittle, and GW
Pharmaceuticals, the Examiner found, among other things, that a person of
ordinary skill in the art would have arrived at the claimed ratio of CBD:THC
based on the ratios disclosed in Werner, as well as based on the amounts of
THC and CBD respectively used in the animal experiments disclosed in
Sofia and Malfait. Final Act. 16, 20–21. The Examiner further found that
from this starting point, it would have been obvious “to optimize the ratio
and doses, to achieve rheumatoid arthritis disease modification, while also
alleviating the pain associated with rheumatoid arthritis, giving the required
ratios of claims 43 and 52 as a result of routine optimization.” Id. at 16.
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We adopt the Examiner’s findings of fact with respect to these
obviousness rejections. See id. at 13–25; Ans. 15–20. We determine,
however, that as with the Examiner’s rejection of the claims as being
obvious over Werner alone, the Examiner’s analysis for these obviousness
rejections is deficient with respect to identifying support in the cited prior art
for a “therapeutically effective amount” of the formulation that is “effective
to decrease Disease Activity Score.” Nevertheless, as will be discussed
below, we find that the cited prior art would have led a person of ordinary
skill in the art to a “therapeutically effective amount” of a combination of
CBD and THC, “wherein the amount of the pharmaceutical formulation
administered to the subject is effective to decrease Disease Activity Score.”
Accordingly, we affirm the rejections of (i) claims 43, 45, 52, 59–62, and
64–66 over Werner, Sofia, Bendele, and Malfait, and (ii) claims 43, 45, 52,
55–62, and 64–66 over Werner, Sofia, Bendele, Malfait, Whittle, and GW
Pharmaceuticals, but because our reasoning in affirming these rejections
supplements or differs somewhat from that articulated by the Examiner, we
denominate our affirmances as new grounds of rejection pursuant to
37 C.F.R. § 41.50(b) to provide Appellants an opportunity to respond.
Werner teaches therapeutically effective amounts (dosages) of THC
for use in palliative cancer therapy and MS-related spasms. Werner ¶ 16.
Werner also teaches preferred ratios of THC:CBD (id. ¶¶ 3–5), and thus by
extension, teaches dosages of CBD to administer for use in palliative cancer
therapy and MS-related spasms. Werner further teaches that with respect to
palliative cancer therapy, the THC:CBD compositions provide relief from
depression and chronic pain, and with respect to MS, the compositions
provide, among other things, pain-relieving effects. Id. ¶¶ 16–17. Werner
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further teaches that the THC:CBD compositions can similarly provide pain-
relieving and antidepressant effects, as well as anti-inflammatory effects, in
arthritis patients. Id. ¶¶ 21–23.
Sofia teaches that in a rat model for arthritis, THC demonstrated anti-
inflammatory, analgesic, and disease-modifying effects. See, e.g., Sofia 646,
649–51, 653; Final Act. 14–15. Bendele teaches that the animal model used
in Sofia has a proven track record of predictability as a model for
rheumatoid arthritis. Bendele, Abstract; Final Act. 15–16. Malfait teaches
that in a murine model for collagen-induced arthritis, CBD demonstrated
anti-arthritic, immunosuppressive, and anti-inflammatory action. See, e.g.,
Malfait 9561; Final Act. 16.
Pharmaceutical dose has been recognized as a result-effective
parameter susceptible to routine optimization. See, e.g., Merck & Co. v.
Biocraft Labs., Inc., 874 F.2d 804, 809 (Fed. Cir. 1989) (drug dosage
limitations resulted from routine experimentation); Eli Lilly & Co. v. Teva
Pharms. USA, Inc., 619 F.3d 1329, 1342 (Fed. Cir. 2010) (“[C]onducting
clinical trials to test for an optimal dose for a drug is generally a routine
process . . .”) (citation and internal quotations omitted). As discussed above,
Werner taught dosages of THC:CBD compositions that provide
antidepressant and analgesic effects in palliative cancer therapy and in the
treatment of MS spasms, and also suggested that such compositions would
similarly provide analgesic and antidepressant effects, as well as anti-
inflammatory effects, in arthritis patients. Further, Sofia and Malfait taught
that THC and CBD, respectively, have anti-inflammatory, disease-
modifying, and/or analgesic effects in arthritis. In view of these teachings, a
person of ordinary skill in the art would have been motivated to treat arthritis
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patients with a THC/CBD formulation, and would have started with the dose
ranges taught in Werner, which were known to provide antidepressant and
analgesic effects in patients, albeit those with cancer or MS, and would have
used routine optimization to refine the dose as needed to treat arthritis
patients. Thus, in the absence of evidence of criticality in the dose
limitations (which has not been shown on this record, and which are only
generally or broadly claimed), we determine that such limitations do not
impart patentability. See, e.g., Merck & Co., 874 F.2d at 809.
As to the claimed ratio of CBD:THC, we agree with and adopt the
Examiner’s analysis as to why a person of ordinary skill in the art would
have arrived at the claimed ratio based on the cited prior art. As discussed
above, Werner teaches a range of ratios of CBD:THC that encompass the
claimed ratio, and Sofia and Malfait provide further motivation to select
about a 1:1 ratio from Werner as a starting point from which to optimize the
ratio. See Final Act. 14–17; Ans. 18–20.
Appellants argued that deriving a ratio of CBD:THC based on Sofia
and Malfait, where the drugs were used individually and in different animal
models, is based on hindsight. Appeal Br. 13; see also Reply Br. 6. We are
not persuaded by this argument. As noted, Werner teaches a range of ratios
of CBD:THC that encompasses the claimed ratio, which provides an
analgesic effect, and thus, would have led a person of ordinary skill in the art
to the claimed range. Further, we find it reasonable that a person of ordinary
skill in the art would have been guided by a comparison of the dosages of
THC and CBD respectively used in the similar models disclosed in Sofia
and Malfait in further optimizing the CBD:THC ratios taught in Werner.
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Appellants argued that the cited prior art does not teach “an amount
[of a CBD:THC formulation] effective to decrease Diseases Activity Score”
(Appeal Br. 13), and that the “Examiner improperly assumed that treating
analgesia alone is sufficient to decrease Disease Activity Score.” Reply Br.
4. We are not persuaded by these arguments. The Specification indicates
that Disease Activity Score comprises, among other things, assessments of
joint swelling and tenderness and how the patient is feeling (including with
regard to pain). Spec. 26:19–29; 16:11–22; see also Appeal Br. 6 (listing
metrics considered for Disease Activity Score). We agree with the
Examiner that Werner’s teaching that CBD:THC compositions have
analgesic effect (Werner ¶¶ 16, 21) would alone predict a lower Disease
Activity Score, based on at least the “how the patient is feeling” component
of this scoring system. Ans. 10–11. Further, the anti-inflammatory and
disease-modifying effects of the composition (taught by Werner, Sofia,
and/or Malfait) would likely impact the joint swelling and tenderness
assessment. Further, we note that although Appellants questioned the
Examiner’s assumption that pain relief would necessarily reduce the Disease
Activity Score (Reply Br. 4–5), they did not offer any evidence that a
reduction in pain would fail to reduce the score. Attorney argument is “no
substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581
(Fed. Cir. 1989).
Appellants additionally argued that a person of ordinary skill in the art
would not have been motivated to combine THC and CBD to treat patients
with arthritis, including because Werner does not teach that CBD contributes
any disease-modifying effect, and because Sofia and Malfait each teach the
use of only one of the cannabinoids, and “one of ordinary skill in the art
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would not have wanted to modulate the effects of CBD and THC.” Appeal
Br. 12–13; Reply Br. 6. We are not persuaded by these arguments. Werner
teaches benefits from the combination, because CBD modulates and
enhances the effects of THC, including by “lead[ing] to a marked reduction
in side effects.” Werner ¶ 24. Indeed, the Specification acknowledges that
THC:CBD combination formulations for the treatment of various diseases
and conditions, including arthritis, were known in the prior art. Spec. 6:8–
7:13. Additionally, Sofia and Malfait respectively teach that THC and CBD
each have disease-modifying effects in arthritis patients, which provides
sufficient motivation to use both drugs in combination. See, e.g., Merck &
Co., 874 F.2d at 808 (“Given the prior art teaching that both amiloride and
hydrochlorothiazide are natriuretic, it is to be expected that their co-
administration would induce more sodium excretion than would either
diuretic alone.”).
Appellants additionally argued that “Whittle discloses the use of a
high CBD:THC ratio (>19:1),” and thus, “based on the teachings of Whittle,
one of ordinary skill in the art would have considered it necessary to use
high doses of CBD to treat rheumatoid arthritis.” Appeal Br. 16. This
argument characterizes Whittle as limited to a >19:1 CBD:THC ratio, but
Whittle’s disclosure is broader. For example, Whittle claims a liquid
formulation containing CBD and THC for use in the treatment of rheumatoid
arthritis, wherein the CBD is present in an amount by weight which is
greater than the amount by weight of THC. See Whittle, claims 62, 32, 27.
These claims are not limited to embodiments where the CBD content is
more than 19 times greater than the THC content. And even if Whittle
would have led a person of ordinary skill in the art to a CBD:THC ratio of
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>19:1, this alone would not have rendered the ratios taught or suggested by
other references (such as Werner, Sofia, and Malfait, as discussed above)
any less obvious. Cf. Merck & Co., 874 F.2d at 807 (finding that a prior art
patent that “discloses a multitude of effective combinations does not render
any particular formulation less obvious”).
Appellants additionally argued that “the teachings of GW
Pharmaceuticals provide little – if any guidance – to arrive at a
pharmaceutical formulation comprising a ratio of CBD:THC by weight that
is 1.5:1 to 1:1.5 and an amount effective to decrease Disease Activity
Score.” Appeal Br. 16. This argument is not persuasive, because as
discussed above, teachings in other references (Werner, Sofia, Malfait)
would have led a person of ordinary skill in the art to the claimed ratio and
dosage. One cannot show nonobviousness by attacking references
individually when the rejection is based on a combination of references. In
re Keller, 642 F.2d 413, 426 (CCPA 1981).
In sum, we affirm the Examiner’s rejection of claim 43 as obvious
over (i) Werner, Sofia, Bendele, and Malfait, and (ii) Werner, Sofia,
Bendele, Malfait, Whittle, and GW Pharmaceuticals, for the reasons
provided by the Examiner, and the additional reasons discussed above. We
additionally affirm the Examiner’s rejection of dependent claims 45, 52, 59–
62, and 64–66 over Werner, Sofia, Bendele, and Malfait, and claims 45, 52,
55–62, and 64–66 over Werner, Sofia, Bendele, Malfait, Whittle, and GW
Pharmaceuticals, for the reasons provided by the Examiner, as supplemented
by the additional reasons discussed above. As noted above, because our
statement of the rejections supplements or differs somewhat from that of the
Examiner with respect to the claim limitations “therapeutically effective
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amount” and “wherein the amount of the pharmaceutical formulation
administered to the subject is effective to decrease Disease Activity Score,”
we designate these two obviousness rejections as New Grounds under 37
C.F.R. § 41.50(b) to provide Appellants with a full and fair opportunity to
respond to the rejections.

SUMMARY
We reverse the rejection of claims 43, 45, 55, 59–62, and 64–66 under
35 U.S.C. § 102 as anticipated by Werner.
We reverse the rejection of claims 43, 45, 52, 55, 59–62, and 64–66
under 35 U.S.C. § 103 as obvious over Werner.
We affirm the rejection of claims 43, 45, 52, 59–62, and 64–66 under
35 U.S.C. § 103 as obvious over Werner, Sofia, Bendele, and Malfait, and
the rejection of claims 43, 45, 52, 55–62, and 64–66 under 35 U.S.C. § 103
as obvious over Werner, Sofia, Bendele, Malfait, Whittle, and GW
Pharmaceuticals. However, as discussed above, we designate our
affirmance of these rejections as New Grounds of Rejection.
TIME PERIOD FOR RESPONSE
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellants, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new grounds of rejection to
avoid termination of the appeal as to the rejected claims:
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(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. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .
Should Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If Appellants elect prosecution before the Examiner and this does not
result in allowance of the application, abandonment, or a second appeal, this
case should be returned to the Patent Trial and Appeal Board for final action
on the affirmed rejection, including any timely request for rehearing thereof.
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
37 C.F.R. § 41.50(b)