Ex Parte Greve

Patent Trial and Appeal Board

Dec 14, 2017

13062388 (P.T.A.B. Dec. 14, 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.
13/062,388 07/05/2011 Harald Greve 78-10866 3686
77741 7590 12/18/2017
Rrannnn Sowers; Rr rYarraft PP
EXAMINER
47 South Meridian Street KIM, JENNIFER M
Suite 400
Indianapolis, IN 46204 ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
12/18/2017 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):
docket @ bscattorney s. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARALD GREVE
Appeal 2017-001169
Application 13/062,388
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a
combination therapeutic for the prophylactic or therapeutic treatment of
respiratory disorders. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“[Bjoth for bronchial asthma and for COPD [chronic obstructive
pulmonary disease] — in addition to a basic therapy with bronchodilators —
1 Appellant identifies the Real Party in Interest as Maria Clementine Martin
Klosterfrau Vertriebsgesellschaft mbH (see App. Br. 3).
Appeal 2017-001169
Application 13/062,388
topical or local, in particular inhalative or inhalable, corticosteroids are
[also] used” (Spec. 4:28—31). The prior art describes “a combination therapy
with, firstly, orally administered terpene compounds, in particular 1, 8-cineol
or menthol, and, secondly, likewise systemic, in particular orally
administe[re]d corticosteroids for the anti-inflammatory treatment of chronic
bronchial asthma” (Spec. 8:16—20).
The Specification states “[hjowever, the administration of systemic
corticosteroids is associated with serious side-effects.” (Spec. 8:24—26) and
“[a]s a consequence, the prior-art treatment methods of bronchopulmonary
disorders or respiratory disorders often do not give the desired therapeutic
result, or only with unwanted side-effects” (Spec. 9:1—4).
The Claims
Claims 16, 20-23, 26, 27, 31, 32, 41, and 42 are on appeal.
Independent claim 16 is representative and reads as follows:
16. A combination therapeutic for the prophylactic or
therapeutic treatment of respiratory disorders selected from
bronchopulmonary disorders to reduce the dose or to enhance
the activity of a topically administrable inhalative respiratory
therapeutic in the prophylactic or therapeutic treatment of the
respiratory disorders, wherein the combination therapeutic is in
the form of a kit and comprises:
(a) at least one systemically administrable monoterpene,
wherein the monoterpene is 1,8-cineol and
wherein the monoterpene is present in the form of an oral
enteric preparation which dissolves in the small intestine, and
(b) at least one topically administrable respiratory therapeutic,
wherein the topically administrable respiratory therapeutic is an
inhalative respiratory therapeutic selected from the group
consisting of (i) corticosteroids; (ii) sympathomimetics; and
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mixtures as well as combinations thereof; and wherein the
bronchopulmonary disorder is bronchial asthma, bronchitis or
chronic obstructive pulmonary disorder (COPD).
The Issue
The Examiner rejected claims 16, 20-23, 26, 27, 31, 32, 41, and 42
under 35 U.S.C. § 103(a) as obvious over Juergens,2 Britto,3 and Fischli4
(Final Act. 2-4).
The Examiner finds “Juergens teaches that because of the synergistic
effect, a combination treatment comprising 1,8 -cineol and the conventional
corticosteroids such as beclomethasone is recommended” (Final Act. 2—3).
The Examiner finds the Juergens teaches 1,8 —cineol administration “in the
form of gastric juice-resistant capsules with a dose unit of lOOmg/capsule”
(id. at 3).
The Examiner acknowledges Juergens does not teach
“beclomethasone in inhalation form”; “a kit”; and “employment of enteric
coating” (Final Act. 3). The Examiner finds Fischli teaches that for
“preparations which are resistant to gastric fluids it is necessary to apply a
gastric fluid-resistant (enteric) coating” (id.). The Examiner finds Britto
teaches “a metered dose inhaler comprising beclomethasone dipropionate
optionally in combination with one or more other pharmacologically active
agents” (id.).
The Examiner finds it obvious to “modify the combination
therapeutics of Juergens and employ beclomethasone in inhalation form
2 Juergens, U., US 5,889,049, issued Mar. 30, 1999.
3 Britto et al., US 6,511,653 Bl, issued Jan. 28, 2003
4 Fischli et al., US 4,929,741, issued May 29, 1990.
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Application 13/062,388
because beclomethasone in an inhalation aerosol form is readily available in
the market and has been accepted by the medical community” (Final Act. 4).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that Juergens, Britto, and Fischli render claim 16 obvious?
(ii) If so, has Appellant presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Juergens teaches “ 1,8-cineol is suitable for treating
inflammatory allergic and/or inflammatory bronchopulmonary diseases
requiring steroid treatment and exacerbated by infection” (Juergens 2:48—
51).
2. Juergens teaches: “Because of the synergistic effect, a
combination treatment comprising 1,8-cineol and the conventional
corticosteroids prednisone, prednisolone, fluocortolone, beclomethasone,
budesonide or fhmisolide is recommended” (Juergens 2:66 to 3:2; emphasis
added).
3. Juergens teaches the 1,8 cineol “dosage of 200 mg/day to 900
mg/day (by preference 600 mg/day) can be administered in the form of
gastric juice-resistant capsules with a dose unit of 100 mg/capsule”
(Juergens 3:13—15).
4. Fischli teaches: “For the preparation of pharmaceutical
preparations which are resistant to gastric fluids it is necessary to apply a
gastric fluid-resistant (enteric) coating which can consist of, for example,
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hydroxypropylmethylcellulose phthalate or other suitable material, as those
skilled in the art will understand” (Fischli 11:57—62).
5. Britto teaches “[bjeclomethasone dipropionate in aerosol form,
has been accepted by the medical community as useful in the treatment of
asthma and is marketed under the trademarks ‘Beclovent’, ‘Becotide’, and
‘Beconase’” (Britto 2:33—36).
6. Britto teaches “beclomethasone dipropionate (or a
physiologically acceptable solvate thereof) in combination with one or more
other pharmacologically active agents. Such medicaments may be selected
from any suitable drug useful in inhalation therapy” (Britto 3:5—9).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2-4; FF 1—6) and agree that the
claims are obvious over Juergens, Fischli, and Britto. We address
Appellant’s arguments below.
Prima Facie Obviousness
Appellant contends
the Juergens patent teaches administering both components by
mouth (systemically) whereas the current application requires
the monoterpene to be administered systemically, whereas the
respiratory therapeutic is required to be administered topically,
the very distinction noted by Prof. Dr. Juergens. As a result,
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Applicant’s combined therapeutic requires a method of
administration that is different from that taught by Juergens.
(App. Br. 17-18).
We find this argument unpersuasive because it fails to address the
teachings of Juergens, Fischli, and Britto in combination. Juergens teaches
treatment of bronchopulmonary disease with 1,8-cineol (FF 1) in oral enteric
form (FF 3) in synergistic combination with corticosteroids including
beclomethasone (FF 2). While Juergens does not teach an aerosol inhalation
form of a corticosteroid, as acknowledged by the Examiner (see Final Act.
3), Britto teaches that aerosol inhalation forms of the corticosteroid
beclomethasone were well known (FF 5) and useful in combination therapy
with other agents (FF 6). It is this combination of Juergens and Britto that
renders claim 16 obvious, not the teachings of Juergens alone. “Non­
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant cites the Juergens5 Declaration “to illustrate the principle
that there are differences in the effects obtained for systemic and topical
administration of medicants” and contends “the Examiner dismissed Dr.
Juergens’ opinion supported by Attachment A, and maintained what appears
to be an unspoken and unsupported belief in the equivalence in the two
modes of medicant administration” (App. Br. 20). In the cited portion, Dr.
Juergens stated
5 Declaration of Dr. Prof. Uwe R. Juergens, dated Feb. 5, 2014.
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Application 13/062,388
it was not at all foreseeable or predictable on the basis of the
teaching of my patent, the other cited art, or their combination
that the “exhalation” of the systemically applied monoterpene
in the alveolar and/or bronchial epithelium would be effective
enough to provide concentrations sufficient to allow the
interaction of 1,8-cineol with the topically administered
respiratory therapeutic within the respiratory system such that
the combination can act together to advantageously impact the
respiratory system in a synergistic manner.
(Juergens Decl. 111).
We have considered the Juergens Declaration, and recognize Dr.
Juergens expertise and familiarity with the technology, but find it
unpersuasive of nonobviousness when weighted with the evidence presented
in Juergens and Britto. Dr. Juergens points out that topical and systemic
treatments with compounds may provide different results (Juergens Decl.
19) and specifically contends that he considered only systemic treatments
and did not consider inhalation treatment with corticosteroids (Juergens
Decl. 110).
However, the issue is not whether systemic and oral administration
modes are equivalent, but rather whether the ordinary artisan would have
had reason to use inhalation administration routes as disclosed by Britto in
the combination treatment method of Juergens. Dr. Juergens provides no
experimental or other evidence supporting the position that known treatment
options such as the aerosol forms of beclomethasone of Britto, specifically
“accepted by the medical community as useful in the treatment of asthma”
(FF 5) and therefore demonstrated to have biologic effects on the specific
respiratory target tissue in the current claim 16, would not be expected to
provide benefits when used in combination with other therapeutic agents
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such as 1,8-cineol (FF 1), which were known to be useful in combination
with corticosteroids, albeit in systemic form (FF 2). Dr. Juergens simply
states his expert opinion. However, “[t]he Board has broad discretion as to
the weight to give to declarations offered in the course of prosecution . . .
[and] the Board is entitled to weigh the declarations and conclude that the
lack of factual corroboration warrants discounting the opinions expressed in
the declarations.” In re Am. Acad. Science Tech Ctr., 367 F.3d 1359, 1368
(Fed. Cir. 2004).
We recognize, but find unpersuasive, Appellant’s contention that “the
Examiner dismissed Dr. Juergens’ opinion supported by Attachment A, and
maintained what appears to be an unspoken and unsupported belief in the
equivalence in the two modes of medicant administration” (App. Br. 20).6
In fact, the Examiner addressed this issue (see Ans. 3). Moreover,
Appellant has provided evidence that supports the Examiner’s obviousness
position regarding the use of inhaled and system corticosteroids.
Attachment B to the Juergens Declaration, the prior art document by Havill
et al.,7 states “[tjopical corticosteroids are generally preferred to systemic
steroids because of enhanced control of local disease and a potential
reduction in adverse effects.” (Juergens Deck Attachment B, 1). Havill et
al. further notes “inhaled steroids have a more favourable side effect profile
than systemic steroids” {id. at 3). Similarly, Attachment C, the prior art
6 We note that Appellant’s request for a § 104(d)(2) affidavit or declaration
by the Examiner is clearly inappropriate because the Examiner is relying not
on personal knowledge but on the teachings of the cited references.
7 Havill et al., Poorly Recognised Adverse Effects of Inhaled Corticosteroids,
http://www.medsafe.govt.nz/profs/puarticles/2.htm (July 1998).
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document by Barnes,8 states “inhaled corticosteroids have become first-line
therapy and by far the most effective anti-inflammatory treatment” (id. at
Attachment C, 1). Attachment D, a post-filing date reference by Roberts et
al.,9 states “Beclomethasone dipropionate (BDP)... is a glucocorticoid
administered by inhalation to treat asthma” (id. at Attachment D, 1) and
states “[ijnhaled glucocorticoids are the mainstay treatment of asthma” (id.
at Attachment D, 6).
Thus, in addition to Britto’s direct teaching to treat asthma with
inhaled beclomethasone (FF 5) in combination with other drugs (FF 6), the
references cited by Appellant provide specific reasons known and available
to the ordinary artisan that would have led to the use of inhaled steroids due
to their “enhanced control of local disease” and “more favourable side effect
profile” (Juergens Decl. Attachment B 1, 3) and because they are “by far the
most effective anti-inflammatory treatment” (id. at Attachment C, 1). As we
balance Dr. Juergens’ opinion Declaration against the evidence cited by the
Examiner and in the attachments, we remain persuaded that the ordinary
artisan would have had reason to modify the 1,8-cineol and beclomethasone
treatment taught by Juergens to use inhaled beclomethasone as taught by
Britto for the reasons recited above.
We recognize, but find unpersuasive, Appellant’s arguments that
“[w]e don’t fully understand, in the case of Prof. Dr. Juergen’s fully
8 Barnes, P., How corticosteroids control inflammation: Quintiles Prize
Lecture 2005, 148 Br. J. Pharmacol. 245—254 (2006).
9 Roberts et al., Metabolism of Beclomethasone Diproprionate by
Cytochrome P450 3A Enzymes, 345 J. Pharmacol. Exp. Ther. 308—316
(2013).
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Application 13/062,388
systemically administered combination, whether the interaction of the two
components occurs in the liver, the lungs, or elsewhere” (App. Br. 25).
There is no evidence that the two components, the corticosteroid and the 1,8-
cineol, interact directly at all in either the Specification or the cited art, and
this is not a limitation of claim 16. See In re Self, 671 F.2d 1344, 1348
(CCPA 1982) (“[AJppellanf s arguments fail from the outset because . . .
they are not based on limitations appearing in the claims.”)
For purposes of a therapeutic treatment, once the combination of
agents has been suggested as efficacious for a particular condition, as
evidenced here for 1,8-cineol and beclomethasone for bronchopulmonary
diseases by Juergens, the specific mode of action would only matter if
evidence was presented that the preferred mode of administration failed to
achieve the therapeutic effect. Here, Britto, and Attachments B and C to the
Juergens Declaration all evidence that inhaled beclomethasone results in the
desired therapeutic effect (FF 5; Juergens Decl Attachment B, 1 and
Attachment C, 1), rendering Appellant’s argument regarding the mode of
action less relevant to the ultimate determination of obviousness.
We recognized, but find unpersuasive, Appellant’s contention that
“the proposed modification of the therapeutic taught by Prof. Dr. Juergens
would have been expected to render the modified therapeutic unsatisfactory
for its intended purpose” (App. Br. 32, citing Juergens Decl. 8 and Greve
Decl. 11). No specific evidence supporting these opinion findings was
presented, and Britto specifically evidences that beclomethasone aerosol
“has been accepted by the medical community as useful in the treatment of
asthma” (FF 5) along with the teachings in Attachments B and C that
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“[tjopical corticosteroids are generally preferred to systemic steroids”
(Juergens Decl. Attachment B, 1) and that “inhaled corticosteroids have
become first-line therapy and by far the most effective anti-inflammatory
treatment” (id. at Attachment C, 1). Thus, the balance of the evidence
supports the Examiner’s position that the skilled artisan would reasonable
have expected that improving the method of Juergens by using the inhaled
beclomethasone of Britto would be successful. “Obviousness does not
require absolute predictability of success ... all that is required is a
reasonable expectation of success.'1'’ In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009) (citation omitted).
We recognize, but find unpersuasive, Appellant’s contention that “the
Examiner has only posited that one skilled in the art would make the
proposed combination because the components were commercially
available, whereas Applicant has provided the reasoned opinion of the
inventor on the cited patent to refute the Examiner’s position” (App. Br. 35).
While we have already provided reasons why we find the combination
obvious and predictable based on the combined teachings of Juergens,
Fischli, and Britto (FF 1—6), we note that the evidence presented by
Appellant regarding the knowledge of a person of ordinary skill also
supports a finding of obviousness based on the knowledge that “[tjopical
corticosteroids are generally preferred to systemic steroids” (Juergens Decl.,
Attachment B, 1) and that “inhaled corticosteroids have become first-line
therapy and by far the most effective anti-inflammatory treatment” (id. at
Attachment C, 1).
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Application 13/062,388
We also do not find that the Examiner relied upon inherency, as
argued by Appellant (see, e.g., Reply Br. 16), but rather on the express
teachings of the prior art (FF 1—6) and the knowledge of the ordinary artisan.
Unexpected Results
Appellant states “[pjlease note paragraphs 8 and 10 of Dr. Greve’s
Declaration where greater than expected results are described, and the
presence of an unexpected antioxidant property is discussed” (App. Br. 28).
Appellant cites the Greve Declaration,10 which states “administration of 1,8-
cineol may allow the topical or inhalative respiratory therapeutic in question
to be used for the first time for certain respiratory disorders or for certain
stages of the respiratory disorders,” including COPD, where its lack of
sensitivity had previously precluded its use (Greve Decl. 1 8). Appellant
also cites the Greve Declaration’s statement that a “further unexpected and
unpredictable result of the combined systemic and topical administration of
medicants according to claims [sic] 16 and new claims 40-42 was the
antioxidative and anti-inflammatory effect of 1,8-cineol and its ability to
moderate the oxidative effect resulting from the administration of
beclometasone” (Greve Decl. 110).
The Greve Declaration cites the Specification’s teaching that
for the first time, the present study now shows that the strong
inhibition of the production of O2" radicals by therapeutic
concentrations of 1,8-cineol in combination with beclometasone
can be demonstrated and provides an advantage which cannot
be mediated in an isolated manner by the inhalative steroid
alone. This is not a purely additive effect but the mediation of
the effect of 1,8-cineol on the combination of 1,8-cineol and
10 Declaration of Dr. Harald Greve, dated Feb. 5, 2014.
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beclometasone, without it being possible to detect an
independent antioxidative effect of beclometasone.
(Spec. 62:15 to 63:5).
We have considered the evidence in the Specification and the Greve
Declaration, but find the evidence, considered as a whole with the prima
facie case of obviousness, does not support a finding of non-obviousness.
In particular, we note that the Specification lacks a comparison with
the closest prior art of Juergens, and fails to demonstrate any unexpected
result for the inhaled form of a corticosteroid such as beclomethasone
combined with 1,8-cineol that is compared to Juergens treatment with
systemic corticosteroids and 1,8-cineol (see Juergens, Table II). See In re
Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”). Indeed,
Appellant essentially admits that no such testing was performed when
stating “had Applicant relied on comparative testing, it would have been
helpful for the Examiner to cite where that occurred” (Reply Br. 7).
In addition, Appellant has provided only opinion evidence in either
the Greve Decl. or Juergens Deck that the improved treatment would not
have been the expected result. Given the teaching by Juergens that 1,8-
cineol is synergistic with corticosteroids such as beclomethasone (FF 2) and
the teaching of Britto that inhaled beclomethasone was medically accepted
and combinable with other agents (FF 5—6), and the evidence of Attachment
B that the ordinary artisan would have known inhaled corticosteroids were
preferred over systemic treatments for enhanced control of local disease and
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reduction in side effects (Juergens Decl. Attachment B, 1), improved
treatment using inhaled beclomethasone appears to be the expected result,
rather than an unexpected result. See In re Skoner, 517 F.2d 947, 950
(CCPA 1975) (“Expected beneficial results are evidence of obviousness of a
claimed invention. Just as unexpected beneficial results are evidence of
unobviousness”).
To the extent that Dr. Greve contends the result is unexpected based
on his personal assessment, “an affidavit by an applicant or co-applicant as
to the advantages of his invention is less persuasive than one made by a
disinterested person.” In re Bulina, 362 F.2d 555, 559 (CCPA 1966). We
consider the evidence, but we balance it with the other teachings of record.
We recognize, but find unpersuasive, Appellant’s contentions that the
“unexpected results derived from Applicant’s combination therapy include,
but are not limited to: unexpectedly providing a treatment for COPD,
demonstrating both the presence of an unexpected property (i.e., antioxidant
properties and consistent therapeutic effects), and the absence of an expected
property (i.e., side effects)” (App. Br. 31).
Appellant provides no evidence that the treatment works for COPD in
patients, with the only clinical results being drawn to “persistent bronchial
asthma” (see Spec. 52, example 2). Thus, there is no evidence of
unexpected results for COPD patients. Moreover, the claims are not
commensurate in scope with this result because the claims encompass
treatment of bronchial asthma and bronchitis as well as COPD. Unexpected
results must be “commensurate in scope with the degree of protection sought
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by the claimed subject matter.” In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005).
We find the “antioxidant” property argument unpersuasive of
unexpected results because, as discussed above, no comparison with the
closest prior art was performed. Indeed, the experiments performed in the
Specification showing antioxidant activity (see, e.g., Spec. 62, Table 4) were
performed by in vitro treatment of cells in culture, which more closely
mimics systemic administration rather than inhaled administration because
just as systemically administered drug is delivered in a solution to every cell,
so too did the experiment incubate the cells with “different concentrations of
beclomethasone” in solution form, rather than aerosol (see Spec. 60:6—10).
Therefore, this result also fails to evidence unexpected results for the inhaled
form of beclomethasone relative to the systemic form.
Lastly, reduction in side effects is clearly an expected result of topical
administration, as expressly explained in Attachment B that “[tjopical
corticosteroids are generally preferred to systemic steroids because of
enhanced control of local disease and a potential reduction in adverse
effects.” (Juergens Decl. Attachment B, 1).
We recognize, but find unpersuasive, Appellant’s reliance on
Attachment D (see, e.g., Reply Br. 9). However, claim 16 is not drawn to a
specific mode of action of beclomethasone, but rather to a specific mode of
administration, inhaled. Attachment D, a post-filing date reference, provides
no specific evidence regarding any unexpected results for the combination of
1,8-cineol and beclomethasone. We find Appellant’s arguments regarding
the difference in the action of other drugs in inhaled versus systemic form
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such as insulin (see, e.g., Reply Br. 9) particularly irrelevant given the
express suggestion by Britto to administer beclomethasone in inhaled form
(FF 5).
We therefore conclude that the asserted results, when properly
evaluated and weighted with the prima facie case of obviousness, does not
result in determining that the claims are nonobvious.
Conclusion of Law
(i) The evidence of record supports the Examiner’s conclusion that
Juergens, Britto, and Fischli render claim 16 obvious.
(ii) Appellant has not presented evidence of secondary considerations,
that when weighed with the evidence of obviousness, is sufficient to support
a conclusion of non-obviousness.
SUMMARY
In summary, we affirm the rejection of claim 16 under 35 U.S.C.
§ 103(a) as obvious over Juergens, Britto, and Fischli. Claims 20—23, 26,
27, 31, 32, 41, and 42 fall with claim 16.
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
16