Ex Parte VISCOMI et al

Patent Trial and Appeal Board

Jul 19, 2018

13559013 (P.T.A.B. Jul. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/559,013 07/26/2012
72932 7590 07/20/2018
Steinfl + Bruno LLP
155 N. Lake Ave. Ste 700
Pasadena, CA 91101
FIRST NAMED INVENTOR
Giuseppe Claudio VISCOMI
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
Pl342-US 9018
EXAMINER
FUBARA, BLESSING M
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
07/20/2018 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GIUSEPPE CLAUDIO VISCO MI, PAOLA MAFFEI,
VITTORIA LAURO, FIORELLA CALANNI, BEATRICE VITALI, and
FEDERICA CRUCIANI 1
Appeal2017-007540
Application 13/559,013
Technology Center 1600
Before ERIC B. GRIMES, JAMES A. WORTH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition, which have been rejected as anticipated and
obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part but designate the affirmance a new ground of
rejection.
1 Appellants identify the Real Party in Interest as Alfa Wassermann S .P.A.
Appeal Br. 2.
Appeal2017-007540
Application 13/559,013
STATEMENT OF THE CASE
"Rifaximin ... is a semysinthetic [sic] antibiotic drug belonging to the
rifampicin group." Spec. ,r 3. It can take any of several crystalline forms,
polymorphous forms, or amorphous forms. Id. ,r,r 4--7. "Rifaximin[']s
characteristics make it a compound useful in topical treatments, such as
those useful for treating vaginal infections, for example bacterial vaginosis."
Id. ,I 13.
Claims 1-12, 14--20, 28, 30-39, and 61---63 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A pharmaceutical composition comprising:
(a) rifaximin granules comprising an amorphous form or a
crystalline form of rifaximin, in an amount less than 500 mg
and one or more of an intragranular excipient; and
(b) one or more of an extragranular excipient including at least
one disintegrant;
wherein said pharmaceutical composition has selective
bactericidal activity against vaginal pathogenic bacteria.
The claims stand rejected as follows:
Claims 1, 8-12, 14--16, 19, 20, 28, 30, 322-34, 39, and 61---63 under
35 U.S.C. § I02(e) as anticipated by Selbo, 3 with evidence provided by
Wiesinger-Mayr4 and Neurath5 (Ans. 2), and
2 The statement of the rejection does not include claim 32, but it is discussed
in the body of the rejection. Ans. 2, 3. We therefore understand its omission
from the statement of the rejection to be inadvertent. Appellants understood
the rejection to apply to claim 32. Appeal Br. 7.
3 Selbo et al., US 2012/007835 Al, published Mar. 29, 2012.
4 Wiesinger-Mayr et al., US 2009/0291854 Al, published Nov. 26, 2009.
5 Neurath et al., US 2007/0082035 Al, published Apr. 12, 2007.
2
Appeal2017-007540
Application 13/559,013
Claims 1-12, 14--20, 28, and 30-39 under 35 U.S.C. § I03(a) as
obvious based on Selbo, with evidence provided by Wiesinger-Mayr and
Neurath, and Pilgaonkar6 (Ans. 4).
I
The Examiner has rejected claims 1, 8-12, 14--16, 19, 20, 28, 30, 33,
34, 39, and 61---63 as anticipated by Selbo, as evidenced by Wiesinger-Mayr
and Neurath, with respect to certain claims. The Examiner finds that Selbo
discloses tablet formulations of rifaximin containing "granules of rifaximin
in polymorphic form and pharmaceutical excipients such as intragranular
and extragranular excipients," which anticipates the composition of claim 1.
Ans. 2-3. The Examiner also finds that Selbo discloses that its composition
is effective in treating bacterial vaginosis, and cites Wiesinger-Mayr and
Neurath as evidence that some of the specific bacteria recited in claims 20
and 30 on appeal are causes ofvaginosis. Id. at 3.
We agree with the Examiner that Selbo anticipates claim 1, but rely
on a different part of the reference to support that finding. The Examiner
cites Selbo's ,r,r 19-21, 33-37, 132, 133, 136, 141, and 153 in support of the
rejection. Id. However,
for the instant rejection under 35 U.S.C. § I02(e) to have been
proper, the ... reference must clearly and unequivocally
disclose the claimed compound or direct those skilled in the art
to the compound without any need for picking, choosing, and
combining various disclosures not directly related to each other
by the teachings of the cited reference.
In re Arkley, 455 F.2d 586, 587 (CCPA 1972).
6 Pilgaonkar et al., US 2010/0215740 Al, published Aug. 26, 2010.
3
Appeal2017-007540
Application 13/559,013
Here, the Examiner has essentially pieced together disclosures in
different parts of Selbo in order to meet all of the limitations of claim 1.
"[S]uch picking and choosing may be entirely proper in the making of a 103,
obviousness rejection ... but it has no place in the making of a 102,
anticipation rejection." Id. See also Richardson v. Suzuki Motor Co., Ltd.,
868 F.2d 1226, 1236 (Fed. Cir. 1989) ("Every element of the claimed
invention must be literally present, arranged as in the claim."). The
Examiner's basis for rejecting claim 1 as anticipated therefore does not meet
the standard of § 102.
However, in responding to Appellants' arguments, the Examiner cited
Selbo' s Table 3 7, which does disclose a specific composition meeting all of
the limitations of claim 1. The composition comprises rifaximin granules
that comprise 47.2% rifaximin and the intragranular excipients HPMC-AS (a
polymer) and Pluronic F-127 (a wetting agent). Selbo 26, Table 37.
"HPMC-AS" stands for hydroxypropyl methylcellulose acetate succinate.
Id. ,r 16. Hydroxypropyl methylcellulose is an excipient. See Spec. ,r 55
("The rifaximin granules comprise excipients chosen among one or more of
diluent, binder and lubricant agents.") and ,r 60 ("The diluent suitable for the
preparation of rifaximin granules is preferably chosen from the group
comprising ... hydroxypropyl methylcellulose.").
In Selbo' s composition, the rifaximin granules are combined with
other components, including "Croscarmellose Na [Extra-Granular]" (Selbo
26, Table 37 (bracketed material in original)), which is described as a
"Disintegrant" (id.). Selbo discloses that the final composition included
635.59 mg per tablet of rifaximin granules. Id. Since the rifaximin granules
4
Appeal2017-007540
Application 13/559,013
added to the tablet contained 47.2% rifaximin, each tablet contained 47.2%
of 635.59 mg, or 300 mg, of rifaximin (635.59 x 0.472 = 300). Each tablet
in Selbo' s composition therefore contained less than 500 mg of rifaximin, as
recited in claim 1.
With regard to the recitation in claim 1 that the composition "has
selective bactericidal activity against vaginal pathogenic bacteria," we agree
with the Examiner (Ans. 17-18) that this property would be inherent in a
prior art composition, like Selbo' s, that meets all of the structural limitations
of claim 1. "[A] reference may anticipate even when the relevant properties
of the thing disclosed were not appreciated at the time." Abbott Labs. v.
Baxter Pharm. Products, Inc., 471 F.3d 1363, 1367 (Fed. Cir. 2006). See
also In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint
of patent law, a compound and all of its properties are inseparable; they are
one and the same thing.").
With regard to the recitation in claim 1 that the "rifaximin granules
compris[ e] an amorphous form or a crystalline form of rifaximin," we agree
with the Examiner's position that "rifaximin is either in amorphous state or
crystalline state" and therefore the "rifaximin in the art applied against the
claims ... either has to teach amorphous form of rifaximin or crystalline
form of rifaximin." Ans. 7. Specifically, the plain English definition 7 of
"amorphous," in this context, is "having no real or apparent crystalline
form• an amorphous material." Thus, the rifaximin in Selbo's composition
7 See www.merriam-webster.com/dictionary/amorphous, last accessed July
5,2018.
5
Appeal2017-007540
Application 13/559,013
must be in either crystalline or amorphous form because, if it is not
crystalline, then by definition it is amorphous.
For these reasons, we find that the composition described in Selbo's
Table 37 meets all of the limitations of, and anticipates, the composition of
claim 1.
Appellants argue that "Selbo relates to 'new rifaximin forms
comprising solid dispersions of rifaximin "' ( Appeal Br. 7, emphasis
removed) and "indicates that 'solid dispersions of rifaximin' are a 'new
rifaximin form' distinguishable from 'rifaximin ... in amorphous state or
crystalline state'," as recited in claim 1 (id. at 8). Similarly, Appellants
argue that "Selbo's 'solid dispersions of rifaximin' are distinguishable from
crystalline forms of rifaximin." Id. at 8-10 ( emphasis removed). Appellants
also argue that "Selbo's 'solid dispersions of rifaximin' are distinguishable
from amorphous forms of rifaximin." Id. at 10-11 ( emphasis removed).
"Appellants thus contend that, based on the teaching ofNewman[ 8], a
skilled person would understand that Selbo's 'polymer ... dispersion'
provide[s] a different state, 'a single-phase', distinguishable from
amorphous and crystalline state." Id. at 13. Appellants also argue that "the
difference from an amorphous form and a solid dispersion form of a
compound is further evidenced by additional evidence of record which are in
clear contradiction with the Examiner's position." Id., citing Harmon. 9
8 Newman et al., "Assessing the Performance of Amorphous Solid
Dispersions," 101 J. PHARM. Sci. 1355-1377 (2012).
9 Harmon et al., "Amorphous Solid Dispersions: Analytical Challenges and
Opportunities," AAPS NEWSMAGAZINE 14--20 (Sept. 2009).
6
Appeal2017-007540
Application 13/559,013
Finally, on this point, Appellants argue that "Paudel[ 10J shows that spray
drying of 'poorly water soluble drugs' with 'HPMC-AS' ... result[s] in
'amorphous solid dispersion' of the drug ... where rifaximin is included in a
state different from an 'amorphous state', [or] a 'crystalline state."' Id. at
15.
These arguments are not persuasive because claim 1 recites rifaximin
granules comprising either an amorphous form or a crystalline form of
rifaximin, together with at least one intragranular excipient. The issue,
therefore, is not whether Selbo discloses granules consisting of amorphous
or crystalline rifaximin, but whether Selbo' s granules included amorphous or
crystalline rifaximin. For the reasons discussed above, we agree with the
Examiner that the rifaximin in Selbo' s granules is necessarily either
amorphous or crystalline.
Selbo' s statement that its "solid dispersion[ s] of rifaximin ... are
XRPD amorphous, but distinguishable from XRPD of amorphous
rifaximin," Selbo ,r 140, is not to the contrary. As Appellants themselves
pointed out, "a skilled person would understand that Selbo' s 'polymer ...
dispersion' provide[s] a different state, 'a single-phase', distinguishable
from amorphous and crystalline state." Appeal Br. 13. We agree that,
because Selbo' s polymer dispersion is different from the amorphous or
crystalline drug itself, it would be expected to be distinguishable; e.g., by
XRPD analysis.
10 Paudel et al., "Manufacturing of solid dispersions of poorly water soluble
drugs by spray drying: Formulation and process considerations," 453 INT'L
J. PHARMACEUTICS, 253-284 (2013).
7
Appeal2017-007540
Application 13/559,013
Appellants also argue that Selbo' s compositions do not comprise
extracellular disintegrants, because "the paragraphs relied upon by the
Examiner relate to intragranular disintegrants according to Selbo' s own
indications." Appeal Br. 15-16 (citing Selbo's ,r,r 19, 21, and 188 11).
Appellants make a similar argument with regard to claims 14, 15, and 33,
which recite Markush groups of disintegrants, including croscarmellose
sodium. Appeal Br. 21-22, 31.
We agree with Appellants that the passages of Selbo cited by the
Examiner in the statement of the rejection do not expressly describe a
composition comprising an extracellular disintegrant. As discussed
previously, however, Selbo's Table 37 discloses a composition that
comprises "Croscarmellose Na [Extra-Granular]," which is described as a
"Disintegrant." Selbo 26, Table 37 (bracketed material in original). The
composition described in Selbo's Table 37 therefore comprises an
extracellular disintegrant.
With regard to claim 30, Appellants rely on the same arguments as
presented with regard to claim 1. Appeal Br. 29-30. Those arguments are
not persuasive for the reasons discussed above.
With regard to claims 8 and 32, Appellants argue that Selbo does not
teach a composition comprising 2-20% disintegrant. Appeal Br. 19. This
argument is unpersuasive, because Selbo discloses that its tablet composition
includes 5% extragranular Croscarmellose Na, a disintegrant. Selbo 27
(Table 37).
11 As noted previously, the Examiner actually cites Selbo's ,r,r 19-21, 33-37,
132, 133, 136, 141, and 153 in support of the rejection. Ans. 3.
8
Appeal2017-007540
Application 13/559,013
Appellants also argue that Selbo does not disclose the functional
characteristics recited in claims 9, 11, and 12. Appeal Br. 19--20.
Appellants make the same argument with regard to claim 39. Id. at 32.
As the Examiner pointed out, however, the "same compositions must
have [the] same properties/ characteristics. " Ans. 18. Because the prior art
composition appears to meet all of the structural limitations of claim 1, it is
reasonable to conclude it will share the functional characteristics of the
claimed composition as well. See In re Best, 562 F.2d 1252, 1254--55
(CCPA 1977):
"[I]t is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things
in the prior art, does not cause a claim drawn to those things to
distinguish over the prior art. Additionally, where the Patent
Office has reason to believe that a functional limitation asserted
to be critical for establishing novelty in the claimed subject
matter may, in fact, be an inherent characteristic of the prior art,
it possesses the authority to require the applicant to prove that
the subject matter shown to be in the prior art does not possess
the characteristic relied on."
(Quoting In re Swinehart, 439 F.2d 210, 212-13 (CCPA 1971).) Appellants
have not provided evidence to show that the prior art compositions do not
have the functional properties recited in claims 9, 11, 12, and 39. We
therefore do not find Appellants' argument persuasive.
With regard to claim 16, Appellants argue that Selbo does not disclose
crospovidone as an extragranular disintegrant. Appeal Br. 22-23.
Appellants make a similar argument with regard to claim 34. Id. at 31-32.
We agree with Appellants that Selbo does not anticipate claims 16 and
34. The Examiner points to Selbo's ,r,r 19, 21, and 132 as disclosing
"crospovidone, a disintegrant." Ans. 3. However, as Appellants have noted,
9
Appeal2017-007540
Application 13/559,013
the disclosures in those passages relate to intragranular release controlling
agents, not to an extragranular disintegrant. The composition described in
Selbo's Table 37 includes an extragranular disintegrant, but not
crospovidone. Thus, the Examiner has not shown that Selbo discloses a
composition meeting all of the limitations of claims 16 and 34, and we
reverse the rejection of those claims for anticipation.
With regard to claim 19, 12 Appellants argue that "the Examiner has
not provided any indication that would support the conclusion that Selbo' s
'sugars, starches, celluloses, phosphate buffer solutions and others' of Selbo
par. [00160] are bioadhesive agents, buffering agents, or mixtures thereof"
Appeal Br. 27. Appellants make a similar argument with regard to claims
61 13 and 63. 14 Id. at 28, 35.
The Examiner finds that "the composition of Selbo further contains
pharmaceutically acceptable carriers such as sugars, starches, celluloses,
phosphate buffer solutions and others (paragraph [O 160]), thereby
anticipating claims 19 and 61 and the bioadhesive agent of claim 63." Ans.
3. Selbo' s exemplary pharmaceutical carriers indeed include those listed by
the Examiner. Selbo ,r 160.
12 Claim 19 reads: "The pharmaceutical composition according to claim 1,
wherein the composition further comprises bioadhesive agents, buffering
agents, or mixtures thereof." Appeal Br. 54 (Claims App'x).
13 Claim 61 reads: "The pharmaceutical composition according to claim 1,
further comprising buffering agents, antiseptic agents, or antibiotic agents or
mixtures thereof." Appeal Br. 60 (Claims App'x).
14 Claim 63 reads: "The pharmaceutical composition according to claim 62,
further comprising a bioadhesive agent." Appeal Br. 60 (Claims App'x).
10
Appeal2017-007540
Application 13/559,013
The instant rejection, however, is based on anticipation, not
obviousness. "[U]nless a prior art reference discloses within the four
comers of the document not only all of the limitations claimed but also all of
the limitations arranged or combined in the same way as recited in the claim,
it cannot be said to prove prior invention of the thing claimed and, thus,
cannot anticipate under 35 U.S.C. § 102." Net MoneyIN, Inc. v. VeriSign,
Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). See also In re Arkley, 455 F.2d
586, 587 (CCPA 1972) ("[P]icking, choosing, and combining various
disclosures not directly related to each other by the teachings of the cited
reference ... may be entirely proper in the making of a 103, obviousness
rejection ... but it has no place in the making of a 102, anticipation
rejection.").
Here, the Examiner has not pointed to any of the components of the
composition of Selbo's Table 37 that falls into the categories of agents
recited in claims 19, 61, and 63. We therefore reverse the rejection of those
claims as anticipated by Selbo.
With regard to claim 28, Appellants argue that "if the Examiner
agrees that 'Selbo's solid dispersion is not a crystalline form' then the
Examiner should also take the position that Selbo cannot anticipate 'ftlhe
pharmaceutical composition ... wherein the ri(aximin is in a polymorphous
form."' Appeal Br. 27-28.
The Examiner finds that "[ t ]he polymorphic form of the rifaximin in
Selbo anticipates claim 28." Ans. 3. "While the Examiner agrees with
appellant that the rifaximin in Selbo according the x-ray data is not
crystalline, rifaximin in the solid amorphous dispersion is amorphous ...
11
Appeal2017-007540
Application 13/559,013
and amorphous form is a polymorphous form (see paragraph [0137])." Id. at
20.
Appellants' Specification states that "[ t ]he term 'rifaximin' is
intended in the broad sense and includes not only 'rifaximin' but also its
pharmaceutically acceptable salts, solvates, hydrates, derived enantiomers,
polymorphs, amorphous forms, co-crystals and pharmaceutically acceptable
complexes." Spec. ,r 87 (emphasis added). The Specification therefore
distinguishes between amorphous forms and polymorphs of rifaximin. The
broadest reasonable interpretation, in light of the Specification, of the
"polymorphous form" recited in claim 28 therefore does not include
amorphous forms.
Selbo does not describe the rifaximin in its Table 37 as being
polymorphic, and in fact the Examiner has found that the "rifaximin in the
solid amorphous dispersion is amorphous" (Ans. 20), which is not a
"polymorphous form" under the broadest reasonable interpretation of that
term. We therefore reverse the rejection of claim 28 as anticipated by Selbo.
With regard to claim 62, Appellants present the same arguments as
presented with regard to claim 1. Appeal Br. 33-34. Those arguments are
not persuasive for the reasons discussed above. Appellants also argue that
the Examiner has not shown that "Selbo teaches the claimed feature of
'intragranular excipient in granules wherein the intragranular excipients
consist of a binder, diluents, lubricants or mixtures thereof,"' as recited in
claim 62. Appeal Br. 34.
We affirm the rejection of claim 62 as anticipated by Selbo. Selbo's
Table 37 identifies the components of its granules, including "HPMC-AS,"
12
Appeal2017-007540
Application 13/559,013
which is identified as "Polymer." Selbo 26 (Table 37). "HPMC-AS" stands
for "hydroxypropyl methylcellulose acetate succinate." Id. ,r 16.
Appellants' Specification states that suitable diluents for preparing rifaximin
granules include "hydroxypropyl methylcellulose." Spec. ,r 60. Thus, the
broadest reasonable interpretation of the "diluents" recited in claim 62
would include forms of hydroxypropyl methylcellulose, such as the
hydroxypropyl methylcellulose acetate succinate used in Selbo' s
formula ti on.
Claims 10 and 20 were not argued separately and therefore fall with
claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
II
The Examiner has rejected claims 1-12, 14--20, 28, and 30-39 as
obvious based on Selbo, with evidence provided by Wiesinger-Mayr and
N eurath, and Pilgaonkar "with respect to claims 17 and 18 for binder." Ans.
4. The Examiner finds that "Selbo does not disclose the amounts of
rifaximin recited in these claims 2-7, 31 and 35-38." Id. at 5. The Examiner
concludes, however, that "one having the goal to prepare the rifaximin
composition of Selbo would have the motivation to use amounts of rifaximin
that would stay close to what is disclosed in Selbo and to optimize the
composition with a desire and expectation of producing a composition that
would be effective to treat vaginosis" or other conditions. Id.
With regard to claim 1, Appellants argue that Selbo does not teach
rifaximin granules comprising an amorphous form or a crystalline form of
rifaximin, or an extragranular disintegrant. Appeal Br. 37-38. Appellants
also argue that Selbo teaches against replacing a solid dispersion of
13
Appeal2017-007540
Application 13/559,013
rifaximin with an amorphous or crystalline form of rifaximin, and teaches
against replacing an intragranular release-controlling agent with an
extragranular disintegrant. Id. at 3 8--41. Appellants makes the same
arguments with respect to claim 30. Id. at 43--44. All of these arguments
are fully addressed in the previous discussion of the anticipation rejection.
With regard to claims 2-7, Appellants argue that one of skill in the art
"would be motivated to optimize compositions comprising 'solid dispersions
of rifaximin' as well as 'intragranular release controlling agents comprising
disintegrants' and extragranular 'binding agents', thus teaching against a
modification of Selbo's composition to include the features of claims 2-7 ,"
presumably meaning amorphous or crystalline rifaximin and extragranular
disintegrant, which are limitations of claims 2-7 because they depend from
claim 1. Appeal Br. 41--4 2. Appellants make the same argument with
respect to claims 31 and 35-38. Id. at 44--45.
This argument is unpersuasive because, as discussed above in the
context of anticipation, Selbo teaches rifaximin granules containing
amorphous or crystalline rifaximin, and a composition comprising an
extragranular disintegrant. Appellants do not dispute the Examiner's
conclusion that it would have been obvious to optimize the amount of
rifaximin in Selbo' s composition. We therefore agree with the Examiner
that the compositions of claims 2-7 would have been obvious to a person of
ordinary skill in the art based on the cited references.
With regard to claim 8, Appellants argue that Selbo teaches against an
extragranular disintegrant in an amount of 2-20%. Appeal Br. 42. This
argument is addressed above in the context of anticipation.
14
Appeal2017-007540
Application 13/559,013
With regard to claims 9-12, 14--16, 19, 20, and 28, Appellants argue
that the Examiner has not made a prima facie case of obviousness because
additional facts and evidence have not been provided to show that the
features of these claims would be taught or suggested by the cited
references. Appeal Br. 42--43. Appellants make the same argument with
respect to claims 33, 34, and 39. Id. at 45.
This argument is unpersuasive with respect to claims 9-12, 14, 15, 20,
33, and 39, because these claims are anticipated by Selbo, as discussed
above in the context of the § 102( e) rejection. "It is well settled that
'anticipation is the epitome of obviousness."' In re McDaniel, 293 F.3d
1379, 1385 (Fed. Cir. 2002). We therefore affirm the rejection of these
claims as obvious based on Selbo and the other cited references.
With respect to claims 16, 19, 28, and 34, however, Appellants'
argument is persuasive. As discussed previously, the anticipation rejection
of these claims is reversed because the Examiner did not show that Selbo
discloses a composition meeting all of their limitations. In stating the
rejection for obviousness, the Examiner provided no "articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness," KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007), that
the limitations of claims 16, 19, 28, and 34 would have been obvious based
on the cited references. See Ans. 5. We therefore agree with Appellants that
the Examiner has not made a prima facie case of obviousness with respect to
claims 16, 19, 28, and 34, and we reverse the rejection under 35 U.S.C.
§ 103(a) as to those claims.
15
Appeal2017-007540
Application 13/559,013
With regard to claims 17 15 and 18, the Examiner finds that "starch is
contemplated for inclusion in the composition of Selbo." Ans. 5. The
Examiner concludes that "[ t ]he presence of starch renders obvious
pregelatinized starch because starch, pregelatinized starch,
polyvinylpyrrolidone (PVP), cospovidone [sic], and cellulose derivatives are
all binders." Id. (citing Pilgaonkar ,r 38).
Appellants argue that Selbo does not teach or suggest a
pharmaceutical composition comprising an intragranular binder. Appeal Br.
48.
We agree with Appellants that the Examiner has not shown that the
composition of claims 17 and 18 would have been prima facie obvious based
on the cited references. Selbo discloses that its composition can comprise an
intragranular release controlling agent. See, e.g., Selbo ,r,r 19--21. The
discussion of starch that the Examiner cites, however, relates to
pharmaceutical compositions, not components of the rifaximin granules
themselves.
Selbo states that "pharmaceutical compositions comprising rifaximin
SD compositions and a pharmaceutically acceptable carrier ... [can] further
comprise excipients, for example, one or more of a diluting agent, binding
agent," etc. Id. ,r 156. Selbo also states that starch is a suitable carrier. Id.
15 Claim 17 reads: "The pharmaceutical composition according to claim 1,
wherein the intragranular excipient comprises a binder selected from the
group consisting of pregelatinized starch, arabic gum, maltodextrine,
copovidone, saccharose and mixtures thereof." Appeal Br. 53-54 (Claims
App 'x ). Claim 18 depends from claim 17 and specifies that the binder is
copovidone.
16
Appeal2017-007540
Application 13/559,013
,r 160. However, Selbo suggests both a carrier (e.g., starch) and binding
agent as an extragranular components of a pharmaceutical composition, not
intragranular excipients. We therefore reverse the rejection under 35 U.S.C.
§ 103(a) of claims 17 and 18.
Claim 32 was not argued separately and therefore falls with claim 30.
37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 102(e) based on Selbo, and
evidence provided by Wiesinger-Mayr and Neurath, with respect to claims
1, 8-12, 14, 15, 20, 30, 32, 33, 39, and 62. We reverse the§ 102(e) rejection
with respect to claims 16, 19, 28, 34, 61, and 63.
We affirm the rejection under 35 U.S.C. § 103(a) based on Selbo, and
evidence provided by Wiesinger-Mayr and Neurath, and Pilgaonkar with
respect to claims 1-12, 14, 15, 20, 30-33, and 35-39. We reverse the
§ 103(a) rejection with respect to claims 16-19, 28, and 34.
As a result, claims 16-19, 28, 34, 61, and 63 are not subject to any
outstanding rejection.
We affirm-in-part but designate the affirmance a new ground because
we rely on a different disclosure of Selbo than was relied on by the
Examiner in the rejections on appeal. See In re Kronig, 539 F.2d 1300, 1302
(CCPA 1976) ("[T]he ultimate criterion of whether a rejection is considered
'new' in a decision by the board is whether appellants have had fair
opportunity to react to the thrust of the rejection."); In re Leithem, 661 F.3d
1316, 1320 (Fed. Cir. 2011) ("The thrust of the Board's rejection changes
when ... it finds facts not found by the examiner regarding the differences
17
Appeal2017-007540
Application 13/559,013
between the prior art and the claimed invention, and these facts are the
principal evidence upon which the Board's rejection was based.").
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37 CPR
§ 4I.50(b ). Section 4I.50(b) provides "[a] new ground of rejection pursuant
to this paragraph shall not be considered final for judicial review." Section
41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(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. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under§ 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
18
Appeal2017-007540
Application 13/559,013
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
AFFIRMED-IN-PART, 37 C.F.R. § 4I.50(b)
19