AVANTOR PERFORMANCE MATERIALS, LLC

Patent Trials and Appeals Board

Apr 23, 2020

15398207 - (D) (P.T.A.B. Apr. 23, 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.
15/398,207 01/04/2017 Nandu DEORKAR 2198-50PCT/US/
CIP/RCE/CON
2302
23869 7590 04/23/2020
Hoffmann & Baron LLP
6900 Jericho Turnpike
Syosset, NY 11791
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1613
MAIL DATE DELIVERY MODE
04/23/2020 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 NANDU DEORKAR, JAMES FARINA,
LILIANA MIINEA, and SAMEER RANADIVE
__________

Appeal 2019-005304
Application1 15/398,207
Technology Center 1600
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of making an excipient, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s Specification states that “[i]n order to successfully form
tablets, the tableting mixture must flow freely from a feeder hopper into a
tablet die, and be suitably compressible.” (Spec. ¶ 3.) It is further noted that

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 Avantor
Performance Materials, LLC. (Appeal Br. 3.)
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an active pharmaceutical ingredient (API) is “typically mixed with varying
proportions of various excipients to impart desired flow and compressibility
properties” in order to successfully provide that API in a tablet dosage form.
(Id.) Appellant’s invention is directed to an excipient for use in making
tablet dosage forms of and API. (Id. ¶ 2.)
Claims 7, 31–35, and 37–39 are on appeal.2 Claim 31 is
representative, reproduced below, reformatted for clarity, and with bracketed
letters added:
31. A method of making an excipient comprising:
[a] mixing a microcrystalline cellulose (“MCC”) slurry
with a disintegrant slurry to form a MCC/disintegrant slurry;
[b] mixing a binder in water to form a viscous binder
slurry;
[c] homogenizing the binder slurry with the
MCC/disintegrant slurry to form a homogenized slurry;
and
[d] spray dry granulating the homogenized slurry to form
substantially homogeneous, substantially spherical particles of
excipient.
(Appeal Br. 15.)

The prior art relied upon by the Examiner is:
Name Reference Date
Erkoboni et al. US 5,725,886 Mar. 10, 1998
Gomi et al. US 2004/0043964 A1 Mar. 4, 2004
Rowe, Handbook of Pharmaceutical Excipients: Povidone, 508–513
(Pharmaceutical Press 2003)

2 Claims 1–6, 16–30, and 40–51 remain pending, but are drawn to a non-
elected invention. (Final Action 2; Appeal Br. 2.)
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The following grounds of rejection by the Examiner are before us on
review:
Claims 31–34 under 35 U.S.C. § 103(a) as unpatentable over
Erkoboni.
Claim 35 under 35 U.S.C. § 103(a) as unpatentable over Erkoboni and
Rowe.
Claims 7 and 37–39 under 35 U.S.C. § 103(a) as unpatentable over
Erkoboni, Rowe, and Gomi.
DISCUSSION
Appellant argues all the obviousness rejections together. Appellant,
however, does present an argument concerning the use of a rotary nozzle
(see Appeal Br. 12), which is only a limitation of independent claim 7, not
independent claim 31. We address representative claim 31 first and then
address the separate argument as to claim 7.
The Examiner finds that Erkoboni teaches a method of making a
particulate material in which a microcrystalline cellulose (MCC) is mixed
with an aqueous solution of a non-ionic hydrocolloid to form a well
dispersed slurry, which is then spray dried. (Final Action 4.) The Examiner
further finds that Erkoboni teaches the hydrocolloid can be “at least one of
hydroxypropylmethylcellulose (HPMC, binder), polyvinylpyrollidone (a
known disintegrant and binder, claim 1), hydroxypropyl cellulose, and
methylcellulose.” (Id.) In addition, the Examiner notes that Erkoboni’s
Example 2 provides a specific homogenized particle that includes HPMC
with MCC, where the HPMC was added to water, which was then added to
the MCC before homogenizing the two together. (Id.)
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The Examiner recognizes that Erkoboni “does not expressly teach the
step of combining the microcrystalline cellulose with PVP” but it “does
expressly teach and claim the inclusion of PVP - and exemplifies forming
the HPMC solution and the microcrystalline cellulose slurry prior [to]
combining them.” (Id. at 5.) Thus, the Examiner concludes that “inclusion
of the PVP in either the MCC or the HPMC solution prior to combining the
two slurries/solutions is prima facie obvious” and that there would have been
a “reasonable expectation of success absent evidence of criticality for the
specific order of steps claimed (step of PVP being in the MCC slurry over
the HPMC solution) of new/unexpected results.” (Id.)
We agree with the Examiner’s findings and conclusion of
obviousness.
Erkoboni teaches mixing MCC with an aqueous hydrocolloid, and it
indicates that the hydrocolloid can be HPMC or PVP or both. (Erkoboni
2:60–3:5, 3:17–35; see also id. at 6:5–14 (claim 1).) Erkoboni teaches that
where the hydrocolloid is viscous such that it is difficult to produce a
flowable slurry, the hydrocolloid can be used as a more dilute solution. (Id.
at 3:43–46.) Additionally, Erkoboni teaches “[a]fter the blending [of the
slurry of MCC with the aqueous solution of the nonionic hydrocolloid] is
complete, the slurry is dried, preferably by spray drying” and that
“[c]onventional spray drying equipment and operating procedures are
employed.” (Id. at 3:47–49.)
Erkoboni does not teach combining MCC with a hydrocolloid to form
one slurry and then combining that slurry with a second hydrocolloid slurry.
Nevertheless, Erkoboni does suggest that all three ingredients can be
combined together in two different slurries and homogenized to form a
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uniform dispersion where the hydrocolloid materials “become intimately
associated” with the MCC in a slurry. (Id. at 3:30–32, 2:60–3:5 (noting a
number of compounds that are suitable as hydrocolloids), 6:5–14 (claim 1
(noting that the hydrocolloid is “selected from at least one of the group
consisting of methylcellulose, hydroxypropyl methylcellulose,
hydroxypropyl cellulose, and polyvinylpyrollidone”)).) In light of all of the
teachings noted, we conclude that, absent evidence of new or unexpected
results, the order of steps of mixing HPMC, MCC, and PVP would have
been obvious to one of ordinary skill in the art, e.g., providing PVP in the
MCC slurry first and then combining with an HPMC aqueous slurry, which
slurries are then homogenized. In re Burhans, 154 F.2d 690, 692 (CCPA
1946) (selection of any order of performing process steps is prima facie
obvious in the absence of new or unexpected results). For this reason, we do
not find Appellant’s argument that the references do not teach the exact
claimed method (Appeal Br. 10–11; Reply Br. 2) persuasive of non-
obviousness.
Appellant does not provide any evidence of new or unexpected
properties of the claimed invention against the closest prior art, i.e.,
Erkoboni. Rather, Appellant merely asserts that “the art has not yielded
results as disclosed in the present application” “which display the
unexpected results of the claimed method” (Appeal Br. 11) and that the
excipient is improved (id. at 12 (citing Spec. 9); see also Reply Br. 2–3).
“To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention.” Bristol-Myers
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Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
Moreover, “[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)).
Furthermore, “[a]ttorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
The Specification states that there are structural differences between
the excipient produced by the claimed process and the traditional excipients,
Prosolv and Ludipress. (Spec. ¶ 44.) However, there is no evidence that
either of those traditional excipients are the composition that includes MCC
and a hydrocolloid as produced by the process set forth in Erkoboni.
Moreover, the compositions that the Specification refers to as
“denot[ing]” a structural difference are not one made by the process recited
in the claims. In particular, the Specification relies on Figures 1 and 2 as
demonstrating the homogeneous structure. (Id.) Figure 1 illustrates a
composition “produced according to Example 1” and Figure 2 illustrates a
composition “produced according to Example 2.” (Id. ¶¶ 26–27.) Examples
1 and 2 of the Specification describe the process of making an MCC-
HPMC- crospovidone excipient “according to the present invention” in
which powdered MCC was converted into a slurry, and HPMC was
combined with crospovidone which together was converted into a slurry.
(Id. ¶¶ 65–66 (Example 1), 70–71 (Example 2).) Then the MCC was added
to the HPMC-crospovidone slurry. (Id.) The claimed process, however,
requires mixing MCC as a slurry with a disintegrant slurry and then mixing
that combination with a viscous binder slurry. Example 3 of the
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Specification is the sole exemplification of the claimed method. (Id. ¶¶ 74–
75.) Examples 1 and 2 of the Specification employ the process of
combining MCC and the hydrocolloid ingredients set forth in Erkoboni,
where the hydrocolloid includes more than one compound.
Furthermore, while the Specification compares characteristics (id.
¶¶ 83–85 (Example 6 (characteristic comparisons)), ¶¶ 89–93 (Example 8
(characteristic comparisons)) including the flowability index of an excipient
made by Examples 3 and 1 of the Specification and a composition that is
said not to be made according to the invention, i.e., Example 4 of the
Specification that combines dry MCC, HPMC, and crospovidone all of
which are mixed together prior to the addition of water (id. ¶¶ 78–79
(Example 4)), Example 4 is not the method that Erkoboni teaches.
Moreover, Appellant does not provide evidence indicating the other
excipients tested for their compressibility index (id. ¶¶ 90–91 (Emcocel,
Avicel PH 102, and Prosolv 90) are made by the process described in
Erkoboni. In fact, these other excipients appear to be simply MCC that is
not combined with another polymer ingredient. (Id. ¶ 91 (Table 7).)
Consequently, Appellant’s argument does not establish that the properties
described in the Specification are new or unexpected compared to the closest
prior art.
Furthermore, we do not find Appellant’s argument that “[t]he
compositions of Erkoboni are not ready-to-use excipients as presently
claimed, but are composition[s] used to make such excipients” (Appeal Br.
12) persuasive. That is because Erkoboni suggests making a particle having
all of the claimed ingredients required by claim 31 and using a similar
process, where Appellant has not established unexpected results in the order
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of combining the slurries. How the spray dried particles are used thereafter
is irrelevant to the claimed method of making the particles.
Appellant also argues that Erkoboni “does not use a rotary nozzle at
the claimed RPM[, and, therefore] there is no indication that the process
disclosed in Erkoboni would formulate an excipient having the improved
properties disclosed and wherein the microcrystalline cellulose and binder
are indistinguishable when viewed with a SEM.” (Appeal Br. 12.) We do
not find this argument persuasive as to claim 31, which simply requires
spray drying the homogenized slurry. As discussed above, Erkoboni does
teach spray drying a homogenized slurry and Appellant has not provided
evidence to establish Erkoboni’s composition does not have the properties
disclosed in the Specification and argued by Appellant as being improved,
nor does Appellant establish that there is a structural difference, i.e., that the
ingredients that make up the Erkoboni MCC hydrocolloid spray dried
material are distinguishable when viewed with a SEM. It is noted that the
PTO does not have the facilities to perform tests on the prior art. In re Best,
562 F.2d 1252, 1254–55 (CCPA 1977) (“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.”). Nor does Appellant provide any
scientific argument why Erkoboni’s composition would not have the alleged
“improved properties disclosed” or be a composition in which “the
microcrystalline cellulose and binder are indistinguishable when viewed
with a SEM.” (Id.)
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For the foregoing reasons, we affirm the Examiner’s rejection of
claims 31–34 under 35 U.S.C. § 103(a) as unpatentable over Erkoboni, and
claim 35 under 35 U.S.C. § 103(a) as unpatentable over Erkoboni and Rowe.
Claim 7
All of the foregoing applies to claim 7 as well, except for the fact that
claim 7 does require spray drying using a rotary nozzle. However, in this
regard, we note that the Examiner relies on Gomi for the obviousness of
using such a mechanism. In particular, the Examiner states:
Gomi et al. teaches that known machines used for spray
drying include pressure nozzles (also known as single nozzle)
and rotary disks (also known as rotary nozzles or
rotary/centrifugal/spinning disk atomizers). Gomi et al. also
teaches that rotary disk speed range from 500-30,000 RPM and
that these machines are known to be useful for spray drying
cellulose particles [paragraph 43-44] (microcrystalline
cellulose, same field of endeavor).
(Final Action 8–9.) The Examiner further explains that Erkoboni “does
teach spray drying for the method . . . and teaches that conventional spray
drying equipment and operating procedures are employed for the method
(Page 7 line 33-35).” (Id. at 8.) The Examiner concludes, in light of these
teachings, that one of ordinary skill in the art would have been motivated to
substitute a functionally equivalent spray dryer, taught in Gomi, in the
method of Erkoboni with a reasonable expectation of success and found it
obvious to optimize the nozzle speed within the claimed range with a
reasonable expectation of success absent evidence of the criticality of these
features. (Id. at 9.) We agree with the Examiner that substituting one
known equivalent for another in the Erkoboni process would have been
obvious as would the determination of the optimum speed to operate the
rotary nozzle through routine experimentation. (Final Action 9; Ans. 6.)
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We do not find Appellant’s argument that Gomi “teaches away from
the processes of the presently claimed invention since it warns against”
“[t]he bulk density of the excipient made by the presently claimed method
[which] is in the range of 0.1 – 0.4 g/cc, which is clearly stated by Gomi as
an undesirable density range” (Appeal Br. 13). First, as the Examiner states
Gomi is relied upon “merely to address that spray drying machines are
known to include pressure nozzles (single nozzle) and rotary disks that have
a disk speed range of 500-30,000 RPM and are known to be useful for spray
drying cellulose particles.” (Ans. 6.) That Gomi might teach its MCC
particles for the purposes described therein to be at a lower density does not
address the obviousness of using the claimed rotary disk in Erkoboni’s
process to make the particles described for use therein. Second, Appellant’s
claim does not recite any limitation as to density.
Thus, we also affirm the Examiner’s rejection of claims 7 and 37–39
under 35 U.S.C. § 103(a) as unpatentable over Erkoboni, Rowe, and Gomi.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
31–34 103(a) Erkoboni 31–34
35 103(a) Erkoboni, Rowe 35
7, 37–39 103(a) Erkoboni, Rowe,
Gomi
7, 37–39
Overall
Outcome
7, 31–35,
37–39

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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) (2018).
AFFIRMED